EN Official Journal of the European Union L 228/74

COMMISSION DECISION

of 26 August 2010

on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union

(notified under document C(2010) 5780)

(Text with EEA relevance)

(2010/472/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 (1), and in particular Article 17(2)(b), Article 17(3), the first indent of Article 18(1), and the introductory phrase and point (b) of Article 19 thereof,

Whereas:

(1) Directive 92/65/EEC lays down the animal health conditions governing imports into the Union of semen, ova and embryos of animals of the ovine and caprine species (‘the commodities’). It provides only commodities that come from a third country included on a list of third countries drawn up in accordance with that Directive and accompanied by a health certificate corresponding to a model also drawn up in accordance with that Directive, may be imported into the Union. The health certificate must certify that commodities come from approved collection and storage centres or collection and production teams offering guarantees at least equivalent to those laid down in Annex D(I) to that Directive.

(2) Commission Decision 2008/635/EC of 22 July 2008 on imports of semen, ova and embryos of the ovine and caprine species into the Community as regards lists of third countries and of semen collection centres and embryo collection teams, and certification requirements (2) currently sets out the list of third countries from which Member States are to authorise imports of the commodities.

(3) Directive 92/65/EEC, as amended by Council Directive 2008/73/EC (3), introduced a simplified procedure for the listing of semen collection and storage centres and embryo collection and production teams in third countries approved for imports of the commodities into the Union.

(4) In addition, Annex D to Directive 92/65/EEC, as amended by Commission Regulation (EU) No 176/2010 (4), sets out certain new requirements for the commodities which are to apply from 1 September 2010. It introduces rules concerning semen storage centres and detailed conditions for their approval and supervision. It also sets out detailed conditions for the approval and supervision of embryo collection and production teams, for the collection and processing of in vivo derived embryos and the production and processing of in vitro fertilised embryos and micromanipulated embryos. It also amended the conditions to be applied to the donor animals of semen, ova and embryos of animals of the ovine and caprine species.

(5) Accordingly, it is necessary to establish new health certificates for imports into the Union of the commodities taking into account the amendments made to Directive 92/65/EEC by Directive 2008/73/EC and Regulation (EU) No 176/2010.

(6) In addition, it is appropriate that consignments of the commodities imported into the Union from Switzerland are accompanied by a health certificate drawn up in accordance with the models used for trade within the Union in semen, ova and embryos of animals of the ovine and caprine species set out in Commission Decision 2010/470/EU of 26 August 2010 laying down model health certificates for trade within the Union of semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species (5), with the adaptations set out in point 7 of Chapter IX(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 (6).

(7) In the application of this Decision, account should be taken of the specific certification requirements and model health attestations which may be 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 (7), as approved by Council Decision 1999/201/EC (8).

(8) In the application of this Decision, account should also be taken of the specific certification requirements and model health attestations which may be laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products (9), as approved by Council Decision 97/132/EC (10).

(9) In the interest of clarity and consistency of Union's legislation, Decision 2008/635/EC should be repealed and replaced by this Decision.

(10) To avoid any disruption of trade, the use of health certificates issued in accordance with Decision 2008/635/EC should be authorised during a transitional period subject to certain consitions.

(11) 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

Subject matter

This Decision sets out a list of third countries or parts thereof from which Members States are to authorise the importation into the Union of consignments of semen, ova and embryos of animals of the ovine and caprine species.

It also lays down certification requirements for the importation of those commodities into the Union.

Article 2

Imports of semen

Member States shall authorise imports of consignments of semen of animals of the ovine and caprine species provided that they comply with the following conditions:

(a) they come from a third country or part thereof listed in Annex I;

(b) they come from an approved semen collection or storage centre listed in accordance with Article 17(3)(b) of Directive 92/65/EEC;

(c) they are accompanied by a health certificate drawn up in accordance with the following model health certificates set out in Part 2 of Annex II, and completed in accordance with the explanatory notes set out in Part 1 of that Annex: (i) model 1 as set out in Section A, for consignments of semen dispatched from an approved semen collection centre of origin of the semen; (ii) model 2 as set out in Section B, for consignments of semen dispatched from an approved semen storage centre. However, where specific certification requirements are laid down in bilateral agreements between the Union and third countries, those requirements shall apply.

(d) they comply with the requirements set out in the health certificates referred to in point (c).

Article 3

Imports of ova and embryos

Member States shall authorise imports of consignments of ova and embryos of animals of the ovine and caprine species provided that they comply with the following conditions:

(a) they come from a third country or part thereof listed in Annex III;

(b) they come from an approved embryo collection or production team listed in accordance with Article 17(3)(b) of Directive 92/65/EEC;

(c) they are accompanied by a health certificate drawn up in accordance with the model set out in Part 2 of Annex IV, and completed in accordance with the explanatory notes set out in Part 1 of that Annex. However, where specific certification requirements are laid down in bilateral agreements between the Union and third countries, those requirements must apply.

(d) they comply with the requirements set out in the health certificate referred to in point (c).

Article 4

General conditions concerning the transport of consignments of semen, ova and embryos to the Union

1. Consignments of semen, ova and embryos of animals of the ovine and caprine species shall not be transported in the same container as other consignments of semen, ova and embryos that:

(a) are not intended for introduction into the Union, or

(b) are of a lower health status.

2. During transport to the European Union, consignments of semen, ova and embryos shall be placed in closed and sealed containers and the seal must not be broken during the transport.

Article 5

Repeal

Decision 2008/635/EC is repealed.

Article 6

Transitional provisions

For a transitional period until 31 August 2011, Member States shall authorise imports from third countries of stocks of the following commodities:

(a) semen of animals of the ovine and caprine species which were collected, processed and stored in accordance with Directive 92/65/EEC by 31 August 2010 and which are accompanied by a health certificate issued not later than 31 May 2011 in accordance with the model set out in Annex II to Decision 2008/635/EC.

(b) ova and embryos of animals of the ovine and caprine species which were collected or produced, processed and stored in accordance with Directive 92/65/EEC by 31 August 2010 and which are accompanied by a health certificate issued not later than 31 May 2011 in accordance with the model set out in Annex VI to Decision 2008/635/EC.

Article 7

Applicability

This Decision shall apply from 1 September 2010.

Article 8

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 26 August 2010. For the Commission John DALLI Member of the Commission

(1) OJ L 268, 14.9.1992, p. 54.

(2) OJ L 206, 2.8.2008, p. 17.

(3) OJ L 219, 14.8.2008, p. 40.

(4) OJ L 52, 3.3.2010, p. 14.

(5) See page 15 of this Official Journal.

(6) OJ L 114, 30.4.2002, p. 1.

(7) OJ L 71, 18.3.1999, p. 3.

(8) OJ L 71, 18.3.1999, p. 1.

(9) OJ L 57, 26.2.1997, p. 5.

(10) OJ L 57, 26.2.1997, p. 4.

ANNEX I List of third countries or parts thereof from which Member States are to authorise imports of consignments of semen of animals of the ovine and caprine species ISO Code Name of the third country Remarks Description of the territory (if appropriate) Additional guarantees AU Australia The additional guarantees as regards testing set out in points II.4.9 and II.4.10 of the health certificate set out in Section A of Part 2 of Annex II are compulsory. CA Canada Territory as described in Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (1). The additional guarantee as regards testing set out in point II.4.9 of the health certificate set out in Section A of Part 2 of Annex II is compulsory. CH Switzerland (2) CL Chile GL Greenland HR Croatia IS Iceland NZ New Zealand PM Saint Pierre and Miquelon US United States The additional guarantee as regards testing set out in point II.4.9 of the health certificate set out in Section A of Part 2 of Annex II is compulsory. (1) OJ L 73, 20.3.2010, p. 1. (2) Certificates in accordance with 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 Agreement on Scientific and Technological Cooperation of 4 April 2002 on the conclusion of seven Agreements with the Swiss Federation (OJ L 114, 30.4.2002, p. 132).

ANNEX II PART 1 Explanatory notes for the certification (a) The health certificates shall be issued by the competent authority of the exporting third country, in accordance with the model set out in Part 2 of Annex II. If the Member State of destination requires additional certification requirements, attestations to certify that those requirements are fulfilled shall be also incorporated in the original form of the health certificate. (b) The original of the health certificate shall consist of a single sheet of paper, or, where more text is required, it must be in such a form that all sheets of paper required are part of an integrated whole and indivisible. (c) Where the model health certificate states that certain statements shall be kept as appropriate, statements which are not relevant, may be crossed out and initialled and stamped by the certifying officer, or completely deleted from certificate. (d) The health certificate shall be drawn up in at least one of the official languages of the Member State of the border inspection post of introduction of the consignment into the European Union and of the Member State of destination. However, those Member States may authorise the certificate to be drawn up in the official language of another Member State, and accompanied, if necessary, by an official translation. (e) If for the reasons of identification of the items of the consignment (schedule in Box I.28 of the model health certificate), additional sheets of paper are attached to the health certificate, those sheets of paper shall also be considered as forming part of the original of the health certificate by application of the signature and stamp of the certifying officer, on each of the pages. (f) When the health certificate, including additional schedules referred to in (e), comprises more than one page, each page shall be numbered (page number) of (total number of pages), at the end of the page and shall bear the certificate reference number that has been designated by the competent authority on the top of the pages. (g) The original of the health certificate must be completed and signed by an official veterinarian the last working day prior to loading of the consignment for exportation to the European Union. The competent authorities of the exporting third country shall ensure that certification requirements equivalent to those laid down in Council Directive 96/93/EC (1) are followed. The colour of the signature and the stamp of the official veterinarian shall be different to that of the printing on the health certificate. This requirement also applies to stamps other than those embossed or watermarks. (h) The original of the health certificate must accompany the consignment until it reaches the border inspection post of introduction into the European Union. (i) The certificate reference number referred to in Box I.2 and Box II.a of the model health certificate must be issued by the competent authority of the exporting third country. PART 2 Model health certificates for imports of consignments of semen of animal of the ovine and caprine species Section A MODEL 1 — Health certificate for semen dispatched from an approved semen collection centre of origin of the semen Section B MODEL 2 — Health certificate for semen dispatched from an approved semen storage centre (1) OJ L 13, 16.1.1997, p. 28.

ANNEX III List of third countries or parts thereof from which Member States are to authorise imports of consignments of ova and embryos of animals of the ovine and caprine species ISO Code Name of the third country Remarks Description of the territory (if appropriate) Additional guarantees AU Australia The additional guarantees as regards testing set out in points II.2.6 and II.2.7 of the health certificate set out in Part 2 of Annex IV are compulsory. CA Canada Territory as described in Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (1) as last amended. The additional guarantee as regards testing set out in point II.2.7 of the health certificate set out in Part 2 of Annex IV is compulsory. CH Switzerland (2) CL Chile GL Greenland HR Croatia IS Iceland NZ New Zealand PM Saint Pierre and Miquelon US United States The additional guarantee as regards testing set out in point II.2.7 of the health certificate set out in Part 2 of Annex IV is compulsory. (1) OJ L 73, 20.3.2010, p. 1. (2) Certificates in accordance with 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 Agreement on Scientific and Technological Cooperation of 4 April 2002 on the conclusion of seven Agreements with the Swiss Federation (OJ L 114, 30.4.2002, p. 132).