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Document 52013SC0497
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union
/* SWD/2013/0497 final */
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Seventh Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union /* SWD/2013/0497 final */
COMMISSION STAFF WORKING DOCUMENT Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh Report on the Statistics on the Number of Animals used for Experimental
and
other Scientific Purposes in the Member States of the European Union I. INTRODUCTION The objective of this report is to present
statistical data on the number of animals used for scientific purposes in the
Member States of the European Union during the year 2011(*) in accordance with
provisions of Article 26 of Directive 86/609/EEC of 24 November 1986 [1] regarding the protection of animals used for experimental and other
scientific purposes. The first two statistical reports drafted
in accordance with the provisions of the above mentioned directive which were
published in 1994[2]
and 1999[3],
covering data on experimental animals collected in 1991 and 1996 respectively,
allowed only a limited amount of statistical analysis due to the absence of a
consistent system of reporting the data on the use of experimental animals. In
1997 an agreement was reached between the competent authorities of the Member
States and the Commission to submit data for future reports under a format of
eight harmonized tables. The Fifth Statistical report published in 2007[4] contained for the first
time data collected in the 10 Member States which joined the EU in 2004. The
Sixth Statistical Report published in 2010[5]
gave an overview of the number of animals used in the year 2008 in 27 Member
States. This Seventh Statistical Report contains
the results of the data collected by all 27 Member States in 2011 with the
exception of one (France) which provided data from 2010. The Commission Staff Working Document
accompanies the Report from the Commission to the Council and the European
Parliament – Seventh Report on the Number of Animals used for Experimental and
other Scientific Purposes in the Member States of the European Union. The
report summarises the data and conclusions presented in this document. (*) Except for one Member State reporting for 2010 II. DATA
SUBMITTED AND GENERAL
ASSESSMENT II.1. Data
submitted by the Member States As in 2008 all 27 Member States submitted
the data in the agreed format of the eight EU Tables, referred to as table 1 to
8 hereunder. A quality control check has been carried
out on the set of data submitted for 2011 that is essentially governed by five
criteria based on certain relationships between the data in the different
tables. –
The first of these relationships concerns the
total number of animals used by species of column 1.2 of table 1 and of column
2.10 of table 2. Since both tables concern the total of animals used by species
the totals of the tables 1 and 2 should be identical. –
The second relationship concerns column 2.6 of
table 2 'animals used for toxicological and other safety evaluation' which is
broken down into types of products/endpoints in table 3; into Regulatory
requirements in table 6; and into types of toxicological tests in table 7.
Therefore, the totals of column 2.6 must be equal to the totals of tables 3, 6,
7 and in addition table 8 'type of tests versus products'. –
The third relationship is that the sum of column
2.4 and 2.5 of table 2 must be equal to the total of table 5. –
The fourth relationship exists between the total
row of table 3 and the total column of table 8. Both the row and the column
concern the total number of animals used for toxicological and other safety
test by type of products/procedure and should therefore be equal. –
In the fifth relationship, the total row of table
7 should be equal to the total row of table 8. The
first and last two criteria have not been fully respected in the most recent
collection of data by some Member States and could unfortunately not be
corrected in time for the start of the analysis for this report. Despite these
marginal errors, the data provided by the Member States give a consistent basis
for a sound statistical analysis of all eight EU Tables. II.2. General
assessment Each Member State is requested, pursuant to
Article 13 of Directive 86/609/EEC, to submit to the Commission the statistical
data on the animals used for experimental and other scientific purposes. The
data for this report covers the
year 2011 with the exception of France which provided data from 2010. Council Resolution 86/C331/02 of the
representatives of the Governments of the Member States of the European
Communities, meeting within the Council of 24 November 1986 regarding the
protection of animals used for experimental and other scientific purposes[6] allowed the use of
animals in experiments for education and training, but where the purposes of
such experiments were not covered by the Directive, Member States according to
the Resolution applied national provisions which are no less severe than those
of the Directive. Therefore, when reporting a number of Member States have also
included animals covered by the Resolution in the report. It should be noted that this is the last
time that animal use data has been collected in accordance with the requirements
of Directive 86/609/EEC. This Directive has been replaced by Directive
2010/63/EU on the protection of animals used for scientific purposes, and the
submission and publication of data have been completely revised with effect
from 10 May 2013. The first part of this report aims at
providing a comprehensive overview on the numbers of animals used for various
experimental purposes in the Community in 2011. The purposes of the use of
animals have been analysed, and some of these purposes have been broken down
further into more precise parameters. It also considers different legislative
requirements regarding the use of experimental animals and the type of testing
carried out on different species. Due to differences in the reporting year
and an increase in the number of Member States over the years, it is not
possible to draw accurate quantitative conclusions on the evolution of the use
of animals for experimental purposes in the EU. However, some trend comparisons
have been made, and any significant changes in use have been highlighted in the
report. The second part of this report provides the
individual data from the Member States together with the respective comments. In the EU, the
total number of animals used for experimental and other scientific purposes from
the data collected in 2011 in accordance with the provision of the Directive
for this report is just under 11,5 million (with data from France from 2010). This
is a reduction of over half a million animals in the EU since the previous
report covering the year 2008. The Member States contributing with a biggest
net reduction include Belgium, France, Italy, Sweden and UK. In addition, credit should be given to some of the other Member States using smaller numbers of
animals, however, with a significant drop in percentage terms. As in previous reports rodents and rabbits
represent 80% of the total number of animals used in the EU. Mice are by far
the most commonly used species accounting for 61% of the total use, followed by
rats with 14%. The second most
used group of animals was, as in previous years, cold-blooded animals which
represent almost 12,5%. The third largest group of animals used was birds with
5,9% of the total use. As stated in the previous three statistical
reports no ‘Great Apes’ were used in experiments in the
EU in 2011. II.3. Structure of the Report The report is divided into two parts: A A
global compilation and overview for the European Union of the statistical data
of the Member States for 2011.
A consolidated table has been computed on the basis of
the data submitted and is presented at the end of each chapter. Each table is
illustrated by a graphical presentation to give a more readable overview of the
EU situation.
As France submitted data from 2010 the totals used in this report are a mixture
of years. Comparisons were nevertheless made on this basis since no other data
were available.
The numbering of tables and graphical presentation in Part A of the report are
linked to the numbers of the EU tables and not to the numbering of the chapters
of the report. B Contains the data submitted by each Member State with Member State comments.
PART A: COMPILATION AND OVERVIEW OF THE
DATA OF 2011 III.1. Results
of EU Table 1: Species and number
of animals Two types of information can be drawn from
the data submitted in EU Table 1. The first relates to the total number of
animals subdivided into 25 species used by the Member States. The second type
of information relates to the place of origin of the animals used for experimental
or other scientific purposes. III.1.1. The data on the total
number of animals used in the Member States Table 1.1 of this report presents the
consolidated data on the number of animals used by species. The total number of animals used in 2011 in
the 27 Member States amounts to
11 481 521 animals. It is important to note that the total number of animals
used in 2011 has decreased by over 500 000 (4.3%) animals in comparison to 2008.
III.1.2. Treatment and
interpretation of the data of table 1.1 In order to present an overall evaluation
and subsequently a graphical analysis, animal species were grouped in classes.
The result of this exercise is presented in table 1.2 at the end of this
chapter. This grouping in table 1.2 allows an overview of the species used as
is illustrated in figure 1.1. It should also be pointed out that re-used
animals are not included in the figures so that animals are not counted twice.
Rodents together with rabbits represent 80%
of the total number of animals used. Mice (60,9%) and rats (13,9%) are by far
the most commonly used species. The second most used group is represented
by cold-blooded animals namely reptiles, amphibians and fish at 12,4%. Birds is the next highest animal group used
for experimental purposes at 5,9%. The Artiodactyla and Perissodactyla
group including horses, donkeys and cross-bred animals (Perissodactyla),
pigs, goats, sheep and cattle (Artiodactyla) represent only 1,2% of the
total number of animals used in the Member States. Carnivores represent 0,25% of the total
number of animals used and non-human primates represent 0,05% of the animals
used in 2011. III.1.3. Comparison
with the data of the previous reports In this chapter, and the following chapters
dealing with comparisons, it should be noted that in 1996, 2002, 2005, 2008 and
for this report France reported data respectively for 1997, 2001, 2004, 2007 and
2010 which does not allow a rigorous comparison between data reported for each
year. Nevertheless, assuming that fluctuations in the annual numbers of animals
used per species in a country are limited, it is possible to make
semi-quantitative estimates of the trends by comparing changes in proportions
of use, expressed as a percentage. Comparison between proportions of classes of animals used
in 1996, 1999, 2002, 2005, 2008 and 2011 Class of species || 1996(*) || 1999 || 2002(**) || 2005(***) || 2008(****) || 2011(*****) % Rodents-rabbits || 81,3 || 86,9 || 78,0 || 77,5 || 82,2 || 80,0 % Cold-blooded animals || 12,9 || 6,6 || 15,4 || 15, || 9,6 || 12,4 % Birds || || 4,7 || 5 || 5,4 || 6,4 || 5,9 % Artio and Perissodactyla || || 1,2 || 1,2 || 1,1 || 1,4 || 1,2 (*)
14 Member States reporting for 1996, one for 1997 (**) 14 Member States reporting for
2002, one for 2001 (***) 24 Member States reporting for
2005, one for 2004 (****) 27 Member States reporting for
2008, one for 2007 (*****) 27 Member States reporting for 2011,
one for 2010 The percentage of rodents and rabbits shows
some fluctuation, but remains close to 80%. The proportion of cold-blooded
animals used in 1996, in 2002, in 2005 and 2008 is between 9,6 to 15%. However,
in 1999 a much lower percentage of 6,6% was observed. In 2011, the use of
cold-blooded animals increased from the last report but the percentage of
animals used seems to fit perfectly into the cohort from 9,6 to 15% of the
total number of animals. Birds representing the third largest
percentage of animals, seem to have reached a plateau in 2008. For the first
time in 2011 the number of birds has decreased (by over
88 000). The group of horses, donkeys and cross-bred animals (Artiodactyla)
and pigs, goats, sheep and cattle (Perissodactyla) fluctuates at around
1%. The effect of the inclusion of the data of
new Member States since 2005 i.e. Bulgaria and Romania, did not lead to an
increase in the total number of animals, on the contrary, there was already a
decrease reported in 2008 and for 2011 the decrease has continued (by more than
500 000 animals). However, the use of some individual species has increased.
This is displayed in Table 1.0 below. Table 1.0 contains a comparison of the
change that has taken place since 2008 for each species, expressed by number of
animals per species, between EU 27 (data from 2011) and EU 27 (data from 2008)
(first three columns) and in percentage per species (fourth column). Table 1.0: Changes in species number and proportion
between 2008 and 2011 Species || Number of animals in EU 27 2008 || Number of animals in EU 27 2011 || Change since 2008 || % change by species 1.a Mice (Mus musculus) || 7122188 || 6999312 || -122876 || -1,73 1.b Rats (Rattus norvegicus) || 2121727 || 1602969 || -518758 || -24,45 1.c Guinea-Pigs (Cavia porcellus) || 220985 || 171584 || -49401 || -22,35 1.d Hamsters (Mesocricetus ) || 32739 || 25251 || -7488 || -22,87 1.e Other Rodents (other Rodentia) || 39506 || 28465 || -11041 || -27,95 1.f Rabbits (Oryctolagus cuniculus) || 333213 || 358213 || 25000 || 7,50 1.g Cats (Felis catus) || 4088 || 3713 || -375 || -9,17 1.h Dogs (Canis familiaris) || 21315 || 17896 || -3419 || -16,04 1.i Ferrets (Mustela putorius furo) || 3208 || 2540 || -668 || -20,82 1.j Other Carnivores || 2853 || 4982 || 2129 || 74,62 1.k Horses, donkeys and cross- breds (Equidae) || 5976 || 6686 || 710 || 11,88 1.l Pigs (Sus) || 92813 || 77280 || -15533 || -16,74 1.m Goats (Capra) || 3840 || 2907 || -933 || -24,30 1.n Sheep (Ovis) || 30190 || 28892 || -1298 || -4,30 1.o Cattle (Bos) || 33952 || 30914 || -3038 || -8,95 1.p Prosimians (Prosimia) || 1261 || 83 || -1178 || -93,42 1.q New World Monkeys (Ceboidea) || 904 || 700 || -204 || -22,57 1.r Old World Monkeys (Cercopithecoidea) || 7404 || 5312 || -2092 || -28,25 1.s Apes (Hominoidea) || 0 || 0 || 0 || 0,00 1.t Other Mammals (other Mammalia) || 5704 || 7888 || 2184 || 38,29 1.u Quail (Coturnix coturnix) || 9626 || 5614 || -4012 || -41,68 1.v Other birds (other Aves) || 754485 || 669451 || -85034 || -11,27 1.w Reptiles (Reptilia) || 4101 || 3824 || -277 || -6,75 1.x Amphibians (Amphibia) || 61789 || 29583 || -32206 || -52,12 1.y Fish (Pisces) || 1087155 || 1397462 || 310307 || 28,54 1.z TOTAL || 12001022 || 11481521 || -519501 || -4,33 There is a clear increase in the total numbers
of five species out of the 25 species reported. For other species a net
decrease is observed. The changes per species are reported in
table 1.0 under the last column 'percentage change by species' and in the column
'change since 2008' reflecting the magnitude of the change. The highest increase is noted for fish used
in comparison to 2008 (310 307). There has been a significant proportional increase
in the number of rabbits since 2008 (25 000). For species used in lower numbers (i.e. in
the thousands range) there is an increase in the number of animals in the
category other carnivores (2 129), horses, donkeys and cross-breds (710) and other
mammals (2 184). The largest decrease observed in 2011 for
species used in greater numbers (i.e. in the millions range) is for rats with a
reduction of more than 500 000 animals. In the same range there is also a
reduction in the use of mice (122 876). There is also a significant reduction in
the use of 'other birds' (more than 85 000) and guinea-pigs (49 401). There is a clear decrease in the use of
prosimians and non-human primates. The most notable proportional reduction is
in the use of prosimians (1 178) which represents a decrease of 94%. The total
number of new world monkeys is down from 904 in 2008 to 700 in 2011 (22,5%),
and use of old world monkeys has also decreased from 7 404 to
5 312 (28%). No use of great apes has been reported in EU
since in 1999. Member States submitted a break down of the
category 'other', for the following species: Other Rodents: gerbils, old world jerboas (Jaculus jaculus); chinchillas, beavers,
ground squirrels, hamsters, grey dwarf hamsters (Cricetulus migratorius) and different species of mice. Other Carnivores: wild-life
species used for zoological and ecological studies e.g. foxes, badgers, seals,
otters and fitchew. Other Mammals: boars, bats and shrews, llamas, moles, European bison and red deer. Other
birds: mainly Japanese quail (coturnix japonica)
and bob-white quail, poultry species, and zebra finches, canary, parakeet,
parrot and farmed avian species for example, chickens (Gallus gallus
domesticus). Table 1.1: Total number of animals used for
experimental purposes in the EU Member States Data of
2011 (*) Species || AT || BE || BG || CY || CZ || DK || ET || FI || FR || DE || EL || HU || IE || IT || LV || LT || LU || MT || NL || PL || PT || RO || SP || SK || SI || SE || UK || Totals 1.a.Mice || 153153 || 408883 || 3819 || 1328 || 72855 || 141991 || 26048 || 73503 || 1326274 || 1451046 || 24354 || 143755 || 248958 || 515946 || 6300 || 2131 || 470 || 0 || 237784 || 95115 || 24399 || 44575 || 634912 || 8747 || 11133 || 185913 || 1155920 || 6999312 1.b.Rats || 9026 || 89547 || 2569 || 0 || 30829 || 67159 || 2556 || 18586 || 252589 || 312740 || 2266 || 70873 || 10476 || 155136 || 4020 || 1297 || 32 || 0 || 98881 || 38171 || 11290 || 5161 || 126406 || 5327 || 393 || 35202 || 252437 || 1602969 1.c. Guinea-Pigs || 3797 || 24300 || 3700 || 0 || 3304 || 4672 || 72 || 11 || 35543 || 24258 || 39 || 9228 || 545 || 13784 || 0 || 177 || 0 || 0 || 5493 || 8943 || 4 || 6607 || 13749 || 645 || 48 || 1151 || 11514 || 171584 1.d. Hamsters || 125 || 2435 || 516 || 0 || 119 || 178 || 120 || 201 || 8210 || 4187 || || 88 || 0 || 517 || 0 || 0 || 0 || 0 || 3632 || 278 || 6 || 263 || 1492 || 0 || 0 || 881 || 2003 || 25251 1.e .Other Rodents || 64 || 421 || || || 1316 || 115 || 0 || 2682 || 224 || 4111 || || 0 || || 1946 || || || || 0 || 979 || 11710 || 74 || || 80 || 17 || 0 || 1483 || 3243 || 28465 1.f. Rabbits || 15633 || 54001 || 822 || 0 || 7677 || 3602 || 3 || 357 || 125913 || 87303 || 701 || 7567 || 715 || 8392 || 0 || 274 || 0 || 0 || 6293 || 2198 || 102 || 2195 || 21302 || 299 || 234 || 710 || 11920 || 358213 1.g.Cats || 14 || 630 || 8 || 0 || 181 || 0 || 0 || 454 || 569 || 585 || 19 || 34 || 120 || 0 || 0 || 0 || 0 || 0 || 174 || 480 || || 0 || 229 || 10 || 0 || 34 || 172 || 3713 1.h.Dogs || 75 || 490 || 0 || 0 || 1386 || 470 || 0 || 2805 || 3032 || 2474 || 4 || 675 || 473 || 408 || 9 || 0 || 0 || 0 || 692 || 229 || 20 || 0 || 1252 || 0 || 0 || 530 || 2872 || 17896 1.i Ferrets || 12 || 192 || 0 || 0 || 193 || 129 || 0 || 0 || 351 || 96 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 852 || 0 || || 0 || 87 || 0 || 0 || 76 || 552 || 2540 1.j. Other Carnivores || 0 || 0 || || || 45 || 197 || 0 || 656 || 0 || 262 || || 0 || || 0 || || || || 0 || 430 || 2149 || || || 245 || || 0 || 256 || 742 || 4982 1.k. Horses, donkeys and cross-breds || 128 || 54 || || || 595 || 67 || 40 || 23 || 373 || 1140 || || 9 || 238 || 34 || || || || 0 || 2371 || 766 || || 14 || 346 || || 7 || 107 || 374 || 6686 1.l.Pigs || 1553 || 2622 || 110 || || 2283 || 8694 || 325 || 681 || 7364 || 15090 || 390 || 1278 || 286 || 2486 || || 19 || || 0 || 14686 || 1147 || 474 || 2 || 11046 || 84 || 13 || 2277 || 4370 || 77280 1.m Goats || 60 || 86 || || || 106 || 74 || 0 || 40 || 710 || 394 || || 0 || 39 || 34 || || || || 0 || 284 || 396 || 99 || || 455 || || 0 || 13 || 117 || 2907 1.n. Sheep || 683 || 542 || 320 || || 1147 || 191 || 0 || 684 || 5491 || 3287 || 8 || 160 || 348 || 243 || || || || 0 || 2600 || 379 || 29 || 131 || 2790 || 14 || 4 || 285 || 9556 || 28892 1.o.Cattle || 1582 || 810 || || || 783 || 513 || 6750 || 63 || 2362 || 4300 || || 5 || 1700 || 27 || || || || 0 || 2383 || 3489 || || 3 || 1464 || 0 || 0 || 370 || 4310 || 30914 1.p. Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 83 1.q. NW Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 163 || 191 || || 0 || 0 || 79 || 0 || 0 || 0 || 0 || 22 || 0 || || 0 || 1 || 0 || 0 || 0 || 244 || 700 1.r. OW Monkeys || 0 || 20 || 0 || 0 || 30 || 0 || 0 || 0 || 1564 || 1579 || || 7 || 0 || 371 || 0 || 0 || 0 || 0 || 184 || 0 || || 0 || 342 || 0 || 0 || 0 || 1215 || 5312 1.s Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t.Other Mammals || 0 || 64 || || || 2838 || 32 || 20 || 17 || 2 || 1154 || || 0 || 480 || 184 || || || || 10 || 41 || 594 || || || 56 || || 0 || 1625 || 771 || 7888 1.u.Quail || 0 || 651 || 0 || 0 || 230 || 0 || 0 || 0 || 122 || 2821 || || 235 || 0 || 4 || 0 || 0 || 0 || 0 || 68 || 1247 || || 9 || 105 || 88 || 0 || 0 || 34 || 5614 1.v.Other birds || 1940 || 16493 || 1080 || || 170261 || 3245 || 701 || 4426 || 71821 || 31271 || || 36304 || 503 || 29305 || || 20 || || 0 || 99354 || 13615 || 433 || 1196 || 21341 || 486 || 0 || 2804 || 162852 || 669451 1.w.Reptiles || 0 || 459 || || || 1258 || 237 || 0 || 15 || 74 || 1011 || || 0 || || 239 || || || || 0 || 133 || 15 || || || 0 || || 0 || 0 || 383 || 3824 1.x Amphibians || 176 || 2113 || 4285 || || 3989 || 115 || 0 || 73 || 3279 || 4453 || 220 || 725 || 21 || 894 || || 149 || || 0 || 1247 || 964 || 25 || || 1097 || || 0 || 1216 || 4542 || 29583 1.y.Fish || 3267 || 60266 || 30 || || 52771 || 51159 || 4400 || 30766 || 354039 || 119949 || || 5236 || 88 || 51786 || || || || 0 || 36034 || 100275 || 9601 || || 61330 || || 42 || 36108 || 420315 || 13974622 1.z.TOTAL || 191288 || 665079 || 17259 || 1328 || 354196 || 282840 || 41035 || 136043 || 2200152 || 2073702 || 28001 || 276179 || 264990 || 781815 || 10329 || 4067 || 502 || 10 || 514617 || 282160 || 46556 || 60156 || 900127 || 15717 || 11874 || 271041 || 2050458 || 11481521 (*) France is reporting for 2010 Table 1.2: Classes of animals used for experimental
purposes in the EU Member States Data of 2011 (*) Species || AT || BE || BG || CY || CZ || DK || ET || FI || FR || DE || EL || HU || IE || IT || LV || LT || LU || MT || NL || PL || PT || RO || SP || SK || SI || SE || UK || Totals Mice || 153153 || 408883 || 3819 || 1328 || 72855 || 141991 || 26048 || 73503 || 1326274 || 1451046 || 24354 || 143755 || 248958 || 515946 || 6300 || 2131 || 470 || 0 || 237784 || 95115 || 24399 || 44575 || 634912 || 8747 || 11133 || 185913 || 1155920 || 6999312 Rats || 9026 || 89547 || 2569 || 0 || 30829 || 67159 || 2556 || 18586 || 252589 || 312740 || 2266 || 70873 || 10476 || 155136 || 4020 || 1297 || 32 || 0 || 98881 || 38171 || 11290 || 5161 || 126406 || 5327 || 393 || 35202 || 252437 || 1602969 Guinea-Pigs || 3797 || 24300 || 3700 || 0 || 3304 || 4672 || 72 || 11 || 35543 || 24258 || 39 || 9228 || 545 || 13784 || 0 || 177 || 0 || 0 || 5493 || 8943 || 4 || 6607 || 13749 || 645 || 48 || 1151 || 11514 || 171584 Hamsters+ other rodents || 189 || 2856 || 516 || 0 || 1435 || 293 || 120 || 2883 || 8434 || 8298 || 0 || 88 || 0 || 2463 || 0 || 0 || 0 || 0 || 4611 || 11988 || 80 || 263 || 1572 || 17 || 0 || 2364 || 5246 || 53716 Rabbits || 15633 || 54001 || 822 || 0 || 7677 || 3602 || 3 || 357 || 125913 || 87303 || 701 || 7567 || 715 || 8392 || 0 || 274 || 0 || 0 || 6293 || 2198 || 102 || 2195 || 21302 || 299 || 234 || 710 || 11920 || 358213 Cold-blooded animals (1) || 3443 || 62838 || 4315 || 0 || 58018 || 51511 || 4400 || 30854 || 357392 || 125413 || 220 || 5961 || 109 || 52919 || 0 || 149 || 0 || 0 || 37414 || 101254 || 9626 || 0 || 62427 || 0 || 42 || 37324 || 425240 || 1430869 Birds (2) || 1940 || 17144 || 1080 || 0 || 170491 || 3245 || 701 || 4426 || 71943 || 34092 || 0 || 36539 || 503 || 29309 || 0 || 20 || 0 || 0 || 99422 || 14862 || 433 || 1205 || 21446 || 574 || 0 || 2804 || 162886 || 675065 Artio+Perissodactyla (3) || 4006 || 4114 || 430 || 0 || 4914 || 9539 || 7115 || 1491 || 16300 || 24211 || 398 || 1452 || 2611 || 2824 || 0 || 19 || 0 || 0 || 22324 || 6177 || 602 || 150 || 16101 || 98 || 24 || 3052 || 18727 || 146679 Carnivores || 101 || 1312 || 8 || 0 || 1805 || 796 || 0 || 3915 || 3952 || 3417 || 23 || 709 || 593 || 408 || 9 || 0 || 0 || 0 || 2148 || 2858 || 20 || 0 || 1813 || 10 || 0 || 896 || 4338 || 29131 Prosimians+monkeys+apes || 0 || 20 || 0 || 0 || 30 || 0 || 0 || 0 || 1810 || 1770 || 0 || 7 || 0 || 450 || 0 || 0 || 0 || 0 || 206 || 0 || 0 || 0 || 343 || 0 || 0 || 0 || 1459 || 6095 Other Mammals || 0 || 64 || || || 2838 || 32 || 20 || 17 || 2 || 1154 || || 0 || 480 || 184 || || || || 10 || 41 || 594 || || || 56 || || 0 || 1625 || 771 || 7888 TOTAL || 191288 || 665079 || 17259 || 1328 || 354196 || 282840 || 41035 || 136043 || 2200152 || 2073702 || 28001 || 276179 || 264990 || 781815 || 10329 || 4067 || 502 || 10 || 514617 || 282160 || 46556 || 60156 || 900127 || 15717 || 11874 || 271041 || 2050458 || 11481521 Species || AT || BE || BG || CY || CZ || DK || ET || FI || FR || DE || EL || HU || IE || IT || LV || LT || LU || MT || NL || PL || PT || RO || SP || SK || SI || SE || UK || Totals Mice || 80,06 || 61,48 || 22,13 || 100,00 || 20,57 || 50,20 || 63,48 || 54,03 || 60,28 || 69,97 || 86,98 || 52,05 || 93,95 || 65,99 || 60,99 || 52,40 || 93,63 || 0,00 || 46,21 || 33,71 || 52,41 || 74,10 || 70,54 || 55,65 || 93,76 || 68,59 || 56,37 || 60,96 Rats || 4,72 || 13,46 || 14,88 || 0,00 || 8,70 || 23,74 || 6,23 || 13,66 || 11,48 || 15,08 || 8,09 || 25,66 || 3,95 || 19,84 || 38,92 || 31,89 || 6,37 || 0,00 || 19,21 || 13,53 || 24,25 || 8,58 || 14,04 || 33,89 || 3,31 || 12,99 || 12,31 || 13,96 Guinea-Pigs || 1,98 || 3,65 || 21,44 || 0,00 || 0,93 || 1,65 || 0,18 || 0,01 || 1,62 || 1,17 || 0,14 || 3,34 || 0,21 || 1,76 || 0,00 || 4,35 || 0,00 || 0,00 || 1,07 || 3,17 || 0,01 || 10,98 || 1,53 || 4,10 || 0,40 || 0,42 || 0,56 || 1,49 Hamsters + other rodents || 0,10 || 0,43 || 2,99 || 0,00 || 0,41 || 0,10 || 0,29 || 2,12 || 0,38 || 0,40 || 0,00 || 0,03 || 0,00 || 0,32 || 0,00 || 0,00 || 0,00 || 0,00 || 0,90 || 4,25 || 0,17 || 0,44 || 0,17 || 0,11 || 0,00 || 0,87 || 0,26 || 0,47 Rabbits || 8,17 || 8,12 || 4,76 || 0,00 || 2,17 || 1,27 || 0,01 || 0,26 || 5,72 || 4,21 || 2,50 || 2,74 || 0,27 || 1,07 || 0,00 || 6,74 || 0,00 || 0,00 || 1,22 || 0,78 || 0,22 || 3,65 || 2,37 || 1,90 || 1,97 || 0,26 || 0,58 || 3,12 Cold-blooded animals (1) || 1,80 || 9,45 || 25,00 || 0,00 || 16,38 || 18,21 || 10,72 || 22,68 || 16,24 || 6,05 || 0,79 || 2,16 || 0,04 || 6,77 || 0,00 || 3,66 || 0,00 || 0,00 || 7,27 || 35,89 || 20,68 || 0,00 || 6,94 || 0,00 || 0,35 || 13,77 || 20,74 || 12,46 Birds (2) || 1,01 || 2,58 || 6,26 || 0,00 || 48,13 || 1,15 || 1,71 || 3,25 || 3,27 || 1,64 || 0,00 || 13,23 || 0,19 || 3,75 || 0,00 || 0,49 || 0,00 || 0,00 || 19,32 || 5,27 || 0,93 || 2,00 || 2,38 || 3,65 || 0,00 || 1,03 || 7,94 || 5,88 Artio+Perissodactyla (3) || 2,09 || 0,62 || 2,49 || 0,00 || 1,39 || 3,37 || 17,34 || 1,10 || 0,74 || 1,17 || 1,42 || 0,53 || 0,99 || 0,36 || 0,00 || 0,47 || 0,00 || 0,00 || 4,34 || 2,19 || 1,29 || 0,25 || 1,79 || 0,62 || 0,20 || 1,13 || 0,91 || 1,28 Carnivores || 0,05 || 0,20 || 0,05 || 0,00 || 0,51 || 0,28 || 0,00 || 2,88 || 0,18 || 0,16 || 0,08 || 0,26 || 0,22 || 0,05 || 0,09 || 0,00 || 0,00 || 0,00 || 0,42 || 1,01 || 0,04 || 0,00 || 0,20 || 0,06 || 0,00 || 0,33 || 0,21 || 0,25 Prosimians+monkeys+apes || 0,00 || 0,00 || 0,00 || 0,00 || 0,01 || 0,00 || 0,00 || 0,00 || 0,08 || 0,09 || 0,00 || 0,00 || 0,00 || 0,06 || 0,00 || 0,00 || 0,00 || 0,00 || 0,04 || 0,00 || 0,00 || 0,00 || 0,04 || 0,00 || 0,00 || 0,00 || 0,07 || 0,05 Other Mammals || 0,00 || 0,01 || 0,00 || 0,00 || 0,80 || 0,01 || 0,05 || 0,01 || 0,00 || 0,06 || 0,00 || 0,00 || 0,18 || 0,02 || 0,00 || 0,00 || 0,00 || 100,00 || 0,01 || 0,21 || 0,00 || 0,00 || 0,01 || 0,00 || 0,00 || 0,60 || 0,04 || 0,07 TOTAL || 100,00 || 100,00 || 100,00 || 100,0 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,0 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || 100,00 || FR(*) France reporting for 2010 || || (1) Reptiles + amphibians + fish || || (2) Quails and Other birds || || (3) Horses, donkeys, and cross-breds + pigs + goats and sheep + cattle || || (4) Cats + dogs + ferrets + other carnivores || III.2. Results
of EU Table 1: Origin of animals used III.2.1. The data on the origin of
the species The consolidated results of EU Table 1 on
the origin of some selected species used for experimental purposes in the 27
Member States are reported in table 1.3 at the end of this chapter. The
consolidated table 1.3 only indicates species for which the origin must be
reported. In addition, EU Table 1 contains
information on the number of animals re-used in experiments. III.2.2. Treatment and
interpretation of the data The data of column 1.3 and 1.4 of table 1.3
of this report have been grouped to represent animals coming from the European
Union. Figure 1.2 represents the percentage of
animals from the reported origin versus the species. The chart indicates that the majority of
species used in 2011 originate from EU breeding centres. However, certain
species such as cats, dogs, ferrets and old world monkeys originated from both
EU and non-EU breeding centres. III.2.3. Comparison with data of
the previous year The general pattern shown in figure 1.2 on
the origin of species remains rather similar to that of previous reports, with clear
preference for animals which are bred in the EU. There is an increase in the
use of dogs of EU origin from 72% to 85%, ferrets from 71% to 76% and old world
monkeys from 54% to 66%. However, there is a decrease in use of new world
monkeys from 99% to 92% and quails from 96% to 87% bred in the EU. Table 1.3: NUMBER OF ANIMALS USED IN RELATION TO THEIR
PLACE OF ORIGIN Data of 2011 (*) 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals || 1.a. Mice (Mus musculus) || 6999312 || 5651922 || 900047 || 274313 || 173030 || 3768 || 1.b. Rats (Rattus norvegicus) || 1602969 || 1253176 || 322045 || 13051 || 14697 || 3035 || 1.c. Guinea-Pigs (Cavia porcellus) || 171584 || 120124 || 47311 || 3922 || 227 || 962 || 1.d. Hamsters (Mesocricetus ) || 25251 || 18626 || 4676 || 0 || 1949 || 54 || 1.f. Rabbits (Oryctolagus cuniculus) || 358213 || 336922 || 17009 || 1200 || 3082 || 15958 || 1.g. Cats (Felis catus) || 3713 || 2299 || 379 || 34 || 1001 || 1181 || 1.h. Dogs (Canis familiaris) || 17896 || 12246 || 3025 || 292 || 2333 || 4178 || 1.i. Ferrets (Mustela putorius furo) || 2540 || 1035 || 893 || 40 || 572 || 64 || 1.p. Prosimians (Prosimia) || 83 || 83 || 0 || 0 || 0 || 33 || 1.q. New World Monkeys (Ceboidea) || 700 || 630 || 19 || 0 || 51 || 322 || 1.r. Old World Monkeys (Cercopithecoidea) || 5312 || 1698 || 1813 || 5 || 1796 || 1492 || 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 1.u. Quail (Coturnix coturnix) || 5614 || 4914 || 0 || 0 || 700 || 0 || 1.z. TOTAL || 9193187 || 7403665 || 1297217 || 292857 || 199445 || || *
France reporting
for 2010 Note
1: Column 1.5 concerns only those Member Countries of the Council of Europe
which, at the beginning of the reporting period, are Parties to the Convention
ETS 123. Thus an updated list of those countries has to be used when filling
this column Note
2: Only species for which the origin has to be reported are included in this
table. Note
3: The number of re-used animals in column 1.7 should be excluded from the
total in column 1.2. III.3. Results
of EU Table 2: Purposes of the experiments III.3.1. The data on purposes of
the experiments The consolidated data on purposes of the
experiments of the 27 Member States are presented in table 2.1 at the end of
this chapter. III.3.2. Treatment and
interpretation of the data Table 2.2 presents the results of the
consolidated data of the purposes of the procedures carried out in the 27
Member States in 2011. In order to facilitate the presentation of results some
species and some purposes were grouped in table 2.2. The percentage of the number of animals
used for selected purposes is presented in figure 2.1. More than 60% of animals were used for research
and development in the fields of human medicine, veterinary medicine, dentistry
and in biological studies of fundamental nature. Production and quality control of products
and devices in human medicine, veterinary medicine and dentistry required the
use of 14% of the total number of animals. Toxicological and other safety evaluation
represents 8,75% of the total number of animals used for experimental purposes.
Other purposes of procedures represents 9%
of the total number of animals and covers a wide range of experiments such as
virology, immunology for production of monoclonal and polyclonal antibodies,
physiology of foetal-maternal interaction in mouse gene transgensis,
oncological treatment, pharmaceutical research and development, combined drug
testing and genetics. III.3.3. Comparison
with the data of the previous report The comparison aims to detect changes in
trends rather than draw formal conclusions. The most significant change since
2008 is that the number of animals used for research and development for human
medicine, dentistry and veterinary medicine has dropped, as it did between 2005
and 2008. This time the drop is from 22,8% to 18,8% (in terms of animal numbers
the decrease is 575 518 animals). There is a reduction
of more than
62 000 fish and 41 500 'other birds' whereas the percentage of animals
used for fundamental biological research has increased sharply from 38% to 46%
(715 519 animals). Both fundamental biological research and research and
development in human and veterinary medicine are the areas using by far the
highest number of animals in the EU. The number of animals used for
toxicological and other safety evaluation amounts to 8,75% of the total. This
represents 1 004 873 animals in this report. The decrease in the numbers of animals used
for toxicological and other safety evaluations since the report of 2008 is modest
but represents nevertheless 37 280 animals. The percentage of animals used for
toxicology and safety evaluation was 9.9% in 2002, 8,2% in 2005, 8,7% in 2008
and 8,75% for this report which indicates a trend of stability for this area of
use. The number of animals used for production
and quality control of devices for medicine, veterinary medicine and dentistry
has gone down by approximately 192 000. In spite of the overall decrease, the
use of rabbits has increased by more than 81 000 animals for production and
quality control of products and devices for human medicine and dentistry. Further substantial increases since 2008 have
been observed for mice (521 000) and fish (324 000) used in larger numbers for
fundamental biological studies. There is also an increase in the use of fish
(above 83 000) and birds (above 10 000) for 'other experiments'. Regarding the increase of mice for
biological studies of fundamental nature, Member States indicated that it was
due to an increase in developmental assays and research using transgenic mice as specific
models for e.g. ocular research, bone metabolism and fertility. The type of studies include LD50, ED50,
potency testing and immunogenicity testing, studies in the area of
neuroscience, of immunology, studies on physiopathological mechanisms of
tumours and research to gain experience for the determination of mechanisms of
action of diseases for therapeutic purposes. The increase use of fish in area of
fundamental research was attributed to studies on fish production, genetics, bio-molecular studies, cancer research, physiopathology
and diagnosis. Fish have also been used for neurology, cardiovascular
studies and in selection according to bioenergetic
properties of their cardiac cells. Fish increase in the category of 'other
experiments' was attributed to single testing of biocides and to telemetric
monitoring of some common species in the environment. Fish are also exclusively
used under this heading by some Member States for vaccine studies. Table 2.2 Number of animals used for
selected purposes versus species Species || Biological studies of a fundamental nature || Research, development and quality control of products and devices for human medicine and dentistry and for veterinary medicine || Toxicological and other safety evaluations (including safety evaluation of products) || Diagnosis of disease || Education and training || Other || Total Mice || 3602370 || 2350205 || 464850 || 135042 || 82167 || 364381 || 6999015 Rats || 491345 || 725109 || 272581 || 18295 || 48152 || 47589 || 1603266 Other rodents || 36159 || 145153 || 28569 || 4527 || 4234 || 6658 || 225300 Rabbits || 12648 || 253488 || 23185 || 6083 || 2068 || 60741 || 358213 Carnivores || 8733 || 8706 || 7873 || 1905 || 1149 || 798 || 29164 Artio+Perissodactyla || 51876 || 48240 || 5221 || 7558 || 14297 || 19454 || 146646 Prosimians+monkeys+apes || 631 || 1375 || 3435 || 0 || 209 || 445 || 6095 Other mammals || 6822 || 773 || 179 || 53 || 26 || 35 || 7888 Birds || 294768 || 191575 || 17202 || 7480 || 3025 || 161015 || 675065 Cold-blooded animals || 785221 || 31373 || 181778 || 4314 || 24654 || 403529 || 1430869 TOTAL || 5290573 || 3755997 || 1004873 || 185257 || 179981 || 1064645 || 11481521 Figure 2.2 presents the number of animals
used for selected purposes by classes of species. The highest number of mice and rats used is
attributed to biological studies of a fundamental nature and research,
development and quality control of products and devices for medicine, dentistry
and veterinary medicine. There has been an increase in the number of
cold-blooded animals (essentially fish) used for other purposes and also for
biological studies of fundamental nature since 2008. Table 2.1: Number of
animals used in experiments for selected purposes
Purposes versus species
data of 2011* 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10. Total 1.a. Mice (Mus musculus) || 3602370 || 1458291 || 781514 || 110400 || 464850 || 135042 || 82167 || 364381 || 6999015 1.b. Rats (Rattus norvegicus) || 491345 || 549341 || 157145 || 18623 || 272581 || 18295 || 48152 || 47589 || 1603266 1.c. Guinea-Pigs (Cavia porcellus) || 8426 || 25777 || 86142 || 16350 || 26722 || 2067 || 3293 || 2807 || 171584 1.d. Hamsters (Mesocricetus ) || 5605 || 8230 || 125 || 5876 || 1547 || 408 || 440 || 3020 || 25251 1.e. Other Rodents (other Rodentia) || 22128 || 2653 || 0 || 0 || 300 || 2052 || 501 || 831 || 28465 1.f. Rabbits (Oryctolagus cuniculus) || 12648 || 19434 || 212043 || 22011 || 23185 || 6083 || 2068 || 60741 || 358213 1.g. Cats (Felis catus) || 855 || 885 || 81 || 223 || 325 || 981 || 169 || 194 || 3713 1.h. Dogs (Canis familiaris) || 3715 || 4671 || 65 || 927 || 7488 || 458 || 351 || 221 || 17896 1.i. Ferrets (Mustela putorius furo) || 927 || 1223 || 86 || 4 || 28 || 9 || 79 || 217 || 2573 1.j. Other Carnivores (other Carnivora) || 3236 || 0 || 0 || 541 || 32 || 457 || 550 || 166 || 4982 1.k. Horses, donkeys and cross-breds (Equidae) || 1449 || 868 || 235 || 2522 || 122 || 902 || 168 || 387 || 6653 1.l. Pigs (Sus) || 24084 || 20806 || 839 || 6841 || 3537 || 3067 || 10022 || 8084 || 77280 1.m. Goats (Capra) || 783 || 535 || 159 || 6 || 8 || 187 || 358 || 871 || 2907 1.n. Sheep (Ovis) || 9816 || 2643 || 4250 || 2126 || 746 || 1854 || 1206 || 6251 || 28892 1.o. Cattle (Bos) || 15744 || 3228 || 251 || 2931 || 808 || 1548 || 2543 || 3861 || 30914 1.p. Prosimians (Prosimia) || 83 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83 1.q. New World Monkeys (Ceboidea) || 244 || 221 || 79 || 0 || 44 || 0 || 0 || 112 || 700 1.r. Old World Monkeys (Cercopithecoidea) || 304 || 937 || 138 || 0 || 3391 || 0 || 209 || 333 || 5312 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 6822 || 531 || 4 || 238 || 179 || 53 || 26 || 35 || 7888 1.u. Quail (Coturnix coturnix) || 1591 || 0 || 0 || 0 || 3094 || 9 || 80 || 840 || 5614 1.v. Other birds (other Aves) || 293177 || 36178 || 16855 || 138542 || 14108 || 7471 || 2945 || 160175 || 669451 1.w. Reptiles (Reptilia) || 3202 || 98 || 0 || 0 || 0 || 412 || 111 || 1 || 3824 1.x. Amphibians (Amphibia) || 16489 || 946 || 0 || 0 || 2695 || 5 || 9127 || 321 || 29583 1.y. Fish (Pisces) || 765530 || 20692 || 0 || 9637 || 179083 || 3897 || 15416 || 403207 || 1397462 1.z. TOTAL || 5290573 || 2158188 || 1260011 || 337798 || 1004873 || 185257 || 179981 || 1064645 || 11481521 (*) France is reporting for 2010 III.4. Results
of EU Table 3: Toxicological and safety evaluation by type of product/endpoint III.4.1. The data on toxicological
and safety evaluation by type of product/endpoint The consolidated table giving the number of
animals used for toxicological and other safety evaluation of products (EU
Table 3) in 27 Member States in 2011 is presented in table 3 at the end of this
chapter. In this table the number of animals used for toxicological or other
safety evaluation is broken down into types of products for which testing was
required. The percentage of the number of animals
used for different types of product is presented in figure 3. III.4.2. Treatment and
interpretation of the data The number of animals used for
toxicological and other safety evaluation for different products, or for
testing potential contaminants to the environment amounts to 1 004 873 which
represents only 8,75% of the total number of animals used for scientific purposes
in 2011 (see table 2.1, column 2.6). Toxicological or other safety evaluations
are split according to the type of sector for which they are intended. The
percentage of animals used for toxicological evaluation of three groups of
products/substances, i.e. additives in food for human consumption, cosmetics
and household products, is very small (0,35%) when compared to the other
product groups. Products or devices used for human
medicine, veterinary medicine and dentistry represents 39,8% of the animals
used for toxicological or other safety evaluations. The group of products/substances falling
under the scrutiny of Member States authorities concerned with safety of health
and of the environment by chemical products, such as industrial chemicals and
pesticides, used 15,9% of the animals for toxicological and other safety
evaluations. There is little change with regard to the
number of animals used for toxicological tests for products intended for
industry and for agriculture in comparison to 2008, but there is a net increase
of the number of animals used for potential contaminants of the environment. The
increase is from above 65 000 to approximately 92 000. A significant decrease has been observed in
the number of animals used for testing food for animal consumption in
comparison to 2008 from 54 000 to 4 600 which is more than a ten-fold decrease
but also for cosmetics and toiletries where the decrease is from 1 960 to 90 animals.
This is important to highlight as there is a testing ban in the EU for
cosmetics and cosmetic ingredients in place since 2009. There is, however, a substantial increase
in the number of animals used for tests for 'other toxicological or safety evaluations'
from 223 000 to 345 000 animals (roughly 122 000 animals which represent an
increase of 54%). An increase was also observed in the 2008 report. Member States reported that under this heading, animals are
used in metabolic studies and preclinical research, testing substances and
products in human and veterinary medicine and in teratology studies on. They are also used in toxicity test to
aquatic vertebrates not included in other categories, in LD50, ED50, pyrogen
testing, and testing for algae biotoxins and other foodstuff contaminants. Table 3: Number of animals used in
toxicological and other safety evaluation
Products
versus species Data of 2011* 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contaminants in the general environment which do not appear in other columns || 3.10 Other toxicological or safety evaluations || 3.11 Total 1.a. Mice (Mus musculus) || 140441 || 15395 || 20073 || 40 || 40 || 652 || 1156 || 1910 || 285003 || 464710 1.b. Rats (Rattus norvegicus) || 146109 || 35867 || 47684 || 804 || 50 || 1502 || 196 || 4323 || 36186 || 272721 1.c. Guinea-Pigs (Cavia porcellus) || 19132 || 2180 || 872 || 76 || 0 || 0 || 7 || 0 || 4455 || 26722 1.d. Hamsters (Mesocricetus ) || 1121 || 73 || 151 || 8 || 0 || 0 || 0 || 0 || 194 || 1547 1.e. Other Rodents (other Rodentia) || 70 || 48 || 0 || 0 || 0 || 0 || 0 || 0 || 182 || 300 1.f. Rabbits (Oryctolagus cuniculus) || 14616 || 2012 || 2373 || 49 || 0 || 0 || 16 || 4 || 4115 || 23185 1.g. Cats (Felis catus) || 325 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 325 1.h. Dogs (Canis familiaris) || 6260 || 247 || 0 || 0 || 0 || 0 || 0 || 0 || 981 || 7488 1.i. Ferrets (Mustela putorius furo) || 28 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28 1.j. Other Carnivores (other Carnivore) || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32 1.k. Horses, donkeys and cross-breds (Equidae) || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122 1.l. Pigs (Sus) || 2589 || 5 || 0 || 0 || 0 || 0 || 196 || 152 || 595 || 3537 1.m. Goats (Capra) || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8 1.n. Sheep (Ovis) || 569 || 0 || 0 || 0 || 0 || 0 || 21 || 140 || 16 || 746 1.o. Cattle (Bos) || 732 || 19 || 0 || 0 || 0 || 0 || 6 || 0 || 51 || 808 1.p. Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.q. New World Monkeys (Ceboidea) || 38 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 44 1.r. Old World Monkeys (Cercopithecoidea) || 2589 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 802 || 3391 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.u. Quail (Coturnix coturnix) || 0 || 2859 || 0 || 0 || 0 || 0 || 0 || 0 || 235 || 3094 1.v. Other birds (other Aves) || 8558 || 1775 || 0 || 0 || 0 || 0 || 3006 || 64 || 884 || 14287 1.w. Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.x. Amphibians (Amphibia) || 0 || 336 || 0 || 0 || 0 || 0 || 0 || 2340 || 19 || 2695 1.y. Fish (Pisces) || 56463 || 20255 || 7163 || 0 || 0 || 276 || 0 || 83433 || 11493 || 179083 1.z. TOTAL || 399794 || 81079 || 78316 || 977 || 90 || 2430 || 4604 || 92366 || 345217 || 1004873 (*) France reporting for 2010 III.5. Results of EU Table 4: Animals
used for studies of diseases III.5.1. The data on animals used
for studies of diseases The
consolidated table of results of animals used for studies of diseases (EU Table
4) in the 27 Member States is presented in table 4.1 at the end of this
chapter. III.5.2. Treatment and
interpretation of the data Table 4.1 gives the number of animals used
per type of studies on diseases. In 2011 the number of animals used for the
study of both animal and human diseases represented 6 599 320 animals which is
more than half (57%) the total number of animals used for scientific purposes
in the EU. Figure 4.1 presents the percentage of
animals used in studies per type of disease, 90% of which are used for the
study of human diseases. In 2011, the overall number of animals used
for studies on human and animal diseases has increased to a little more than
276 000 animals. The use of animals for specific studies on animal diseases in
2011 (which had a decrease of 50% in 2008) is comparatively unchanged from the
2008 report. There is a reduction in the use of cold-blooded animals by just
under 22 500. It is important to note that there has been
a net increase of more than 115 000 animals used for studies on cardiovascular
diseases, and of more than 250 000 for human cancer studies. In comparison to 2008, increases of the use
of animals have also been observed for dogs, totalling above 1 000; for other carnivores
about 500; for other mammals a little above 300 and for other birds above 2 500. On the other hand, the number of rats used
for studies on diseases has decreased by more than 250 000 animals. Table 4.1: Number of
animals used in experiments for studies on human and animal diseases Main category of
diseases versus species
Data of 2011 * 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 1.a. Mice (Mus musculus) || 373188 || 872698 || 1049177 || 2106651 || 303009 || 4702052 1.b. Rats (Rattus norvegicus) || 118848 || 409386 || 36156 || 438491 || 5337 || 1008156 1.c. Guinea-Pigs (Cavia porcellus) || 2880 || 1893 || 44 || 27472 || 2373 || 34662 1.d. Hamsters (Mesocricetus ) || 3000 || 398 || 779 || 5517 || 3269 || 12963 1.e. Other Rodents (other Rodentia) || 1713 || 912 || 0 || 4723 || 2830 || 10178 1.f. Rabbits (Oryctolagus cuniculus) || 5208 || 825 || 2852 || 24023 || 4523 || 37424 1.g. Cats (Felis catus) || 2 || 64 || 4 || 217 || 2026 || 2313 1.h. Dogs (Canis familiaris) || 860 || 79 || 187 || 3360 || 6543 || 11029 1.i. Ferrets (Mustela putorius furo) || 0 || 156 || 0 || 2175 || 55 || 2386 1.j. Other Carnivores (other Carnivore) || 19 || 0 || 0 || 538 || 1035 || 1592 1.k. Horses, donkeys and cross-breds (Equidae) || 1 || 0 || 0 || 135 || 2083 || 2219 1.l. Pigs (Sus) || 6118 || 527 || 227 || 8743 || 16278 || 31893 1.m. Goats (Capra) || 72 || 15 || 54 || 604 || 281 || 1026 1.n. Sheep (Ovis) || 897 || 93 || 23 || 10683 || 3032 || 14728 1.o. Cattle (Bos) || 220 || 0 || 0 || 2960 || 6507 || 9687 1.p. Prosimians (Prosimia) || 0 || 58 || 0 || 25 || 0 || 83 1.q. New World Monkeys (Ceboidea) || 15 || 171 || 0 || 385 || 0 || 571 1.r. Old World Monkeys (Cercopithecoidea) || 369 || 88 || 61 || 1746 || 45 || 2309 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 0 || 154 || 18 || 833 || 700 || 1705 1.u. Quail (Coturnix coturnix) || 0 || 640 || 0 || 244 || 4 || 888 1.v. Other birds (other Aves) || 1037 || 2302 || 100 || 20365 || 204069 || 227873 1.w. Reptiles (Reptilia) || 0 || 39 || 0 || 407 || 695 || 1141 1.x. Amphibians (Amphibia) || 549 || 393 || 180 || 6066 || 949 || 8137 1.y. Fish (Pisces) || 4814 || 45004 || 16059 || 367640 || 40788 || 474305 1.z. TOTAL || 519810 || 1335895 || 1105921 || 3034003 || 606431 || 6599320 *
France reporting for 2010 Table
4.2: Number of animals used in studies of diseases by classes of animals Classes of animals || Human Cardiovascular diseases || Human nervous and mental disorder || Human cancer (excl. evaluation of carcino. hazards) || Other human diseases || Specific animal diseases || Total Mice || 373188 || 872698 || 1049177 || 2106651 || 303009 || 4702052 Rats || 118848 || 409386 || 36156 || 438491 || 5337 || 1008156 Guinea-Pigs || 2880 || 1893 || 44 || 27472 || 2373 || 34662 Other Rodents || 4713 || 1310 || 779 || 10240 || 6099 || 23141 Rabbits || 5208 || 825 || 2852 || 24023 || 4523 || 37424 Carnivores || 881 || 299 || 191 || 6290 || 9659 || 17320 Artio + Perissodactyla || 7308 || 635 || 304 || 23125 || 28181 || 59553 Prosimians+Monkeys+Apes || 384 || 317 || 61 || 2156 || 45 || 2963 Other Mammals || 0 || 154 || 18 || 833 || 700 || 1705 Birds || 1037 || 2942 || 100 || 20609 || 204073 || 228761 Cold-blooded animals || 5363 || 45436 || 16239 || 374113 || 42432 || 483583 TOTAL || 519810 || 1335895 || 1105921 || 3034003 || 606431 || 6599320 || || || || || || Classes of animals % || Human Cardiovascular diseases || Human nervous and mental disorder || Human cancer (excl. evaluation of carcino. hazards) || Other human diseases || Specific animal diseases || Total Mice || 7,94 || 18,56 || 22,31 || 44,80 || 6,44 || 100,00 Rats || 11,79 || 40,61 || 3,59 || 43,49 || 0,53 || 100,00 Guinea-Pigs || 8,31 || 5,46 || 0,13 || 79,26 || 6,85 || 100,00 Other Rodents || 20,37 || 5,66 || 3,37 || 44,25 || 26,36 || 100,00 Rabbits || 13,92 || 2,20 || 7,62 || 64,19 || 12,09 || 100,00 Carnivores || 5,09 || 1,73 || 1,10 || 36,32 || 55,77 || 100,00 Artio + Perissodactyla || 12,27 || 1,07 || 0,51 || 38,83 || 47,32 || 100,00 Prosimians+Monkeys+Apes || 12,96 || 10,70 || 2,06 || 72,76 || 1,52 || 100,00 Other Mammals || 0,00 || 9,03 || 1,06 || 48,86 || 41,06 || 100,00 Birds || 0,45 || 1,29 || 0,04 || 9,01 || 89,21 || 100,00 Cold-blooded animals || 1,11 || 9,40 || 3,36 || 77,36 || 8,77 || 100,00 Species of table 4.1 were grouped into
classes of animals and presented in table 4.2. The relative percentage of
animals per class of species used in studies by type of disease has been
calculated and is also presented in the lower part of table 4.2. Figure 4.2 shows the proportion of animals
used by classes per type of studies of diseases. The top of each bar shows the relative
percentage of animals used for studies on specific animal diseases. For this
category a significant decrease in numbers of both Artiodactyla and Perissodactyla,
has been recorded. However, an increase in the numbers of carnivores was observed
for the same purpose. In addition to the year
2011 having been relatively quiet from a zoo-sanitary point of view, and thus the
pressure for testing in farm animals relatively low, other reasons indicated by
Member States for a decrease in this area include - reduction of
livestock housing capacity; - move away from large
animal-based to more basic laboratory-based bioscience type studies (on tissue
culture, cell lines etc. rather than animal type studies); - as larger animals
models are particularly expensive to run, it was suggested that they may have
become unsustainable for some laboratories; - larger animal models
are normally used just before going into clinical trials and as such are
cyclical. Regarding the increased
use of carnivores Member States indicated that these animals have been used in
veterinary clinical trials, studies on genetic diseases, for research and
development of products and devices for veterinary medicine and for vaccine
studies (e.g. leishmania). The data on the use of most species for all
types of studies on both human and animal diseases show a similarity to the report
of 2008. However, there is a substantial decrease in the use of 'other rodents'
for studies of human diseases in particular 'human nervous and mental disorders'.
III.6. Results
of EU Table 5: Animals used in production and quality control of products
for human medicine and dentistry and for veterinary medicine III.6.1. The data on animals used
in production and quality control of products for human medicine and dentistry
and for veterinary medicine The consolidated table for the 27 Member
States reporting the origin of the regulatory requirements in relation to
animals used for the production and quality control of products for human
medicine and dentistry and for veterinary medicine (EU Table 5) is presented in
table 5 at the end of this chapter. III.6.2. Treatment and
interpretation of the data The number of animals used in tests for the
production and quality control of products for human medicine and dentistry and
for veterinary medicine represents 13,9% of the total number of animals used
for experimental purposes in 2011. Figure 5 gives the percentages of the animals
used to satisfy the different regional regulatory requirements in this area. The largest proportion of animals in this
area (47%) was used to simultaneously satisfy requirements from several pieces
of legislation emanating from the EU, the Council of Europe, from national
legislation and from legislation outside of the EU. The testing carried out to
satisfy EU legislation including the European Pharmacopoeia covered 35,9% of
the animals used in this area. In comparison to the report of 2008 it is
important to note that there is an increase in the number of animals used for 'no
regulatory requirements'. It should also be noted that, there is a slight
increase in the number of animals used to satisfy national legislation, despite
the fact that there is a net reduction of the total number of animals used in
this sector (192 000). Table 5 Number of animals used in the
production and quality control of products and devices for human medicine and
dentistry and for veterinary medicine Regulatory
requirements versus species Data of 2011
* 5.1 Species || 5.2 National legislation specific to a single EC Member State (1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation (2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total 1.a. Mice (Mus musculus) || 48385 || 250338 || 2162 || 33046 || 486522 || 71461 || 891914 1.b. Rats (Rattus norvegicus) || 3962 || 69859 || 0 || 4477 || 93887 || 3583 || 175768 1.c. Guinea-Pigs (Cavia porcellus) || 1406 || 35856 || 0 || 4836 || 54984 || 5278 || 102492 1.d. Hamsters (Mesocricetus ) || 0 || 1667 || 0 || 0 || 4334 || 0 || 6001 1.e. Other Rodents (other Rodentia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.f. Rabbits (Oryctolagus cuniculus) || 1628 || 96730 || 13 || 880 || 71826 || 62757 || 234054 1.g. Cats (Felis catus) || 0 || 265 || 0 || 0 || 38 || 1 || 304 1.h. Dogs (Canis familiaris) || 118 || 597 || 0 || 0 || 262 || 15 || 992 1.i. Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 32 || 58 || 90 1.j. Other Carnivores (other Carnivore) || 19 || 213 || 0 || 0 || 0 || 309 || 541 1.k. Horses, donkeys and cross-breds (Equidae) || 338 || 231 || 0 || 0 || 105 || 2083 || 2757 1.l. Pigs (Sus) || 324 || 3694 || 15 || 0 || 2465 || 774 || 7382 1.m. Goats (Capra) || 0 || 448 || 0 || 0 || 6 || 9 || 463 1.n. Sheep (Ovis) || 109 || 1651 || 0 || 4 || 691 || 3901 || 6376 1.o. Cattle (Bos) || 64 || 1806 || 0 || 4 || 741 || 546 || 3161 1.p. Prosimians (Prosimia) || 0 || 21 || 0 || 0 || 0 || 0 || 21 1.q. New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 79 || 0 || 79 1.r. Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 138 || 0 || 138 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 56 || 4 || 60 1.u. Quail (Coturnix coturnix) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.v. Other birds (other Aves) || 3811 || 106761 || 0 || 385 || 36585 || 8037 || 155579 1.w. Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.x. Amphibians (Amphibia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.y. Fish (Pisces) || 1600 || 3296 || 0 || 0 || 0 || 4741 || 9637 1.z. TOTAL || 61764 || 573433 || 2190 || 43632 || 752751 || 163557 || 1597809 (*) France reporting for 2010 Examples: || 5.2 - France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out || || 5.3 - UK is testing according to EC legislation || || and not to the body which has issued the actual test method, guideline or protocol || || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || || 5.6 - Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. || || || || || Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, Switzerland, 'the former Yugoslav Rep. of Macedonia' Turkey, Ukraine III.7. Results
of EU harmonized Table 6: Origin of regulatory requirements for animals
used in toxicological
and other safety evaluations III.7.1. The data on the origin of
regulatory requirements for animals used in toxicological and other safety
evaluations The consolidated table for the 27 Member
States reporting data on animals used in toxicological and other safety
evaluations in relation to the origin of regulatory requirements (EU Table 6)
is presented in table 6 at the end of this chapter. III.7.2. Treatment and
interpretation of the data The use of animals for the regulatory
requirements of different regions in the area of toxicological or other safety
evaluation presented in figure 6 follows a similar pattern to that of the use
of animals used for regulatory purposes in human medicine, dentistry and in
veterinary medicine in different regions, presented in the figure 5 in the
previous chapter. As pointed out earlier, the number of
animals used in toxicological or other safety evaluation represents 8,75% of
the total number of animals used for experimental purposes in the EU. Animals used to simultaneously satisfy
regulatory requirements from several pieces of legislation represent 56% of the
animals used in this area. The testing required under EU legislation including
the European Pharmacopoeia accounts for the second highest percentage in this
area, namely 21,27%. The percentage of the use of animals to
satisfy requirements of different legislation has increased from fewer than 50%
to more than 56%. There is also a decrease in the number of animals
used for 'no regulatory requirements'. In addition to the examples of the type of
testing reported under 'no regulatory requirements' in the last report (namely those
of in-house methods to verify the safety and efficacy of veterinary biologicals
and medicinal products carried according to company’s or known international
standards), Member States reported preliminary studies for trial of doses, optimisation
of numbers and candidates, and probing mechanism of action of
toxicities associated with clinically approved drugs or combination studies
involving clinically approved drugs. Table
6: Number of animals used in toxicological and other safety
evaluations Regulatory
requirements versus species Data of 2011* 6.1 Species || 6.2 National legislation specific to a single EC Member State1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation2) || 6.5 Other legislation || 6.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 6.7 No regulatory requirements || 6.8 Total 1.a. Mice (Mus musculus) || 33212 || 105801 || 361 || 5263 || 299377 || 20836 || 464850 1.b. Rats (Rattus norvegicus) || 17657 || 44614 || 924 || 10481 || 183446 || 15459 || 272581 1.c. Guinea-Pigs (Cavia porcellus) || 817 || 14340 || 37 || 1466 || 8503 || 1559 || 26722 1.d. Hamsters (Mesocricetus ) || 149 || 278 || 0 || 174 || 946 || 0 || 1547 1.e. Other Rodents (other Rodentia) || 4 || 70 || 0 || 0 || 191 || 35 || 300 1.f. Rabbits (Oryctolagus cuniculus) || 1211 || 8685 || 257 || 1481 || 10796 || 525 || 22955 1.g. Cats (Felis catus) || 68 || 283 || 0 || 0 || 76 || 16 || 443 1.h. Dogs (Canis familiaris) || 737 || 1011 || 0 || 603 || 5024 || 107 || 7482 1.i. Ferrets (Mustela putorius furo) || 0 || 118 || 0 || 0 || 20 || 0 || 138 1.j. Other Carnivores (other Carnivore) || 0 || 8 || 0 || 0 || 0 || 0 || 8 1.k. Horses, donkeys and cross-breds (Equidae) || 60 || 65 || 0 || 0 || 18 || 0 || 143 1.l. Pigs (Sus) || 36 || 1292 || 0 || 307 || 1691 || 95 || 3421 1.m. Goats (Capra) || 0 || 127 || 0 || 0 || 8 || 0 || 135 1.n. Sheep (Ovis) || 320 || 58 || 0 || 69 || 159 || 140 || 746 1.o. Cattle (Bos) || 238 || 89 || 0 || 0 || 436 || 24 || 787 1.p. Prosimians (Prosimia) || 0 || 21 || 0 || 0 || 0 || 0 || 21 1.q. New World Monkeys (Ceboidea) || 0 || 11 || 0 || 0 || 20 || 13 || 44 1.r. Old World Monkeys (Cercopithecoidea) || 221 || 234 || 0 || 348 || 2558 || 30 || 3391 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.u. Quail (Coturnix coturnix) || 45 || 380 || 0 || 0 || 2669 || 0 || 3094 1.v. Other birds (other Aves) || 591 || 9654 || 0 || 0 || 3696 || 346 || 14287 1.w. Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.x. Amphibians (Amphibia) || 0 || 0 || 0 || 0 || 1539 || 1156 || 2695 1.y. Fish (Pisces) || 34625 || 26566 || 0 || 3762 || 43305 || 70825 || 179083 1.z. TOTAL || 89991 || 213705 || 1579 || 23954 || 564478 || 111166 || 1004873 (*) France is reporting for 2010 Examples: || 6.2 - France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and not to the body which has issued the actual test method, guideline or protocol || 6.3 - UK is testing according to EC legislation || || 6.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || || 6.6 - Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. || || || || || || Footnotes:1) EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, || || Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || || 2) Member Countries of Council of Europe (non-EC): Albania, Andorra, Croatia, Iceland, Liechtenstein, Moldova, Norway, Russia, San Marino, || || Switzerland, 'the former Yugoslav Rep. of Macedonia', Turkey, Ukraine || || || III.8. Results of EU Table 7: Animals
used in toxicity tests for toxicological and other safety evaluations III.8.1. The data on animals used
in toxicity test for toxicological and other safety evaluations The consolidated table for the 27 Member
States reporting on animals used in toxicity tests for the purpose of
toxicological and other safety evaluations of products (EU Table 7) is
presented in table 7.1 at the end of this chapter. III.8.2. Treatment and
interpretation of the data For the convenience of the presentation of
results some of the toxicity tests of table 7.1 have been grouped according to
systemic and local toxicity and CMR effects in table 7.2. A graph showing the
percentage of animals used per toxicity test groups in 2011 is presented in figure
7. As pointed out in the previous chapter, the
number of animals used in toxicological and other safety evaluations represents
8,75% of the total number of animals used for experimental purposes. In figure 7 the largest percentage (47,5%)
of use of animals is due to acute and sub-acute toxicity tests. Taking into
account sub-chronic and chronic toxicity, the percentage of animals used in
short- and long-term systemic toxicity testing accounts for 55% of the total
number of animals used in this area. Nearly 15% animals were used for testing
carcinogenicity, mutagenicity and toxicity to reproduction. Another important
category of use of animals in 2011 is for 'other tests' with 22%. In addition to the type of testing reported
under 'other toxicological and safety evaluation' in the previous report (namely
those of neurotoxicity, toxicokinetics, testing of biological evaluation of
medical devices: intracutaneous testing of reactivity in rabbits, studies into
the penetration of nanoparticles through tissue and their biocompatibility,
studies into the evaluation of sensitization potential of dyestuffs used in the
textile industry and pharmacological studies included in safety tests), Member
States reported that this heading covered also target
animal studies carried out on companion animals to different regulatory
standards e.g. US EPA, FDA, tests to determine the residues
of veterinary medicaments in calves and in broilers, test to determine the non-toxicity
and irreversibility of toxins and efficacy of vaccines (blue tongue,
clostridium). By looking both at numbers and relative
percentages of use of animals in comparison to the previous reports there are
two noticeable changes: There is a continuous increase over the
last four reports of the proportion of animals used for acute and sub-acute
tests, from 36%, 42%, 45% to 47,5% respectively. This represents in animal numbers
an increase of more than 8 400 animals since the last report. Contrary to the previous three reports
where a steady decrease was observed, for 2011 the number of the animals used
for reproductive toxicity testing has increased from 9% in 2008 to 11,35%. In
terms of animal numbers it means an increase of almost 19 000 animals. Table 7.1 Number of animals
used in toxicological and other safety evaluations Type of
tests versus species
Data
of 2011* 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || 7.2.1. LD50, LC50 || 7.2.2. Other lethal methods || 7.2.3. Non lethal clinical signs methods || || || || || || || || || || || 1.a. Mice (Mus musculus) || 220544 || 51356 || 43637 || 64 || 16846 || 30 || 16436 || 5271 || 1188 || 9931 || 742 || 0 || 98796 || 464841 1.b. Rats (Rattus norvegicus) || 8376 || 10870 || 65185 || 1490 || 64 || 0 || 42274 || 6445 || 20189 || 11278 || 61209 || 0 || 45200 || 272508 1.c. Guinea-Pigs (Cavia porcellus) || 773 || 1847 || 1546 || 88 || 15214 || 0 || 1630 || 110 || 0 || 0 || 254 || 0 || 5270 || 26732 1.d. Hamsters (Mesocricetus ) || 0 || 0 || 210 || 11 || 0 || 0 || 489 || 0 || 0 || 50 || 0 || 0 || 857 || 1617 1.e. Other Rodents (other Rodentia) || 182 || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 274 || 460 1.f. Rabbits (Oryctolagus cuniculus) || 15 || 143 || 2947 || 3151 || 44 || 2080 || 634 || 0 || 2560 || 0 || 2978 || 0 || 8515 || 23067 1.g. Cats (Felis catus) || 0 || 0 || 34 || 0 || 0 || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 285 || 331 1.h. Dogs (Canis familiaris) || 0 || 123 || 2469 || 0 || 0 || 0 || 2785 || 0 || 0 || 0 || 95 || 0 || 1903 || 7375 1.i. Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 52 || 52 1.j. Other Carnivores (other Carnivore) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 || 11 1.k. Horses, donkeys and cross- breds (Equidae) || 0 || 0 || 33 || 0 || 0 || 0 || 0 || 0 || 60 || 0 || 0 || 0 || 148 || 241 1.l. Pigs (Sus) || 0 || 39 || 807 || 45 || 0 || 0 || 729 || 0 || 22 || 0 || 86 || 0 || 1682 || 3410 1.m. Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8 || 8 1.n. Sheep (Ovis) || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 0 || 299 || 0 || 0 || 0 || 438 || 767 1.o. Cattle (Bos) || 0 || 0 || 45 || 0 || 0 || 0 || 24 || 0 || 230 || 0 || 0 || 0 || 488 || 787 1.p. Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.q. New World Monkeys (Ceboidea) || 0 || 0 || 24 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 44 1.r. Old World Monkeys (Cercopithecoidea) || 0 || 0 || 877 || 0 || 0 || 0 || 1306 || 0 || 266 || 0 || 15 || 0 || 927 || 3391 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.u. Quail (Coturnix coturnix) || 329 || 370 || 0 || 0 || 0 || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 2350 || 3094 1.v. Other birds (other Aves) || 423 || 182 || 4584 || 0 || 0 || 0 || 0 || 50 || 0 || 0 || 556 || 0 || 8492 || 14287 1.w. Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.x. Amphibians (Amphibia) || 0 || 0 || 1660 || 0 || 0 || 0 || 0 || 0 || 500 || 0 || 0 || 516 || 19 || 2695 1.y. Fish (Pisces) || 34137 || 11641 || 11898 || 0 || 0 || 0 || 13730 || 0 || 16468 || 29 || 6381 || 38890 || 45909 || 179083 1.z. TOTAL || 264779 || 76575 || 135956 || 4849 || 32168 || 2110 || 80124 || 11876 || 41782 || 21288 || 72316 || 39406 || 221644 || 1004873 (*) France reporting for 2010 Table
7.2 Grouping of certain type of tests on animals of table 7.1
7.1 Species || Acute and sub-acute toxicity testing methods (including limit test) || Irritation /sensitization tests || Sub- chronic and chronic toxicity || Mutagenicity and carcinogenicity || Reproductive and developmental toxicity || Toxicity to aquatic vertebrates not included in other columns || Other || Total 1.a. Mice (Mus musculus) || 315537 || 16940 || 16436 || 15202 || 1930 || 0 || 98796 || 464841 1.b. Rats (Rattus norvegicus) || 84431 || 1554 || 42274 || 17723 || 81398 || 0 || 45200 || 272508 1.c. Guinea-Pigs (Cavia porcellus) || 4166 || 15302 || 1630 || 110 || 254 || 0 || 5270 || 26732 1.d. Hamsters (Mesocricetus ) || 210 || 11 || 489 || 50 || 0 || 0 || 857 || 1617 1.e. Other Rodents (other Rodentia) || 186 || 0 || 0 || 0 || 0 || 0 || 274 || 460 1.f. Rabbits (Oryctolagus cuniculus) || 3105 || 5275 || 634 || 0 || 5538 || 0 || 8515 || 23067 1.g. Cats (Felis catus) || 34 || 0 || 12 || 0 || 0 || 0 || 285 || 331 1.h. Dogs (Canis familiaris) || 2592 || 0 || 2785 || 0 || 95 || 0 || 1903 || 7375 1.i. Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 || 52 || 52 1.j. Other Carnivores (other Carnivore) || 0 || 0 || 0 || 0 || 0 || 0 || 11 || 11 1.k. Horses, donkeys and cross-breds (Equidae) || 33 || 0 || 0 || 0 || 60 || 0 || 148 || 241 1.l. Pigs (Sus) || 846 || 45 || 729 || 0 || 108 || 0 || 1682 || 3410 1.m. Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0 || 8 || 8 1.n. Sheep (Ovis) || 0 || 0 || 30 || 0 || 299 || 0 || 438 || 767 1.o. Cattle (Bos) || 45 || 0 || 24 || 0 || 230 || 0 || 488 || 787 1.p. Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.q. New World Monkeys (Ceboidea) || 24 || 0 || 0 || 0 || 0 || 0 || 20 || 44 1.r. Old World Monkeys (Cercopithecoidea) || 877 || 0 || 1306 || 0 || 281 || 0 || 927 || 3391 1.s. Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.t. Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.u. Quail (Coturnix coturnix) || 699 || 0 || 45 || 0 || 0 || 0 || 2350 || 3094 1.v. Other birds (other Aves) || 5189 || 0 || 0 || 50 || 556 || 0 || 8492 || 14287 1.w. Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 1.x. Amphibians (Amphibia) || 1660 || 0 || 0 || 0 || 500 || 516 || 19 || 2695 1.y. Fish (Pisces) || 57676 || 0 || 13730 || 29 || 22849 || 38890 || 45909 || 179083 1.z. TOTAL || 477310 || 39127 || 80124 || 33164 || 114098 || 39406 || 221644 || 1004873 III.9. Results
of EU Table 8: Type of toxicity tests carried out for toxicological and
other safety evaluations of products III.9.1. The data on type of
toxicity tests carried out for toxicological and other safety evaluations
of products The consolidated table for the type of
toxicity tests carried out for toxicological or other safety evaluations of
products for the 27 Member States reporting (EU Table 8) is presented in table
8.1 of this report. III.9.2. Treatment and
interpretation of the data As pointed out earlier, animals used in
toxicological and other safety evaluation represent 8,75% of the total number
of animals used for experimental purposes. In order to facilitate the interpretation
of the results some types of toxicity testing have been grouped and the results
can be found in consolidated table 8.2 at the end of this chapter. The treatment
and interpretation of the data on animals used for toxicity tests with regard
to the type of products was done for the first time in the Fifth Statistical
Report. Figure 8 gives the proportion of animals
used for toxicity and other safety evaluation by types of products. Figure 8 shows that the majority of animals
tested in acute/sub-acute toxicity are intended for the purpose of 'human
medicine, dentistry and veterinary medicine' and for 'other toxicological and
safety evaluation'. For irritation/sensitization properties and for
carcinogenicity/mutagenicity and reprotox the three categories of uses; human
medicine, agriculture and industrial products show a similar pattern of use of
animals. Whereas the largest number of animals used in sub-chronic and chronic
toxicity test are carried out mainly for human medicine, dentistry and
veterinary medicine. In Figure 8 it is difficult to show the
numbers of animals used for testing, for example, household products and
additives for human consumption because they are much lower than in the other
categories e.g. for household products only 800 animals were used whereas for
products for human medicine, dentistry and veterinary medicine almost
400 000 animals were used. Overall products intended for medicine,
dentistry and veterinary medicine required the highest proportion of animals
for the different types of tests i.e. approximately 39%. In comparison to 2008
the amount of animals used in 2011 has been reduced by more than 130 000. The next highest proportion is for 'other'
toxicological evaluations, above 34%, (22% in 2008) this means an increase of
use of 122 000 animals. The third type of test using the largest number of
animals is that used for potential and actual contaminants in the general environment
with 92 000 animals or 9%. Table 8.1: Number of
animals used in toxicological and other safety evaluations Type of
tests versus products Data of 2011* 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino- genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || 8.2.1. LD50, LC50 || 8.2.2. Other lethal methods || 8.2.3. Non lethal clinical signs methods || || || || || || || || || || || 8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 40400 || 13904 || 86828 || 1772 || 14410 || 336 || 49351 || 6087 || 15247 || 10796 || 35906 || 1671 || 122646 || 399354 8.b. Products/ substances used or intended to be used mainly in agriculture || 6079 || 7825 || 7479 || 992 || 3047 || 801 || 8200 || 4884 || 8335 || 2255 || 12359 || 7089 || 11634 || 80979 8.c. Products/ substances used or intended to be used mainly in industry || 3635 || 1690 || 13974 || 1461 || 10200 || 613 || 2691 || 4 || 11493 || 6805 || 14682 || 2208 || 9564 || 79020 8.d. Products/ substances used or intended to be used mainly in the household || 40 || 119 || 79 || 47 || 76 || 2 || 80 || 0 || 0 || 0 || 46 || 0 || 348 || 837 8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries || 25 || 25 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 90 8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption || 25 || 131 || 57 || 0 || 24 || 0 || 1300 || 0 || 0 || 152 || 0 || 0 || 741 || 2430 8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption || 53 || 928 || 0 || 0 || 0 || 0 || 100 || 0 || 0 || 54 || 0 || 0 || 3469 || 4604 8.h. Potential or actual contaminants in the general environment which do not appear in other columns || 27673 || 9521 || 6620 || 2 || 0 || 0 || 10759 || 664 || 5264 || 28 || 4439 || 25529 || 1867 || 92366 8.i. Other toxicological or safety evaluations || 186849 || 42432 || 20879 || 575 || 4411 || 358 || 7643 || 237 || 1443 || 1198 || 4884 || 2909 || 71375 || 345193 8.j. TOTAL || 264779 || 76575 || 135956 || 4849 || 32168 || 2110 || 80124 || 11876 || 41782 || 21288 || 72316 || 39406 || 221644 || 1004873 (*) France reporting for 2010 Table 8.2: Number
of animals used in toxicological and other safety evaluation per types of
products 8.1. Products || Acute and sub-acute toxicity testing methods (including limit test) || Irritation/sensitization tests || Sub- chronic and chronic toxicity || Carcinogenicity, Mutagenicity and Reprotox || Toxicity to aquatic vertebrates not included in other columns || Other || Total 8.a. Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 141132 || 16518 || 49351 || 68036 || 1671 || 122646 || 399354 8.b. Products/ substances used or intended to be used mainly in agriculture || 21383 || 4840 || 8200 || 27833 || 7089 || 11634 || 80979 8.c. Products/ substances used or intended to be used mainly in industry || 19299 || 12274 || 2691 || 32984 || 2208 || 9564 || 79020 8.d. Products/ substances used or intended to be used mainly in the household || 238 || 125 || 80 || 46 || 0 || 348 || 837 8.e. Products/ substances used or intended to be used mainly as cosmetics or toiletries || 90 || 0 || 0 || 0 || 0 || 0 || 90 8.f. Products/ substances used or intended to be used mainly as additives in food for human consumption || 213 || 24 || 1300 || 152 || 0 || 741 || 2430 8.g. Products/ substances used or intended to be used mainly as additives in food for animal consumption || 981 || 0 || 100 || 54 || 0 || 3469 || 4604 8.h. Potential or actual contaminants in the general environment which do not appear in other columns || 43814 || 2 || 10759 || 10395 || 25529 || 1867 || 92366 8.i. Other toxicological or safety evaluations || 250160 || 5344 || 7643 || 7762 || 2909 || 71375 || 345193 8.j. TOTAL || 477310 || 39127 || 80124 || 147262 || 39406 || 221644 || 1004873
[1] OJL 358, 18.12.1986, p.1. [2] COM (94) 195 final [3] COM (1999) 191 final [4] COM (2007) 675 final [5] COM (2010) 1107 final/2 [6] OJ C 331, 23.12.86, p. 2. COMMISSION STAFF WORKING DOCUMENT Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh Report on the Statistics on the Number of Animals used for Experimental
and
other Scientific Purposes in the Member States of the European Union PART
B I: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATE TABLE OF CONTENTS BELGIUM.................................................................................................................................. 5 BULGARIA............................................................................................................................. 19 CZECH REPUBLIC................................................................................................................ 32 DENMARK.............................................................................................................................. 41 GERMANY.............................................................................................................................. 50 BELGIUM Statistical data submitted The statistical data were submitted by the "SPF
Santé Publique, Sécurité de la Chaine Alimentaire et Environnement" (Federal Public Service Health, Food Chain Safety and Environment). Comments of the Belgian authorities 1. Laboratories In 2011, 367 laboratories were approved for
the use of animals for experimental purposes. They all provided their
statistical data on the number of animals used in the course of 2011. Of these
laboratories, 21% did not carry out any animal experiments in 2011. 2. Number
of animals used in experiments A total of 665,079 animals were used (Table
1), which is 5% less than the figure for 2010. Table 1: 2011 - Number of animals used
in experiments Species || Number Mice || 408 883 Rats || 89 547 Guinea pigs || 24 300 Hamsters || 2 435 Other rodents || 421 Rabbits || 54 001 Cats || 630 Dogs || 490 Ferrets || 192 Other carnivores || 0 Horses, donkeys and cross-breeds || 54 Pigs || 2 622 Goats || 86 Sheep || 542 Cattle || 810 Prosimians || 0 New world monkeys || 0 Old world monkeys || 20 Apes || 0 Other mammals || 64 Quails || 651 Other birds || 16 493 Reptiles || 459 Amphibians || 2 113 Fish || 60 266 TOTAL || 665 079 As regards the breakdown of the different
animal species (Table 2), rodents and rabbits together made up 87.15% of
the total number of animals used. Next come, in descending order, reptiles,
amphibians and fish (9%) and birds (2.58%). Other species (farm animals, dogs
and cats, monkeys) were much less used. Table 2: 2011 - Breakdown of species
used in experiments Species || Percentage || Number Rodents || 79.03% || 525 586 Rabbits || 8.12% || 54 001 Dogs/Cats || 0.17% || 1 120 Farm animals || 0.62% || 4 114 Primates || 0.0030% || 20 Birds || 2.58% || 17 144 Other warm-blooded animals || 0.04% || 256 Cold-blooded animals || 9.45% || 62 838 3. Experiments
carried out Animals are most used in the following
fields (Figures 1 and 2): ·
Basic research (38%), where the most commonly
used animals were rodents (73%) and fish (20%). ·
Research and development of products and devices
used in human and veterinary medicine (27%), where 96% of the animals used were
rodents. ·
Tests on the production and quality control of
products and devices used in human and veterinary medicine (28%); 72% of the
animals used were rodents and 26% rabbits. As regards these tests, 98% of the
animals were used to comply with statutory requirements. Key to table: Toxicologie - Toxicology Diagnostic - Diagnosis Formation - Training Autres - Other Biol. Fond - Basic biology R&D - Research and Development QC - Quality Control Figure 1: 2011 - Breakdown of the
experimental fields In 2011, toxicological safety tests
accounted for only 1.7% of the animals used in experiments; 85% of these
animals were used in safety tests required by law. Rodents accounted for 76% of
all the animals used in toxicological tests. The other species used were mainly
fish (5%), birds (9%), dogs (3%) and rabbits (2%). Key to table: Rongeurs - Rodents Oiseaux - Birds Animaux à sang froid - Cold-blooded
animals Lapins - Rabbits Autres - Other Formation - Training Diagnostic - Diagnosis Toxicologie - Toxicology QC - Quality Control R&D - Research and Development Biologie fondamentale - Basic biology Figure 2: 2011 - Breakdown of
experimental fields by the animals most used The increase in the number of cats used as
test animals (from 349 in 2010 to 630 in 2011) is mainly due to the research
project on the sterilisation / early castration of cats. The project is part of
the multiannual plan of the Animal Welfare Service of the Federal Public
Service (SPF) for Public Health. 4. The
provenance of the animals used in experiments In 2011, 87% of the animals provided by
approved establishments came from Council of Europe Member States. The other
species of animal that must not be reared solely for the purposes of animal
experiments (farm animals) came from establishments that meet the current legal
requirements for commercial establishments. The number of animals reused in
certain experiments was 0.01% of the total number of animals used in 2011. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 408883 || 135811 || 250514 || 40 || 22518 || 1.b. || Rats (Rattus norvegicus) || 89547 || 17337 || 71081 || 0 || 1129 || 1.c. || Guinea-Pigs (Cavia porcellus) || 24300 || 1942 || 22358 || 0 || 0 || 1.d. || Hamsters (Mesocricetus ) || 2435 || 412 || 1683 || 0 || 340 || 1.e. || Other Rodents (other Rodentia) || 421 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 54001 || 53146 || 851 || 0 || 4 || 379 1.g. || Cats (Felis catus) || 630 || 24 || 20 || 0 || 586 || 53 1.h. || Dogs (Canis familiaris) || 490 || 13 || 427 || 0 || 50 || 408 1.i. || Ferrets (Mustela putorius furo) || 192 || 0 || 192 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 0 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 54 || || || || || 1.l. || Pigs (Sus) || 2622 || || || || || 1.m. || Goats (Capra) || 86 || || || || || 1.n. || Sheep (Ovis) || 542 || || || || || 1.o. || Cattle (Bos) || 810 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 20 || 10 || 6 || 3 || 1 || 54 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 64 || || || || || 1.u. || Quail (Coturnix coturnix) || 651 || 11 || 0 || 0 || 640 || 1.v. || Other birds (other Aves) || 16493 || || || || || 1.w. || Reptiles (Reptilia) || 459 || || || || || 1.x. || Amphibians (Amphibia) || 2113 || || || || || 1.y. || Fish (Pisces) || 60266 || || || || || 1.z. || TOTAL || 665079 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 169926 || 118167 || 100056 || 3341 || 1939 || 7424 || 5308 || 2722 || 408883 2.b. || Rats || 18109 || 52400 || 9850 || 594 || 6524 || 387 || 1585 || 98 || 89547 2.c. || Guinea-Pigs || 252 || 2200 || 19469 || 1600 || 190 || 0 || 586 || 3 || 24300 2.d. || Hamsters || 350 || 532 || 0 || 1426 || 0 || 0 || 127 || 0 || 2435 2.e. || Other Rodents || 368 || 0 || 0 || 0 || 0 || 0 || 15 || 38 || 421 2.f. || Rabbits || 1280 || 1941 || 49354 || 1036 || 257 || 0 || 123 || 10 || 54001 2.g. || Cats || 22 || 4 || 0 || 18 || 0 || 586 || 0 || 0 || 630 2.h. || Dogs || 37 || 8 || 0 || 34 || 349 || 50 || 12 || 0 || 490 2.i. || Ferrets || 0 || 177 || 0 || 0 || 0 || 0 || 15 || 0 || 192 2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.k. || Horses, donkeys and cross breds || 19 || 6 || 0 || 2 || 0 || 0 || 27 || 0 || 54 2.l. || Pigs || 1285 || 334 || 0 || 533 || 92 || 15 || 107 || 256 || 2622 2.m. || Goats || 20 || 66 || 0 || 0 || 0 || 0 || 0 || 0 || 86 2.n. || Sheep || 351 || 105 || 0 || 48 || 0 || 14 || 24 || 0 || 542 2.o. || Cattle || 379 || 104 || 0 || 237 || 63 || 0 || 17 || 10 || 810 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 9 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 20 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 15 || 49 || 0 || 0 || 0 || 0 || 0 || 0 || 64 2.u. || Quail || 651 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 651 2.v. || Other birds || 10884 || 1801 || 0 || 1536 || 1080 || 102 || 2 || 1088 || 16493 2.w. || Reptiles || 375 || 84 || 0 || 0 || 0 || 0 || 0 || 0 || 459 2.x. || Amphibians || 730 || 900 || 0 || 0 || 336 || 0 || 147 || 0 || 2113 2.y. || Fish || 51605 || 1250 || 0 || 0 || 551 || 0 || 3860 || 3000 || 60266 2.z. || TOTAL || 256667 || 180139 || 178729 || 10405 || 11381 || 8578 || 11955 || 7225 || 665079 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 1322 || 20 || 60 || 0 || 0 || 321 || 0 || 0 || 216 || 1939 3.b. || Rats || 6251 || 9 || 209 || 0 || 0 || 0 || 0 || 0 || 55 || 6524 3.c. || Guinea-Pigs || 190 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 190 3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 251 || 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 257 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 349 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 349 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 55 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 37 || 92 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.o. || Cattle || 14 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 49 || 63 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 552 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 528 || 1080 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 336 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 336 3.y. || Fish || 0 || 137 || 414 || 0 || 0 || 0 || 0 || 0 || 0 || 551 3.z. || TOTAL || 8984 || 508 || 683 || 0 || 0 || 321 || 0 || 0 || 885 || 11381 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 14294 || 44652 || 46555 || 125337 || 4758 || 232925 4.b. || Rats || 4332 || 29474 || 1749 || 28049 || 384 || 63926 4.c. || Guinea-Pigs || 800 || 0 || 0 || 1284 || 82 || 2166 4.d. || Hamsters || 0 || 0 || 14 || 490 || 0 || 504 4.e. || Other Rodents || 0 || 0 || 0 || 603 || 108 || 711 4.f. || Rabbits || 160 || 0 || 21 || 1147 || 104 || 1425 4.g. || Cats || 0 || 0 || 0 || 31 || 590 || 621 4.h. || Dogs || 115 || 0 || 0 || 5 || 54 || 174 4.i. || Ferrets || 0 || 0 || 0 || 177 || 0 || 177 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 8 || 8 4.l. || Pigs || 239 || 0 || 0 || 157 || 324 || 720 4.m. || Goats || 20 || 0 || 0 || 0 || 0 || 20 4.n. || Sheep || 286 || 0 || 0 || 126 || 17 || 429 4.o. || Cattle || 0 || 0 || 0 || 0 || 266 || 266 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 15 || 0 || 15 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 16 || 15 || 0 || 31 4.u. || Quail || 0 || 640 || 0 || 0 || 0 || 640 4.v. || Other birds || 0 || 45 || 0 || 292 || 8612 || 8949 4.w. || Reptiles || 0 || 0 || 0 || 0 || 84 || 84 4.x. || Amphibians || 0 || 0 || 0 || 404 || 38 || 442 4.y. || Fish || 0 || 80 || 0 || 2096 || 6053 || 8229 4.z. || TOTAL || 20246 || 74891 || 48355 || 160228 || 21482 || 322462 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 0 || 9859 || 0 || 12626 || 79132 || 1780 || 103397 || 5.b. || Rats || 90 || 0 || 0 || 3060 || 5254 || 2040 || 10444 || 5.c. || Guinea-Pigs || 0 || 1121 || 0 || 2848 || 17100 || 0 || 21069 || 5.d. || Hamsters || 0 || 84 || 0 || 0 || 1342 || 0 || 1426 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 0 || 369 || 0 || 758 || 49263 || 0 || 50390 || 5.g. || Cats || 0 || 18 || 0 || 0 || 0 || 0 || 18 || 5.h. || Dogs || 0 || 30 || 0 || 0 || 4 || 0 || 34 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 2 || 0 || 0 || 0 || 0 || 2 || 5.l. || Pigs || 0 || 533 || 0 || 0 || 0 || 0 || 533 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 48 || 0 || 0 || 0 || 0 || 48 || 5.o. || Cattle || 0 || 237 || 0 || 0 || 0 || 0 || 237 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 0 || 1536 || 0 || 0 || 0 || 0 || 1536 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 90 || 13837 || 0 || 19292 || 152095 || 3820 || 189134 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 25 || 537 || 0 || 0 || 797 || 580 || 1939 || 6.b. || Rats || 114 || 55 || 0 || 0 || 5965 || 390 || 6524 || 6.c. || Guinea-Pigs || 0 || 0 || 0 || 0 || 0 || 190 || 190 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 0 || 0 || 0 || 0 || 255 || 2 || 257 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 0 || 0 || 0 || 0 || 349 || 0 || 349 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 0 || 0 || 0 || 92 || 0 || 92 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.o. || Cattle || 0 || 0 || 0 || 0 || 39 || 24 || 63 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 0 || 552 || 0 || 0 || 528 || 0 || 1080 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 336 || 336 || 6.y. || Fish || 0 || 0 || 0 || 414 || 0 || 137 || 551 || 6.z. || TOTAL || 139 || 1144 || 0 || 414 || 8025 || 1659 || 11381 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 180 || 128 || 415 || 0 || 80 || 0 || 427 || 0 || 0 || 0 || 208 || 0 || 501 || 1939 7.b. || Rats || 0 || 52 || 2213 || 0 || 0 || 0 || 815 || 490 || 0 || 454 || 2062 || 0 || 438 || 6524 7.c. || Guinea-Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 190 || 190 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 49 || 3 || 0 || 3 || 0 || 0 || 0 || 0 || 197 || 0 || 5 || 257 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 229 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 120 || 349 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 0 || 55 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 37 || 92 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 24 || 0 || 0 || 0 || 0 || 0 || 39 || 63 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1080 || 1080 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 336 || 0 || 336 7.y. || Fish || 414 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 137 || 0 || 551 7.z. || TOTAL || 594 || 180 || 2961 || 3 || 80 || 3 || 1266 || 490 || 0 || 454 || 2467 || 473 || 2410 || 11381 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 180 || 180 || 2743 || 0 || 0 || 0 || 1042 || 490 || 0 || 454 || 2467 || 0 || 1428 || 8984 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 9 || 3 || 20 || 3 || 0 || 0 || 0 || 0 || 0 || 473 || 0 || 508 8.c. || Products/substances used or intended to be used mainly in industry || 414 || 0 || 209 || 0 || 60 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 683 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 321 || 321 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.i. || Other toxicological or safety evaluations || 0 || 0 || 0 || 0 || 0 || 0 || 224 || 0 || 0 || 0 || 0 || 0 || 661 || 885 8.j. || TOTAL || 594 || 180 || 2961 || 3 || 80 || 3 || 1266 || 490 || 0 || 454 || 2467 || 473 || 2410 || 11381 BULGARIA Statistical data submitted The statistical data were submitted by the
Ministry of Agriculture and Food. Comments of the Bulgarian authorities The objective of this report is to present the approximation of laws, regulations and administrative provisions
of the Member States regarding the protection of animals used for experimental
and other scientific purposes, the statistical data on
the number of animals used for experimental and other scientific purposes in Republic of Bulgaria. This report contains statistical data on
the animals used for experimental and other scientific purposes. The data for
this report covers the year
2011. The Bulgarian Food
Safety Agency (BFSA) is the competent authority on Animal welfare issues in Republic
of Bulgaria. An organizational
and implementation principle is that the AW requirements on the matters
concerning animals used for experimental purposes must be performed by the 28 Regional Food Safety Directorates (RFSD)
within the BFSA. The requirements of Directive 86/609/EEC
have been transposed into the
national legislation, namely in Ordinance № 15 on the minimum requirements for protection and
welfare of laboratory animals and the requirements to
the establishments using, breeding and/or supplying such animals (in force since 01.05.2006; published in SG No. 17 of 24 February 2006) and in the Law for Veterinary Activities. In Bulgaria, experiments involving usage of
live animals are carried out only where it is not possible to apply any
alternative method(s) of the same purpose and result. The use of experimental animals is
permitted only in premises, that
are authorized as being in compliance with the requirements laid down in
Article 153 (1) of the Law on Veterinary Activities and which have official
permit signed by the BFSA Executive Director. The BFSA Executive Director would issue the above mentioned permit on
the basis of an ethical assessment and a positive opinion from the Animal Ethics
Commission within BFSA. The Animal Ethics Commission has been
established as a permanently operating consultative body with the BFSA Executive Director. The members of the Animal
Ethics Commission are as follows: An official veterinary officer representing
BFSA; 1. A veterinarian representing the Faculties of Veterinary Medicine; 2. A physician of toxicological specialization representing Ministry of
Health; 3. A scientist or researcher of biological specialization representing
Bulgarian Academy of Sciences; 4. An environmental expert representing Ministry of Environment and
Water; 5. A zoologist representing the Biology Faculty at Sofia University; 6. A physician representing the Medical University in Sofia; 7. Two representatives of NGOs operating in the field of AW and
protection of animals; 8. A lawyer representing the Ministry of Agriculture and Food; 9. A veterinarian representing the Ministry of Agriculture and Food. The BFSA have a register of licenses for animals used for scientific purposes, published on the web-site: http://babh.government.bg/uploads/File/ENG/Registers/ZHOJ/Register_engl_opitni_jivotni.pdf The register is updated regularly. In order to present an overall evaluation
and subsequently a graphical analysis, animal species were grouped. The Figure
1 gives an overview of the species used in 2011 in Republic of Bulgaria. Amphibians
represent the highest percentage of the animals used in 2011 (24.83%) followed
by the mice (22.13%) and guinea pigs (21.44%) are by far the most commonly used
species. Comparison
between proportions of classes of animals used in 2008 and 2011 Class of species || 2008 (%) || 2011(%) Mice || 49,90 || 22,13 Rats || 13,85 || 14,88 Guinea-Pigs || 11,80 || 21,44 Hamsters || 0,56 || 2,99 Rabbits- || 2,50 || Cats || 0,03 || 4,76 Dogs || 0,05 || 0,05 Horses || 0,05 || Pigs || 0,42 || Goats || 0,25 || Sheep || 0,77 || Cattle || 0,39 || Other birds || 4,54 || 0,64 Amphibians || 14,74 || 24.83 Fish - || 0,15 || 0.17 Comparison with the data of the previous report The comparison
aims to detect changes in trends rather than draw formal conclusions. The most
significant change that has taken place since 2008 is that the number of
animals used for research and development for human medicine, dentistry and
veterinary medicine has dropped sharply from 32,581 to 17,259. The number of
mice used in 2011 has drastically decreased with more than 25% - from 49.90 %
in 2008 to 22.13% in 2011. In 2011 the use of cold-blooded animals has
increased with about 10% - from 14, 75% in 2008 to 24,83%. Birds seem to
be decrease over the years from 4.54 to 0.64%. The group of horses, donkeys and
cross-bred animals (artiodactyla) and pigs, goats, sheep and cattle
(perissodactyla) fluctuates at around 1%. In Bulgaria the
animals used for scientific purposes in 2011 are originated from EU countries. The following experiments were carried
out in 2011: ·
Education and training
(E&T) ·
Biological studies of a fundamental nature ·
Research and development of products and devices
for human medicine and dentistry and for veterinary medicine (R&D) ·
Toxicological and other safety evaluations
(including safety evaluation of products and devices for human medicine and
dentistry and for veterinary ·
Medicine (T&S evaluations) ·
Studies and Diagnosis of
Human and Animal disease (S&D of
disease) Experiments
which are not permitted in Bulgaria: (1)
for educational purposes, which cause death of
animals; in educational establishments animal experiments shall be replaced by
other methods for visualizing the subject taught in all cases where the use of
animals might be replaced by other methods and if the aim is not to provide the
students with specific practical skills; (2)
if the result can be achieved with any method
not involving the use of live animal(s); (3)
if they use stray and/or domestic dogs or cats
as experimental animals. Table 2.2
presents the results of the consolidated data of the purposes of the procedures
carried out in Republic of Bulgaria in 2011. The number of
animals used for selected purposes is presented in Figure 2: The percentage
of animals used for selected purposes is presented in Figure 3: The main
percentage of used animals is for education and training – 33.79%. The 25, 59%
of animals were used in fundamental biological studies. Toxicological
and other safety evaluation represents 17.41% of the total number of animals
used for experimental purposes. Production and
quality control of products and devices in human medicine, veterinary medicine
and dentistry required the use of 4.64% of the total number of animals. Conclusion: In 2011 in Republic of Bulgaria there is a huge decrease with about 53% in
the total number of animals used. The main percentage of used animals is for education and training. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 3819 || 2206 || 13 || 1600 || || 1.b. || Rats (Rattus norvegicus) || 2569 || 2569 || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 3700 || 700 || || 3000 || || 1.d. || Hamsters (Mesocricetus ) || 516 || 516 || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 822 || 579 || 3 || 240 || || 110 1.g. || Cats (Felis catus) || 8 || 8 || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || 110 || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || 320 || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 1080 || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || 4285 || || || || || 1.y. || Fish (Pisces) || 30 || || || || || 1.z. || TOTAL || 17259 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 1034 || 265 || 200 || 400 || 1195 || 40 || 685 || || 3819 2.b. || Rats || 1082 || 682 || || || 10 || || 627 || 168 || 2569 2.c. || Guinea-Pigs || 390 || || 532 || 1200 || 1510 || || 68 || || 3700 2.d. || Hamsters || 512 || || || || || || 4 || || 516 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || 9 || || 60 || 310 || 240 || || 193 || 10 || 822 2.g. || Cats || || || 8 || || || || || || 8 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || || || || 110 || || || || || 110 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || 300 || || || 20 || || || || || 320 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || 1030 || || || || 50 || || || || 1080 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || 60 || || || || || || 4225 || || 4285 2.y. || Fish || || || || || || || 30 || || 30 2.z. || TOTAL || 4417 || 947 || 800 || 2040 || 3005 || 40 || 5832 || 178 || 17259 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 945 || || || || || || || || 250 || 1195 3.b. || Rats || || || || || || || || || 10 || 10 3.c. || Guinea-Pigs || 1100 || || || || || || || || 410 || 1510 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 120 || || || || || || || || 120 || 240 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || 50 || 50 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 2165 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 840 || 3005 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 40 || 211 || || 204 || 170 || 625 4.b. || Rats || || 5 || || 233 || 84 || 322 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || || || || 16 || || 16 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || || || 0 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || 80 || 80 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 40 || 216 || 0 || 453 || 334 || 1043 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || 600 || || || || || 600 || 5.b. || Rats || || || || || || || 0 || 5.c. || Guinea-Pigs || || 1600 || || || || || 1732 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || 150 || || || || || 370 || 5.g. || Cats || || 8 || || || || || 8 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 110 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 20 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 0 || 2358 || 0 || 0 || 0 || 0 || 2840 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || 1195 || || || || || 1195 || 6.b. || Rats || || 10 || || || || || 10 || 6.c. || Guinea-Pigs || || 1510 || || || || || 1510 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || 240 || || || || || 240 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || || || 0 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || || 0 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || 50 || || || || || 50 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || || 0 || 6.z. || TOTAL || 0 || 3005 || 0 || 0 || 0 || 0 || 3005 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || 945 || || || || || || 50 || || || || || 200 || 1195 7.b. || Rats || || || || || || || || 10 || || || || || || 10 7.c. || Guinea-Pigs || || 1100 || || || || || || 110 || || || || || 300 || 1510 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || 120 || || || || || || || || || || || 120 || 240 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || || || || || || || || || || || || 0 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || 50 || || || || || || 50 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 0 || 2165 || 0 || 0 || 0 || 0 || 0 || 220 || 0 || 0 || 0 || 0 || 620 || 3005 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 1325 || || || || || || 220 || || || || || 620 || 2165 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || || 840 || || || || || || || || || || || || 840 8.j. || TOTAL || 0 || 2165 || 0 || 0 || 0 || 0 || 0 || 220 || 0 || 0 || 0 || 0 || 620 || 3005 CZECH REPUBLIC Statistical data submitted The statistical data were submitted by the Ministry
of Agriculture (Ministerstvo zemědělství). Comments of the Czech authorities Protection of animals and animal welfare in
the Czech Republic (CR) is the responsibility of the Ministry
of Agriculture. The animal welfare activities are implemented pursuant to
Act No. 246/1992 Coll., on the protection of animals against cruelty,
as amended. The supervision over these matters has been the responsibility of
the State Veterinary Administrations’ inspectors in 13 regions of the CR and in
Prague since 1992. Altogether 131 inspections of experiments
on animals were carried out in 2011, involving 118,558 animals. The administrative
procedure was carried out with the user establishment taking blood samples of
horses for pharmacological purposes. In 2011 a total of 354,196 animals were
used for experimental and other scientific purposes in the CR. It shall be
pointed out that 45.95% of it is represented by ringed birds (162,768 birds)
since pursuant to the relevant Czech legislation even bird ringing is an
experiment. Only 0.09 % were cats (181 cats),
0.72 % dogs (1,386 dogs), 0.02% monkeys (30 monkeys) of the remaining 191,428
animals used for experimental and scientific purposes while no apes were used.
Rodents and rabbits (60.60%, i.e. 116,010 animals) and fish (27.61%, i.e. 52,861
fish) represent the prevailing majority of animals used. In the last couple of years the number of
experimental animals used in the CR was approximately the same (approximately
210,000 animals excluding ringed birds). Fluctuations in numbers, if any, are
caused by experiments using fish and poultry because these experiments are
usually conducted on a large group of animals (a flock in houses or stock in
water reservoirs). The use of alternative methods to
experiments on animals has been pushed through in the CR. Persons who manage,
control and conduct experiments on animals are obliged to seek in the registers
of validated alternative methods such methods which are applicable to their
experiment. In the experimental project the applicant shall declare in writing
that no validated alternative method can be applied for the given purpose. The training courses for persons who
manage, control and conduct experiments on animals comprise also teaching of
alternative methods to experiments on animals. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 72855 || 72599 || 256 || 0 || 0 || 1.b. || Rats (Rattus norvegicus) || 30829 || 30641 || 188 || 0 || 0 || 1.c. || Guinea-Pigs (Cavia porcellus) || 3304 || 3304 || 0 || 0 || 0 || 1.d. || Hamsters (Mesocricetus ) || 119 || 49 || 70 || 0 || 0 || 1.e. || Other Rodents (other Rodentia) || 1316 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 7677 || 4540 || 3137 || 0 || 0 || 20 1.g. || Cats (Felis catus) || 181 || 181 || 0 || 0 || 0 || 260 1.h. || Dogs (Canis familiaris) || 1386 || 1346 || 40 || 0 || 0 || 52 1.i. || Ferrets (Mustela putorius furo) || 193 || 185 || 8 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 45 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 595 || || || || || 1.l. || Pigs (Sus) || 2283 || || || || || 1.m. || Goats (Capra) || 106 || || || || || 1.n. || Sheep (Ovis) || 1147 || || || || || 1.o. || Cattle (Bos) || 783 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 30 || 30 || 0 || 0 || 0 || 0 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 2838 || || || || || 1.u. || Quail (Coturnix coturnix) || 230 || 230 || 0 || 0 || 0 || 1.v. || Other birds (other Aves) || 170261 || || || || || 1.w. || Reptiles (Reptilia) || 1258 || || || || || 1.x. || Amphibians (Amphibia) || 3989 || || || || || 1.y. || Fish (Pisces) || 52771 || || || || || 1.z. || TOTAL || 354196 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 41191 || 4154 || 286 || 12623 || 5310 || 4594 || 2924 || 1773 || 72855 2.b. || Rats || 21280 || 5046 || 78 || 550 || 2228 || 122 || 1525 || 0 || 30829 2.c. || Guinea-Pigs || 1263 || 316 || 0 || 1071 || 600 || 2 || 52 || 0 || 3304 2.d. || Hamsters || 12 || 100 || 0 || 0 || 0 || 0 || 4 || 3 || 119 2.e. || Other Rodents || 1163 || 0 || 0 || 0 || 70 || 0 || 48 || 35 || 1316 2.f. || Rabbits || 1123 || 111 || 69 || 5665 || 418 || 83 || 163 || 45 || 7677 2.g. || Cats || 0 || 56 || 0 || 8 || 112 || 0 || 5 || 0 || 181 2.h. || Dogs || 0 || 1021 || 0 || 118 || 232 || 0 || 15 || 0 || 1386 2.i. || Ferrets || 0 || 185 || 0 || 0 || 8 || 0 || 0 || 0 || 193 2.j. || Other Carnivores || 13 || 0 || 0 || 0 || 32 || 0 || 0 || 0 || 45 2.k. || Horses, donkeys and cross breds || 6 || 170 || 0 || 387 || 11 || 0 || 13 || 8 || 595 2.l. || Pigs || 1042 || 487 || 0 || 556 || 127 || 0 || 71 || 0 || 2283 2.m. || Goats || 62 || 0 || 0 || 0 || 0 || 20 || 18 || 6 || 106 2.n. || Sheep || 646 || 58 || 0 || 92 || 0 || 315 || 36 || 0 || 1147 2.o. || Cattle || 259 || 167 || 0 || 253 || 21 || 20 || 63 || 0 || 783 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 0 || 28 || 0 || 0 || 0 || 0 || 0 || 2 || 30 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 2477 || 0 || 0 || 182 || 179 || 0 || 0 || 0 || 2838 2.u. || Quail || 161 || 0 || 0 || 0 || 0 || 0 || 69 || 0 || 230 2.v. || Other birds || 162768 || 5608 || 0 || 689 || 0 || 55 || 349 || 792 || 170261 2.w. || Reptiles || 1166 || 0 || 0 || 0 || 0 || 0 || 92 || 0 || 1258 2.x. || Amphibians || 3891 || 0 || 0 || 0 || 0 || 0 || 64 || 34 || 3989 2.y. || Fish || 13772 || 0 || 0 || 0 || 32490 || 284 || 644 || 5581 || 52771 2.z. || TOTAL || 252295 || 17507 || 433 || 22194 || 41838 || 5495 || 6155 || 8279 || 354196 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 4739 || 0 || 62 || 0 || 0 || 0 || 0 || 237 || 272 || 5310 3.b. || Rats || 1366 || 0 || 862 || 0 || 0 || 0 || 0 || 0 || 0 || 2228 3.c. || Guinea-Pigs || 469 || 0 || 131 || 0 || 0 || 0 || 0 || 0 || 0 || 600 3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.e. || Other Rodents || 70 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 70 3.f. || Rabbits || 358 || 0 || 60 || 0 || 0 || 0 || 0 || 0 || 0 || 418 3.g. || Cats || 112 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 112 3.h. || Dogs || 232 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 232 3.i. || Ferrets || 8 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8 3.j. || Other Carnivores || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32 3.k. || Horses, donkeys and cross breds || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 3.l. || Pigs || 127 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 127 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.o. || Cattle || 21 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 21 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 179 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 179 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 0 || 0 || 560 || 0 || 0 || 0 || 0 || 29102 || 2828 || 32490 3.z. || TOTAL || 7724 || 0 || 1675 || 0 || 0 || 0 || 0 || 29339 || 3100 || 41838 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 1196 || 1873 || 10234 || 13084 || 1008 || 27395 4.b. || Rats || 2107 || 1700 || 2516 || 8609 || 367 || 15299 4.c. || Guinea-Pigs || 0 || 0 || 0 || 141 || 94 || 235 4.d. || Hamsters || 0 || 0 || 0 || 30 || 70 || 100 4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 4.f. || Rabbits || 116 || 0 || 0 || 390 || 185 || 691 4.g. || Cats || 0 || 0 || 0 || 4 || 52 || 56 4.h. || Dogs || 9 || 0 || 0 || 68 || 944 || 1021 4.i. || Ferrets || 0 || 0 || 0 || 185 || 0 || 185 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 6 || 170 || 176 4.l. || Pigs || 150 || 76 || 24 || 279 || 558 || 1087 4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 4.n. || Sheep || 2 || 0 || 0 || 919 || 58 || 979 4.o. || Cattle || 0 || 0 || 0 || 6 || 182 || 188 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 28 || 0 || 28 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 0 || 2709 || 4157 || 6866 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 4.y. || Fish || 0 || 0 || 0 || 0 || 697 || 697 4.z. || TOTAL || 3580 || 3649 || 12774 || 26458 || 8542 || 55003 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 3327 || 8742 || 0 || 125 || 0 || 715 || 12909 || 5.b. || Rats || 61 || 550 || 0 || 17 || 0 || 0 || 628 || 5.c. || Guinea-Pigs || 326 || 745 || 0 || 0 || 0 || 0 || 1071 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 168 || 5069 || 0 || 0 || 0 || 497 || 5734 || 5.g. || Cats || 0 || 8 || 0 || 0 || 0 || 0 || 8 || 5.h. || Dogs || 0 || 118 || 0 || 0 || 0 || 0 || 118 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 338 || 20 || 0 || 0 || 17 || 12 || 387 || 5.l. || Pigs || 60 || 0 || 0 || 0 || 198 || 0 || 258 || 5.m. || Goats || 0 || 298 || 0 || 0 || 0 || 0 || 298 || 5.n. || Sheep || 3 || 0 || 0 || 0 || 76 || 13 || 92 || 5.o. || Cattle || 0 || 0 || 0 || 0 || 232 || 0 || 232 || 5.p. || Prosimians || 0 || 21 || 0 || 0 || 0 || 0 || 21 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 68 || 182 || 0 || 15 || 606 || 0 || 871 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 4351 || 15753 || 0 || 157 || 1129 || 1237 || 22627 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 1030 || 4043 || 0 || 0 || 0 || 237 || 5310 || 6.b. || Rats || 853 || 1375 || 0 || 0 || 0 || 0 || 2228 || 6.c. || Guinea-Pigs || 88 || 512 || 0 || 0 || 0 || 0 || 600 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.e. || Other Rodents || 0 || 70 || 0 || 0 || 0 || 0 || 70 || 6.f. || Rabbits || 89 || 99 || 0 || 0 || 0 || 0 || 188 || 6.g. || Cats || 0 || 230 || 0 || 0 || 0 || 0 || 230 || 6.h. || Dogs || 114 || 112 || 0 || 0 || 0 || 0 || 226 || 6.i. || Ferrets || 0 || 118 || 0 || 0 || 0 || 0 || 118 || 6.j. || Other Carnivores || 0 || 8 || 0 || 0 || 0 || 0 || 8 || 6.k. || Horses, donkeys and cross breds || 0 || 32 || 0 || 0 || 0 || 0 || 32 || 6.l. || Pigs || 0 || 11 || 0 || 0 || 0 || 0 || 11 || 6.m. || Goats || 0 || 127 || 0 || 0 || 0 || 0 || 127 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.p. || Prosimians || 0 || 21 || 0 || 0 || 0 || 0 || 21 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 0 || 179 || 0 || 0 || 0 || 0 || 179 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 30580 || 1910 || 0 || 0 || 0 || 0 || 32490 || 6.z. || TOTAL || 32754 || 8847 || 0 || 0 || 0 || 237 || 41838 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 295 || 543 || 429 || 0 || 99 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3944 || 5310 7.b. || Rats || 196 || 853 || 108 || 0 || 0 || 0 || 314 || 0 || 127 || 269 || 280 || 0 || 81 || 2228 7.c. || Guinea-Pigs || 0 || 0 || 0 || 88 || 166 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 346 || 600 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 70 || 70 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 230 7.f. || Rabbits || 10 || 0 || 29 || 131 || 0 || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 112 || 300 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 118 || 118 7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122 || 122 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 32 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 || 11 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 127 || 127 7.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 21 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 179 || 179 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 20793 || 8909 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2788 || 0 || 32490 7.z. || TOTAL || 21294 || 10305 || 566 || 219 || 265 || 18 || 314 || 0 || 127 || 269 || 280 || 2788 || 5393 || 41838 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 245 || 1396 || 29 || 177 || 78 || 0 || 206 || 0 || 127 || 160 || 0 || 0 || 5306 || 7724 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.c. || Products/substances used or intended to be used mainly in industry || 736 || 0 || 108 || 42 || 187 || 18 || 108 || 0 || 0 || 109 || 280 || 0 || 87 || 1675 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 20181 || 7563 || 157 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1438 || 0 || 29339 8.i. || Other toxicological or safety evaluations || 132 || 1346 || 272 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1350 || 0 || 3100 8.j. || TOTAL || 21294 || 10305 || 566 || 219 || 265 || 18 || 314 || 0 || 127 || 269 || 280 || 2788 || 5393 || 41838 DENMARK Statistical data submitted The statistical data were submitted by the 'Dyreforsøgstilsynet'
(Animal Experiments Inspectorate). Comments of Danish authorities In 2011, 282,840 animals were used for
experimental purposes in Denmark, 11,372 more than in 2010. This is a modest
increase of 4.2%. However the number of traditional
laboratory animals such as mice and rats decreased from 2010 to 2011 from 154,963
to 141,991 mice and from 69,186 to 67,159 rats. This is probably due to random
changes and a general decrease in activity due to financial difficulties in
Denmark. However attention should be drawn to one
particular figure: the increase in the use of fish for experimental purposes.
From 2010 to 2011 the number of fish increased from 27,780 animals in 2010 to
51,159 animals in 2011. This increase alone almost explains the total increase
of animals used for experimental purposes in 2011. A large portion of the fish – 24,968 - were
used for modeling human neurological disorders. But many fish were also used
for development of vaccines for fish in aquaculture, potentially reducing the
need for antibiotics. When collecting the statistical information
for 2011, the Animal Experiments Inspectorate also asked for data on which and
how many of the animals were genetically modified. A total of 21,961 mice, 60 rats, 50 pigs
and 7,278 fish included in the statistics were used for in vivo experimental
purposes. Furthermore 13 new genetic modified mice strains and 83 cloned pigs
were produced. 12 of the cloned pigs were used in experiments. 4,746 mice not
included in the statistics, were used for in vitro experimental
purposes. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 141991 || 105803 || 32302 || 14 || 3872 || 1.b. || Rats (Rattus norvegicus) || 67159 || 41624 || 23412 || 0 || 2123 || 1.c. || Guinea-Pigs (Cavia porcellus) || 4672 || 290 || 4378 || 0 || 4 || 1.d. || Hamsters (Mesocricetus ) || 178 || 0 || 90 || 0 || 88 || 1.e. || Other Rodents (other Rodentia) || 115 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 3602 || 509 || 688 || 0 || 2405 || 82 1.g. || Cats (Felis catus) || 0 || 0 || 0 || 0 || 0 || 0 1.h. || Dogs (Canis familiaris) || 470 || 13 || 426 || 0 || 31 || 51 1.i. || Ferrets (Mustela putorius furo) || 129 || 129 || 0 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 197 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 67 || || || || || 1.l. || Pigs (Sus) || 8694 || || || || || 1.m. || Goats (Capra) || 74 || || || || || 1.n. || Sheep (Ovis) || 191 || || || || || 1.o. || Cattle (Bos) || 513 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 32 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || 0 || 0 || 0 || 0 || 1.v. || Other birds (other Aves) || 3245 || || || || || 1.w. || Reptiles (Reptilia) || 237 || || || || || 1.x. || Amphibians (Amphibia) || 115 || || || || || 1.y. || Fish (Pisces) || 51159 || || || || || 1.z. || TOTAL || 282840 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 50102 || 65748 || 11983 || 200 || 3490 || 1223 || 1540 || 7705 || 141991 2.b. || Rats || 13806 || 38037 || 7700 || 0 || 5190 || 53 || 1724 || 649 || 67159 2.c. || Guinea-Pigs || 187 || 312 || 4015 || 15 || 88 || 0 || 19 || 36 || 4672 2.d. || Hamsters || 88 || 0 || 0 || 0 || 90 || 0 || 0 || 0 || 178 2.e. || Other Rodents || 0 || 115 || 0 || 0 || 0 || 0 || 0 || 0 || 115 2.f. || Rabbits || 114 || 572 || 300 || 56 || 150 || 2405 || 5 || 0 || 3602 2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.h. || Dogs || 31 || 115 || 0 || 0 || 311 || 0 || 13 || 0 || 470 2.i. || Ferrets || 111 || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 129 2.j. || Other Carnivores || 197 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 197 2.k. || Horses, donkeys and cross breds || 16 || 31 || 4 || 0 || 0 || 0 || 16 || 0 || 67 2.l. || Pigs || 4265 || 1695 || 450 || 40 || 629 || 81 || 950 || 584 || 8694 2.m. || Goats || 0 || 13 || 0 || 0 || 0 || 54 || 0 || 7 || 74 2.n. || Sheep || 80 || 0 || 0 || 0 || 0 || 0 || 44 || 67 || 191 2.o. || Cattle || 392 || 28 || 5 || 5 || 0 || 0 || 83 || 0 || 513 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32 2.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.v. || Other birds || 2950 || 215 || 2 || 72 || 0 || 4 || 2 || 0 || 3245 2.w. || Reptiles || 237 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 237 2.x. || Amphibians || 115 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 115 2.y. || Fish || 41565 || 2855 || 0 || 0 || 600 || 0 || 139 || 6000 || 51159 2.z. || TOTAL || 114288 || 109754 || 24459 || 388 || 10548 || 3820 || 4535 || 15048 || 282840 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 490 || 706 || 2132 || 0 || 0 || 0 || 0 || 0 || 162 || 3490 3.b. || Rats || 2512 || 238 || 156 || 386 || 0 || 216 || 10 || 1656 || 16 || 5190 3.c. || Guinea-Pigs || 58 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 88 3.d. || Hamsters || 90 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 90 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28 || 150 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 308 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3 || 311 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 599 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 629 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 600 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 600 3.z. || TOTAL || 4779 || 944 || 2288 || 386 || 0 || 216 || 10 || 1656 || 269 || 10548 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 2765 || 25452 || 9063 || 45769 || 340 || 83389 4.b. || Rats || 2500 || 24728 || 407 || 17345 || 14 || 44994 4.c. || Guinea-Pigs || 60 || 126 || 0 || 93 || 28 || 307 4.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 4.e. || Other Rodents || 0 || 0 || 0 || 115 || 0 || 115 4.f. || Rabbits || 0 || 0 || 2405 || 470 || 0 || 2875 4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 4.h. || Dogs || 0 || 8 || 27 || 80 || 30 || 145 4.i. || Ferrets || 0 || 0 || 0 || 111 || 0 || 111 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 42 || 42 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 13 || 13 4.l. || Pigs || 469 || 95 || 62 || 2122 || 51 || 2799 4.m. || Goats || 0 || 0 || 54 || 8 || 0 || 62 4.n. || Sheep || 0 || 0 || 0 || 72 || 0 || 72 4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 20 || 20 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 0 || 117 || 1050 || 1167 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 105 || 0 || 0 || 0 || 105 4.y. || Fish || 0 || 24968 || 0 || 0 || 0 || 24968 4.z. || TOTAL || 5794 || 75482 || 12018 || 66302 || 1588 || 161184 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 0 || 9950 || 0 || 1165 || 1043 || 25 || 12183 || 5.b. || Rats || 0 || 206 || 0 || 0 || 7494 || 0 || 7700 || 5.c. || Guinea-Pigs || 15 || 3593 || 0 || 0 || 60 || 362 || 4030 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 12 || 34 || 0 || 0 || 0 || 310 || 356 || 5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 4 || 4 || 5.l. || Pigs || 40 || 22 || 0 || 0 || 428 || 0 || 490 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.o. || Cattle || 5 || 0 || 0 || 0 || 0 || 5 || 10 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 72 || 0 || 0 || 0 || 2 || 0 || 74 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 144 || 13805 || 0 || 1165 || 9027 || 706 || 24847 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 216 || 0 || 0 || 0 || 248 || 3026 || 3490 || 6.b. || Rats || 303 || 0 || 0 || 0 || 2428 || 2459 || 5190 || 6.c. || Guinea-Pigs || 22 || 0 || 0 || 0 || 36 || 30 || 88 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 90 || 0 || 90 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 0 || 0 || 0 || 0 || 150 || 0 || 150 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 0 || 0 || 0 || 0 || 311 || 0 || 311 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 0 || 0 || 0 || 629 || 0 || 629 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 0 || 0 || 0 || 0 || 0 || 600 || 600 || 6.z. || TOTAL || 541 || 0 || 0 || 0 || 3892 || 6115 || 10548 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 0 || 706 || 275 || 6 || 102 || 0 || 78 || 107 || 0 || 101 || 0 || 0 || 2115 || 3490 7.b. || Rats || 0 || 0 || 1340 || 196 || 32 || 0 || 1184 || 48 || 0 || 96 || 1952 || 0 || 342 || 5190 7.c. || Guinea-Pigs || 0 || 0 || 22 || 0 || 0 || 0 || 36 || 0 || 0 || 0 || 0 || 0 || 30 || 88 7.d. || Hamsters || 0 || 0 || 90 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 90 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 39 || 66 || 0 || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 150 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 2 || 0 || 0 || 0 || 309 || 0 || 0 || 0 || 0 || 0 || 0 || 311 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 0 || 4 || 0 || 0 || 0 || 531 || 0 || 0 || 0 || 86 || 0 || 8 || 629 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 600 || 600 7.z. || TOTAL || 0 || 706 || 1772 || 268 || 134 || 0 || 2183 || 155 || 0 || 197 || 2038 || 0 || 3095 || 10548 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 0 || 0 || 1758 || 240 || 134 || 0 || 1924 || 0 || 0 || 29 || 86 || 0 || 608 || 4779 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 706 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 238 || 0 || 0 || 944 8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 4 || 0 || 168 || 56 || 0 || 2060 || 2288 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 46 || 0 || 340 || 386 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 216 || 0 || 0 || 0 || 0 || 0 || 0 || 216 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 10 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 44 || 0 || 0 || 1612 || 0 || 0 || 1656 8.i. || Other toxicological or safety evaluations || 0 || 0 || 14 || 28 || 0 || 0 || 33 || 107 || 0 || 0 || 0 || 0 || 87 || 269 8.j. || TOTAL || 0 || 706 || 1772 || 268 || 134 || 0 || 2183 || 155 || 0 || 197 || 2038 || 0 || 3095 || 10548 GERMANY Statistical data submitted The statistical data were submitted by the 'Bundesministerium für Verbraucherschutz, Ernährung und
Landwirtschaft' (Federal Ministry for Consumer
protection, Food and Agriculture). Comments of German authorities In 2011, a total of 2,073,702 vertebrates
were used in Germany for experimental and other scientific purposes. This is a
decrease of 4,338 animals compared to the previous year. This means that for
the second time in a row, the number of animals used for the first time has
decreased from the previous year. Almost 87% of the test animals used were
rodents, primarily mice and rats. Fish accounted for 6%, and rabbits for 4%.
While there was an increase particularly in the numbers of mice, fish and sheep
used, there were also some decreases, including for rats, birds, dogs, cats and
monkeys. 60% of the
animals were used to research diseases in humans or animals. With regard to
the purposes of the experiments, there was an increase of 2.7% in basic
biological research, 4.4% in the production and quality control of medical
products and 0.5% in toxicological testing or other safety testing. On the
other hand, there was a decrease of 10.1% in their use in the research and
development of products and equipment for medicine, dentistry and veterinary
medicine, and a decrease of 21.7% in the diagnosis of diseases. The current
state of scientific knowledge means that experiments on animals cannot be
dispensed with altogether, despite the increased use of alternative methods.
The German Government nevertheless aims to limit these to the extent they
cannot be avoided and, in cases where animal testing is currently
indispensable, to ensure that the conditions in which the animals are kept and
used are in line with animal protection laws. Despite this, all efforts must
continue to be made to replace animal testing with alternative methods whenever
possible. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 1 451 046 || 1 242 489 || 193 228 || 6 894 || 8 435 || 1.b. || Rats (Rattus norvegicus) || 312 740 || 216 556 || 95 205 || 72 || 907 || 1.c. || Guinea-Pigs (Cavia porcellus) || 24 258 || 23 177 || 990 || 17 || 74 || 1.d. || Hamsters (Mesocricetus ) || 4 187 || 3 391 || 592 || 0 || 204 || 1.e. || Other Rodents (other Rodentia) || 4 111 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 87 303 || 85 679 || 1 616 || 0 || 8 || 1 857 1.g. || Cats (Felis catus) || 585 || 214 || 182 || 0 || 189 || 328 1.h. || Dogs (Canis familiaris) || 2 474 || 832 || 750 || 0 || 892 || 1 015 1.i. || Ferrets (Mustela putorius furo) || 96 || 6 || 15 || 40 || 35 || 0 1.j. || Other Carnivores (other Carnivora) || 262 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 1 140 || || || || || 1.l. || Pigs (Sus) || 15 090 || || || || || 1.m. || Goats (Capra) || 394 || || || || || 1.n. || Sheep (Ovis) || 3 287 || || || || || 1.o. || Cattle (Bos) || 4 300 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 80 1.q. || New World Monkeys (Ceboidea) || 191 || 157 || 5 || 0 || 29 || 219 1.r. || Old World Monkeys (Cercopithecoidea) || 1 579 || 244 || 1 331 || 0 || 4 || 848 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 1 154 || || || || || 1.u. || Quail (Coturnix coturnix) || 2 821 || 2 821 || 0 || 0 || 0 || 1.v. || Other birds (other Aves) || 31 271 || || || || || 1.w. || Reptiles (Reptilia) || 1 011 || || || || || 1.x. || Amphibians (Amphibia) || 4 453 || || || || || 1.y. || Fish (Pisces) || 119 949 || || || || || 1.z. || TOTAL || 2 073 702 || || || || || Note 1: Column 1.5 concerns only those
Member Countries of the Council of Europe which, at the beginning of the
reporting period, are Parties to the Convention ETS 123. Thus an updated list of
those countries has to be used when filling in this column. Note 2: Only the white boxes need to
be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 860 843 || 322 810 || 101 215 || 9 430 || 63 820 || 9 816 || 42 134 || 40 978 || 1 451 046 2.b. || Rats || 65 804 || 128 824 || 46 788 || 3 637 || 48 180 || 415 || 16 370 || 2 722 || 312 740 2.c. || Guinea-Pigs || 815 || 4 102 || 13 642 || 655 || 3 875 || 10 || 393 || 766 || 24 258 2.d. || Hamsters || 1 082 || 2 375 || 49 || 0 || 66 || 0 || 159 || 456 || 4 187 2.e. || Other Rodents || 1 775 || 1 451 || 0 || 0 || 0 || 461 || 189 || 235 || 4 111 2.f. || Rabbits || 1 193 || 3 574 || 78 308 || 854 || 2 115 || 56 || 239 || 964 || 87 303 2.g. || Cats || 35 || 369 || 71 || 1 || 66 || 5 || 14 || 24 || 585 2.h. || Dogs || 25 || 954 || 0 || 0 || 1 260 || 197 || 26 || 12 || 2 474 2.i. || Ferrets || 87 || 9 || 0 || 0 || 0 || 0 || 0 || 0 || 96 2.j. || Other Carnivores || 49 || 0 || 0 || 213 || 0 || 0 || 0 || 0 || 262 2.k. || Horses, donkeys and cross breds || 305 || 302 || 0 || 23 || 0 || 424 || 57 || 29 || 1 140 2.l. || Pigs || 2 878 || 6 616 || 92 || 556 || 339 || 2 096 || 2 287 || 226 || 15 090 2.m. || Goats || 97 || 185 || 6 || 0 || 2 || 9 || 90 || 5 || 394 2.n. || Sheep || 772 || 974 || 1 166 || 6 || 19 || 64 || 179 || 107 || 3 287 2.o. || Cattle || 1 063 || 839 || 6 || 730 || 32 || 730 || 802 || 98 || 4 300 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 82 || 11 || 0 || 0 || 0 || 0 || 0 || 98 || 191 2.r. || Old World Monkeys || 36 || 56 || 0 || 0 || 1 072 || 0 || 199 || 216 || 1 579 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 1 117 || 0 || 4 || 0 || 0 || 0 || 26 || 7 || 1 154 2.u. || Quail || 10 || 0 || 0 || 0 || 2 804 || 0 || 7 || 0 || 2 821 2.v. || Other birds || 11 559 || 5 602 || 8 334 || 791 || 424 || 1 507 || 608 || 2 446 || 31 271 2.w. || Reptiles || 569 || 14 || 0 || 0 || 0 || 412 || 16 || 0 || 1 011 2.x. || Amphibians || 3 303 || 34 || 0 || 0 || 140 || 5 || 734 || 237 || 4 453 2.y. || Fish || 64 436 || 364 || 0 || 60 || 50 442 || 117 || 3 201 || 1 329 || 119 949 2.z. || TOTAL || 1 017 935 || 479 465 || 249 681 || 16 956 || 174 656 || 16 324 || 67 730 || 50 955 || 2 073 702 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 50 679 || 4 858 || 7 922 || 0 || 0 || 0 || 0 || 40 || 321 || 63 820 3.b. || Rats || 24 817 || 8 943 || 13 234 || 135 || 0 || 0 || 0 || 787 || 264 || 48 180 3.c. || Guinea-Pigs || 2 594 || 676 || 509 || 76 || 0 || 0 || 0 || 0 || 20 || 3 875 3.d. || Hamsters || 16 || 0 || 50 || 0 || 0 || 0 || 0 || 0 || 0 || 66 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 1 593 || 342 || 178 || 2 || 0 || 0 || 0 || 0 || 0 || 2 115 3.g. || Cats || 66 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 66 3.h. || Dogs || 1 166 || 94 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 260 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 339 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 339 3.m. || Goats || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 3.n. || Sheep || 19 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 19 3.o. || Cattle || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 32 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 1 072 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 072 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 2 804 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 804 3.v. || Other birds || 40 || 342 || 0 || 0 || 0 || 0 || 0 || 0 || 42 || 424 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 140 || 0 || 140 3.y. || Fish || 3 994 || 14 444 || 2 890 || 0 || 0 || 0 || 0 || 28 994 || 120 || 50 442 3.z. || TOTAL || 86 427 || 32 505 || 24 783 || 213 || 0 || 0 || 0 || 29 961 || 767 || 174 656 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 104 726 || 175 441 || 267 231 || 464 178 || 5 571 || 1 017 147 4.b. || Rats || 31 810 || 57 964 || 9 645 || 82 775 || 1 198 || 183 392 4.c. || Guinea-Pigs || 519 || 197 || 18 || 3 031 || 53 || 3 818 4.d. || Hamsters || 1 549 || 5 || 56 || 1 343 || 0 || 2 953 4.e. || Other Rodents || 0 || 193 || 0 || 1 587 || 951 || 2 731 4.f. || Rabbits || 1 257 || 137 || 131 || 2 359 || 273 || 4 157 4.g. || Cats || 0 || 7 || 0 || 9 || 378 || 394 4.h. || Dogs || 239 || 6 || 7 || 115 || 654 || 1 021 4.i. || Ferrets || 0 || 6 || 0 || 90 || 0 || 96 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 29 || 29 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 17 || 976 || 993 4.l. || Pigs || 2 219 || 113 || 55 || 1 403 || 5 358 || 9 148 4.m. || Goats || 9 || 15 || 0 || 138 || 79 || 241 4.n. || Sheep || 245 || 63 || 0 || 828 || 508 || 1 644 4.o. || Cattle || 5 || 0 || 0 || 289 || 1 421 || 1 715 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 7 || 33 || 0 || 44 || 0 || 84 4.r. || Old World Monkeys || 8 || 4 || 17 || 32 || 0 || 61 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 141 || 0 || 50 || 1 || 192 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 108 || 0 || 0 || 1 460 || 7 032 || 8 600 4.w. || Reptiles || 0 || 39 || 0 || 0 || 462 || 501 4.x. || Amphibians || 438 || 91 || 0 || 629 || 5 || 1 163 4.y. || Fish || 1 248 || 2 823 || 371 || 5 330 || 553 || 10 325 4.z. || TOTAL || 144 387 || 237 278 || 277 531 || 565 707 || 25 502 || 1 250 405 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 0 || 90 686 || 0 || 16 092 || 80 || 3 787 || 110 645 || 5.b. || Rats || 0 || 49 838 || 0 || 0 || 196 || 391 || 50 425 || 5.c. || Guinea-Pigs || 0 || 13 842 || 0 || 185 || 11 || 259 || 14 297 || 5.d. || Hamsters || 0 || 49 || 0 || 0 || 0 || 0 || 49 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 0 || 42 872 || 0 || 0 || 1 352 || 34 938 || 79 162 || 5.g. || Cats || 0 || 71 || 0 || 0 || 0 || 1 || 72 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 213 || 0 || 0 || 0 || 0 || 213 || 5.k. || Horses, donkeys and cross breds || 0 || 17 || 0 || 0 || 0 || 6 || 23 || 5.l. || Pigs || 75 || 470 || 0 || 0 || 0 || 103 || 648 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 6 || 6 || 5.n. || Sheep || 24 || 0 || 0 || 0 || 0 || 1 148 || 1 172 || 5.o. || Cattle || 0 || 730 || 0 || 0 || 0 || 6 || 736 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 4 || 4 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 0 || 869 || 0 || 0 || 8 057 || 199 || 9 125 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 60 || 60 || 5.z. || TOTAL || 99 || 199 657 || 0 || 16 277 || 9 696 || 40 908 || 266 637 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 89 || 54 028 || 0 || 0 || 8 673 || 1 030 || 63 820 || 6.b. || Rats || 361 || 24 238 || 0 || 299 || 20 199 || 3 083 || 48 180 || 6.c. || Guinea-Pigs || 0 || 3 279 || 0 || 0 || 596 || 0 || 3 875 || 6.d. || Hamsters || 0 || 66 || 0 || 0 || 0 || 0 || 66 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 0 || 1 453 || 0 || 0 || 662 || 0 || 2 115 || 6.g. || Cats || 28 || 38 || 0 || 0 || 0 || 0 || 66 || 6.h. || Dogs || 2 || 573 || 0 || 94 || 577 || 14 || 1 260 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 236 || 0 || 0 || 99 || 4 || 339 || 6.m. || Goats || 0 || 0 || 0 || 0 || 2 || 0 || 2 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 19 || 0 || 19 || 6.o. || Cattle || 0 || 32 || 0 || 0 || 0 || 0 || 32 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 234 || 0 || 0 || 838 || 0 || 1 072 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 370 || 0 || 0 || 2 434 || 0 || 2 804 || 6.v. || Other birds || 0 || 50 || 0 || 0 || 292 || 82 || 424 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 140 || 140 || 6.y. || Fish || 556 || 7 143 || 0 || 120 || 20 435 || 22 188 || 50 442 || 6.z. || TOTAL || 1 036 || 91 740 || 0 || 513 || 54 826 || 26 541 || 174 656 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 27 634 || 1 829 || 6 599 || 0 || 7 771 || 0 || 1 222 || 1 054 || 130 || 5 644 || 342 || 0 || 11 595 || 63 820 7.b. || Rats || 1 818 || 2 545 || 15 606 || 560 || 0 || 0 || 5 848 || 1 880 || 2 546 || 2 930 || 6 778 || 0 || 7 669 || 48 180 7.c. || Guinea-Pigs || 20 || 0 || 0 || 0 || 3 417 || 0 || 0 || 0 || 0 || 0 || 254 || 0 || 184 || 3 875 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 50 || 0 || 0 || 16 || 66 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 73 || 281 || 15 || 180 || 19 || 0 || 138 || 0 || 1 043 || 0 || 366 || 2 115 7.g. || Cats || 0 || 0 || 32 || 0 || 0 || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 22 || 66 7.h. || Dogs || 0 || 123 || 318 || 0 || 0 || 0 || 386 || 0 || 0 || 0 || 0 || 0 || 433 || 1 260 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 39 || 114 || 0 || 0 || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 174 || 339 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 2 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 19 || 19 7.o. || Cattle || 0 || 0 || 16 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 16 || 32 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 208 || 0 || 0 || 0 || 465 || 0 || 266 || 0 || 15 || 0 || 118 || 1 072 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 164 || 370 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 270 || 2 804 7.v. || Other birds || 55 || 0 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 349 || 424 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 140 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 140 7.y. || Fish || 2 451 || 0 || 0 || 0 || 0 || 0 || 5 396 || 0 || 8 170 || 0 || 2 502 || 29 895 || 2 028 || 50 442 7.z. || TOTAL || 32 142 || 4 906 || 23 126 || 841 || 11 203 || 180 || 13 360 || 2 934 || 11 250 || 8 624 || 10 934 || 29 895 || 25 261 || 174 656 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 28 254 || 2 446 || 14 560 || 71 || 4 465 || 46 || 5 635 || 1 174 || 2 114 || 2 644 || 4 250 || 1 671 || 19 097 || 86 427 8.b. || Products/substances used or intended to be used mainly in agriculture || 2 097 || 2 312 || 2 313 || 96 || 1 408 || 87 || 852 || 1 140 || 7 078 || 2 185 || 3 735 || 4 567 || 4 635 || 32 505 8.c. || Products/substances used or intended to be used mainly in industry || 1 569 || 110 || 5 891 || 674 || 5 059 || 45 || 1 397 || 0 || 748 || 3 634 || 2 949 || 1 866 || 841 || 24 783 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 55 || 0 || 76 || 2 || 80 || 0 || 0 || 0 || 0 || 0 || 0 || 213 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 172 || 38 || 307 || 0 || 0 || 0 || 5 396 || 620 || 1 310 || 0 || 0 || 21 791 || 327 || 29 961 8.i. || Other toxicological or safety evaluations || 50 || 0 || 0 || 0 || 195 || 0 || 0 || 0 || 0 || 161 || 0 || 0 || 361 || 767 8.j. || TOTAL || 32 142 || 4 906 || 23 126 || 841 || 11 203 || 180 || 13 360 || 2 934 || 11 250 || 8 624 || 10 934 || 29 895 || 25 261 || 174 656 COMMISSION STAFF WORKING DOCUMENT Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh Report on the Statistics on the Number of Animals used for Experimental
and
other Scientific Purposes in the Member States of the European Union PART
B II: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATE TABLE OF CONTENTS ESTONIA................................................................................................................................... 5 IRELAND................................................................................................................................ 16 GREECE.................................................................................................................................. 27 SPAIN...................................................................................................................................... 37 ESTONIA Statistical
data submitted The statistical data were submitted by the
Animal Welfare and Zootechnics bureau of the Ministry of Agriculture. Comments of
Estonian authorities Estonia has 10 approved experimental animal
breeding and user establishments. Six of them are active at the University of
Tartu. Commission of the authorization of the
animal testing permits first started in August 2004. During the period 2009-2011 there have been
issued 92 licenses for conducting animal experiments in Estonia. Most of the
experiments have been conducted at the University of Tartu. The majority of laboratory animals used are
from authorized breeding establishments in Estonia. Most experiments have been carried out in
the development of products and devices for human medicine and fields of
biological studies of a fundamental nature and research. In the field of biological studies, the
majority of experiments involved the investigation of human diseases (nervous
and mental illnesses, various forms of cancer). The authorization and licensing
animal testing and conducting animal experiments is regulated by national and
EU legislation. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 26048 || 3379 || 21109 || 0 || 1560 || 1.b. || Rats (Rattus norvegicus) || 2556 || 500 || 2056 || 0 || 0 || 1.c. || Guinea-Pigs (Cavia porcellus) || 72 || 0 || 72 || 0 || 0 || 1.d. || Hamsters (Mesocricetus ) || 120 || 0 || 120 || 0 || 0 || 1.e. || Other Rodents (other Rodentia) || 0 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 3 || 3 || 0 || 0 || 0 || 0 1.g. || Cats (Felis catus) || 0 || 0 || 0 || 0 || 0 || 0 1.h. || Dogs (Canis familiaris) || 0 || 0 || 0 || 0 || 0 || 0 1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 0 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 40 || || || || || 1.l. || Pigs (Sus) || 325 || || || || || 1.m. || Goats (Capra) || 0 || || || || || 1.n. || Sheep (Ovis) || 0 || || || || || 1.o. || Cattle (Bos) || 6750 || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || 20 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 701 || || || || || 1.w. || Reptiles (Reptilia) || 0 || || || || || 1.x. || Amphibians (Amphibia) || 0 || || || || || 1.y. || Fish (Pisces) || 4400 || || || || || 1.z. || TOTAL || 41035 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 8631 || 17357 || 0 || 0 || 60 || 0 || 0 || 0 || 26048 2.b. || Rats || 1664 || 892 || 0 || 0 || 0 || 0 || 0 || 0 || 2556 2.c. || Guinea-Pigs || 72 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 72 2.d. || Hamsters || 0 || 120 || 0 || 0 || 0 || 0 || 0 || 0 || 120 2.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.f. || Rabbits || 0 || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 3 2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.k. || Horses, donkeys and cross breds || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 40 2.l. || Pigs || 0 || 83 || 0 || 0 || 242 || 0 || 0 || 0 || 325 2.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.o. || Cattle || 6710 || 0 || 0 || 0 || 24 || 16 || 0 || 0 || 6750 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 2.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.v. || Other birds || 216 || 0 || 0 || 0 || 485 || 0 || 0 || 0 || 701 2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.y. || Fish || 400 || 4000 || 0 || 0 || 0 || 0 || 0 || 0 || 4400 2.z. || TOTAL || 17753 || 22455 || 0 || 0 || 811 || 16 || 0 || 0 || 41035 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 60 || || || || || || || || || 60 3.b. || Rats || 0 || || || || || || || || || 0 3.c. || Guinea-Pigs || 0 || || || || || || || || || 0 3.d. || Hamsters || 0 || || || || || || || || || 0 3.e. || Other Rodents || 0 || || || || || || || || || 0 3.f. || Rabbits || 0 || || || || || || || || || 0 3.g. || Cats || 0 || || || || || || || || || 0 3.h. || Dogs || 0 || || || || || || || || || 0 3.i. || Ferrets || 0 || || || || || || || || || 0 3.j. || Other Carnivores || 0 || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || 0 || || || || || || || || || 0 3.l. || Pigs || 242 || || || || || || || || || 242 3.m. || Goats || 0 || || || || || || || || || 0 3.n. || Sheep || 0 || || || || || || || || || 0 3.o. || Cattle || 24 || || || || || || || || || 24 3.p. || Prosimians || 0 || || || || || || || || || 0 3.q. || New World Monkeys || 0 || || || || || || || || || 0 3.r. || Old World Monkeys || 0 || || || || || || || || || 0 3.s. || Apes || 0 || || || || || || || || || 0 3.t. || Other Mammals || 0 || || || || || || || || || 0 3.u. || Quail || 0 || || || || || || || || || 0 3.v. || Other birds || 485 || || || || || || || || || 485 3.w. || Reptiles || 0 || || || || || || || || || 0 3.x. || Amphibians || 0 || || || || || || || || || 0 3.y. || Fish || 0 || || || || || || || || || 0 3.z. || TOTAL || 811 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 811 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 0 || 4450 || 7588 || 5719 || 0 || 17757 4.b. || Rats || 40 || 596 || 6 || 250 || 0 || 892 4.c. || Guinea-Pigs || 0 || 0 || 0 || 32 || 0 || 32 4.d. || Hamsters || 0 || 0 || 0 || 120 || 0 || 120 4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 4.f. || Rabbits || 0 || 0 || 0 || 3 || 0 || 3 4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 4.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 4.l. || Pigs || 0 || 0 || 0 || 83 || 0 || 83 4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 4.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 4.o. || Cattle || 0 || 0 || 0 || 0 || 10 || 10 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 0 || 0 || 36 || 36 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 4.y. || Fish || 0 || 0 || 0 || 0 || 4000 || 4000 4.z. || TOTAL || 40 || 5046 || 7594 || 6207 || 4046 || 22933 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || 0 || || 0 || 5.b. || Rats || || || || || 0 || || 0 || 5.c. || Guinea-Pigs || || || || || 0 || || 0 || 5.d. || Hamsters || || || || || 0 || || 0 || 5.e. || Other Rodents || || || || || 0 || || 0 || 5.f. || Rabbits || || || || || 0 || || 0 || 5.g. || Cats || || || || || 0 || || 0 || 5.h. || Dogs || || || || || 0 || || 0 || 5.i. || Ferrets || || || || || 0 || || 0 || 5.j. || Other Carnivores || || || || || 0 || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || 0 || || 0 || 5.l. || Pigs || || || || || 0 || || 0 || 5.m. || Goats || || || || || 0 || || 0 || 5.n. || Sheep || || || || || 0 || || 0 || 5.o. || Cattle || || || || || 0 || || 0 || 5.p. || Prosimians || || || || || 0 || || 0 || 5.q. || New World Monkeys || || || || || 0 || || 0 || 5.r. || Old World Monkeys || || || || || 0 || || 0 || 5.s. || Apes || || || || || 0 || || 0 || 5.t. || Other Mammals || || || || || 0 || || 0 || 5.u. || Quail || || || || || 0 || || 0 || 5.v. || Other birds || || || || || 0 || || 0 || 5.w. || Reptiles || || || || || 0 || || 0 || 5.x. || Amphibians || || || || || 0 || || 0 || 5.y. || Fish || || || || || 0 || || 0 || 5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || || || 60 || || 60 || 6.b. || Rats || || || || || 0 || || 0 || 6.c. || Guinea-Pigs || || || || || 0 || || 0 || 6.d. || Hamsters || || || || || 0 || || 0 || 6.e. || Other Rodents || || || || || 0 || || 0 || 6.f. || Rabbits || || || || || 0 || || 0 || 6.g. || Cats || || || || || 0 || || 0 || 6.h. || Dogs || || || || || 0 || || 0 || 6.i. || Ferrets || || || || || 0 || || 0 || 6.j. || Other Carnivores || || || || || 0 || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || 0 || || 0 || 6.l. || Pigs || || || || || 242 || || 242 || 6.m. || Goats || || || || || 0 || || 0 || 6.n. || Sheep || || || || || 0 || || 0 || 6.o. || Cattle || || || || || 24 || || 24 || 6.p. || Prosimians || || || || || 0 || || 0 || 6.q. || New World Monkeys || || || || || 0 || || 0 || 6.r. || Old World Monkeys || || || || || 0 || || 0 || 6.s. || Apes || || || || || 0 || || 0 || 6.t. || Other Mammals || || || || || 0 || || 0 || 6.u. || Quail || || || || || 0 || || 0 || 6.v. || Other birds || || || || || 485 || || 485 || 6.w. || Reptiles || || || || || 0 || || 0 || 6.x. || Amphibians || || || || || 0 || || 0 || 6.y. || Fish || || || || || 0 || || 0 || 6.z. || TOTAL || 0 || 0 || 0 || 0 || 811 || 0 || 811 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || || 60 || || || || || || || || || || || 60 7.b. || Rats || || || 0 || || || || || || || || || || || 0 7.c. || Guinea-Pigs || || || 0 || || || || || || || || || || || 0 7.d. || Hamsters || || || 0 || || || || || || || || || || || 0 7.e. || Other Rodents || || || 0 || || || || || || || || || || || 0 7.f. || Rabbits || || || 0 || || || || || || || || || || || 0 7.g. || Cats || || || 0 || || || || || || || || || || || 0 7.h. || Dogs || || || 0 || || || || || || || || || || || 0 7.i. || Ferrets || || || 0 || || || || || || || || || || || 0 7.j. || Other Carnivores || || || 0 || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || 0 || || || || || || || || || || || 0 7.l. || Pigs || || || 242 || || || || || || || || || || || 242 7.m. || Goats || || || 0 || || || || || || || || || || || 0 7.n. || Sheep || || || 0 || || || || || || || || || || || 0 7.o. || Cattle || || || 24 || || || || || || || || || || || 24 7.p. || Prosimians || || || 0 || || || || || || || || || || || 0 7.q. || New World Monkeys || || || 0 || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || 0 || || || || || || || || || || || 0 7.s. || Apes || || || 0 || || || || || || || || || || || 0 7.t. || Other Mammals || || || 0 || || || || || || || || || || || 0 7.u. || Quail || || || 0 || || || || || || || || || || || 0 7.v. || Other birds || || || 485 || || || || || || || || || || || 485 7.w. || Reptiles || || || 0 || || || || || || || || || || || 0 7.x. || Amphibians || || || 0 || || || || || || || || || || || 0 7.y. || Fish || || || 0 || || || || || || || || || || || 0 7.z. || TOTAL || 0 || 0 || 811 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 811 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || 811 || || || || || || || || || || || 811 8.b. || Products/substances used or intended to be used mainly in agriculture || || || 0 || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || 0 || || || || || || || || || || || 0 8.d. || Products/substances used or intended to be used mainly in the household || || || 0 || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || 0 || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || 0 || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || 0 || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || 0 || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || || || 0 || || || || || || || || || || || 0 8.j. || TOTAL || 0 || 0 || 811 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 811 IRELAND Statistical data submitted The statistical data
for Ireland were provided by the Department of Health. Comments of Irish authorities[1] General ·
A total of 264,990 animals were used. This
represents an increase of 135% compared to the 112,835 animals used in 2008. ·
131 new licences were issued in 2011. This is a
reduction of 49% on the 259 licences issued in 2008. In this context, a change
in procedures, whereby licences are issued to the project leader rather than
each researcher working on the project, contributed to this reduction. ·
Rodents accounted for 98% (259,879) of all
animals used which compares to 74% (83,124) of all animals in 2008. ·
No primates were used. This was in accordance
with Ireland’s policy not to licence for the use of primates. ·
Of the animals used, 7% (17,739) were bred in
registered breeding establishments in Ireland while 6% (16,955) came from other
Member States in the EU and 86% (228,688) came from Non-EU Member States of the
Council of Europe which are parties to Convention ETS 123. When rodents are
excluded from this analysis, the % of animals bred in registered breeding
establishments in Ireland rises to 72%. ·
Regulatory requirements (195,649) and studies
related to human and animal diseases (67,977) accounted for 99.5% of all
animals used in scientific procedures. Animals Used for Selected Purposes ·
Of the 264,990 animals used, 67,977 (26%) were
involved in studies on human and animal diseases. ·
Of the 259,979 rodents used, 64,883 (25%) were
involved in studies on human and animal diseases. ·
Of the 473 dogs used, 361 (76%) were involved in
studies specific to animal diseases. ·
Of the 120 cats, 64 (53%) were involved in
studies specific to animal diseases. ·
Of the 238 horses, donkeys and crossbreds used,
216 (91%) were involved in studies specific to animal diseases. ·
Of the 348 sheep used, 317 (91%) were involved
in studies specific to animal diseases. ·
Of the 1,700 cattle used, 942 (55%) were
involved in studies on human and animal diseases. ·
All “other mammals” (480) were involved in
studies specific to animal diseases. ·
Of the 503 “other birds” used, 463 (92%) were
involved in studies specific to animal diseases. Toxicological and other Safety Evaluations ·
No animals were used in the testing of cosmetic
products. This was in accordance with Ireland’s policy not to licence procedures
involving the testing of cosmetics. ·
Toxicological and other safety evaluations
accounted for 74% (195,446) of animals used which compares with 52,065 (46%) in
2008. ·
195,309 (99.9%) of toxicological and other
safety evaluations were done pursuant to regulatory requirements. ·
194,607 (99.6%) of the animals used in
toxicological and other safety evaluations were rodents. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 248958 || 11182 || 12986 || 223996 || 794 || 1.b. || Rats (Rattus norvegicus) || 10476 || 2952 || 3781 || 3595 || 148 || 1.c. || Guinea-Pigs (Cavia porcellus) || 545 || || 96 || 449 || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 715 || 30 || 47 || 638 || || 177 1.g. || Cats (Felis catus) || 120 || 120 || || || || 59 1.h. || Dogs (Canis familiaris) || 473 || 473 || || || || 120 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 238 || || || || || 1.l. || Pigs (Sus) || 286 || || || || || 1.m. || Goats (Capra) || 39 || || || || || 1.n. || Sheep (Ovis) || 348 || || || || || 1.o. || Cattle (Bos) || 1700 || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || 480 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 503 || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || 21 || || || || || 1.y. || Fish (Pisces) || 88 || || || || || 1.z. || TOTAL || 264990 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 20283 || 33835 || 184 || || 194158 || 269 || 15 || 214 || 248958 2.b. || Rats || 5659 || 4624 || || || || 117 || 4 || 72 || 10476 2.c. || Guinea-Pigs || || 96 || || || 449 || || || || 545 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || 35 || 45 || || || 635 || || || || 715 2.g. || Cats || || 64 || || || 56 || || || || 120 2.h. || Dogs || || 361 || || || 112 || || || || 473 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || 7 || || || 22 || || 209 || || || 238 2.l. || Pigs || 5 || 54 || 7 || || 36 || || || 184 || 286 2.m. || Goats || || 39 || || || || || || || 39 2.n. || Sheep || 317 || || || || || || 2 || 29 || 348 2.o. || Cattle || 904 || 24 || || 134 || || 14 || 550 || 74 || 1700 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || 480 || || || || || || || 480 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || 463 || || 40 || 503 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || 21 || || || || || || || || 21 2.y. || Fish || 52 || || || || || || || 36 || 88 2.z. || TOTAL || 27283 || 39622 || 191 || 156 || 195446 || 1072 || 571 || 649 || 264990 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 105 || || || || || || || || 194053 || 194158 3.b. || Rats || || || || || || || || || || 0 3.c. || Guinea-Pigs || || || || || || || || || 449 || 449 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || || || || || || || || || 635 || 635 3.g. || Cats || 56 || || || || || || || || || 56 3.h. || Dogs || 112 || || || || || || || || || 112 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || 36 || || || 36 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 273 || 0 || 0 || 0 || 0 || 0 || 36 || 0 || 195137 || 195446 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 1387 || 9044 || 1927 || 41831 || 198 || 54387 4.b. || Rats || 746 || 4273 || || 5381 || || 10400 4.c. || Guinea-Pigs || || 26 || || 22 || 48 || 96 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || 17 || || || 63 || || 80 4.g. || Cats || || || || || 64 || 64 4.h. || Dogs || || || || || 361 || 361 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || 216 || 216 4.l. || Pigs || 52 || || 5 || || 2 || 59 4.m. || Goats || || || || 26 || 13 || 39 4.n. || Sheep || || || || || 317 || 317 4.o. || Cattle || 193 || || || || 749 || 942 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || 480 || 480 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || 463 || 463 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || 21 || 21 4.y. || Fish || || || || 40 || 12 || 52 4.z. || TOTAL || 2395 || 13343 || 1932 || 47363 || 2944 || 67977 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 54 || 130 || || || || || 184 || 5.b. || Rats || || || || || || || 0 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || || || || || || 0 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || 22 || || || || || 22 || 5.l. || Pigs || || || || || || 7 || 7 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || 134 || || || || || 134 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 54 || 286 || 0 || 0 || 0 || 7 || 347 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 20 || 624 || || || 193429 || 85 || 194158 || 6.b. || Rats || || || || || || || 0 || 6.c. || Guinea-Pigs || || || || || 449 || || 449 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || || || || 635 || || 635 || 6.g. || Cats || 40 || || || || || 16 || 56 || 6.h. || Dogs || 80 || 32 || || || || || 112 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || 36 || 36 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || || 0 || 6.z. || TOTAL || 140 || 656 || 0 || 0 || 194513 || 137 || 195446 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 175812 || 624 || 20 || || || || 85 || || || || || || 17617 || 194158 7.b. || Rats || || || || || || || || || || || || || || 0 7.c. || Guinea-Pigs || || || || || || || || || || || || || 449 || 449 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || || || || || || || || || 635 || 635 7.g. || Cats || || || || || || || || || || || || || 56 || 56 7.h. || Dogs || || || || || || || || || || || || || 112 || 112 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || 36 || 36 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 175812 || 624 || 20 || 0 || 0 || 0 || 85 || 0 || 0 || 0 || 0 || 0 || 18905 || 195446 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || 20 || || || || 85 || || || || || || 168 || 273 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || 36 || 36 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || 175812 || 624 || || || || || || || || || || || 18701 || 195137 8.j. || TOTAL || 175812 || 624 || 20 || 0 || 0 || 0 || 85 || 0 || 0 || 0 || 0 || 0 || 18905 || 195446 GREECE Statistical data submitted The statistical data were submitted by the 'ΥΠΟΥΡΓΕΙΟ
ΓΕΩΡΓΙΑΣ
ΓΕΝΙΚΗ Δ/ΝΣΗ
ΚΤΗΝΙΑΤΡΙΚΗΣ' (Ministry of Rural Development and Food, Directorate for Veterinary
Care, Drugs & Practice). Comments of Greek authorities The legal basis for the collection of
statistics on the number and use of vertebrate animals for experimental and
other scientific purposes in Greece is provided by: - Presidential Decree No 160/91 (Government
Gazette, Series I, No 64) on the protection of animals used for experimental
and other scientific purposes, in accordance with Council Directive 86/609/EEC,
and - Law No 2015/92 (Government Gazette,
Series I, No 30) approving the European Convention on the protection of animals
used for experimental and other scientific purposes. For the collection of statistics relating
to the year 2011, the tables, data and glossary of terms set out in European
Commission document EL/11/97/04100000 W00 of 24 June 1997 were used. The
Directorate for Veterinary Care, Drugs and Practice (Directorate-General for
Veterinary Affairs, Ministry of Rural Development and Food) sent them directly
to the educational establishments (universities and colleges of technology),
research centres, healthcare institutions and businesses and pharmaceutical
companies which use vertebrate animals for experimental and other scientific
purposes. These documents were not sent to cosmetics manufacturers for the year
in question, as our department was informed that no cosmetics company uses
animals for experimental purposes in Greece. The total number of animals used in experiments
in Greece in 2011 was 28,001, of which: 95.21% (26,659
animals) were rodents (24,354 mice - 91.35%, 2,266 rats - 8.5%,
39 guinea pigs - 0.15%), of which 29.54% were used for basic biological
research, 31.10% for research and development of medical, dental and veterinary
products and appliances, 0.07% to control the production and quality of medical
and dental products and appliances, 29.6% for toxicological and other safety
studies, 7.77% for the diagnosis of disease, 0.76% for education and training purposes
and, finally, 1.16% for other purposes. 2.5% (701
animals) were rabbits, of which 66.33% were used for basic
biological research, 7.99% for the production and quality control of veterinary
products and appliances, 14.27% for toxicological and other safety studies,
2.57% for the diagnosis of disease, 7.13% for education and training purposes
and, finally, 1.71% for other purposes. 1.39% (390
animals) were pigs, of which 58.72% were used for basic
biological research, 1.03% for research and development of medical, dental and
veterinary products and appliances, 3.08% for toxicological and other safety
studies, 1.03% for the diagnosis of disease, 34.62% for education and training
purposes and 1.54% for other purposes. ·
0.79% were amphibians
(220 animals), which were used for education and training purposes. ·
0.07% were cats
(19 animals), which were used for basic biological studies. ·
0.03% were sheep
(8 animals), which were all used for the diagnosis of disease. ·
0.01% were dogs
(4 animals), which were all used for basic biological research. The above data and the tables that have
already been sent to you show that the three categories of experiment for which
animals were most used in Greece in 2011 were biological research, followed by
research and development of medical, dental and veterinary products and
appliances and, lastly, toxicological and other safety studies. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 24354 || 24284 || || || 70 || 1.b. || Rats (Rattus norvegicus) || 2266 || 2251 || || || 15 || 1.c. || Guinea-Pigs (Cavia porcellus) || 39 || || || || 39 || 1.d. || Hamsters (Mesocricetus ) || || || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 701 || 683 || || || 18 || 1.g. || Cats (Felis catus) || 19 || 19 || || || || 1.h. || Dogs (Canis familiaris) || 4 || 4 || || || || 1.i. || Ferrets (Mustela putorius furo) || || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || 390 || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || 8 || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || || || || || || 1.q. || New World Monkeys (Ceboidea) || || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || || || || || || 1.s. || Apes (Hominoidea) || || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || || || || || || 1.v. || Other birds (other Aves) || || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || 220 || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 28001 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The number of re-used animals in column
1.7 should be excluded from the total in the column 1.2
TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 5965 || 8291 || || || 7822 || 2033 || 117 || 126 || 24354 2.b. || Rats || 1910 || || 19 || || 70 || || 85 || 182 || 2266 2.c. || Guinea-Pigs || || || || || || 39 || || || 39 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || 465 || || || 56 || 100 || 18 || 50 || 12 || 701 2.g. || Cats || 19 || || || || || || || || 19 2.h. || Dogs || 4 || || || || || || || || 4 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || 229 || 4 || || || 12 || 4 || 135 || 6 || 390 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || || || || 8 || || || 8 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || || || || 0 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || 220 || || 220 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 8592 || 8295 || 19 || 56 || 8004 || 2102 || 607 || 326 || 28001 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || || || || || || || || || 7822 || 7822 3.b. || Rats || 70 || || || || || || || || || 70 3.c. || Guinea-Pigs || || || || || || || || || || 0 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 100 || || || || || || || || || 100 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || 12 || || || || || || || || || 12 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 182 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 7822 || 8004 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || || 5638 || 2530 || 1516 || 20 || 9704 4.b. || Rats || 246 || 120 || 160 || 107 || || 633 4.c. || Guinea-Pigs || || || || || 39 || 39 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || 5 || || || 17 || 18 || 40 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || 7 || || || 4 || 10 || 21 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || 8 || 8 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 258 || 5758 || 2690 || 1644 || 95 || 10445 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || || || 0 || 5.b. || Rats || || 19 || || || || || 19 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || 56 || || || || || 56 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 0 || 75 || 0 || 0 || 0 || 0 || 75 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || || || 7822 || || 7822 || 6.b. || Rats || 70 || || || || || || 70 || 6.c. || Guinea-Pigs || || || || || || || 0 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || 100 || || || || || || 100 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || || || 0 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || 12 || || || || || || 12 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || || 0 || 6.z. || TOTAL || 182 || 0 || 0 || 0 || 7822 || 0 || 8004 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || 7822 || || || || || || || || || || || || 7822 7.b. || Rats || || || || || || || || || || || || || 70 || 70 7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || || 40 || || || || || || || 60 || 100 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || || || || || || || || || || || || 0 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || 12 || 12 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 0 || 7822 || 0 || 0 || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 142 || 8004 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || || || || 40 || || || || || || || 142 || 182 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || || 7822 || || || || || || || || || || || || 7822 8.j. || TOTAL || 0 || 7822 || 0 || 0 || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 142 || 8004 SPAIN Statistical data submitted The Statistical data were provided by the Ministry for Agriculture, Food and the Environment,
Directorate-General for Agriculture, Food and the Environment, Sub Directorate-General
for Livestock Products. Comments of Spanish authorities The 2011 statistical report on the use of
animals for experimental purposes was drawn up by the Ministry for Agriculture,
Food and the Environment using data submitted by the Autonomous Communities
which, in turn, received data from users registered in their respective
territories. In comparison with the previous report that
was submitted in 2009, there was no significant variation in the total number
of animals used. There were, however, a number of changes affecting the
distribution of the data, reflecting current trends in the type of animals and
their uses. There was: ·
An increase in the use of mice but a drop in the
use of rats; ·
A drop in the use of primates with the focus on
their use in safety tests (tests of chronic and sub-chronic toxicity); ·
An increase in animals coming from 'other
sources', which have tripled in number, the increase in mice being especially
significant. Most of these come from the United States and – in much fewer
numbers – from Japan, Canada and Australia. For the most part these are
genetically modified animals; ·
An increase in their use in studies of
fundamental biology and of human and animal diseases, and for quality
production and control; and ·
A drop in their use in safety studies
(essentially toxicology). TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 634912 || 519577 || 88532 || 798 || 26005 || 0 1.b. || Rats (Rattus norvegicus) || 126406 || 105889 || 18579 || 157 || 1781 || 0 1.c. || Guinea-Pigs (Cavia porcellus) || 13749 || 10116 || 3633 || 0 || 0 || 0 1.d. || Hamsters (Mesocricetus ) || 1492 || 1255 || 225 || 0 || 12 || 0 1.e. || Other Rodents (other Rodentia) || 80 || 0 || 0 || 0 || 0 || 0 1.f. || Rabbits (Oryctolagus cuniculus) || 21302 || 19614 || 1181 || 0 || 507 || 0 1.g. || Cats (Felis catus) || 229 || 108 || 0 || 0 || 121 || 0 1.h. || Dogs (Canis familiaris) || 1252 || 1112 || 95 || 0 || 45 || 0 1.i. || Ferrets (Mustela putorius furo) || 87 || 87 || 0 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 245 || 0 || 0 || 0 || 0 || 0 1.k. || Horses, donkeys and cross breds (Equidae) || 346 || 0 || 0 || 0 || 0 || 0 1.l. || Pigs (Sus) || 11046 || 69 || 4 || 0 || 0 || 0 1.m. || Goats (Capra) || 455 || 0 || 0 || 0 || 0 || 0 1.n. || Sheep (Ovis) || 2790 || 10 || 0 || 0 || 0 || 0 1.o. || Cattle (Bos) || 1464 || 0 || 0 || 0 || 0 || 0 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 1 || 1 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 342 || 288 || 54 || 0 || 0 || 0 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 56 || 0 || 0 || 0 || 0 || 0 1.u. || Quail (Coturnix coturnix) || 105 || 45 || 0 || 0 || 60 || 0 1.v. || Other birds (other Aves) || 21341 || 4 || 0 || 0 || 0 || 0 1.w. || Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 1.x. || Amphibians (Amphibia) || 1097 || 0 || 0 || 0 || 0 || 0 1.y. || Fish (Pisces) || 61330 || 1535 || 0 || 0 || 0 || 0 1.z. || TOTAL || 900127 || 659710 || 112303 || 955 || 28531 || 0 Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 370944 || 103633 || 24773 || 27598 || 49146 || 36806 || 5623 || 16389 || 634912 2.b. || Rats || 54843 || 34986 || 81 || 6597 || 5726 || 10841 || 6678 || 6654 || 126406 2.c. || Guinea-Pigs || 164 || 4213 || 4537 || 3376 || 1346 || 54 || 55 || 4 || 13749 2.d. || Hamsters || 606 || 348 || 0 || 0 || 128 || 408 || 2 || 0 || 1492 2.e. || Other Rodents || 15 || 0 || 0 || 0 || 0 || 0 || 25 || 40 || 80 2.f. || Rabbits || 1447 || 2612 || 6381 || 7613 || 1405 || 1235 || 267 || 342 || 21302 2.g. || Cats || 44 || 36 || 2 || 26 || 0 || 0 || 0 || 121 || 229 2.h. || Dogs || 50 || 691 || 0 || 192 || 157 || 4 || 88 || 70 || 1252 2.i. || Ferrets || 50 || 37 || 0 || 0 || 0 || 0 || 0 || 0 || 87 2.j. || Other Carnivores || 245 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 245 2.k. || Horses, donkeys and cross breds || 10 || 36 || 27 || 4 || 60 || 202 || 7 || 0 || 346 2.l. || Pigs || 407 || 4145 || 43 || 628 || 251 || 521 || 2080 || 2971 || 11046 2.m. || Goats || 43 || 55 || 51 || 2 || 0 || 0 || 137 || 167 || 455 2.n. || Sheep || 413 || 427 || 0 || 614 || 387 || 144 || 713 || 92 || 2790 2.o. || Cattle || 72 || 366 || 0 || 36 || 322 || 185 || 3 || 480 || 1464 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 2.r. || Old World Monkeys || 7 || 73 || 0 || 0 || 252 || 0 || 10 || 0 || 342 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 0 || 0 || 0 || 56 || 0 || 0 || 0 || 0 || 56 2.u. || Quail || 0 || 0 || 0 || 0 || 45 || 0 || 0 || 60 || 105 2.v. || Other birds || 875 || 3930 || 321 || 11482 || 2835 || 1250 || 131 || 517 || 21341 2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.x. || Amphibians || 1097 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1097 2.y. || Fish || 36936 || 6291 || 0 || 0 || 7195 || 2365 || 146 || 8397 || 61330 2.z. || TOTAL || 468269 || 161879 || 36216 || 58224 || 69255 || 54015 || 15965 || 36304 || 900127 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 12996 || 0 || 0 || 0 || 0 || 0 || 796 || 621 || 34733 || 49146 3.b. || Rats || 5420 || 18 || 115 || 0 || 0 || 0 || 16 || 0 || 157 || 5726 3.c. || Guinea-Pigs || 1346 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1346 3.d. || Hamsters || 128 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 128 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 1218 || 0 || 131 || 47 || 0 || 0 || 9 || 0 || 0 || 1405 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 157 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 157 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 60 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 60 3.l. || Pigs || 235 || 0 || 0 || 0 || 0 || 0 || 16 || 0 || 0 || 251 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 387 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 387 3.o. || Cattle || 322 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 322 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 252 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 252 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45 3.v. || Other birds || 333 || 0 || 0 || 0 || 0 || 0 || 2502 || 0 || 0 || 2835 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 4000 || 0 || 0 || 0 || 0 || 276 || 0 || 456 || 2463 || 7195 3.z. || TOTAL || 26854 || 63 || 246 || 47 || 0 || 276 || 3339 || 1077 || 37353 || 69255 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 35673 || 85766 || 141240 || 121534 || 16315 || 400528 4.b. || Rats || 6520 || 27751 || 1430 || 47935 || 574 || 84210 4.c. || Guinea-Pigs || 0 || 12 || 0 || 4208 || 122 || 4342 4.d. || Hamsters || 20 || 241 || 400 || 270 || 286 || 1217 4.e. || Other Rodents || 0 || 285 || 0 || 14 || 0 || 299 4.f. || Rabbits || 125 || 69 || 6 || 2648 || 1798 || 4646 4.g. || Cats || 2 || 12 || 0 || 0 || 26 || 40 4.h. || Dogs || 0 || 0 || 3 || 287 || 284 || 574 4.i. || Ferrets || 0 || 36 || 0 || 51 || 0 || 87 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 60 || 60 4.l. || Pigs || 776 || 100 || 32 || 771 || 2452 || 4131 4.m. || Goats || 0 || 0 || 0 || 33 || 30 || 63 4.n. || Sheep || 22 || 0 || 0 || 147 || 365 || 534 4.o. || Cattle || 0 || 0 || 0 || 0 || 383 || 383 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 1 || 0 || 0 || 0 || 1 4.r. || Old World Monkeys || 4 || 40 || 2 || 281 || 0 || 327 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 56 || 56 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 0 || 0 || 5202 || 5202 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 46 || 100 || 409 || 0 || 555 4.y. || Fish || 2306 || 608 || 9603 || 10278 || 5979 || 28774 4.z. || TOTAL || 45448 || 114967 || 152816 || 188866 || 33932 || 536029 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 0 || 37024 || 0 || 0 || 8459 || 6888 || 52371 || 5.b. || Rats || 0 || 6678 || 0 || 0 || 0 || 0 || 6678 || 5.c. || Guinea-Pigs || 0 || 3524 || 0 || 984 || 3363 || 42 || 7913 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 0 || 8021 || 13 || 0 || 5901 || 59 || 13994 || 5.g. || Cats || 0 || 28 || 0 || 0 || 0 || 0 || 28 || 5.h. || Dogs || 0 || 192 || 0 || 0 || 0 || 0 || 192 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 31 || 0 || 0 || 0 || 0 || 31 || 5.l. || Pigs || 0 || 591 || 15 || 0 || 0 || 65 || 671 || 5.m. || Goats || 0 || 51 || 0 || 0 || 0 || 2 || 53 || 5.n. || Sheep || 30 || 532 || 0 || 0 || 0 || 52 || 614 || 5.o. || Cattle || 10 || 15 || 0 || 0 || 0 || 11 || 36 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 56 || 0 || 56 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 1144 || 10580 || 0 || 0 || 79 || 0 || 11803 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 1184 || 67267 || 28 || 984 || 17858 || 7119 || 94440 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 2040 || 18978 || 75 || 465 || 25054 || 2534 || 49146 || 6.b. || Rats || 931 || 1039 || 0 || 61 || 2771 || 924 || 5726 || 6.c. || Guinea-Pigs || 0 || 787 || 0 || 168 || 0 || 391 || 1346 || 6.d. || Hamsters || 128 || 0 || 0 || 0 || 0 || 0 || 128 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 0 || 1062 || 0 || 102 || 230 || 11 || 1405 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 0 || 0 || 0 || 0 || 157 || 0 || 157 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 60 || 0 || 0 || 0 || 0 || 0 || 60 || 6.l. || Pigs || 22 || 183 || 0 || 0 || 46 || 0 || 251 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 299 || 20 || 0 || 0 || 68 || 0 || 387 || 6.o. || Cattle || 230 || 38 || 0 || 0 || 54 || 0 || 322 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 252 || 0 || 252 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 45 || 0 || 0 || 0 || 0 || 0 || 45 || 6.v. || Other birds || 0 || 2735 || 0 || 0 || 100 || 0 || 2835 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 456 || 4000 || 0 || 0 || 2463 || 276 || 7195 || 6.z. || TOTAL || 4211 || 28842 || 75 || 796 || 31195 || 4136 || 69255 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 5380 || 25942 || 8962 || 0 || 0 || 0 || 5000 || 0 || 0 || 0 || 0 || 0 || 3862 || 49146 7.b. || Rats || 68 || 323 || 234 || 0 || 32 || 0 || 2724 || 0 || 390 || 0 || 294 || 0 || 1661 || 5726 7.c. || Guinea-Pigs || 0 || 389 || 0 || 0 || 562 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 395 || 1346 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 128 || 0 || 0 || 0 || 0 || 0 || 0 || 128 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 0 || 261 || 26 || 84 || 263 || 0 || 169 || 0 || 33 || 0 || 569 || 1405 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 157 || 0 || 0 || 0 || 0 || 0 || 0 || 157 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 60 || 0 || 0 || 0 || 0 || 60 7.l. || Pigs || 0 || 0 || 0 || 6 || 0 || 0 || 0 || 0 || 22 || 0 || 0 || 0 || 223 || 251 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 299 || 0 || 0 || 0 || 88 || 387 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 0 || 0 || 0 || 92 || 322 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 252 || 0 || 0 || 0 || 0 || 0 || 0 || 252 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 45 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2835 || 2835 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 732 || 0 || 3500 || 0 || 0 || 0 || 2963 || 7195 7.z. || TOTAL || 5448 || 26654 || 9196 || 267 || 620 || 84 || 9301 || 0 || 4670 || 0 || 327 || 0 || 12688 || 69255 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 1100 || 3659 || 394 || 167 || 620 || 6 || 8279 || 0 || 4670 || 0 || 327 || 0 || 7632 || 26854 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 0 || 0 || 0 || 0 || 63 || 0 || 0 || 0 || 0 || 0 || 0 || 63 8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 53 || 0 || 78 || 115 || 0 || 0 || 0 || 0 || 0 || 0 || 246 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 47 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 47 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 276 || 0 || 0 || 0 || 0 || 0 || 0 || 276 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 53 || 768 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2518 || 3339 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 546 || 0 || 0 || 0 || 0 || 0 || 456 || 0 || 0 || 0 || 0 || 0 || 75 || 1077 8.i. || Other toxicological or safety evaluations || 3749 || 22227 || 8802 || 0 || 0 || 0 || 112 || 0 || 0 || 0 || 0 || 0 || 2463 || 37353 8.j. || TOTAL || 5448 || 26654 || 9196 || 267 || 620 || 84 || 9301 || 0 || 4670 || 0 || 327 || 0 || 12688 || 69255 [1] N.B. Two corrections were identified after the data
submission: 1) The 39 goats should be corrected to 13 goats. The detailed
information in Table 4 should be corrected from 26 goats in Column 4.5 and 13
goats in Column 4.6 to zero goats in Column 4.5 and 13 goats in Column 4.6; 2)
2 pigs listed in Column 4.6 should be moved to Column 4.5. COMMISSION STAFF WORKING DOCUMENT Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh Report on the Statistics on the Number of Animals used for Experimental
and
other Scientific Purposes in the Member States of the European Union PART
B III: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES TABLE OF CONTENTS FRANCE.................................................................................................................................... 6 ITALY...................................................................................................................................... 15 CYPRUS.................................................................................................................................. 24 LATVIA................................................................................................................................... 29 LITHUANIA............................................................................................................................ 35 LUXEMBOURG..................................................................................................................... 44 HUNGARY.............................................................................................................................. 48 MALTA.................................................................................................................................... 57 THE NETHERLANDS............................................................................................................ 60 FRANCE Statistical data submitted The statistical data were submitted by the 'Ministère
de l’Enseignement Supérieur et de la Recherche' (Ministry for Higher
Education and Research). Comments of the French authorities This study was
realized by the IsoCL Company (formerly Eficom Marketudes) for the
Research and Higher Education Ministry. In France, 2.2
million animals were used for scientific purposes in 2010, whereas 2.3 million
were used in 2007. It appears that the number of animals used showed a steady
state since 1999 with about 2.2 million. It represents a decrease of 40% in
comparison with the figures of the first statistical study in 1990. 1,326,274 of
the animals used were mice (60%). Fish accounted for 354,039 (16%) of the
animals used, rats for 252,589 (11%), and rabbits for 125,913 (6%). Cool-blooded
animals (fish, amphibian and reptiles) accounted for 357,392 (16%) of the
animals used. Non-human
primates accounted for 1,810 animals, 0.08% of the animals used, a reduction of
34% compared with 2007. Most of the non-human primates used were
cercopithecoidea (86%) and more precisely Macaca cynomolgus (70%).
Similarly to previous years, no apes were used for scientific purposes. Since 2007,
rodents (1,622,840) showed a reduction of 20%, whereas rabbits (125,913) and
fish (354,039) presented an increase of 31% and 1650%, respectively. Concerning the
purpose, 1,103,214 animals (50%) were used for research purposes: 598,532
animals (27%) were used for fundamental biology studies and 504,682 (23%) were
used for research and development and production and quality control relating
to human medicine, dentistry and veterinary medicine. 403,426 animals (18%)
were used for production and quality control of products and devices for human
medicine and dentistry. Toxicological or other safety evaluations used 78,041
animals (3.5%). TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 1 326 274 || 1 193 758 || 20 682 || 39 110 || 72 724 || 914 1.b. || Rats (Rattus norvegicus) || 252 589 || 244 910 || 674 || 1 030 || 5 975 || 2 132 1.c. || Guinea-Pigs (Cavia porcellus) || 35 543 || 31 181 || 3 857 || 410 || 95 || 0 1.d. || Hamsters (Mesocricetus ) || 8 210 || 6 805 || 243 || 0 || 1 162 || 0 1.e. || Other Rodents (other Rodentia) || 224 || 0 || 0 || 0 || 0 || 0 1.f. || Rabbits (Oryctolagus cuniculus) || 125 913 || 125 912 || 0 || 1 || 0 || 1 102 1.g. || Cats (Felis catus) || 569 || 479 || 69 || 0 || 21 || 130 1.h. || Dogs (Canis familiaris) || 3 032 || 1 840 || 373 || 129 || 690 || 825 1.i. || Ferrets (Mustela putorius furo) || 351 || 0 || 0 || 0 || 351 || 72 1.j. || Other Carnivores (other Carnivora) || 0 || 0 || 0 || 0 || 0 || 0 1.k. || Horses, donkeys and cross breds (Equidae) || 373 || 0 || 0 || 0 || 0 || 0 1.l. || Pigs (Sus) || 7 364 || 0 || 0 || 0 || 0 || 0 1.m. || Goats (Capra) || 710 || 0 || 0 || 0 || 0 || 0 1.n. || Sheep (Ovis) || 5 491 || 0 || 0 || 0 || 0 || 0 1.o. || Cattle (Bos) || 2 362 || 0 || 0 || 0 || 0 || 0 1.p. || Prosimians (Prosimia) || 83 || 83 || 0 || 0 || 0 || 83 1.q. || New World Monkeys (Ceboidea) || 163 || 160 || 3 || 0 || 0 || 156 1.r. || Old World Monkeys (Cercopithecoidea) || 1 564 || 666 || 63 || 0 || 835 || 514 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 2 || 0 || 0 || 0 || 0 || 0 1.u. || Quail (Coturnix coturnix) || 122 || 122 || 0 || 0 || 0 || 0 1.v. || Other birds (other Aves) || 71 821 || 0 || 0 || 0 || 0 || 0 1.w. || Reptiles (Reptilia) || 74 || 0 || 0 || 0 || 0 || 0 1.x. || Amphibians (Amphibia) || 3 279 || 0 || 0 || 0 || 0 || 0 1.y. || Fish (Pisces) || 354 039 || || || || || 1.z. || TOTAL || 2 200 152 || 1 605 916 || 25 964 || 40 680 || 81 853 || 5 928 Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 547 843 || 347 485 || 312 483 || 13 527 || 22 074 || 2 879 || 10 722 || 69 261 || 1 326 274 2.b. || Rats || 45 681 || 130 052 || 3 638 || 163 || 41 799 || 152 || 10 105 || 20 999 || 252 589 2.c. || Guinea-Pigs || 464 || 4 816 || 25 829 || 750 || 2 609 || 0 || 75 || 1 000 || 35 543 2.d. || Hamsters || 567 || 3 361 || 0 || 1 416 || 542 || 0 || 80 || 2 244 || 8 210 2.e. || Other Rodents || 118 || 100 || 0 || 0 || 0 || 0 || 6 || 0 || 224 2.f. || Rabbits || 1 343 || 6 922 || 53 613 || 1 015 || 3 733 || 8 || 424 || 58 855 || 125 913 2.g. || Cats || 40 || 317 || 0 || 132 || 68 || 0 || 0 || 12 || 569 2.h. || Dogs || 125 || 1 012 || 0 || 375 || 1 483 || 0 || 6 || 31 || 3 032 2.i. || Ferrets || 36 || 288 || 4 || 0 || 20 || 0 || 3 || 0 || 351 2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.k. || Horses, donkeys and cross breds || 3 || 96 || 94 || 5 || 0 || 0 || 10 || 165 || 373 2.l. || Pigs || 136 || 1 759 || 0 || 681 || 245 || 4 || 1 951 || 2 588 || 7 364 2.m. || Goats || 78 || 35 || 0 || 0 || 0 || 7 || 0 || 590 || 710 2.n. || Sheep || 18 || 510 || 10 || 808 || 161 || 0 || 5 || 3 979 || 5 491 2.o. || Cattle || 3 || 443 || 0 || 108 || 239 || 0 || 19 || 1 550 || 2 362 2.p. || Prosimians || 83 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 83 2.q. || New World Monkeys || 31 || 125 || 0 || 0 || 6 || 0 || 0 || 1 || 163 2.r. || Old World Monkeys || 110 || 484 || 86 || 0 || 811 || 0 || 0 || 73 || 1 564 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 2.u. || Quail || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 122 2.v. || Other birds || 294 || 3 818 || 7 669 || 38 277 || 45 || 0 || 58 || 21 660 || 71 821 2.w. || Reptiles || 74 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 74 2.x. || Amphibians || 1 016 || 12 || 0 || 0 || 0 || 0 || 2 238 || 13 || 3 279 2.y. || Fish || 345 || 3 047 || 0 || 0 || 4 206 || 0 || 418 || 346 023 || 354 039 2.z. || TOTAL || 598 532 || 504 682 || 403 426 || 57 257 || 78 041 || 3 050 || 26 120 || 529 044 || 2 200 152 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 9 604 || 3 122 || 1 765 || 0 || 0 || 52 || 0 || 872 || 6 659 || 22 074 3.b. || Rats || 15 019 || 5 979 || 4 235 || 0 || 40 || 70 || 54 || 756 || 15 646 || 41 799 3.c. || Guinea-Pigs || 914 || 750 || 150 || 0 || 0 || 0 || 0 || 0 || 795 || 2 609 3.d. || Hamsters || 254 || 73 || 21 || 0 || 0 || 0 || 0 || 0 || 194 || 542 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 1 043 || 397 || 212 || 0 || 0 || 0 || 0 || 0 || 2 081 || 3 733 3.g. || Cats || 68 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 68 3.h. || Dogs || 693 || 88 || 0 || 0 || 0 || 0 || 0 || 0 || 702 || 1 483 3.i. || Ferrets || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 112 || 0 || 0 || 0 || 0 || 0 || 0 || 3 || 130 || 245 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 140 || 0 || 161 3.o. || Cattle || 233 || 0 || 0 || 0 || 0 || 0 || 6 || 0 || 0 || 239 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 6 3.r. || Old World Monkeys || 242 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 569 || 811 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 45 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 86 || 2 049 || 0 || 0 || 0 || 0 || 0 || 0 || 2 071 || 4 206 3.z. || TOTAL || 28 333 || 12 458 || 6 383 || 0 || 40 || 122 || 81 || 1 771 || 28 853 || 78 041 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 94 767 || 142 675 || 178 443 || 261 176 || 221 146 || 898 207 4.b. || Rats || 38 018 || 78 662 || 4 392 || 53 274 || 1 539 || 175 885 4.c. || Guinea-Pigs || 652 || 281 || 26 || 4 028 || 293 || 5 280 4.d. || Hamsters || 506 || 0 || 72 || 1 109 || 2 241 || 3 928 4.e. || Other Rodents || 0 || 0 || 0 || 80 || 138 || 218 4.f. || Rabbits || 1 438 || 184 || 79 || 6 483 || 89 || 8 273 4.g. || Cats || 0 || 19 || 0 || 44 || 294 || 357 4.h. || Dogs || 68 || 41 || 1 || 286 || 741 || 1 137 4.i. || Ferrets || 0 || 0 || 0 || 273 || 51 || 324 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 99 || 99 4.l. || Pigs || 544 || 29 || 0 || 549 || 777 || 1 899 4.m. || Goats || 0 || 0 || 0 || 31 || 89 || 120 4.n. || Sheep || 170 || 0 || 0 || 69 || 289 || 528 4.o. || Cattle || 4 || 0 || 0 || 3 || 439 || 446 4.p. || Prosimians || 0 || 58 || 0 || 25 || 0 || 83 4.q. || New World Monkeys || 0 || 0 || 0 || 156 || 0 || 156 4.r. || Old World Monkeys || 343 || 12 || 0 || 194 || 45 || 594 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 2 || 0 || 0 || 2 4.u. || Quail || 0 || 0 || 0 || 122 || 0 || 122 4.v. || Other birds || 0 || 0 || 0 || 299 || 3 813 || 4 112 4.w. || Reptiles || 0 || 0 || 0 || 24 || 50 || 74 4.x. || Amphibians || 36 || 40 || 0 || 67 || 885 || 1 028 4.y. || Fish || 0 || 0 || 0 || 3 127 || 265 || 3 392 4.z. || TOTAL || 136 546 || 222 001 || 183 015 || 331 419 || 233 283 || 1 106 264 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 24 926 || 49 841 || 2 162 || 0 || 223 452 || 25 629 || 326 010 || 5.b. || Rats || 3 282 || 243 || 0 || 0 || 274 || 2 || 3 801 || 5.c. || Guinea-Pigs || 0 || 3 064 || 0 || 280 || 23 235 || 0 || 26 579 || 5.d. || Hamsters || 0 || 1 416 || 0 || 0 || 0 || 0 || 1 416 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 488 || 27 006 || 0 || 0 || 2 338 || 24 796 || 54 628 || 5.g. || Cats || 0 || 132 || 0 || 0 || 0 || 0 || 132 || 5.h. || Dogs || 118 || 257 || 0 || 0 || 0 || 0 || 375 || 5.i. || Ferrets || 0 || 0 || 0 || , || 4 || 0 || 4 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 99 || 0 || 0 || 0 || 0 || 99 || 5.l. || Pigs || 0 || 681 || 0 || 0 || 0 || 0 || 681 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 818 || 0 || 0 || 0 || 0 || 818 || 5.o. || Cattle || 0 || 108 || 0 || 0 || 0 || 0 || 108 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 86 || 0 || 86 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 0 || 45 916 || 0 || 0 || 0 || 30 || 45 946 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 28 814 || 129 581 || 2 162 || 280 || 249 389 || 50 457 || 460 683 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 7 193 || 3 680 || 0 || 4 092 || 5 029 || 2 080 || 22 074 || 6.b. || Rats || 10 268 || 3 372 || 162 || 9 058 || 16 064 || 2 875 || 41 799 || 6.c. || Guinea-Pigs || 610 || 954 || 0 || 745 || 163 || 137 || 2 609 || 6.d. || Hamsters || 21 || 62 || 0 || 174 || 285 || 0 || 542 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 873 || 684 || 250 || 1 336 || 469 || 121 || 3 733 || 6.g. || Cats || 0 || 0 || 0 || 0 || 68 || 0 || 68 || 6.h. || Dogs || 270 || 28 || 0 || 428 || 757 || 0 || 1 483 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 20 || 0 || 20 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 0 || 0 || 120 || 125 || 0 || 245 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 21 || 0 || 0 || 0 || 0 || 140 || 161 || 6.o. || Cattle || 6 || 8 || 0 || 0 || 225 || 0 || 239 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 6 || 0 || 6 || 6.r. || Old World Monkeys || 170 || 0 || 0 || 348 || 270 || 23 || 811 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 0 || 0 || 0 || 0 || 45 || 0 || 45 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 0 || 0 || 0 || 2 071 || 2 049 || 86 || 4 206 || 6.z. || TOTAL || 19 432 || 8 788 || 412 || 18 372 || 25 575 || 5 462 || 78 041 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 364 || 1 593 || 2 575 || 28 || 2 307 || 0 || 5 996 || 2 226 || 702 || 220 || 0 || 0 || 6 063 || 22 074 7.b. || Rats || 102 || 2 195 || 2 652 || 0 || 0 || 0 || 10 494 || 1 273 || 2 579 || 1 633 || 1 089 || 0 || 19 782 || 41 799 7.c. || Guinea-Pigs || 0 || 13 || 0 || 0 || 1 130 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 466 || 2 609 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 265 || 0 || 0 || 0 || 0 || 0 || 277 || 542 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 260 || 348 || 0 || 295 || 16 || 0 || 424 || 0 || 0 || 0 || 2 390 || 3 733 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 68 || 68 7.h. || Dogs || 0 || 0 || 78 || 0 || 0 || 0 || 563 || 0 || 0 || 0 || 0 || 0 || 842 || 1 483 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 20 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 0 || 15 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 230 || 245 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 161 || 161 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 239 || 239 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 6 7.r. || Old World Monkeys || 0 || 0 || 31 || 0 || 0 || 0 || 216 || 0 || 0 || 0 || 0 || 0 || 564 || 811 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 45 || 45 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 0 || 0 || 86 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 049 || 2 071 || 4 206 7.z. || TOTAL || 466 || 3 801 || 5 697 || 376 || 3 437 || 295 || 17 550 || 3 499 || 3 705 || 1 853 || 1 089 || 2 049 || 34 224 || 78 041 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 226 || 1 053 || 5 657 || 85 || 864 || 40 || 8 426 || 1 701 || 1 120 || 1 330 || 447 || 0 || 7 384 || 28 333 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 1 596 || 0 || 160 || 750 || 144 || 5 085 || 1 798 || 664 || 70 || 142 || 2 049 || 0 || 12 458 8.c. || Products/substances used or intended to be used mainly in industry || 0 || 211 || 0 || 116 || 1 823 || 96 || 0 || 0 || 840 || 371 || 0 || 0 || 2 926 || 6 383 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 40 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 70 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 52 || 122 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 54 || 0 || 0 || 27 || 81 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 153 || 0 || 0 || 0 || 0 || 1 267 || 0 || 0 || 28 || 0 || 0 || 323 || 1 771 8.i. || Other toxicological or safety evaluations || 240 || 718 || 0 || 15 || 0 || 15 || 2 772 || 0 || 1 081 || 0 || 500 || 0 || 23 512 || 28 853 8.j. || TOTAL || 466 || 3 801 || 5 697 || 376 || 3 437 || 295 || 17 550 || 3 499 || 3 705 || 1 853 || 1 089 || 2 049 || 34 224 || 78 041 ITALY Statistical data
submitted The statistical data were submitted by Ministry
of Health, Directorate General for Animal Health and Veterinary Medicinal
Products, Office VI, Animal Welfare. Comments of the Italian authorities The data collected have been used for the ‘EU
harmonised statistical tables’ produced by the competent national EU
authorities for 1997. In general the trend of an overall decrease in
the numbers of the animals used for experiments has been confirmed and from
1999 the numbers have been consistently under 1 million animals. This said, there has been a significant increase
in percentage terms in the use of mice (+ 2.01) and fish (+ 5.01) with regard
to 2008. The tables also show data on the animals used
for in vitro studies (euthanized to remove organs, tissues and cells). 88.99 %
of the species of animals used were rodents or rabbits. 53.78 % of animals were used in basic
biological studies. 33.87 % of animals were used for research and
development, for the production and quality control of products and appliances
for human medicine, orthodontics and veterinary medicine. 7.82 % of animals were used in toxicological
studies. 4.53 % of animals were used to diagnose
illnesses, for teaching and other purposes. In general a decrease has been noted in the
number of animals used for the production and quality control of products and
appliances for human medicine, orthodontics and veterinary medicine and for
toxicological studies (- 4.22% with regard to 2008). Article 24 of Directive 86/609/EEC, which was
transposed into Italian law with Legislative Decree No 116/92, has allowed the
introduction of stricter measures which concern, in particular, the use of
non-human primates, dogs and cats as stipulated in Article 3(2) of the
above-mentioned Legislative Decree: 'as regards non-human primates, dogs and
cats, the authorisation referred to in Article 8(1)(b) is also required.' However the use of non-human primates, dogs
and cats is permitted only after obtaining specific prior authorisation
from the Ministry of Health. All this has resulted in non-human primates,
dogs and cats accounting overall for 0.11% of the total animals used. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || || 515946 || 486030 || 13639 || 117 || 16160 1.b. || Rats (Rattus norvegicus) || || 155136 || 153134 || 1067 || 0 || 935 1.c. || Guinea-Pigs (Cavia porcellus) || || 13784 || 11155 || 2629 || 0 || 0 1.d. || Hamsters (Mesocricetus ) || || 517 || 517 || 0 || 0 || 0 1.e. || Other Rodents (other Rodentia) || || 1946 || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || || 8392 || 7847 || 545 || 0 || 0 1.g. || Cats (Felis catus) || || 0 || 0 || 0 || 0 || 0 1.h. || Dogs (Canis familiaris) || || 408 || 214 || 154 || 0 || 40 1.i. || Ferrets (Mustela putorius furo) || || 0 || 0 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || || 0 || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || 34 || || || || 1.l. || Pigs (Sus) || || 2486 || || || || 1.m. || Goats (Capra) || || 34 || || || || 1.n. || Sheep (Ovis) || || 243 || || || || 1.o. || Cattle (Bos) || || 27 || || || || 1.p. || Prosimians (Prosimia) || || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || || 79 || 68 || 11 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || || 371 || 40 || 291 || 2 || 38 1.s. || Apes (Hominoidea) || || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || || 184 || || || || 1.u. || Quail (Coturnix coturnix) || || 4 || 4 || 0 || 0 || 0 1.v. || Other birds (other Aves) || || 29305 || || || || 1.w. || Reptiles (Reptilia) || || 239 || || || || 1.x. || Amphibians (Amphibia) || || 894 || || || || 1.y. || Fish (Pisces) || || 51786 || || || || 1.z. || TOTAL || 864318 || 781815 || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 307552 || 112340 || 35049 || 1821 || 29226 || 25026 || 25 || 4907 || 515946 2.b. || Rats || 60920 || 23858 || 53323 || 880 || 14109 || 857 || 639 || 550 || 155136 2.c. || Guinea-Pigs || 1206 || 2812 || 2671 || 518 || 6531 || 21 || 0 || 25 || 13784 2.d. || Hamsters || 327 || 28 || 0 || 0 || 161 || 0 || 0 || 1 || 517 2.e. || Other Rodents || 92 || 493 || 0 || 0 || 0 || 1361 || 0 || 0 || 1946 2.f. || Rabbits || 556 || 398 || 4681 || 659 || 1918 || 161 || 0 || 19 || 8392 2.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.h. || Dogs || 0 || 49 || 0 || 0 || 359 || 0 || 0 || 0 || 408 2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.k. || Horses, donkeys and cross breds || 23 || 0 || 0 || 0 || 0 || 8 || 0 || 3 || 34 2.l. || Pigs || 319 || 350 || 7 || 840 || 453 || 1 || 473 || 43 || 2486 2.m. || Goats || 3 || 3 || 0 || 0 || 0 || 28 || 0 || 0 || 34 2.n. || Sheep || 108 || 109 || 0 || 0 || 18 || 0 || 0 || 8 || 243 2.o. || Cattle || 5 || 0 || 0 || 20 || 2 || 0 || 0 || 0 || 27 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 68 || 0 || 0 || 11 || 0 || 0 || 0 || 79 2.r. || Old World Monkeys || 19 || 55 || 35 || 0 || 262 || 0 || 0 || 0 || 371 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 184 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 184 2.u. || Quail || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 4 2.v. || Other birds || 3694 || 664 || 5 || 19778 || 4124 || 956 || 0 || 84 || 29305 2.w. || Reptiles || 238 || 0 || 0 || 0 || 0 || 0 || 0 || 1 || 239 2.x. || Amphibians || 894 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 894 2.y. || Fish || 44307 || 1660 || 0 || 1600 || 3986 || 0 || 0 || 233 || 51786 2.z. || TOTAL || 420451 || 142887 || 95771 || 26116 || 61160 || 28419 || 1137 || 5874 || 781815 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contaminants in the general environment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total 3.a. || Mice || 5390 || 0 || 90 || 0 || 0 || 0 || 160 || 0 || 23586 || 29226 3.b. || Rats || 10041 || 603 || 2228 || 0 || 0 || 311 || 0 || 0 || 926 || 14109 3.c. || Guinea-Pigs || 5992 || 468 || 0 || 0 || 0 || 0 || 0 || 0 || 71 || 6531 3.d. || Hamsters || 153 || 0 || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 161 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 1812 || 69 || 21 || 0 || 0 || 0 || 0 || 4 || 12 || 1918 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 359 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 359 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 309 || 0 || 0 || 0 || 0 || 0 || 144 || 0 || 0 || 453 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 18 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18 3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 2 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 3.r. || Old World Monkeys || 262 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 262 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 3620 || 0 || 0 || 0 || 0 || 0 || 504 || 0 || 0 || 4124 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 310 || 0 || 1866 || 0 || 0 || 0 || 0 || 1810 || 0 || 3986 3.z. || TOTAL || 28277 || 1140 || 4205 || 8 || 0 || 311 || 808 || 1814 || 24597 || 61160 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 17852 || 53875 || 88910 || 124413 || 17426 || 302476 4.b. || Rats || 3670 || 27783 || 5572 || 18448 || 606 || 56079 4.c. || Guinea-Pigs || 58 || 376 || 0 || 3330 || 0 || 3764 4.d. || Hamsters || 28 || 90 || 0 || 158 || 0 || 276 4.e. || Other Rodents || 0 || 0 || 0 || 1197 || 749 || 1946 4.f. || Rabbits || 122 || 43 || 3 || 545 || 179 || 892 4.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 4.h. || Dogs || 15 || 24 || 140 || 82 || 0 || 261 4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 4.l. || Pigs || 73 || 0 || 9 || 165 || 1 || 248 4.m. || Goats || 0 || 0 || 0 || 0 || 31 || 31 4.n. || Sheep || 14 || 0 || 2 || 59 || 33 || 108 4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 57 || 0 || 11 || 0 || 68 4.r. || Old World Monkeys || 4 || 10 || 42 || 50 || 0 || 106 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 5 || 5 4.u. || Quail || 0 || 0 || 0 || 0 || 4 || 4 4.v. || Other birds || 0 || 0 || 0 || 0 || 120 || 120 4.w. || Reptiles || 0 || 0 || 0 || 0 || 99 || 99 4.x. || Amphibians || 0 || 41 || 0 || 7 || 0 || 48 4.y. || Fish || 0 || 0 || 0 || 21151 || 120 || 21271 4.z. || TOTAL || 21836 || 82299 || 94678 || 169616 || 19373 || 387802 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 3477 || 13930 || 0 || 100 || 14863 || 4500 || 36870 || 5.b. || Rats || 72 || 4662 || 0 || 0 || 49469 || 0 || 54203 || 5.c. || Guinea-Pigs || 536 || 203 || 0 || 0 || 2450 || 0 || 3189 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 363 || 4063 || 0 || 0 || 914 || 0 || 5340 || 5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.l. || Pigs || 121 || 692 || 0 || 0 || 34 || 0 || 847 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.o. || Cattle || 0 || 20 || 0 || 0 || 0 || 0 || 20 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 35 || 0 || 35 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 1249 || 18534 || 0 || 0 || 0 || 0 || 19783 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 1600 || 0 || 0 || 0 || 0 || 0 || 1600 || 5.z. || TOTAL || 7418 || 42104 || 0 || 100 || 67765 || 4500 || 121887 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 21297 || 3702 || 10 || 0 || 4212 || 5 || 29226 || 6.b. || Rats || 3640 || 7086 || 0 || 0 || 2961 || 422 || 14109 || 6.c. || Guinea-Pigs || 93 || 4962 || 30 || 0 || 1444 || 2 || 6531 || 6.d. || Hamsters || 0 || 150 || 0 || 0 || 11 || 0 || 161 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 136 || 1409 || 0 || 0 || 311 || 62 || 1918 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 227 || 132 || 0 || 0 || 0 || 0 || 359 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 453 || 0 || 0 || 0 || 0 || 453 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 0 || 18 || 0 || 0 || 0 || 0 || 18 || 6.o. || Cattle || 2 || 0 || 0 || 0 || 0 || 0 || 2 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 11 || 0 || 0 || 0 || 0 || 11 || 6.r. || Old World Monkeys || 51 || 0 || 0 || 0 || 211 || 0 || 262 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 0 || 4124 || 0 || 0 || 0 || 0 || 4124 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 240 || 3476 || 0 || 0 || 0 || 270 || 3986 || 6.z. || TOTAL || 25686 || 25523 || 40 || 0 || 9150 || 761 || 61160 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino-genicity || 7.8 Develop-mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 320 || 5089 || 11864 || 0 || 0 || 0 || 733 || 0 || 0 || 182 || 36 || 0 || 11002 || 29226 7.b. || Rats || 24 || 405 || 5618 || 6 || 0 || 0 || 4390 || 0 || 493 || 92 || 2710 || 0 || 371 || 14109 7.c. || Guinea-Pigs || 0 || 5 || 116 || 0 || 6410 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6531 7.d. || Hamsters || 0 || 0 || 0 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 150 || 161 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 5 || 0 || 234 || 351 || 0 || 117 || 54 || 0 || 34 || 0 || 4 || 0 || 1119 || 1918 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 249 || 0 || 0 || 0 || 107 || 0 || 0 || 0 || 0 || 0 || 3 || 359 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 0 || 187 || 3 || 0 || 0 || 80 || 0 || 0 || 0 || 0 || 0 || 183 || 453 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18 || 18 7.o. || Cattle || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 11 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 11 7.r. || Old World Monkeys || 0 || 0 || 99 || 0 || 0 || 0 || 145 || 0 || 0 || 0 || 0 || 0 || 18 || 262 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 0 || 0 || 3365 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 759 || 4124 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 760 || 0 || 2136 || 0 || 0 || 0 || 1050 || 0 || 0 || 0 || 0 || 0 || 40 || 3986 7.z. || TOTAL || 1109 || 5499 || 23881 || 371 || 6410 || 117 || 6559 || 0 || 527 || 274 || 2750 || 0 || 13663 || 61160 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta-genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 329 || 402 || 12418 || 314 || 5942 || 78 || 5248 || 0 || 218 || 152 || 856 || 0 || 2320 || 28277 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 90 || 91 || 36 || 468 || 33 || 0 || 0 || 0 || 0 || 422 || 0 || 0 || 1140 8.c. || Products/substances used or intended to be used mainly in industry || 0 || 82 || 2149 || 21 || 0 || 6 || 100 || 0 || 289 || 90 || 1468 || 0 || 0 || 4205 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 8 || 8 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 36 || 25 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 0 || 0 || 218 || 311 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 160 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 648 || 808 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 760 || 0 || 0 || 0 || 0 || 0 || 1050 || 0 || 0 || 0 || 4 || 0 || 0 || 1814 8.i. || Other toxicological or safety evaluations || 20 || 4729 || 9198 || 0 || 0 || 0 || 161 || 0 || 20 || 0 || 0 || 0 || 10469 || 24597 8.j. || TOTAL || 1109 || 5499 || 23881 || 371 || 6410 || 117 || 6559 || 0 || 527 || 274 || 2750 || 0 || 13663 || 61160 CYPRUS Statistical data submitted The statistical data were submitted by Veterinary Services of the Republic of Cyprus. Comments of the Cypriot authorities None TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 1328 || 1301 || 10 || || 17 || 1.b. || Rats (Rattus norvegicus) || 0 || || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || || 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 1328 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 1139 || 108 || || || || || 81 || || 1328 2.b. || Rats || || || || || || || || || 0 2.c. || Guinea-Pigs || || || || || || || || || 0 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || || || || || || || || || 0 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || || || || || || || || || 0 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || || || || || || || 0 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || || || || 0 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 1139 || 108 || 0 || 0 || 0 || 0 || 81 || 0 || 1328 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || || 211 || 183 || 157 || || 551 4.b. || Rats || || || || || || 0 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || || || || || || 0 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || || || 0 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 0 || 211 || 183 || 157 || 0 || 551 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory requirements versus
species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || || || 0 || 5.b. || Rats || || || || || || || 0 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || || || || || || 0 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine LATVIA Statistical data submitted The statistical data were submitted by the State
Food and Veterinary Service. Comments of Latvian authorities None TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 6300 || 6300 || || || || 1.b. || Rats (Rattus norvegicus) || 4020 || 4020 || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || || 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 9 || || 9 || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 10329 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 1200 || 2111 || 2989 || || || || || || 6300 2.b. || Rats || 1370 || 527 || 2123 || || || || || || 4020 2.c. || Guinea-Pigs || || || || || || || || || 0 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || || || || || || || || || 0 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || 9 || || || || || || || 9 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || || || || || || || || || 0 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || || || || || || || 0 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || || || || 0 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 2570 || 2647 || 5112 || 0 || 0 || 0 || 0 || 0 || 10329 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total 3.a. || Mice || || || || || || || || || || 0 3.b. || Rats || || || || || || || || || || 0 3.c. || Guinea-Pigs || || || || || || || || || || 0 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || || || || || || || || || || 0 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 854 || 1587 || 291 || 579 || || 3311 4.b. || Rats || 605 || 1002 || || 290 || || 1897 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || || || || || || 0 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || 9 || || 9 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || || || 0 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 1459 || 2589 || 291 || 878 || 0 || 5217 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || 2989 || || || || || 2989 || 5.b. || Rats || || 2123 || || || || || 2123 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || || || || || || 0 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 0 || 5112 || 0 || 0 || 0 || 0 || 5112 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine LITHUANIA Statistical
data submitted The statistical
data have been submitted by the Animal Health and Welfare Department of the State
Food and Veterinary Service of the Republic of Lithuania. Comments of
Lithuanian authorities The legal basis
for the collection of statistics on the number and use of vertebrate animals
for experimental and other scientific purposes in Lithuania is provided by: The State Food
and Veterinary Service Director Decree No B1-639 (Government Gazette
2009, No 8-287) on the protection of animals used for experimental and
other scientific purposes, in accordance with Council Directive 86/609/EEC and
European Convention on the protection of animals used for experimental and
other scientific purposes. The total
number of animals used in experiments in Lithuania in 2011 was 4,067. Rodents accounted for 88,64% of all animals
used – 3,605 animals (2,131 mice – accounting for 59,11 %, 1,297 rats -
accounting for 35,98 %, 177 guinea pigs – accounting for 4,91 %). Rabbits represent 6,74
% (274 animals). Cold-blooded animals (amphibians)
represented 3,66 % of the animals used – 149 animals, of which 100 % were used
for education and training purposes. Pigs accounted for 0,5 % of the animals
used (19 animals), of which 52,63 % were used for research and development of
products and devices for human medicine and dentistry and for veterinary
medicine, 47,37 % for diagnosis of disease purposes. Birds accounted for 0,5 % (20 animals), of
which 100% were used for research and development of products and devices for
human medicine and dentistry and for veterinary medicine. No primates
were used. No animals have
been used for cosmetics testing. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 2131 || 2131 || || || || 1.b. || Rats (Rattus norvegicus) || 1297 || 1297 || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 177 || 177 || || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 274 || 274 || || || || 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || 19 || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 20 || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || 149 || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 4067 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The number of re-used animals in column
1.7 should be excluded from the total in the column 1.2
TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 574 || 1014 || 25 || || 200 || 309 || 9 || || 2131 2.b. || Rats || 670 || 506 || || || 26 || 90 || 5 || || 1297 2.c. || Guinea-Pigs || 55 || 110 || || || 7 || || 5 || || 177 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || 53 || 206 || || || 7 || 2 || 6 || || 274 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || || 10 || || || || 9 || || || 19 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || || || || || || || 0 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || 20 || || || || || || || 20 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || 149 || || 149 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 1352 || 1866 || 25 || 0 || 240 || 410 || 174 || 0 || 4067 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total 3.a. || Mice || || || || || || || 200 || || || 200 3.b. || Rats || || || || || || || 26 || || || 26 3.c. || Guinea-Pigs || || || || || || || 7 || || || 7 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || || || || || || || 7 || || || 7 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 240 || 0 || 0 || 240 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || || || 300 || 400 || || 700 4.b. || Rats || || || || || || 0 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || || || || || || 0 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || || || 0 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || 43 || || 43 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 0 || 0 || 300 || 443 || 0 || 743 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 25 || || || || || || 25 || 5.b. || Rats || || || || || || || 0 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || || || || || || 0 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 25 || 0 || 0 || 0 || 0 || 0 || 25 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || 200 || || || || 200 || 6.b. || Rats || || || 26 || || || || 26 || 6.c. || Guinea-Pigs || || || 7 || || || || 7 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || || 7 || || || || 7 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || || || 0 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || || 0 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || || 0 || 6.z. || TOTAL || 0 || 0 || 240 || 0 || 0 || 0 || 240 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino-genicity || 7.8 Develop-mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || || || || || || || || || || || || 200 || 200 7.b. || Rats || || || || || || || || || || || || || 26 || 26 7.c. || Guinea-Pigs || || || || || || || || || || || || || 7 || 7 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || || || || || || || || || 7 || 7 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || || || || || || || || || || || || 0 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 240 || 240 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || || || || || || || || || || || || 200 || 200 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || 26 || 26 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || 7 || 7 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || 7 || 7 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || || || || || || || || || || || || || || 0 8.j. || TOTAL || || || || || || || || || || || || || || 0 LUXEMBOURG Statistical data submitted The statistical data were submitted by the 'Ministère de
l’Agriculture, de la viticulture et du développement rural. Administration des Services Vétérinaires'
(Ministry of Agriculture, viticulture and rural development. Administration of
Veterinary Services). Comments of Luxembourg authorities None TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 470 || 470 || || || || 1.b. || Rats (Rattus norvegicus) || 32 || 32 || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || || 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 502 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The number of re-used animals in column 1.7 should be
excluded from the total in the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 470 || || || || || || || || 470 2.b. || Rats || 32 || || || || || || || || 32 2.c. || Guinea-Pigs || || || || || || || || || 0 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || || || || || || || || || 0 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || || || || || || || || || 0 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || || || || || || || 0 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || || || || 0 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 502 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 502 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 100 || 50 || 280 || 40 || || 470 4.b. || Rats || 20 || 12 || || || || 32 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || || || || || || 0 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || || || 0 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 120 || 62 || 280 || 40 || 0 || 502 HUNGARY Statistical data submitted The statistical data were submitted by the Ministry of Rural Development. Comments of the Hungarian authorities The total
number of animals used for experimental and other scientific purposes in 2011
was 276.179 which represents a 9,4% decrease compared to the same figure of
2008. The use of
other rodents, goats and reptiles fell to zero. The decrease was considerable
in the number of cattle (94,6%), horses and donkeys (77,5%), hamsters (59%),
amphibians (38,7%), rats (20,7%), and sheep (20%). On the other
hand the use of fish more than doubled and eighteen times as many quals were
used than in 2008. The trend of
monkeys turned in the past few years: no new world monkey were used, but the
number of old world monkeys grew. Compared to
2008 no rabbits, but cats were re-used. The amount of
animals used for production and quality control of products and devices for
veterinary medicine (more than doubled) and for toxicological and other safety
evaluations (almost doubled) were increased , but a lot less (half) were used
to education and training. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 143755 || 104761 || 38678 || 316 || 0 || 0 1.b. || Rats (Rattus norvegicus) || 70873 || 56330 || 13520 || 1023 || 0 || 0 1.c. || Guinea-Pigs (Cavia porcellus) || 9228 || 9101 || 81 || 46 || 0 || 0 1.d. || Hamsters (Mesocricetus ) || 88 || 88 || 0 || 0 || 0 || 0 1.e. || Other Rodents (other Rodentia) || 0 || 0 || 0 || 0 || 0 || 0 1.f. || Rabbits (Oryctolagus cuniculus) || 7567 || 7233 || 13 || 321 || 0 || 0 1.g. || Cats (Felis catus) || 34 || 25 || 9 || 0 || 0 || 20 1.h. || Dogs (Canis familiaris) || 675 || 370 || 144 || 161 || 0 || 88 1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 0 || 0 || 0 || 0 || 0 || 0 1.k. || Horses, donkeys and cross breds (Equidae) || 9 || 0 || 0 || 0 || 0 || 0 1.l. || Pigs (Sus) || 1278 || 79 || 2 || 0 || 0 || 0 1.m. || Goats (Capra) || 0 || 0 || 0 || 0 || 0 || 0 1.n. || Sheep (Ovis) || 160 || 0 || 0 || 0 || 0 || 0 1.o. || Cattle (Bos) || 5 || 0 || 0 || 0 || 0 || 0 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 7 || 7 || 0 || 0 || 0 || 0 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 0 || 0 || 0 || 0 || 0 || 0 1.u. || Quail (Coturnix coturnix) || 235 || 235 || 0 || 0 || 0 || 0 1.v. || Other birds (other Aves) || 36304 || 0 || 0 || 0 || 0 || 0 1.w. || Reptiles (Reptilia) || 0 || 0 || 0 || 0 || 0 || 0 1.x. || Amphibians (Amphibia) || 725 || 0 || 0 || 0 || 0 || 0 1.y. || Fish (Pisces) || 5236 || 2142 || 0 || 0 || 0 || 0 1.z. || TOTAL || 276179 || 26269 || 7891 || 1577 || 0 || 0 Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 34512 || 69495 || 15833 || 2992 || 15649 || 3175 || 829 || 1270 || 143755 2.b. || Rats || 22398 || 32540 || 111 || 0 || 12961 || 20 || 2123 || 720 || 70873 2.c. || Guinea-Pigs || 436 || 781 || 858 || 1508 || 5398 || 0 || 169 || 78 || 9228 2.d. || Hamsters || 88 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 88 2.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.f. || Rabbits || 2128 || 772 || 221 || 1077 || 3052 || 110 || 207 || 0 || 7567 2.g. || Cats || 14 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 34 2.h. || Dogs || 228 || 89 || 0 || 0 || 340 || 0 || 18 || 0 || 675 2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.k. || Horses, donkeys and cross breds || 0 || 8 || 0 || 0 || 1 || 0 || 0 || 0 || 9 2.l. || Pigs || 885 || 101 || 0 || 252 || 39 || 0 || 1 || 0 || 1278 2.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.n. || Sheep || 6 || 37 || 0 || 112 || 0 || 0 || 0 || 5 || 160 2.o. || Cattle || 2 || 0 || 0 || 0 || 3 || 0 || 0 || 0 || 5 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 7 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 7 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.u. || Quail || 0 || 0 || 0 || 0 || 235 || 0 || 0 || 0 || 235 2.v. || Other birds || 5177 || 1485 || 0 || 27725 || 30 || 15 || 146 || 1726 || 36304 2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.x. || Amphibians || 125 || 0 || 0 || 0 || 0 || 0 || 600 || 0 || 725 2.y. || Fish || 374 || 0 || 0 || 0 || 4198 || 100 || 564 || 0 || 5236 2.z. || TOTAL || 66380 || 105328 || 17023 || 33666 || 41906 || 3420 || 4657 || 3799 || 276179 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 10608 || 560 || 921 || 0 || 0 || 0 || 0 || 139 || 3421 || 15649 3.b. || Rats || 3909 || 958 || 269 || 0 || 0 || 0 || 0 || 219 || 7606 || 12961 3.c. || Guinea-Pigs || 3854 || 20 || 0 || 0 || 0 || 0 || 0 || 0 || 1524 || 5398 3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 1941 || 144 || 0 || 0 || 0 || 0 || 0 || 0 || 967 || 3052 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 196 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 144 || 340 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 3.l. || Pigs || 37 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 2 || 39 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.o. || Cattle || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 235 || 235 3.v. || Other birds || 30 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 0 || 252 || 342 || 0 || 0 || 0 || 0 || 1720 || 1884 || 4198 3.z. || TOTAL || 20579 || 1934 || 1532 || 0 || 0 || 0 || 0 || 2078 || 15783 || 41906 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 993 || 61386 || 6711 || 15545 || 2316 || 86951 4.b. || Rats || 3537 || 33058 || 563 || 5954 || 0 || 43112 4.c. || Guinea-Pigs || 46 || 0 || 0 || 176 || 68 || 290 4.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 4.f. || Rabbits || 518 || 13 || 0 || 174 || 198 || 903 4.g. || Cats || 0 || 0 || 0 || 0 || 9 || 9 4.h. || Dogs || 177 || 0 || 0 || 16 || 0 || 193 4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 1 || 1 4.l. || Pigs || 0 || 0 || 0 || 17 || 58 || 75 4.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 4.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 4.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 0 || 15 || 566 || 581 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 0 || 0 || 100 || 0 || 100 4.y. || Fish || 0 || 0 || 0 || 0 || 304 || 304 4.z. || TOTAL || 5271 || 94457 || 7274 || 21997 || 3520 || 132519 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 14094 || 4471 || 0 || 210 || 50 || 0 || 18825 || 5.b. || Rats || 111 || 0 || 0 || 0 || 0 || 0 || 111 || 5.c. || Guinea-Pigs || 215 || 2151 || 0 || 0 || 0 || 0 || 2366 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 13 || 1233 || 0 || 52 || 0 || 0 || 1298 || 5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.l. || Pigs || 0 || 252 || 0 || 0 || 0 || 0 || 252 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 112 || 0 || 0 || 0 || 0 || 112 || 5.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 0 || 27355 || 0 || 370 || 0 || 0 || 27725 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 14433 || 35574 || 0 || 632 || 50 || 0 || 50689 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 1155 || 11809 || 0 || 90 || 2112 || 483 || 15649 || 6.b. || Rats || 466 || 5317 || 0 || 186 || 6903 || 89 || 12961 || 6.c. || Guinea-Pigs || 0 || 1308 || 0 || 531 || 3559 || 0 || 5398 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 13 || 2154 || 0 || 0 || 885 || 0 || 3052 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 16 || 99 || 0 || 81 || 144 || 0 || 340 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 1 || 0 || 0 || 0 || 0 || 1 || 6.l. || Pigs || 0 || 20 || 0 || 0 || 2 || 17 || 39 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.o. || Cattle || 0 || 3 || 0 || 0 || 0 || 0 || 3 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 235 || 0 || 235 || 6.v. || Other birds || 0 || 30 || 0 || 0 || 0 || 0 || 30 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 1284 || 1094 || 0 || 20 || 1800 || 0 || 4198 || 6.z. || TOTAL || 2934 || 21835 || 0 || 908 || 15640 || 589 || 41906 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 8746 || 0 || 2189 || 0 || 2574 || 0 || 0 || 0 || 0 || 269 || 0 || 0 || 1871 || 15649 7.b. || Rats || 3915 || 0 || 3008 || 0 || 0 || 0 || 2606 || 0 || 96 || 364 || 2008 || 0 || 964 || 12889 7.c. || Guinea-Pigs || 631 || 0 || 1291 || 0 || 1822 || 0 || 1582 || 0 || 0 || 0 || 0 || 0 || 72 || 5398 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 1866 || 377 || 0 || 328 || 0 || 0 || 0 || 0 || 362 || 0 || 119 || 3052 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 148 || 0 || 0 || 0 || 176 || 0 || 0 || 0 || 0 || 0 || 16 || 340 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 1 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1 7.l. || Pigs || 0 || 0 || 37 || 0 || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 39 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.o. || Cattle || 0 || 0 || 3 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 3 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 155 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 80 || 235 7.v. || Other birds || 0 || 0 || 30 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 30 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 2327 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 712 || 1159 || 4198 7.z. || TOTAL || 15774 || 0 || 8573 || 377 || 4396 || 328 || 4366 || 0 || 96 || 633 || 2370 || 712 || 4281 || 41906 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 9377 || 0 || 6655 || 19 || 395 || 0 || 2630 || 0 || 96 || 0 || 488 || 0 || 919 || 20579 8.b. || Products/substances used or intended to be used mainly in agriculture || 1043 || 0 || 388 || 97 || 95 || 97 || 0 || 0 || 0 || 0 || 124 || 0 || 90 || 1934 8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 772 || 0 || 0 || 0 || 0 || 418 || 0 || 342 || 0 || 1532 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 1220 || 0 || 130 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 370 || 358 || 2078 8.i. || Other toxicological or safety evaluations || 4134 || 0 || 1400 || 261 || 3134 || 231 || 1736 || 0 || 0 || 215 || 1758 || 0 || 2914 || 15783 8.j. || TOTAL || 15774 || 0 || 8573 || 377 || 4396 || 328 || 4366 || 0 || 96 || 633 || 2370 || 712 || 4281 || 41906 MALTA Statistical data submitted The data were submitted by the Ministry for
Resources and Rural Affairs, Veterinary and Phytosanitary Regulation Department. Comments of Malta authorities None TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 0 || || || || || 1.b. || Rats (Rattus norvegicus) || 0 || || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 0 || || || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || 0 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 0 || || || || || 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || 0 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 0 || || || || || 1.l. || Pigs (Sus) || 0 || || || || || 1.m. || Goats (Capra) || 0 || || || || || 1.n. || Sheep (Ovis) || 0 || || || || || 1.o. || Cattle (Bos) || 0 || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || 10 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 0 || || || || || 1.w. || Reptiles (Reptilia) || 0 || || || || || 1.x. || Amphibians (Amphibia) || 0 || || || || || 1.y. || Fish (Pisces) || 0 || || || || || 1.z. || TOTAL || 10 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The number of re-used animals in column
1.7 should be excluded from the total in the column 1.2
TABLE 2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || || || || || || || || || 0 2.b. || Rats || || || || || || || || || 0 2.c. || Guinea-Pigs || || || || || || || || || 0 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || || || || || || || || || 0 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || || || || || || || || || 0 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || || || || || || || 0 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || 10 || || || || || || || || 10 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || || || || 0 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10 THE NETHERLANDS Statistical data submitted The statistical data were prepared, quality
assured and submitted by the 'Nederlandse Voedsel en Waren Autoriteit'
(Netherlands Food and Consumer Product Safety Authority). Comments of the Dutch authorities On 5 February 1997, the revised version of
the Experiments on Animals Act (1977) entered into force. The provisions of the European Directive on
the approximation of laws, regulations and administrative provisions of the
Member States regarding the protection of animals used for experimental and
other scientific purposes (86/609/EEC) have been implemented. In addition, among others the following
provisions have been issued: -
Animal experiments using LD50/LC50
methods are prohibited. However, for acute dermal and acute respiratory
toxicity tests a general exemption is granted, due to the lack of validated
alternative methods. -
Animal experiments for new or existing cosmetics
are prohibited. -
Since 2003 animal experiments on great apes are
prohibited. -
Every animal experiment to be performed has to
be recommended by a recognised ethical review committee. Such a committee comprises
at least seven members, one of whom is the chairperson. In addition, such
a committee comprises in equal numbers experts in the fields of animal
experiments, experts in the field of alternative methods, experts in the field
of animal welfare and protection and experts in the field of ethical
assessment. At least two of these experts are not involved in the conduct of
experiments on animals. The chairperson and at least two members are not in the
employ of any licence holder applying to the committee. The animal welfare
officer is involved already at an early stage in the review of experiments and
acts as a permanent advisor for the ethical review committee. At this moment 23
ethical review committees are recognized. Licenses to
perform animal experiments are issued by the Minister of Public Health, Welfare
and Sport to a natural or legal person who is a mandated representative of an
establishment for animal use. So licensed, those people are responsible for
assuring that the legal requirements are complied with. The welfare of the
experimental animals is supervised by a qualified veterinarian or another
competent person in charge of the licensee. A Standing Committee advises the Minister on the administration of the Act and other
related issues. The Committee consists of experts in the field of animal
experimentation, laboratory animal science and animal welfare. The enforcement of the Act has
been commissioned to the Netherlands Food and Consumer Product Safety
Authority.
The
creation of transgenic animals
In 2011, for the creation of
transgenic animals, 12,251 animals (11,494 mice, 546 rats, 48 other birds and
163 fish) were used. Breeding of animals which had a fenotype
with harmful effect In 2011 there were 11,890 animals used for
breeding which had a fenotype with harmful effects. Concerning 11,015
genetically altered mice, 172 genetically altered rats and 703 mice without a
genetical modification
Collection of data
72 establishments completed the 2011
registration form. These establishments can be categorized as follows: a) Universities and university hospitals 15 b) Public health research institutes
4 c) Agricultural and veterinary research institutes
3 d) Other research institutes
4 e) Industries and companies 38 f) Schools for vocational training
6 g) Breeders 2 The killing of an animal without any
previous intervention In the Netherlands, the killing of an
animal without any previous intervention in the framework of research or
testing, e.g. for organ/blood collection, is considered to be an experiment.
The rationale of this is that the Inspectorate must have the power to supervise
the killing of laboratory animals. This is in contrast to the Council of
Europe Convention ETS 123 and Directive 86/609/EEC, where the use of an animal for an experimental or other scientific
purpose is not considered an experiment if the least painful method of killing
accepted in modern practice (‘humane’ methods’) is used. In 2011, 67,196 animals were killed without
previous intervention. Re-use of the animals (in 2011, 8,077
animals) is included as well in the Dutch statistics Total number of animals used In 2011, according to the EU Tables, the
total number of animals used was 514,617. This is 3,2% (16,314) more than the number
of animals used in 2010 (498,303). The total number of genetically modified animals
that was used was 93,349. When split up into species, the numbers of
genetically modified animals used are: 89,704 mice, 419 rats, 200 rabbits and
3,026 fish. Discomfort General Data has to be registered after an
experiment has been performed. This includes data on the degree of discomfort;
i.e. experienced discomfort. As a consequence of the animal experiments
performed in 2008: ·
36,35% of the animals experienced minor
discomfort; ·
29,30% of the animals experienced minor/moderate
discomfort; ·
21,67% of the animals experienced moderate
discomfort; ·
8,98% of the animals experienced moderate/severe
discomfort; ·
3,68% of the animals experienced severe
discomfort; and ·
0.02% of the animals experienced very severe
discomfort. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 237 784 || 202 725 || 31 817 || || 3 242 || 1.b. || Rats (Rattus norvegicus) || 98 881 || 57 765 || 41 029 || || 87 || 1.c. || Guinea-Pigs (Cavia porcellus) || 5 493 || 3 191 || 2 287 || || 15 || 1.d. || Hamsters (Mesocricetus ) || 3 632 || 3 476 || 156 || || 0 || 1.e. || Other Rodents (other Rodentia) || 979 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 6 293 || 1 614 || 4 651 || || 28 || 138 1.g. || Cats (Felis catus) || 174 || 103 || 0 || || 71 || 22 1.h. || Dogs (Canis familiaris) || 692 || 415 || 149 || || 128 || 289 1.i. || Ferrets (Mustela putorius furo) || 852 || 0 || 666 || || 186 || 14 1.j. || Other Carnivores (other Carnivora) || 430 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 2 371 || || || || || 1.l. || Pigs (Sus) || 14 686 || || || || || 1.m. || Goats (Capra) || 284 || || || || || 1.n. || Sheep (Ovis) || 2 600 || || || || || 1.o. || Cattle (Bos) || 2 383 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 22 || 0 || 0 || || 22 || 1 1.r. || Old World Monkeys (Cercopithecoidea) || 184 || 73 || 20 || || 91 || 111 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || || 0 || 0 1.t. || Other Mammals (other Mammalia) || 41 || || || || || 1.u. || Quail (Coturnix coturnix) || 68 || 68 || 0 || || 0 || 1.v. || Other birds (other Aves) || 99 354 || || || || || 1.w. || Reptiles (Reptilia) || 133 || || || || || 1.x. || Amphibians (Amphibia) || 1 247 || || || || || 1.y. || Fish (Pisces) || 36 034 || || || || || 1.z. || TOTAL || 514 617 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 166 354 || 30 471 || 4 930 || 14 372 || 5 229 || 9 380 || 7 048 || || 237 784 2.b. || Rats || 28 621 || 4 886 || 28 937 || 5 802 || 27 619 || || 3 016 || || 98 881 2.c. || Guinea-Pigs || 505 || 524 || 829 || 3 465 || 116 || || 54 || || 5 493 2.d. || Hamsters || 432 || 245 || || 2 916 || || || 39 || || 3 632 2.e. || Other Rodents || 699 || 280 || || || || || || || 979 2.f. || Rabbits || 498 || 402 || 366 || 1 973 || 2 872 || 28 || 154 || || 6 293 2.g. || Cats || 49 || || || 38 || || || 87 || || 174 2.h. || Dogs || 164 || 101 || || 183 || 152 || || 92 || || 692 2.i. || Ferrets || 282 || 497 || 58 || || || || 15 || || 852 2.j. || Other Carnivores || 121 || || || 309 || || || || || 430 2.k. || Horses, donkeys and cross breds || 24 || 194 || 101 || 2 030 || || || 22 || || 2 371 2.l. || Pigs || 8 925 || 3 387 || 6 || 1 671 || 43 || || 654 || || 14 686 2.m. || Goats || 139 || 137 || || 1 || || || 7 || || 284 2.n. || Sheep || 274 || 273 || 1 900 || 26 || || || 127 || || 2 600 2.o. || Cattle || 586 || 883 || 237 || 307 || || || 370 || || 2 383 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || 5 || 17 || || || || || || || 22 2.r. || Old World Monkeys || 39 || 145 || || || || || || || 184 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || 39 || 2 || || || || || || || 41 2.u. || Quail || 68 || || || || || || || || 68 2.v. || Other birds || 65 293 || 11 532 || 22 || 21 180 || || 281 || 1 046 || || 99 354 2.w. || Reptiles || 133 || || || || || || || || 133 2.x. || Amphibians || 127 || || || || 1 120 || || || || 1 247 2.y. || Fish || 31 967 || || || || 3 580 || || 487 || || 36 034 2.z. || TOTAL || 305 344 || 53 976 || 37 386 || 54 273 || 40 731 || 9 689 || 13 218 || 0 || 514 617 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total 3.a. || Mice || 3 020 || 80 || 1 985 || || || 144 || || || || 5 229 3.b. || Rats || 7 127 || 6 150 || 14 093 || 28 || || 200 || || || 21 || 27 619 3.c. || Guinea-Pigs || 67 || || 49 || || || || || || || 116 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 1 783 || || 1 089 || || || || || || || 2 872 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || 152 || || || || || || || || || 152 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || 43 || || || || || || || || || 43 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || 1 120 || || 1 120 3.y. || Fish || || || || || || || || 3 372 || 208 || 3 580 3.z. || TOTAL || 12 192 || 6 230 || 17 216 || 28 || 0 || 344 || 0 || 4 492 || 229 || 40 731 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 18 898 || 17 365 || 52 091 || 71 800 || 11 253 || 171 407 4.b. || Rats || 3 625 || 11 731 || 1 350 || 9 474 || 139 || 26 319 4.c. || Guinea-Pigs || 0 || 55 || 0 || 391 || 430 || 876 4.d. || Hamsters || 0 || 0 || 0 || 168 || 245 || 413 4.e. || Other Rodents || 0 || 0 || 0 || 288 || 0 || 288 4.f. || Rabbits || 230 || 0 || 164 || 411 || 54 || 859 4.g. || Cats || 0 || 0 || 0 || 0 || 42 || 42 4.h. || Dogs || 68 || 0 || 0 || 43 || 154 || 265 4.i. || Ferrets || 0 || 0 || 0 || 779 || 0 || 779 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 10 || 184 || 194 4.l. || Pigs || 421 || 0 || 32 || 188 || 3 737 || 4 378 4.m. || Goats || 33 || 0 || 0 || 147 || 34 || 214 4.n. || Sheep || 10 || 0 || 0 || 271 || 266 || 547 4.o. || Cattle || 0 || 0 || 0 || 19 || 969 || 988 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 1 || 0 || 17 || 0 || 18 4.r. || Old World Monkeys || 0 || 0 || 0 || 169 || 0 || 169 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 10 || 0 || 10 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 100 || 373 || 26 516 || 26 989 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 4.y. || Fish || 0 || 4 162 || 119 || 936 || 184 || 5 401 4.z. || TOTAL || 23 285 || 33 314 || 53 856 || 85 494 || 44 207 || 240 156 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || 1 320 || || 1 864 || 11 596 || 4 522 || 19 302 || 5.b. || Rats || || 4 354 || || 684 || 29 053 || 648 || 34 739 || 5.c. || Guinea-Pigs || || 190 || || 250 || 2 034 || 1 820 || 4 294 || 5.d. || Hamsters || || || || || 2 916 || || 2 916 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || 1 || || 70 || 1 892 || 376 || 2 339 || 5.g. || Cats || || || || || 38 || || 38 || 5.h. || Dogs || || || || || 168 || 15 || 183 || 5.i. || Ferrets || || || || || || 58 || 58 || 5.j. || Other Carnivores || || || || || || 309 || 309 || 5.k. || Horses, donkeys and cross breds || || || || || 82 || 2 049 || 2 131 || 5.l. || Pigs || || || || || 1 290 || 387 || 1 677 || 5.m. || Goats || || || || || || 1 || 1 || 5.n. || Sheep || || || || || 2 || 1 924 || 1 926 || 5.o. || Cattle || 25 || || || 4 || 104 || 411 || 544 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || 18 381 || 2 821 || 21 202 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 25 || 5 865 || 0 || 2 872 || 67 556 || 15 341 || 91 659 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || || 5 || 3 598 || 1 626 || 5 229 || 6.b. || Rats || || || || 80 || 27 346 || 193 || 27 619 || 6.c. || Guinea-Pigs || || || || || 114 || 2 || 116 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || || || || 2 863 || 9 || 2 872 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || 152 || || 152 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || 33 || 10 || 43 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || 1 120 || || 1 120 || 6.y. || Fish || || || || || 3 072 || 508 || 3 580 || 6.z. || TOTAL || 0 || 0 || 0 || 85 || 38 298 || 2 348 || 40 731 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino-genicity || 7.8 Develop- mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || 1 525 || 210 || || 2 577 || || || || || 877 || || || 40 || 5 229 7.b. || Rats || || 617 || 5 173 || 179 || || || 968 || 610 || 10 211 || 83 || 9 479 || || 299 || 27 619 7.c. || Guinea-Pigs || || || 63 || || 49 || || || || || || || || 4 || 116 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || 109 || 162 || || 136 || 170 || || || || 1 177 || || 1 118 || 2 872 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || 99 || || || || 40 || || || || || || 13 || 152 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || 29 || || || || || || || || || || 14 || 43 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || 1 120 || || || || || || || || || || || 1 120 7.y. || Fish || 570 || 288 || 605 || || || || 2 117 || || || || || || || 3 580 7.z. || TOTAL || 570 || 2 430 || 7 408 || 341 || 2 626 || 136 || 3 295 || 610 || 10 211 || 960 || 10 656 || 0 || 1 488 || 40 731 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta-genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 1 657 || 2 789 || 100 || 1 255 || 48 || 610 || || 783 || 103 || 3 447 || || 1 400 || 12 192 8.b. || Products/substances used or intended to be used mainly in agriculture || || 16 || 455 || || || || 200 || 610 || || || 4 913 || || 36 || 6 230 8.c. || Products/substances used or intended to be used mainly in industry || || 465 || 2 383 || 241 || 1 347 || 88 || 200 || || 9 428 || 716 || 2 296 || || 52 || 17 216 8.d. || Products/substances used or intended to be used mainly in the household || || 4 || 24 || || || || || || || || || || || 28 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || 32 || || 24 || || 168 || || || 120 || || || || 344 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 570 || 288 || 1 725 || || || || 1 909 || || || || || || || 4 492 8.i. || Other toxicological or safety evaluations || || || || || || || 208 || || || 21 || || || || 229 8.j. || TOTAL || 570 || 2 430 || 7 408 || 341 || 2 626 || 136 || 3 295 || 610 || 10 211 || 960 || 10 656 || 0 || 1 488 || 40 731 COMMISSION STAFF WORKING DOCUMENT Accompanying document to the
REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN
PARLIAMENT
Seventh Report on the Statistics on the Number of Animals used for Experimental
and
other Scientific Purposes in the Member States of the European Union PART B IV: DATA AND SUMMARY OF THE
COMMENTS SUBMITTED BY THE MEMBER STATES TABLE OF CONTENTS AUSTRIA................................................................................................................................... 5 POLAND.................................................................................................................................. 18 PORTUGAL............................................................................................................................. 29 ROMANIA............................................................................................................................... 37 SLOVENIA.............................................................................................................................. 37 SLOVAKIA............................................................................................................................. 37 FINLAND................................................................................................................................ 37 SWEDEN................................................................................................................................. 37 UNITED KINGDOM.............................................................................................................. 37 AUSTRIA Statistical data submitted The statistical data were submitted by the 'Bundesministerium für Wissenschaft und Forschung' (Federal
Ministry of Science and Research). Comments of the Austrian authorities
Slight increase of animal numbers by 2.1%
compared to previous year. 85% of animals used are mice and rats.
Internationally Compared Low Animal
Numbers in Austria.
Rise in animal numbers primarily for
R&D and production and quality control of pharmaceuticals.
No great apes used, No animal experiments
for cosmetics.
In long term comparison reduction in
animal numbers of 61% since 1990.
Statistics in EU-wide standardized form.
After 2 years of decrease, the number of
animals used in procedures in Austria during 2011 has risen again for the first
time. The increase in 2011 is 2.1% as compared to 2010, however the numbers are
still lower than in previous years (7,9 % lower than in 2009 and 13,2 % lower
than in 2008). The animal use statistics for 2011 shows that in total 191,288
animals were used in procedures in Austria. Compared to previous years, this total
number lies within the range of variation of the last years, yet is still well
below the number of the earliest years. Relative to 1990 (the year statistics
were recorded for the first time, in which year 482,166 animals were used in
procedures) the number of animals is reduced by about 61%. Development of the numbers of animals
used since 1990. Breakdown according to areas of
competence. A breakdown of the numbers according to
areas of competence for administration of the Animal Experiments Law ranks them
as follows: Health (BMG:
Federal Ministry of Health - primarily R & D for pharmaceuticals,
production and quality control of pharmaceuticals and medicinal products,
animal health products) is placed first with 116,613 (61 %) animals, before Science and Research (BMWF: Federal Ministry of Science and Research: universities,
Austrian Academy of Sciences, etc. - primarily basic research, in particular
health related research) which is second with 68.024 (35 %) animals, Industry
(BMWFJ: Federal Ministry of Economy, Family and Youth - primarily basic
research) comes in third with 4.807 (3 %) animals and Environmental Protection and Agriculture (BMLFUW: Federal Ministry of Agriculture, Forestry, Environment and
Water Management - primarily safety testing of chemicals and protection of the
environment) is last with 1.884 (1 %) animals used. Predominantly mice and rats are used as
experimental animals Of the total number of 191.288 animals used
in procedures in Austria during 2011 were: 162.179 84,78% mice
and rats 15.633 8,17% rabbits 4.006 2,09% guinea
pigs 3.797 1,98% agricultural
animals 3.267 1,71% birds 1.940 1,01% fish 201 0,11% small
animals (hamsters, ferrets, other rodents) 176 0,09% amphibia
and reptiles 89 0,05% dogs
and cats Animal Tests for Humans and Animals The number of animals used in procedures in
2011 - with 85% (162,179) predominantly mice and rats – is generally due to
increased biomedical research in Austria as well as businesses active in
biomedical, pharmaceutical and biological research and production. This
research and development was directed to production and quality control of
human and veterinary pharmaceuticals and medicinal products manufactured for
the international market and for combating severe diseases such as cancer or
cardiovascular diseases. A significant part was also devoted to the
development, production and quality control of vaccines for the international
market, in particular vaccines (testing of charges) for which there was a
demand from health authorities all over the world. The major part of rabbits
and guinea pigs was used for these purposes. In scientific and basic research the aims
were inter alia improvement of the knowledge in the area of cancer research
and development of effective therapies with reduced side effects or stress for
the patients. Fundamental and applied research was conducted on cardiovascular
diseases (myocardial infarction and its consequences) and neurological
disorders (e.g. Alzheimer, Parkinson and prion-related diseases). Increased biomedical research as well as
the development of pharmaceuticals and medicinal products requires animal tests
- as a first step and precondition for clinical testing on humans – in the
interest of health and safety of humans and animals. The same is also true for
quality control of pharmaceuticals and medicinal products. Last but not least, animal tests are also
required for animal health, meaning that for the development of veterinary
pharmaceuticals it is necessary to conduct clinical studies on animal patients,
and animal tests are similarly necessary for the development of diagnostic and
therapeutic measures for animals. The major part of agricultural animals was
used for these purposes. No animal experiments for cosmetics In accordance with the legal prohibition of
animal experiments for cosmetics (§ 3 Abs. 5 Tierversuchsgesetz) in force since
1999 there were naturally no animal experiments carried out for cosmetics. No great apes used It is particularly gratifying that in 2011
in Austria no animal experiments on great apes were carried out, in accordance
with the legal prohibition of animal experiments on great apes which is in
force since January 1, 2006 (BGBl. I, Nr. 162/2005). This also reflects a
general trend in Europe to restrict such experiments as far as possible and to
avoid them altogether according to the best available science. Statistics in EU-wide standardized form In accordance with the amended Animal
Experiments Law (BGBl. I, Nr. 169/1999) and the Ordinance on Animal Use
Statistics (BGBl. II Nr. 199/2000) the Animal Use Statistics 2011 provides the
statistical data in a standardized form and gives details about the origin of
the animals, the purposes for which they were used (basic research, R&D for
medicines and medicinal products, for quality control, etc.). Internationally Compared Low Animal
Numbers in Austria The number of animals used in procedures in
Austria contributed less than 1.9 % to the total number of 12.0 million vertebrate
animals used in Europe, as can be seen from the EU-wide animal use statistics
for 2008 (the last year for which the European Commission compiled such a
statistics). In international comparison, the figures of animal numbers in
Austria still remain low. These comparatively low numbers of animals are due to
at least three interconnected developments in relation to animals experiments: 1. Application of „3R“ Firstly, scientists, researchers and users
themselves apply the principles of the „3R“(Reduction, Refinement, Replacement)
- which also guide the Austrian Animal Experiments Law - to the widest possible
extent, as well as using alternatives. 2. Restrictive authorization practice
for projects Second, all authorities issue permits for
projects very restrictively in accordance with the strict provisions of the
Animal Experiments Law and the Ordinance on Animal Experiments, which allow
animal experiments only under very restrictive conditions and stipulate that
projects may only be permitted, if no other satisfactory methods are available
to achieve the aim without using live animals. 3. Support for research on Alternative
Methods to Animal Testing Finally, public financial support for
developing and promoting alternative methods contributes to motivation of users
and researches: 3.1. Financial support for research
projects aimed at developing alternative methods, totalling more than 2,562
Mio. EUR for 29 projects, as well as promoting the use of alternative methods
nationally and internationally, 3.2. National Award for Alternative
Methods, i.e. a specific award publicly recognizing scientific achievements in
the area of alternative methods. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 153153 || 43464 || 106502 || 44 || 3143 || 1.b. || Rats (Rattus norvegicus) || 9026 || 4593 || 4433 || 0 || 0 || 1.c. || Guinea-Pigs (Cavia porcellus) || 3797 || 1432 || 2365 || 0 || 0 || 1.d. || Hamsters (Mesocricetus ) || 125 || 0 || 125 || 0 || 0 || 1.e. || Other Rodents (other Rodentia) || 64 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 15633 || 12718 || 2899 || 0 || 16 || 20 1.g. || Cats (Felis catus) || 14 || 12 || 2 || 0 || 0 || 8 1.h. || Dogs (Canis familiaris) || 75 || 0 || 0 || 0 || 75 || 0 1.i. || Ferrets (Mustela putorius furo) || 12 || 0 || 12 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 0 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 128 || || || || || 1.l. || Pigs (Sus) || 1553 || || || || || 1.m. || Goats (Capra) || 60 || || || || || 1.n. || Sheep (Ovis) || 683 || || || || || 1.o. || Cattle (Bos) || 1582 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 0 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 1940 || || || || || 1.w. || Reptiles (Reptilia) || 0 || || || || || 1.x. || Amphibians (Amphibia) || 176 || || || || || 1.y. || Fish (Pisces) || 3267 || || || || || 1.z. || TOTAL || 191288 || || || || || Note 1: Column
1.5 concerns only those Member countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The number of re-used animals in column
1.7 should be excluded from the total in the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 58092 || 44836 || 45925 || 0 || 1523 || 1186 || 969 || 622 || 153153 2.b. || Rats || 4977 || 2656 || 144 || 0 || 966 || 18 || 215 || 50 || 9026 2.c. || Guinea-Pigs || 31 || 293 || 2331 || 0 || 1142 || 0 || 0 || 0 || 3797 2.d. || Hamsters || 49 || 0 || 76 || 0 || 0 || 0 || 0 || 0 || 125 2.e. || Other Rodents || 64 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 64 2.f. || Rabbits || 100 || 331 || 14539 || 6 || 624 || 0 || 27 || 6 || 15633 2.g. || Cats || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 12 || 14 2.h. || Dogs || 20 || 0 || 0 || 0 || 0 || 6 || 19 || 30 || 75 2.i. || Ferrets || 0 || 12 || 0 || 0 || 0 || 0 || 0 || 0 || 12 2.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.k. || Horses, donkeys and cross breds || 118 || 0 || 0 || 0 || 0 || 0 || 0 || 10 || 128 2.l. || Pigs || 301 || 979 || 0 || 0 || 28 || 29 || 216 || 0 || 1553 2.m. || Goats || 18 || 2 || 0 || 0 || 0 || 0 || 0 || 40 || 60 2.n. || Sheep || 109 || 2 || 0 || 0 || 0 || 70 || 50 || 452 || 683 2.o. || Cattle || 180 || 4 || 0 || 0 || 0 || 44 || 140 || 1214 || 1582 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.v. || Other birds || 1192 || 602 || 4 || 0 || 0 || 6 || 136 || 0 || 1940 2.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.x. || Amphibians || 176 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 176 2.y. || Fish || 3008 || 0 || 0 || 0 || 221 || 0 || 38 || 0 || 3267 2.z. || TOTAL || 68435 || 49719 || 63019 || 6 || 4504 || 1359 || 1810 || 2436 || 191288 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contaminants in the general environment which do not appear in other columns || 3.10 Other toxicological or safety evaluations || 3.11 Total 3.a. || Mice || 1099 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 424 || 1523 3.b. || Rats || 242 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 724 || 966 3.c. || Guinea-Pigs || 128 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1014 || 1142 3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 474 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 150 || 624 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 28 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 98 || 221 3.z. || TOTAL || 1971 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 2410 || 4504 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 4578 || 8013 || 22611 || 49401 || 24 || 84627 4.b. || Rats || 378 || 1586 || 1269 || 3624 || 4 || 6861 4.c. || Guinea-Pigs || 6 || 5 || 0 || 363 || 0 || 374 4.d. || Hamsters || 49 || 0 || 0 || 76 || 0 || 125 4.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 4.f. || Rabbits || 18 || 27 || 1 || 820 || 8 || 874 4.g. || Cats || 0 || 0 || 0 || 0 || 14 || 14 4.h. || Dogs || 0 || 0 || 0 || 0 || 11 || 11 4.i. || Ferrets || 0 || 0 || 0 || 12 || 0 || 12 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 4.l. || Pigs || 180 || 0 || 1 || 349 || 474 || 1004 4.m. || Goats || 0 || 0 || 0 || 2 || 0 || 2 4.n. || Sheep || 18 || 0 || 0 || 16 || 9 || 43 4.o. || Cattle || 4 || 0 || 0 || 0 || 204 || 208 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 0 || 0 || 30 || 1570 || 1600 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 10 || 0 || 0 || 0 || 10 4.y. || Fish || 1152 || 0 || 0 || 1115 || 210 || 2477 4.z. || TOTAL || 6383 || 9641 || 23882 || 55808 || 2528 || 98242 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 0 || 5706 || 0 || 0 || 40219 || 0 || 45925 || 5.b. || Rats || 104 || 0 || 0 || 0 || 0 || 40 || 144 || 5.c. || Guinea-Pigs || 0 || 181 || 0 || 0 || 2125 || 25 || 2331 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 76 || 0 || 76 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 0 || 7459 || 0 || 0 || 6912 || 174 || 14545 || 5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 0 || 0 || 0 || 0 || 4 || 0 || 4 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.z. || TOTAL || 104 || 13346 || 0 || 0 || 49336 || 239 || 63025 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 0 || 1045 || 0 || 0 || 478 || 0 || 1523 || 6.b. || Rats || 0 || 32 || 0 || 0 || 934 || 0 || 966 || 6.c. || Guinea-Pigs || 0 || 54 || 0 || 0 || 1088 || 0 || 1142 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 0 || 260 || 0 || 7 || 357 || 0 || 624 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 28 || 28 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 0 || 0 || 0 || 0 || 221 || 0 || 221 || 6.z. || TOTAL || 0 || 1391 || 0 || 7 || 3078 || 28 || 4504 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 0 || 0 || 945 || 0 || 0 || 0 || 34 || 0 || 0 || 424 || 0 || 0 || 120 || 1523 7.b. || Rats || 0 || 532 || 32 || 0 || 0 || 0 || 402 || 0 || 0 || 0 || 0 || 0 || 0 || 966 7.c. || Guinea-Pigs || 0 || 0 || 54 || 0 || 1088 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1142 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 23 || 107 || 30 || 0 || 108 || 22 || 0 || 0 || 0 || 0 || 0 || 334 || 624 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 0 || 0 || 28 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 28 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 0 || 98 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 0 || 221 7.z. || TOTAL || 0 || 653 || 1138 || 58 || 1088 || 108 || 458 || 0 || 0 || 424 || 0 || 123 || 454 || 4504 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 0 || 23 || 1138 || 28 || 74 || 0 || 266 || 0 || 0 || 0 || 0 || 0 || 442 || 1971 8.b. || Products/substances used or intended to be used mainly in agriculture || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.c. || Products/substances used or intended to be used mainly in industry || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 123 || 0 || 123 8.i. || Other toxicological or safety evaluations || 0 || 630 || 0 || 30 || 1014 || 108 || 192 || 0 || 0 || 424 || 0 || 0 || 12 || 2410 8.j. || TOTAL || 0 || 653 || 1138 || 58 || 1088 || 108 || 458 || 0 || 0 || 424 || 0 || 123 || 454 || 4504 POLAND Statistical data submitted The statistical
data were submitted by the Ministry of Science and Higher Education, Warsaw. Comments of the Polish authorities In Poland the Ministry of Science and
Higher Education is
responsible for gathering the statistical data on the use of animals for
scientific purposes and sending the to the European Commission. The first report
on number of animals used for scientific purposes in Poland passed to EC
concerned 2005. Since then, the number of animals used for scientific purposes
is maintained at a stable level – an average of about 250,000 animals per year. In 2011 282,160 animals
were used for scientific purposes in Poland. Report on number of animals used
for scientific purposes was submitted in 2012 to the Ministry of Science and
Higher Education by 94 authorized experimental units. The largest group of
animals used for research constitutes fish, mice and rats. The following
table and graph present a comparison of the species of animals used for
scientific purposes in 2011 compared to 2010. 2011 || 2010 Species || Number Percentage || Species || Number Percentage Mice || 95 115 || 33,70 % || Mice || 88 040 || 38,66 % Rats || 38 171 || 13,53 % || Rats || 49 050 || 21,54 % Guinea-Pigs || 8943 || 3,17 % || Guinea-Pigs || 7 626 || 3,35 % Other Rodents || 11 710 || 4,15 % || Other Rodents || 10 069 || 4,42 % Other birds || 13 615 || 5,88 % || Other birds || 16 151 || 7 % Fish || 100 275 || 35,54 % || Fish || 42 467 || 18,65 % Other animals || 13 899 || 4,92 % || Other animals || 14 274 || 6,26 % The increase in 2011 of used fish, mice and
rats for scientific purposes is due to increased number of experiments carried
out on animals in Poland. It is correlated with establishing in 2011 new
financing research agency (National Centre for Research) funding research
grants for basic research. The primary purpose for which animals were
used in experiments in 2011 is biological studies of fundamental nature. For
this kind of research 72.91 % of animals were used from all animals used for
scientific purposes in 2011. A large group of animals used for scientific
purposes in 2011 constitutes animals used in projects for research and
development of products and devices for human medicine and density and for
veterinary medicine (9.7% of all animals used for scientific purposes in 2011)
and concerning production and quality control of products and devices for human
medicine and density (5.8 % of animals used for scientific purposes in 2011).
For other categories of research 9.85 % of animals were used. For the purposes
of education and training 4,877 animals were used in 2011 representing 1.73%. The below graph shows the usage of animals
in 2011 in Poland by a particular purpose of research. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 95 115 || 91577 || 1551 || 1319 || 668 || 1.b. || Rats (Rattus norvegicus) || 38 171 || 30451 || 522 || 7173 || 25 || 1.c. || Guinea-Pigs (Cavia porcellus) || 8943 || 8839 || 104 || 0 || 0 || 1.d. || Hamsters (Mesocricetus ) || 278 || 278 || 0 || 0 || 0 || 1.e. || Other Rodents (other Rodentia) || 11710 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 2198 || 2186 || 0 || 0 || 12 || 527 1.g. || Cats (Felis catus) || 480 || 480 || 0 || 0 || 0 || 0 1.h. || Dogs (Canis familiaris) || 229 || 187 || 0 || 0 || 42 || 0 1.i. || Ferrets (Mustela putorius furo) || 0 || 0 || 0 || 0 || 0 || 0 1.j. || Other Carnivores (other Carnivora) || 2149 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 766 || || || || || 1.l. || Pigs (Sus) || 1147 || || || || || 1.m. || Goats (Capra) || 396 || || || || || 1.n. || Sheep (Ovis) || 379 || || || || || 1.o. || Cattle (Bos) || 3489 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 594 || || || || || 1.u. || Quail (Coturnix coturnix) || 1247 || 1247 || 0 || 0 || 0 || 1.v. || Other birds (other Aves) || 13615 || || || || || 1.w. || Reptiles (Reptilia) || 15 || || || || || 1.x. || Amphibians (Amphibia) || 964 || || || || || 1.y. || Fish (Pisces) || 100275 || || || || || 1.z. || TOTAL || 282160 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 57785 || 15787 || 9500 || 2529 || 3611 || 4340 || 1222 || 341 || 95115 2.b. || Rats || 23112 || 8013 || 1342 || 400 || 3288 || 1523 || 307 || 186 || 38171 2.c. || Guinea-Pigs || 86 || 2248 || 4453 || 932 || 916 || 300 || 0 || 8 || 8943 2.d. || Hamsters || 272 || 0 || 0 || 0 || 0 || 0 || 6 || 0 || 278 2.e. || Other Rodents || 11264 || 0 || 0 || 0 || 0 || 230 || 216 || 0 || 11710 2.f. || Rabbits || 501 || 465 || 757 || 26 || 255 || 25 || 155 || 14 || 2198 2.g. || Cats || 23 || 4 || 0 || 0 || 0 || 390 || 63 || 0 || 480 2.h. || Dogs || 72 || 0 || 0 || 0 || 0 || 97 || 60 || 0 || 229 2.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.j. || Other Carnivores || 1142 || 0 || 0 || 0 || 0 || 457 || 550 || 0 || 2149 2.k. || Horses, donkeys and cross breds || 738 || 0 || 0 || 0 || 0 || 13 || 15 || 0 || 766 2.l. || Pigs || 661 || 136 || 0 || 62 || 149 || 84 || 55 || 0 || 1147 2.m. || Goats || 250 || 0 || 0 || 0 || 0 || 0 || 106 || 40 || 396 2.n. || Sheep || 277 || 67 || 0 || 0 || 0 || 15 || 20 || 0 || 379 2.o. || Cattle || 2658 || 64 || 0 || 110 || 0 || 412 || 215 || 30 || 3489 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 541 || 0 || 0 || 0 || 0 || 53 || 0 || 0 || 594 2.u. || Quail || 453 || 0 || 0 || 0 || 10 || 0 || 4 || 780 || 1247 2.v. || Other birds || 9195 || 580 || 334 || 2176 || 0 || 535 || 449 || 346 || 13615 2.w. || Reptiles || 12 || 0 || 0 || 0 || 0 || 0 || 3 || 0 || 15 2.x. || Amphibians || 214 || 0 || 0 || 0 || 0 || 0 || 750 || 0 || 964 2.y. || Fish || 96484 || 0 || 0 || 0 || 1630 || 1000 || 681 || 480 || 100275 2.z. || TOTAL || 205740 || 27364 || 16386 || 6235 || 9859 || 9474 || 4877 || 2225 || 282160 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami-nants in the general envi-ronment which do not appear in other columns || 3.10 Other toxico-logical or safety evaluations || 3.11 Total 3.a. || Mice || 757 || 160 || 0 || 0 || 0 || 110 || 0 || 0 || 2584 || 3611 3.b. || Rats || 433 || 458 || 33 || 0 || 0 || 680 || 0 || 150 || 1534 || 3288 3.c. || Guinea-Pigs || 489 || 266 || 33 || 0 || 0 || 0 || 0 || 0 || 128 || 916 3.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.f. || Rabbits || 173 || 46 || 36 || 0 || 0 || 0 || 0 || 0 || 0 || 255 3.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 149 || 0 || 149 3.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10 3.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.y. || Fish || 0 || 1207 || 423 || 0 || 0 || 0 || 0 || 0 || 0 || 1630 3.z. || TOTAL || 1852 || 2147 || 525 || 0 || 0 || 790 || 0 || 299 || 4246 || 9859 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 1408 || 29588 || 7893 || 8254 || 1830 || 48973 4.b. || Rats || 1748 || 13374 || 824 || 4663 || 295 || 20904 4.c. || Guinea-Pigs || 33 || 72 || 0 || 28 || 0 || 133 4.d. || Hamsters || 0 || 0 || 62 || 0 || 300 || 362 4.e. || Other Rodents || 0 || 286 || 0 || 30 || 0 || 316 4.f. || Rabbits || 0 || 12 || 40 || 305 || 5 || 362 4.g. || Cats || 0 || 0 || 4 || 0 || 56 || 60 4.h. || Dogs || 0 || 0 || 7 || 0 || 110 || 117 4.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 4.j. || Other Carnivores || 0 || 0 || 0 || 0 || 941 || 941 4.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 24 || 24 4.l. || Pigs || 66 || 0 || 0 || 82 || 50 || 198 4.m. || Goats || 0 || 0 || 0 || 100 || 0 || 100 4.n. || Sheep || 0 || 0 || 21 || 30 || 21 || 72 4.o. || Cattle || 0 || 0 || 0 || 40 || 140 || 180 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 0 || 0 || 0 || 118 || 118 4.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 4.v. || Other birds || 0 || 640 || 0 || 0 || 360 || 1000 4.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 4.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 4.y. || Fish || 0 || 0 || 0 || 0 || 1058 || 1058 4.z. || TOTAL || 3255 || 43972 || 8851 || 13532 || 5308 || 74918 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 2292 || 2692 || 0 || 505 || 0 || 6540 || 12029 || 5.b. || Rats || 165 || 506 || 0 || 716 || 0 || 355 || 1742 || 5.c. || Guinea-Pigs || 194 || 5101 || 0 || 90 || 0 || 0 || 5385 || 5.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 580 || 110 || 0 || 0 || 0 || 93 || 783 || 5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.l. || Pigs || 2 || 60 || 0 || 0 || 0 || 0 || 62 || 5.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 110 || 110 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 334 || 1136 || 0 || 0 || 0 || 1040 || 2510 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 0 || 0 || 0 || || 0 || 0 || 5.z. || TOTAL || 3567 || 9605 || 0 || 1311 || 0 || 8138 || 22621 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 108 || 1757 || 30 || 390 || 0 || 1326 || 3611 || 6.b. || Rats || 0 || 1032 || 736 || 525 || 0 || 995 || 3288 || 6.c. || Guinea-Pigs || 0 || 916 || 0 || 0 || 0 || 0 || 916 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.f. || Rabbits || 0 || 255 || 0 || 0 || 0 || 0 || 255 || 6.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.l. || Pigs || 0 || 0 || 0 || 149 || 0 || 0 || 149 || 6.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 10 || 0 || 0 || 0 || 0 || 10 || 6.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.y. || Fish || 0 || 0 || 0 || 0 || 1630 || 0 || 1630 || 6.z. || TOTAL || 108 || 3970 || 766 || 1064 || 1630 || 2321 || 9859 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcinogenicity || 7.8 Develop- mental toxicity || 7.9 Muta-genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 153 || 0 || 876 || 0 || 0 || 0 || 558 || 0 || 0 || 0 || 0 || 0 || 2024 || 3611 7.b. || Rats || 160 || 0 || 737 || 549 || 0 || 0 || 1125 || 0 || 256 || 0 || 0 || 0 || 461 || 3288 7.c. || Guinea-Pigs || 0 || 340 || 0 || 0 || 570 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 916 7.d. || Hamsters || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.f. || Rabbits || 0 || 0 || 0 || 154 || 0 || 39 || 0 || 0 || 0 || 0 || 0 || 0 || 62 || 255 7.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.h. || Dogs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.l. || Pigs || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 149 || 149 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 10 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 10 7.v. || Other birds || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.y. || Fish || 1238 || 0 || 0 || 0 || 0 || 0 || 313 || 0 || 0 || 0 || 0 || 79 || 0 || 1630 7.z. || TOTAL || 1561 || 340 || 1613 || 703 || 570 || 39 || 1996 || 0 || 256 || 0 || 0 || 79 || 2702 || 9859 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcinogenicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 96 || 0 || 628 || 360 || 242 || 0 || 8 || 0 || 0 || 0 || 0 || 0 || 518 || 1852 8.b. || Products/substances used or intended to be used mainly in agriculture || 994 || 0 || 42 || 82 || 266 || 23 || 371 || 0 || 160 || 0 || 0 || 0 || 209 || 2147 8.c. || Products/substances used or intended to be used mainly in industry || 390 || 0 || 11 || 22 || 54 || 16 || 0 || 0 || 0 || 0 || 0 || 0 || 32 || 525 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 640 || 0 || 0 || 0 || 0 || 0 || 150 || 790 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 0 || 290 || 7 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 299 8.i. || Other toxicological or safety evaluations || 81 || 50 || 925 || 237 || 8 || 0 || 977 || 0 || 96 || 0 || 0 || 79 || 1793 || 4246 8.j. || TOTAL || 1561 || 340 || 1613 || 703 || 570 || 39 || 1996 || 0 || 256 || 0 || 0 || 79 || 2702 || 9859 PORTUGAL Statistical data submitted The statistical data were submitted by the 'Ministério
da Agricultura, Desenvolvimento, Mar, Ambiente e Ordenamento do Território –
Direcção Geral de Alimentação e Veterinária – Direcção de Serviços de Protecção
Animal' (Ministry of Agriculture, Sea, Environment and Spatial Planning –
General Direction of Feed and Veterinary – Directorate for Animal Protection). Comments of the Portuguese authorities 1.
Total number of animals used by species In 2011, the total number of animals used
for experimental and other scientific purposes in Portugal was 46,556. Compared to the data of 2008, where the
total number of used animals was 50888, it means that with regard to 2008 it
was a decrease on the use of animals of 8,51%. Mice are the most commonly used species
representing 52,41% of the total number of animals. The second most used group of animals was
Rats (24,25%). The third most used group is represented by
the Cold-blooded animals (20,68%) and the fourth by the group of Artio and
Perissodactyla with 1,29%. Rodents with Rabbits represent 77,06% of
the total number of animals used. Non-human primates, as it has been used to
happen in Portugal, continued to not being used. Comparison with
the data of the previous report (data of 2008) The percentages of classes of animals used
in 2008 (50,888 animals) and in 2011 (46,556 animals) are represented in the
following table: Class of animals || 2008 (%) || 2011 (%) Mice || 78,23 || 52,41 Rats || 12,91 || 24,25 Guinea-pigs || 0,30 || 0,009 Hamsters and other rodents || 0,06 || 0,17 Rabbits || 0,19 || 0,22 Cold-blooded animals || 7,47 || 20,68 Quail and other birds || 0,31 || 0,93 Artio Perissodactyla || 0,52 || 1,29 Carnivors || 0,00 || 0,043 In 2011, looking at the data by groups of
animals, the percentage of rodents and rabbits suffered a decrease, from 91,69%
in 2008 to 77,06% in 2011 due to a decrease on mouse use. The noticed decrease
on mouse use was the reflection of two circumstances:
several institutions were improving their
establishments or moved to new facilities that had been built and
therefore the use of animals was stopped.
there was a substantial increase on the use of
cold-blooded animals, from 7,47% in 2008, to 20,68% in 2011, mainly due to
the increase on the use of fish models.
Among the group of the Cold-blooded
animals, Fish were the most used animals to being used followed by the use of
amphibians. Within the Artiodactyla, Pigs were once
again the most used animals (78,74%). 2.
Number of animals used by purposes of
experiments In 2011, the percentage of animals (total
46,556) used by purposes of experiments was the following: ·
87,92% of animals were used in “Fundamental
biology”; ·
2,39% in “Research and development for human
medicine, veterinary medicine, dentistry”; ·
0,21% in “Production and quality control of
products and devices in human medicine and dentistry and veterinary medicine”; ·
2,32% in “Toxicological and other safety
evaluation”; ·
2,80% in “Diagnosis of disease”; ·
3,22% in “Education and training”; ·
1,14% in “Other purposes”. Referring to the use of species versus
experimental purposes, the highest amount of use of Mice, Rats and Fish is in “Fundamental
biology” and the highest second amount of use of Fish is in “Toxicological
and other safety evaluation”. Comparison with
the data of the previous report (data of 2008) From 2008 to 2011, there was only a
decrease in the percentage of animals in two categories: “Research and
development for human medicine, veterinary medicine, dentistry” and “Other
purposes”, with the most significant decrease of 7,35% in the percentage of
animals that were used for “Research and development for human medicine,
veterinary medicine, dentistry”. The percentage of animals used in the rest
of the other categories increased, for example: The most significant increase in 2011 was
in the percentage of animals that were used for “Fundamental biology”
which increased 4,1% (from 83,82%, in 2008, to 87,92%, in 2011). The percentage of animals used for “Toxicological
and other safety evaluation” increased from 0,61% to 2,32% and the
percentage of animals used for “Education and training” increased from
1,83% to 3,22%. 3.
Number of
animals used for “Toxicological and safety evaluation” by type of
products In 2011, the use of animals in “Toxicological
and other safety evaluation” represents only 2,32%, which only refers to
1079 animals (28 mice, 102 rats and 949 fish), from the total of 46,556 animals
that were used for experimental purposes in Portugal. “Potential or actual contaminants in the
general environment which do not appear in other columns” represents 53,29% of all the animals used for “Toxicological
and other safety evaluation”. The other percentages of uses in this
category are the following: ·
“Products/substances or devices for human
medicine and dentistry and for veterinary medicine” represent 13,35%. ·
“Products/substances used or intended to be used
mainly in agriculture” represent 18,63%. ·
“Other toxicological or safety evaluations”
represent 14,74%. Comparison with
the data of the previous report (data of 2008) Compared to the data of 2008, in 2011 there
was an increase on the use of animals in “Toxicological and other safety
evaluation”. The percentage of animals used for “Toxicological
and other safety evaluation” increased from 0,61% to 2,32% (from 310 to 1,079
animals). The data of 2011 refers to more two
categories of products than the ones that had been tested in 2008. Animals used to test “Products/substances
or devices for human medicine and dentistry and for veterinary medicine”
and “Products/substances used or intended to be used mainly in agriculture”
were represented in 2011 but not in 2008. “Potential or actual contaminants in the
general environment which do not appear in other columns” represented, in
2008, 61,29% of the animals used for “Toxicological and other safety
evaluation” and, in 2011, 53,29%; “Other toxicological or safety
evaluations” represented 38,71% in 2008 while, in 2011, 14,74%, which means
that there was a decrease in 2011. As in 2008, in 2011 the other groups of products/substances
were not tested which means that, for example, there were no animals used for
the purpose of evaluating the safety of Cosmetics or Additives in food for
animal consumption. 4.
Number of
animals used for the study of diseases In 2011, the number of animals used for the
“Studies on humans and animals diseases” was 20,973, which represents
45,05% of the total number of animals (46,556 animals) that were used. The percentages of animals per type of
diseases were: ·
1,79% in “Human cardiovascular diseases”; ·
25,50% in “Human nervous and mental disorder's; ·
5,63% in “Human cancer (excl. evaluation of
carcino hazards)”; ·
65,72% in “Other human diseases”; ·
1,36% in “Specific animal diseases”. The percentage of the number of animals
used for studies of human diseases represents 98,64% (20,687 animals) of the
total number of animals used for all studies of diseases (20,973 animals). In 2011, the number of animals used to
study animal diseases was only 286 (1,36%) while in 2008, that number had been
568 (3,85%), which means that in 2011, there was decrease in the use of animals
for the study of animal diseases. 5.
Number of
animals used for “Toxicological and other safety evaluations” by the
types of tests As referred previously, in 2011, the use of
animals in “Toxicological and other safety evaluation” represents only
2,32%, which only refers to 1,079 animals, of a total of 46,556 animals that
were used for experimental purposes in Portugal. Comparison with
the data of the previous report (data of 2008) The percentages of animals used in toxicity
tests for “Toxicological and other safety evaluation” in 2008 (310
animals) and in 2011 (1,079 animals) are represented in the following table: Type of tests || 2008 (%) || 2011 (%) Acute and sub-acute toxicity testing methods (including limit test) || 0 || 35,87 Irritation/sensitization tests || 0 || 0 Sub-chronic and chronic toxicity || 0 || 0 Mutagenicity and Carcinogenicity || 38,71 || 14,74 Reproductive and developmental toxicity || 0 || 0 Toxicity of aquatic vertebrates not included in other columns || 0 || 49,40 Other tests || 61,29 || 0 In 2011 there was an increase on the uses
of tests compared to data of 2008, and the biggest increase (49,40%) occurred
on the uses of “Toxicity of aquatic vertebrates not included in other
columns”. 6.
Type of toxicity
tests carried out for “Toxicological and other safety evaluations” of
products As pointed out previously, in 2011, the use
of animals in “Toxicological and other safety evaluation” represents
only 2,32%, which only refers to 1,079 animals, of a total of 46,556 animals
that were used for experimental purposes in Portugal. Comparison with
the data of the previous report (data of 2008) The numbers of animals used for “Toxicological
and other safety evaluation” per types of products in 2008 (310 animals) and
in 2011 (1079 animals) are represented in the following tables: Types of products || 2008 (%) || 2011 (%) Products/substances or devices for human medicine and dentistry and for veterinary medicine || 38,71 || 13,35 Products/ substances used or intended to be used mainly in agriculture || 0 || 18,63 Potential or actual contaminants in the general environment which do not appear in other columns || 61,29 || 53,29 Other toxicological or safety evaluations || 0 || 14,74 In 2011, the number of animals used to test
“Products/substances or devices for human medicine and dentistry and for
veterinary medicine” were 144 animals distributed in “LD50, LC50”
and in “Other lethal methods”. In 2011, in comparision to 2008, there was
an increase of the number of animals used to test “Products/substances used
or intended to be used mainly in agriculture” from 0% in 2008, to 18,63%,
in 2011. All the animals were used in “Non lethal clinical signs methods”.
Related to the “Potential or actual
contaminants in the general environment which do not appear in other columns”,
in 2011 there was a decrease of 8%, compared the 2008, from 61,29%, in 2008, to
53,29%, in 2011. The tests that were performed in this category, were “Other
lethal methods” and “Toxicity to aquatic vertebrates not included in other
columns”. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 24399 || 17341 || 5023 || || 2035 || 60 1.b. || Rats (Rattus norvegicus) || 11290 || 6784 || 4153 || || 353 || 24 1.c. || Guinea-Pigs (Cavia porcellus) || 4 || || 4 || || || 4 1.d. || Hamsters (Mesocricetus ) || 6 || || 6 || || || 1.e. || Other Rodents (other Rodentia) || 74 || || || || 24 || 1.f. || Rabbits (Oryctolagus cuniculus) || 102 || 90 || || || 12 || 1.g. || Cats (Felis catus) || || || || || || 1.h. || Dogs (Canis familiaris) || 20 || 20 || || || || 1.i. || Ferrets (Mustela putorius furo) || || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || 474 || || || || || 1.m. || Goats (Capra) || 99 || || || || || 1.n. || Sheep (Ovis) || 29 || || || || || 1.o. || Cattle (Bos) || || || || || || 1.p. || Prosimians (Prosimia) || || || || || || 1.q. || New World Monkeys (Ceboidea) || || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || || || || || || 1.s. || Apes (Hominoidea) || || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || || || || || || 1.v. || Other birds (other Aves) || 433 || || || || || 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || 25 || || || || || 1.y. || Fish (Pisces) || 9601 || || || || || 1.z. || TOTAL || 46556 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 22005 || 558 || || || 28 || 1217 || 518 || 73 || 24399 2.b. || Rats || 10081 || 453 || || || 102 || 88 || 543 || 23 || 11290 2.c. || Guinea-Pigs || || || || || || || 4 || || 4 2.d. || Hamsters || || || || || || || || 6 || 6 2.e. || Other Rodents || 74 || || || || || || || || 74 2.f. || Rabbits || 16 || || || || || || 21 || 65 || 102 2.g. || Cats || || || || || || || || || 2.h. || Dogs || || 20 || || || || || || || 20 2.i. || Ferrets || || || || || || || || || 2.j. || Other Carnivores || || || || || || || || || 2.k. || Horses, donkeys and cross breds || || || || || || || || || 2.l. || Pigs || || 60 || || || || || 370 || 44 || 474 2.m. || Goats || || || 99 || || || || || || 99 2.n. || Sheep || || 24 || || || || || 5 || || 29 2.o. || Cattle || || || || || || || || || 2.p. || Prosimians || || || || || || || || || 2.q. || New World Monkeys || || || || || || || || || 2.r. || Old World Monkeys || || || || || || || || || 2.s. || Apes || || || || || || || || || 2.t. || Other Mammals || || || || || || || || || 2.u. || Quail || || || || || || || || || 2.v. || Other birds || 113 || || || || || || || 320 || 433 2.w. || Reptiles || || || || || || || || || 2.x. || Amphibians || 25 || || || || || || || || 25 2.y. || Fish || 8616 || || || || 949 || || 36 || || 9601 2.z. || TOTAL || 40930 || 1115 || 99 || 0 || 1079 || 1305 || 1497 || 531 || 46556 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || || || || || || || || || 28 || 28 3.b. || Rats || || || || || || || || || 102 || 102 3.c. || Guinea-Pigs || || || || || || || || || || 3.d. || Hamsters || || || || || || || || || || 3.e. || Other Rodents || || || || || || || || || || 3.f. || Rabbits || || || || || || || || || || 3.g. || Cats || || || || || || || || || || 3.h. || Dogs || || || || || || || || || || 3.i. || Ferrets || || || || || || || || || || 3.j. || Other Carnivores || || || || || || || || || || 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 3.l. || Pigs || || || || || || || || || || 3.m. || Goats || || || || || || || || || || 3.n. || Sheep || || || || || || || || || || 3.o. || Cattle || || || || || || || || || || 3.p. || Prosimians || || || || || || || || || || 3.q. || New World Monkeys || || || || || || || || || || 3.r. || Old World Monkeys || || || || || || || || || || 3.s. || Apes || || || || || || || || || || 3.t. || Other Mammals || || || || || || || || || || 3.u. || Quail || || || || || || || || || || 3.v. || Other birds || || || || || || || || || || 3.w. || Reptiles || || || || || || || || || || 3.x. || Amphibians || || || || || || || || || || 3.y. || Fish || 144 || 201 || || || || || || 575 || 29 || 949 3.z. || TOTAL || 144 || 201 || || || || || || 575 || 159 || 1079 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || || 2335 || 856 || 12162 || 202 || 15555 4.b. || Rats || 372 || 2989 || 324 || 1597 || 12 || 5294 4.c. || Guinea-Pigs || || || || || || 4.d. || Hamsters || || || || || || 4.e. || Other Rodents || || 24 || || || || 24 4.f. || Rabbits || 4 || || || || 12 || 16 4.g. || Cats || || || || || || 4.h. || Dogs || || || || || || 4.i. || Ferrets || || || || || || 4.j. || Other Carnivores || || || || || || 4.k. || Horses, donkeys and cross breds || || || || || || 4.l. || Pigs || || || || || 60 || 60 4.m. || Goats || || || || 24 || || 24 4.n. || Sheep || || || || || || 4.o. || Cattle || || || || || || 4.p. || Prosimians || || || || || || 4.q. || New World Monkeys || || || || || || 4.r. || Old World Monkeys || || || || || || 4.s. || Apes || || || || || || 4.t. || Other Mammals || || || || || || 4.u. || Quail || || || || || || 4.v. || Other birds || || || || || || 4.w. || Reptiles || || || || || || 4.x. || Amphibians || || || || || || 4.y. || Fish || || || || || || 4.z. || TOTAL || 376 || 5348 || 1180 || 13783 || 286 || 20973 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || || || || 5.b. || Rats || || || || || || || || 5.c. || Guinea-Pigs || || || || || || || || 5.d. || Hamsters || || || || || || || || 5.e. || Other Rodents || || || || || || || || 5.f. || Rabbits || || || || || || || || 5.g. || Cats || || || || || || || || 5.h. || Dogs || || || || || || || || 5.i. || Ferrets || || || || || || || || 5.j. || Other Carnivores || || || || || || || || 5.k. || Horses, donkeys and cross breds || || || || || || || || 5.l. || Pigs || || || || || || || || 5.m. || Goats || || 99 || || || || || 99 || 5.n. || Sheep || || || || || || || || 5.o. || Cattle || || || || || || || || 5.p. || Prosimians || || || || || || || || 5.q. || New World Monkeys || || || || || || || || 5.r. || Old World Monkeys || || || || || || || || 5.s. || Apes || || || || || || || || 5.t. || Other Mammals || || || || || || || || 5.u. || Quail || || || || || || || || 5.v. || Other birds || || || || || || || || 5.w. || Reptiles || || || || || || || || 5.x. || Amphibians || || || || || || || || 5.y. || Fish || || || || || || || || 5.z. || TOTAL || || 99 || || || || || 99 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || 28 || || || || || 28 || 6.b. || Rats || || 102 || || || || || 102 || 6.c. || Guinea-Pigs || || || || || || || || 6.d. || Hamsters || || || || || || || || 6.e. || Other Rodents || || || || || || || || 6.f. || Rabbits || || || || || || || || 6.g. || Cats || || || || || || || || 6.h. || Dogs || || || || || || || || 6.i. || Ferrets || || || || || || || || 6.j. || Other Carnivores || || || || || || || || 6.k. || Horses, donkeys and cross breds || || || || || || || || 6.l. || Pigs || || || || || || || || 6.m. || Goats || || || || || || || || 6.n. || Sheep || || || || || || || || 6.o. || Cattle || || || || || || || || 6.p. || Prosimians || || || || || || || || 6.q. || New World Monkeys || || || || || || || || 6.r. || Old World Monkeys || || || || || || || || 6.s. || Apes || || || || || || || || 6.t. || Other Mammals || || || || || || || || 6.u. || Quail || || || || || || || || 6.v. || Other birds || || || || || || || || 6.w. || Reptiles || || || || || || || || 6.x. || Amphibians || || || || || || || || 6.y. || Fish || || 949 || || || || || 949 || 6.z. || TOTAL || || 1079 || || || || || 1079 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || || || || || || || 28 || || || || || || 28 7.b. || Rats || || || || || || || || 102 || || || || || || 102 7.c. || Guinea-Pigs || || || || || || || || || || || || || || 7.d. || Hamsters || || || || || || || || || || || || || || 7.e. || Other Rodents || || || || || || || || || || || || || || 7.f. || Rabbits || || || || || || || || || || || || || || 7.g. || Cats || || || || || || || || || || || || || || 7.h. || Dogs || || || || || || || || || || || || || || 7.i. || Ferrets || || || || || || || || || || || || || || 7.j. || Other Carnivores || || || || || || || || || || || || || || 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 7.l. || Pigs || || || || || || || || || || || || || || 7.m. || Goats || || || || || || || || || || || || || || 7.n. || Sheep || || || || || || || || || || || || || || 7.o. || Cattle || || || || || || || || || || || || || || 7.p. || Prosimians || || || || || || || || || || || || || || 7.q. || New World Monkeys || || || || || || || || || || || || || || 7.r. || Old World Monkeys || || || || || || || || || || || || || || 7.s. || Apes || || || || || || || || || || || || || || 7.t. || Other Mammals || || || || || || || || || || || || || || 7.u. || Quail || || || || || || || || || || || || || || 7.v. || Other birds || || || || || || || || || || || || || || 7.w. || Reptiles || || || || || || || || || || || || || || 7.x. || Amphibians || || || || || || || || || || || || || || 7.y. || Fish || 96 || 90 || 201 || || || || || || || 29 || || 533 || || 949 7.z. || TOTAL || 96 || 90 || 201 || || || || || 130 || || 29 || || 533 || || 1079 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 96 || 48 || || || || || || || || || || || || 144 8.b. || Products/substances used or intended to be used mainly in agriculture || || || 201 || || || || || || || || || || || 201 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || 42 || || || || || || || || || || 533 || || 575 8.i. || Other toxicological or safety evaluations || || || || || || || || 130 || || 29 || || || || 159 8.j. || TOTAL || 96 || 90 || 201 || || || || || 130 || || 29 || || 533 || || 1079 ROMANIA Statistical data submitted The data were
submitted by the Directorate, National Sanitary Veterinary and Food Safety
Authority. Comments of Romania authorities None TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 44575 || 44575 || || || || 1483 1.b. || Rats (Rattus norvegicus) || 5161 || 5161 || || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 6607 || 6607 || || || || 824 1.d. || Hamsters (Mesocricetus ) || 263 || 263 || || || || 1.e. || Other Rodents (other Rodentia) || || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 2195 || 2195 || || || || 444 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 14 || 14 || || || || 1.l. || Pigs (Sus) || 2 || 2 || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || 131 || 131 || || || || 11 1.o. || Cattle (Bos) || 3 || 3 || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 9 || 9 || || || || 1.v. || Other birds (other Aves) || 1196 || 1196 || || || || 12 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 60156 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 1448 || 2620 || 8243 || 8008 || 5358 || 17559 || 140 || 1189 || 44565 2.b. || Rats || 952 || 263 || || || 345 || 3266 || 150 || || 5171 2.c. || Guinea-Pigs || || 56 || 2622 || 148 || 671 || 1447 || 1663 || || 6607 2.d. || Hamsters || 263 || || || || || || || || 263 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || || 65 || 1409 || 80 || 69 || 526 || 5 || 41 || 2195 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || 2 || 9 || 3 || || || || || 14 2.l. || Pigs || || || || 2 || || || || || 2 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || || || 112 || 2 || || || || 17 || 131 2.o. || Cattle || || || 3 || || || || || || 3 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || 9 || || || 9 2.v. || Other birds || || 66 || || 747 || || 286 || || 97 || 1196 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 2663 || 3072 || 12398 || 8990 || 6443 || 23093 || 1958 || 1344 || 60156 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 4783 || || 35 || 40 || 40 || 25 || || || 295 || 5218 3.b. || Rats || 50 || 80 || || 115 || 10 || 25 || || || 205 || 485 3.c. || Guinea-Pigs || 671 || || || || || || || || || 671 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 69 || || || || || || || || || 69 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 5573 || 80 || 35 || 155 || 50 || 50 || 0 || 0 || 500 || 6443 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 259 || 236 || 300 || 443 || 1620 || 2858 4.b. || Rats || 56 || 430 || 250 || 221 || || 957 4.c. || Guinea-Pigs || || || || 25 || 4 || 29 4.d. || Hamsters || 103 || 30 || || 120 || || 253 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || 3 || || || || 1 || 4 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || || || 0 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 421 || 696 || 550 || 809 || 1625 || 4101 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || || 16251 || 16251 || 5.b. || Rats || || || || || || || || 5.c. || Guinea-Pigs || || || || || || 2770 || 2770 || 5.d. || Hamsters || || || || || || || || 5.e. || Other Rodents || || || || || || || || 5.f. || Rabbits || || || || || || 1489 || 1489 || 5.g. || Cats || || || || || || || || 5.h. || Dogs || || || || || || || || 5.i. || Ferrets || || || || || || || || 5.j. || Other Carnivores || || || || || || || || 5.k. || Horses, donkeys and cross breds || || || || || || 12 || 12 || 5.l. || Pigs || || || || || || 2 || 2 || 5.m. || Goats || || || || || || || || 5.n. || Sheep || || || || || || 114 || 114 || 5.o. || Cattle || || || || || || 3 || 3 || 5.p. || Prosimians || || || || || || || || 5.q. || New World Monkeys || || || || || || || || 5.r. || Old World Monkeys || || || || || || || || 5.s. || Apes || || || || || || || || 5.t. || Other Mammals || || || || || || || || 5.u. || Quail || || || || || || || || 5.v. || Other birds || || || || || || 747 || 747 || 5.w. || Reptiles || || || || || || || || 5.x. || Amphibians || || || || || || || || 5.y. || Fish || || || || || || || || 5.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 21388 || 21388 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || || || || 5358 || 5358 || 6.b. || Rats || || || || || || 345 || 345 || 6.c. || Guinea-Pigs || || || || || || 671 || 671 || 6.d. || Hamsters || || || || || || || || 6.e. || Other Rodents || || || || || || || || 6.f. || Rabbits || || || || || || 69 || 69 || 6.g. || Cats || || || || || || || || 6.h. || Dogs || || || || || || || || 6.i. || Ferrets || || || || || || || || 6.j. || Other Carnivores || || || || || || || || 6.k. || Horses, donkeys and cross breds || || || || || || || || 6.l. || Pigs || || || || || || || || 6.m. || Goats || || || || || || || || 6.n. || Sheep || || || || || || || || 6.o. || Cattle || || || || || || || || 6.p. || Prosimians || || || || || || || || 6.q. || New World Monkeys || || || || || || || || 6.r. || Old World Monkeys || || || || || || || || 6.s. || Apes || || || || || || || || 6.t. || Other Mammals || || || || || || || || 6.u. || Quail || || || || || || || || 6.v. || Other birds || || || || || || || || 6.w. || Reptiles || || || || || || || || 6.x. || Amphibians || || || || || || || || 6.y. || Fish || || || || || || || || 6.z. || TOTAL || 0 || 0 || 0 || 0 || 0 || 6443 || 6443 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 480 || 161 || 70 || 30 || 30 || 30 || 38 || || || || || || 4510 || 5349 7.b. || Rats || 90 || 105 || || || || || 4 || || || || || || 145 || 344 7.c. || Guinea-Pigs || || || || || || || 12 || || || || || || 669 || 681 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || || || || || || || || || 69 || 69 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || || || || || || || || || || || || 0 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 570 || 266 || 70 || 30 || 30 || 30 || 54 || 0 || 0 || 0 || 0 || 0 || 5393 || 6443 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 320 || 25 || 70 || 30 || 30 || 30 || 50 || || || || || || 5028 || 5583 8.b. || Products/substances used or intended to be used mainly in agriculture || 80 || || || || || || || || || || || || || 80 8.c. || Products/substances used or intended to be used mainly in industry || 15 || 20 || || || || || || || || || || || || 35 8.d. || Products/substances used or intended to be used mainly in the household || 40 || 115 || || || || || || || || || || || || 155 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 25 || 25 || || || || || || || || || || || || 50 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 25 || 25 || || || || || || || || || || || || 50 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || 65 || 56 || || || || || 4 || || || || || || 365 || 490 8.j. || TOTAL || 570 || 266 || 70 || 30 || 30 || 30 || 54 || 0 || 0 || 0 || 0 || 0 || 5393 || 6443 SLOVENIA Statistical data submitted The statistical data were submitted by the
Veterinary Administration of the Republic of Slovenia (VARS). Comments of Slovenian authorities Commentary to the Annual Report on the Use
of Animals in Procedures in 2011. Veterinary Administration of the Republic
of Slovenia (VARS) is the competent authority in the Republic of Slovenia for
drawing up the Annual Report on the Use of Animals in Procedures, based on the
Animal Protection Act (ZZZiv-UPB2, UL RS 43/2007). Procedures may be performed
by establishments only, which have been authorised by VARS (25 user
establishments) for conducting procedures on animals. Each user establishment
designates an animal welfare expert, who collects data on the annual use of
animals within the establishment in the form of 8 EU tables, which are
submitted to VARS. VARS prepares a collective Annual Report on the Use of
Animals in Procedures, which is made accessible to the public as information of
public character. As procedure on animals shall be regarded
the use of animals for the experimental or other scientific purposes, which may
cause pain, suffering, distress or lasting harm to the animals, and other
measures, which may lead to or bring about a birth of an animal under such
circumstances. In the Republic of Slovenia, procedures on animals are
prohibited for the ethically unacceptable targets, as testing of weapons of war,
cosmetic preparations, tobacco or alcohol products, or for procedures where the
musculature paralysing agents are used without the appropriate anaesthesia. Use
of animals for the educational purposes has been restricted, as procedures may
be conducted only in the form of presentations to the students of veterinary medicine
and of human medicine, provided that no alternative teaching aid (film, image,
model, preparation etc) is at disposal. In 2011, a total of 11,874 animals were used in procedures, which is by 4.54 % less animals as compared to 2008, where a
total of 12,438 animals were used. A major portion constitute the laboratory
rodents with 97.47 %, followed by rabbits with 1.97 %, fish with 0.35 %, and
other animals (pigs, horses, sheep) with 0.20 % . Laboratory rodents and rabbits originate
from the Slovenian approved breeding establishments (28.07 %) and from the
other EU Member States (the remaining portion). Other animals – rearing animals
- originate from the agricultural holdings, where the animal owners give their
consent in writing to the use of such animals in procedures. Most animals were used in the applied
research for the development, generation and control of quality of products and
means intended for use in human medicine, dentistry and veterinary medicine,
and to a lesser extent, for the assessment of toxicity (90.67 %). Only 8.00 % of
the animals were used in baseline research studies, 0.60 % for the education
and training purposes, 0.08 % for diagnosing diseases, and the remaining 0.65 %
for other non-defined purposes of use. Rabbits were reused in series of procedures
within the applicable procedures for the identification of quality of products
intended for use in human medicine, dentistry and veterinary medicine. Pigs were used in the education of students
of veterinary medicine and in the training of surgeons in human medicine. Seven
horses were used in the research study of identifying the impacts of Vitamin E and
Coenzyme Q10 on the oxidative stress within a certain physical activity of the
recreational horses, 4 castrated male ovine animals were used in obtaining the
ruminal fluid (juice) by operative insertion of a fistula for the nutritional
research purposes, and 42 fish in their natural habitat were used for the telemetric
monitoring purposes in the Sava River basin. By the adoption of relevant legislation,
and taking into account the 3R principle, and through an implemented control
system, the use of animals in procedures has decreased over the recent five
years, on the average to around 12,700 animals, where the laboratory rodents
with over 95.00 % constitute a major portion. Non-human primates are not used
in procedures, and neither the carnivores within the recent five years. Through
the well-qualified staff involved in procedures on animals within the past
5-year period in Slovenia, the responsibility for and attitude towards the
animals of the researchers have improved, which is reflected in the accurate
keeping of procedure protocols, the careful selection of methods and in the
subsequent precise implementation of procedures. In decreasing the number of
animals used in procedures, in pharmaceutical industry in particular, the
validated alternative methods and/or the use of cell cultures and tissues have
had an important role. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 11133 || 3004 || 8129 || || || 1.b. || Rats (Rattus norvegicus) || 393 || 250 || 143 || || || 1.c. || Guinea-Pigs (Cavia porcellus) || 48 || 48 || || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || 0 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 234 || 13 || 221 || || || 209 1.g. || Cats (Felis catus) || 0 || || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || 0 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 7 || || || || || 1.l. || Pigs (Sus) || 13 || || || || || 1.m. || Goats (Capra) || 0 || || || || || 1.n. || Sheep (Ovis) || 4 || || || || || 1.o. || Cattle (Bos) || 0 || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || 0 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 0 || || || || || 1.w. || Reptiles (Reptilia) || 0 || || || || || 1.x. || Amphibians (Amphibia) || 0 || || || || || 1.y. || Fish (Pisces) || 42 || || || || || 1.z. || TOTAL || 11874 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 664 || 1962 || 7957 || 195 || || 10 || 30 || 28 || 10846 2.b. || Rats || 232 || 247 || || || 183 || || 18 || || 680 2.c. || Guinea-Pigs || 48 || || || || || || || || 48 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || || || || || || || || || 0 2.f. || Rabbits || || || 222 || || || || 12 || || 234 2.g. || Cats || || || || || || || || || 0 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || 7 || 7 2.l. || Pigs || 2 || || || || || || 11 || || 13 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || 4 || || || || || || || || 4 2.o. || Cattle || || || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || || || || || || || || || 0 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || 42 || 42 2.z. || TOTAL || 950 || 2209 || 8179 || 195 || 183 || 10 || 71 || 77 || 11874 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || || || || || || || || || || 0 3.b. || Rats || 183 || || || || || || || || || 183 3.c. || Guinea-Pigs || || || || || || || || || || 0 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || || || || || || || || || || 0 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 183 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 183 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || || 253 || 1842 || 224 || || 2319 4.b. || Rats || 18 || 55 || || 342 || || 415 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || || || || || || 0 4.g. || Cats || || || || || || 0 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || || || 2 || || 2 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || || || 0 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || || || 0 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 18 || 308 || 1842 || 568 || 0 || 2736 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || 8152 || || || || || 8152 || 5.b. || Rats || || || || || || || 0 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || 222 || || || || || 222 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || || 0 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 0 || 8374 || 0 || 0 || 0 || 0 || 8374 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || || || || || 0 || 6.b. || Rats || || 183 || || || || || 183 || 6.c. || Guinea-Pigs || || || || || || || 0 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || || || || || || 0 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || || || 0 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || || 0 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || || 0 || 6.z. || TOTAL || 0 || 183 || 0 || 0 || 0 || 0 || 183 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || || || || || || || || || || || || || 0 7.b. || Rats || || 40 || || || || || || || || 143 || || || || 183 7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || || || || || || || || || || 0 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || || || || || || || || || || || || 0 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 143 || 0 || 0 || 0 || 183 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 40 || || || || || || || || 143 || || || || 183 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || || || || || || || || || || || || || || 0 8.j. || TOTAL || 0 || 40 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 143 || 0 || 0 || 0 || 183 SLOVAKIA Statistical data submitted The statistical data were submitted by the State Veterinary and Food Administration of the Slovak Republic. Comments of Slovakian authorities The State Veterinary and Food Administration
of the Slovak Republic (hereinafter referred to as the „SVFA SR“) is a
competent authority of the Slovak Republic in the matter of protection of
animals used for experimental purposes. The SVFA SR approves in compliance with
Article 6 paragraph 2 letter i) point 2 and 3 of Act No 39/2007 Coll. on
Veterinary Care as amended (hereinafter referred to as „Act 39/2007 Coll“.), the performance of experiments on animals
and breeding, supplying and experimental establishments. The original Ordinance
of the Government of the Slovak Republic No
289/2003 Coll. by which the Directive 86/609/EEC was transposed into the legal
order of the Slovak Republic, was amended in compliance with Commission
recommendations 2007/526/EC of 18.06.2007, that concerned the
accommodation and care of animals used for experimental and other scientific
purposes. On 1 February 2009 a new Ordinance of the Government of the Slovak
Republic No 23/2009 Coll. entered into force (hereinafter referred to as the „Ordinance of the Government of the SR No
23/2009 Coll“.), in which the requirements for the protection of
animals used for experimental or other scientific purposes are specified in
detail. In this Ordinance the transitional period for harmonizing the
requirements in respect of accommodation and care of animals from the year 2009
till 31.12.2013 was indicated. The SVFA SR manages, directs, coordinates and
controls 40 District Veterinary and Food Administrations (hereinafter
referred to as the „DVFA“). All employees of the veterinary administration
working in the field of animal protection are veterinarians participating in
execution of controls in establishments. The controls are performed based on
the methodical instructions and checklists worked out by the competent
authority in compliance with requirements laid down in Ordinance of the
Government of the SR No 23/2009 Coll. and in Act No 39/2007 Coll. Approval of
establishments: All kinds of establishments are approved by
the SVFA SR based on the application submitted by applicants and results from
the control carried out directly in the establishment. By the control performed
in the establishment the compliance with the observance of requirements laid
down in Ordinance of the Government of the SR No 23/2009 Coll. are judged. In
the establishment, mainly the control of applicant´s documents, control of
records kept by an applicant and physical control of the establishment are
performed. All controls performed in establishments are
non-discriminatory. They are performed for the purpose of approval of the
establishment, control of already approved establishments carried out for the
purpose of compliance with requirements laid down in Ordinance of the
Government of SR No 23/2009 Coll. or a control is performed on an impulse. Totally, 24 establishments
asked the SVFA SR for the approval of its establishment for keeping
animals and performance of experiments on animals according to requirements
laid down in Ordinance of the Government of the SR No 23/2009 Coll. In one
approved establishment an additional approval of new premises– quarantine was
carried out. One establishment fulfilled the requirements laid down in
Ordinance of the Government of SR No 23/2009 Coll. during the execution of the
control, for this reason it was not necessary to carry out the subsequent
control. Kinds and
numbers of controls performed in establishments for the year 2011 in the Slovak
Republic Kind of the control || Number of controls Judgement of suitability of the establishment for carrying out experiments || 25 Subsequent control || 23 Totally performed controls || 48 The SVFA SR after having issued the decision
on approval of the establishment shall issue an official number to the
respective establishment under which the establishment is kept in the lists of
approved supplying, breeding and user establishments in the Slovak
Republic on the website of the SVFA SR www.svssr.sk. In compliance with paragraph 11 Article 39 of Act No 39/2007 Coll.
In the Slovak Republic is possible to breed the animals for the purpose of
their usage in experiments only in approved breeding and supplying establishments.
According to the Act, it is possible to perform the experiments on animals only
in approved experimental establishments. In the year 2011,
the SVFA SR registered totally 66 approved establishments. Out of this, there
were 53 experimental establishments, 10 experimental establishments bred
animals for their own need, 2 breeding establishments and 1 supplying
establishment. Compared to the year 2008, in which the report was given for
individual Member States, the number of approved establishments was changed.
Out of the total number of 75 approved establishments, the number decreased to
66 approved establishments. The changes concern mainly the number of
experimental and breeding establishments. Since the year 2009, several
establishments submitted an application for cancellation of its approval. It
was due to the cancellation of the establishment itself, or change in respect
of activity of the establishment. Many establishments were not able to fulfil
the requirements concerning the care and accommodation of animals laid down in
Ordinance of the Government of the SR No 23/2009 Coll. In the year 2011, some
establishments e.g. of the Slovak Academy of Sciences divided according to kept
animal species. It means, that one establishment has also 3 official numbers of
approval according to animal species used in experiments. Total number of
approved establishments in the Slovak Republic in the year 2011. Kind of establishment || Number of establishments Experimental establishment || 53 Experimental establishment with breeding of animals for own use || 10 Breeding establishment || 2 Supplying establishment || 1 Total || 66 Approval of experiments: In the Slovak Republic it is possible to use
the animals only in approved experiments in approved experimental establishment.
The SVFA SR approves the experiments performed
on animals based on the application for approval of an experiment, submitted by
an applicant– approved experimental establishment. An application must be
completed by the applicant in compliance with Article 8 of Ordinance of the
Government of the SR No 23/2009. It must contain all the prescribed data
concerning the used animals, mainly their species, number and origin, manner of
their marking in the experiment, used anaesthesia within an experiment, performance
of the experiment with indication of the aim, purpose of the experiment and
expected results. In an application the name of a contracting veterinarian, a
person submitting an experiment and person responsible for the care of animals
are indicated. The document on the existence of the relevant alternative method
to the submitted experiment shall be attached to each experiment. The applicant
shall find out and search in internationally checked registers of alternative
method the relevant alternative to the submitted experiment. A detailed
specification of the manner of observance of principles 3R shall be attached to
the application. An applicant shall submit the experiment first for the
assessment to the ethic commission which shall be established according to the
Act in each experimental establishment. The ethic commission is comprised of
minimum 5 members, out of which 1/3 must not be dependent from the experimental
establishment. The ethic commission on the submitted project of an experiment,
shall assess the observance of principles 3R, existence of alternative method
contrary to the submitted experiment, justification of each experiment, purpose
and its aim, use of the animals in the experiment, caused pain. An applicant
may submit his/her project of an experiment for approval by the SVFA SR only
after recommendation for submission, issued by the ethic commission. The SVFA SR has in compliance with Act No.
71/1967 Coll. on Administrative Proceedings (Administrative Codex) minimum 30
days for assessment of an application for approval of the experiment. The SVFA
SR, as a competent authority, may by the DECISION APPROVE, REFUSE, SUSPEND the
performance of the experiment or may STOP an ADMINISTRATIVE PROCEEDINGS. The
SVFA SR upon approval of experiments must observe the rules of the personal
data protection and protection of data with signs of trade secret or
intellectual property indicated in an application for approval of the
experiment. Since 01.01.2011,
the SVFA SR approved experiments only to those establishments which were
approved in compliance with requirements laid down in Ordinance of the Government
of the SR No 23/2009 Coll. Therefore, the number of approved experiments for
the year 2011 decreased, because not all registered establishments were still
approved in compliance with new requirements laid down in Ordinance of the
Government of the SR No 23/2009 Coll. Survey on the
number of approved experiments and on the number of interruptions of
administrative proceedings: Year || 2009 || 2010 || 2011 || Approval of experiment || 115 || 176 || 103 || Appeal for removal of deficiencies || 48 || 25 || 34 || Commentary to completed tables: To the Table 1
Most of used animals originate from domestic approved breeding establishments
or approved experimental establishments with breeding of animals for own use.
The animals which originated from foreign suppliers or breeders originated from
the EU Member States, mainly from the Czech Republic, Hungary, Germany, Poland
or France. An increased number of animals repeatedly used in experiments
(domestic rabbit 82 animals, 150 domestic fowl) is for the reason of an
increased performance of experiments to order for the purpose of manufacture,
development of substances intended for disease diagnostics. The hyperimmune
sera from which the antibodies were purified, were obtained from immunized
animals. To the Table 2 The
SVFA SR approved 103 experiments using experimental animals, stopped 34
administrative proceedings within experiment approval for the year 2011. The
total number of animals used in experiments does not represent entirely the
number of used animals for the year 2011. It is for the reason that into the
indicated number of used animals in the year 2011 also animals are included,
which were used from experiments approved already in the year 2009, 2010, 2011.
In the Slovak Republic, the experiments are approved for the period of 3 years.
In the column 2.8. the number of animals are indicated which were used within
preparation of exepriments - so called pilot studies for performance of the
experiment. The animals were used for the introduction of new surgical methods
being used in the course of performance of experiments concerning demanding
surgical interventions and other handling of animals. The pilot studies were
approved by the competent authority as experiments. The usage of animals to
obtain the necessary skills of persons performing the experiments – training of
persons – the SVFA SR approved as a pre-experiment within the performance of
the experiment. In the column 2.9 the numbers of animals used as a live
collection for maintenance of viruses, parasites and breeding of ticks or
animals used for preparation of primocultures are indiated. Each preparation of
a collection was approved as a separate experiment. To the Table 3. In
the column 3.2 the animals were used for evaluation of products and substances
for human medicine (testing of new medicines, medical devices, surgical
supplies – suitability of new polymers in treatment of hernia). In the column
3.4 the numbers of animals are indicated which are used for the control of
various chemical substances and substances e.g. for evaluation of human risk of
amines, NH3, aldehydes, amides, alkylamides, nitrosamines as independent
substances and their combinations, substances used as additive for slowing down
or stopping the growth of microorganisms in paint substances, in fibres from
plastic products or substances which are a part of fuel oils, lubricants and
substances used in rubber industry. The orders for re-testing of the same
substance produced in various batches were done in several establishments. In
some cases, whole series of standard toxicological safety tests were carried
out with the same substance, based on the EU legislation e.g. REACH. In the
column 3.8 the animals were used for the purpose of testing the substance used
in food industry as a supplement of food in a form of enterosolvent pellets of
microcrystalline cellulose, either independent or enriched by lactose, or an
influence of chosen feed additives was controlled. In the column 3.10 the
numbers of animals are indicated with the aim to validate in in vivo experiments
on animals findings of alternative in vitro experiments characterizing the
toxicological profile of nanoelemens which will be perspectively used in
further experiments for a toxicological evaluation of substances. To the Table 4
Explanation to the column 4.5. The animals were used for the purpose of
investigation of immune systems, infectious diseases and metabolism disorders
in humans and in the column 4.6 in animals. To the Table No 5
In the Slovak Republic the experiments upon animals are performed in compliance
with the valid national legislation, in which the legal acts of the European
Communities and the European Union are incorporated. In the column 5.3 the
experiments are performed in compliance with the valid legislation of the
European Pharmacopoeia. In the column 5.7 the methods for the control of human
products/substances were used that were created by the experimental
establishment as a modified method based on the approved
pharmacopoeial methods or as a new individual method. To the Table 6 The
Slovak Republic has adopted the legislation in the field of medicines and
medical devices e.g. Act No 362/2011 Coll. on Medicines and Medical Devices and
on change and supplement of some acts, in the field
of chemical substances and preparations the Act No 163/2001 Coll. on
Chemical Substances and Preparations, we have adopted the Decree of the
Ministry of Economy No 2/2005 Annex 5 Part B Methods B for testing of
substances according to OECD methods that are conformable to OECD methods. The
acts are elaborated and prepared in compliance with the EU legislation
according to which the individual preparations, products are tested. In the
column 6.3 the numbers of animals used in compliance with the European
Pharmacopoeia are indicated. To the Table 7 In
the column 7.2.1. the tests were performed mainly by methods OECD TG 402, 423,
425. In the column 7.2.3 mainly the tests of the control of the product
quality, tests of wholesomeness and efficiency according to the Slovak
Pharmacopoeia 1 and the European Pharmacopoeia 6 were carried out. In compliance with the Ordinance of the
Government of the Slovak Republic No 23/2009 Coll. each approved establishment
shall be obliged, in order to maintain its approval, to submit yearly to the
SVFA SR a notification on the number of used animals for the respective year.
The notification shall be submitted according to the specimen presented in the
Ordinance of the Government. The approved establishments shall be obliged to
keep records on the number of used GMO animals in the experiment. Based on the
collected data, the SVFA SR shall yearly work out a notification about the
activity of the SVFA SR in which the numbers of approved establishments, the numbers
of approved and refused experiments as well as the numbers and species of used
animals in the experiment for the respective year are published. The competent authority performs consulting
services for public in the field of animal welfare, organizes trainings for
employees of approved establishments the purpose of which is interpretation of
the valid legislation of the Slovak Republic in the field of animal welfare, it
organizes seminars and lectures in respect of the protection of experimental
animals used for experimental purposes. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 8747 || 6560 || 2187 || 0 || 0 || 0 1.b. || Rats (Rattus norvegicus) || 5327 || 3943 || 1384 || 0 || 0 || 0 1.c. || Guinea-Pigs (Cavia porcellus) || 645 || 329 || 316 || || || 1.d. || Hamsters (Mesocricetus ) || 0 || || || || || 1.e. || Other Rodents (other Rodentia) || 17 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 299 || 237 || 62 || || || 82 1.g. || Cats (Felis catus) || 10 || 10 || || || || 1.h. || Dogs (Canis familiaris) || 0 || || || || || 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || || || || || || 1.l. || Pigs (Sus) || 84 || || || || || 1.m. || Goats (Capra) || || || || || || 1.n. || Sheep (Ovis) || 14 || || || || || 5 1.o. || Cattle (Bos) || 0 || || || || || 1 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || || || || || || 1.u. || Quail (Coturnix coturnix) || 88 || 88 || || || || 1.v. || Other birds (other Aves) || 486 || || || || || 150 1.w. || Reptiles (Reptilia) || || || || || || 1.x. || Amphibians (Amphibia) || || || || || || 1.y. || Fish (Pisces) || || || || || || 1.z. || TOTAL || 15717 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 4333 || 1561 || 0 || 403 || 188 || 2215 || 47 || 0 || 8747 2.b. || Rats || 3311 || 695 || 0 || 0 || 633 || 0 || 300 || 388 || 5327 2.c. || Guinea-Pigs || || 507 || || || || 100 || || 38 || 645 2.d. || Hamsters || || || || || || || || || 0 2.e. || Other Rodents || 17 || || || || || || || || 17 2.f. || Rabbits || 78 || 114 || 15 || 65 || 15 || 12 || || || 299 2.g. || Cats || 10 || || || || || || || || 10 2.h. || Dogs || || || || || || || || || 0 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || || || || || || || || || 0 2.k. || Horses, donkeys and cross breds || || || || || || || || || 0 2.l. || Pigs || 2 || 82 || || || || || || || 84 2.m. || Goats || || || || || || || || || 0 2.n. || Sheep || 5 || 9 || || || || || || || 14 2.o. || Cattle || || 0 || || || || || || || 0 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || || || || || || || || || 0 2.u. || Quail || 88 || || || || || || || || 88 2.v. || Other birds || 108 || || 45 || 216 || 90 || || || 27 || 486 2.w. || Reptiles || || || || || || || || || 0 2.x. || Amphibians || || || || || || || || || 0 2.y. || Fish || || || || || || || || || 0 2.z. || TOTAL || 7952 || 2968 || 60 || 684 || 926 || 2327 || 347 || 453 || 15717 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 188 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 188 3.b. || Rats || 275 || 0 || 118 || 0 || 0 || 0 || 90 || 0 || 150 || 633 3.c. || Guinea-Pigs || || || || || || || || || || 0 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 15 || || || || || || || || || 15 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || || || || || || || || || || 0 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || 90 || || || || || || || || || 90 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || || || 0 3.z. || TOTAL || 568 || 0 || 118 || 0 || 0 || 0 || 90 || 0 || 150 || 926 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 403 || 141 || 2019 || 3531 || 2015 || 8109 4.b. || Rats || 1586 || 914 || 297 || 1209 || || 4006 4.c. || Guinea-Pigs || || || || 607 || || 607 4.d. || Hamsters || || || || || || 0 4.e. || Other Rodents || 17 || || || || || 17 4.f. || Rabbits || || 60 || || 144 || || 204 4.g. || Cats || || || || 10 || || 10 4.h. || Dogs || || || || || || 0 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || || 2 || || 47 || 35 || 84 4.m. || Goats || || || || || || 0 4.n. || Sheep || || || || 9 || 5 || 14 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || 88 || || 88 4.v. || Other birds || || || || 108 || || 108 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || || || 0 4.z. || TOTAL || 2006 || 1117 || 2316 || 5753 || 2055 || 13247 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 0 || 403 || 0 || 0 || 0 || 0 || 403 || 5.b. || Rats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || 65 || || || || 15 || 80 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || 216 || || || || 45 || 261 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 0 || 684 || 0 || 0 || 0 || 60 || 744 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 0 || 188 || 0 || 0 || 0 || 0 || 188 || 6.b. || Rats || 220 || 413 || 0 || 0 || 0 || 0 || 633 || 6.c. || Guinea-Pigs || || || || || || || 0 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || 15 || || || || || 15 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || || || 0 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || || 0 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || 90 || || || || || 90 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || || 0 || 6.z. || TOTAL || 220 || 706 || 0 || 0 || 0 || 0 || 926 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || || 20 || || || || 120 || || || 48 || || || || 188 7.b. || Rats || 55 || || || || || || 90 || || 220 || || 268 || || || 633 7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || 3 || 12 || || || || || || || || 15 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || || || || || || || || || || || || 0 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || 90 || || || || || || || || || || || 90 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || || || || || || || || 0 7.z. || TOTAL || 55 || 0 || 110 || 0 || 3 || 12 || 210 || 0 || 220 || 48 || 268 || 0 || 0 || 926 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 55 || || 110 || || 3 || 12 || 120 || || 70 || 48 || 150 || || || 568 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || 118 || || || 118 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || 90 || || || || || || || 90 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || || || || || || || || 0 8.i. || Other toxicological or safety evaluations || || || || || || || || || 150 || || || || || 8.j. || TOTAL || 55 || || 110 || 0 || 3 || 12 || 210 || 0 || 220 || 48 || 268 || 0 || 0 || 926 FINLAND Statistical data submitted The
statistical data were collected by the Regional State Administrative Agency of
Southern Finland and submitted by the Ministry of Agriculture and Forestry. Comments of Finnish authorities In 2011, a
total of 136,043 experimental animals were used in Finland. From the year 2008
with 138,600 animals, no significant changes have been seen in the numbers of
animals used or reasons for their use. Of all
experimental animals used 68% were mice (73,503 animals) and rats (18,586
animals). Fish accounted for about 23% (30,766 animals) of the total use. There
has been a continuous slight decrease in the use of rats and rabbits from year
to year since 2008. The increased numbers of cats (454 animals) and dogs (2,805
animals) resulted from the research projects studying the genetic diseases of
these species with blood samplings from pet animals. Besides these projects, 51
dogs and 0 cats and were used in experiments. As in
previous years, a major part of the animals (75%) were used for biological
studies of a fundamental nature or for research and development of human and
veterinary medicine (20%). The most
important human diseases studied in Finland with animals were the nervous and
mental disorders, indicating the major role of research groups in universities
and private sector focusing on this research area. The use for
toxicological and other safety evaluations was 1% of the total use, rats and
fish being the species used. The use of animals for education and training was
also minimal, 1% of the total number of animals used. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 73503 || 50985 || 21512 || 32 || 974 || 1.b. || Rats (Rattus norvegicus) || 18586 || 5208 || 12680 || || 698 || 1.c. || Guinea-Pigs (Cavia porcellus) || 11 || || 11 || || || 1.d. || Hamsters (Mesocricetus ) || 201 || 30 || 28 || || 143 || 1.e. || Other Rodents (other Rodentia) || 2682 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 357 || 96 || 261 || || || 28 1.g. || Cats (Felis catus) || 454 || 454 || || || || 1.h. || Dogs (Canis familiaris) || 2805 || 2755 || 50 || || || 16 1.i. || Ferrets (Mustela putorius furo) || 0 || || || || || 1.j. || Other Carnivores (other Carnivora) || 656 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 23 || || || || || 1.l. || Pigs (Sus) || 681 || || || || || 1.m. || Goats (Capra) || 40 || || || || || 1.n. || Sheep (Ovis) || 684 || || || || || 1.o. || Cattle (Bos) || 63 || || || || || 1.p. || Prosimians (Prosimia) || 0 || || || || || 1.q. || New World Monkeys (Ceboidea) || 0 || || || || || 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || || || || || 1.s. || Apes (Hominoidea) || 0 || || || || || 1.t. || Other Mammals (other Mammalia) || 17 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || || || || || 1.v. || Other birds (other Aves) || 4426 || || || || || 1.w. || Reptiles (Reptilia) || 15 || || || || || 1.x. || Amphibians (Amphibia) || 73 || || || || || 1.y. || Fish (Pisces) || 30766 || || || || || 1.z. || TOTAL || 136043 || 59528 || 34542 || 32 || 1815 || 44 Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 55762 || 16869 || || || 81 || 40 || 711 || 40 || 73503 2.b. || Rats || 8172 || 9438 || || || 479 || || 497 || || 18586 2.c. || Guinea-Pigs || 11 || || || || || || || || 11 2.d. || Hamsters || 60 || 141 || || || || || || || 201 2.e. || Other Rodents || 2680 || || || || || || 2 || || 2682 2.f. || Rabbits || 205 || 109 || || || 31 || 12 || || || 357 2.g. || Cats || 454 || || || || || || || || 454 2.h. || Dogs || 2753 || 24 || || || 28 || || || || 2805 2.i. || Ferrets || || || || || || || || || 0 2.j. || Other Carnivores || 656 || || || || || || || || 656 2.k. || Horses, donkeys and cross breds || 22 || || || || || || 1 || || 23 2.l. || Pigs || 214 || 83 || 210 || || || 15 || 79 || 80 || 681 2.m. || Goats || 40 || || || || || || || || 40 2.n. || Sheep || 13 || || 650 || || || 20 || 1 || || 684 2.o. || Cattle || 25 || 12 || || 24 || || 1 || 1 || || 63 2.p. || Prosimians || || || || || || || || || 0 2.q. || New World Monkeys || || || || || || || || || 0 2.r. || Old World Monkeys || || || || || || || || || 0 2.s. || Apes || || || || || || || || || 0 2.t. || Other Mammals || 17 || || || || || || || || 17 2.u. || Quail || || || || || || || || || 0 2.v. || Other birds || 912 || 9 || || 3095 || || 8 || 18 || 384 || 4426 2.w. || Reptiles || 15 || || || || || || || || 15 2.x. || Amphibians || 73 || || || || || || || || 73 2.y. || Fish || 29894 || || || || 720 || || 152 || || 30766 2.z. || TOTAL || 101978 || 26685 || 860 || 3119 || 1339 || 96 || 1462 || 504 || 136043 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nents in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 81 || || || || || || || || || 81 3.b. || Rats || 261 || || 140 || || || || || || 78 || 479 3.c. || Guinea-Pigs || || || || || || || || || || 0 3.d. || Hamsters || || || || || || || || || || 0 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 31 || || || || || || || || || 31 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || 28 || || || || || || || || || 28 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || || || 0 3.y. || Fish || || || || || || || || 720 || || 720 3.z. || TOTAL || 401 || 0 || 140 || 0 || 0 || 0 || 0 || 720 || 78 || 1339 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 7268 || 20901 || 5422 || 7391 || || 40982 4.b. || Rats || 1555 || 10484 || 1409 || 1353 || || 14801 4.c. || Guinea-Pigs || || || || || || 0 4.d. || Hamsters || || || 143 || || || 143 4.e. || Other Rodents || || || || || || 0 4.f. || Rabbits || 121 || || || 145 || || 266 4.g. || Cats || || || || || 454 || 454 4.h. || Dogs || 22 || || 2 || || 2753 || 2777 4.i. || Ferrets || || || || || || 0 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || || 0 4.l. || Pigs || 284 || || || 20 || || 304 4.m. || Goats || || || || || || 0 4.n. || Sheep || 1 || || || 29 || || 30 4.o. || Cattle || || || || || 67 || 67 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || || || 0 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || 2 || 17 || 19 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || || || || || || 0 4.y. || Fish || || || || 8960 || || 8960 4.z. || TOTAL || 9251 || 31385 || 6976 || 17900 || 3291 || 68803 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || || || 0 || 5.b. || Rats || || || || || || || 0 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || || || || || || || 0 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || 210 || 210 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || 650 || 650 || 5.o. || Cattle || 24 || || || || || || 24 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || 3095 || 3095 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 24 || 0 || 0 || 0 || 0 || 3955 || 3979 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 - Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || 6 || || || || 75 || 81 || 6.b. || Rats || 261 || 140 || || || || 78 || 479 || 6.c. || Guinea-Pigs || || || || || || || 0 || 6.d. || Hamsters || || || || || || || 0 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || 3 || || || || 28 || 31 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || 28 || || || || || || 28 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || || 0 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || || 0 || 6.y. || Fish || || || || || || 720 || 720 || 6.z. || TOTAL || 289 || 149 || 0 || 0 || 0 || 901 || 1339 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Swiss requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep., Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, 'the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || || 6 || 75 || || || || || || || || || || || 81 7.b. || Rats || || || 293 || || || || || || 100 || || || || 86 || 479 7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0 7.d. || Hamsters || || || || || || || || || || || || || || 0 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || 3 || || || 28 || || || || || || || || 31 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || 28 || || || || || || || || || || || 28 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || || 0 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || || || || || || 0 7.y. || Fish || || || || || || || 90 || || || || 630 || || || 720 7.z. || TOTAL || 0 || 6 || 399 || 0 || 0 || 28 || 90 || 0 || 100 || 0 || 630 || 0 || 86 || 1339 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 6 || 347 || || || 28 || || || || || || || 20 || 401 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || 40 || || || || || || 100 || || || || || 140 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || 90 || || || || 630 || || || 720 8.i. || Other toxicological or safety evaluations || || || 12 || || || || || || || || || || 66 || 78 8.j. || TOTAL || 0 || 6 || 399 || 0 || 0 || 28 || 90 || 0 || 100 || 0 || 630 || 0 || 86 || 1339 SWEDEN Statistical data submitted The statistical data were submitted by the Board of Agriculture. Comments of Swedish authorities According to the EU definition (Directive
86/609/EEC), the number of laboratory animals used during 2011 in Sweden was
296,684 including reused animals and 271,041 excluding reused animals. This is
a decrease compared to the 501,499 animals (including reused animals) reported
for 2008 mostly explained by the fact that tagged fish are no longer, starting
2009, included in these statistics. During 2011, the number of fish used for
this purpose was 120,500. Apart from that, the figures for 2011 also reflect
well the minor fluctuation that has been seen during the last 5 years in the
number of laboratory animals used in Sweden. From 1990 until 2002, the mean number of
laboratory animals used in Sweden was about 315,000 with the highest number
1994 (approximately 351,000) and the lowest 1997 (approximately 267,000). From
2003-2008, however, there has been an increase in the number of animals used
due to the fact that tagging of fish for assessment studies have been included.
Apart from fish, mice and rats are the animals predominately used in animal
experimentation in Sweden. During the last 10 years the trend has been an
increase in the use of mice whereas the use of rats, rabbits and guinea pigs
has decreased. The increased use of mice as laboratory animals is most probably
due to the increased use of transgenic technique(s).
Specific use of animals As in previous years, most laboratory
animals used during 2011 were used for fundamental biological research. Only 3.5% of the animals were used in
toxicological research, and the most common animals used in toxicological
research were rats, mice and fish. Swedish definition According to Swedish legislation, all use
of animals with a scientific purpose is defined as animal experimentation.
Sweden therefore also collects statistical data on for example animals used in
behaviour studies, feeding trials and animals being killed for the use of their
tissues and organs. During 2011, 412,629 animals were reported being used for
these purposes. In addition, Sweden also keeps statistical records of fish used
in assessment studies. In this category, during 2011 approximately 7,734,200
fish were caught by trawling or netting, whereas 120,500 fish were tagged. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 185913 || 136491 || 46206 || || 3216 || 1.b. || Rats (Rattus norvegicus) || 35202 || 7559 || 27545 || || 98 || 1.c. || Guinea-Pigs (Cavia porcellus) || 1151 || 747 || 404 || || || 1.d. || Hamsters (Mesocricetus ) || 881 || 0 || 881 || || || 1.e. || Other Rodents (other Rodentia) || 1483 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 710 || 675 || 35 || 0 || || 6 1.g. || Cats (Felis catus) || 34 || 0 || 0 || 34 || || 0 1.h. || Dogs (Canis familiaris) || 530 || 447 || 33 || 2 || 48 || 133 1.i. || Ferrets (Mustela putorius furo) || 76 || 76 || 0 || 0 || || 0 1.j. || Other Carnivores (other Carnivora) || 256 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 107 || || || || || 1.l. || Pigs (Sus) || 2277 || || || || || 1.m. || Goats (Capra) || 13 || || || || || 1.n. || Sheep (Ovis) || 285 || || || || || 1.o. || Cattle (Bos) || 370 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 0 || 0 || 0 || 0 || 0 || 0 1.r. || Old World Monkeys (Cercopithecoidea) || 0 || 0 || 0 || 0 || 7 || 7 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals (other Mammalia) || 1625 || || || || || 1.u. || Quail (Coturnix coturnix) || 0 || 0 || 0 || 0 || 0 || 1.v. || Other birds (other Aves) || 2804 || || || || || 1.w. || Reptiles (Reptilia) || 0 || || || || || 1.x. || Amphibians (Amphibia) || 1216 || || || || || 1.y. || Fish (Pisces) || 36108 || || || || || 1.z. || TOTAL || 271041 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 129685 || 50027 || 2 || || 531 || 1008 || 567 || 4093 || 185913 2.b. || Rats || 16700 || 14564 || 6 || || 2888 || 340 || 471 || 233 || 35202 2.c. || Guinea-Pigs || 158 || 824 || || || || || 50 || 119 || 1151 2.d. || Hamsters || 14 || 758 || || || 90 || || 19 || || 881 2.e. || Other Rodents || 1483 || || || || || || || || 1483 2.f. || Rabbits || 330 || 365 || 4 || || 2 || || 3 || 6 || 710 2.g. || Cats || 20 || || || || || || || 14 || 34 2.h. || Dogs || 81 || 59 || || || 284 || 104 || 2 || || 530 2.i. || Ferrets || 76 || || || || || || 33 || || 109 2.j. || Other Carnivores || 256 || || || || || || || || 256 2.k. || Horses, donkeys and cross breds || 51 || || || || || 10 || || 13 || 74 2.l. || Pigs || 1124 || 271 || || || || 208 || 582 || 92 || 2277 2.m. || Goats || 0 || || || || || || || 13 || 13 2.n. || Sheep || 64 || || || || || || || 221 || 285 2.o. || Cattle || 9 || 74 || || || || 6 || 280 || 1 || 370 2.p. || Prosimians || 0 || || || || || || || || 0 2.q. || New World Monkeys || 0 || || || || || || || || 0 2.r. || Old World Monkeys || 0 || || || || || || || || 0 2.s. || Apes || 0 || || || || || || || || 0 2.t. || Other Mammals || 1617 || || || || || || || 8 || 1625 2.u. || Quail || 0 || || || || || || || || 0 2.v. || Other birds || 2358 || 216 || 60 || || || 130 || || 40 || 2804 2.w. || Reptiles || 0 || || || || || || || || 0 2.x. || Amphibians || 536 || || || || 680 || || || || 1216 2.y. || Fish || 10790 || || || || 9369 || 31 || 5020 || 10898 || 36108 2.z. || TOTAL || 165352 || 67158 || 72 || 0 || 13844 || 1837 || 7027 || 15751 || 271041 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 530 || || || || || || || 1 || || 531 3.b. || Rats || 2837 || || || || || || || 51 || || 2888 3.c. || Guinea-Pigs || || || || || || || || || || 0 3.d. || Hamsters || 90 || || || || || || || || || 90 3.e. || Other Rodents || || || || || || || || || || 0 3.f. || Rabbits || 2 || || || || || || || || || 2 3.g. || Cats || || || || || || || || || || 0 3.h. || Dogs || 284 || || || || || || || || || 284 3.i. || Ferrets || || || || || || || || || || 0 3.j. || Other Carnivores || || || || || || || || || || 0 3.k. || Horses, donkeys and cross breds || || || || || || || || || || 0 3.l. || Pigs || || || || || || || || || || 0 3.m. || Goats || || || || || || || || || || 0 3.n. || Sheep || || || || || || || || || || 0 3.o. || Cattle || || || || || || || || || || 0 3.p. || Prosimians || || || || || || || || || || 0 3.q. || New World Monkeys || || || || || || || || || || 0 3.r. || Old World Monkeys || || || || || || || || || || 0 3.s. || Apes || || || || || || || || || || 0 3.t. || Other Mammals || || || || || || || || || || 0 3.u. || Quail || || || || || || || || || || 0 3.v. || Other birds || || || || || || || || || || 0 3.w. || Reptiles || || || || || || || || || || 0 3.x. || Amphibians || || || || || || || || 680 || || 680 3.y. || Fish || 2533 || || || || || || || 5356 || 1480 || 9369 3.z. || TOTAL || 6276 || 0 || 0 || 0 || 0 || 0 || 0 || 6088 || 1480 || 13844 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 16401 || 48508 || 29123 || 79082 || 1689 || 174803 4.b. || Rats || 2991 || 17328 || 788 || 9837 || || 30944 4.c. || Guinea-Pigs || 40 || 463 || || 479 || || 982 4.d. || Hamsters || 745 || || || 27 || || 772 4.e. || Other Rodents || || || || 99 || 824 || 923 4.f. || Rabbits || 254 || 54 || 2 || 389 || || 699 4.g. || Cats || || 20 || || || || 20 4.h. || Dogs || 54 || || || 5 || 185 || 244 4.i. || Ferrets || || 76 || || || || 76 4.j. || Other Carnivores || || || || || || 0 4.k. || Horses, donkeys and cross breds || || || || || 61 || 61 4.l. || Pigs || 416 || 8 || 1 || 559 || 271 || 1255 4.m. || Goats || || || || || || 0 4.n. || Sheep || 37 || || || 27 || 80 || 144 4.o. || Cattle || || || || || || 0 4.p. || Prosimians || || || || || || 0 4.q. || New World Monkeys || || || || || || 0 4.r. || Old World Monkeys || || || || || || 0 4.s. || Apes || || || || || || 0 4.t. || Other Mammals || || || || 20 || || 20 4.u. || Quail || || || || || || 0 4.v. || Other birds || || || || 1015 || 1318 || 2333 4.w. || Reptiles || || || || || || 0 4.x. || Amphibians || 75 || 31 || || 430 || || 536 4.y. || Fish || 0 || || 274 || 60 || 1378 || 1712 4.z. || TOTAL || 21013 || 66488 || 30188 || 92029 || 5806 || 215524 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || || || || || || 2 || 2 || 5.b. || Rats || || || || || || 6 || 6 || 5.c. || Guinea-Pigs || || || || || || || 0 || 5.d. || Hamsters || || || || || || || 0 || 5.e. || Other Rodents || || || || || || || 0 || 5.f. || Rabbits || 4 || || || || || || 4 || 5.g. || Cats || || || || || || || 0 || 5.h. || Dogs || || || || || || || 0 || 5.i. || Ferrets || || || || || || || 0 || 5.j. || Other Carnivores || || || || || || || 0 || 5.k. || Horses, donkeys and cross breds || || || || || || || 0 || 5.l. || Pigs || || || || || || || 0 || 5.m. || Goats || || || || || || || 0 || 5.n. || Sheep || || || || || || || 0 || 5.o. || Cattle || || || || || || || 0 || 5.p. || Prosimians || || || || || || || 0 || 5.q. || New World Monkeys || || || || || || || 0 || 5.r. || Old World Monkeys || || || || || || || 0 || 5.s. || Apes || || || || || || || 0 || 5.t. || Other Mammals || || || || || || || 0 || 5.u. || Quail || || || || || || || 0 || 5.v. || Other birds || || || || || || 60 || 60 || 5.w. || Reptiles || || || || || || || 0 || 5.x. || Amphibians || || || || || || || 0 || 5.y. || Fish || || || || || || || 0 || 5.z. || TOTAL || 4 || 0 || 0 || 0 || 0 || 68 || 72 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || || || || || 530 || 1 || 531 || 6.b. || Rats || || || || || 2837 || 51 || 2888 || 6.c. || Guinea-Pigs || || || || || || || 0 || 6.d. || Hamsters || || || || || 90 || || 90 || 6.e. || Other Rodents || || || || || || || 0 || 6.f. || Rabbits || || || || || 2 || || 2 || 6.g. || Cats || || || || || || || 0 || 6.h. || Dogs || || || || || 284 || || 284 || 6.i. || Ferrets || || || || || || || 0 || 6.j. || Other Carnivores || || || || || || || 0 || 6.k. || Horses, donkeys and cross breds || || || || || || || 0 || 6.l. || Pigs || || || || || || || 0 || 6.m. || Goats || || || || || || || 0 || 6.n. || Sheep || || || || || || || 0 || 6.o. || Cattle || || || || || || || 0 || 6.p. || Prosimians || || || || || || || 0 || 6.q. || New World Monkeys || || || || || || || 0 || 6.r. || Old World Monkeys || || || || || || || 0 || 6.s. || Apes || || || || || || || 0 || 6.t. || Other Mammals || || || || || || || 0 || 6.u. || Quail || || || || || || || 0 || 6.v. || Other birds || || || || || || || 0 || 6.w. || Reptiles || || || || || || || 0 || 6.x. || Amphibians || || || || || || 680 || 680 || 6.y. || Fish || 651 || || || || 1508 || 7210 || 9369 || 6.z. || TOTAL || 651 || 0 || 0 || 0 || 5251 || 7942 || 13844 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || || || || 196 || || || || 200 || || 1 || || || || 134 || 531 7.b. || Rats || || || 1099 || || || || 463 || || 184 || 448 || 75 || || 619 || 2888 7.c. || Guinea-Pigs || || || || || || || || || || || || || || 0 7.d. || Hamsters || || || 80 || || || || || || || || || || 10 || 90 7.e. || Other Rodents || || || || || || || || || || || || || || 0 7.f. || Rabbits || || || || || || || || || || || || || 2 || 2 7.g. || Cats || || || || || || || || || || || || || || 0 7.h. || Dogs || || || 74 || || || || 207 || || || || || || || 281 7.i. || Ferrets || || || || || || || || || || || || || || 0 7.j. || Other Carnivores || || || || || || || || || || || || || || 0 7.k. || Horses, donkeys and cross breds || || || || || || || || || || || || || 3 || 3 7.l. || Pigs || || || || || || || || || || || || || || 0 7.m. || Goats || || || || || || || || || || || || || || 0 7.n. || Sheep || || || || || || || || || || || || || || 0 7.o. || Cattle || || || || || || || || || || || || || || 0 7.p. || Prosimians || || || || || || || || || || || || || || 0 7.q. || New World Monkeys || || || || || || || || || || || || || || 0 7.r. || Old World Monkeys || || || || || || || || || || || || || || 0 7.s. || Apes || || || || || || || || || || || || || || 0 7.t. || Other Mammals || || || || || || || || || || || || || || 0 7.u. || Quail || || || || || || || || || || || || || || 0 7.v. || Other birds || || || || || || || || || || || || || || 0 7.w. || Reptiles || || || || || || || || || || || || || || 0 7.x. || Amphibians || || || || || || || || || 500 || || || 180 || || 680 7.y. || Fish || || 28 || || || || || || || 4798 || || 1969 || 2574 || || 9369 7.z. || TOTAL || 0 || 28 || 1449 || 0 || 0 || 0 || 870 || 0 || 5483 || 448 || 2044 || 2754 || 768 || 13844 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || || 28 || 1449 || || || || 819 || || 1529 || 448 || 1235 || || 768 || 6276 8.b. || Products/substances used or intended to be used mainly in agriculture || || || || || || || || || || || || || || 0 8.c. || Products/substances used or intended to be used mainly in industry || || || || || || || || || || || || || || 0 8.d. || Products/substances used or intended to be used mainly in the household || || || || || || || || || || || || || || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || || || || || || || || || || || || || || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || || || || || || || || || || || || || || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || || || || || || || || || || || || || || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || || || || || || || 51 || || 3954 || || 809 || 1274 || || 6088 8.i. || Other toxicological or safety evaluations || || || || || || || || || || || || 1480 || || 1480 8.j. || TOTAL || 0 || 28 || 1449 || 0 || 0 || 0 || 870 || 0 || 5483 || 448 || 2044 || 2754 || 768 || 13844 UNITED KINGDOM Statistical data submitted The United Kingdom statistical data for
2011 were prepared, quality assured and submitted by the Home Office. Within the United Kingdom (UK), Great
Britain (GB) and Northern Ireland (NI) publish separate, annual statistical reports
based largely on the number of procedures started rather than numbers of
animals used. The 2011 data collection process was 100% complete. In accord with our established practice the
UK figures presented here have been recompiled from the original data in terms
of animal numbers for the classes of animal use recorded in the EU statistical
tables. It should be noted that the UK also regulates, and the UK domestic
statistical reports enumerate, animals bred for the maintenance of colonies of
genetically modified or harmful mutant animals, and that category of animal use
largely accounts for the differences in the figures in the original GB & NI
publications and those in this EU report. Comments of United Kingdom authorities In the UK, just over 2.05 million animals
were used for the first time in procedures started in 2011, a fall of 216,426
(-10%) on the number reported for 2008. The decrease was largely accounted for
by decreases in numbers of rats (-90,852), fish (-63,730), mice (-56,323) and
guinea pigs (-17,736) along with an increase in the use of other birds
(+37,775). 1,828,672 (89%) of the animals used
(2,050,458) were mice (56%), fish (20%) or rats (12%). Cold-blooded animals (fish, amphibia, and
reptiles) accounted for 425,240 (21%) of the animals used. Cats, dogs, equidae and non-human primates
are accorded special protection in the UK and collectively amounted to 4,877
animals, 0.2% of the animals used, a reduction of 3228 (-40%) compared with
2008. Non-human primates accounted for 1,459 animals,
0.07% of animals used, a decrease of 1895 animals (-56%) compared with 2008
(there was a fall in the numbers of new world monkeys and old world monkeys
used). 1,425,640 animals (70%) were used for
fundamental biological studies, research and development and production and
quality control relating to human medicine, dentistry and veterinary medicine. Toxicological or other safety evaluation
used 229,674 animals (11%), a decrease of 55,214 since 2008. There was a decrease in the number of
toxicology and other safety evaluation experiments carried out in 2011 not to
satisfy any regulatory requirements (45,546), down 48,639 compared with 2008,
largely due to decreases in such use of fish (-47,084). 146,505 animals (7%) were used for the
production and quality control of products and devices for human medicine,
dentistry or veterinary medicine, 29,857 less than in 2008. This decrease was
accounted for by a decrease in the number of mice (-16,669) and fish (-15,393). Approximately 43% of animals used received
some form of anaesthesia, compared to approximately 40% in 2008 (for the other
animals the use of anaesthesia would have been deemed to increase the severity
of the procedure. As in 2008 no animals were used in 2011 to
evaluate the safety of either cosmetic products or cosmetic ingredients. No animals were used in
2011 for monoclonal antibody production using the ascites method. TABLE
1: NUMBER OF ANIMALS USED IN RELATION TO THEIR PLACE OF ORIGIN Origin
versus species 1.1 Species || 1.2 Total || 1.3 Animals coming from registered breeding or supplying establishments within the reporting country || 1.4 Animals coming from elsewhere in the EC || 1.5 Animals coming from Member Countries of the Council of Europe which are parties to the Convention ETS 123 (excluding EC Member States) || 1.6 Animals coming from other origins || 1.7 Re-used animals 1.a. || Mice (Mus musculus) || 1155920 || 1143119 || 5171 || 33 || 7597 || 1.b. || Rats (Rattus norvegicus) || 252437 || 251420 || 593 || 1 || 423 || 1.c. || Guinea-Pigs (Cavia porcellus) || 11514 || 7788 || 3726 || 0 || 0 || 1.d. || Hamsters (Mesocricetus ) || 2003 || 1546 || 457 || 0 || 0 || 1.e. || Other Rodents (other Rodentia) || 3243 || || || || || 1.f. || Rabbits (Oryctolagus cuniculus) || 11920 || 11049 || 799 || 0 || 72 || 2042 1.g. || Cats (Felis catus) || 172 || 62 || 97 || 0 || 13 || 75 1.h. || Dogs (Canis familiaris) || 2872 || 2205 || 375 || 0 || 292 || 731 1.i. || Ferrets (Mustela putorius furo) || 552 || 552 || 0 || 0 || 0 || 139 1.j. || Other Carnivores (other Carnivora) || 742 || || || || || 1.k. || Horses, donkeys and cross breds (Equidae) || 374 || || || || || 1.l. || Pigs (Sus) || 4370 || || || || || 1.m. || Goats (Capra) || 117 || || || || || 1.n. || Sheep (Ovis) || 9556 || || || || || 1.o. || Cattle (Bos) || 4310 || || || || || 1.p. || Prosimians (Prosimia) || 0 || 0 || 0 || 0 || 0 || 0 1.q. || New World Monkeys (Ceboidea) || 244 || 244 || 0 || 0 || 0 || 103 1.r. || Old World Monkeys (Cercopithecoidea) || 1215 || 340 || 48 || 0 || 827 || 375 1.s. || Apes (Hominoidea) || 0 || 0 || 0 || 0 || 0 || 0 1.t. || Other Mammals(other Mammalia) || 771 || || || || || 1.u. || Quail (Coturnix coturnix) || 34 || 34 || 0 || 0 || 0 || 1.v. || Other birds (other Aves) || 162852 || || || || || 1.w. || Reptiles (Reptilia) || 383 || || || || || 1.x. || Amphibians (Amphibia) || 4542 || || || || || 1.y. || Fish (Pisces) || 420315 || || || || || 1.z. || TOTAL || 2050458 || || || || || Note 1: Column
1.5 concerns only those Member Countries of the Council of Europe which, at the
beginning of the reporting period, are Parties to the Convention ETS 123. Thus
an updated list of those countries has to be used when filling in this column. Note 2: Only
the white boxes need to be completed. Note 3: The
number of re-used animals in column 1.7 should be excluded from the total in
the column 1.2 TABLE
2: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR SELECTED PURPOSES Purpose
versus species 2.1 Species || 2.2 Biological studies of a fundamental nature || 2.3 Research and development of products and devices for human medicine and dentistry and for veterinary medicine (excluding toxicological and other safety evaluations counted in column 2.6) || 2.4 Production and quality control of products and devices for human medicine and dentistry || 2.5 Production and quality control of products and devices for veterinary medicine || 2.6 Toxicological and other safety evaluations (including safety evaluation of products and devices for human medicine and dentistry and for veterinary medicine) || 2.7 Diagnosis of disease || 2.8 Education and training || 2.9 Other || 2.10 Total 2.a. || Mice || 684033 || 86787 || 99881 || 12961 || 54212 || 4493 || 903 || 212650 || 1155920 2.b. || Rats || 79959 || 55152 || 3005 || 0 || 99255 || 6 || 1165 || 13895 || 252437 2.c. || Guinea-Pigs || 2283 || 1567 || 4354 || 1112 || 1274 || 94 || 100 || 730 || 11514 2.d. || Hamsters || 883 || 222 || 0 || 118 || 470 || 0 || 0 || 310 || 2003 2.e. || Other Rodents || 2316 || 214 || 0 || 0 || 230 || 0 || 0 || 483 || 3243 2.f. || Rabbits || 1174 || 427 || 1744 || 1520 || 5287 || 1402 || 14 || 352 || 11920 2.g. || Cats || 125 || 13 || 0 || 0 || 23 || 0 || 0 || 11 || 172 2.h. || Dogs || 125 || 158 || 65 || 25 || 2421 || 0 || 0 || 78 || 2872 2.i. || Ferrets || 285 || 0 || 24 || 4 || 0 || 9 || 13 || 217 || 552 2.j. || Other Carnivores || 557 || 0 || 0 || 19 || 0 || 0 || 0 || 166 || 742 2.k. || Horses, donkeys and cross breds || 67 || 23 || 0 || 46 || 50 || 36 || 0 || 152 || 374 2.l. || Pigs || 1404 || 170 || 24 || 910 || 852 || 0 || 0 || 1010 || 4370 2.m. || Goats || 33 || 0 || 3 || 3 || 6 || 69 || 0 || 3 || 117 2.n. || Sheep || 6059 || 48 || 412 || 398 || 161 || 1204 || 0 || 1274 || 9556 2.o. || Cattle || 2497 || 220 || 0 || 967 || 102 || 120 || 0 || 404 || 4310 2.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.q. || New World Monkeys || 125 || 0 || 79 || 0 || 27 || 0 || 0 || 13 || 244 2.r. || Old World Monkeys || 77 || 85 || 17 || 0 || 994 || 0 || 0 || 42 || 1215 2.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 2.t. || Other Mammals || 751 || 0 || 0 || 0 || 0 || 0 || 0 || 20 || 771 2.u. || Quail || 34 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 34 2.v. || Other birds || 14559 || 30 || 59 || 10778 || 4945 || 1873 || 0 || 130608 || 162852 2.w. || Reptiles || 383 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 383 2.x. || Amphibians || 4086 || 0 || 0 || 0 || 419 || 0 || 0 || 37 || 4542 2.y. || Fish || 330979 || 1225 || 0 || 7977 || 58946 || 0 || 0 || 21188 || 420315 2.z. || TOTAL || 1132794 || 146341 || 109667 || 36838 || 229674 || 9306 || 2195 || 383643 || 2050458 TABLE
3: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Products
versus species 3.1 Species || 3.2 Products/ substances or devices for human medicine and dentistry and for veterinary medicine || 3.3 Products/ substances used or intended to be used mainly in agriculture || 3.4 Products/ substances used or intended to be used mainly in industry || 3.5 Products/ substances used or intended to be used mainly in the household || 3.6 Products/ substances used or intended to be used mainly as cosmetics or toiletries || 3.7 Products/ substances used or intended to be used mainly as additives in food for human consumption || 3.8 Products/ substances used or intended to be used mainly as additives in food for animal consumption || 3.9 Potential or actual contami- nants in the general envi- ronment which do not appear in other columns || 3.10 Other toxico- logical or safety evaluations || 3.11 Total 3.a. || Mice || 32882 || 5789 || 5364 || 0 || 0 || 0 || 0 || 0 || 10177 || 54212 3.b. || Rats || 64995 || 12431 || 12433 || 0 || 0 || 0 || 0 || 704 || 8692 || 99255 3.c. || Guinea-Pigs || 1260 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 14 || 1274 3.d. || Hamsters || 390 || 0 || 80 || 0 || 0 || 0 || 0 || 0 || 0 || 470 3.e. || Other Rodents || 0 || 48 || 0 || 0 || 0 || 0 || 0 || 0 || 182 || 230 3.f. || Rabbits || 3511 || 1008 || 646 || 0 || 0 || 0 || 0 || 0 || 122 || 5287 3.g. || Cats || 23 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 23 3.h. || Dogs || 2224 || 65 || 0 || 0 || 0 || 0 || 0 || 0 || 132 || 2421 3.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.k. || Horses, donkeys and cross breds || 50 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 50 3.l. || Pigs || 451 || 5 || 0 || 0 || 0 || 0 || 0 || 0 || 396 || 852 3.m. || Goats || 0 || 6 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 3.n. || Sheep || 145 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 16 || 161 3.o. || Cattle || 83 || 19 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 102 3.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.q. || New World Monkeys || 27 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 27 3.r. || Old World Monkeys || 775 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 219 || 994 3.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.v. || Other birds || 3184 || 1433 || 0 || 0 || 0 || 0 || 0 || 64 || 264 || 4945 3.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 3.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 400 || 19 || 419 3.y. || Fish || 44796 || 1965 || 668 || 0 || 0 || 0 || 0 || 11205 || 312 || 58946 3.z. || TOTAL || 154796 || 22769 || 19191 || 0 || 0 || 0 || 0 || 12373 || 20545 || 229674 TABLE
4: NUMBER OF ANIMALS USED IN EXPERIMENTS FOR STUDIES ON HUMAN AND ANIMAL
DISEASES Main
categories versus species 4.1 Species || 4.2 Human cardiovascular diseases || 4.3 Human nervous and mental disorders || 4.4 Human cancer (excluding evaluations of carcinogenic hazards or risks) || 4.5 Other human diseases || 4.6 Studies specific to animal diseases || 4.7 Total 4.a. || Mice || 49326 || 133047 || 165534 || 652881 || 15108 || 1015896 4.b. || Rats || 12368 || 63367 || 3205 || 137521 || 121 || 216582 4.c. || Guinea-Pigs || 666 || 280 || 0 || 9234 || 1112 || 11292 4.d. || Hamsters || 0 || 32 || 32 || 1606 || 127 || 1797 4.e. || Other Rodents || 1696 || 124 || 0 || 710 || 60 || 2590 4.f. || Rabbits || 820 || 226 || 0 || 7494 || 1599 || 10139 4.g. || Cats || 0 || 6 || 0 || 119 || 47 || 172 4.h. || Dogs || 93 || 0 || 0 || 2364 || 262 || 2719 4.i. || Ferrets || 0 || 38 || 0 || 497 || 4 || 539 4.j. || Other Carnivores || 19 || 0 || 0 || 538 || 23 || 580 4.k. || Horses, donkeys and cross breds || 1 || 0 || 0 || 102 || 271 || 374 4.l. || Pigs || 222 || 104 || 6 || 1946 || 2060 || 4338 4.m. || Goats || 10 || 0 || 0 || 95 || 5 || 110 4.n. || Sheep || 92 || 30 || 0 || 8081 || 1056 || 9259 4.o. || Cattle || 14 || 0 || 0 || 2603 || 1677 || 4294 4.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 4.q. || New World Monkeys || 8 || 79 || 0 || 157 || 0 || 244 4.r. || Old World Monkeys || 10 || 22 || 0 || 977 || 0 || 1009 4.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 4.t. || Other Mammals || 0 || 13 || 0 || 738 || 20 || 771 4.u. || Quail || 0 || 0 || 0 || 34 || 0 || 34 4.v. || Other birds || 929 || 1617 || 0 || 13945 || 143157 || 159648 4.w. || Reptiles || 0 || 0 || 0 || 383 || 0 || 383 4.x. || Amphibians || 0 || 29 || 80 || 3977 || 0 || 4086 4.y. || Fish || 108 || 12363 || 5692 || 314547 || 19975 || 352685 4.z. || TOTAL || 66382 || 211377 || 174549 || 1160549 || 186684 || 1799541 TABLE
5: NUMBER OF ANIMALS USED IN PRODUCTION AND QUALITY CONTROL OF PRODUCTS
AND DEVICES FOR HUMAN MEDICINE AND DENTISTRY AND FOR VETERINARY MEDICINE Regulatory
requirements versus species 5.1 Species || 5.2 National legislation specific to a single EC Member State 1) || 5.3 EC legislation including European Pharmacopoeia (requirements) || 5.4 Member Country of Council of Europe (but not EC) legislation 2) || 5.5 Other legislation || 5.6 Any combination of 5.2/ 5.3/ 5.4/ 5.5 || 5.7 No regulatory requirements || 5.8 Total || 5.a. || Mice || 190 || 3843 || 0 || 359 || 107628 || 822 || 112842 || 5.b. || Rats || 77 || 680 || 0 || 0 || 2147 || 101 || 3005 || 5.c. || Guinea-Pigs || 120 || 541 || 0 || 199 || 4606 || 0 || 5466 || 5.d. || Hamsters || 0 || 118 || 0 || 0 || 0 || 0 || 118 || 5.e. || Other Rodents || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.f. || Rabbits || 0 || 0 || 0 || 0 || 3254 || 10 || 3264 || 5.g. || Cats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.h. || Dogs || 0 || 0 || 0 || 0 || 90 || 0 || 90 || 5.i. || Ferrets || 0 || 0 || 0 || 0 || 28 || 0 || 28 || 5.j. || Other Carnivores || 19 || 0 || 0 || 0 || 0 || 0 || 19 || 5.k. || Horses, donkeys and cross breds || 0 || 40 || 0 || 0 || 6 || 0 || 46 || 5.l. || Pigs || 26 || 393 || 0 || 0 || 515 || 0 || 934 || 5.m. || Goats || 0 || 0 || 0 || 0 || 6 || 0 || 6 || 5.n. || Sheep || 52 || 141 || 0 || 4 || 613 || 0 || 810 || 5.o. || Cattle || 0 || 562 || 0 || 0 || 405 || 0 || 967 || 5.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.q. || New World Monkeys || 0 || 0 || 0 || 0 || 79 || 0 || 79 || 5.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 17 || 0 || 17 || 5.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.v. || Other birds || 944 || 437 || 0 || 0 || 9456 || 0 || 10837 || 5.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.x. || Amphibians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 5.y. || Fish || 0 || 3296 || 0 || 0 || 0 || 4681 || 7977 || 5.z. || TOTAL || 1428 || 10051 || 0 || 562 || 128850 || 5614 || 146505 || Examples: || 5.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 5.2 - 5.5 refer to the legislation imposing that the test be carried out and || 5.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 5.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 5.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 5.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 5.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
6: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Regulatory
requirements versus species 6.1 Species || 6.2 National legislation specific to a single EC Member State 1) || 6.3 EC legislation including European Pharmacopoeia (requirements) || 6.4 Member Country of Council of Europe (but not EC) legislation 2) || 6.5 Other legislation || 6.6 Any combination of 6.2/ 6.3/ 6.4/ 6.5 || 6.7 No regulatory requirements || 6.8 Total || 6.a. || Mice || 39 || 4181 || 46 || 221 || 47335 || 2390 || 54212 || 6.b. || Rats || 170 || 220 || 0 || 272 || 95038 || 3555 || 99255 || 6.c. || Guinea-Pigs || 4 || 58 || 0 || 22 || 1054 || 136 || 1274 || 6.d. || Hamsters || 0 || 0 || 0 || 0 || 470 || 0 || 470 || 6.e. || Other Rodents || 4 || 0 || 0 || 0 || 191 || 35 || 230 || 6.f. || Rabbits || 0 || 1051 || 0 || 36 || 3977 || 223 || 5287 || 6.g. || Cats || 0 || 15 || 0 || 0 || 8 || 0 || 23 || 6.h. || Dogs || 0 || 35 || 0 || 0 || 2293 || 93 || 2421 || 6.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.k. || Horses, donkeys and cross breds || 0 || 32 || 0 || 0 || 18 || 0 || 50 || 6.l. || Pigs || 2 || 389 || 0 || 38 || 423 || 0 || 852 || 6.m. || Goats || 0 || 0 || 0 || 0 || 6 || 0 || 6 || 6.n. || Sheep || 0 || 20 || 0 || 69 || 72 || 0 || 161 || 6.o. || Cattle || 0 || 8 || 0 || 0 || 94 || 0 || 102 || 6.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.q. || New World Monkeys || 0 || 0 || 0 || 0 || 14 || 13 || 27 || 6.r. || Old World Monkeys || 0 || 0 || 0 || 0 || 987 || 7 || 994 || 6.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.v. || Other birds || 591 || 1844 || 0 || 0 || 2246 || 264 || 4945 || 6.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6.x. || Amphibians || 0 || 0 || 0 || 0 || 419 || 0 || 419 || 6.y. || Fish || 858 || 7994 || 0 || 1137 || 10127 || 38830 || 58946 || 6.z. || TOTAL || 1668 || 15847 || 46 || 1795 || 164772 || 45546 || 229674 || Examples: || 6.2 – France is testing due to a UK (or FR) specific requirement || Note: || columns 6.2 - 6.5 refer to the legislation imposing that the test be carried out and || 6.3 - UK is testing according to EC legislation || || not to the body which has issued the actual test method, guideline or protocol. || 6.4 – Spain is testing due to a Norwegian requirement || Example: || a test required by French legislation and carried out in Belgium according to an || 6.5 – Poland is testing due to a US specific requirement || || ISO protocol must be coded as a national (FR) legislative requirement and be || 6.6 – Germany is testing due to a Czech requirement (also an EC requirement) || || entered into column 6.2 in the tables submitted by Belgium. Footnotes: || 1) || EC Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Rep, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom || 2) || Member Countries of Council of Europe (non-EC): Albania, Andorra, Armenia, Azerbaijan, Bosnia and Herzegovina, Croatia, Georgia, Iceland, Liechtenstein, Moldova, Monaco, Norway, Russia, San Marino, Serbia and Montenegro, Switzerland, ‘the former Yugoslav Rep. of Macedonia’, Turkey, Ukraine TABLE
7: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus species 7.1 Species || 7.2 Acute and sub-acute toxicity testing methods (including limit test) || 7.3 Skin irritation || 7.4 Skin sensitisation || 7.5 Eye irritation || 7.6 Sub- chronic and chronic toxicity || 7.7 Carcino- genicity || 7.8 Develop- mental toxicity || 7.9 Muta- genicity || 7.10 Repro-ductive toxicity || 7.11 Toxicity to aquatic vertebra-tes not included in other columns || 7.12 Other || 7.13 Total || || 7.2.1. LD50, LC50 || 7.2.2 Other lethal methods || 7.2.3 Non lethal clinical signs methods || || || || || || || || || || || 7.a. || Mice || 1180 || 4443 || 7857 || 0 || 1306 || 0 || 1945 || 1806 || 355 || 2166 || 156 || 0 || 32998 || 54212 7.b. || Rats || 1948 || 3203 || 27072 || 0 || 0 || 0 || 10847 || 2032 || 2987 || 4766 || 34214 || 0 || 12186 || 99255 7.c. || Guinea-Pigs || 122 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 1152 || 1274 7.d. || Hamsters || 0 || 0 || 40 || 0 || 0 || 0 || 96 || 0 || 0 || 0 || 0 || 0 || 334 || 470 7.e. || Other Rodents || 182 || 4 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 44 || 230 7.f. || Rabbits || 0 || 0 || 178 || 987 || 0 || 692 || 45 || 0 || 1795 || 0 || 162 || 0 || 1428 || 5287 7.g. || Cats || 0 || 0 || 2 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 21 || 23 7.h. || Dogs || 0 || 0 || 1244 || 0 || 0 || 0 || 840 || 0 || 0 || 0 || 95 || 0 || 242 || 2421 7.i. || Ferrets || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.j. || Other Carnivores || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.k. || Horses, donkeys and cross breds || 0 || 0 || 32 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 18 || 50 7.l. || Pigs || 0 || 0 || 124 || 8 || 0 || 0 || 104 || 0 || 0 || 0 || 0 || 0 || 616 || 852 7.m. || Goats || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 6 || 6 7.n. || Sheep || 0 || 0 || 0 || 0 || 0 || 0 || 30 || 0 || 0 || 0 || 0 || 0 || 131 || 161 7.o. || Cattle || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 102 || 102 7.p. || Prosimians || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.q. || New World Monkeys || 0 || 0 || 13 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 14 || 27 7.r. || Old World Monkeys || 0 || 0 || 539 || 0 || 0 || 0 || 228 || 0 || 0 || 0 || 0 || 0 || 227 || 994 7.s. || Apes || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.t. || Other Mammals || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.u. || Quail || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.v. || Other birds || 368 || 182 || 594 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 556 || 0 || 3245 || 4945 7.w. || Reptiles || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 7.x. || Amphibians || 0 || 0 || 400 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 19 || 419 7.y. || Fish || 5488 || 2228 || 8870 || 0 || 0 || 0 || 4032 || 0 || 0 || 0 || 1280 || 0 || 37048 || 58946 7.z. || TOTAL || 9288 || 10060 || 46965 || 995 || 1306 || 692 || 18167 || 3838 || 5137 || 6932 || 36463 || 0 || 89831 || 229674 TABLE
8: NUMBER OF ANIMALS USED IN TOXICOLOGICAL AND OTHER SAFETY EVALUATIONS Types
of tests versus products 8.1 Products || 8.2 Acute and sub-acute toxicity testing methods (including limit test) || 8.3 Skin irritation || 8.4 Skin sensitisation || 8.5 Eye irritation || 8.6 Sub- chronic and chronic toxicity || 8.7 Carcino genicity || 8.8 Develop- mental toxicity || 8.9 Muta- genicity || 8.10 Repro-ductive toxicity || 8.11 Toxicity to aquatic vertebra-tes not included in other columns || 8.12 Other || 8.13 Total || || 8.2.1. LD50, LC50 || 8.2.2 Other lethal methods || 8.2.3 Non lethal clinical signs methods || || || || || || || || || || || 8.a. || Products/substances or devices for human medicine and dentistry and for veterinary medicine || 122 || 1616 || 35252 || 181 || 308 || 8 || 14003 || 2502 || 4520 || 5285 || 22153 || 0 || 68846 || 154796 8.b. || Products/substances used or intended to be used mainly in agriculture || 1865 || 3105 || 3980 || 518 || 40 || 414 || 1629 || 1336 || 433 || 0 || 2785 || 0 || 6664 || 22769 8.c. || Products/substances used or intended to be used mainly in industry || 511 || 802 || 3183 || 292 || 898 || 266 || 771 || 0 || 88 || 1299 || 7515 || 0 || 3566 || 19191 8.d. || Products/substances used or intended to be used mainly in the household || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.e. || Products/substances used or intended to be used mainly as cosmetics or toiletries || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.f. || Products/substances used or intended to be used mainly as additives in food for human consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.g. || Products/substances used or intended to be used mainly as additives in food for animal consumption || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 8.h. || Potential or actual contaminants in the general environment which do not appear in other columns || 4224 || 1147 || 4294 || 0 || 0 || 0 || 540 || 0 || 0 || 0 || 1384 || 0 || 784 || 12373 8.i. || Other toxicological or safety evaluations || 2566 || 3390 || 256 || 4 || 60 || 4 || 1224 || 0 || 96 || 348 || 2626 || 0 || 9971 || 20545 8.j. || TOTAL || 9288 || 10060 || 46965 || 995 || 1306 || 692 || 18167 || 3838 || 5137 || 6932 || 36463 || 0 || 89831 || 229674