Accept Refuse

EUR-Lex Access to European Union law

This document is an excerpt from the EUR-Lex website

Document 52010SC1107

COMMISSION STAFF WORKING DOCUMENT Accompanying document to the REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

/* SEC/2010/1107 final */

In force


EN

EUROPEAN COMMISSION

Brussels, 30.9.2010

SEC(2010) 1107 final

VOL B - Part II ([I], [III])

COMMISSION STAFF WORKING DOCUMENT

DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

Accompanying document to the

REPORT FROM THE COMMISSION TO THE COUNCIL AND THE EUROPEAN PARLIAMENT

Sixth Report on the Statistics on the Number of Animals used for Experimental and other Scientific Purposes in the Member States of the European Union

COM(2010) 511 final

Important notice

This is a document of the Commission services and cannot be considered binding to this institution in any way.

VOL B - Part II: DATA AND SUMMARY OF THE COMMENTS SUBMITTED BY THE MEMBER STATES

TABLE OF CONTENTS

FRANCE    5

ITALY    14

CYPRUS    23

LATVIA    28

LITHUANIA    35

LUXEMBOURG    35

HUNGARY    35

MALTA    35

THE NETHERLANDS    35

FRANCE

Statistical data submitted

The statistical data have been submitted by the “Ministère de la Recherche et des Nouvelles Technologies” (Ministry for Research and New Technologies).

Comments of the French authorities

This study was realized by the EFICOM Markétudes Company for the Research and Higher Education Ministry.

The number of animals used in France shows a steady state since 1999 with about 2.5 million. It represents a decrease of 30% in comparison with the figures of the first statistical study in 1990. In 2007, a slight increasing tendency could be observed which led to values similar to the 1997 figures. Since 1999, the amount of rodents used is stable (2.1 million). Even if some animal groups are more often used (the number of birds and rabbits has doubled and the number of fish has increased by 37%), there is a reverse tendency for other species (the amount of dogs has decreased by 15%). The use of non human primates is steady from 1999, probably because of their incompressible scientific interests.

Concerning the results of the survey, when significant differences were revealed between 2007 and previous years, some verification was done in order to identify the origin of these sudden evolutions. These differences could always be explained by: either new activity, for example the production of therapeutic antibodies giving an explanation to rabbits increase observed since 2004, or the opening or the closure of laboratories. The other variations were not significant and supported the figures provided by experimental centres and laboratories.

This study showed that the public sector used half (47%) of the total amount of animals, of which 80% is for basic research and education. On the other hand, the private sector used the remaining 53%, of which 40% are dedicated to research and development, 37% to production and control, and 6% to toxicological evaluations.

Similar to the numbers observed in 2004, the present study shows that there are about 450 centres for animal experimentation (this number can vary depending on juridical conventions that link laboratories to these centres).

It represents a third of the figure established in 1990. This decrease in the number of experimental centres shows that laboratories are merged or clustered in order to share centralized installations and competent staff. The « disappearance » of 900 experimental animal houses shows the pressure brought by the animal protection associations and the concerned authorities for fifteen years. It was supported by very significant investments to come up to the current sanitary, ethic and scientific expectations. Of course, this diminution did not obviously result in a proportional decrease of the number of animals, but it sets practices that warrant respect and well-being to 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)

1.561.809

1.423.488

47.564

2.534

88.223

 

1.b.

Rats (Rattus norvegicus)

392.773

367.102

16.411

10

9.250

 

1.c.

Guinea-Pigs (Cavia porcellus)

46.030

41.952

3.895

0

183

 

1.d.

Hamsters (Mesocricetus )

12.063

10.271

959

0

833

 

1.e.

Other Rodents (other Rodentia)

3.594

 

 

 

 

 

1.f.

Rabbits (Oryctolagus cuniculus)

96.427

96.169

5

0

253

430

1.g.

Cats (Felis catus)

1.848

1.391

245

3

209

644

1.h.

Dogs (Canis familiaris)

4.131

2.928

262

0

941

805

1.i.

Ferrets (Mustela putorius furo)

800

591

0

0

209

0

1.j.

Other Carnivores (other Carnivora)

0

 

 

 

 

 

1.k.

Horses, donkeys and cross breds (Equidae)

652

 

 

 

 

 

1.l.

Pigs (Sus)

8.768

 

 

 

 

 

1.m.

Goats (Capra)

1.159

 

 

 

 

 

1.n.

Sheep (Ovis)

3.573

 

 

 

 

 

1.o.

Cattle (Bos)

3.206

 

 

 

 

 

1.p.

Prosimians (Prosimia)

718

718

0

0

0

33

1.q.

New World Monkeys (Ceboidea)

233

213

20

0

0

135

1.r.

Old World Monkeys (Cercopithecoidea)

1.797

610

262

0

925

244

1.s.

Apes (Hominoidea)

0

0

0

0

0

0

1.t.

Other Mammals (other Mammalia)

0

 

 

 

 

 

1.u.

Quail (Coturnix coturnix)

1.548

48

1.500

0

0

 

1.v.

Other birds (other Aves)

156.814

 

 

 

 

 

1.w.

Reptiles (Reptilia)

758

 

 

 

 

 

1.x.

Amphibians (Amphibia)

9.451

 

 

 

 

 

1.y.

Fish (Pisces)

20.228

 

 

 

 

 

1.z.

TOTAL

2.328.380

 

 

 

 

 

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

585.129

429.558

279.987

45.522

50.866

12.308

18.947

139.492

1.561.809

2.b.

Rats

80.421

182.333

5.161

13.121

47.447

697

14.196

49.397

392.773

2.c.

Guinea-Pigs

739

3.705

30.748

2.230

7.317

2

274

1.015

46.030

2.d.

Hamsters

1.590

2.618

0

6.414

21

10

4

1.406

12.063

2.e.

Other Rodents

941

1.690

0

0

0

0

918

45

3.594

2.f.

Rabbits

3.348

6.202

50.152

7.147

7.737

125

799

20.917

96.427

2.g.

Cats

138

790

0

544

24

0

3

349

1.848

2.h.

Dogs

354

1.072

0

732

1.834

0

8

131

4.131

2.i.

Ferrets

0

162

8

0

237

0

13

380

800

2.j.

Other Carnivores

0

0

0

0

0

0

0

0

0

2.k.

Horses, donkeys and cross breds

196

139

83

20

0

0

75

139

652

2.l.

Pigs

470

2.860

0

2.545

434

23

241

2.195

8.768

2.m.

Goats

330

41

3

19

29

0

18

719

1.159

2.n.

Sheep

1.331

638

27

655

205

0

56

661

3.573

2.o.

Cattle

310

541

0

298

84

140

30

1.803

3.206

2.p.

Prosimians

568

0

0

0

0

150

0

0

718

2.q.

New World Monkeys

63

77

0

0

0

0

0

93

233

2.r.

Old World Monkeys

184

198

139

0

1.128

0

0

148

1.797

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

1.548

0

1.548

2.v.

Other birds

2.821

7.491

9.280

86.122

5.251

1.400

6.593

37.856

156.814

2.w.

Reptiles

758

0

0

0

0

0

0

0

758

2.x.

Amphibians

5.013

52

0

0

179

0

4.207

0

9.451

2.y.

Fish

5.836

200

0

0

2.954

0

7.643

3.595

20.228

2.z.

TOTAL

690.540

640.367

375.588

165.369

125.747

14.855

55.573

260.341

2.328.380



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

23.187

3.441

2.074

0

704

0

0

3.776

17.684

50.866

3.b.

Rats

26.440

6.006

3.375

159

0

0

0

1.499

9.968

47.447

3.c.

Guinea-Pigs

4.468

608

1.755

0

38

0

0

0

448

7.317

3.d.

Hamsters

0

0

21

0

0

0

0

0

0

21

3.e.

Other Rodents

0

0

0

0

0

0

0

0

0

0

3.f.

Rabbits

5.247

563

481

0

43

0

0

0

1.403

7.737

3.g.

Cats

24

0

0

0

0

0

0

0

0

24

3.h.

Dogs

1.160

104

0

0

0

0

0

0

570

1.834

3.i.

Ferrets

237

0

0

0

0

0

0

0

0

237

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

404

0

0

0

0

0

0

30

0

434

3.m.

Goats

21

0

0

0

0

0

0

8

0

29

3.n.

Sheep

205

0

0

0

0

0

0

0

0

205

3.o.

Cattle

84

0

0

0

0

0

0

0

0

84

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

930

0

0

0

0

0

0

0

198

1.128

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

25

0

0

0

0

0

5.000

0

226

5.251

3.w.

Reptiles

0

0

0

0

0

0

0

0

0

0

3.x.

Amphibians

179

0

0

0

0

0

0

0

0

179

3.y.

Fish

0

1.457

0

0

300

0

0

1.047

150

2.954

3.z.

TOTAL

62.611

12.179

7.706

159

1.085

0

5.000

6.360

30.647

125.747



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

60.574

232.877

180.979

333.623

218.942

1.026.995

4.b.

Rats

45.947

84.717

15.812

106.175

10.800

263.451

4.c.

Guinea-Pigs

479

312

190

2.639

826

4.446

4.d.

Hamsters

434

708

0

1.042

2.034

4.218

4.e.

Other Rodents

300

1.774

60

191

306

2.631

4.f.

Rabbits

1.197

2

123

6.710

1.643

9.675

4.g.

Cats

0

31

0

60

837

928

4.h.

Dogs

114

133

13

499

667

1.426

4.i.

Ferrets

0

0

0

162

0

162

4.j.

Other Carnivores

0

0

0

0

0

0

4.k.

Horses, donkeys and cross breds

0

0

0

0

335

335

4.l.

Pigs

736

0

0

547

2.070

3.353

4.m.

Goats

0

10

0

6

355

371

4.n.

Sheep

140

62

0

97

1.670

1.969

4.o.

Cattle

0

0

0

0

991

991

4.p.

Prosimians

0

40

0

308

370

718

4.q.

New World Monkeys

0

4

0

115

21

140

4.r.

Old World Monkeys

0

20

0

362

0

382

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

120

0

0

11.592

11.712

4.w.

Reptiles

0

0

0

0

758

758

4.x.

Amphibians

0

52

2.399

658

1.956

5.065

4.y.

Fish

900

250

0

930

3.956

6.036

4.z.

TOTAL

110.821

321.112

199.576

454.124

260.129

1.345.762



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

2.709

71.121

371

407

244.482

6.419

325.509

5.b.

Rats

4.053

194

405

12.732

383

515

18.282

5.c.

Guinea-Pigs

0

5.042

0

32

27.904

0

32.978

5.d.

Hamsters

0

6.414

0

0

0

0

6.414

5.e.

Other Rodents

0

0

0

0

0

0

0

5.f.

Rabbits

10

37.019

0

0

3.859

16.411

57.299

5.g.

Cats

0

536

0

8

0

0

544

5.h.

Dogs

0

732

0

0

0

0

732

5.i.

Ferrets

0

0

0

0

8

0

8

5.j.

Other Carnivores

0

0

0

0

0

0

0

5.k.

Horses, donkeys and cross breds

0

20

0

0

83

0

103

5.l.

Pigs

0

2.454

0

91

0

0

2.545

5.m.

Goats

19

0

0

0

3

0

22

5.n.

Sheep

189

466

0

0

27

0

682

5.o.

Cattle

0

298

0

0

0

0

298

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

139

0

139

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

86.034

0

80

9.280

8

95.402

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

6.980

210.330

776

13.350

286.168

23.353

540.957

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

6.960

13.193

658

2.783

20.930

6.342

50.866

6.b.

Rats

8.250

5.748

79

9.219

20.712

3.439

47.447

6.c.

Guinea-Pigs

286

2.516

0

0

4.515

0

7.317

6.d.

Hamsters

21

0

0

0

0

0

21

6.e.

Other Rodents

0

0

0

0

0

0

0

6.f.

Rabbits

260

1.314

0

1.405

4.734

24

7.737

6.g.

Cats

0

24

0

0

0

0

24

6.h.

Dogs

53

191

0

723

867

0

1.834

6.i.

Ferrets

211

0

0

26

0

0

237

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

55

18

0

149

212

0

434

6.m.

Goats

29

0

0

0

0

0

29

6.n.

Sheep

0

0

0

0

205

0

205

6.o.

Cattle

0

84

0

0

0

0

84

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

190

0

732

198

8

1.128

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

25

0

5.000

0

226

5.251

6.w.

Reptiles

0

0

0

0

0

0

0

6.x.

Amphibians

0

0

0

0

179

0

179

6.y.

Fish

82

0

0

0

1.457

1.415

2.954

6.z.

TOTAL

16.207

23.303

737

20.037

54.009

11.454

125.747

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

1.455

7.107

9.877

648

1.733

0

12.298

2.524

730

139

0

0

14.355

50.866

7.b.

Rats

36

1.169

5.128

12

1.290

78

16.839

5.287

2.075

1.547

4.489

0

9.497

47.447

7.c.

Guinea-Pigs

0

0

36

0

6.584

0

0

0

0

0

86

0

611

7.317

7.d.

Hamsters

0

0

0

0

0

0

0

0

0

21

0

0

0

21

7.e.

Other Rodents

0

0

0

0

0

0

0

0

0

0

0

0

0

0

7.f.

Rabbits

0

0

349

1.059

0

377

568

0

669

0

965

0

3.750

7.737

7.g.

Cats

0

0

0

0

0

0

0

0

0

0

0

0

24

24

7.h.

Dogs

0

0

461

0

0

0

1.106

0

0

0

18

0

249

1.834

7.i.

Ferrets

0

0

211

0

0

0

0

0

0

0

0

0

26

237

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

56

0

0

0

84

0

294

434

7.m.

Goats

0

0

0

0

0

0

0

0

0

0

0

0

29

29

7.n.

Sheep

0

0

0

0

0

0

0

0

0

0

0

0

205

205

7.o.

Cattle

0

0

0

0

0

0

0

0

0

0

0

0

84

84

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

80

0

0

0

864

0

0

0

0

0

184

1.128

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

5.251

5.251

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

179

179

7.y.

Fish

1.907

0

0

0

0

0

890

0

0

0

0

82

75

2.954

7.z.

TOTAL

3.398

8.276

16.142

1.719

9.607

455

32.621

7.811

3.474

1.707

5.642

82

34.813

125.747



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

1.965

5.233

9.654

638

4.460

170

14.646

3.293

1.141

1.480

5.211

0

14.720

62.611

8.b.

Products/substances used or intended to be used mainly in agriculture

1.430

310

0

100

608

88

5.944

2.682

867

0

150

0

0

12.179

8.c.

Products/substances used or intended to be used mainly in industry

0

1.378

665

942

1.673

182

230

246

626

101

60

0

1.603

7.706

8.d.

Products/substances used or intended to be used mainly in the household

0

0

0

0

0

0

159

0

0

0

0

0

0

159

8.e.

Products/substances used or intended to be used mainly as cosmetics or toiletries

300

0

43

39

699

4

0

0

0

0

0

0

0

1.085

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

5.000

5.000

8.h.

Potential or actual contaminants in the general environment which do not appear in other columns

0

2.600

0

0

0

0

2.014

0

0

890

327

82

447

6.360

8.i.

Other toxicological or safety evaluations

221

3.397

589

0

0

6

3.792

2.604

300

0

1.902

0

17.836

30.647

8.j.

TOTAL

3.916

12.918

10.951

1.719

7.440

450

26.785

8.825

2.934

2.471

7.650

82

39.606

125.747

ITALY

Statistical data submitted

The statistical data have been submitted by the Ministry of Health – Department for public veterinary health food and animal safety, Directorate-General for animal health and veterinary medicines, Office X

Comments of the Italian 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)

553000

528861

12593

223

11323

 

1.b.

Rats (Rattus norvegicus)

230347

224605

5077

0

665

 

1.c.

Guinea-Pigs (Cavia porcellus)

13875

9924

3951

0

0

 

1.d.

Hamsters (Mesocricetus )

717

604

36

0

77

 

1.e.

Other Rodents (other Rodentia)

1235

 

 

 

 

 

1.f.

Rabbits (Oryctolagus cuniculus)

9706

9061

645

0

0

603

1.g.

Cats (Felis catus)

26

0

0

0

26

0

1.h.

Dogs (Canis familiaris)

943

720

70

0

153

52

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)

46

 

 

 

 

 

1.l.

Pigs (Sus)

3607

 

 

 

 

 

1.m.

Goats (Capra)

41

 

 

 

 

 

1.n.

Sheep (Ovis)

469

 

 

 

 

 

1.o.

Cattle (Bos)

462

 

 

 

 

 

1.p.

Prosimians (Prosimia)

0

0

0

0

0

0

1.q.

New World Monkeys (Ceboidea)

18

11

7

0

0

53

1.r.

Old World Monkeys (Cercopithecoidea)

344

182

107

2

53

72

1.s.

Apes (Hominoidea)

0

0

0

0

0

0

1.t.

Other Mammals (other Mammalia)

151

 

 

 

 

 

1.u.

Quail (Coturnix coturnix)

249

4

0

0

245

 

1.v.

Other birds (other Aves)

32241

 

 

 

 

 

1.w.

Reptiles (Reptilia)

454

 

 

 

 

 

1.x.

Amphibians (Amphibia)

2432

 

 

 

 

 

1.y.

Fish (Pisces)

13955

 

 

 

 

 

1.z.

TOTAL

864318

 

 

 

 

 

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

311807

143156

26423

2300

34150

21911

10

13243

553000

2.b.

Rats

86363

55681

67788

205

17730

1340

159

1081

230347

2.c.

Guinea-Pigs

2710

2170

3521

397

4751

30

0

296

13875

2.d.

Hamsters

227

258

0

0

145

87

0

0

717

2.e.

Other Rodents

160

215

0

0

0

860

0

0

1235

2.f.

Rabbits

1628

1140

4538

305

2009

6

0

80

9706

2.g.

Cats

26

0

0

0

0

0

0

0

26

2.h.

Dogs

20

46

0

0

877

0

0

0

943

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

31

0

15

0

0

0

0

0

46

2.l.

Pigs

1350

1174

15

84

435

0

344

205

3607

2.m.

Goats

37

3

0

1

0

0

0

0

41

2.n.

Sheep

171

190

62

12

23

0

0

11

469

2.o.

Cattle

270

134

0

6

9

2

0

41

462

2.p.

Prosimians

0

0

0

0

0

0

0

0

0

2.q.

New World Monkeys

0

18

0

0

0

0

0

0

18

2.r.

Old World Monkeys

12

41

51

0

238

0

0

2

344

2.s.

Apes

0

0

0

0

0

0

0

0

0

2.t.

Other Mammals

104

0

0

47

0

0

0

0

151

2.u.

Quail

4

0

0

0

0

0

0

245

249

2.v.

Other birds

7393

3565

12

12736

6621

1081

0

833

32241

2.w.

Reptiles

454

0

0

0

0

0

0

0

454

2.x.

Amphibians

2346

20

0

0

0

66

0

0

2432

2.y.

Fish

6049

400

0

2518

2018

0

0

2970

13955

2.z.

TOTAL

421162

208211

102425

18611

69006

25383

513

19007

864318



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

8016

80

208

0

0

54

169

4082

21541

34150

3.b.

Rats

14149

254

1142

0

0

205

0

0

1980

17730

3.c.

Guinea-Pigs

4408

87

215

0

0

0

0

0

41

4751

3.d.

Hamsters

145

0

0

0

0

0

0

0

0

145

3.e.

Other Rodents

0

0

0

0

0

0

0

0

0

0

3.f.

Rabbits

1896

9

41

0

0

0

0

0

63

2009

3.g.

Cats

0

0

0

0

0

0

0

0

0

0

3.h.

Dogs

877

0

0

0

0

0

0

0

0

877

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

147

0

0

0

0

0

288

0

0

435

3.m.

Goats

0

0

0

0

0

0

0

0

0

0

3.n.

Sheep

23

0

0

0

0

0

0

0

0

23

3.o.

Cattle

9

0

0

0

0

0

0

0

0

9

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

238

0

0

0

0

0

0

0

0

238

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

5691

450

480

0

0

6621

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

210

0

158

0

0

0

0

1650

0

2018

3.z.

TOTAL

35809

880

1764

0

0

259

937

5732

23625

69006



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

17719

72970

123899

130189

7073

351850

4.b.

Rats

6348

42732

4325

33482

545

87432

4.c.

Guinea-Pigs

380

326

0

2366

182

3254

4.d.

Hamsters

20

21

50

357

0

448

4.e.

Other Rodents

0

244

0

297

654

1195

4.f.

Rabbits

82

262

54

1410

13

1821

4.g.

Cats

0

0

0

0

0

0

4.h.

Dogs

12

0

0

17

0

29

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

31

31

4.l.

Pigs

163

0

8

170

110

451

4.m.

Goats

0

0

0

0

3

3

4.n.

Sheep

31

0

0

42

16

89

4.o.

Cattle

7

0

0

2

2

11

4.p.

Prosimians

0

0

0

0

0

0

4.q.

New World Monkeys

0

18

0

0

0

18

4.r.

Old World Monkeys

0

2

0

41

0

43

4.s.

Apes

0

0

0

0

0

0

4.t.

Other Mammals

0

0

0

0

6

6

4.u.

Quail

0

0

0

0

249

249

4.v.

Other birds

0

0

0

0

1358

1358

4.w.

Reptiles

0

0

0

0

86

86

4.x.

Amphibians

0

101

0

241

66

408

4.y.

Fish

0

0

1629

66

3268

4963

4.z.

TOTAL

24762

116676

129965

168680

13662

453745



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

6375

7376

0

100

13027

1845

28723

5.b.

Rats

241

1730

0

0

64208

1814

67993

5.c.

Guinea-Pigs

657

627

0

0

2634

0

3918

5.d.

Hamsters

0

0

0

0

0

0

0

5.e.

Other Rodents

0

0

0

0

0

0

0

5.f.

Rabbits

344

3773

0

0

714

12

4843

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

15

0

0

0

0

0

15

5.l.

Pigs

99

0

0

0

0

0

99

5.m.

Goats

1

0

0

0

0

0

1

5.n.

Sheep

65

0

0

0

0

9

74

5.o.

Cattle

6

0

0

0

0

0

6

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

51

0

51

5.s.

Apes

0

0

0

0

0

0

0

5.t.

Other Mammals

13

34

0

0

0

0

47

5.u.

Quail

0

0

0

0

0

0

0

5.v.

Other birds

853

11895

0

0

0

0

12748

5.w.

Reptiles

0

0

0

0

0

0

0

5.x.

Amphibians

0

0

0

0

0

0

0

5.y.

Fish

2170

0

0

0

348

0

2518

5.z.

TOTAL

10839

25435

0

100

80982

3680

121036

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

19994

4665

0

0

9102

389

34150

6.b.

Rats

2093

5724

0

0

9557

356

17730

6.c.

Guinea-Pigs

104

3731

0

0

916

0

4751

6.d.

Hamsters

0

122

0

0

23

0

145

6.e.

Other Rodents

0

0

0

0

0

0

0

6.f.

Rabbits

6

1389

0

0

566

48

2009

6.g.

Cats

0

0

0

0

0

0

0

6.h.

Dogs

176

305

0

0

396

0

877

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

435

0

0

0

0

435

6.m.

Goats

0

0

0

0

0

0

0

6.n.

Sheep

0

23

0

0

0

0

23

6.o.

Cattle

0

9

0

0

0

0

9

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

238

0

238

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

6171

0

0

0

450

6621

6.w.

Reptiles

0

0

0

0

0

0

0

6.x.

Amphibians

0

0

0

0

0

0

0

6.y.

Fish

1650

158

0

0

0

210

2018

6.z.

TOTAL

24023

22732

0

0

20798

1453

69006

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

590

5698

7128

110

0

0

5666

77

177

344

743

0

13617

34150

7.b.

Rats

104

453

3884

38

2

0

10261

2

507

363

717

0

1399

17730

7.c.

Guinea-Pigs

0

0

23

80

4630

0

0

0

0

0

0

0

18

4751

7.d.

Hamsters

0

0

0

0

0

0

0

0

0

0

0

0

145

145

7.e.

Other Rodents

0

0

0

0

0

0

0

0

0

0

0

0

0

0

7.f.

Rabbits

0

0

371

250

0

90

130

0

235

0

0

0

933

2009

7.g.

Cats

0

0

0

0

0

0

0

0

0

0

0

0

0

0

7.h.

Dogs

0

0

179

0

0

0

681

0

0

0

0

0

17

877

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

56

0

0

0

40

0

0

0

0

0

339

435

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

23

23

7.o.

Cattle

0

0

0

0

0

0

0

0

0

0

0

0

9

9

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

57

0

0

0

122

0

0

0

0

0

59

238

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

4595

1020

0

0

0

0

0

0

0

0

1006

6621

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

930

0

368

0

0

0

720

0

0

0

0

0

0

2018

7.z.

TOTAL

1624

6151

16661

1498

4632

90

17620

79

919

707

1460

0

17565

69006



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

184

350

12772

1469

4330

69

11879

79

625

513

701

0

2838

35809

8.b.

Products/substances used or intended to be used mainly in agriculture

0

120

65

3

87

6

0

0

0

0

100

0

499

880

8.c.

Products/substances used or intended to be used mainly in industry

0

224

361

26

215

15

200

0

244

194

189

0

96

1764

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

35

0

0

0

174

0

50

0

0

0

0

259

8.g.

Products/substances used or intended to be used mainly as additives in food for animal consumption

0

169

0

0

0

0

0

0

0

0

0

0

768

937

8.h.

Potential or actual contaminants in the general environment which do not appear in other columns

930

0

0

0

0

0

3099

0

0

0

470

0

1233

5732

8.i.

Other toxicological or safety evaluations

510

5288

3428

0

0

0

2268

0

0

0

0

0

12131

23625

8.j.

TOTAL

1624

6151

16661

1498

4632

90

17620

79

919

707

1460

0

17565

69006

CYPRUS

Statistical data submitted

The statistical data have been submitted by “Veterinary Services of the Republic of Cyprus”.

Remark: Cyprus reported data only in tables 1, 2, 4 and 5. The remaining tables are not applicable.

Comments of the Cypriot authorities

At present only rodents (mice) are used in animal experimentation in Cyprus. The use of experimental mice concentrates mainly on the generation and use of genetically modified mice to study basic biological processes like:

Development of the central nervous system and early development of the mouse embryo.

Generation of mouse models of inherited diseases or diseases with a genetic component and study of disease progression. These include haemoglobinopathies and neurodegenerative diseases.

Testing of genetically engineered molecules as putative anti-neoplastic agents on genetically immuno-compromised animals, challenged with carcinogenic cells.

Testing of modified forms of natural vitamins as potential antioxidants on induced models of diabetes.

Use of mice to study the effect of various agents on heart physiology.

The Veterinary Services are satisfied that the animals are kept in a very rigorously monitored, pathogen-free environment (monitored according to FELASA guidelines). No outbreak of all pathogens tested has been observed. We are also satisfied that the principles of the three Rs are duly adhered to.

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)

2114

2114

 

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

2114

 

 

 

 

 

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

1701

320

93

2114

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

1701

0

320

0

0

0

93

0

2114



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

205

70

165

440

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

205

70

165

0

440



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

320

320

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

320

320

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 have been submitted by the Ministry of Agriculture – 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)

6912

6912

 

1.b.

Rats (Rattus norvegicus)

2407

2407

 

1.c.

Guinea-Pigs (Cavia porcellus)

32

32

 

1.d.

Hamsters (Mesocricetus )

0

 

1.e.

Other Rodents (other Rodentia)

 

 

 

 

 

1.f.

Rabbits (Oryctolagus cuniculus)

48

48

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

9399

 

 

 

 

 

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

1032

1952

2710

668

550

6912

2.b.

Rats

325

460

1037

280

305

2407

2.c.

Guinea-Pigs

32

32

2.d.

Hamsters

0

2.e.

Other Rodents

0

2.f.

Rabbits

48

48

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

1357

2412

3795

0

32

948

855

0

9399



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