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(1), and in particular the second paragraph of Article 17 thereof,

24.9.2011 | EN | Official Journal of the European Union | L 247/22 ---|---|---|--- * * * COMMISSION IMPLEMENTING DECISION of 20 September 2011 amending Annex D to Council Directive 88/407/EEC as regards trade within the Union in semen of domestic animals of the bovine species dispatched from the semen collection and storage centres (notified under document C(2011) 6425) (Text with EEA relevance) (2011/629/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 (1), and in particular the second paragraph of Article 17 thereof, Whereas: (1) | Directive 88/407/EEC lays down the animal health conditions applicable to, inter alia, trade within the Union of semen of domestic animals of bovine species and establishes the model animal health certificates for such trade in that commodity. ---|--- (2) | Directive 88/407/EEC, as amended by Council Directive 2008/73/EC (2), introduces a simplified procedure for the listing of semen collection and storage centres in the Member States. ---|--- (3) | In addition, Directive 88/407/EEC provides that Member States are to make the admission of semen conditional upon submission of an animal health certificate drawn up by an official veterinarian of the Member State of collection in accordance with Annex D. That Annex sets out three different model animal health certificates, D1, D2 and D3, for trade within the Union in semen of domestic animal of the bovine species. ---|--- (4) | Annex D to Directive 88/407/EEC should therefore be amended to take account of the simplified procedure for the listing of semen collection and storage centres in the Member States. ---|--- (5) | Commission Decision 2010/470/EU (3) lays 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. That Decision aimed to ensure full traceability of the commodities concerned collected in a semen collection centre and dispatched from a semen storage centre, whether or not the latter constitute part of a semen collection centre approved under a different approval number. ---|--- (6) | In the interests of consistency of Union legislation, the structure of model health certificates set out in Decision 2010/470/EU should be taken into account in the model animal health certificates for trade within the Union in semen of domestic animals of bovine species. ---|--- (7) | In particular, the model animal health certificate in Annex D3 concerns trade within the Union in semen and stocks of semen of domestic animals of the bovine species dispatched from the semen collection and storage centres. ---|--- (8) | In order to ensure full traceability of the semen, the model animal health certificate in Annex D3 should be supplemented by additional certification requirements and only used for trade in semen collected in a semen collection centre and dispatched from a semen storage centre, whether or not the latter constitute part of a semen collection centre approved under a different approval number. ---|--- (9) | It is also necessary to adapt the dates in the titles of certificates in Annexes D2 and D3 related to the stocks of semen collected, processed and stored before 31 December 2004 to reflect the provisions of Article 2(1) and (2) of Council Directive 2003/43/EC of 26 May 2003 amending Directive 88/407/EEC laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the bovine species (4). ---|--- (10) | In addition, the model animal health certificates in Annexes D1 and D2 should be adapted to the structure of model health certificates set out in Decision 2010/470/EU. ---|--- (11) | Annex D to Directive 88/407/EEC should therefore be amended accordingly. ---|--- (12) | To avoid any disruption of trade, the use of animal health certificates issued in accordance with Annex D to Directive 88/407/EEC, applying until 31 October 2011, should be authorised during a transitional period subject to certain conditions. ---|--- (13) | 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 D to Directive 88/407/EEC is replaced by the text in the Annex to this Decision. Article 2 For a transitional period until 31 December 2011, Member States may authorise trade in semen and stocks of semen of domestic animals of the bovine species accompanied by an animal health certificate issued not later than 31 October 2011 in accordance with the models set out in Annex D to Directive 88/407/EEC, applying until 31 October 2011. Article 3 This Decision shall apply from 1 November 2011. Article 4 This Decision is addressed to the Member States. Done at Brussels, 20 September 2011. For the Commission John DALLI Member of the Commission * * * (1) OJ L 194, 22.7.1988, p. 10. (2) OJ L 219, 14.8.2008, p. 40. (3) OJ L 228, 31.8.2010, p. 15. (4) OJ L 143, 11.6.2003, p. 23. * * * ANNEX ‘ANNEX D MODEL ANIMAL HEALTH CERTIFICATES FOR TRADE WITHIN THE UNION ‘ANNEX D1 Model of animal health certificate applicable to trade within the Union in semen of domestic animals of the bovine species collected, processed and stored in accordance with Council Directive 88/407/EEC, as amended by Directive 2003/43/EC, dispatched from a semen collection centre where the semen was collected Text of image Part I: Details of consignment presented EUROPEAN UNION Intra trade certificate I.1. Consignor Name Address Postcode 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 Postcode 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 Semen centre Name Approval number Address Postcode I.13. Place of destination Semen centre Holding Name Approval number Address Postcode 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 (HS code) 05 11 10 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 (Scientific name) Breed Donor identity Date of collection Approval number of the centre Quantity Text of image Part II: Сertification EUROPEAN UNION Bovine semen — D1 II. Health information II.a. Certificate reference No II.b. II.1 Animal Health Attestation 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(1) and Chapter II(1) of Annex A to Directive 88/407/EEC; II.1.2. was collected from bulls, which: II.1.2.1. meet the requirements of Chapters I and II of Annex B to Directive 88/407/EEC, (1) either II.1.2.2. [have not been vaccinated against foot-and-mouth disease within 12 months prior to collection;] (1) or II.1.2.2. [have been vaccinated against foot-and-mouth disease less than 12 months and more than 30 days prior to the collection, and 5 % of doses of semen of each collection, with a minimum of 5 straws, have been submitted to a virus isolation test for foot-and-mouth disease, carried out with negative results in the laboratory (…) (3) situated in or designated by the Member State of destination;] II.1.3. was collected, processed, stored and transported under conditions which comply with the standards laid down in Annex C to Directive 88/407/EEC; II.1.4. was stored in approved conditions for a minimum period of 30 days immediately following collection (4). Notes Part I: Box I.12.: place of origin shall correspond to the semen collection centre (as defined in Article 2(b) first indent of Directive 88/407/EEC) where the semen was collected. Box I.13.: place of destination shall correspond to the semen collection or storage centre (as defined in Article 2(b) of Directive 88/407/EEC), 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. Part II: (1) Delete as appropriate. (2) Only semen collection centres listed in accordance with Article 5(2) of Council Directive 88/407/EEC on the Commission website: http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm (3) Name of the laboratory. (4) May be deleted for fresh semen. — 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 D2 Model of animal health certificate applicable from 1 January 2005 to trade within the Union in stocks of semen collected, processed and stored before 31 December 2004 in conformity with the provisions of Council Directive 88/407/EEC, applying until 1 July 2004 and traded after that date in accordance with Article 2(2) of Directive 2003/43/EC, dispatched from a semen collection centre where the semen was collected Text of image Part I: Details of consignment presented EUROPEAN UNION Intra trade certificate I.1. Consignor Name Address Postcode 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 Postcode 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 Semen centre Name Approval number Address Postcode I.13. Place of destination Semen centre Holding Name Approval number Address Postcode 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 (HS code) 05 11 10 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 (Scientific name) Breed Donor identity Date of collection Approval number of the centre Quantity Text of image Part II: Certification EUROPEAN UNION Bovine semen — D2 II. Health information II.а. Certificate reference No II.b. II.1 Animal Health Attestation I, the undersigned official veterinarian, hereby certify that: II.1.1 The semen described above was collected before the date of 31 December 2004 on a semen collection centre which: (a) was approved under conditions laid down in Chapter I of Annex A to Directive 88/407/EEC; (b) was operated and supervised under conditions laid down in Chapter II of Annex A to Directive 88/407/EEC. II.1.2 At the time the semen described above was collected, all bovine animals at the semen collection centre: (a) came from herds and/or were born to dams which satisfy the conditions of points 1(b) and (c) in Chapter I of Annex B to Directive 88/407/EEC; (b) have, within the 30 days preceding the quarantine isolation period, undergone, with negative results: — the tests referred to in points 1(d)(i), (ii) and (iii) of Chapter I of Annex B to Directive 88/407/EEC, and, — a serum neutralisation test or ELISA test for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, and, — a virus isolation test (fluorescent antibody test or immunoperoxidase test) for bovine viral diarrhoea, which in the case of an animal less than 6 months of age has been deferred until that age was reached, (c) have satisfied the quarantine isolation period of 30 days and have been subjected with the required negative results to the following health tests: — a serological test for brucellosis carried out in accordance with the procedure described in Annex C to Directive 64/432/EEC, — either an immunofluorescent antibody test or a culture test for Campylobacter fetus infection on a sample of preputial material or artificial vagina washings, or, in the case of a female animal, a vaginal mucus agglutination test, — a microscopic examination and culture test for Trichomonas foetus on a sample of preputial material or artificial vagina washings, or in case of a female animal a vaginal mucus agglutination test, (d) have undergone, at least once a year, with negative results, the routine tests referred to in points 1(a), (b) and (c) in Chapter II of Annex B to Directive 88/407/EEC. II.1.3 At the time the semen described above was collected, (a) all female bovine animals in the centre have undergone, at least once a year, a vaginal mucus agglutination test for Campylobacter fetus infection with negative results, and (b) all bulls used for semen production have undergone with negative result either an immunofluorescent antibody test or a culture test for Campylobacter fetus infection on a sample of preputial material or artificial vagina washings carried out within 12 months prior to collection. II.1.4 The semen described above was collected from bulls standing in a semen collection centre in which: (1) either [all bovine animals have not been vaccinated against infectious bovine rhinotracheitis and have undergone at least once a year with negative result a serum neutralisation test or an ELISA test for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis;] (1) or [bovine animals not vaccinated against infectious bovine rhinotracheitis have undergone, at least once a year, with negative result a serum neutralisation test or ELISA test for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, and testing for infectious bovine rhinotracheitis is not carried out on bulls which have received a first vaccination against infectious bovine rhinotracheitis at the insemination centre after they have been tested with negative result in a serum neutralisation test or ELISA test for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis and which since the first vaccination have been regularly re-vaccinated with an interval of not more than 6 months;]. Text of image EUROPEAN UNION Bovine semen — D2 II.1.5. The semen described above was collected from bulls which: II.1.5.1. (1) either [have not been vaccinated against foot-and-mouth disease within 12 months prior to collection;] (1) or [have been vaccinated against foot-and-mouth disease less than 12 months and more than 30 days prior to collection, and 5 % of doses of the semen from each collection, with a minimum of five straws, have been submitted to a virus isolation test for foot-and-mouth disease, carried out with negative results in the laboratory (…) (2), situated in or designated by the Member State of destination;] II.1.5.2. (1) either [have not been vaccinated against infectious bovine rhinotracheitis,] (1) or [have been vaccinated against infectious bovine rhinotracheitis in accordance with point II.1.4,]. II.1.6. The semen described above was stored in approved conditions for a minimum period of 30 days immediately following collection (3). II.1.7. The semen described above was sent to the place of loading in a sealed container and bearing the number detailed in Box I.23. Notes Part I: Box I.12.: place of origin shall correspond to the semen collection centre (as defined in Article 2(b) first indent of Directive 88/407/EEC) where the semen was collected. Box I.13.: place of destination shall correspond to the semen collection or storage centre (as defined in Article 2(b) of Directive 88/407/EEC), 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 and shall be earlier than 31 December 2004. 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. Part II: (1) Delete as appropriate. (2) Name of the laboratory. (3) May be deleted for fresh semen. — 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 D3 Model of animal health certificate applicable to trade within the Union in semen of domestic animals of the bovine species collected, processed and stored in accordance with Council Directive 88/407/EEC, as amended by Directive 2003/43/EC, and in stocks of semen collected, processed and stored before 31 December 2004 in conformity with the provisions of Council Directive 88/407/EEC, applying until 1 July 2004, and traded after that date in accordance with Article 2(2) of Directive 2003/43/EC, dispatched from a semen storage centre Text of image Part I: Details of consignment presented EUROPEAN UNION Intra trade certificate I.1. Consignor Name Address Postcode 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 Postcode I.6. No(s) of related original certificates No(s) of accompanying documents 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 Semen centre Name Approval number Address Postcode I.13. Place of destination Semen centre Holding Name Approval number Address Postcode 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 (HS code) 05 11 10 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 (Scientific name) Breed Donor identity Date of collecion Approval number of the centre Quantity Text of image Part II: Сertification EUROPEAN UNION Bovine semen — D3 II. Health information II.a. Certificate reference No II.b. II.1 Animal Health Attestation I, the undersigned official veterinarian, hereby certify that the semen described above: (1) either [II.1. was collected, processed and stored for a minimum period of 30 days immediately following collection in a semen collection centre (2) situated in the Member State of origin of the semen and operated and supervised in accordance with Chapter I(1) and Chapter II(1) of Annex A to Directive 88/407/EEC, and from where the semen was accepted into the semen storage centre detailed in Box I.12. situated in the same Member State of origin of the semen under animal health and veterinary certification conditions at least as strict as those provided for in: (1) either [Annex D1 to Directive 88/407/EEC (3);]] (1) and/or [Annex D2 to Directive 88/407/EEC (4);]] (1) and/or [Annex D3 to Directive 88/407/EEC (3) (4);]] (1) and/or [until 31 October 2011, Annex D3 to Directive 88/407/EEC (3) (4) (5);]] (1) and/or [II.1. was collected, processed and stored for a minimum period of 30 days immediately following collection in a semen collection centre (2) situated in the European Union and operated and supervised in accordance with Chapter I(1) and Chapter II(1) of Annex A to Directive 88/407/EEC and was accepted into the semen storage centre detailed in Box I.12., in accordance with: (1) either [Annex D1 to Directive 88/407/EEC (3);]] (1) and/or [Annex D2 to Directive 88/407/EEC (4);]] (1) and/or [Annex D3 to Directive 88/407/EEC (3) (4);]] (1) and/or [until 31 October 2011, Annex D3 to Directive 88/407/EEC (3) (4) (5);]] (1) and/or [II.1. was collected, processed and stored for a minimum period of 30 days immediately following collection in a semen collection centre (2) situated in a third country or part(s) thereof listed in Annex I to Commission Decision 2011/630/EU which is operated and supervised in accordance with Chapter I(1) and Chapter II(1) of Annex A to Directive 88/407/EEC, and was imported into the European Union under the conditions of Articles 8 to 12 of Directive 88/407/EEC in accordance with: (1) either [Section A of Part 2 of Annex II to Decision 2011/630/EU (3);]] (1) and/or [until 31 October 2011, Part 1 of Annex II to Decision 2004/639/EC (3);]] (1) and/or [Section B of Part 2 of Annex II to Decision 2011/630/EU (4);]] (1) and/or [until 31 October 2011, Part 2 of Annex II to Decision 2004/639/EC (4);]] (1) and/or [Section C of Part 2 of Annex II to Decision 2011/630/EU (3) (4);]] (1) and/or [until 31 October 2011, Part 3 of Annex II to Decision 2004/639/EC (3) (4);]] II.2. was stored in the semen storage centre (2) indicated in Box I.12. which is operated and supervised in accordance with Chapter I(2) and Chapter II(2) of Annex A to Directive 88/407/EEC. Notes Part I: Box I.6.: Number(s) of related original certificates shall correspond to the serial number(s) of the individual official national document(s), INTRA health certificate(s) or CVED(s) that accompanied the semen described above from the semen collection centre of its origin to the described above semen storage centre. Box I.12: place of origin shall correspond to the semen storage centre (as defined in Article 2(b) of Directive 88/407/EEC) of dispatch of the semen. Box I.13: place of destination shall correspond to the semen collection or storage centre (as defined in Article 2(b) of Directive 88/407/EEC), 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 collection centre of the semen origin. Text of image EUROPEAN UNION Bovine semen — D3 Part II: (1) Delete as appropriate (2) Only semen collection or storage centres listed in accordance with Article 5(2) or Article 9(1) 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 (3) For semen collected, processed and stored in accordance with provisions of Directive 88/407/EEC, as amended by Directive 2003/43/EC. (4) For semen collected, processed and stored before 31 December 2004 in conformity with the provisions of Directive 88/407/EEC applying until 1 July 2004. (5) Annex D3 to Directive 88/407/EEC as introduced by Commission Decision 2008/120/EC. — 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: ’ * * *