amending Annex E to Council Directive 91/68/EEC, Annex III to Commission Decision 2010/470/EU and Annex II to Commission Decision 2010/472/EU concerning trade in and imports into the Union of ovine and caprine animals and semen of animals of the ovine and caprine species in relation to the rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
(notified under document C(2016) 7026)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 91/68/EEC of 28 January 1991 on animal health conditions governing intra-Community trade in ovine and caprine animals (1), and in particular Article 14(2) thereof,
Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC (2), and in particular the fourth indent of Article 11(2), Article 17(2)(b), the first indent of Article 18(1) and the introductory phrase and point (b) of Article 19 thereof,
Whereas:
(1)
Directive 91/68/EEC lays down the animal health conditions governing intra-Union trade in ovine and caprine animals. It provides, inter alia, that ovine and caprine animals must be accompanied during transportation to their destination by a health certificate conforming to Model I, II or III set out in Annex E thereto.
(2)
Regulation (EC) No 999/2001 of the European Parliament and of the Council (3) lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals. Annex VII to that Regulation sets out the measures for the control and eradication of TSEs. In addition, Chapter A of Annex VIII to that Regulation lays down, inter alia, the conditions for intra-Union trade in live animals.
(3)
Regulation (EC) No 999/2001 was recently amended by Commission Regulation (EU) 2016/1396 (4). Those amendments provide, inter alia, for an exemption from the conditions set out in point 4.1 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001, which are aimed at preventing the spread of classical scrapie in farmed animals kept on holdings, for ovine and caprine animals moved exclusively between approved bodies, institutes or centres as defined in Article 2(1)(c) of Directive 92/65/EEC.
(4)
Regulation (EU) 2016/1396 also introduces specific conditions for intra-Union trade in ovine and caprine animals of rare breeds which do not comply with the requirements of point 4.1 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001. Those specific conditions were introduced to maintain a possibility for regular exchange of such animals between Member States in order to avoid inbreeding and to preserve the genetic diversity in rare breed populations.
(5)
The health certificates conforming to Models II and III set out in Annex E to Directive 91/68/EEC should therefore be amended in order to reflect the requirements relating to intra-Union trade in ovine and caprine animals of rare breeds or of those moved between approved bodies, institutes or centres laid down in Regulation (EC) No 999/2001, as amended by Regulation (EU) 2016/1396.
(6)
In addition, some Member States notified the Commission of problems related to additional administrative work caused by the obligation to provide in point I.31 of health certificates conforming to Models I, II and III set out in Annex E to Directive 91/68/EEC details such as breed and quantity of animals forming the consignment. To reduce administrative burden for the official veterinarians, it is appropriate to remove from point I.31 of those model health certificates information on the breed, as such information is not necessary in relation to the health status of the animals in the consignment, and on the quantity of those animals, as such information is already stated in point I.20 and an official identification number of each individual animal must be provided in point I.31.
(7)
Furthermore, in order to state more precisely the conditions for individual identification of the animals in points II.5 and II.6 of the health certificates conforming to Models II and III in Annex E to Directive 91/68/EEC, it is necessary to introduce in those points a reference to Council Regulation (EC) No 21/2004 (5).
(8)
Directive 91/68/EEC should therefore be amended accordingly.
(9)
Directive 92/65/EEC lays down conditions applicable to trade in and imports into the Union, inter alia, of semen of animals of the ovine and caprine species.
(10)
Annex III to Commission Decision 2010/470/EU (6) lays down model health certificates for trade within the Union in consignments of semen of animals of the ovine and caprine species. Part A of that Annex sets out the model health certificate for semen collected after 31 August 2010 and dispatched from an approved semen collection centre of origin of the semen.
(11)
Annex II to Commission Decision 2010/472/EU (7) lays down, inter alia, model health certificates for the imports into the Union of consignments of semen of animals of the ovine and caprine species. Section A of Part 2 of that Annex sets out the model health certificate for semen dispatched from an approved semen collection centre of origin of the semen.
(12)
Point 4.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 sets out the scrapie-related conditions to be fulfilled for intra-Union trade in semen of ovine and caprine animals. Chapter H of Annex IX to Regulation (EC) No 999/2001 sets out the scrapie-related conditions to be fulfilled for imports of semen of ovine and caprine animals.
(13)
Regulation (EU) 2016/1396 introduces specific conditions for semen collection centres amongst the conditions for a holding to be recognised as having a negligible risk or a controlled risk of classical scrapie in points 1.2 and 1.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001, given that the risk of spreading scrapie via male ovine and caprine animals kept at semen collection centres approved and supervised in accordance with the conditions set out in Annex D to Directive 92/65/EEC is limited. A reference to those specific conditions is also introduced in the conditions for trade in and import of semen of ovine and caprine animals set out in Annexes VIII and IX to Regulation (EC) No 999/2001 respectively.
(14)
The model health certificate for intra-Union trade in consignments of semen of animals of the ovine and caprine species set out in Part A of Annex III to Decision 2010/470/EU and the model health certificate for imports into the Union of consignments of semen of animals of the ovine and caprine species set out in Section A of Part 2 of Annex II to Decision 2010/472/EU should therefore be amended in order to reflect the requirements relating to semen collection centres laid down in Regulation (EC) No 999/2001, as amended by Regulation (EU) 2016/1396.
(15)
In addition, Chapter H of Annex IX to Regulation (EC) No 999/2001, as amended by Regulation (EU) 2016/1396, provides that meat-and-bone meal should be understood as defined in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE) (8), rather than in point 27 of Annex I to Commission Regulation (EC) No 142/2011 (9).
(16)
Therefore, point II.4.10.4 of the model health certificate for imports into the Union of consignments of semen of animals of the ovine and caprine species set out in Section A of Part 2 of Annex II to Decision 2010/472/EU should be amended according to the amended provisions of Chapter H of Annex IX to Regulation (EC) No 999/2001.
(17)
Decisions 2010/470/EU and 2010/472/EU should therefore be amended accordingly.
(18)
Regulation (EU) 2016/1396 provides that the amendments made to Annex IX to Regulation (EC) No 999/2001 and related to imports of certain commodities are to apply from 1 July 2017. In addition, to avoid any disruption of imports into the Union of consignments of semen of ovine and caprine animals, the use of certificates issued in accordance with Decision 2010/472/EU as applicable prior to the amendments being introduced by this Decision should be authorised during a transitional period subject to certain conditions.
(19)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS DECISION:
Article 1
Annex E to Directive 91/68/EEC is amended in accordance with Annex I to this Decision.
Article 2
Annex III to Decision 2010/470/EU is amended in accordance with Annex II to this Decision.
Article 3
Annex II to Decision 2010/472/EU is amended in accordance with Annex III to this Decision.
Article 4
Article 3 of this Decision shall apply from 1 July 2017.
For a transitional period until 31 December 2017, consignments of semen of ovine and caprine animals, accompanied by a health certificate issued in accordance with the model set out in Section A of Part 2 of Annex II to Decision 2010/472/EU, as applicable before the amendments made by this Decision, shall be authorised for importation into the Union provided that the certificate was issued no later than 30 November 2017.
(3) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).
(4) Commission Regulation (EU) 2016/1396 of 18 August 2016 amending certain Annexes to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 225, 19.8.2016, p. 76).
(5) Council Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the identification and registration of ovine and caprine animals and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC (OJ L 5, 9.1.2004, p. 8).
(6) Commission Decision 2010/470/EU of 26 August 2010 laying down model health certificates for trade within the Union in semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species (OJ L 228, 31.8.2010, p. 15).
(7) Commission Decision 2010/472/EU of 26 August 2010 on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union (OJ L 228, 31.8.2010, p. 74).
(9) Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
ANNEX I
Annex E to Directive 91/68/EEC is replaced by the following:
I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:
(1) either [II.1. The animals were born and have been reared since birth on Union territory.]
(1) or [II.1. The animals were imported from a third country in accordance with Commission Regulation (EU) No 206/2010 at least 30 days prior to loading.]
II.2. The animals:
II.2.1. have been inspected today (within 24 hours prior to loading) and show no clinical sign of disease;
II.2.2. are not animals which are to be destroyed under a scheme to eradicate a contagious or infectious disease;
II.2.3. come from a holding which has been free from any official prohibition on health grounds, for the last 42 days in the case of brucellosis, for the last 30 days in the case of rabies, for the last 15 days in the case of anthrax, and, have not been in contact with animals from holdings which did not comply with these conditions;
II.2.4. do not come from a holding and have not been in contact with animals from holdings in a protection zone which has been set up under Union legislation and from which animals are prohibited from leaving;
II.2.5. are not the subject of animal health measures pursuant to Union legislation on foot-and-mouth disease and have not been vaccinated against foot-and-mouth disease.
II.3. Based on the written declaration made by the keeper or an examination of the holding register and movement documents kept in accordance with Council Regulation (EC) No 21/2004, in particular in Sections B and C of the Annex to that Regulation:
II.3.1. the animals have remained on a single holding of origin for a period of at least the last 21 days, or on the holding of origin since birth where the animals are less than 21 days old, and no biungulate animal imported from a third country has been introduced into the holding of origin during the last 30 days, unless those animals were introduced in accordance with Article 4a(2) of Council Directive 91/68/EEC, and
(1) either [have remained on a single holding of origin into which no animals of the ovine or caprine species have been introduced, unless those animals were introduced in accordance with Article 4a(1) of Directive 91/68/EEC, during the last 21 days.]
(1) or [are to be consigned directly from a single holding to the slaughterhouse of destination.]
II.4.1. The animals were transported using means of transport and containment which had, before-hand, been cleansed and disinfected using an officially approved disinfectant, and in such a way as to provide effective protection of the animals’ health status.
II.4.2. Based on the official documentation accompanying the animals, the consignment covered by this health certificate is due to start the journey on (insert date) (2).
II.4.3. At the time of inspection the animals covered by this health certificate were fit to be transported on the intended journey in accordance with the provisions of Council Regulation (EC) No 1/2005 (3) (4).
II.5. This certificate
(1) either [is valid for 10 days from the date of inspection on the holding of origin, or in the approved assembly centre or approved dealer’s premises in the Member State of origin;]
(1) or [expires in accordance with Article 9(6) of Directive 91/68/EEC on (insert date)] (5).
— Box reference I.19: Use the appropriate CN code under the following headings: 0104 10 or 0104 20.
— Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) must be included.
— Box reference I.31: Identification system: The animals must bear: An individual number which permits tracing of their premises of origin, in accordance with Council Regulation (EC) No 21/2004.
Age: (months).
Sex: (M = male, F = female, C = castrated).
Part II:
(1) Delete where not applicable.
(2) In the case where a consignment is grouped in an assembly centre and comprises animals that were loaded on different dates, the date on which the journey commenced for the whole consignment is considered to be the earliest date when any part of the consignment left the holding of origin.
(3) This statement does not exempt transporters from their obligations in accordance with Union rules in force in particular regarding the fitness of animals to be transported.
(4) To be completed in case of consignment grouped in an approved assembly centre or in approved dealer’s premises.
(5) To be completed in case of consignment grouped in an approved assembly centre located in the Member State of transit.
— The colour of the stamp and the signature must be different from that of the other particulars in the certificate.
Official veterinarian or official inspector
Name (in capital letters): Qualification and title:
I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:
(1) either [II.1. The animals were born and have been reared since birth on Union territory.]
(1) or [II.1. The animals were imported from a third country in accordance with Commission Regulation (EU) No 206/2010 at least 30 days prior to loading.]
II.2. The animals:
II.2.1. have been inspected today (within 24 hours prior to loading) and show no clinical sign of disease;
II.2.2. are not animals which are to be destroyed under a scheme to eradicate a contagious or infectious disease;
II.2.3. come from a holding which has been free from any official prohibition on health grounds, for the last 42 days in the case of brucellosis, for the last 30 days in the case of rabies, for the last 15 days in the case of anthrax, and, have not been in contact with animals from holdings which did not comply with these conditions;
II.2.4. do not come from a holding and have not been in contact with animals from holdings in a protection zone which has been set up under Union legislation and from which animals are prohibited from leaving;
II.2.5. are not the subject of animal health measures pursuant to Union legislation on foot-and-mouth disease and have not been vaccinated against foot-and-mouth disease.
II.3. Based on the written declaration made by the keeper or an examination of the holding register and movement documents kept in accordance with Council Regulation (EC) No 21/2004, in particular in Sections B and C of the Annex to that Regulation, the animals have remained on a single holding of origin for a period of at least the last 30 days, or on the holding of origin since birth where the animals are less than 30 days old, and no animal of the ovine and caprine species has been introduced into the holding of origin during the last 21 days and no biungulate animal imported from a third country has been introduced into the holding of origin during the last 30 days, unless those animals were introduced in accordance with Article 4a(1) of Council Directive 91/68/EEC.
(1) [II.4. The animals comply with the additional guarantees provided for in Articles 7 or 8 of Directive 91/68/EEC and laid down for the Member State of destination or part of its territory (insert Member State or part of its territory) in Commission Decision …/…/… (insert number).]
II.5. The animals comply with at least one of the following conditions and therefore qualify for admission to an ovine or caprine holding which is officially brucellosis-free (B. melitensis):
(1) either [the holding of origin is situated in a Member State or part of its territory (insert name of Member State or part of its territory) which is recognised as being officially brucellosis-free in accordance with Commission Decision …/…/… (insert number).]
(1) or [they come from an officially brucellosis-free (B. melitensis) holding.]
(1) or [they come from a brucellosis-free (B. melitensis) holding, and
(i) are identified individually in accordance with Council Regulation (EC) No 21/2004,
(ii) have never been vaccinated against brucellosis or have not been vaccinated against brucellosis in the last two years or the animals are females over two years old which were vaccinated against brucellosis before the age of seven months,
(iii) were isolated under official supervision on the holding of origin and, during such isolation, underwent, with negative results, two tests for brucellosis in accordance with Annex C to Directive 91/68/EEC, separated by an interval of at least six weeks.]
II.6. The animals comply with at least one of the following conditions and therefore qualify for admission to an ovine or caprine holding which is brucellosis-free (B. melitensis):
(1) either [they come from an officially brucellosis-free (B. melitensis) holding.]
(1) and/or [they come from a brucellosis-free (B. melitensis) holding.]
(1) and/or [until the qualifying date under eradication plans approved pursuant to Council Decision 90/242/EEC, they originate from a holding other than officially brucellosis-free or brucellosis-free and comply with the following conditions:
(i) are identified individually in accordance with Council Regulation (EC) No 21/2004,
(ii) originate from a holding in which all the animals of species susceptible to brucellosis (B. melitensis) have been free of clinical symptoms or any other symptoms of brucellosis for at least the last 12 months; and
(1) either [have not been vaccinated against brucellosis (B. melitensis) in the last two years, and were isolated under veterinary supervision on the holding of origin and, during such isolation, underwent, with negative results, two tests for brucellosis in accordance with Annex C to Directive 91/68/EEC, separated by an interval of at least six weeks.]]
(1) or [were vaccinated with Rev. 1 vaccine before the age of seven months, but not later than 15 days before their introduction into the holding of destination.]]
(1) [II.7. The animals are intended for a Member State or zone of a Member State listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 of the European Parliament and of the Council as having a negligible risk status for classical scrapie, or for a Member State listed in point 3.2 of that Section as having an approved national scrapie control programme, and
(1) either [come from a holding situated in a Member State or zone of a Member State listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie.]]
(1) and/or [come from a holding recognised as having a negligible risk of classical scrapie in accordance with point 1.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 and listed as such by the competent authority of the Member State in accordance with point 1.1 of that Section.]]
(1) and/or [come from a holding not subject to the measures laid down in points 3 and 4 of Chapter B of Annex VII to Regulation (EC) No 999/2001 and the animals are of the ovine species of the ARR/ARR prion protein genotype.]]
(1) and/or [come from and are destined for an approved body, institute or centre as defined in Article 2(1)(c) of Directive 92/65/EEC.]]
(1) or [comply with the conditions set out in point 4.1(d) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001.]]
II.8.1. The animals were transported using means of transport and containment which had, before-hand, been cleansed and disinfected using an officially approved disinfectant, and in such a way as to provide effective protection of the animals’ health status.
II.8.2. Based on the official documentation accompanying the animals, the consignment covered by this health certificate is due to start the journey on (insert date) (2).
II.8.3. At the time of inspection the animals covered by this health certificate were fit to be transported on the intended journey in accordance with the provisions of Council Regulation (EC) No 1/2005 (3).
— Box reference I.19: Use the appropriate CN code under the following headings: 0104 10 or 0104 20.
— Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) must be included.
— Box reference I.31: Identification system: The animals must bear: An individual number which permits tracing of their premises of origin, in accordance with Council Regulation (EC) No 21/2004.
Age: (months).
Sex: (M = male, F = female, C = castrated).
Part II:
(1) Delete where not applicable.
(2) In the case where a consignment is grouped in an assembly centre and comprises animals that were loaded on different dates, the date on which the journey commenced for the whole consignment is considered to be the earliest date when any part of the consignment left the holding of origin.
(3) This statement does not exempt transporters from their obligations in accordance with Union rules in force in particular regarding the fitness of animals to be transported.
— This certificate is valid for 10 days.
— The colour of the stamp and the signature must be different from that of the other particulars in this certificate.
Official veterinarian or official inspector
Name (in capital letters): Qualification and title:
I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:
(1) either [II.1. The animals were born and have been reared since birth on Union territory.]
(1) or [II.1. The animals were imported from a third country in accordance with Commission Regulation (EU) No 206/2010 at least 30 days prior to loading.]
II.2. The animals:
II.2.1. have been inspected today (within 24 hours prior to loading) and show no clinical sign of disease;
II.2.2. are not animals which are to be destroyed under a scheme to eradicate a contagious or infectious disease;
II.2.3. come from a holding which has been free from any official prohibition on health grounds, for the last 42 days in the case of brucellosis, for the last 30 days in the case of rabies, for the last 15 days in the case of anthrax, and, have not been in contact with animals from holdings which did not comply with these conditions;
II.2.4. do not come from a holding and have not been in contact with animals from holdings in a protection zone which has been set up under Union legislation and from which animals are prohibited from leaving;
II.2.5. are not the subject of animal health measures pursuant to Union legislation on foot-and-mouth disease and have not been vaccinated against foot-and-mouth disease.
II.3. Based on the written declaration made by the keeper or an examination of the holding register and movement documents kept in accordance with Council Regulation (EC) No 21/2004, in particular in Sections B and C of the Annex to that Regulation, the animals have remained on a single holding of origin for a period of at least the last 30 days, or on the holding of origin since birth where the animals are less than 30 days old, and no animal of the ovine and caprine species has been introduced into the holding of origin during the last 21 days and no biungulate animal imported from a third country has been introduced into the holding of origin during the last 30 days, unless those animals were introduced in accordance with Article 4a(1) of Council Directive 91/68/EEC.
(1) [II.4. The animals comply with the additional guarantees provided for in Articles 7 or 8 of Directive 91/68/EEC and laid down for the Member State of destination or part of its territory (insert Member State or part of its territory) in Commission Decision …/…/… (insert number).]
II.5. The animals comply with at least one of the following conditions and therefore qualify for admission to an ovine or caprine holding which is officially brucellosis-free (B. melitensis):
(1) either [the holding of origin is situated in a Member State or part of its territory (insert name of Member State or part of its territory) which is recognised as being officially brucellosis-free in accordance with Commission Decision …/…/… (insert number).]
(1) or [they come from an officially brucellosis-free (B. melitensis) holding.]
(1) or [they come from a brucellosis-free (B. melitensis) holding, and
(i) are identified individually in accordance with Council Regulation (EC) No 21/2004,
(ii) have never been vaccinated against brucellosis or have not been vaccinated against brucellosis in the last two years or the animals are females over two years old which were vaccinated against brucellosis before the age of seven months,
(iii) were isolated under official supervision on the holding of origin and, during such isolation, underwent, with negative results, two tests for brucellosis in accordance with Annex C to Directive 91/68/EEC, separated by an interval of at least six weeks.]
II.6. The animals comply with at least one of the following conditions and therefore qualify for admission to an ovine or caprine holding which is brucellosis-free (B. melitensis):
(1) either [they come from an officially brucellosis-free (B. melitensis) holding.]
(1) or [they come from a brucellosis-free (B. melitensis) holding.]
(1) or [until the qualifying date under eradication plans approved pursuant to Council Decision 90/242/EEC, they originate from a holding other than officially brucellosis-free or brucellosis-free and satisfy the following conditions:
(i) are identified individually in accordance with Council Regulation (EC) No 21/2004,
(ii) originate from a holding in which all the animals of species susceptible to brucellosis (B. melitensis) have been free of clinical symptoms or any other symptoms of brucellosis for at least the last 12 months; and
(1) either [have not been vaccinated against brucellosis (B. melitensis) in the last two years, and were isolated under veterinary supervision on the holding of origin and, during such isolation, underwent, with negative results, two tests for brucellosis in accordance with Annex C to Directive 91/68/EEC, separated by an interval of at least six weeks.]]
(1) or [were vaccinated with Rev. 1 vaccine before the age of seven months, and were not vaccinated in the 15 days before the date of emission of this health certificate.]]
(1) [II.7. They are uncastrated breeding rams and:
(i) come from a holding on which no case of contagious epididymitis of rams (B. ovis) has been recorded in the last 12 months,
(ii) have been kept permanently on that holding for the last 60 days,
(iii) have undergone, within the last 30 days, with a negative result, a test to detect contagious epididymitis of rams (B. ovis) in accordance with Annex D to Directive 91/68/EEC.]
II.8. To the best of the knowledge of the undersigned and according to the written declaration made by the owner, the animals were not obtained from a holding and have not been in contact with animals from a holding in which the following diseases have been clinically detected:
(i) within the last six months, contagious agalactia of sheep (Mycoplasma agalactiae) and contagious agalactia of goats (Mycoplasma agalactiae, M. capricolum, M. mycoides subsp. mycoides large colony),
(ii) within the last 12 months, paratuberculosis or caseous lymphadenitis,
(iii) within the last three years, pulmonary adenomatosis, maedi/visna or caprine viral arthritis/encephalitis. However, this time limit is reduced to 12 months if animals affected by maedi/visna or caprine viral arthritis/encephalitis have been slaughtered and the remaining animals have reacted negatively to two tests.
(1) either [II.9. The animals are intended for a Member State or zone of a Member State listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie or for a Member State listed in point 3.2 of that Section as having an approved national scrapie control programme, and
(1) either [come from a holding situated in a Member State or zone of a Member State listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie.]]
(1) and/or [come from a holding recognised as having a negligible risk of classical scrapie in accordance with point 1.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 and listed as such by the competent authority of the Member State in accordance with point 1.1 of that Section.]]
(1) and/or [come from a holding not subject to the measures laid down in points 3 and 4 of Chapter B of Annex VII to Regulation (EC) No 999/2001 and the animals are of the ovine species of the ARR/ARR prion protein genotype.]]
(1) and/or [come from and are destined for an approved body, institute or centre as defined in Article 2(1)(c) of Directive 92/65/EEC.]]
(1) or [comply with the conditions set out in point 4.1(d) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001.]]
(1) or [II.9. The animals are intended for a Member State or zone of a Member State other than those listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie or other than those listed in point 3.2 of that Section as having an approved national scrapie control programme, and
(1) either [come from a holding situated in a Member State or zone of a Member State listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie.]]
(1) and/or [come from a holding recognised as having a negligible risk of classical scrapie in accordance with point 1.2 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 and listed as such by the competent authority of the Member State in accordance with point 1.1 of that Section.]]
(1) and/or [come from a holding not subject to the measures laid down in points 3 and 4 of Chapter B of Annex VII to Regulation (EC) No 999/2001 and the animals are of the ovine species of the ARR/ARR prion protein genotype.]]
(1) and/or [come from a holding recognised as having a controlled risk of classical scrapie in accordance with point 1.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 and listed as such by the competent authority of the Member State in accordance with point 1.1 of that Section.]]
(1) and/or [come from and are destined for an approved body, institute or centre as defined in Article 2(1)(c) of Directive 92/65/EEC.]]
(1) or [comply with the conditions set out in point 4.1(d) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001.]]
II.10.1. The animals were transported using means of transport and containment which had, before-hand, been cleansed and disinfected using an officially approved disinfectant, and in such a way as to provide effective protection of the animals’ health status.
II.10.2. Based on the official documentation accompanying the animals, the consignment covered by this health certificate is due to start the journey on (insert date) (2).
II.10.3. At the time of inspection the animals covered by this health certificate were fit to be transported on the intended journey in accordance with the provisions of Council Regulation (EC) No 1/2005 (3).
Notes
Part I:
— Box reference I.19: Use the appropriate CN code under the following headings: 0104 10 or 0104 20.
— Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) must be included.
— Box reference I.31: Identification system: The animals must bear an individual number which permits tracing of their premises of origin in accordance with Council Regulation (EC) No 21/2004.
(2) In the case where a consignment is grouped in an assembly centre and comprises animals that were loaded on different dates, the date at which the journey commenced for the whole consignment is considered to be the earliest date when any part of the consignment left the holding of origin.
(3) This statement does not exempt transporters from their obligations in accordance with Union rules in force in particular regarding the fitness of animals to be transported.
— This certificate is valid for 10 days.
— The colour of the stamp and the signature must be different from that of the other particulars in the certificate.
Official veterinarian or official inspector
Name (in capital letters): Qualification and title:
Local Veterinary Unit: LVU No:
Date: Signature:
Stamp:
’
ANNEX II
In Annex III to Decision 2010/470/EU, Part A is replaced by the following:
‘Part A
Model health certificate IIIA for trade within the Union in consignments of semen of animals of the ovine and caprine species collected in accordance with Council Directive 92/65/EEC after 31 August 2010 and dispatched from an approved semen collection centre of origin of the semen
I, the undersigned official veterinarian, hereby certify that:
II.1. The semen described above:
II.1.1. was collected, processed and stored in a semen collection centre (2) approved and supervised by the competent authority in accordance with Chapter I(I)(1) and Chapter I(II)(1) of Annex D to Directive 92/65/EEC;
II.1.2. comes from donor animals which meet the requirements of Chapter II(II) of Annex D to Directive 92/65/EEC;
II.1.3. was collected, processed, stored and transported under conditions which comply with the requirements of Chapters II(II) and III(I) of Annex D to Directive 92/65/EEC;
(1) either [II.1.4. was collected from animals which have been kept continuously since birth on a holding or holdings recognised as having a negligible or controlled risk of classical scrapie according to point 1 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001, except during the period when they were kept at a semen collection centre that complied during that period with the conditions set out in the four indents of point 1.3(c)(iv) of that Section;]
(1) or [II.1.4. was collected from animals which have been kept continuously for the last three years before the collection on a holding or holdings which has/have complied for the last three years before the collection with the requirements laid down in points 1.3(a) to (f) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001, except during the period when they were kept at a semen collection centre that complied during that period with the conditions set out in the four indents of point 1.3(c)(iv) of that Section;]
(1) or [II.1.4. was collected from animals which have been kept continuously since birth in a Member State or zone of a Member State listed in point 2.3 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001 as having a negligible risk status for classical scrapie;]
(1) or [II.1.4. was collected from ovine animals of the ARR/ARR prion protein genotype;]
II.1.5. was sent to the place of loading in a sealed container in accordance with point 1.4 of Chapter III(I) of Annex D to Directive 92/65/EEC and bearing the number detailed in Box I.23.
(1) either [II.2. No antibiotics or no mixture of antibiotics were added to the semen.]
(1) or [II.2. The following antibiotic or combination of antibiotics was added to produce a concentration in the final diluted semen of not less than (3):
]
Notes
Part I:
Box I.12: Place of origin shall correspond to the semen collection centre of origin of the semen.
Box I.13: Place of destination shall correspond to the semen collection or storage centre or to the holding of semen destination.
Box I.23: Identification of container and seal number shall be indicated.
Box I.31: Donor identity shall correspond to the official identification of the animal.
Date of collection shall be indicated in the following format: dd/mm/yyyy.
Approval number of the centre shall correspond to the approval number of the semen centre indicated in Box I.12 where the semen was collected.
I, the undersigned, official veterinarian, hereby certify that:
II.1. The exporting country
(name of exporting country) (2)
II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia and Rift Valley fever during the 12 months immediately prior to collection of the semen to be exported and until its date of dispatch to the Union and no vaccination against these diseases took place during that period;
II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the semen to be exported and until its date of dispatch to the Union and no vaccination against this disease took place during that period.
II.2. The semen collection centre described in Box I.11 and at which the semen to be exported was collected and stored:
II.2.1. meets the conditions for the approval of semen collection centres laid down in Chapter I(I)(1) of Annex D to Directive 92/65/EEC;
II.2.2. is operated and supervised in accordance with the conditions applicable to semen collection centres and storage centres laid down in Chapter I(II)(1) of Annex D to Directive 92/65/EEC.
II.3. The ovine (1)/caprine (1) animals standing at the semen collection centre:
II.3.1. prior to their stay in the quarantine accommodation described in point II.3.3,
(1) (4) either [II.3.1.1. originate from the territory described in Box I.8, which has been recognised as officially brucellosis (B. melitensis)-free,]
(1) or [II.3.1.1. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC,]
(1) or [II.3.1.1. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3), carried out with negative results on samples taken on (date) and on (date) at least six months apart, the latter being within 30 days before entry into the quarantine accommodation,]
and have not been kept previously in a holding of a lower status;
II.3.1.2. have been kept continuously for at least 60 days on a holding where no case of contagious epididymitis (Brucella ovis) has been diagnosed in the last 12 months,
(1) and [they are animals of the ovine species and have undergone during the 60 days prior to their stay in the quarantine accommodation described in point II.3.3 a complement fixation test, or any other test with an equivalent documented sensitivity and specificity, to detect contagious epididymitis with result of less than 50 ICFTU/ml;]
II.3.1.3. to the best of my knowledge do not come from holdings and have not been in contact with animals of a holding, in which, based on the official notification system and according to the written declaration made by the owner, any of the following diseases has been clinically detected within the periods referred to in points (a) to (d) prior to their stay in the quarantine accommodation described in point II.3.3.
(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides “large colony”), within the last six months,
(b) paratuberculosis and caseous lymphadenitis, within the last 12 months,
(c) pulmonary adenomatosis, within the last three years;
(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;]
(1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]
II.3.2. have undergone the following tests carried out on a blood sample collected within the 28 days preceding the commencement of the period of quarantine specified in point II.3.3 for:
— brucellosis (B. melitensis), with negative results in each case in accordance with Annex C to Directive 91/68/EEC;
— contagious epididymitis (Brucella. ovis), in the case of sheep only, with negative results in each case in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;
— border disease in accordance with point 1.4(c) of Chapter II(II) of Annex D to Directive 92/65/EEC;
II.3.3. have satisfied the quarantine isolation period of at least 28 days in a quarantine accommodation specifically approved for the purpose by the competent authority and during that period:
II.3.3.1. only animals of at least the same health status were present in the quarantine accommodation;
II.3.3.2. the animals have undergone the following tests, carried out by the laboratory approved by the competent authority of the exporting country on samples taken not earlier than 21 days after the animals were admitted to the quarantine accommodation, for:
— brucellosis (B. melitensis) with negative results in each case in accordance with Annex C to Directive 91/68/EEC;
— contagious epididymitis (Brucella ovis), in the case of sheep only, with negative results in each case in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;
— border disease in accordance with point 1.6 of Chapter II(II) of Annex D to Directive 92/65/EEC;
II.3.4. have undergone at least once a year the routine tests for:
— brucellosis (B. melitensis) with negative results in each case in accordance with Annex C to Directive 91/68/EEC;
— contagious epididymitis (Brucella ovis), in the case of sheep only, with negative results in each case in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity;
— border disease in accordance with point 5(c) of Chapter II(II) of Annex D to Directive 92/65/EEC.
II.4. The semen to be exported was obtained from donor rams (1)/bucks (1) which:
II.4.1. were admitted to the approved semen collection centre with the express permission of the centre veterinarian.
II.4.2. show no clinical signs of disease on the day of admission to the approved semen collection centre and on the day the semen was collected;
(1) either [II.4.3. have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection of the semen;]
(1) or [II.4.3. have been vaccinated against foot-and-mouth disease at least 30 days prior to the collection, and 5 % (with a minimum of five straws) of each collection have been submitted to a virus isolation test for foot-and-mouth disease with negative results;]
II.4.4. have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to collection of the semen, in the case of collections of fresh semen;
II.4.5. have not served naturally after their entry to the quarantine accommodation described in point II.3.3 and up to and including the day of semen collection;
II.4.6. have been kept at approved semen collection centres:
II.4.6.1. which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch, and which are situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days prior to collection of the semen;
II.4.6.2. which have been free, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, from brucellosis (B. melitensis), contagious epididymitis (Brucella. ovis), anthrax and rabies;
(1) either [II.4.7. have remained in the exporting country for at least the past six months prior to collection of the semen to be exported;]
(1) or [II.4.7. during the last six months prior to collection of the semen they complied with the animal health conditions applying to donors of the semen which is intended for export to the Union and they have been imported into the exporting country at least 30 days prior to collection of the semen from (2);]
(1) either [II.4.8. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the semen;]
(1) or [II.4.8. were kept during a bluetongue virus seasonally free period in a seasonally free zone for at least 60 days prior to, and during collection of the semen;]
(1) or [II.4.8. were kept in a vector-protected establishment for at least 60 days prior to, and during collection of the semen;]
(1) or [II.4.8. were subjected to a serological test for the detection of antibody to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, with negative results, on blood samples taken at least every 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of semen;]
(1) or [II.4.8. were subjected to an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals with negative results on blood samples taken at commencement and final collection for this consignment of semen and at least every 7 days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of semen;]
(1) (5) either [II.4.9. were resident in the exporting country which according to official findings is free from epizootic haemorrhagic disease (EHD);]
(1) or [II.4.9. were resident in the exporting country in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: and were subjected with negative results in each case to:
(1) either [a serological test (6) for the detection of antibody to the EHDV group carried out in an approved laboratory on samples of blood taken on two occasions not more than 12 months apart prior to and not less than 21 days after the final collection for this consignment of semen.]]
(1) or [a serological test (6) for the detection of antibody to the EHDV group, carried out in an approved laboratory on samples of blood taken at intervals of not more than 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of semen.]]
(1) or [an agent identification test (6) carried out in an approved laboratory on samples of blood taken at commencement and conclusion of, and at least every 7 days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of semen.]]
II.4.10. have been kept continuously since birth in a country where the following conditions are fulfilled:
II.4.10.1. classical scrapie is compulsorily notifiable;
II.4.10.2. an awareness, surveillance and monitoring system is in place;
II.4.10.3. ovine and caprine animals affected with classical scrapie are killed and completely destroyed;
II.4.10.4. the feeding to ovine and caprine animals of meat-and-bone meal, or greaves of ruminant origin, as defined in the OIE Terrestrial Animal Health Code, has been banned and effectively enforced in the whole country for a period of at least the last seven years;
(1) either [II.4.11. have been kept continuously for a period of the last three years preceding the date of the collection of the semen to be exported in a holding or holdings which has/have fulfilled during that period all the requirements set out in points 1.3(a) to (f) of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001, except during the period when they were kept at a semen collection centre that complied during that period with the conditions set out in the four indents of point 1.3(c)(iv) of that Section;]
(1) or [II.4.11. are ovine animals of ARR/ARR prion protein genotype.]
II.5. The semen to be exported:
II.5.1. was collected after the date on which the semen collection centre was approved by the competent authority of the exporting country;
II.5.2. was collected, processed, preserved, stored and transported in accordance with the requirements applicable to semen laid down in Chapter III(I) of Annex D to Directive 92/65/EEC;
II.5.3. was sent to the place of loading in a sealed container in accordance with the requirements for semen to be subject to trade laid down in point 1.4 of Chapter III(I) of Annex D to Directive 92/65/EEC and bearing the number indicated in Box I.23.
(1) either [II.6. No antibiotics were added to the semen.]
(1) or [II.6. The following antibiotic or combination of antibiotics was added to produce a concentration in the final diluted semen of not less than (7):
]
Notes
Part I:
Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.
Box I.11: Place of origin shall correspond to the approved semen collection centre in which the semen was collected and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animals/semen/ovine_caprine/index_en.htm
Box I.22: Number of packages shall correspond to the number of containers.
Box I.23: Identification of container and seal number shall be indicated.
Box I.26: Fill in according to whether it is a transit or an import certificate.
Box I.27: Fill in according to whether it is a transit or an import certificate.
Box I.28: Species: select amongst “Ovis aries” or “Capra hircus” as appropriate.
Donor identity shall correspond to the official identification of the animal.
Date of collection shall be indicated in the following format: dd.mm.yyyy.
Approval number of the centre shall correspond to the approval number of the semen collection centre indicated in Box I.11.
Part II:
(1) Delete as necessary.
(2) Only third countries listed in Annex I to Decision 2010/472/EU.
(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.
(4) Only for the territory appearing with the entry “V” in column 6 of Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010, p. 1.).
(5) See remarks for exporting country concerned in Annex I to Decision 2010/472/EU.
(6) Standards for EHD virus diagnostic tests are described in Chapter 2.1.7 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
(7) Insert names and concentrations.
— The signature and the stamp must be in a different colour to that of the printing.
Official veterinarian
Name (in capital letters): Qualification and title: