http://www.legislation.gov.uk/id/eudn/2006/168

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 species1, 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 species2.

(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 Community3, 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/EEC4, 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 embryos5.

(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:

F1 Article 1General conditions for imports of embryos

F21.

The appropriate authority may authorise imports of embryos of domestic animals of the bovine species if the embryos—

(a)

were collected or produced in a third country listed in Annex 1 to this Decision, or part thereof, as the appropriate authority may specify in a document published for the purposes of this Article;

(b)

are accompanied by the model certificate referred to in Articles 2 and 3; and

(c)

were collected or produced by embryo collection or production teams which meet the conditions—

(i)

described in subparagraphs (a) to (c) of Article 8(1) of Directive 89/556/EEC, as it had effect immediately before IP completion day and as read in accordance with paragraph 3; and

(ii)

imposed by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), relating to the protection of public health or animal health in Great Britain on the import of a consignment of embryos, in a document published for the purposes of this Article.

F32.

In this Decision:

“appropriate authority” means the Secretary of State (in relation to England), the Welsh Ministers (in relation to Wales) and the Scottish Ministers (in relation to Scotland); but the “appropriate authority” is the Secretary of State if consent is given by:

(a)

in relation to Wales, the Welsh Ministers;

(b)

in relation to Scotland, the Scottish Ministers;

“third country” means any country or territory other than the British Islands.

3.

For the purposes of this Article, subparagraph (b) of Article 8(1) of, and Chapter II of Annex A to, Directive 89/556/EEC are to be read as if—

(a)

in Article 8(1)(b), for “the Community” there were substituted “ Great Britain ”;

(b)

in Annex A, in Chapter II—

(i)

in paragraph 1(a), for “this Directive” there were substituted “ national legislation ”;

(ii)

in paragraph 1(h), the final sentence were omitted;

(iii)

paragraph 1(m) were omitted;

(iv)

in paragraph 1(n), the second and final sentences were omitted;

(v)

in paragraph 2, in the final subparagraph, for “Directive 88/407/EEC” there were substituted “national legislation relating to the storage of bovine semen.

Article 2Imports of in vivo derived embryos

F4The appropriate authority shall authorise imports of embryos derived by in vivo fertilisation and complying with the animal health requirements set out in the model veterinary certificate F5, in the form published by the appropriate authority from time to time.

F6Article 3Imports of in vitro produced embryos

1.

The appropriate authority shall authorise imports of embryos which are produced by in vitro fertilisation using semen from a third country listed in Annex 1 of Commission Implementing Decision 2011/630/EU and in respect of which the model veterinary certificate, in the form published by the appropriate authority from time to time, has been completed to the satisfaction of the appropriate authority.

2.

The appropriate authority must 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 which comply with the animal health requirements set out in a model veterinary certificate, in the form published by the appropriate authority from time to time, on condition that such embryos are implanted exclusively into female bovine animals present in the country of destination indicated in that certificate.

F7Article 4Transitional measures

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Article 5Repeal

Decision 2005/217/EC is repealed.

Article 6Applicability

This Decision shall apply from 1 January 2006.

F8Article 7Addressees

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F9ANNEX I

ISO code	Third country	Applicable veterinary certificate
AR	Argentina	F11...	F11...	F11...
AU	Australia	F11...	F11...	F11...
CA	Canada	F11...	F11...	F11...
CH	Switzerland	F11...	F11...	F11...
F12EU member States, Liechtenstein and Norway
F13...
IL	Israel	F11...	F11...	F11...
MK	the former Yugoslav Republic of Macedonia	F11...	F11...	F11...
NZ	New Zealand	F11...	F11...	F11...
US	United States	F11...	F11...	F11...
F10. . .

F14ANNEX II

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F15ANNEX III

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16ANNEX IV

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F17ANNEX V

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .