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)

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:

[F1 Article 1 U.K. General conditions for imports of embryos

[F2 1. 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.]

[F3 2. 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.]]

Textual Amendments

F1 Substituted by Commission Decision of 30 November 2009 amending Decision 2006/168/EC as regards the listing of embryo collection and production teams approved for imports of bovine embryos into the Community (notified under document C(2009) 9320) (Text with EEA relevance) (2009/873/EC).

F2 Art. 1(1) substituted (10.2.2025) by The Official Controls (Amendment) Regulations 2025 (S.I. 2025/102), regs. 1(1)(b), 32(2)

F3 Art. 1(2)(3) inserted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(2)(c) (with regs. 69-71)

Article 2 U.K. Imports of in vivo derived embryos

[F4 The 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].

Textual Amendments

F4 Words in Art. 2 substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(3)(a) (with regs. 69-71)

F5 Words in Art. 2 substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(3)(b) (with regs. 69-71)

[F6 Article 3 U.K. Imports 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.]

Textual Amendments

F6 Art. 3 substituted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(4) (with regs. 69-71)

F7 Article 4 U.K. Transitional measures

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

Textual Amendments

F7 Art. 4 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(5) (with regs. 69-71)

Article 5 U.K. Repeal

Decision 2005/217/EC is repealed.

Article 6 U.K. Applicability

This Decision shall apply from 1 January 2006.

F8 Article 7 U.K. Addressees

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

Textual Amendments

F8 Art. 7 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(5) (with regs. 69-71)

[F9 ANNEX I U.K.

Textual Amendments

F9 Substituted by Commission Implementing Decision of 17 July 2012 amending Annexes I to IV to Decision 2006/168/EC as regards certain veterinary certification requirements for imports into the Union of bovine embryos (notified under document C(2012) 4816) (Text with EEA relevance) (2012/414/EU).

Modifications etc. (not altering text)

C1 Annex 1: power to amend conferred (31.12.2020) by The Trade in Animals and Animal Products (Legislative Functions) and Veterinary Surgeons (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1225), regs. 1(3), 4; 2020 c. 1, Sch. 5 para. 1(1)

F10 . . .]
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 ...
[F12 EU 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 ...

Textual Amendments

F10 Annex 1 table notes omitted (10.2.2025) by virtue of The Official Controls (Amendment) Regulations 2025 (S.I. 2025/102), regs. 1(1)(b), 32(3)

F11 Words in Annex 1 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(6)(a)(i) (with regs. 69-71)

F12 Words in Annex 1 inserted (31.12.2020) by The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(6)(a)(ii) (with regs. 69-71)

F13 Deleted by Commission Regulation (EU) No 519/2013 of 21 February 2013 adapting certain regulations and decisions in the fields of free movement of goods, freedom of movement for persons, right of establishment and freedom to provide services, company law, competition policy, agriculture, food safety, veterinary and phytosanitary policy, fisheries, transport policy, energy, taxation, statistics, social policy and employment, environment, customs union, external relations, and foreign, security and defence policy, by reason of the accession of Croatia.

F14 ANNEX II U.K.

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

Textual Amendments

F14 Annex 2 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(7) (with regs. 69-71)

F15 ANNEX III U.K.

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

Textual Amendments

F15 Annex 3 omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(7) (with regs. 69-71)

F16 ANNEX IV U.K.

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

Textual Amendments

F16 Annex IV omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(7) (with regs. 69-71)

F17 ANNEX V U.K.

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

Textual Amendments

F17 Annex V omitted (31.12.2020) by virtue of The Import of, and Trade in, Animals and Animal Products (Miscellaneous Amendments) (EU Exit) Regulations 2020 (S.I. 2020/1462), regs. 1(3), 46(7) (with regs. 69-71)

(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.