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[X1Commission 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)]

[X1THE 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

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 [F1Great 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, [F3and makes provision for the specification for the purposes of this Regulation by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), of territories or parts thereof,] from which the consignments referred to in paragraph 1 may be introduced into [F4Great Britain].

F53.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4. This Regulation shall apply without prejudice to any specific certification requirements laid down in other [F6retained EU law or in agreements concluded by the United Kingdom] with third countries.

Textual Amendments

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 [F72009/156/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)

[F8‘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.]

(i)

[F9“specific condition” has the meaning given in Article 2c;]

(j)

[F9“supplementary guarantee”—

(i)

in relation to ungulates, means the guarantee given under paragraph 2 of Article 2d;

(ii)

in relation to fresh meat, means the guarantee given under paragraph 2 of Article 13b.]

Textual Amendments

[F10Article 2aU.K.Publication of code representing country or part thereof

The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article a system of words, letters or numbers representing, for the purposes of a veterinary certificate under this Regulation, a third country listed in Annex 1 or Annex 2, or a territory or part thereof.

Textual Amendments

Article 2bU.K.Publication of closing date and opening date

1.The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article a “closing date” or an “opening date” in relation to a third country listed in Annex 2, or a territory or part thereof.

2.Meat from animals slaughtered on or before a closing date may be imported into Great Britain from the country or territory to which the closing date relates for 90 days from that date. Consignments carried on vessels on the high seas may be imported into Great Britain from the country or territory to which the closing date relates if certified before the closing date for 40 days from that date.

3.Where an opening date has been specified in relation to a third country or territory or part thereof under paragraph 1, only meat slaughtered on or after that opening date may be imported into Great Britain from that country or part.

Textual Amendments

Article 2cU.K.Specific conditions – live ungulates and fresh meat

1.The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose a specific condition on the introduction of an ungulate into Great Britain, or on the importation of fresh meat of an ungulate intended for human consumption into Great Britain.

2.The Secretary of State must publish any specific condition required under this Article in a document published for the purposes of this Article.

3.“Specific condition” means one of the conditions set out in the list headed “Specific Conditions (see footnotes in each certificate)” in Annex 1.

Textual Amendments

Article 2dU.K.Supplementary guarantees – live ungulates

1.The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose conditions relating to the protection of public health, animal health or food safety in Great Britain on the import of an ungulate into Great Britain from a third country listed in column 1 of Annex 1, or a territory or part thereof.

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

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

Textual Amendments

CHAPTER II U.K. CONDITIONS FOR THE INTRODUCTION OF LIVE ANIMALS INTO [F11GREAT BRITAIN]

Article 3U.K. General conditions for the introduction of ungulates into [F12Great Britain]

Consignments of ungulates shall only be introduced [F13from third countries] into [F14Great Britain] if they comply with the following conditions:

(a)

they come from [F15such of the third countries] listed in [F16column 1] of the table set out in Part 1 of Annex I [F17or a territory or part of any such third country, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article] 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 [F18, in the form published by the appropriate authority from time to time], taking into account [F19any specific conditions that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 2c], 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)

[F20any supplementary guarantees laid down in that certificate that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 2d;]

(ii)

any additional veterinary certification requirements that the [F21appropriate authority may include] in the certificate.

Textual Amendments

[F22 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, [F23the 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 [F24appropriate authority] of the animal health risks that each of the consignments may present for [F25Great Britain];

(b)the consignments concerned come from F26...:

(i)

[F27such of the third countries included in one of the lists set out in] Part 1 of Annex I or in Part 1 of Annex II to this Regulation [F28, or territories or parts thereof, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales) may specify in a document published for the purposes of this Article],

(ii)

[F29a third country, territory or part thereof which is included in one of the lists set out in, or specified by the Secretary of State in accordance with] [F30Regulation (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 [F31Great Britain];

(f)the ungulates are accompanied by an appropriate veterinary certificate, [F32in the form published by the appropriate authority from time to time];

(g)the ungulates comply with the requirements set out in the F33... veterinary certificate referred to in point (f).

F34...

2.Where exceptional circumstances render compliance with points (c) and (d) of paragraph 1 impossible, the [F35appropriate 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 [F36appropriate authority] has granted such permit after having carried out a risk assessment that has indicated that the introduction of the ungulates concerned F37... does not constitute an animal health risk F37...;

(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 [F38appropriate] 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.

[F39Where 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.]

[F403.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

[F41 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

[F22 Article 3c U.K. List of approved bodies, institutes or centres in third countries, territories and parts thereof

[F421.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.

[F433.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.[F44The 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.

[F45 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.]

F466.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ]

Textual Amendments

[F47 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 [F48Great 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 [F48Great Britain] in accordance with Article 3a F49... shall not originate from more than one holding and shall not be assembled in assembly centres.]

Textual Amendments

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 [F50Great 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

F51 Article 6 U.K. Special conditions for certain consignments of ungulates imported into St Pierre and Miquelon and introduced into the Union

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

Textual Amendments

Article 7 U.K. General conditions for the introduction into [F52Great Britain] of certain species of bees

1.Consignments of [F53queen bees (Apis mellifera and Bombus spp.) and bumble bees (Bombus spp.) shall only be introduced into Great Britain] from F54...:

(a)[F55such third countries] listed in Part 1 of Annex II [F56, or territories or parts thereof, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this paragraph];

(b)[F57third countries or territories] 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 [F58Great Britain] from a part of a third country or territory listed in Part 1 of Annex II [F59and specified by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), in a document published for the purposes of this paragraph,] 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 [F60Great 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 [F61referred 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 [F62referred to in paragraph 1] shall:

(a) be accompanied by the appropriate veterinary certificate, [F63in 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

Article 8 U.K. General conditions concerning the transport of live animals to [F64Great Britain]

During the period after loading in the third country of origin and before arrival at the [F65border control post] of introduction into [F64Great Britain], consignments of live animals shall not be:

(a)

transported together with live animals that:

(i)

are not intended for introduction into [F64Great Britain]; or

(ii)

are of a lower health status;

(b)

[F47unloaded 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 [F64Great Britain].]

Textual Amendments

Article 9 U.K. Time limit for the period of transport to [F66Great Britain] of live animals

Consignments of live animals shall only be introduced [F67from third countries into Great Britain] where the consignment arrives at the [F68border control post] F69... 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 [F70the 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

Article 10 U.K. Special conditions regarding the spraying of consignments of live animals transported by air to [F71Great 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 [F72the 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

Article 11 U.K. Conditions to be applied following the introduction into [F73Great Britain] of certain consignments of ungulates

[F471. Following their introduction into [F73Great 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 [F73Great 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

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

F74. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F75 Article 12a U.K. Derogation for the transit of certain consignments of live bovine animals for breeding and production through Lithuania

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

Textual Amendments

Article 13 U.K. Conditions to be applied following the introduction into [F76Great 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 [F77Great 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

[F22 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 [F78Great 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 F79... 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 [F80Great Britain], and

(b)[F81the 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

Textual Amendments

CHAPTER III U.K. CONDITIONS FOR THE INTRODUCTION OF FRESH MEAT INTO [F82GREAT 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 [F83Great Britain] if they comply with the following conditions:

(a)

they come from [F84such of the third countries] listed in [F85column 1] of the table in Part 1 of Annex II [F86or a territory or part of any such third country, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article] for which there is a [F87veterinary 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 [F88border control post] of introduction into [F89Great Britain accompanied by the appropriate veterinary certificate, in the form published by the appropriate authority from time to time], taking into account [F90any specific conditions that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 2c], 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)

[F91any supplementary guarantees that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 14b(2);]

(ii)

any additional veterinary certification requirements that the [F92appropriate authority may include] in the certificate.

Textual Amendments

[F93Article 14bU.K.Supplementary guarantees, fresh meat

1.The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose conditions relating to the protection of public health, animal health or food safety in Great Britain on the import into Great Britain of a consignment of meat intended for human consumption from a third country listed in column 1 of Annex 2, or a territory or part thereof.

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

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

Textual Amendments

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

In accordance with [F94Article 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

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

The introduction into [F95Great Britain] of consignments of fresh meat not intended for importation into [F95Great Britain] but destined for a third country either by immediate transit or after storage in [F95Great Britain] in accordance with [F96Commission Delegated Regulation (EU) 2019/2124], shall only be authorised if the consignments comply with the following conditions:

(a)

they come from [F97such of the third countries] listed in [F98column 1] of the table in Part 1 of Annex II [F99or territory or part of any such third country, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article], for which there is [F100an 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 [F101appropriate] veterinary certificate referred to in point (a);

(c)

they are accompanied by a veterinary certificate, drawn up in accordance with the model veterinary certificate [F102, 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)

[F103they 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

F104 Article 17 U.K. Derogation for transit through Latvia, Lithuania and Poland

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

Textual Amendments

F105 Article 17a U.K. Derogation for transit through Croatia of consignments coming from Bosnia and Herzegovina and destined to third countries

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

Textual Amendments

Textual Amendments

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

[F106Article 17bU.K.Matters relating to the exercise of powers under this Regulation

1.The powers exercisable by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), under the provisions listed in paragraph 2 are exercisable only where it is necessary or appropriate to do so in the light of an assessment of the risk to animal or public health in the United Kingdom, taking into account the public health criteria and matters specified in paragraph 3.

2.The provisions are—

(a)Article 2b (specification of closing date and opening date);

(b)Article 2c (specific conditions – live ungulates and fresh meat);

(c)Article 2d (supplementary guarantees – live ungulates);

(d)in Article 3 (specification of third country, territory or part thereof from which ungulates may be imported into Great Britain), paragraph 1;

(e)in Article 3a (specification of third country, territory or part thereof from which ungulates may be imported into Great Britain for an approved body, institute or centre), paragraph 1(b)(i);

(f)in Article 7, (specification of third country or part thereof from which certain species of bees may be imported into Great Britain), paragraph 1(a) and paragraph 2;

(g)in Article 14 (general conditions for the import into Great Britain of fresh meat), point (a);

(h)in Article 14b (supplementary guarantees – fresh meat), paragraph 1;

(i)Article 16 (specification of third countries and parts thereof authorised for the transit and storage of fresh meat).

3.Any assessment which is relied on for the purposes of paragraph 1 with regard to imports of ungulate animals listed in Annex 1 to Council Directive 2004/68/EC2 must be appropriate to the circumstances and have been approved by the Secretary of State, the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), taking into account—

(a)the health status of livestock, other domestic animals and wildlife and the environmental situation in the third country, with particular regard to the general situation as regards animal health in the third country and any animal disease that is exotic, notifiable or reportable in the United Kingdom that may pose a risk to the health and environmental situation of the United Kingdom;

(b)the legislation of the third country in relation to animal health and welfare;

(c)the organisation of the competent veterinary authority and its inspection services in the third country, the powers available to undertake those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply the third country’s legislation effectively;

(d)the assurances which the competent veterinary authority of the third country can give regarding compliance with legislation in that country that is of relevance to protection of animal health in the United Kingdom;

(e)whether the third country is a member of the OIE, and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious animal diseases in its territory, in particular those diseases listed by the OIE;

(f)the assurances given by the third country to inform the United Kingdom within 24 hours of the confirmation of the occurrence of any diseases of ungulates listed in Annex 2 to Council Directive 2004/68/EC and of any change in the vaccination policy concerning such diseases, or any proposed changes in the national health rules concerning live ungulate animals, in particular regarding importation;

(g)any experience of previous imports of live animals from the third country and the results of any import controls carried out;

(h)the animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for Great Britain;

(i)the results of inspections or audits carried out in the third country, in particular the results of the assessment of the competent authorities of those inspections or audits;

(j)the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on importation from other third countries.

4.Any assessment which is relied upon for the purposes of paragraph 1 with regard to the imports of fresh meat in accordance with Council Directive 2002/99/EC must be appropriate to the circumstances and must have been approved by the Secretary of State the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales).

5.Where the Scottish Ministers or the Welsh Ministers request that the Secretary of State exercise a power under a provision listed in paragraph 2, the Secretary of State must have regard to that request.

6.In this Article—

Textual Amendments

Article 18 U.K. Certification

The veterinary certificates required by this Regulation shall be completed in accordance with the explanatory notes [F107, as published by the appropriate authority from time to time].

However, that requirement shall not preclude the use of electronic certification F108....

Textual Amendments

F109 Article 19 U.K. Transitional provisions

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

Textual Amendments

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 .

F110 This Regulation shall be binding in its entirety ....

Textual Amendments

ANNEX I U.K. UNGULATES

[F111PART 1 U.K.

List of third countries F112...a

a

Without prejudice to specific certification requirements provided for by any relevant agreement between the [F113United Kingdom] and third countries.

b

Exclusively for live animals other than animals belonging to the cervidae species.

c

F114. . .

d

Not including Kosovo under UNSCR 1244/99.

e
f
F116. . .
ISO code and name of third country F117... F118... Veterinary certificate F119...
Model(s) F120...
1 2 3 4 5 6
F115
[F121CA — Canada POR-X, BOV-X, OVI-X, OVI-Y, RUM]b
CH – Switzerland F114. . .
CL – Chile BOV-X,OVI-X, RUM
POR-X, SUI
[F122EU member States, Liechtenstein and Norway F116. . .BOV-X, BOV-Y, OVI-X, OVI-Y, POR-X, POR-Y, RUM, SUI]
GL – Greenland OVI-X, RUM
F123
IS – Iceland BOV-X, BOV-Y RUM, OVI-X, OVI-Y
POR-X, POR-Y
ME – Montenegro
[F124MK-The Republic of North Macedonia
[F125NZ – New Zealand

BOV-X, BOV-Y,

RUM,

POR-X, POR-Y

OVI-X, OVI-Y]

F126. . .
RS – Serbia d
RU – Russia
BOV-X-TRANSIT-RU
[F127US – United States POR-X]

Textual Amendments

F122Words 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)

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

F128...

:

‘II’

:

territory recognised as having an official tuberculosis-free status for the purposes of exports to [F129Great 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 [F129Great 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 [F129Great 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 [F129Great 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 [F129Great 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 [F129Great 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 [F129Great 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 [F129Great Britain] of live animals certified according to the model of certificate POR-X.

F128...

:

‘[F130XI’

:

holdings or compartments recognised as applying controlled housing conditions in accordance with Article 8 of [F131Commission Implementing Regulation (EU) 2015/1375].]

‘[F132XII’

:

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 [F129Great Britain] of live animals certified according to the model of veterinary certificate BOV-X or BOV-Y.]

‘[F124XIII’

:

territory recognised as having an official bluetongue and epizootic haemorrhagic disease seasonally free status, for the purpose of exports to [F129Great Britain] of live animals certified according to the model of veterinary certificate BOV-X, OVI-X, OVI-Y or RUM.]]]

Textual Amendments

F128Words 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)

F129Words 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)

F131Words 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)

Textual Amendments

Modifications etc. (not altering text)

F133 PART 2 U.K. Models of Veterinary Certificates

Textual Amendments

F134 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

F134Annex 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)

F135 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

F135Annex 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 [F136Great Britain].

VIII.

Animals to be introduced into [F136Great 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 [F136Great 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 [F136Great 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 [F137appropriate 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

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 [F138in 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 [F138in 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

[F139Brucellosis ( 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 [F138in a manner equivalent to the standards in] Annex C to Directive 64/432/EEC.]

Textual Amendments

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

Tests shall be carried out [F138in 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 [F138in 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.

[F127Vesicular 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.]

F140 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)

F140 Animal species covered U.K.

F140 CHAPTER 1 U.K. Residence and quarantine

F140 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

F140 CHAPTER 2 U.K. Animal health tests

F140 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.5 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.8 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.9 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.
F140 2.1.13 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .U.K.

Textual Amendments

F140Annex 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

[F139PART 1 U.K.

List of third countries F141... a

Footnotes:
a

Without prejudice to specific certification requirements provided for in [F142agreements 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 [F143Great Britain] for 90 days from that date. Consignments carried on vessels on the high seas may be imported into [F143Great 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 [F143Great Britain] (no date in column 8 means that there are no time restrictions).

d

F144. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

e

Not including Kosovo which is at present under international administration pursuant to United Nations Security Council Resolution 1244 of 10 June 1999 .

f

[F132Hereafter 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

[F145Only for fresh meat originating from New Zealand, for which New Zealand is authorised for introduction into [F143Great Britain], which is accompanied by the appropriate model of veterinary certificate issued by the competent authority of New Zealand, destined to [F143Great Britain] and being unloaded, with or without storage and reloaded in an approved establishment during transit through Singapore.

h

Upon entry into [F143Great 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

F144. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

j

[F146Only for transit of consignments of fresh meat of domestic bovine animals via Bulgaria into Turkey.]

F147. . .
*

=

F148...

—

=

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).

F149. . .

No offal is authorised for introduction into [F143Great Britain] (except, in the case of bovine species, diaphragm and masseter muscles).]

ISO code and name of third country F150... F150... Veterinary certificate F151... F151... F151...
Model(s) F152...
1 2 3 4 5 6 7 8
AL – Albania —
[F124AR-Argentina EQU
[F153BOV, OVI, RUF, RUW]
F154. . .
F155. . .
F156. . .
F157. . .
AU – Australia BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
[F121BA – Bosnia and Herzegovina j BOV ]
BH – Bahrain —
[F158BR — BRAZIL EQU
[F159BOV]
F160. . .
F161. . .
F162. . .
F163. . .]
[F164BW — Botswana EQU, EQW
[F165BOV, OVI, RUF, RUW]
F166. . .
F167. . .
F168. . .
F169. . .
F170. . .]
BY – Belarus —
BZ – Belize BOV, EQU
CA – Canada BOV, OVI, POR, EQU, SUF, SUW, RUF, RUW
CH – Switzerland F148. . .
CL – Chile BOV, OVI, POR, EQU, RUF, RUW, SUF
CN – China —
CO – Colombia EQU
CR – Costa Rica BOV, EQU
CU – Cuba BOV, EQU
DZ – Algeria —
[F171EU member States, Liechtenstein and Norway F147... BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW [F172, EQW]]
ET – Ethiopia —
FK – Falkland Islands BOV, OVI, EQU
GL – Greenland BOV, OVI, EQU, RUF, RUW
GT – Guatemala BOV, EQU
HK – Hong Kong —
HN – Honduras BOV, EQU
F123. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F125IL – Israel f — ]
IN – India —
IS – Iceland BOV, OVI, EQU, RUF, RUW [F173, POR, SUF, SUW, EQW]
[F174JP — Japan BOV]
KE – Kenya —
MA – Morocco EQU
ME – Montenegro BOV, OVI, EQU
MG – Madagascar —
[F124MK-The Republic of North Macedonia BOV, OVI, EQU]
MU – Mauritius —
MX – Mexico BOV, EQU
NA – Namibia EQU, EQW
[F175BOV, OVI, RUF, RUW]
F176. . .
NC – New Caledonia BOV, RUF, RUW
NI – Nicaragua —
NZ – New Zealand BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
PA – Panama BOV, EQU
[F125PY – Paraguay EQU
[F177BOV]
F178. . .]
RS – Serbia e BOV, OVI, EQU
RU – Russia [F179RUF]
F180. . .
[F145SG — Singapore g NZ-TRANSIT-SG]h
SV – El Salvador —
SZ – Swaziland EQU, EQW
[F181BOV, RUF, RUW]
F182. . .
F183. . .
TH – Thailand —
TN – Tunisia —
TR – Turkey [F184EQU]
F185. . .
UA – Ukraine —
US – United States BOV, OVI, POR, EQU,SUF, SUW, RUF, RUW
[F186UY – Uruguay EQU
[F187BOV, OVI]
F188. . .
F188. . .]
[F189ZA – South Africa EQU, EQW]
F190...
ZW – Zimbabwe — ]

Textual Amendments

F142Words 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)

F143Words 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)

F171Words 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)

Modifications etc. (not altering text)

F191 PART 2 U.K. Models of veterinary certificates

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

Textual Amendments

F191Annex 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)

F192 ANNEX III U.K.

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

Textual Amendments

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 . ]]

[F193 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

F194 PART 2 U.K. Tables of animals and the corresponding model veterinary certificates

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

Textual Amendments

F194Annex 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)

F195 ANNEX V U.K. Explanatory notes for completing the veterinary certificates (referred to in Article 18)

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

Textual Amendments

[F22ANNEX VI U.K.

PART 1 U.K.

Table 1
‘RUM-A’

:

[F196Model 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

Table 2
‘SUI-A’

:

[F196Model 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’

:

[F196Model 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.

F197 PART 2 U.K.

Textual Amendments

F197Annex 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 [F198, 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 [F199, 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 [F200Great Britain].

Textual Amendments

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 F201...:

  • compliance with the animal health requirements which the animals must fulfil in order to be introduced into [F202Great Britain];

  • [F203that 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 [F204, in the form published by the appropriate authority from time to time].

Textual Amendments

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 [F205, 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 [F206the 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

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 [F207appropriate 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

Editorial Information

Textual Amendments