Commission Implementing Decision of 9 April 2014 amending the Annexes to Implementing Decision 2011/630/EU as regards animal health requirements relating to bluetongue and epizootic haemorrhagic disease (notified under document C(2014) 2256)Text with EEA relevance

Commission Implementing Decision of 9 April 2014 amending the Annexes to Implementing Decision 2011/630/EU as regards animal health requirements relating to bluetongue and epizootic haemorrhagic disease (notified under document C(2014) 2256) (Text with EEA relevance) (2014/199/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 88/407/EEC of 14 June 1988 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species OJ L 194, 22.7.1988, p. 10. , and in particular Article 8(1), the first subparagraph of Article 10(2) and Article 11(2) thereof, Whereas: (1) Annex I to Commission Implementing Decision 2011/630/EU Commission Implementing Decision 2011/630/EU of 20 September 2011 on imports into the Union of semen of domestic animals of the bovine species (OJ L 247, 24.9.2011, p. 32). sets out a list of third countries or parts thereof from which Member States are to authorise imports of semen of domestic animals of the bovine species (semen). Section A of Part 1 of Annex II to that Implementing Decision sets out the model animal health certificate for imports into and transits through the Union of semen dispatched from the semen collection centre where the semen was collected. Section C of Part 1 of that Annex II sets out the model animal health certificate for imports into and transits through the Union of semen dispatched from a semen storage centre. (2) In the list of third countries or parts thereof from which Member States shall authorise imports of semen in Annex I to Implementing Decision 2011/630/EU the discription of additional guarantees for Australia and the United States must be amended in order to take account of the amendments made to the conditions for epizootic haemorrhagic disease (EHD) in points II.5.4.1 and II.5.4.2 of the health attestation in Part II of the model animal health certificate set out in Section A of Part 1 of Annex II to that Decision. (3) Annex I to Implementing Decision 2011/630/EU should therefore be amended accordingly. (4) The model animal health certificates set out in Sections A and C of Part 1 of Annex II to Implementing Decision 2011/630/EU are drawn up in accordance with Commission Decision 2007/240/EC Commission Decision 2007/240/EC of 16 April 2007 laying down new veterinary certificates for importing live animals, semen, embryos, ova and products of animal origin into the Community pursuant to Decisions 79/542/EEC, 92/260/EEC, 93/195/EEC, 93/196/EEC, 93/197/EEC, 95/328/EC, 96/333/EC, 96/539/EC, 96/540/EC, 2000/572/EC, 2000/585/EC, 2000/666/EC, 2002/613/EC, 2003/56/EC, 2003/779/EC, 2003/804/EC, 2003/858/EC, 2003/863/EC, 2003/881/EC, 2004/407/EC, 2004/438/EC, 2004/595/EC, 2004/639/EC and 2006/168/EC (OJ L 104, 21.4.2007, p. 37). , in a format compatible with the integrated computerised veterinary system (TRACES) set up by Commission Decision 2003/623/EC

Commission Decision 2003/623/EC of 19 August 2003 concerning the development of an integrated computerised veterinary system known as TRACES (OJ L 216, 28.8.2003, p. 58). and consist of a description of the consignment in Part I and health attestation in Part II thereof. (5) As in accordance with Article 2(1)(c)(i) and (iii) of Implementing Decision 2011/630/EU the model animal health certificates set out in Section A and Section C of Part 1 of Annex II thereto can only be used for consignments of semen dispatched respectively from a single semen collection or storage centre, the information in point I.11 of the respective model animal health certificate should correspond to the semen collection centre where the semen was collected or the semen storage centre where the semen was dispatched from. Accordingly, only the name, the address and the approval number of a single semen collection or storage centre should be indicated in those points. (6) The health attestation in Part II of the model animal health certificate, set out in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU, lists five alternative conditions for declaring the absence of the bluetongue virus and four alternative conditions for declaring the absence of the EHD virus in donor bulls, including three regimes for the testing of donor bulls for EHD, to be certified when semen is imported from Australia, Canada and the United States. Currently it is only allowed to certify the consignments of semen collected from donor bulls complying with a single condition among those listed in that health attestation. However, certain consignments of semen dispatched to the Union consist of semen collected at different times from donor bulls complying with more than one of those conditions. (7) In addition, Section B of Annex III to Commission Regulation (EC) No 1266/2007 Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue (OJ L 283, 27.10.2007, p. 37). provides that semen intended for intra-Union trade or export to a third country should be collected from donor animals complying with at least one of the conditions listed therein relating to bluetongue which should be specified in the health certificate which model is laid down, inter alia, in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU. (8) As a consequence, there is a need for information on those listed conditions and the applied test regimes of donor bulls for bluetongue and EHD as well as on the dates when those listed conditions were met or tests applied to a particular set of straws of semen collected from an identified donor bull, where imported semen is subsequently dispatched to another Member State. (9) Since all five conditions for declaring the absence of the bluetongue and the four conditions for declaring the absence of EHD provide the same level of animal health guarantees, the wording of the health attestation in Part II of the model animal health certificate set out in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU should be amended in order to allow imports into and transit through the Union of consignments of semen collected from donor bulls complying with more than one listed conditions. Furthermore, detailed information on the conditions and applied test regimes should be included in that model animal health certificate, without necessarily increasing adminsitrative burdens.

(10) To further reduce adminsitrative burdens for the centre veterinarian and for the official veterinarian, it is appropriate in point I.28 of the model animal health certificate set out in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU to remove information on the approval number of the centre and to provide in this point entries for the detailed description of the consignment as regards the conditions for bluetongue and EHD applicable to the particlar straw of semen collected on a disclosed date from an identified donor bull. (11) Annex II to Implementing Decision 2011/630/EU should therefore be amended accordingly. (12) Implementing Decision 2011/630/EU should therefore be amended accordingly. (13) To avoid any disruption of trade, the use of animal health certificates issued in accordance with Implementing Decision 2011/630/EU in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions. (14) 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

The Annexes to Implementing Decision 2011/630/EU are amended in accordance with the Annex to this Decision.

Article 2

For a transitional period until 31 December 2014, Member States shall authorise imports into and transit through the Union of consigments of semen of domestic animals of the bovine species from third countries which are accompanied by an animal health certificate issued not later than 30 November 2014 in accordance with the model animal health certificate set out in Section A or C of Part 1 of Annex II to Implementing Decision 2011/630/EU, before the amendments introduced by 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, 9 April 2014. For the Commission Tonio Borg Member of the Commission

Annex

ANNEX The Annexes to Implementing Decision 2011/630/EU are amended as follows: (1) Annex I is replaced by the following: (2) In Annex II, Part 1 is amended as follows: (a) Section A is replaced by the following: SECTION A Model 1 — Animal health certificate applicable to imports into and transits through the Union of semen of domestic animals of the bovine species collected, processed and stored in accordance with Council Directive 88/407/EEC, dispatched from a semen collection centre where the semen was collected 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 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 10 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 Quantity (total) (Scientific name) Donor/s identity Identification of straw/s Date/s of collection Information relating to BT (6) EHD (7) COUNTRY Bovine semen — Section A II. Health information II.a. Certificate reference No II.b. Part II: Certification I, the undersigned official veterinarian, hereby certify that: II.1. (name of exporting country) (2) was free from rinderpest and foot-and-mouth disease during the 12 months immediately prior to collection of the semen for export and until its date of dispatch to the Union and no vaccination against these diseases has taken place during the same period. II.2. The centre (3) described in Box. I.11 at which the semen to be exported was collected: II.2.1. meets the conditions laid down in Chapter I(1) of Annex A to Directive 88/407/EEC; II.2.2. is operated and supervised in accordance with the conditions laid down in Chapter II(1) of Annex A to Directive 88/407/EEC. II.3. The centre at which the semen to be exported was collected was free from rabies, tuberculosis, brucellosis, anthrax and contagious bovine pleuropneumonia during 30 days prior to the date of collection of the semen to be exported and the 30 days after collection (in the case of fresh semen until the day of dispatch to the Union). II.4. The bovine animals standing at the semen collection centre: II.4.1. come from herds which satisfy the conditions of paragraph 1(b) of Chapter I of Annex B to Directive 88/407/EEC; II.4.2. come from herds or were born to dams which comply with the conditions of paragraph 1(c) of Chapter I of Annex B to Directive 88/407/EEC, or were tested at the age of at least 24 months in accordance with paragraph 1(c) of Chapter II of Annex B to that Directive; II.4.3. underwent the tests required in accordance with paragraph 1(d) of Chapter I of Annex B to Directive 88/407/EEC in the 28 days preceding the quarantine isolation period; II.4.4. have satisfied the quarantine isolation period and testing requirements laid down in paragraph 1(e) of Chapter I of Annex B to Directive 88/407/EEC; II.4.5. have undergone, at least once a year, the routine tests referred to in Chapter II of Annex B to Directive 88/407/EEC. II.5. The semen to be exported was obtained from donor bulls which: II.5.1. satisfy the conditions laid down in Annex C of Directive 88/407/EEC; (1) either [II.5.2. have remained in the exporting country for at least the last six months prior to collection of the semen to be exported;

(1) or [II.5.2. have remained in the exporting country for at least 30 days prior to the collection of the semen since entry and they were imported from (2) during the period of less than six months prior to the collection of the semen and satisfied the animal health conditions applying to donors of the semen which is intended for export to the European Union;] II.5.3. comply with at least one of the following conditions as regards bluetongue, as detailed in the table in point I.28.: (1) either [II.5.3.1. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the semen;] (1) and/or [II.5.3.2. 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) and/or [II.5.3.3. were kept in a vector-protected establishement for at least 60 days prior to, and during, collection of the semen;] (1) and/or [II.5.3.4. were subjected to a serological test for the detection of antibody to the bluetongue virus serogroup, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, with negative results, at least every 60 days throughout the collection period and between 21 and 60 days after the final collection for this consigment of semen;] (1) and/or [II.5.3.5. were subjected to an agent identification test for bluetongue virus, carried out in accordance with the OIE 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, if carried out as polymerase chain reaction (PCR), during collection for this consigment of semen;] II.5.4. comply with at least one of the following conditions as regards epizootic haemorrhagic disease (EHD), as detailed in the table in point I.28.: (1) either [II.5.4.1. were resident in the exporting country which according to official findings is free from epizootic haemorrhagic disease (EHD);] COUNTRY Bovine semen — Section A II. Health information II.a. Certificate reference No II.b. (1) (5) and/or [II.5.4.2. 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 the following tests carried out in an approved laboratory: (1) either [II.5.4.2.1. a serological test (4) 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 semen;]] (1) and/or [II.5.4.2.2. a serological test (4) for the detection of antibody to the EHD virus serogroup, carried out on samples 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) and/or [II.5.4.2.3. an agent identification test (4) carried out on blood samples collected at commencement and conclusion of, and at least every 7 days (virus isolation test) or at least every 28 days, if carried out as PCR, during collection for this consignment of semen.]] II.6. The semen to be exported was collected after the date on which the centre was approved by the competent national authorities of the exporting country. II.7. The semen to be exported was processed, stored and transported under conditions which satisfy the terms of Directive 88/407/EEC. 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 semen collection centre listed in accordance with Article 9(2) of Directive 88/407/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/index_en.htm and where the semen was collected. 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 ‘Bos taurus’, ‘Bison bison’ or ‘Bubalus bubalis’ 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. Part II: (1) Delete as necessary. (2) Only third countries listed in Annex I to Implementing Decision 2011/630/EU. (3) Only semen collection centres listed in accordance with Article 9(2) of Directive 88/407/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/index_en.htm. (4) Standards for EHD virus diagnostic tests are described in the Bluetongue Chapter (2.1.3) of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals. (5) Compulsory for Australia, Canada and the United States. (6) Referring to each straw or batch of straws indicate applicable condition (for example II.5.3.1) (7) Referring to each straw or batch of straws indicate applicable condition (for example II.5.4.1 or II.5.4.2.1) — The signature and the stamp must be in a different colour to that of the printing. COUNTRY Bovine semen — Section A II. Health information II.a. Certificate reference No II.b. Official veterinarian Name (in capital letters): Qualification and title: Date: Signature: Stamp: (b) Section C is replaced by the following: SECTION C Model 3 — Animal health certificate for imports into and transits through the Union of semen of domestic animals of the bovine species collected, processed and stored in accordance with Council Directive 88/407/EEC, and of stocks of semen of domestic animals of the bovine species collected, processed and stored before 31 December 2004 in conformity with Directive 88/407/EEC, applying until 1 July 2004, and imported after 31 December 2004 in accordance with Article 2(2) of Directive 2003/43/EC dispatched from a semen storage centre

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 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. No(s) of related original certificates I.18. Description of commodity I.19. Commodity code (HS code) 05 11 10 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 (Scientific name) Donor identity Date of collection Approval number of the centre Quantity ) COUNTRY Bovine semen – Section C II. Health information II.a. Certificate reference No II.b. Part II: Certification I, the undersigned official veterinarian of, hereby certify that: (name of exporting country) (2) II.1 The centre (3) described in Box I.11 at which the semen to be exported to the European Union was stored: II.1.1. meets the conditions laid down in Chapter I(2) of Annex A to Directive 88/407/EEC; II.1.2. is operated and supervised in accordance with the conditions laid down in Chapter II(2) of Annex A to Directive 88/407/EEC. II.2. The semen to be exported to the European Union: II.2.1. has been collected, processed and stored for a minimum period of 30 days immediately following collection in an approved semen collection centre (4) operated and supervised in accordance with Chapter I(1) and Chapter II(1) of Annex A to Directive 88/407/EEC, and (1) either [located in the exporting country;] (1) and/or [located in (2), and has been imported to the exporting country under conditions at least as strict as for imports of semen of bovine species into the Union in accordance with Directive 88/407/EEC;] II.2.2. was moved to the centre described in Box I.11 under conditions at least as strict as described in: (1) either [Model 1 in Section A of Part 1 of Annex II to Implementing Decision 2011/630/EU (5);] (1) and/or [Model 2 in Section B of Part 1 of Annex II to Implementing Decision 2011/630/EU (5);] (1) and/or [Model 3 in Section C of Part 1 of Annex II to Implementing Decision 2011/630/EU (5);] II.2.3. was stored under conditions which satisfy the terms of Directive 88/407/EEC; [II.2.4. was sent to the place of loading in a sealed container under conditions which comply with Directive 88/407/EEC and bearing the number detailed in Box I.23.

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 semen storage centre of dispatch of the semen. Box I.12: Place of destination: this box is to be filled in only if it is a certificate for transit commodity. Box I.17: Number(s) of related original certificate(s) shall correspond to the serial number of the individual official document(s) or health certificate(s) that accompanied the semen described above from the approved semen collection centre of its origin to the centre described in Box I.11. The original(s) of those document(s) or those certificate(s) or the officially endorsed copies thereof must be attached to this certificate. 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: 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 where the semen was collected. Part II: (1) Delete as necessary. (2) Only third countries listed in Annex I to Implementing Decision 2011/630/EU. (3) Only semen storage centres listed in accordance with Article 9(2) of Directive 88/407/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/index_en.htm. COUNTRY Bovine semen – Section C II. Health information II.a. Certificate reference No II.b. (4) Only semen collection centres listed in accordance with Article 5(2) and 9(2) of Directive 88/407/EEC on the Commission websites: http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm; http://ec.europa.eu/food/animal/semen_ova/bovine/index_en.htm. (5) Only third countries listed in Annex I to Implementing Decision 2011/630/EU and the EU Member States. (6) The original(s) of the document(s) or the health certificate(s) or the officially endorsed copies of thereof that accompanied the semen described above from the approved semen collection centre in which the semen was collected to the approved semen storage centre of the semen dispatch described in Box I.11 must be attached to this certificate. — 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: Date: Signature: Stamp:

Annex

ANNEX I List of third countries or parts thereof from which Member States shall authorise imports of semen of domestic animals of the bovine species The model certificate to be used for imports from Canada is set out in Commission Decision 2005/290/EC of 4 April 2005 on simplified certificates for the importation of bovine semen and fresh pig meat from Canada and amending Decision 2004/639/EC (only for the semen collected in Canada) laid down in accordance with the Agreement between the European Community and the Government of Canada on sanitary measures to protect public and animal health in respect of trade in live animals and animal products, as approved by Council Decision 1999/201/EC.

The model certificates to be used for imports from Switzerland are set out in Annex D to Directive 88/407/EEC, with the adaptations set out in point 4 of Chapter VII(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation. ISO CodeName of the third countryRemarks Description of the territory (if appropriate) Additional guaranteesAUAustraliaThe additional guarantees concerning testing set out in points II.5.4.1 and/or II.5.4.2 of the certificate in Section A of Part 1 of Annex II are compulsory.CACanadaTerritory described as CA-1 in Part 1 of Annex I to Regulation (EU) No 206/2010.CHSwitzerlandCLChileGLGreenlandISIcelandNZNew ZealandPMSaint Pierre and MiquelonUSUnited StatesThe additional guarantees concerning testing set out in points II.5.4.1 and/or II.5.4.2 of the certificate in Section A of Part 1 of Annex II are compulsory.