Commission Regulation (EU) No 206/2010Show full title

[X1 Commission Regulation (EU) No 206/2010

of 12 March 2010

laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements

(Text with EEA relevance)]

[X1 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 Articles 17(2)(b) and 17(3)(a), the first subparagraph of Article 17(3)(c), the fourth indent of Article 18(1) and Article 19 thereof,

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (2) , and in particular Article 8, Article 9(2)(b) and Article 9(4) thereof,

Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC (3) , and in particular the first and second subparagraphs of Article 3(1), the first subparagraph of Article 6(1), Article 7(e), Article 8, the first paragraph of Article 10 and Article 13(1) thereof,

Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (4) , and in particular Article 12 thereof,

Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (5) , and in particular Article 9 thereof,

Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (6) , and in particular Article 11(1) and Article 16 thereof,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (7) , and in particular Article 48(1) thereof,

Whereas:

(1) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries (8) provided for a list to be drawn up of the countries or parts thereof from which Member States are to authorise the importation of certain live animals and fresh meat of certain animals.

(2) Accordingly, Council Decision 79/542/EEC of 21 December 1976 drawing up a list of third countries or parts of third countries, and laying down animal and public health and veterinary certification conditions, for importation into the Community of certain live animals and their fresh meat (9) was adopted. That Decision establishes the sanitary conditions for the importation into the European Union of live animals excluding equidae, and for the importation of fresh meat of such animals, including equidae, but excluding meat preparations. Annexes I and II to that Decision also set out lists of third countries or parts thereof from which certain live animals and their fresh meat may be imported into the Union as well as models of veterinary certificates.

(3) Since the date of adoption of that Decision, a number of new animal health and public health requirements have been laid down in other Union acts, constituting a new regulatory framework in this area. Also, Directive 72/462/EEC has been repealed by Directive 2004/68/EC.

(4) Article 20 of Directive 2004/68/EC states that implementing rules on import established in accordance with Decisions adopted pursuant to Directive 72/462/EEC, inter alia Decision 79/542/EEC, shall remain in force until replaced by measures adopted under the new regulatory framework.

(5) In accordance with Article 4(3) of Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC (10) , once the necessary provisions on the basis of Regulations (EC) No 852/2004, (EC) No 853/2004, (EC) No 854/2004 or Directive 2002/99/EC are adopted, the implementing rules adopted on the basis of Directive 72/462/EEC shall cease to apply.

(6) Decision 79/542/EEC has been amended several times and import provisions based on the new regulatory framework have already been introduced in Decision 79/542/EEC. For the sake of clarity and transparency the measures that are laid down in Decision 79/542/EEC should be laid down in a new legal act. This Regulation includes all the provisions of Decision 79/542/EEC. Consequently, by the entry into force of the present Regulation Decision 79/542/EEC is lapsed and thus no longer applies, pending the explicit repeal of it.

(7) Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Union of live animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Union acts referred to in Annex F to that Directive. Pursuant to that Directive, those live animals, semen, ova and embryos may be imported into the Union only from a third country which is on a list drawn up in accordance with the procedure referred to in that Directive. In addition, such live animals are to be accompanied by a health certificate corresponding to a specimen drawn up in accordance with the procedure referred to therein.

(8) Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products (11) lays down the rules to be observed in issuing the certificates required by veterinary legislation to prevent misleading or fraudulent certification. It is appropriate to ensure that rules and principles at least equivalent to those laid down in that Directive are applied by the official inspectors or veterinarians of third countries. Certain third countries, which are listed in Annex II to this Regulation, have provided sufficient guarantees as to the existence and implementation of such rules and principles. It is therefore appropriate to authorise the introduction of certain live animals into the Union from those third countries, provided that no further restrictions are required by their specific disease situation.

(9) Directive 2002/99/EC lays down the animal health rules concerning the introduction into the Union of products of animal origin and products obtained therefrom intended for human consumption. Pursuant to that Directive, lists are to be drawn up of the third countries or regions of third countries from which imports of specified products of animal origin are permitted and those imports are to comply with certain veterinary certification requirements.

(10) Directive 2004/68/EC lays down the animal health requirements for the importation into and transit through the Union of certain live ungulates. The importation of those live ungulates into and their transit through the Union is authorised only from third countries and territories that appear on a list or lists drawn up in accordance with the procedure referred to in that Directive and those imports are to comply with certain veterinary certification requirements.

(11) Save the provisions of article 17(2) last subparagraph of Directive 92/65/EEC, live animals, and products of animal origin to which Directives 92/65/EEC, 2002/99/EC and 2004/68/EC apply are to be imported into or transit through the Union only if they are accompanied by a veterinary certificate and comply with the relevant requirements laid down in Union legislation.

(12) Accordingly, for the implementation of Directives 92/65/EEC, 2002/99/EC and 2004/68/EC, it is appropriate to lay down in this Regulation lists of third countries, territories and parts thereof and the specific import conditions including model veterinary certificates for certain live animals and the fresh meat of certain animals.

(13) In the interest of consistency of Union legislation, this Regulation should also take into account the public heath requirements laid down in other Union acts and in particular in Regulations (EC) Nos 852/2004, 853/2004 and 854/2004 which lay down rules concerning the hygiene of foodstuffs and food of animal origin and rules for the organisation of official controls on products of animal origin intended for human consumption, as well as the requirements of Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products (12) , and of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (13) .

(14) Regulation (EC) No 882/2004 lays down general rules governing the performance of official controls carried out in the areas of food and feed, animal health and animal welfare. Article 48 thereof empowers the Commission to adopt a list of third countries from which specific products may be imported into the Union. Regulation (EC) No 854/2004 provides specific rules for the organisation of official controls on products of animal origin intended for human consumption, including the establishment of lists of third countries from which imports of products of animal origin are permitted. Those rules provide that those lists may be combined with other lists drawn up for public and animal health purposes.

(15) The model certificates set out in the Annexes to this Regulation should therefore include attestations certifying that the public health requirements laid down in Directive 96/23/EC and Regulations (EC) No 999/2001, 852/2004, 853/2004 and 854/2004, are fulfilled.

(16) The model certificates set out in the Annexes to this Regulation should also include attestations certifying that animal welfare requirements laid down in Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter and killing (14) and Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations (15) are fulfilled.

(17) In order to ensure that the health of live animals introduced into the Union is not jeopardised during their transport from the third country of origin to the Union, certain requirements relating to the transport of live animals should be laid down, including requirements on assembly centres.

(18) In the interest of ensuring the protection of animal health in the Union, live animals should be conveyed directly to their place of destination in the Union.

(19) Fresh meat introduced into the Union for transit to another third country poses a negligible risk to public health. Such meat should, however, comply with all the relevant animal health requirements. Accordingly, specific provisions on the transit, and storage before transit, of fresh meat should therefore be laid down.

(20) Specific conditions for transit via the Union of consignments to and from Russia should be provided for owing to the geographical situation of Kaliningrad which affects only Latvia, Lithuania and Poland.

(21) Consignments of fresh meat, excluding offal and minced meat, of farmed non-domesticated animals of the order Artiodactyla, originating from animals caught in the wild should be authorised for introduction into the Union. In order to rule out any possible animal health risks which could be posed by such introduction, it is appropriate that those animals be separated from wild animals for a period of three months prior to the introduction into the Union of such consignments. Accordingly, the model veterinary certificate for those consignments (RUF) should take that into account.

(22) Commission Decision 2003/881/EC of 11 December 2003 concerning the animal health and certification conditions for imports of bees ( Apis mellifera and Bombus spp.) from certain third countries (16) lays down the animal health and certification conditions for imports of bees from certain third countries. In the interest of simplification of Union legislation, the measures laid down in that Decision should be included in this Regulation. Consequently, Decision 2003/881/EC should be repealed.

(23) It's appropriate to introduce a transitional period to allow Member States and industry to take the necessary measures to comply with the requirements laid down in this Regulation.

(24) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Editorial Information

X1 Substituted by Corrigendum to Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Official Journal of the European Union L 73 of 20 March 2010).

CHAPTER I U.K. SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 U.K. Subject matter and scope

1. This Regulation lays down the veterinary certification requirements for the introduction into [F1 Great Britain] of consignments containing the following live animals or fresh meat:

(a) ungulates;

F2 (b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(c) fresh meat intended for human consumption, excluding meat preparations, of ungulates and equidae.

2. This Regulation lays down the lists of third countries, territories or parts thereof from which the consignments referred to in paragraph 1 may be introduced into [F3 Great Britain].

F4 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. This Regulation shall apply without prejudice to any specific certification requirements laid down in other [F5 retained EU law or in agreements concluded by the United Kingdom] with third countries.

Textual Amendments

F1 Words in Art. 1(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), 56(2)(a)(i) (with regs. 69-71)

F2 Art. 1(1)(b) 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), 56(2)(a)(ii) (with regs. 69-71)

F3 Words in Art. 1(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), 56(2)(b) (with regs. 69-71)

F4 Deleted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F5 Words in Art. 1(4) 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), 56(2)(c) (with regs. 69-71)

Article 2 U.K. Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)

‘ ungulates ’ means ungulates as defined in Article 2(d) of Directive 2004/68/EC;

(b)

‘ fresh meat ’ means fresh meat as defined in point 1.10 of Annex I to Regulation (EC) No 853/2004;

(c)

‘equidae’ means equidae as defined in Article 2(b) of Council Directive [F6 2009/156/EC];

(d)

‘ holding ’ means a farm or other officially supervised agricultural, industrial or commercial undertaking, including zoos, amusement parks and wildlife or hunting reserves where live animals are regularly kept or bred.

(e)

[F7 ‘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:

(i)

in relation to Wales, the Welsh Ministers;

(ii)

in relation to Scotland, the Scottish Ministers;

(f)

‘approved body, institute or centre’ means any permanent, geographically limited establishment, where one or more species of animal are habitually kept or bred, whether or not for commercial ends, for one or more of the following purposes:

(i)

display of the animals and education of the public;

(ii)

conservation of the species;

(iii)

basic or applied scientific research or breeding of animals for the purposes of such research,

and where the establishment concerned is approved by, or registered with, the competent authority (in relation to a third country) or the appropriate authority (in relation to Great Britain);

(g)

‘competent authority’ means the central authority of the country of destination or transit competent to carry out veterinary checks, or any authority to which that central authority has delegated that competence;

(h)

‘third country’ means any country or territory other than the British Islands.]

Textual Amendments

F6 Word in Art. 2(c) 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), 56(3)(a) (with regs. 69-71)

F7 Arts. 2(e)-(h) 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), 56(3)(b) (with regs. 69-71)

CHAPTER II U.K. CONDITIONS FOR THE INTRODUCTION OF LIVE ANIMALS INTO [F8 GREAT BRITAIN]

Article 3 U.K. General conditions for the introduction of ungulates into [F9 Great Britain]

Consignments of ungulates shall only be introduced [F10 from third countries] into [F11 Great Britain] if they comply with the following conditions:

(a)

they come from the third countries, territories or parts thereof listed in columns 1, 2 and 3 of the table set out in Part 1 of Annex I for which there is a model veterinary certificate corresponding to the consignment concerned listed in column 4 of the table in Part 1 of Annex I;

(b)

they are accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model veterinary certificate [F12 , in the form published by the appropriate authority from time to time], taking into account the specific conditions indicated in column 6 of the table in Part 1 of [F13 Annex I], and completed and signed by an official veterinarian of the exporting third country;

(c)

they comply with the requirements set out in the veterinary certificate referred to in point (b), including:

(i)

the supplementary guarantees laid down in that certificate, where indicated in column 5 of the table in Part 1 of Annex I;

(ii)

any additional veterinary certification requirements that the [F14 appropriate authority may include] in the certificate.

Textual Amendments

F9 Words in Art. 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), 56(5)(a) (with regs. 69-71)

F10 Words in Art. 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), 56(5)(b)(i) (with regs. 69-71)

F11 Words in 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), 56(5)(b)(ii) (with regs. 69-71)

F12 Words in Art. 3(b) 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), 56(5)(c)(i) (with regs. 69-71)

F13 Words in Art. 3(b) 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), 56(5)(c)(ii) (with regs. 69-71)

F14 Words in Art. 3(c)(ii) 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), 56(5)(d) (with regs. 69-71)

[F15 Article 3a U.K. Conditions for the introduction of ungulates intended for an approved body, institute or centre

1. By way of derogation from Article 3, [F16 the appropriate authority] may authorise the introduction into its territory of consignments of ungulates of the species listed in Tables 1, 2 and 3 of Part 1 of Annex VI where those consignments are destined for an approved body, institute or centre, provided that the following conditions are complied with:

(a) an assessment has been carried out by the [F17 appropriate authority] of the animal health risks that each of the consignments may present for [F18 Great Britain];

(b) the consignments concerned come from a third country, territory or part thereof which is included in one of the lists set out in:

(i)

Part 1 of Annex I or in Part 1 of Annex II to this Regulation,

(ii)

[F19 Regulation (EU) 2018/659], Decision 2007/777/EC (17), Regulation (EC) No 798/2008 (18), Regulation (EC) No 119/2009 (19), Regulation (EU) No 605/2010 (20),

(c) the ungulates originate from a body, institute or centre in a third country, territory or part thereof, referred to in point (a), which is included in a list established in accordance with Article 3c;

(d) the ungulates have been quarantined in a vector-protected facility at the premises of the body, institute or centre referred to in point (c) for the period provided for in the relevant certificates;

(e) the ungulates are conveyed directly to an approved body, institute or centre in [F20 Great Britain];

(f) the ungulates are accompanied by an appropriate veterinary certificate, [F21 in the form published by the appropriate authority from time to time];

(g) the ungulates comply with the requirements set out in the F22 ... veterinary certificate referred to in point (f).

F23 ...

2. Where exceptional circumstances render compliance with points (c) and (d) of paragraph 1 impossible, the [F24 appropriate authority] may authorise the introduction, into its territory, of ungulates of the species listed in Tables 1, 2 and 3 of Part 1 of Annex VI from other holdings which do not comply with the requirements laid down in those points, provided that the requirements laid down in points (a), (b) and (e) to (g) of paragraph 1 are complied with and that the following additional conditions are met:

(a) a prior application for a permit has been made by the owner, or a natural person representing that owner, and the [F25 appropriate authority] has granted such permit after having carried out a risk assessment that has indicated that the introduction of the ungulates concerned F26 ... does not constitute an animal health risk F26 ...;

(b) the ungulates have been quarantined in the third country, territory or part thereof of origin under official supervision for the time necessary for them to meet the animal health conditions set out in the [F27 appropriate] veterinary certificate referred to in point (f):

(i)

at a place approved by the competent authority of the third country, territory or part thereof of origin of the animals;

(ii)

in accordance with the arrangements prescribed in the permit that shall provide at least the same guarantees as those laid down in points (a), (b) and (e) to (g) of paragraph 1.

[F28 Where ungulates are introduced into Great Britain pursuant to the first subparagraph, they shall be quarantined in an approved body, institute or centre of destination for at least six months from the time of introduction into Great Britain, during which period the requirements provided for in Article 67 of Regulation (EU) 2017/625 may be applied, and protective measures may be put in place, by the appropriate authority.]

[F29 3. The appropriate authority authorising the introduction of ungulates into its territory pursuant to paragraph 1 or 2 shall inform the other appropriate authorities of such authorisation prior to the introduction of the ungulates concerned into Great Britain.]]

Textual Amendments

F15 Inserted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F16 Words in Art. 3a(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), 56(6)(a)(i) (with regs. 69-71)

F17 Words in Art. 3a(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), 56(6)(a)(ii)(aa) (with regs. 69-71)

F18 Words in Art. 3a(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), 56(6)(a)(ii)(bb) (with regs. 69-71)

F19 Words in Art. 3a(1)(b)(ii) 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), 56(6)(a)(iii) (with regs. 69-71)

F20 Words in Art. 3a(1)(e) 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), 56(6)(a)(iv) (with regs. 69-71)

F21 Words in Art. 3a(1)(f) 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), 56(6)(a)(v) (with regs. 69-71)

F22 Words in Art. 3a(1)(g) 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), 56(6)(a)(vi) (with regs. 69-71)

F23 Words in Art. 3a(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), 56(6)(a)(vii) (with regs. 69-71)

F24 Words in Art. 3a(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), 56(6)(b)(i) (with regs. 69-71)

F25 Words in Art. 3a(2)(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), 56(6)(b)(ii)(aa) (with regs. 69-71)

F26 Words in Art. 3a(2)(a) 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), 56(6)(b)(ii)(bb) (with regs. 69-71)

F27 Word in Art. 3a(2)(b) 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), 56(6)(b)(iii) (with regs. 69-71)

F28 Words in Art. 3a(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), 56(6)(b)(iv) (with regs. 69-71)

F29 Art. 3a(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), 56(6)(c) (with regs. 69-71)

[F30 Article 3b U.K. Conditions for the entry and transit of ungulates intended for an approved body, institute or centre through one country of Great Britain to another country of Great Britain

The transit of the ungulates referred to in Article 3a through one country of Great Britain to another country of Great Britain shall be permitted only subject to the authorisation of the appropriate authority of the country of transit. Such authorisation may be granted only on the basis of a risk assessment by that appropriate authority.]

Textual Amendments

F30 Art. 3b 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), 56(7) (with regs. 69-71)

[F15 Article 3c U.K. List of approved bodies, institutes or centres in third countries, territories and parts thereof

[F31 1. Following an assessment of compliance with the conditions laid down in paragraph 2, the appropriate authority may establish a list of approved bodies, institutes and centres from which the introduction of ungulates into its territory may be authorised pursuant to paragraph 1 of Article 3a.]

2. A body, institute or centre in a third country, territory or part thereof shall only be included in the list referred to in paragraph 1 where the following conditions are complied with:

(a) the body, institute or centre complies with the requirements set out in Part 3 of Annex VI;

(b) the body, institute or centre is approved by the competent authority of the third country, territory or part thereof where that body, institute or centre is situated;

(c) the competent authority of the third country, territory or part thereof provides sufficient guarantees that the conditions concerning the approval of bodies, institutes or centres set out in Part 4 of Annex VI are complied with.

[F32 3. The appropriate authority may include in the list referred to in paragraph 1 approved bodies, institutes or centres in any country outside Great Britain which are already included in such a list established by another appropriate authority without having assessed compliance with the conditions laid down in paragraph 2.]

4. [F33 The appropriate authority] shall keep the lists referred to in paragraph (1) up to date, taking into account in particular any suspension or withdrawal of the approval granted by the competent authority of a third country, territory or part thereof to the bodies, institutes or centres situated therein and included in those lists.

[F34 5. The appropriate authority must make available to the public, by means of internet-based information pages, the lists referred to in paragraph 1, and must keep those internet-based information pages up to date.]

F35 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

F15 Inserted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F31 Art. 3c(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), 56(8)(a) (with regs. 69-71)

F32 Art. 3c(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), 56(8)(b) (with regs. 69-71)

F33 Words in Art. 3c(4) 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), 56(8)(c) (with regs. 69-71)

F34 Art. 3c(5) 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), 56(8)(d) (with regs. 69-71)

F35 Art. 3c(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), 56(8)(e) (with regs. 69-71)

[F36 Article 4 U.K. Conditions for the assembly centres for certain consignments of ungulates

1. Consignments of ungulates which contain live animals from more than one holding shall only be introduced into [F37 Great Britain] if they are assembled in assembly centres approved by the competent authority of the third country, territory or part thereof of origin of the animals in accordance with the requirements set out in Part 5 of Annex I.

2. Consignments of ungulates introduced into [F37 Great Britain] in accordance with Article 3a F38 ... shall not originate from more than one holding and shall not be assembled in assembly centres.]

Textual Amendments

F36 Substituted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F37 Words in Art. 4 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), 56(9)(a) (with regs. 69-71)

F38 Words in Art. 4(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), 56(9)(b) (with regs. 69-71)

Article 5 U.K. Protocols for the standardisation of materials and sampling and testing procedures for ungulates

Where sampling and testing is required by the veterinary certificates listed in column 4 of the table in Part 1 of Annex I for the diseases listed in Part 6 of that Annex, for the introduction into [F39 Great Britain] of consignments of ungulates, such sampling and testing shall be carried out by or under the control of the competent authority of the third country of origin in accordance with the Protocols for the standardisation of materials and testing procedures set out in Part 6 of that Annex.

Textual Amendments

F39 Words in Art. 5 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), 56(10) (with regs. 69-71)

F40 Article 6 U.K. Special conditions for certain consignments of ungulates imported into St Pierre and Miquelon and introduced into the Union

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

Textual Amendments

F40 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), 56(11) (with regs. 69-71)

Article 7 U.K. General conditions for the introduction into [F41 Great Britain] of certain species of bees

1. Consignments of [F42 queen bees (Apis mellifera and Bombus spp.) and bumble bees (Bombus spp.) shall only be introduced into Great Britain] from third countries or territories:

(a) listed in Part 1 of Annex II;

(b) where the presence of the American foulbrood, the small hive beetle ( Aethina tumida ) and the Tropilaelaps mite ( Tropilaelaps spp.) is subject to compulsory notification throughout the whole territory of the third country or territory concerned.

2. By way of derogation from paragraph 1(a), consignments of bees may be introduced into [F43 Great Britain] from a part of a third country or territory listed in Part 1 of Annex II which is:

(a) a geographically and epidemiologically isolated part of the third country or territory

(b) listed in the third column of the table in Section 1 of Part 1 of Annex IV.

When that derogation is applied, the introduction into [F44 Great Britain] of consignments of bees shall be prohibited from all other parts of the third country or territory concerned not listed in the third column of the table in Section 1 of Part 1 of Annex IV.

3. Consignments of bees of the species [F45 referred to in paragraph 1] shall consist of either:

(a) cages of queen bees ( Apis mellifera and Bombus spp.), each containing one single queen bee with a maximum of 20 accompanying attendants; or

(b) containers of bumble bees ( Bombus spp.), each containing a colony of a maximum of 200 adult bumble bees.

4. Consignments of bees of the species [F46 referred to in paragraph 1] shall:

(a) be accompanied by the appropriate veterinary certificate, [F47 in the form published by the appropriate authority from time to time], and completed and signed by an official inspector of the exporting third country;

(b) comply with the veterinary requirements set out in the veterinary certificate referred to in point (a).

Textual Amendments

F41 Words in Art. 7 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), 56(12)(a) (with regs. 69-71)

F42 Words in Art. 7(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), 56(12)(b) (with regs. 69-71)

F43 Words in Art. 7(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), 56(12)(c)(i) (with regs. 69-71)

F44 Words in Art. 7(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), 56(12)(c)(ii) (with regs. 69-71)

F45 Words in Art. 7(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), 56(12)(d) (with regs. 69-71)

F46 Words in Art. 7(4) 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), 56(12)(e)(i) (with regs. 69-71)

F47 Words in Art. 7(4)(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), 56(12)(e)(ii) (with regs. 69-71)

Article 8 U.K. General conditions concerning the transport of live animals to [F48 Great Britain]

During the period after loading in the third country of origin and before arrival at the [F49 border control post] of introduction into [F48 Great Britain], consignments of live animals shall not be:

(a)

transported together with live animals that:

(i)

are not intended for introduction into [F48 Great Britain]; or

(ii)

are of a lower health status;

(b)

[F36 unloaded in, or when transported by air, moved to another aircraft, or transported by road, by rail, or moved on foot through a third country, territory or part thereof which is not authorised for imports of the animals concerned into [F48 Great Britain].]

Textual Amendments

F36 Substituted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F48 Words in Art. 8 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), 56(13)(a) (with regs. 69-71)

F49 Words in Art. 8 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), 56(13)(b) (with regs. 69-71)

Article 9 U.K. Time limit for the period of transport to [F50 Great Britain] of live animals

Consignments of live animals shall only be introduced [F51 from third countries into Great Britain] where the consignment arrives at the [F52 border control post] F53 ... within 10 days of the date of issue of the appropriate veterinary certificate.

In the case of transport by sea, that period of 10 days shall be extended by an additional period corresponding to the duration of the journey by sea, as certified by a signed declaration of the master of the ship, drawn up in accordance with [F54 the form required for the declaration, as published by the appropriate authority from time to time,] and attached in its original form to the veterinary certificate.

Textual Amendments

F50 Words in Art. 9 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), 56(14)(a) (with regs. 69-71)

F51 Words in Art. 9 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), 56(14)(b)(i) (with regs. 69-71)

F52 Words in Art. 9 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), 56(14)(b)(ii) (with regs. 69-71)

F53 Words in Art. 9 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), 56(14)(b)(iii) (with regs. 69-71)

F54 Words in Art. 9 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), 56(14)(c) (with regs. 69-71)

Article 10 U.K. Special conditions regarding the spraying of consignments of live animals transported by air to [F55 Great Britain]

Where consignments of live animals, excluding consignments of bees, are transported by air, the crate or container in which they are transported and the surrounding area shall be sprayed with an appropriate insecticide.

That spraying shall be carried out immediately prior to the closing of the aircraft doors after loading, and after any subsequent opening of the doors in a third country, until the aircraft reaches its final destination.

The captain of the aircraft shall certify that the spraying has been carried out by signing a declaration, drawn up in accordance with [F56 the form required for the declaration, as published by the appropriate authority from time to time,] and attached in its original form to the veterinary certificate.

Textual Amendments

F55 Words in Art. 10 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), 56(15)(a) (with regs. 69-71)

F56 Words in Art. 10 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), 56(15)(b) (with regs. 69-71)

Article 11 U.K. Conditions to be applied following the introduction into [F57 Great Britain] of certain consignments of ungulates

[F36 1. Following their introduction into [F57 Great Britain], consignments of ungulates, other than those referred to in Article 3a shall be conveyed in a vector-protected means of transport without delay to the holding of destination.

Those ungulates shall remain on that holding for a period of at least 30 days, unless they are dispatched directly to a slaughterhouse.]

2. Following their introduction into [F57 Great Britain], consignments of ungulates intended for immediate slaughter shall be conveyed without delay to the slaughterhouse of destination where they shall be slaughtered within five working days from the date of arrival at the slaughterhouse.

Textual Amendments

F36 Substituted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F57 Words in Art. 11 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), 56(16) (with regs. 69-71)

Article 12 U.K. Specific conditions concerning the transit through third countries of certain consignments of ungulates

F58 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F58 Art. 12 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), 56(17) (with regs. 69-71)

F59 Article 12a U.K. Derogation for the transit of certain consignments of live bovine animals for breeding and production through Lithuania

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

Textual Amendments

F59 Art. 12a 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), 56(17) (with regs. 69-71)

Article 13 U.K. Conditions to be applied following the introduction into [F60 Great Britain] of consignments of bees referred to in Article 7

1. Consignments of queen bees referred to in Article 7(3)(a) shall be conveyed without delay to the designated place of final destination where the hives shall be placed under the control of the competent authority and the queen bees transferred to new cages before being introduced to local colonies.

2. The cages, attendants, and other material that accompanied the queen bees from the third country of origin shall be sent to a laboratory designated by the competent authority for examination for the presence of:

(a) the small hive beetle ( Aethina tumida ), their eggs or larvae;

(b) signs of the Tropilaelaps mite ( Tropilaelaps spp.).

After that laboratory examination, the cages, attendants and the material shall be destroyed.

3. Consignments of bumble bees (Bombus spp.) referred to in Article 7(3)(b) shall be conveyed without delay to the designated place of destination.

Those bumble bees may stay in the container in which they were introduced into [F61 Great Britain] until the end of the lifespan of the colony.

That container and the material that accompanied the bumble bees from the third country of origin shall be destroyed at the end of the lifespan of the colony at the latest.

Textual Amendments

F60 Words in Art. 13 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), 56(18) (with regs. 69-71)

F61 Words in Art. 13(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), 56(18) (with regs. 69-71)

[F15 Article 13a U.K. Conditions to be applied following the introduction of consignments of ungulates intended for approved bodies, institutes or centres

1. Following their introduction into [F62 Great Britain], consignments of ungulates intended for approved bodies, institutes or centres shall be transported without delay to the approved body, institute or centre of destination in means of transport that are vector-protected and so constructed that the animals cannot escape and faeces, urine, litter, fodder, waste or any other material cannot flow or fall out from the vehicle or container during transportation.

2. The animals shall be kept in quarantine in vector-protected facilities on the premises of the approved body, institute or centre F63 ... for a minimum of 30 days. After the 30 days quarantine period the animals may be moved to another approved body, institute or centre.

3. Animals introduced into an approved body, institute or centre can only be moved to a destination other than an approved body, institute or centre provided that:

(a) at least six months have elapsed from the time of introduction into [F64 Great Britain], and

(b) [F65 the movement is carried out in accordance with the requirements of the competent authority concerned, in order to ensure no risk of possible spread of disease.]

4. By way of derogation from paragraph 3, animals may leave an approved body, institute or centre before the end of the six-month period provided for in that paragraph, only where the following conditions are complied with:

(a) the animals are exported to a third country, territory or part thereof;

(b) for the purpose of their export as referred to in a) the animals are transported in means of transport that are vector-protected and so constructed that the animals cannot escape and faeces, urine, litter, fodder, waste or any other material cannot flow or fall out from the vehicle or container during transportation.]

Textual Amendments

F15 Inserted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F62 Words in Art. 13a(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), 56(19)(a) (with regs. 69-71)

F63 Words in Art. 13a(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), 56(19)(b) (with regs. 69-71)

F64 Words in Art. 13a(3)(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), 56(19)(c)(i) (with regs. 69-71)

F65 Art. 13a(3)(b) 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), 56(19)(c)(ii) (with regs. 69-71)

Textual Amendments

F8 Words in Ch. 2 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), 56(4) (with regs. 69-71)

CHAPTER III U.K. CONDITIONS FOR THE INTRODUCTION OF FRESH MEAT INTO [F66 GREAT BRITAIN ]

Article 14 U.K. General conditions for the importation of fresh meat

Consignments of fresh meat intended for human consumption shall only be imported into [F67 Great Britain] if they comply with the following conditions:

(a)

they come from the third countries, territories or parts thereof listed in columns 1, 2 and 3 of the table in Part 1 of Annex II for which there is a [F68 veterinary certificate, in the form published by the appropriate authority from time to time,] corresponding to the consignment concerned listed in column 4 of the table in Part 1 of Annex II;

(b)

they are presented at the [F69 border control post] of introduction into [F70 Great Britain accompanied by the appropriate veterinary certificate, in the form published by the appropriate authority from time to time], taking into account the specific conditions indicated in column 6 of the table in Part 1 of that Annex, and completed and signed by an official veterinarian of the exporting third country;

(c)

they comply with the requirements set out in the veterinary certificate referred to in point (b), including:

(i)

the supplementary guarantees laid down in that certificate, where indicated in column 5 of the table in Part 1 of Annex II;

(ii)

any additional veterinary certification requirements that the [F71 appropriate authority may include] in the certificate.

Textual Amendments

F67 Words in Art. 14 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), 56(21)(a) (with regs. 69-71)

F68 Words in Art. 14(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), 56(21)(b) (with regs. 69-71)

F69 Words in Art. 14(b) 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), 56(21)(c)(i) (with regs. 69-71)

F70 Words in Art. 14(b) 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), 56(21)(c)(ii) (with regs. 69-71)

F71 Words in Art. 14(c)(ii) 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), 56(21)(d) (with regs. 69-71)

Article 15 U.K. Conditions to be applied following the importation of unskinned carcases of wild cloven-hoofed game

In accordance with [F72 Article 3 of Commission Delegated Regulation (EU) 2019/2126], consignments of unskinned carcases of wild cloven-hoofed game for human consumption after further processing shall be conveyed without delay to the processing establishment of destination.

Textual Amendments

F72 Words in Art. 15 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), 56(22) (with regs. 69-71)

Article 16 U.K. Transit and storage of fresh meat

The introduction into [F73 Great Britain] of consignments of fresh meat not intended for importation into [F73 Great Britain] but destined for a third country either by immediate transit or after storage in [F73 Great Britain] in accordance with [F74 Commission Delegated Regulation (EU) 2019/2124], shall only be authorised if the consignments comply with the following conditions:

(a)

they come from the third countries, territories or parts thereof listed in columns 1, 2 and 3 of the table in Part 1 of Annex II, for which there is [F75 an appropriate veterinary certificate, in the form published by the appropriate authority from time to time];

(b)

they comply with the specific animal health requirements for the consignment concerned, as set out in the [F76 appropriate] veterinary certificate referred to in point (a);

(c)

they are accompanied by a veterinary certificate, drawn up in accordance with the model veterinary certificate [F77 , in the form published by the appropriate authority from time to time], and completed and signed by an official veterinarian of the exporting third country;

(d)

[F78 they are certified as acceptable for transit, including storage as appropriate, on the common health entry document referred to in Article 2(3) of Commission Implementing Regulation (EU) 2019/2130, signed by the official veterinarian of the border control post of introduction into Great Britain.]

Textual Amendments

F73 Words in Art. 16 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), 56(23)(a)(i) (with regs. 69-71)

F74 Words in Art. 16 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), 56(23)(a)(ii) (with regs. 69-71)

F75 Words in Art. 16(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), 56(23)(b) (with regs. 69-71)

F76 Word in Art. 16(b) 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), 56(23)(c) (with regs. 69-71)

F77 Words in Art. 16(c) 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), 56(23)(d) (with regs. 69-71)

F78 Art. 16(d) 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), 56(23)(e) (with regs. 69-71)

F79 Article 17 U.K. Derogation for transit through Latvia, Lithuania and Poland

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

Textual Amendments

F79 Art. 17 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), 56(24) (with regs. 69-71)

F80 Article 17a U.K. Derogation for transit through Croatia of consignments coming from Bosnia and Herzegovina and destined to third countries

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

Textual Amendments

F80 Art. 17a 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), 56(24) (with regs. 69-71)

Textual Amendments

F66 Words in Ch. 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), 56(20) (with regs. 69-71)

CHAPTER IV U.K. GENERAL, TRANSITIONAL AND FINAL PROVISIONS

Article 18 U.K. Certification

The veterinary certificates required by this Regulation shall be completed in accordance with the explanatory notes [F81 , as published by the appropriate authority from time to time].

However, that requirement shall not preclude the use of electronic certification F82 ....

Textual Amendments

F81 Words in Art. 18 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), 56(25)(a) (with regs. 69-71)

F82 Words in Art. 18 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), 56(25)(b) (with regs. 69-71)

F83 Article 19 U.K. Transitional provisions

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

Textual Amendments

F83 Art. 19 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), 56(26) (with regs. 69-71)

Article 20 U.K. Repeal

Decision 2003/881/EC is repealed.

Article 21 U.K. Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

This Regulation shall be binding in its entirety F84 ....

Textual Amendments

F84 Words in Signature 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), 56(27) (with regs. 69-71)

ANNEX I U.K. UNGULATES

[F85 PART 1 U.K.

List of third countries, territories or parts thereof ^a

a Without prejudice to specific certification requirements provided for by any relevant agreement between the [F86 United Kingdom] and third countries.
b Exclusively for live animals other than animals belonging to the cervidae species.
c [F87 This is subject to any specific certification requirements for imports from Switzerland, in such form as the Secretary of State may, with the consent of the appropriate authority, publish from time to time.]
d
e Not including Kosovo under UNSCR 1244/99.
f [F89 Canada: seasonally free period for bluetongue and epizootic haemorrhagic disease is between 1 November and 15 May, in accordance with the OIE Terrestrial Animal Health Code.]
g
ISO code and name of third country	Code of Territory	Description of third country, territory or part thereof	Veterinary certificate		Specific conditions
			Model(s)	SG
1	2	3	4	5	6
F90
[F91 CA — Canada	CA-0	Whole country	POR-X, BOV-X, OVI-X, OVI-Y, RUM b		IVb IX V XIII] f
CH – Switzerland	CH-0	Whole country	c
CL – Chile	CL-0	Whole country	BOV-X,OVI-X, RUM
			POR-X, SUI	B
[F92 EU member States, Liechtenstein and Norway 1		Whole country of each state	BOV-X, BOV-Y, OVI-X, OVI-Y, POR-X, POR-Y, RUM, SUI]
[F92 1 This is subject to any specific certification requirements for imports from EU member States, Liechtenstein and Norway, in such form as the Secretary of State may, with the consent of the appropriate authority, publish from time to time.]
GL – Greenland	GL-0	Whole country	OVI-X, RUM		V
F93
IS – Iceland	IS-0	Whole country	BOV-X, BOV-Y RUM, OVI-X, OVI-Y
			POR-X, POR-Y	B
ME – Montenegro	ME-0	Whole country			I
[F89 MK-The Republic of North Macedonia	MK-0	Whole country			I]
[F94 NZ – New Zealand	NZ-0	Whole country	BOV-X, BOV-Y, RUM, POR-X, POR-Y OVI-X, OVI-Y		III V XII]
PM – St Pierre and Miquelon	PM-0	Whole country	BOV-X, BOV-Y, RUM, OVI-X, OVI-Y CAM
RS – Serbia e	RS-0	Whole country			I
RU – Russia	RU-0	Whole country
	RU-1	Whole country except the region of Kaliningrad
	RU-2	Region of Kaliningrad	BOV-X-TRANSIT-RU		X
[F95 US – United States	US-0	Whole country	POR-X	D ]

Textual Amendments

F86 Words in Annex 1 Pt. 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), 56(28)(a)(ii)(aa) (with regs. 69-71)

F87 Words in Annex 1 Pt. 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), 56(28)(a)(ii)(bb) (with regs. 69-71)

F88 Deleted by Commission Implementing Regulation (EU) 2019/1162 of 1 July 2019 amending Annexes I and II to Regulation (EU) No 206/2010 as regards the models of veterinary certificates BOV-X, OVI-X, OVI-Y and RUM and the lists of third countries, territories or parts thereof from which the introduction into the Union of certain ungulates and of fresh meat is authorised (Text with EEA relevance).

F89 Substituted by Commission Implementing Regulation (EU) 2019/1162 of 1 July 2019 amending Annexes I and II to Regulation (EU) No 206/2010 as regards the models of veterinary certificates BOV-X, OVI-X, OVI-Y and RUM and the lists of third countries, territories or parts thereof from which the introduction into the Union of certain ungulates and of fresh meat is authorised (Text with EEA relevance).

F90 Deleted by Commission Implementing Regulation (EU) 2017/384 of 2 March 2017 amending Annexes I and II to Regulation (EU) No 206/2010 as regards the models of veterinary certificates BOV-X, OVI-X, OVI-Y and RUM and the lists of third countries, territories or parts thereof from which the introduction into the Union of certain ungulates and of fresh meat is authorised (Text with EEA relevance).

F91 Substituted by Commission Implementing Regulation (EU) 2017/384 of 2 March 2017 amending Annexes I and II to Regulation (EU) No 206/2010 as regards the models of veterinary certificates BOV-X, OVI-X, OVI-Y and RUM and the lists of third countries, territories or parts thereof from which the introduction into the Union of certain ungulates and of fresh meat is authorised (Text with EEA relevance).

F92 Words in Annex 1 Pt. 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), 56(28)(a)(i) (with regs. 69-71)

F93 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.

F94 Substituted by Commission Implementing Regulation (EU) 2015/604 of 16 April 2015 amending Annexes I and II to Regulation (EU) No 206/2010 as regards animal health requirements for bovine tuberculosis in the models of veterinary certificates BOV-X and BOV-Y and the entries for Israel, New Zealand and Paraguay in the lists of third countries, territories or parts thereof from which the introduction into the Union of live animals and fresh meat is authorised (Text with EEA relevance).

F95 Inserted by Commission Implementing Regulation (EU) No 102/2013 of 4 February 2013 amending Regulation (EU) No 206/2010 as regards the entry for the United States in the list of third countries, territories or parts thereof authorised for the introduction of live ungulates into the Union, the model veterinary certificate ‘POR-X’ and the protocols for testing for vesicular stomatitis (Text with EEA relevance).

Specific Conditions (see footnotes in each certificate) U.K.

F96 ...

:

‘II’

:

territory recognised as having an official tuberculosis-free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate BOV-X.

‘III’

:

territory recognised as having an official brucellosis-free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate BOV-X.

‘IVa’

:

territory recognised as having an official enzootic-bovine-leukosis (EBL) free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate BOV –X.

‘IVb’

:

recognised as having officially enzootic-bovine-leukosis (EBL)-free herds equivalent to the requirements set out in Annex D to Directive 64/432/EEC for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate BOV–X.

‘V’

:

territory recognised as having an official brucellosis-free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate OVI-X.

‘VI’

:

Geographical constraints:

‘VII’

:

territory recognised as having an official tuberculosis-free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate RUM.

‘VIII’

:

territory recognised as having an official brucellosis-free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate RUM.

‘IX’

:

territory recognised as having an official Aujeszky’s disease -free status for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of certificate POR-X.

F96 ...

:

‘[F98 XI’

:

holdings or compartments recognised as applying controlled housing conditions in accordance with Article 8 of [F99 Commission Implementing Regulation (EU) 2015/1375].]

‘[F100 XII’

:

territory recognised as having officially tuberculosis-free bovine herds equivalent to those recognised based on the conditions laid down in paragraphs 1 and 2 of Annex A.I to Directive 64/432/EEC, for the purposes of exports to [F97 Great Britain] of live animals certified according to the model of veterinary certificate BOV-X or BOV-Y.]

‘[F89 XIII’

:

territory recognised as having an official bluetongue and epizootic haemorrhagic disease seasonally free status, for the purpose of exports to [F97 Great Britain] of live animals certified according to the model of veterinary certificate BOV-X, OVI-X, OVI-Y or RUM.]]

Textual Amendments

F96 Words in Annex 1 Pt. 1 table 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), 56(28)(a)(iii)(aa) (with regs. 69-71)

F97 Words in Annex 1 Pt. 1 table 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), 56(28)(a)(iii)(bb) (with regs. 69-71)

F98 Inserted by Commission Implementing Regulation (EU) No 1218/2014 of 13 November 2014 amending Annexes I and II to Regulation (EU) No 206/2010 as regards animal health requirements for Trichinella in the model of veterinary certificate for imports into the Union of domestic porcine animals intended for breeding, production or slaughter, and of fresh meat thereof (Text with EEA relevance).

F99 Words in Annex 1 Pt. 1 table 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), 56(28)(a)(iii)(cc) (with regs. 69-71)

F100 Inserted by Commission Implementing Regulation (EU) 2015/604 of 16 April 2015 amending Annexes I and II to Regulation (EU) No 206/2010 as regards animal health requirements for bovine tuberculosis in the models of veterinary certificates BOV-X and BOV-Y and the entries for Israel, New Zealand and Paraguay in the lists of third countries, territories or parts thereof from which the introduction into the Union of live animals and fresh meat is authorised (Text with EEA relevance).

Textual Amendments

F85 Substituted by Commission Implementing Regulation (EU) No 644/2012 of 16 July 2012 amending Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements, as regards Russia (Text with EEA relevance).

Modifications etc. (not altering text)

C1 Annex 1 Pt. 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), 9; 2020 c. 1, Sch. 5 para. 1(1)

F101 PART 2 U.K. Models of Veterinary Certificates

Textual Amendments

F101 Annex 1 Pt. 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), 56(28)(b) (with regs. 69-71)

F102 PART 3 U.K. Addendum for transport of animals by sea (To be completed and attached to the veterinary certificate when transport to the Union frontier includes, even for part of the journey, transportation by ship.)

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

Textual Amendments

F102 Annex 1 Pt. 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), 56(28)(b) (with regs. 69-71)

F103 PART 4 U.K. Addendum for transport of animals by air (To be completed and attached to the veterinary certificate when transport to the Union frontier includes, even for part of the journey, transportation by air.)

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

Textual Amendments

F103 Annex 1 Pt. 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), 56(28)(b) (with regs. 69-71)

PART 5 U.K. Conditions for the approval of assembly centres (referred to in Article 4)

In order to be approved, assembly centres must meet the following requirements:

I.

They must be supervised by an official veterinarian.

II.

They must each be situated at the centre of an area of at least 20 km in diameter in which, according to official findings, there has been no case of foot-and-mouth disease for at least a period of 30 days prior to their use as approved assembly centres.

III.

They must, before each use as approved assembly centres, be cleansed and disinfected with a disinfectant officially authorised in the exporting country as effective for the control of foot-and-mouth disease.

IV.

They must have, taking into account their animal capacity:

(a)

a facility dedicated exclusively for use as an assembly centre;

(b)

appropriate facilities, that are easy to clean and disinfect, for loading, unloading and adequate housing of a suitable standard for the animals, for watering and feeding them, and for giving them any necessary treatment;

(c)

appropriate facilities for inspection and isolation;

(d)

appropriate equipment for cleaning and disinfecting rooms and trucks;

(e)

an appropriate storage area for fodder, litter and manure;

(f)

an appropriate system for collecting and disposal of waste water;

(g)

an office for the official veterinarian.

V.

When operating, they must have sufficient veterinarians to carry out all duties set out in Part 5;

VI.

They must only admit animals that are individually identified so as to guarantee traceability. To this end, when animals are admitted the owner or the person in charge of the centre must ensure that the animals are properly identified and accompanied by health documents or certificates for the species and categories involved.

In addition, the owner or the person in charge of the assembly centre must record on a register or in a data base, and retain for at least three years the name of the owner, the origin of the animals, the dates of entry and exit, the identification number of the animals or registration number of the herd of origin and the holding of destination, and, the registration number of the carrier and the registration number of the lorry delivering or collecting animals from that assembly centre.

VII.

All animals passing through the assembly centre must fulfil the health conditions established for the introduction of the relevant category of animal into [F104 Great Britain].

VIII.

Animals to be introduced into [F104 Great Britain] which pass through an assembly centre must, within six days of arrival at the assembly centre, be loaded and dispatched directly to the border of the exporting country:

(a)

without coming into contact with cloven-hoofed animals other than animals which fulfil the health conditions established for the introduction of the relevant category of animal into [F104 Great Britain];

(b)

segregated into consignments so that no consignment contains both animals for breeding or production and animals for immediate slaughter;

(c)

in transport vehicles or containers which have first been cleansed and disinfected with a disinfectant officially authorised in the exporting country as effective for the control of foot-and-mouth disease and which are so constructed that faeces, urine, litter or fodder cannot flow or fall out during transportation.

IX.

Where the conditions for the export of animals to [F104 Great Britain] require that a test is carried out within a specified period before loading, that period must include any period of assembly, up to six days, from the date of arrival of the animals at the approved assembly centre.

X.

The exporting third country must designate the centres which are approved for animals for breeding and production and those centres which are approved for animals for slaughter and must notify the [F105 appropriate authority] of the names and addresses of such premises. That information must be updated regularly.

XI.

The exporting third country shall determine the procedure for official supervision of approved assembly centres and shall ensure that such supervision is carried out.

XII.

The approved assembly centres must be regularly inspected by the competent authority of the third country in order to check that the requirements for approval set out in points I to XI continue to be fulfilled.

If those inspections show that those conditions are no longer complied with, the approval of the centre must be suspended. The approval may be restored only when the competent authority of the third country is satisfied that the centre fully complies with the conditions set out in points I to XI.

Textual Amendments

F104 Words in Annex 1 Pt. 5 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), 56(28)(c)(i) (with regs. 69-71)

F105 Words in Annex 1 Pt. 5 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), 56(28)(c)(i) (with regs. 69-71)

PART 6 U.K. Protocols for the standardisation of materials and testing procedures (referred to in Article 5)

Tuberculosis (TBL) U.K.

The single intradermal tuberculin test using bovine tuberculin shall be carried out [F106 in a manner equivalent to the standards in] Annex B to Directive 64/432/EEC. In the case of Suidae animals, the single intradermal tuberculin test using avian tuberculin shall be carried out [F106 in a manner equivalent to the standards in] Annex B to 64/432/EEC, except that the site of injection shall be the loose skin at the base of the ear.

Textual Amendments

F106 Words in Annex 1 Pt. 6 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), 56(28)(d) (with regs. 69-71)

[F107 Brucellosis ( Brucella abortus ) (BRL) U.K.

The serum agglutination test, complement fixation test, buffered brucella antigen test, enzyme-linked immunosorbent assays (ELISA) and fluorescence polarisation assay (FPA) shall be carried out [F106 in a manner equivalent to the standards in] Annex C to Directive 64/432/EEC.]

Textual Amendments

F107 Substituted by Commission Regulation (EU) No 144/2011 of 17 February 2011 amending Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

Brucellosis (Brucella melitensis) (BRL) U.K.

Tests shall be carried out [F106 in a manner equivalent to the standards in] Annex C to Directive 91/68/EEC.

Enzootic Bovine Leukosis (EBL) U.K.

The agar gel immuno-diffusion test and the enzyme linked immuno-absorbent assay test (ELISA) shall be carried out [F106 in a manner equivalent to the standards in] paragraphs A and C of Chapter II of Annex D to Directive 64/432/EEC.

Bluetongue (BTG) U.K.

A.

The blocking or competitive ELISA test shall be carried out according to the following protocol: U.K.

The competitive ELISA using monoclonal antibody 3-17-A3 is capable of identifying antibodies to all known serotypes of bluetongue virus (BTV).

The principle of the test is the interruption of the reaction between BTV antigen and a group-specific monoclonal antibody (3-17-A3) by the addition of test serum. Antibodies to BTV present in the test serum block the reactivity of the monoclonal antibody (Mab) and result in a reduction in the expected colour development after the addition of enzyme labelled anti-mouse antibody, and chromogen/ substrate. Sera can be tested at a single dilution of 1:5 (spot test – Appendix 1) or may be titrated (serum titration – Appendix 2) to give dilution end-point. Inhibition values higher than 50 % may be regarded as positive.

Material and Reagents: U.K.

1.

Appropriate ELISA microtitre plates.

2.

Antigen: supplied as a cell extracted concentrate, prepared as described below, and stored at either – 20 °C or – 70 °C.

3.

Blocking buffer: phosphate buffered saline (PBS) containing 0,3 % BTV negative adult bovine serum, 0,1 % (v/v) Tween-20 (supplied as polyoxyethylene sorbiton monolaurate syrup) in PBS.

4.

Monoclonal antibody: 3-17-A3 (supplied as hybridoma tissue-culture supernatant) directed against the group-specific polypeptide VP7, stored at - 20 °C or freeze-dried and diluted 1/100 with blocking buffer before use.

5.

Conjugate: rabbit anti-mouse globulin (adsorbed and eluted) conjugated to horseradish peroxidase and kept in the dark at 4 °C.

6.

Chromogen and substrate: Orthophenylene diamine (OPD-chromogen) at a final concentration of 0,4 mg/ml in sterile distilled water. Hydrogen peroxide (30 %w/v-substrate) 0,05 % v/v added immediately before use (5μl H ₂ O ₂ per 10 ml OPD). ( Handle OPD with care - wear rubber gloves - suspected mutagen ).

7.

1 Molar sulphuric acid: 26,6 ml of acid added to 473,4 ml of distilled water. ( Remember Acid must be added to water, never water to acid .)

8.

Orbital shaker.

9.

ELISA plate reader ( the test may be read visually ).

Test format U.K.

Cc: conjugate control (no serum/ no monoclonal antibody); C++: strong positive serum control; C+: weak positive serum control; C-: negative serum control; Cm: monoclonal antibody control (no serum).

APPENDIX 1:

Spot dilution (1:5) format (40 sera/plate)

	Controls		Test Sera
	1	2	3	4	5	6	7	8	9	10	11	12
A	Cc	C-	1	2	3	4	5	6	7	8	9	10
B	Cc	C-	1	2	3	4	5	6	7	8	9	10
C	C++	C++
D	C++	C++
E	C+	C+
F	C+	C+
G	Cm	Cm										40
H	Cm	Cm										40

APPENDIX 2:

Serum titration format (10 sera/plate)

	Controls		Test Sera
	1	2	3	4	5	6	7	8	9	10	11	12
A	Cc	C-	1:5									1:5
B	Cc	C-	1:10									1:10
C	C++	C++	1:20									1:20
D	C++	C++	1:40									1:40
E	C+	C+	1:80									1:80
F	C+	C+	1:160									1:160
G	Cm	Cm	1:320									1:320
H	Cm	Cm	1:640									1:640

Test protocol: U.K.

Conjugate control (Cc)

:

Wells 1A and 1B are a blank control consisting of BTV antigen and conjugate. This may be used to blank the ELISA reader.

Mab control (Cm)

:

Columns 1 and 2, rows G and H are the monoclonal antibody control and contain BTV antigen, monoclonal antibody and conjugate. These wells represent maximum colour. The mean of the optical density readings from this control represents the 0 % inhibition value.

Positive control (C++, C+)

:

Columns 1 and 2, rows C-D-E-F. These wells contain BTV antigen, BTV strong and weak positive antiserum respectively, Mab and conjugate.

Negative control (C-)

:

Wells 2A and 2B are the negative controls, which contain BTV antigen, BTV negative antiserum, Mab and conjugate.

Test sera

:

For large-scale serological surveys and rapid screening, sera may be tested at a single dilution of 1:5 (Appendix 1). Alternatively, 10 sera may be tested over a dilution range from 1:5 to 1:640 (Appendix 2). This will give some indication of the titre of antibody in the test sera.

Procedure: U.K.

1.

Dilute BTV antigen to pre-titrated concentration in PBS, sonicate briefly to disperse aggregated virus (if sonicator is not available, pipette vigorously) and add 50 μl to all wells of the ELISA plate. Tap sides of plate to disperse antigen.

2.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash plates three times by flooding and emptying the wells with non-sterile PBS and blot dry on absorbent paper.

3.

Control wells: Add 100 μl of blocking buffer to Cc wells. Add 50 ul of positive and negative control sera, at a dilution of 1:5 (10 μ l sera + 40 μl blocking buffer), to respective wells C-, C+ and C++. Add 50μl blocking buffer to Mab control wells.

Spot titration method: Add a 1:5 dilution of each test serum in blocking buffer to duplicate wells of columns 3 to 12 (10 μl sera + 40 μl blocking buffer),

or

Serum titration method: Prepare a two-fold dilution series of each test sample (1:5 to 1:640) in blocking buffer across eight wells of single columns 3 to 12.

4.

Immediately after the addition of the test sera, dilute Mab 1:100 in blocking buffer and add 50 μl to all wells of the plate except for the blank control.

5.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash three times with PBS and blot dry.

6.

Dilute rabbit anti-mouse concentrate to 1/ 5 000 in blocking buffer and add 50 μl to all wells of the plate.

7.

Incubate at 37 °C for 60 minutes on an orbital shaker. Wash three times with PBS and blot dry.

8.

Thaw the O-Phenylenediamine dihydrochloride (OPD) and immediately before use add 5 μl of 30 % hydrogen peroxide to each 10 ml of OPD. Add 50 μl to all wells of the plate. Allow colour to develop for approximately 10 minutes and stop the reaction with 1 Molar sulphuric acid (50 μl per well). Colour should develop in the Mab control wells and in those wells containing sera with no antibody to BTV.

9.

Examine and record the plates either visually or using a spectrophotometric reader.

Analysis of results: U.K.

Using the software package print out the optical density (OD) values, and the percentage inhibition (PI) for test and control sera based on the mean value recorded in the antigen control wells. The date expressed as OD and PI values are used to determine whether the test has performed within acceptable limits. The upper control limits (UCL) and lower control limits (LCL) for the Mab control (antigen plus Mab in the absence of test sera) are between OD values 0,4 and 1.4. Any plate that fails to conform to the above criteria must be rejected.

If a computer software package is not available print out the OD values using the ELISA printer. Calculate the mean OD value for the antigen control wells, which is equivalent to the 100 % value. Determine the 50 % OD value and manually calculate the positivity and negativity of each sample.

Percentage inhibition (PI) value = 100 – (OD of each test control/Mean OD of Cm) × 100.

The duplicate negative control serum wells and the duplicate blank wells must record PI values between + 25 % and – 25 %, and between + 95 % and + 105 %, respectively. Failure to be within these limits does not invalidate the plate but does suggest that background colour is developing. The strong and weak positive control sera must record PI values between + 81 % and + 100 %, and between + 51 % and + 80 %, respectively.

The diagnostic threshold for test sera is 50 % (PI 50 % or OD 50 %). Samples recording PI values >50 % are recorded negative. Samples that record PI values above and below the threshold for the duplicate wells are considered doubtful; such samples may be re-tested in the spot test and/or titration. Positive samples may also be titrated to provide an indication of the degree of positivity.

Visual reading: Positive and negative samples are easily discernible by eye; weakly positive or strong negative samples may be more difficult to interpret by eye.

Preparation of BTV ELISA antigen: U.K.

1.

Wash 40-60 roux of confluent BHK-21 cells three times with serum-free Eagle's medium and infect with bluetongue virus serotype 1 in serum-free Eagle's medium.

2.

Incubate at 37 °C and examine daily for cytopathic effect (CPE).

3.

When CPE are complete in 90 % to 100 % of the cell sheet of each roux, harvest the virus by shaking any still-attached cells from the glass.

4.

Centrifuge at 2 000 to 3 000 rpm to pellet the cells.

5.

Discard the supernatant and re-suspend the cells in approximately 30 ml of PBS containing 1 % ‘ Sarkosyl ’ and 2 ml phenylmethylsulphonyl fluoride (lysis buffer). This may cause the cells to form a gel and more lysis buffer may be added to reduce this effect. (NB: phenylmethylsulphonyl fluoride is harmful - handle with extreme caution.)

6.

Disrupt the cells for 60 seconds using an ultrasonic probe at an amplitude of 30 microns.

7.

Centrifuge at 10 000 rpm for 10 minutes.

8.

Store the supernatant at + 4 °C and re-suspend the remaining cell pellet in 10 to 20 ml of lysis buffer.

9.

Sonicate and clarify, storing the supernatant at each stage, a total of three times.

10.

Pool the supernatants and centrifuge at 24 000 rpm (100,000 g) for 120 minutes at + 4 °C over a 5 ml cushion of 40 % sucrose (w/v in PBS) using 30 ml Beckmann centrifuge tubes and an SW 28 rotor.

11.

Discard the supernatant, drain the tubes thoroughly and re-suspend the pellet in PBS by sonication. Store the antigen in aliquots at – 20 °C.

Titration of BTV ELISA antigen: U.K.

Bluetongue ELISA antigen is titrated by the indirect ELISA. Twofold dilutions of antigen are titrated against a constant dilution (1/100) monoclonal antibody 3-17-A3. The protocol is as follows:

1.

Titrate a 1:20 dilution of BTV antigen in PBS across the microtitre plate in a twofold dilution series (50 μl/well) using a multichannel pipette.

2.

Incubate for one hour at 37 °C on an orbital shaker.

3.

Wash plates three times with PBS.

4.

Add 50 μl of monoclonal antibody 3-17-A3 (diluted 1/100) to each well of the microtitre plate.

5.

Incubate for one hour at 37 °C on an orbital shaker.

6.

Wash plates three times with PBS.

7.

Add 50 μl of rabbit anti-mouse globulin conjugated to horseradish peroxidase, diluted to a pre-titrated optimal concentration, to each well of the microtitre plate.

8.

Incubate for one hour at 37 °C on an orbital shaker.

9.

Add substrate and chromogen as described previously. Stop the reaction after 10 minutes by the addition of 1 Molar sulphuric acid (50 μl/well).

In the competitive assay, the monoclonal antibody must be in excess, therefore a dilution of antigen is chosen which falls on the titration curve (not on the plateau region) which gives approximately 0,8 OD after 10 minutes.

B.

The agar gel immuno-diffusion test shall be carried out according to the following protocol: U.K.

Antigen: U.K.

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of a reference strain of bluetongue virus. BHK or Vero cells are recommended. Antigen is present in the supernatant fluid at the end of virus growth but requires 50 to 100-fold concentration to be effective. This may be achieved by any standard protein concentration procedure; virus in the antigen may be inactivated by the addition of 0,3 % (v/v) beta-propiolactone.

Known positive control serum: U.K.

Using the international reference serum and antigen a national standard serum is produced, standardised for optimal proportion against the international reference serum, freeze-dried and used as the known control serum in each test.

Test serum U.K.

Procedure

:

1 % agarose prepared in borate or sodium barbitol buffer, pH 8,5 to 9,0, is poured into a petri dish to a minimum depth of 3,0 mm. A test pattern of seven moisture-free wells, each 5,0 mm in diameter, is cut in the agar. The pattern consists of one centre well and six wells arranged round it in a circle of radius 3 cm. The central well is filled with the standard antigen. Peripheral wells 2, 4 and 6 are filled with known positive serum, wells 1, 3 and 5 are filled with test sera. The system is incubated for up to 72 hours at room temperature in a closed humid chamber.

Interpretation

:

A test serum is positive if it forms a specific precipitin line with the antigen and forms a complete line of identity with the control serum. A test serum is negative if it does not form a specific line with the antigen and it does not bend the line of the control serum. Petri dishes must be examined against a dark background and using indirect illumination.

Epizootic haemorrhagic disease (EHD) U.K.

The agar gel immuno-diffusion test shall be carried out according to the following protocol: U.K.

Antigen: U.K.

Precipitating antigen is prepared in any cell culture system that supports the rapid multiplication of the appropriate serotype(s) of epizootic haemorrhagic disease virus. BHK or Vero cells are recommended. Antigen is present in the supernatant fluid at the end of virus growth but requires 50 to 100-fold concentration to be effective. This may be achieved by any standard protein concentration procedure; virus in the antigen may be inactivated by the addition of 0,3 % (v/v) beta-propiolactone.

Known positive control serum: U.K.

Using the international reference serum and antigen a national standard serum is produced, standardised for optimal proportion against the international reference serum, freeze-dried and used as the known control serum in each test.

Test serum U.K.

Procedure

:

1 % agarose prepared in borate or sodium barbitol buffer, pH 8,5 to 9,0, is poured into a petri dish to a minimum depth of 3,0 mm. A test pattern of seven moisture-free wells, each 5,0 mm in diameter, is cut in the agar. The pattern consists of one centre well and six wells arranged round it in a circle of radius 3 cm. The central well is filled with the standard antigen. Peripheral wells 2, 4 and 6 are filled with known positive serum, wells 1, 3 and 5 are filled with test sera. The system is incubated for up to 72 hours at room temperature in a closed humid chamber.

Interpretation

:

A test serum is positive if it forms a specific precipitin line with the antigen and forms a complete line of identity with the control serum. A test serum is negative if it does not form a specific line with the antigen and it does not bend the line of the control serum. Petri dishes must be examined against a dark background and using indirect illumination.

Infectious bovine rhinotracheitis (IBR) / infectious pustular vulvo-vaginitis (IPV) U.K.

A. The serum neutralisation test shall be carried out according to the following protocol: U.K.

Serum

:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure

:

The constant virus-varying serum neutralisation test on microtitre plates employs MDBK or other susceptible cells. The Colorado, Oxford or any other reference strain of the virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for 24 hours at 37 °C in the microtitre plates before the MDBK cells are added. Cells are used at a concentration which forms a complete monolayer after 24 hours.

Controls

:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation

:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to six days incubation at 37 °C. Serum titres are considered negative if there is no neutralisation at a dilution of 1/2 (undiluted serum).

B. Any other test recognised in the framework of Decision 2004/558/EC (21) . U.K.

Foot-and-mouth disease (FMD) U.K.

A. Collecting oesophageal/pharyngeal samples and testing shall be carried out according to the following protocol: U.K.

Reagents

:

Prior to sampling, transport medium is prepared. Two ml volumes are dispensed in as many containers as there are animals to be sampled. The containers used must withstand freezing over solid CO ₂ or liquid nitrogen. Samples are obtained by the use of a specially-designed sputum collector or ‘probang’. To obtain a sample the probang cup is passed through the mouth, over the dorsum of the tongue and down into the upper part of the oesophagus. Attempts are made to scrape the surface epithelium of the upper oesophagus and pharynx by movements directed laterally and dorsally. The probang is then withdrawn, if possible after the animal has swallowed. The cup must be full and contain a mixture of mucus, saliva, oesophageal fluid and cellular debris. Care must be taken to ensure that each specimen contains some visible cellular material. Very rough handling which causes bleeding must be avoided. Samples from some animals may be heavily contaminated with ruminal contents. Such samples must be discarded and the mouth of the animal flushed with water, or preferably physiological saline, before repeat sampling.

Treatmentof samples:

:

Each sample collected in the probang cup is examined for quality and 2 ml added to an equal volume of transport medium in a container which can withstand freezing. The containers are tightly closed, sealed, disinfected and labelled. The samples are kept cool (+ 4 °C) and examined within three to four hours or placed over dry ice (- 69 °C) or liquid nitrogen and kept frozen until examined. Between animals the probang is disinfected and washed in three changes of clean water.

Testing for FMD virus:

:

Samples are inoculated into cultures of primary bovine thyroid cell cultures using at least three tubes per sample. Other susceptible cells such as primary bovine or porcine kidney cells can be used but it must be kept in mind that for some strains of FMD virus they are less sensitive. The tubes are incubated at 37 °C on a roller apparatus and examined daily for 48 hours for the presence of a cytopathic effect (CPE). If negative, cultures are blind passaged onto new cultures and re-examined for 48 hours. The specificity of any CPE must be confirmed.

Recommended transport media:

1.

0,08M phosphate buffer pH 7,2 containing 0,01 % bovine serum albumin, 0,002 % phenol red and antibiotics.

2.

Tissue culture medium (such as Eagle's MEM) containing 0,04 M Hepes buffer, 0,01 % bovine serum albumin and antibiotics, pH 7,2.

3.

Antibiotics (per ml final) must be added to the transport medium such as penicillin 1 000 IU, neomycin sulphate100 IU, polymyxin B sulphate50 IU, mycostatin100 IU.

B. The virus neutralisation test shall be carried out according to the following protocol: U.K.

Reagents

:

Stock FMDV antigen is prepared in cell cultures or on cattle tongues and stored at - 70 °C or less or at - 20 °C after the addition of 50 % glycerol. This is the stock antigen. FMDV is stable under these conditions and titres vary little over a period of months.

Procedure

:

The test is carried out in flat-bottomed tissue culture grade microtitre plates using susceptible cells such as IB-RS-2, BHK-21 or calf kidney cells. Sera for the test are diluted 1/4 in serum-free cell culture medium with the addition of 100 IU/ml neomycin or other suitable antibiotics. Sera are inactivated at 56 °C for 30 minutes and 0.05 ml amounts are used to prepare a twofold series on microtitre plates using 0,05 ml diluting loops. Pre-titrated virus also diluted in serum-free culture medium and containing 100 TCID50/0.05 ml is then added to each well. Following incubation at 37 °C for one hour to allow neutralisation to take place, 0,05 ml of suspension cells containing 0,5 to 1.0 × 10 ⁶ cells per 1 ml in cell culture medium containing serum free of FMD antibody is added to each well and the plates are sealed. Plates are incubated at 37 °C. Monolayers are normally confluent within 24 hours. CPE is usually sufficiently advanced at 48 hours for a microscopic reading of the test. At this time a final microscopic reading may be made or the plates may be fixed and stained for macroscopic reading, for instance using 10 % formol-saline and 0,05 % methylene blue.

Controls

:

Controls in each test include homologous antiserum of known titre, a cell control, a serum toxicity control, a medium control, and a virus titration from which the actual amount of virus in the test is calculated.

Interpretation

:

Wells with evidence of CPE are considered to be infected and neutralisation titres are expressed as the reciprocal of the final dilution of serum present in the serum/virus mixtures at the 50 % end point estimated according to the Spearman-Karber method. (Karber, G., 1931, Archiv fuer Experimentelle Pathologie und Pharmokologie, 162, 480.). Tests are considered to be valid when the actual amount of virus used per well in the test is between 101,5 and 102,5 TCID50 and when the titre of the reference serum is within twofold of its expected titre, estimated from the mode of previous titrations. When the controls are outside these limits the tests are repeated. An end point titre of 1/11 or less is taken as negative.

C. The detection and quantification of antibody by ELISA shall be carried out according to the following protocol: U.K.

Reagents

:

Rabbit antisera to 146S antigen of seven types of foot-and-mouth disease virus (FMDV) used at a predetermined optimum concentration in carbonate/bicarbonate buffer, pH 9,6. Antigens are prepared from selected strains of virus grown on monolayers of BHK-21 cells. The unpurified supernatants are used and pretitrated according to the protocol but without serum, to give a dilution which after the addition of an equal volume of PBST (phosphate buffered saline containing 0,05 % Tween-20 and phenol red indicator) would give an optical density reading of between 1,2 and 1,5. The viruses can be used inactivated. PBST is used as a diluent. Guinea-pig antisera are prepared by inoculating guinea pigs with 146S antigen of each serotype. A predetermined optimum concentration is prepared in PBST containing 10 % normal bovine serum and 5 % normal rabbit serum. Rabbit anti-guinea-pig immunoglobulin conjugated to horseradish peroxidase is used at a predetermined optimum concentration in PBST containing 10 % normal bovine serum and 5 % normal rabbit serum. Test sera are diluted in PBST.

Procedure: U.K.

1.

ELISA plates are coated with 50 μl of rabbit antiviral sera overnight in a humidity chamber at room temperature.

2.

Fifty microlitres of a duplicate, twofold series of each test serum starting at 1/4 are prepared in U-bottomed multiwell plates (carrier plates). Fifty microlitres of a constant dose of antigen are added to each well and the mixtures are left overnight at 4 °C. The addition of the antigen reduces the starting serum dilution to 1/8.

3.

The ELISA plates are washed five times with PBST.

4.

Fifty microlitres of serum/antigen mixtures are then transferred from the carrier plates to the rabbit-serum-coated ELISA plates and incubated at 37 °C for one hour on a rotary shaker.

5.

After washing, 50 μl of guinea-pig antiserum to the antigen used in point 4 is added to each well. The plates are incubated at 37 °C for one hour a rotary shaker.

6.

The plates are washed and 50 μl of rabbit anti-guinea-pig immunoglobulin conjugated to horseradish peroxidase is added to each well. The plates are incubated at 37 °C for one hour on a rotary shaker.

7.

The plates are washed and 50 μl of orthophenylene diamine containing 0,05 % H ₂ O ₂ (30 %) w/v is added to each well.

8.

The reaction is stopped after 15 minutes with 1,25M H ₂ SO ₄ .

The plates are read spectrophotometrically at 492 nm on an ELISA reader linked to a microcomputer.

Controls

:

For each antigen used 40 wells contain no serum but contain antigen diluted in PBST. A duplicated twofold dilution series of homologous bovine reference antiserum. A duplicate twofold dilution series of negative bovine serum.

Interpretation

:

Antibody titres are expressed as the final dilution of tests serum giving 50 % of the mean OD value recorded in the virus control wells where test serum is absent. Titres in excess of 1/40 are considered positive.

References

:

Hamblin C, Barnett ITR and Hedger RS (1986) ‘ A new enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies against foot-and-mouth disease virus. I. Development and method of ELISA. ’ Journal of Immunological Methods, 93, 115 to 121.11.

Aujeszky's disease (AJD) U.K.

A. The serum neutralisation test shall be carried out according to the following protocol: U.K.

Serum

:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure

:

The constant virus-varying serum neutralisation test on microtitre plates employs Vero or other sensitive cell systems. Aujeszky's disease virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for two hours at 37 °C in the microtitre plates before the appropriate cells are added. Cells are used at a concentration which forms a complete monolayer after 24 hours.

Controls

:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation

:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to seven days incubation at 37 °C. Serum titres less than 1/2 (undiluted serum) are considered negative.

B. Any other test recognised in the framework of Decision 2008/185/EC (22) . U.K.

Transmissible gastro-enteritis (TGE) U.K.

The serum neutralisation test shall be carried out according to the following protocol:

Serum

:

All sera are heat-inactivated at 56 °C for 30 minutes before use.

Procedure

:

The constant virus-varying serum neutralisation test on microtitre plates employs A72 (dog tumour) cells or other sensitive cell systems. TGE virus is used at 100 TCID50 per 0,025 ml; inactivated undiluted serum samples are mixed with an equal volume (0,025 ml) of virus suspension. The virus/serum mixtures are incubated for 30 to 60 minutes at 37 °C in the microtitre plates before the appropriate cells are added. Cells are used at a concentration which forms a complete monolayer after 24 hours. Each cell receives 0,1 ml of cell suspension.

Controls

:

(i) virus infectivity assay, (ii) serum toxicity controls, (iii) uninoculated cell culture controls, (iv) reference antisera.

Interpretation

:

The results of the neutralisation test and the titre of the virus used in the test are recorded after three to five days incubation at 37 °C. Serum titres less than 1/2 (final dilution) are considered negative. If undiluted serum samples are toxic to the tissue cultures, these sera may be diluted 1/2 before being used in the test. This is equivalent to 1/4 final dilution of serum. Serum titres of less than 1/4 (final dilution) are considered negative in these cases.

Swine vesicular disease (SVD) U.K.

Tests for swine vesicular disease (SVD) shall be carried out according to Decision 2000/428/EC (23) .

Classical swine fever (CSF) U.K.

Tests for classical swine fever (CSF) shall be carried out according to Decision 2002/106/EC (24) .

The performance of tests for CSF must follow the guidelines set out in the relevant chapter of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

The evaluation of sensitivity and specificity of the serological test for CSF must be carried out in a national laboratory with a quality assurance scheme in place. Tests employed must be shown to recognise a range of weak and strong positive reference sera and allow detection of antibody in early phase and convalescence.

[F95 Vesicular stomatitis (VS) U.K.

The virus neutralisation (VN) test shall be carried out in accordance with the testing protocols for vesicular stomatitis set out in Chapter 2.1.19 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.

Sera that prevent cytopathic effect (CPE) at dilutions of 1 in 32 or greater shall be considered to contain antibodies to the vesicular stomatitis virus.]

F108 PART 7 U.K. Import and quarantine animal health conditions for animals imported into St. Pierre and Miquelon within a period of less than six months prior to introduction into the Union (referred to in Article 6)

F108 Animal species covered U.K.

F108 CHAPTER 1 U.K. Residence and quarantine

F108 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 CHAPTER 2 U.K. Animal health tests

F108 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

F108 2.1.13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . U.K.

Textual Amendments

F108 Annex 1 Pt. 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), 56(28)(e) (with regs. 69-71)

ANNEX II U.K. FRESH MEAT

[F107 PART 1 U.K.

List of third countries, territories and parts thereof ^a

Footnotes:
a Without prejudice to specific certification requirements provided for in [F109 agreements between the United Kingdom and third countries].
b Meat from animals slaughtered on or before the date set out in column 7 may be imported into [F110 Great Britain] for 90 days from that date. Consignments carried on vessels on the high seas may be imported into [F110 Great Britain] if certified before the date set out in column 7 for 40 days from that date.(N.B.: no date in column 7 means that there are no time restrictions).
c Only meat from animals slaughtered on or after the date set out in column 8 may be imported into [F110 Great Britain] (no date in column 8 means that there are no time restrictions).
d F88 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
e Not including Kosovo which is at present under international administration pursuant to United Nations Security Council Resolution 1244 of 10 June 1999 .
f [F100 Hereafter understood as the State of Israel, excluding the territories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank.]
g [F111 Only for fresh meat originating from New Zealand, for which New Zealand is authorised for introduction into [F110 Great Britain], which is accompanied by the appropriate model of veterinary certificate issued by the competent authority of New Zealand, destined to [F110 Great Britain] and being unloaded, with or without storage and reloaded in an approved establishment during transit through Singapore.
h Upon entry into [F110 Great Britain], the consignments should be accompanied both by this model of veterinary certificate issued in TRACES by the competent authority of Singapore and by the appropriate model of veterinary certificate for import of fresh meat issued by the competent authority of New Zealand, which may be attached in TRACES by the competent authority of Singapore.]
i F88 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
j [F112 Only for transit of consignments of fresh meat of domestic bovine animals via Bulgaria into Turkey.]
l [F113 This is subject to any specific certification requirements for imports from EU member States, Liechtenstein and Norway, in such form as the Secretary of State may, with the consent of the appropriate authority, publish from time to time.]
* = [F114 This is subject to any specific certification requirements for imports from Switzerland, in such form as the Secretary of State may, with the consent of the appropriate authority, publish from time to time.] — = No certificates are laid down and fresh meat imports are prohibited (except for those species where indicated in the line comprising the entry for the whole country).
‘ 1 ’ Category restrictions:
No offal is authorised for introduction into [F110 Great Britain] (except, in the case of bovine species, diaphragm and masseter muscles). ]
ISO code and name of third country	Code of Territory	Description of third country, territory or part thereof	Veterinary certificate		Specific conditions	Closing date b	Opening date c
			Model(s)	SG
1	2	3	4	5	6	7	8
AL – Albania	AL-0	Whole country	—
[F89 AR-Argentina	AR-0	Whole country	EQU
	AR-1	The provinces of: Part of Buenos Aires (excluding territory included in AR-4), Catamarca, Corrientes, Entre Ríos, La Rioja, Mendoza, Misiones, San Juan, San Luis, Santa Fe, Tucuman, Cordoba, La Pampa, Santiago del Estero, Chaco, Formosa, Jujuy, Salta (excluding territory included in AR-3).	BOV RUF RUW	A	1		1 August 2010
	AR-2	The provinces of: Chubut, Santa Cruz, Tierra del Fuego, Part of Neuquén (excluding territory included in AR-4), Part of Río Negro (excluding territory included in AR-4)	BOV OVI RUW RUF				1 August 2008
	AR-3	Part of Salta: the area of 25 km from the border with Bolivia and Paraguay that extends from the Santa Catalina District in the Province of Jujuy, to the Laishi District in the Province of Formosa (the former high-surveillance buffer area)	BOV RUF RUW	A	1		1 July 2016
	AR-4	The provinces of: Part of Neuquén (in Confluencia the zone located east of the Provincial road 17, and in Picun Leufú the zone located east of the Provincial road 17) Part of province of Río Negro (in Avellaneda the zone located north of the Provincial road 7 and east of the Provincial road 250, in Conesa the zone located east of the Provincial road 2, in El Cuy the zone located north of the Provincial road 7 from its intersection with the Provincial road 66 to the border with the Department of Avellaneda, and in San Antonio the zone located east of the Provincial roads 250 and 2) Part of Buenos Aires (Partido (district) de Patagones).	BOV OVI RUW RUF				8 July 2019]
AU – Australia	AU-0	Whole country	BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
[F91 BA – Bosnia and Herzegovina j	BA-0	Whole country	BOV ]
BH – Bahrain	BH-0	Whole country	—
[F115 BR — BRAZIL	BR-0	Whole country	EQU
	BR-1	State of Minas Gerais, State of Espírito Santo, State of Goiás, State of Mato Grosso, State of Rio Grande Do Sul, State of Mato Grosso Do Sul (excluding territory included in BR-4).	BOV	A and H	1		1 December 2008
	BR-2	State of Santa Catarina	BOV	A and H	1		31 January 2008
	BR-3	States of Paraná and São Paulo	BOV	A and H	1		1 August 2008
	BR-4	Part of State of Mato Grosso Do Sul: The area of 15 km from the external borders in the municipalities of Porto Murtinho, Caracol, Bela Vista, Antônio João, Ponta Porã, Aral Moreira, Coronel Sapucaia, Paranhos, Sete Quedas, Japorã, and Mundo Novo and the area in the municipalities of Corumbá and Ladário (the former designated high-surveillance area)	BOV	A and H	1		1 July 2016]
[F116 BW — Botswana	BW-0	Whole country	EQU, EQW
	BW-1	The veterinary disease control zones 3c, 4b, 5, 8, 9 and 18	BOV, OVI, RUF, RUW	F	1	11 May 2011	26 June 2012
	BW-2	The veterinary disease control zones 10, 11, 13 and 14	BOV, OVI, RUF, RUW	F	1		7 March 2002
	BW-3	The veterinary disease control zone 12	BOV, OVI, RUF, RUW	F	1	20 October 2008	20 January 2009
	BW-4	The veterinary disease control zone 4a, except the intensive surveillance buffer zone of 10 km along the boundary with the foot-and-mouth disease vaccination zone and wildlife management areas	BOV	F	1	28 May 2013	18 February 2011
	BW-5	The veterinary disease control zones 6a and 6b	BOV, OVI, RUF, RUW	F	1	28 May 2013	18 August 2016]
BY – Belarus	BY-0	Whole country	—
BZ – Belize	BZ-0	Whole country	BOV, EQU
CA – Canada	CA-0	Whole country	BOV, OVI, POR, EQU, SUF, SUW, RUF, RUW	G
CH – Switzerland	CH-0	Whole country	*
CL – Chile	CL-0	Whole country	BOV, OVI, POR, EQU, RUF, RUW, SUF
CN – China	CN-0	Whole country	—
CO – Colombia	CO-0	Whole country	EQU
CR – Costa Rica	CR-0	Whole country	BOV, EQU
CU – Cuba	CU-0	Whole country	BOV, EQU
DZ – Algeria	DZ-0	Whole country	—
[F113 EU member States, Liechtenstein and Norway l		Whole country of each state	BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW]
ET – Ethiopia	ET-0	Whole country	—
FK – Falkland Islands	FK-0	Whole country	BOV, OVI, EQU
GL – Greenland	GL-0	Whole country	BOV, OVI, EQU, RUF, RUW
GT – Guatemala	GT-0	Whole country	BOV, EQU
HK – Hong Kong	HK-0	Whole country	—
HN – Honduras	HN-0	Whole country	BOV, EQU
F93
F93
[F94 IL – Israel f	IL-0	Whole country	— ]
IN – India	IN-0	Whole country	—
IS – Iceland	IS-0	Whole country	BOV, OVI, EQU, RUF, RUW
[F117 JP — Japan	JP	Whole country	BOV				28 March 2013]
KE – Kenya	KE-0	Whole country	—
MA – Morocco	MA-0	Whole country	EQU
ME – Montenegro	ME-0	Whole country	BOV, OVI, EQU
MG – Madagascar	MG-0	Whole country	—
[F89 MK-The Republic of North Macedonia	MK-0	Whole country	BOV, OVI, EQU ]
MU – Mauritius	MU-0	Whole country	—
MX – Mexico	MX-0	Whole country	BOV, EQU
NA – Namibia	NA-0	Whole country	EQU, EQW
	NA-1	South of the cordon fences which extend from Palgrave Point in the west to Gam in the east	BOV, OVI,RUF, RUW	F and J	1
NC – New Caledonia	NC-0	Whole country	BOV, RUF, RUW
NI – Nicaragua	NI-0	Whole country	—
NZ – New Zealand	NZ-0	Whole country	BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
PA – Panama	PA-0	Whole country	BOV, EQU
[F94 PY – Paraguay	PY-0	Whole country	EQU
	PY-0	Whole country	BOV	A	1		17 April 2015]
RS – Serbia e	RS-0	Whole country	BOV, OVI, EQU
RU – Russia	RU-0	Whole country	—
	RU-1	Region of Murmansk, Yamolo-Nenets autonomous area	RUF
[F111 SG — Singapore g	SG-0	Whole country	NZ-TRANSIT-SG ]h
SV – El Salvador	SV-0	Whole country	—
SZ – Swaziland	SZ-0	Whole country	EQU, EQW
	SZ-1	Area west of the ‘ red line ’ fences which extends northwards from the river Usutu to the frontier with South Africa west of Nkalashane,	BOV, RUF, RUW	F	1
	SZ-2	The veterinary foot and mouth disease surveillance and vaccination control areas as gazetted as a Statutory Instrument under legal notice number 51 of 2001	BOV, RUF, RUW	F	1		4 August 2003
TH – Thailand	TH-0	Whole country	—
TN – Tunisia	TN-0	Whole country	—
TR – Turkey	TR-0	Whole country	—
	TR-1	The provinces of Amasya, Ankara, Aydin, Balikesir, Bursa, Cankiri, Corum, Denizli, Izmir, Kastamonu, Kutahya, Manisa, Usak, Yozgat and Kirikkale	EQU
UA – Ukraine	UA-0	Whole country	—
US – United States	US-0	Whole country	BOV, OVI, POR, EQU,SUF, SUW, RUF, RUW	G
[F118 UY – Uruguay	UY-0	Whole country	EQU
			BOV	A and J	1		1 November 2001
			OVI	A	1 ]
[F119 ZA – South Africa	ZA-0	Whole country	EQU, EQW ]
	F120
ZW – Zimbabwe	ZW-0	Whole country	—

Textual Amendments

F109 Words in Annex 2 Pt. 1 table 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), 56(29)(a)(ii)(aa) (with regs. 69-71)

F110 Words in Annex 2 Pt. 1 table 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), 56(29)(a)(ii)(bb) (with regs. 69-71)

F111 Inserted by Commission Implementing Regulation (EU) 2016/535 of 5 April 2016 amending Annex II to Regulation (EU) No 206/2010 as regards the entry of Singapore in the list of third countries, territories or parts thereof from which the introduction into the Union of fresh meat is authorised (Text with EEA relevance).

F112 Inserted by Commission Implementing Regulation (EU) 2017/384 of 2 March 2017 amending Annexes I and II to Regulation (EU) No 206/2010 as regards the models of veterinary certificates BOV-X, OVI-X, OVI-Y and RUM and the lists of third countries, territories or parts thereof from which the introduction into the Union of certain ungulates and of fresh meat is authorised (Text with EEA relevance).

F113 Words in Annex 2 Pt. 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), 56(29)(a)(i) (with regs. 69-71)

F114 Words in Annex 2 Pt. 1 table 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), 56(29)(a)(iii) (with regs. 69-71)

F115 Substituted by Commission Implementing Regulation (EU) 2016/922 of 10 June 2016 amending Annex II to Regulation (EU) No 206/2010 as regards the list of third countries, territories or parts thereof from which the introduction into the Union of fresh meat is authorised (Text with EEA relevance).

F116 Substituted by Commission Implementing Regulation (EU) 2016/1248 of 28 July 2016 amending Annex II to Regulation (EU) No 206/2010 as regards the entry for Botswana in the list of third countries, territories or parts thereof from which the introduction into the Union of fresh meat is authorised (Text with EEA relevance).

F117 Inserted by Commission Implementing Regulation (EU) No 196/2013 of 7 March 2013 amending Annex II to Regulation (EU) No 206/2010 as regards the new entry for Japan in the list of third countries or parts thereof from which imports into the European Union of certain fresh meat are authorised (Text with EEA relevance).

F118 Substituted by Commission Implementing Regulation (EU) No 71/2013 of 25 January 2013 amending Regulation (EU) No 206/2010 as regards the entry for Uruguay in the list of third countries, territories or parts thereof authorised for the introduction of fresh meat into the Union and correcting that Regulation as regards the model veterinary certificate for ovine and caprine animals intended for breeding or production after importation (Text with EEA relevance).

F119 Substituted by Commission Implementing Regulation (EU) No 342/2011 of 8 April 2011 amending Annex II to Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F120 Deleted by Commission Implementing Regulation (EU) 2020/386 of 9 March 2020 amending Annex II to Decision 2007/777/EC as regards the list of third countries or parts thereof from which the introduction into the Union of meat products and treated stomachs, bladders and intestines is authorised, and amending Annex II to Regulation (EU) No 206/2010 as regards the list of third countries, territories or parts thereof from which the introduction into the Union of fresh meat is authorised (Text with EEA relevance).

Modifications etc. (not altering text)

C2 Annex 2 Pt. 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), 9; 2020 c. 1, Sch. 5 para. 1(1)

F121 PART 2 U.K. Models of veterinary certificates

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

Textual Amendments

F121 Annex 2 Pt. 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), 56(29)(b) (with regs. 69-71)

F122 ANNEX III U.K.

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

Textual Amendments

F122 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), 56(30) (with regs. 69-71)

ANNEX IV U.K. ANIMALS REFERRED TO IN ARTICLE 1(1)(b)

PART 1 U.K. Lists of third countries, territories or parts thereof

SECTION 1 U.K. Parts of third countries or territories referred to in Article 7(2)

a Suspended from 5 May 2010 .] ]
[F123 Country/territory	Code of part of the country/territory	Description of part of the country/territory
US – United States	US-A	The State of Hawaii a

Textual Amendments

F123 Substituted by Commission Regulation (EU) No 810/2010 of 15 September 2010 amending Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).

F124 PART 2 U.K. Tables of animals and the corresponding model veterinary certificates

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

Textual Amendments

F124 Annex 4 Pt. 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), 56(31) (with regs. 69-71)

F125 ANNEX V U.K. Explanatory notes for completing the veterinary certificates (referred to in Article 18)

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

Textual Amendments

F125 Annex 5 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), 56(32) (with regs. 69-71)

[F15 ANNEX VI U.K.

PART 1 U.K.

Table 1
‘RUM-A’ : [F126 Model veterinary certificate, in the form published by the appropriate authority from time to time,] for animals of the species listed below that are originating from and intended for an approved body, institute or centre.
Order	Family	Genera/species
Artiodactyla	Antilocapridae	Antilocapra ssp.
	Bovidae	Addax ssp., Aepyceros ssp., Alcelaphus ssp., Ammodorcas ssp., Ammotragus ssp., Antidorcas ssp., Antilope ssp., Bison ssp., Bos ssp. (including Bibos, Novibos, Poephagus), Boselaphus ssp., Bubalus ssp. (including anoa), Budorcas ssp., Capra ssp., Cephalophus ssp., Connochaetes ssp., Damaliscus ssp. (including Beatragus), Dorcatragus ssp., Gazella ssp., Hemitragus ssp., Hippotragus ssp., Kobus ssp., Litocranius ssp., Madoqua ssp., Naemorhedus ssp. (including Nemorhaedus and Capricornis), Neotragus ssp., Oreamnos ssp., Oreotragus ssp., Oryx ssp., Ourebia ssp., Ovibos ssp., Ovis ssp., Patholops ssp., Pelea ssp., Procapra ssp., Pseudois ssp., Pseudoryx ssp., Raphicerus ssp., Redunca ssp., Rupicapra ssp., Saiga ssp., Sigmoceros-Alecelaphus ssp., Sylvicapra ssp., Syncerus ssp., Taurotragus ssp., Tetracerus ssp., Tragelaphus ssp. ( including Boocerus ).
	Camelidae	Camelus ssp., Lama ssp., Vicugna ssp.
	Cervidae	Alces ssp., Axis-Hyelaphus ssp., Blastocerus ssp., Capreolus ssp., Cervus-Rucervus ssp., Dama ssp., Elaphurus ssp., Hippocamelus ssp., Hydropotes ssp., Mazama ssp., Megamuntiacus ssp., Muntiacus ssp., Odocoileus ssp., Ozotoceros ssp., Pudu ssp., Rangifer ssp.
	Giraffidae	Giraffa ssp., Okapia ssp.
	Moschidae	Moschus ssp.
	Tragulidae	Hyemoschus ssp., Tragulus-Moschiola ssp.

Textual Amendments

F126 Words in Annex 6 Pt. 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), 56(33)(a) (with regs. 69-71)

Table 2
‘SUI-A’ : [F126 Model veterinary certificate, in the form published by the appropriate authority from time to time,] for animals of the species listed below that are originating from and intended for an approved body, institute or centre.
Order	Family	Genera/species
Artiodactyla	Suidae	Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp., Potamochoerus ssp., Sus ssp.
	Tayassuidae	Catagonus ssp., Pecari-Tayassu ssp.
	Hippopotamidae	Hexaprotodon-Choeropsis ssp., Hippopotamus ssp.

Table 3
‘TRE-A’ : [F126 Model veterinary certificate, in the form published by the appropriate authority from time to time,] for animals of the species listed below that are originating from and intended for an approved body, institute or centre.
Order	Family	Genera/species
Perissodactyla	Tapiridae	Tapirus ssp.
	Rhinocerotidae	Ceratotherium ssp., Dicerorhinus ssp., Diceros ssp., Rhinoceros ssp.
Proboscidea	Elephantidae	Elephas ssp., Loxodonta ssp.

F127 PART 2 U.K.

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

Textual Amendments

F127 Annex 6 Pt. 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), 56(33)(b) (with regs. 69-71)

PART 3 U.K. Requirements concerning bodies, institutes or centres in third countries

The body, institute or centre in a third country must:

(a)

be clearly demarcated and separated from its surroundings;

(b)

have adequate means for catching, confining and isolating animals, and have available adequate quarantine facilities and approved standard operating procedures for animals coming from unknown origin;

(c)

have a vector-protected structure complying with the following requirements:

(i)

it has appropriate physical barriers at entry and exit points;

(ii)

the openings of the vector-protected structure are vector-screened with mesh of appropriate gauge impregnated regularly with an approved insecticide according to the instructions of the manufacturer;

(iii)

vector surveillance and control are carried out within and around the vector-protected structure;

(iv)

measures are taken to limit or eliminate breeding sites for vectors in the vicinity of the vector-protected structure;

(v)

standard operating procedures are in place, including descriptions of back-up and alarm systems, for the operation of the vector-protected structure and for the transport of the animals from that structure to the place of loading;

(d)

keep, for a minimum period of ten years, up-to-date records indicating:

(i)

the number and identity (age, sex, species and individual identification, where appropriate) of the animals of each species present on their premises;

(ii)

the number and identity (age, sex, species and individual identification where appropriate) of animals arriving in or leaving their premises, together with information on their origin or destination, the means of transport, and the health status of those animals;

(iii)

the results of blood tests or any other diagnostic procedures carried out on the animals on their premises;

(iv)

cases of disease and, where appropriate, the treatment administered;

(v)

the results of the post-mortem examinations on animals that have died on their premises, including still-born animals;

(vi)

observations made during any isolation or quarantine period;

(e)

be free from the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F128 , in the form published by the appropriate authority from time to time], for at least the previous three years, as evidenced by the records kept pursuant to point (d) and the results of the clinical and laboratory tests carried out on the animals on their premises;

(f)

either have an arrangement with a laboratory approved by the competent authority to perform post-mortem examinations, or have one or more appropriate premises where these examinations may be performed under the authority of the approved veterinarian;

(g)

ensure disposal of the carcasses of animals which die of a disease or are euthanised;

(h)

secure, by contract or legal instrument, the services of a veterinarian approved by and acting under the control of the competent authority, who must perform at least the following tasks:

(i)

ensure that appropriate disease surveillance and control measures are applied in that body, institute or centre. Such measures must be approved by the competent authority of the third country, territory or part thereof where the body, institute or centre is situated, taking into account the disease situation and must include at least the following elements:

• an annual disease surveillance plan including appropriate control measures concerning zoonoses in the animals present on the premises,

• clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases and zoonoses,

• vaccination of susceptible animals against infectious diseases and zoonoses;

(ii)

ensure that any suspect deaths or the presence of any other symptom suggesting that animals have contracted one or more of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F129 , in the form published by the appropriate authority from time to time,] are notified without delay to the competent authority, where that particular disease is notifiable in the third country, territory or part thereof concerned;

(iii)

ensure that incoming animals have been quarantined as necessary, in accordance with the instructions given by the competent authority;

(iv)

ensure compliance with the animal health requirements which the animals must fulfil in order to be introduced into [F130 Great Britain].

Textual Amendments

F128 Words in Annex 6 Pt. 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), 56(33)(c)(i) (with regs. 69-71)

F129 Words in Annex 6 Pt. 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), 56(33)(c)(ii)(aa) (with regs. 69-71)

F130 Words in Annex 6 Pt. 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), 56(33)(c)(ii)(bb) (with regs. 69-71)

PART 4 U.K. Conditions concerning the approval of bodies, institutes or centres in third countries

1. Approval must be granted only to those bodies, institutes or centres which comply with the requirements set out in Part 3. U.K.

2. Where vector protection is required, the approval of a structure as vector-protected must be granted only if the criteria in point (c) of Part 3 are met. In order to grant the approval, the competent authority must verify at least three times during the required protection period (at the beginning, during and at the end of the period) the effectiveness of the vector protection measures, by means of a vector trap inside the vector protected structure. U.K.

3. Each approved body, institute and centre must be assigned an approval number. U.K.

4. Approval must be maintained only as long as the following conditions continue to be met: U.K.

the premises are under the control of an official veterinarian, who must perform at least the following tasks:

(i)

inspect the premises of the body, institute or centre at least once per year;

(ii)

audit the activity of the veterinarian referred to in point (h) of Part 3 and the implementation of the annual disease surveillance plan referred to in the first indent of point (h)(i);

(iii)

ensure that the provisions laid down in Parts 3 and 4 are met;

(iv)

verify F131 ...:

• compliance with the animal health requirements which the animals must fulfil in order to be introduced into [F132 Great Britain];

• [F133 that] the results of the clinical, post-mortem and laboratory tests on the animals have revealed no occurrence of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F134 , in the form published by the appropriate authority from time to time].

Textual Amendments

F131 Word in Annex 6 Pt. 4 para. 4(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), 56(33)(d)(i)(aa) (with regs. 69-71)

F132 Words in Annex 6 Pt. 4 para. 4(iv) 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), 56(33)(d)(i)(bb) (with regs. 69-71)

F133 Word in Annex 6 Pt. 4 para. 4(iv) 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), 56(33)(d)(i)(cc) (with regs. 69-71)

F134 Words in Annex 6 Pt. 4 para. 4(iv) 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), 56(33)(d)(i)(cc) (with regs. 69-71)

5. The approval must be withdrawn where the competent authority finds that the requirements of Part 3 are no longer being fulfilled. U.K.

6. Where notification is given of the suspicion of the occurrence of one of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species [F135 , in the form published by the appropriate authority from time to time], the competent authority must suspend the approval of the body, institute or centre, until the suspicion has been officially ruled out. Depending on the disease involved and the risk of disease transmission, the suspension may relate to [F136 the body], institute or centre as a whole or only to certain categories of animals susceptible to the disease in question. The competent authority must ensure that the measures necessary to confirm or rule out the suspicion and to avoid any spread of disease are taken. U.K.

Textual Amendments

F135 Words in Annex 6 Pt. 4 para. 6 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), 56(33)(d)(ii)(aa) (with regs. 69-71)

F136 Words in Annex 6 Pt. 4 para. 6 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), 56(33)(d)(ii)(bb) (with regs. 69-71)

7. Where the suspected disease referred to in point 6 is confirmed, the approval of the body, institute or centre must be withdrawn. U.K.

8. Where the approval of a body, institute or centre has been withdrawn, it must be restored only where the following conditions are complied with: U.K.

(a)

the disease and the source of infection were eradicated on the premises of the body, institute or centre concerned;

(b)

the premises of the body, institute or centre concerned were appropriately cleaned and desinfected;

(c)

the body, institute or centre concerned complies with the requirements set out in points (a) to (d) and (f) to (h) of Part 3.

9. The competent authority which approved the body, institute or centre must inform the [F137 appropriate authority] that included the body, institute or centre on their lists of approved bodies, institutes and centres of the suspension, withdrawal or restoration of that approval.] U.K.

Textual Amendments

F137 Words in Annex 6 Pt. 4 para. 9 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), 56(33)(d)(iii) (with regs. 69-71)

(1)

[X1 OJ L 268, 14.9.1992, p. 54 .]

(2)

[X1 OJ L 18, 23.1.2003, p. 11 .]

(3)

[X1 OJ L 139, 30.4.2004, p. 321 .]

(4)

[X1 OJ L 139, 30.4.2004, p. 1 .]

(5)

[X1 OJ L 139, 30.4.2004, p. 55 .]

(6)

[X1 OJ L 139, 30.4.2004, p. 206 .]

(7)

[X1 OJ L 165, 30.4.2004, p. 1 .]

(8)

[X1 OJ L 302, 31.12.1972, p. 28 .]

(9)

[X1 OJ L 146, 14.6.1979, p. 15 .]

(10)

[X1 OJ L 157, 30.4.2004, p. 33 .]

(11)

[X1 OJ L 13, 16.1.1997, p. 28 .]

(12)

[X1 OJ L 125, 23.5.1996, p. 10 .]

(13)

[X1 OJ L 147, 31.5.2001, p. 1 .]

(14)

[X1 OJ L 340, 31.12.1993, p. 21 .]

(15)

[X1 OJ L 3, 5.1.2005, p. 1 .]

(16)

[X1 OJ L 328, 17.12.2003, p. 26 .]

(17)

[X1 [F15 OJ L 312, 30.11.2007, p. 49 .] ]

(18)

[X1 [F15 OJ L 226, 23.8.2008, p. 1 .] ]

(19)

[X1 [F15 OJ L 39, 10.2.2009, p. 12 .] ]

(20)

[X1 [F15 OJ L 175, 10.7.2010, p. 1 .'] ]

(21)

[X1 OJ L 249, 23.7.2004, p. 20 .]

(22)

[X1 OJ L 59, 4.3.2008, p. 19 .]

(23)

[X1 OJ L 167, 7.7.2000, p. 22 .]

(24)

[X1 OJ L 39, 9.2.2002, p. 71 .]

Editorial Information

X1 Substituted by Corrigendum to Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Official Journal of the European Union L 73 of 20 March 2010).

Textual Amendments

F15 Inserted by Commission Implementing Regulation (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance).