Commission Implementing Decision of 14 November 2014 amending Decisions 2010/470/EU and 2010/472/EU as regards the animal health requirements relating to scrapie for trade in and imports into the Union of embryos of animals of the ovine and caprine species (notified under document C(2014) 8339)Text with EEA relevance

Commission Implementing Decision of 14 November 2014 amending Decisions 2010/470/EU and 2010/472/EU as regards the animal health requirements relating to scrapie for trade in and imports into the Union of embryos of animals of the ovine and caprine species (notified under document C(2014) 8339) (Text with EEA relevance) (2014/802/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, 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 OJ L 268, 14.9.1992, p. 54. , and in particular the third indent of Article 11(3), Article 17(2)(b), the first indent of Article 18(1), and the introductory phrase and point (b) of Article 19 thereof, Whereas: (1) Part A of Annex IV to Commission Decision 2010/470/EU 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). sets out the model health certificate for intra-Union trade in consignments of ova and embryos of animals of the ovine and caprine species collected or produced after 31 August 2010. (2) Part 2 of Annex IV to Commission Decision 2010/472/EU 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). sets out the model health certificate for the importation into the Union of consignments of ova and embryos of animals of the ovine and caprine species. (3) Regulation (EC) No 999/2001 of the European Parliament and of the Council 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). lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in bovine, ovine and caprine animals. Chapter A of Annex VIII to that Regulation sets out the conditions for intra-Union trade in live animals, semen and embryos. In addition, Annex IX to that Regulation sets out the conditions for the importation into the Union of live animals, embryos, ova and products of animal origin from third countries. (4) In the light of new scientific evidence, Regulation (EC) No 999/2001 was amended by Commission Regulation (EU) No 630/2013 Commission Regulation (EU) No 630/2013 of 28 June 2013 amending the 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 179, 29.6.2013, p. 60).

. Those amendments, relating to scrapie, were reflected by Commission Implementing Decision 2013/470/EU Commission Implementing Decision 2013/470/EU of 20 September 2013 amending Decisions 2010/470/EU and 2010/472/EU as regards the animal health requirements relating to scrapie for trade in and imports into the Union of semen, ova and embryos of animals of the ovine and caprine species (OJ L 252, 24.9.2013, p. 32). in the model health certificate for intra-Union trade in consignments of ova and embryos of animals of the ovine and caprine species set out in Part A of Annex IV to Decision 2010/470/EU and the model health certificate for imports into the Union of consignments of ova and embryos of animals of the ovine and caprine species set out in Part 2 of Annex IV to Decision 2010/472/EU, with a transitional period until 31 December 2014. (5) In accordance with a scientific opinion on the risk of transmission of classical scrapie via in vivo derived embryo transfer in ovine animals of the European Food Safety Authority (EFSA) adopted on 24 January 2013, where it was concluded that the risk of transmitting classical scrapie by the implantation of homozygous or heterozygous ovine ARR embryos could be considered negligible, provided that the OIE recommendations and procedures relating to embryo transfer are followed, the relevant provisions of Regulation (EC) No 999/2001 were amended by Commission Regulation (EU) No 1148/2014 Commission Regulation (EU) No 1148/2014 of 28 October 2014 amending the Annexes II, VII, VIII, IX and X 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 308, 29.10.2014, p. 66). . (6) The model health certificate for intra-Union trade in consignments of ova and embryos of animals of the ovine and caprine species set out in Part A of Annex IV to Decision 2010/470/EU and the model health certificate for imports into the Union of consignments of ova and embryos of animals of the ovine and caprine species set out in Part 2 of Annex IV to Decision 2010/472/EU should therefore be amended in order to reflect the requirements laid down in Regulation (EC) No 999/2001, as amended by Regulation (EU) No 1148/2014. (7) In addition, in the model health certificate for intra-Union trade in consignments of ova and embryos of animals of the ovine and caprine species set out in Part A of Annex IV to Decision 2010/470/EU, certain references to Regulation (EC) No 999/2001 need to be amended in order to remove any ambiguity. (8) Furthermore, in the model health certificate for imports into the Union of consignments of ova and embryos of animals of the ovine and caprine species set out in Part 2 of Annex IV to Decision 2010/472/EU, a more precise wording is required in order to ensure a clear understanding that testing regimes referring to epizootic haemorrhagic disease (EHD) apply to the donor females of ovine or caprine species.

(9) Decisions 2010/470/EU and 2010/472/EU should therefore be amended accordingly. (10) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS DECISION:

Article 1

Annex IV to Decision 2010/470/EU is amended in accordance with Annex I to this Decision.

Article 2

Annex IV to Decision 2010/472/EU is amended in accordance with Annex II to this Decision.

Article 3

This Decision shall apply from 1 January 2015.

Article 4

This Decision is addressed to the Member States. Done at Brussels, 14 November 2014. For the Commission Vytenis Andriukaitis Member of the Commission

Annex

ANNEX I In Annex IV to Decision 2010/470/EU, Part A is replaced by the following: PART A Model health certificate IVA for trade within the Union in consignments of ova and embryos of animals of the ovine and caprine species collected or produced in accordance with Council Directive 92/65/EEC after 31 August 2010 and dispatched by an approved embryo collection or production team of origin of the ova or embryos EUROPEAN UNION Intra trade certificate Part I: Details of consignment presented I.1. Consignor Name Address Postal code I.2. Certificate reference No I.2.a. Local reference No I.3. Central competent authority I.4. Local competent authority I.5. Consignee Name Address Postal code I.6. I.7. I.8. Country of origin ISO code I.9. Region of origin Code I.10. Country of destination ISO code I.11. Region of destination Code I.12. Place of origin Embryo team Name Approval number Address Postal code I.13. Place of destination Holding Embryo team Name Approval number Address Postal code I.14. I.15. I.16. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification I.17. I.18. Description of commodity I.19. Commodity code (CN code) 05 11 99 85 I.20. Quantity I.21. Temperature of products Ambient Chilled Frozen I.22. Number of packages I.23. Seal/Container No I.24. Type of packaging I.25. Commodities certified for: Artificial reproduction I.26. Transit through third country Third country ISO code Exit point Code Entry point BIP No I.27. Transit through Member States Member State ISO code Member State ISO code Member State ISO code I.28. Export Third country ISO code Exit point Code I.29. I.30. I.31. Identification of the commodities Species Category Donor identity Date of collection Approval number of the team Quantity (Scientific name) EUROPEAN UNION Ovine and caprine ova/embryos — Part A II. Health information II.a. Certificate reference number II.b. I, the undersigned official veterinarian, hereby certify that: (1) either [II.1. the in vivo derived embryos (1)/in vivo derived ova (1) described above were collected, processed and stored by an embryo collection team (2) approved and supervised in accordance with Chapter I(III)(1) of Annex D to Directive 92/65/EEC;] (1) or [II.1. the in vitro produced embryos (1)/micromanipulated embryos (1) described above were produced, processed and stored by an embryo production team (2) approved and supervised in accordance with Chapter I(III)(1) and (2) of Annex D to Directive 92/65/EEC;]

(1) either [II.2. the in vivo derived embryos described above meet the requirements of Chapter III(II)(1) of Annex D to Directive 92/65/EEC;] (1) or [II.2. the in vivo derived ova described above meet the requirements of Chapter III(II)(2) of Annex D to Directive 92/65/EEC;] (1) or [II.2. the in vitro produced embryos described above meet the requirements of Chapter III(II)(3) of Annex D to Directive 92/65/EEC;] (1) or [II.2. the micromanipulated embryos described above meet the requirements of Chapter III(II)(4) of Annex D to Directive 92/65/EEC;] (1) [II.3. the consignment consists of embryos of the ovine or caprine species which: (1) either [were collected from animals which have been kept continuously since birth on a holding or holdings recognised as having a negligible or a controlled risk of classical scrapie in accordance with point 1 of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001;]] (1) or [were collected from animals which have been kept continuously for the last three years before the collection on a holding or holdings which have complied for the last three years before collection with the requirements laid down in points (a) to (f) of point 1.3. of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001;]] (1) or [were collected from animals which have been kept continuously since birth in a Member State or zone of a Member State with a negligible risk status for classical scrapie approved in accordance with the first subparagraph of point 2.2. of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001;]] (1) or [were collected from ovine animals and (1) either [are of the ARR/ARR prion protein genotype;]] (1) or [carry at least one ARR allele and were collected after the date of 1 January 2015;]] II.4. the ova or embryos described above come from female donors of the ovine (1)/caprine species (1) which meet the requirements of Chapter IV(3) of Annex D to Directive 92/65/EEC; (1) either [II.5. the embryos described above were conceived as a result of artificial insemination of the donor females with semen which was collected, processed, stored and transported under conditions which comply with the requirements of Chapters I(I), II(I) and III(I) of Annex D to Directive 92/65/EEC;] (1) or [II.5. the embryos described above were conceived as a result of in vitro fertilisation of ova complying with the conditions in Chapter III(II)(2) of Annex D to Directive 92/65/EEC with semen which was collected, processed, stored and transported under conditions which comply with the requirements of Chapters I(I), II(I) and III(I) of Annex D to Directive 92/65/EEC;] (1) or [II.5. the ova have not been in contact with semen of the ovine and caprine species;] II.6. the ova or embryos described above were sent to the place of loading in a sealed container in accordance with point 6 of Chapter III(II) of Annex D to Directive 92/65/EEC and bearing the number detailed in Box I.23. Notes Part I: Box I.12: Place of origin shall correspond to the embryo collection team or embryo production team of embryos collection/production.

Box I.13: Place of destination shall correspond to the embryo collection team, embryo production team or to the holding of ova/embryos destination. Part II: Certification EUROPEAN UNION Ovine and caprine ova/embryos — Part A II. Health information II.a. Certificate reference number II.b. Box I.23: Identification of container and seal number shall be indicated. Box I.31: Category: specify if: in vivo derived embryos, in vivo derived ova, in vitro produced embryos or micromanipulated embryos. 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 team shall correspond to the embryo collection team or embryo production team of ova/embryos collection/production. Part II: (1) Delete as appropriate. (2) Only approved embryo collection or production teams listed in accordance with Article 11(4) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm. — The colour of the stamp and 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

ANNEX II In Annex IV to Decision 2010/472/EU, Part 2 is replaced by the following: PART 2 Model health certificate for imports of consignments of ova and embryos of animals of the ovine and caprine species COUNTRY: Veterinary certificate to EU Part I: Details of dispatched consignment I.1. Consignor Name Address Tel. I.2. Certificate reference No I.2.a. I.3. Central competent authority I.4. Local competent authority I.5. Consignee Name Address Postal code Tel. I.6. Person responsible for the load in EU Name Address Postal code Tel. I.7. Country of origin ISO code I.8. Region of origin Code I.9. Country of destination ISO code I.10. Region of destination Code I.11. Place of origin Name Approval number Address Name Approval number Address Name Approval number Address I.12. Place of destination Name Address Postal code I.13. Place of loading I.14. Date of departure I.15. Means of transport Aeroplane Ship Railway wagon Road vehicle Other Identification Documentary references I.16. Entry BIP in EU I.17. I.18. Description of commodity I.19. Commodity code (HS code) 05 11 99 85 I.20. Quantity I.21. I.22. Number of packages I.23. Seal/Container No I.24. I.25. Commodities certified for: Artificial reproduction I.26. For transit through EU to third country Third country ISO code I.27. For import or admission into EU I.28. Identification of the commodities Species Category Donor identity Date of collection Date of freezing Approval number of the team Quantity (Scientific name) COUNTRY Ovine and caprine ova/embryos II. Health information II.a. Certificate reference number II.b. 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 ova (1)/embryos (1) to be exported and until their date of dispatch to the Union and no vaccination against these diseases took place during that period; (1) either [II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova (1)/embryos (1) and did not carry out vaccination against foot-and-mouth disease during that period;] (1) or [II.1.2. has not been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova (1)/embryos (1) and/or carried out vaccination against foot-and-mouth disease during that period and the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during 30 days prior to collection and no animal of susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least 30 days after, the ova (1)/embryos (1) were collected and the ova (1)/embryos (1) were not subjected to penetration of zona pellucida;] II.2. The ova (1)/embryos (1) to be exported: II.2.1. were collected (1)/produced (1) and processed on premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever in the 30 days immediately prior to their collection; II.2.2. were stored at all times on approved premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis or Rift Valley fever from the time of their collection until 30 days thereafter; II.2.3. were collected (1)/produced (1) by the team described in Box I.11., which has been approved and supervised in accordance with the conditions for the approval and supervision of embryo collection teams and embryo production teams laid down in Chapter I(III) of Annex D to Directive 92/65/EEC; II.2.4. meet the conditions for ova and embryos laid down in Chapter III(II) of Annex D to Directive 92/65/EEC; II.2.5. come from the donor females of ovine (1)/caprine (1) species which: (1) either [II.2.5.1. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during collection of the ova (1)/embryos (1);] (1) or [II.2.5.1. were kept during a bluetongue virus seasonally free period in a seasonally free zone;] (1) or [II.2.5.1. were kept protected from the vector for at least 60 days prior to, and during the collection of the ova (1)/embryos (1);] (1) or [II.2.5.1. underwent a serological test for the detection of antibody to the bluetongue virus serogroup, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection of the ova (1)/embryos (1) and giving negative results;] (1) or [II.2.5.1. underwent an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of the ova (1)/embryos (1) collection or the day of slaughtering and giving negative results;]

II.2.5.2. 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 collection of the ova (1)/embryos (1) to be exported: (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; Part II: Certification COUNTRY Ovine and caprine ova/embryos II. Health information II.a. Certificate reference number II.b. (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.2.5.3. showed no clinical signs of disease on the day of the ova (1)/embryos (1) collection; (1)(4) either [II.2.5.4. originate from the region described in Box I.8., which has been recognised as officially brucellosis (B. melitensis)-free, and] (1) or [II.2.5.4. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC, and] (1) or [II.2.5.4. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from any 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 prior to collection of the ova (1)/embryos (1),] and have not been kept previously in a holding of a lower status; (1) either [II.2.5.5. have remained in the exporting country for at least the past six months prior to collection of the ova (1)/embryos (1) to be exported;] (1) or [II.2.5.5. during the past six months prior to collection of the ova (1)/embryos (1) they complied with the animal health conditions applying to donors of the ova/embryos(1) which are intended for export to the Union and they have been imported into the exporting country at least 30 days prior to collection of the ova (1)/embryos (1) from (2);] II.2.5.6. have been kept continuously since birth in a country where the following conditions are fulfilled: II.2.5.6.1. classical scrapie is compulsorily notifiable;

II.2.5.6.2. an awareness, surveillance and monitoring system is in place; II.2.5.6.3. ovine and caprine animals affected with classical scrapie are killed and completely destroyed; II.2.5.6.4. the feeding to ovine and caprine animals of meat-and-bone meal, or greaves of ruminant origin has been banned and effectively enforced in the whole country for a period of at least the last seven years; (1) either [II.2.5.7. have been kept continuously for the last three years before the collection of the embryos to be exported in a holding or holdings which has/have been complying for the last three years before the collection of the embryos to be exported with the requirements laid down in points (a) to (f) of point 1.3. of Section A of Chapter A of Annex VIII to Regulation (EC) No 999/2001;] (1) or [II.2.5.7. are ovine animals and the embryos (1) either [are of the ARR/ARR prion protein genotype;]] (1) or [carry at least one ARR allele and were collected after the date of 1 January 2015;]] [II.2.6. were collected (1)/produced (1) in the exporting country, (1) either [II.2.6.1. which according to official findings is free from epizootic haemorrhagic disease (EHD);]] (1)(5) or [II.2.6.1. in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: and the donor females of ovine (1)/caprine (1) species were subjected with negative results in each case to the following tests carried out in an approved laboratory: (1) either [a serological test (6) for the detection of antibody to the EHD virus serogroup, carried out on samples of blood taken on two occasions not more than 12 months apart prior to and not less than 21 days following collection for this consignment of ova (1)/embryos (1);]] (1) or [a serological test (6) for the detection of antibody to the EHD virus serogroup, carried out 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 ova (1)/embryos (1);]] COUNTRY Ovine and caprine ova/embryos II. Health information II.a. Certificate reference number II.b. (1) or [an agent identification test (6), carried out on samples of blood collected at commencement and conclusion of, and at least every 7 days, if carried out as virus isolation test, or at least every 28 days, if carried out as polymerase chain reaction, during collection for this consignment of ova (1)/embryos (1);]] II.2.7. were collected (1)/produced (1) after the date on which the embryo collection team was approved by the competent authority of the exporting country; II.2.8. were processed and stored under approved conditions for at least 30 days immediately after their collection (1)/production (1) and transported under conditions for ova and embryos laid down in Chapter III(II) of Annex D to Directive 92/65/EEC; II.2.9. were sent to the place of loading in a sealed container in accordance with the requirements for the transport of embryos laid down in point 6 of Chapter III(II) of Annex D to Directive 92/65/EEC and bearing the number detailed in Box I.23.

(1) [II.2.10. the consignment consists of embryos of the ovine or caprine species which were conceived by artificial insemination (1)/as a result of in vitro fertilisation (1) using semen coming from semen collection centres approved (7) in accordance with: (1) either [II.2.10.1. Article 11(2) of Directive 92/65/EEC and located in a Member State of the European Union; and the semen complies with the requirements of Directive 92/65/EEC.]] (1) or [II.2.10.1. Article 17(3)(b) of Directive 92/65/EEC and located in a third country or part thereof listed in Annex I to Decision 2010/472/EU, and the semen complies with the requirements set out in Part 2 of Annex II to that Decision.]] 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 embryo collection team or embryo production team by which the ova/embryos were collected/produced, processed and stored; and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/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. Category: specify if in vivo derived embryos, in vivo derived ova, in vitro produced embryos or micromanipulated embryos. Donor identity shall correspond to the official identification of the animal. Date of collection shall be indicated for in vivo derived embryos and in the following format: dd.mm.yyyy. Date of freezing shall be indicated in the following format: dd.mm.yyyy. Approval number of the team: shall correspond to the approved embryo collection team or embryo production team by which the ova/embryos were collected/produced, processed and stored; and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htm. Part II: (1) Delete as appropriate. (2) Only third countries or parts thereof listed in Annex I to Decision 2010/472/EU. COUNTRY Ovine and caprine ova/embryos II. Health information II.a. Certificate reference number II.b. (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 or part thereof concerned in Annex III to Decision 2010/472/EU. (6) Standards for EHD virus diagnostic tests are described in Chapter 2.1.3. of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals. (7) Only approved semen collection centres listed in accordance with Article 11(4) and Article 17(3)(b) of Directive 92/65/EEC on the Commission websites: