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:

[F1 Article 1 U.K.Subject matter and definitions

1. This Decision sets out a list of third countries [F2 and makes provision for the specification by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), of those third countries] or parts thereof from which the importation of consignments of semen, ova and embryos of animals of the ovine and caprine species into Great Britain is authorised.

It lays down certification requirements for the importation of those commodities into Great Britain.

2. In this Decision:

• [F3 — “additional guarantee” means the guarantee given under paragraph 2 of Article 1a;]

• — “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.]

Textual Amendments

F1 Art. 1 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), 57(2) (with regs. 69-71)

F2 Words in Art. 1(1) inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(2)(a)

F3 Words in Art. 1(2) inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(2)(b)

[F4 Article 1a U.K.Additional guarantees

1. The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose conditions relating to the protection of public health or animal health in Great Britain on the import of a consignment of semen, ova or embryos of the ovine or caprine species into Great Britain from a third country listed in Annex 1.

2. The person exporting the consignment from the third country to Great Britain, or another person acting on their behalf, must provide evidence that any condition imposed under paragraph 1 in relation to the consignment is satisfied by giving an additional guarantee in accordance with the health certificate for the consignment concerned.

3. The Secretary of State must publish any conditions imposed under paragraph 1 in a document published for the purposes of this Article.]

Textual Amendments

F4 Art. 1a inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(3)

[F5 Article 2 U.K.Imports of semen

The appropriate authority must 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 [F6 such third country] listed in Annex I [F7 , or part thereof, as the Secretary of State may, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), specify in a document published for the purposes of this Article];

(b) they come from an approved semen collection or storage centre which meets conditions and standards that are at least equivalent to those described in Article 11(2) and (3) of Directive 92/65/EEC;

(c) they are accompanied by the relevant health certificate, in the form published by the appropriate authority from time to time—

(i)

for consignments of semen dispatched from an approved semen collection centre of origin of the semen; or

(ii)

for consignments of semen dispatched from an approved semen storage centre; F8 ...

[F9 (ca) they comply with any additional guarantees that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 1a; and]

(d) they comply with the requirements set out in the relevant health certificate.]

Textual Amendments

F5 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), 57(3) (with regs. 69-71)

F6 Words in Art. 2(a) substituted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(4)(a)(i)

F7 Words in Art. 2(a) inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(4)(a)(ii)

F8 Word in Art. 2(c) omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(4)(b)

F9 Art. 2(ca) inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(4)(c)

[F10 Article 3 U.K.Imports of ova and embryos

The appropriate authority must 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 [F11 such third country] listed in Annex III [F12 , or part thereof, as the Secretary of State may, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), specify in a document published for the purposes of this Article];

(b) they come from an approved embryo collection or production team which meets conditions and standards that are at least equivalent to those described in Article 11(2) and (3) of Directive 92/65/EEC;

(c) they are accompanied by the relevant health certificate, in the form published by the appropriate authority from time to time;

[F13 (ca) they comply with any additional guarantees that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 1a;]

(d) they comply with the requirements set out in the relevant health certificate.

However, where specific certification requirements are laid down in bilateral agreements between the United Kingdom and a third country, those requirements are to apply.]

Textual Amendments

F10 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), 57(4) (with regs. 69-71)

F11 Words in Art. 3(a) substituted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(5)(a)(i)

F12 Words in Art. 3(a) inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(5)(a)(ii)

F13 Art. 3(ca) inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(5)(b)

Article 4 U.K.General conditions concerning the transport of consignments of semen, ova and embryos to [F14 Great Britain]

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 [F15 Great Britain], or

(b) are of a lower health status.

2. During transport to [F16 Great Britain], consignments of semen, ova and embryos shall be placed in closed and sealed containers and the seal must not be broken during the transport.

Textual Amendments

F14 Words in Art. 4 heading 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), 57(5)(a) (with regs. 69-71)

F15 Words in Art. 4(1)(a) 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), 57(5)(b) (with regs. 69-71)

F16 Words in Art. 4(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), 57(5)(c) (with regs. 69-71)

[F17 Article 4a U.K. Matters relating to the exercise of powers under this Decision

1. The powers exercisable by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), under the provisions listed in paragraph 2 may be exercised only where it is necessary or appropriate to do so in the light of an assessment of the risk to animal and human health in the United Kingdom, taking into account—

(a) whether there are any diseases referred to in Annex A of Council Directive 92/65/EEC, or other exotic animal diseases present in the third country, which might endanger animal health in the United Kingdom;

(b) whether the third country is capable of guaranteeing the implementation of its legislation, and whether the organisation of its veterinary and inspection services enables the country effectively to undertake or supervise such services;

(c) whether the veterinary services of the third country are able to provide assurance that health requirements at least equivalent to those laid down in Chapter 2 of Council Directive 92/65/EEC are being complied with;

(d) any on-the-spot inspections by experts from the United Kingdom undertaken to verify whether the assurances given by the third country regarding the conditions of production and placing on the market can be considered equivalent to those applied in the United Kingdom.

2. The provisions are—

(a) Article 1a (additional guarantees);

(b) Article 2(a) (specification of third country or part thereof from which semen of the ovine and caprine species may be imported into Great Britain);

(c) Article 3(a) (specification of third country or part thereof from which ova and embryos of the ovine and caprine species may be imported into Great Britain).

3. Any assessment which is relied upon for the purposes of paragraph 1 must have been approved by the Secretary of State, the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales).

4. Where the Scottish Ministers or the Welsh Ministers request that the Secretary of State exercise a power under a provision listed in paragraph 1 the Secretary of State must have regard to that request.]

Textual Amendments

F17 Art. 4a inserted (1.7.2022) by The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(6)

Article 5 U.K.Repeal

Decision 2008/635/EC is repealed.

F18 Article 6 U.K.Transitional provisions

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

Textual Amendments

F18 Art. 6 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), 57(6) (with regs. 69-71)

Article 7 U.K.Applicability

This Decision shall apply from 1 September 2010.

F19 Article 8 U.K.Addressees

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

Textual Amendments

F19 Art. 8 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), 57(6) (with regs. 69-71)

[F20 ANNEX I U.K.

Textual Amendments

F20 Substituted by Commission Implementing Decision of 17 July 2012 amending Decision 2010/472/EU as regards animal health requirements relating to Simbu viruses and epizootic haemorrhagic disease (notified under document C(2012) 4831) (Text with EEA relevance) (2012/411/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), 10; 2020 c. 1, Sch. 5 para. 1(1)

List of third countries F21 ... from which [F22 the appropriate authority is] to authorise imports of consignments of semen of animals of the ovine and caprine species

F23 . . .
F24 . . .]
ISO Code	Name of the third country	F25 ...
AU	Australia
CA	Canada
CH	Switzerland F23 ...
CL	Chile
GL	Greenland
	[F26 EU member States, Liechtenstein and Norway F24 ...]
F27 ...
IS	Iceland
NZ	New Zealand
PM	Saint Pierre and Miquelon
US	United States

Textual Amendments

F21 Words in Annex 1 heading omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(7)(a)

F22 Words in Annex 1 Table heading 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), 57(7)(a) (with regs. 69-71)

F23 Annex I footnote omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(7)(c)(i)

F24 Annex I footnote omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(7)(c)(ii)

F25 Words in Annex I table omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(7)(b)

F26 Words in Annex 1 Table 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), 57(7)(b)(ii) (with regs. 69-71)

F27 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.

F28 ANNEX II U.K.

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

Textual Amendments

F28 Annex II 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), 57(8) (with regs. 69-71)

[F20 ANNEX III U.K.

Modifications etc. (not altering text)

C2 Annex 3: 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), 10; 2020 c. 1, Sch. 5 para. 1(1)

List of third countries F29 ... from which [F30 the appropriate authority is] to authorise imports of consignments of ova and embryos of animals of the ovine and caprine species

F31 . . .
F32 . . .]
ISO Code	Name of the third country	F33 ...
AU	Australia
CA	Canada
CH	Switzerland F31 ...
CL	Chile
	[F34 EU member States, Liechtenstein and Norway F32 ...]
GL	Greenland
F27 ...
IS	Iceland
NZ	New Zealand
PM	Saint Pierre and Miquelon
US	United States.

Textual Amendments

F29 Words in Annex 3 heading omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(8)(a)

F30 Words in Annex 3 heading 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), 57(9)(a) (with regs. 69-71)

F31 Annex 3 footnote omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(8)(c)(i)

F32 Annex 3 footnote omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(8)(c)(ii)

F33 Words in Annex 3 Table omitted (1.7.2022) by virtue of The Import of Animals and Animal Products and Approved Countries (Amendment) Regulations 2022 (S.I. 2022/735), regs. 1(2), 11(8)(b)

F34 Words in Annex 3 Table 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), 57(9)(b)(ii) (with regs. 69-71)

F35 ANNEX IV U.K.

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

Textual Amendments

F35 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), 57(10) (with regs. 69-71)

(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.