Commission Decision

of 4 January 2006

establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC

(notified under document number C(2005) 5796)

(Text with EEA relevance)

(2006/168/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species [1], and in particular Article 7(1) and Article 9(1)(b) thereof,

Whereas:

(1) Directive 89/556/EEC sets out the animal health conditions governing intra-Community trade in and importation from third countries of fresh and frozen embryos of domestic animals of the bovine species.

(2) That Directive provides, inter alia, that bovine embryos are not to be sent from one Member State to another unless they have been conceived by artificial insemination or in vitro fertilisation using semen from a donor sire standing at a semen collection centre approved by the competent authority for the collection, processing and storage of semen or semen imported in accordance with 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 [2].

(3) Commission Decision 92/452/EEC of 30 July 1992 establishing lists of embryo collection teams and embryo production teams approved in third countries for export of bovine embryos to the Community [3], provides that Member States are to import such embryos from third countries only if they have been collected, processed, including in vitro fertilisation, and stored by embryo collection teams included in the lists in that Decision.

(4) Following trade problems relating to new, stricter requirements for bovine semen used for fertilisation introduced by Commission Decision 92/471/EEC [4], the Commission adopted Decision 2005/217/EC of 9 March 2005 establishing the animal health conditions and the veterinary certification requirements for imports into the Community of bovine embryos [5].

(5) Decision 2005/217/EC allows for a transitional period expiring on 31 December 2006 for imports of bovine embryos collected or produced before 1 January 2006 and conceived using semen not fully complying with Directive 88/407/EEC on condition that such embryos are implanted into female bovine animals present in the Member State of destination and are excluded from intra-Community trade.

(6) The International Embryo Transfer Society (IETS) has assessed as negligible the risk of transmission of certain contagious diseases via embryos to recipients or offspring, provided that the embryos are handled properly between their collection and their transfer. That position is also that of the World Organisation for Animal Health (OIE) as far as in vivo derived embryos are concerned. Nevertheless, in the interests of animal health, appropriate safeguards should be taken upstream with regard to semen used for fertilisation, in particular with respect to in vitro generated embryos.

(7) Community requirements for imports of bovine embryos derived by natural (in vivo) fertilisation and produced by in vitro fertilisation, in particular as regards semen used for fertilisation, should therefore be adapted.

(8) In the light of the risk assessment carried out by the IETS and in line with the recommendations of the OIE, the conditions governing imports of in vivo derived bovine embryos should be simplified while stricter animal health requirements should be maintained for imports of in vitro produced embryos, with special restrictions where the zona pellucida has been damaged during the process.

(9) In the interests of clarity of Community legislation, Decision 2005/217/EC should be repealed and replaced by this Decision.

(10) However, in order to enable economic operators to adapt to the new requirements set out in this Decision it is appropriate to provide for a transitional period whereby imports of embryos of domestic animals of the bovine species collected or produced before 1 January 2006 may, subject to certain conditions, be imported into the Community according to the requirements set out in Annex V to this Decision.

(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

General conditions for imports of embryos

Member States shall authorise imports of embryos of domestic animals of the bovine species (embryos) collected or produced in a third country listed in Annex I to this Decision by approved embryo collection or production teams listed in the Annex to Decision 92/452/EEC.

Article 2

Imports of in vivo derived embryos

Member States shall authorise imports of embryos derived by in vivo fertilisation and complying with the animal health requirements set out in the model veterinary certificate in Annex II.

Article 3

Imports of in vitro produced embryos

1. Member States shall authorise imports of embryos which are produced by in vitro fertilisation using semen complying with Directive 88/407/EEC and which meet the animal health requirements set out in the model veterinary certificate in Annex III to this Decision.

2. Member States shall authorise imports of embryos which are produced by in vitro fertilisation using semen produced in approved semen collection centres or stored in semen storage centres in third countries listed in Annex I to Commission Decision 2004/639/EC [6] and which comply with the animal health requirements set out in the model veterinary certificate in Annex IV to this Decision on condition that such embryos are:

(a) excluded from intra-Community trade; and

(b) implanted exclusively into female bovine animals present in the Member State of destination indicated in the veterinary certificate.

Article 4

Transitional measures

By way of derogation from Articles 2 and 3, Member States shall authorise, until 31 December 2006, the importation of embryos from the third countries listed in Annex I provided that such embryos comply with:

(a) the animal health requirements set out in the model veterinary certificate in Annex V; and

(b) the following conditions:

(i) they must be collected or produced before 1 January 2006;

(ii) they must only be used for implantation into female bovine animals present in the Member State of destination indicated in the veterinary certificate;

(iii) they must be excluded from intra-Community trade;

(iv) they must be accompanied by such a certificate duly completed before 1 January 2007.

Article 5

Repeal

Decision 2005/217/EC is repealed.

Article 6

Applicability

This Decision shall apply from 1 January 2006.

Article 7

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 4 January 2006.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 302, 19.10.1989, p. 1. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

[2] OJ L 194, 22.7.1988, p. 10. Directive as last amended by Commission Decision 2004/101/EC (OJ L 30, 4.2.2004, p. 15).

[3] OJ L 250, 29.8.1992, p. 40. Decision as last amended by Decision 2005/774/EC (OJ L 291, 5.11.2005, p. 46).

[4] OJ L 270, 15.9.1992, p. 27. Decision as last amended by Decision 2004/786/EC (OJ L 346, 23.11.2004, p. 32).

[5] OJ L 69, 16.3.2005, p. 41.

[6] OJ L 292, 15.9.2004, p. 21.

--------------------------------------------------

ANNEX I

ISO code | Country | Applicable Veterinary Certificate | Remarks |

AR | Argentina | ANNEX II | ANNEX III | ANNEX IV | |

AU | Australia | ANNEX II | ANNEX III | ANNEX IV | The additional guarantees set out in point 11.5.2 of the certificate in Annex II and in points 11.6.2 of the certificates in Annexes III and IV are compulsory. |

CA | Canada | ANNEX II | ANNEX III | ANNEX IV | |

CH | Switzerland [1] | ANNEX II | ANNEX III | ANNEX IV | |

HR | Croatia | ANNEX II | ANNEX III | ANNEX IV | |

IL | Israel | ANNEX II | ANNEX III | ANNEX IV | |

MK | Former Yugoslav Republic of Macedonia [2] | ANNEX II | ANNEX III | ANNEX IV | |

NZ | New Zealand | ANNEX II | ANNEX III | ANNEX IV | |

RO | Romania | ANNEX II | ANNEX III | ANNEX IV | |

US | United States of America | ANNEX II | ANNEX III | ANNEX IV | |

[1] Without prejudice to specific certification requirements provided for by any relevant Community agreement with third countries.

[2] Provisional code that does not affect the definitive denomination of the country to be attributed after the conclusion of the negotiations currently taking place in the United Nations.

--------------------------------------------------

ANNEX II

In vivo derived embryos of domestic animals of the bovine species for import, collected in accordance with Council Directive 89/556/EEC

+++++ TIFF +++++

+++++ TIFF +++++

+++++ TIFF +++++

--------------------------------------------------

ANNEX III

In vitro produced embryos of domestic animals of the bovine species for import, conceived using semen complying with Council Directive 88/407/EEC

+++++ TIFF +++++

+++++ TIFF +++++

+++++ TIFF +++++

--------------------------------------------------

ANNEX IV

In vitro produced embryos of domestic animals of the bovine species conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting country

+++++ TIFF +++++

+++++ TIFF +++++

+++++ TIFF +++++

--------------------------------------------------

ANNEX V

VETERINARY CERTIFICATE EMBRYOS OF DOMESTIC ANIMALS OF THE BOVINE SPECIES FOR IMPORTS COLLECTED OR PRODUCED BEFORE 1 JANUARY 2006

+++++ TIFF +++++

+++++ TIFF +++++

+++++ TIFF +++++

--------------------------------------------------