2010R0206 — EN — 17.06.2015 — 017.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B ▼C1 COMMISSION REGULATION (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance) ▼B (OJ L 073 20.3.2010, p. 1)

Amended by:





Corrected by:









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COMMISSION REGULATION (EU) No 206/2010

of 12 March 2010

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

(Text with EEA relevance)







THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC ( 1 ), and in particular Articles 17(2)(b) and 17(3)(a), the first subparagraph of Article 17(3)(c), the fourth indent of Article 18(1) and Article 19 thereof, Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 2 ), and in particular Article 8, Article 9(2)(b) and Article 9(4) thereof, Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC ( 3 ), and in particular the first and second subparagraphs of Article 3(1), the first subparagraph of Article 6(1), Article 7(e), Article 8, the first paragraph of Article 10 and Article 13(1) thereof, Having regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs ( 4 ), and in particular Article 12 thereof, Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( 5 ), and in particular Article 9 thereof, Having regard to Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption ( 6 ), and in particular Article 11(1) and Article 16 thereof, Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules ( 7 ), and in particular Article 48(1) thereof, Whereas: (1) Council Directive 72/462/EEC of 12 December 1972 on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine, fresh meat or meat products from third countries ( 8 ) provided for a list to be drawn up of the countries or parts thereof from which Member States are to authorise the importation of certain live animals and fresh meat of certain animals. (2) Accordingly, Council Decision 79/542/EEC of 21 December 1976 drawing up a list of third countries or parts of third countries, and laying down animal and public health and veterinary certification conditions, for importation into the Community of certain live animals and their fresh meat ( 9 ) was adopted. That Decision establishes the sanitary conditions for the importation into the European Union of live animals excluding equidae, and for the importation of fresh meat of such animals, including equidae, but excluding meat preparations. Annexes I and II to that Decision also set out lists of third countries or parts thereof from which certain live animals and their fresh meat may be imported into the Union as well as models of veterinary certificates. (3) Since the date of adoption of that Decision, a number of new animal health and public health requirements have been laid down in other Union acts, constituting a new regulatory framework in this area. Also, Directive 72/462/EEC has been repealed by Directive 2004/68/EC. (4) Article 20 of Directive 2004/68/EC states that implementing rules on import established in accordance with Decisions adopted pursuant to Directive 72/462/EEC, inter alia Decision 79/542/EEC, shall remain in force until replaced by measures adopted under the new regulatory framework. (5) In accordance with Article 4(3) of Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC ( 10 ), once the necessary provisions on the basis of Regulations (EC) No 852/2004, (EC) No 853/2004, (EC) No 854/2004 or Directive 2002/99/EC are adopted, the implementing rules adopted on the basis of Directive 72/462/EEC shall cease to apply. (6) Decision 79/542/EEC has been amended several times and import provisions based on the new regulatory framework have already been introduced in Decision 79/542/EEC. For the sake of clarity and transparency the measures that are laid down in Decision 79/542/EEC should be laid down in a new legal act. This Regulation includes all the provisions of Decision 79/542/EEC. Consequently, by the entry into force of the present Regulation Decision 79/542/EEC is lapsed and thus no longer applies, pending the explicit repeal of it. (7) Directive 92/65/EEC lays down the animal health requirements governing trade in and imports into the Union of live animals, semen, ova and embryos not subject to the animal health requirements laid down in the specific Union acts referred to in Annex F to that Directive. Pursuant to that Directive, those live animals, semen, ova and embryos may be imported into the Union only from a third country which is on a list drawn up in accordance with the procedure referred to in that Directive. In addition, such live animals are to be accompanied by a health certificate corresponding to a specimen drawn up in accordance with the procedure referred to therein. (8) Council Directive 96/93/EC of 17 December 1996 on the certification of animals and animal products ( 11 ) lays down the rules to be observed in issuing the certificates required by veterinary legislation to prevent misleading or fraudulent certification. It is appropriate to ensure that rules and principles at least equivalent to those laid down in that Directive are applied by the official inspectors or veterinarians of third countries. Certain third countries, which are listed in Annex II to this Regulation, have provided sufficient guarantees as to the existence and implementation of such rules and principles. It is therefore appropriate to authorise the introduction of certain live animals into the Union from those third countries, provided that no further restrictions are required by their specific disease situation. (9) Directive 2002/99/EC lays down the animal health rules concerning the introduction into the Union of products of animal origin and products obtained therefrom intended for human consumption. Pursuant to that Directive, lists are to be drawn up of the third countries or regions of third countries from which imports of specified products of animal origin are permitted and those imports are to comply with certain veterinary certification requirements. (10) Directive 2004/68/EC lays down the animal health requirements for the importation into and transit through the Union of certain live ungulates. The importation of those live ungulates into and their transit through the Union is authorised only from third countries and territories that appear on a list or lists drawn up in accordance with the procedure referred to in that Directive and those imports are to comply with certain veterinary certification requirements. (11) Save the provisions of article 17(2) last subparagraph of Directive 92/65/EEC, live animals, and products of animal origin to which Directives 92/65/EEC, 2002/99/EC and 2004/68/EC apply are to be imported into or transit through the Union only if they are accompanied by a veterinary certificate and comply with the relevant requirements laid down in Union legislation. (12) Accordingly, for the implementation of Directives 92/65/EEC, 2002/99/EC and 2004/68/EC, it is appropriate to lay down in this Regulation lists of third countries, territories and parts thereof and the specific import conditions including model veterinary certificates for certain live animals and the fresh meat of certain animals. (13) In the interest of consistency of Union legislation, this Regulation should also take into account the public heath requirements laid down in other Union acts and in particular in Regulations (EC) Nos 852/2004, 853/2004 and 854/2004 which lay down rules concerning the hygiene of foodstuffs and food of animal origin and rules for the organisation of official controls on products of animal origin intended for human consumption, as well as the requirements of Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products ( 12 ), and of Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies ( 13 ). (14) Regulation (EC) No 882/2004 lays down general rules governing the performance of official controls carried out in the areas of food and feed, animal health and animal welfare. Article 48 thereof empowers the Commission to adopt a list of third countries from which specific products may be imported into the Union. Regulation (EC) No 854/2004 provides specific rules for the organisation of official controls on products of animal origin intended for human consumption, including the establishment of lists of third countries from which imports of products of animal origin are permitted. Those rules provide that those lists may be combined with other lists drawn up for public and animal health purposes. (15) The model certificates set out in the Annexes to this Regulation should therefore include attestations certifying that the public health requirements laid down in Directive 96/23/EC and Regulations (EC) No 999/2001, 852/2004, 853/2004 and 854/2004, are fulfilled. (16) The model certificates set out in the Annexes to this Regulation should also include attestations certifying that animal welfare requirements laid down in Council Directive 93/119/EC of 22 December 1993 on the protection of animals at the time of slaughter and killing ( 14 ) and Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations ( 15 ) are fulfilled. (17) In order to ensure that the health of live animals introduced into the Union is not jeopardised during their transport from the third country of origin to the Union, certain requirements relating to the transport of live animals should be laid down, including requirements on assembly centres. (18) In the interest of ensuring the protection of animal health in the Union, live animals should be conveyed directly to their place of destination in the Union. (19) Fresh meat introduced into the Union for transit to another third country poses a negligible risk to public health. Such meat should, however, comply with all the relevant animal health requirements. Accordingly, specific provisions on the transit, and storage before transit, of fresh meat should therefore be laid down. (20) Specific conditions for transit via the Union of consignments to and from Russia should be provided for owing to the geographical situation of Kaliningrad which affects only Latvia, Lithuania and Poland. (21) Consignments of fresh meat, excluding offal and minced meat, of farmed non-domesticated animals of the order Artiodactyla, originating from animals caught in the wild should be authorised for introduction into the Union. In order to rule out any possible animal health risks which could be posed by such introduction, it is appropriate that those animals be separated from wild animals for a period of three months prior to the introduction into the Union of such consignments. Accordingly, the model veterinary certificate for those consignments (RUF) should take that into account. (22) Commission Decision 2003/881/EC of 11 December 2003 concerning the animal health and certification conditions for imports of bees (Apis mellifera and Bombus spp.) from certain third countries ( 16 ) lays down the animal health and certification conditions for imports of bees from certain third countries. In the interest of simplification of Union legislation, the measures laid down in that Decision should be included in this Regulation. Consequently, Decision 2003/881/EC should be repealed. (23) It's appropriate to introduce a transitional period to allow Member States and industry to take the necessary measures to comply with the requirements laid down in this Regulation. (24) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1. This Regulation lays down the veterinary certification requirements for the introduction into the Union of consignments containing the following live animals or fresh meat:

(a) ungulates;

(b) the animals listed in Part 2 of Annex IV;

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

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

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4. This Regulation shall apply without prejudice to any specific certification requirements laid down in other Union acts or in agreements concluded by the Union with third countries.

Article 2

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 90/426/EEC ( 17 );

(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.







CHAPTER II

CONDITIONS FOR THE INTRODUCTION OF LIVE ANIMALS INTO THE UNION

Article 3

General conditions for the introduction of ungulates into the Union

Consignments of ungulates shall only be introduced into the Union if they comply with the following conditions:

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

(b) they are accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model veterinary certificate set out in Part 2 of Annex I, taking into account the specific conditions indicated in column 6 of the table in Part 1 of that Annex, and completed and signed by an official veterinarian of the exporting third country;

(c) they comply with the requirements set out in the veterinary certificate referred to in point (b), including: (i) the supplementary guarantees laid down in that certificate, where indicated in column 5 of the table in Part 1 of Annex I; (ii) any additional veterinary certification requirements that the Member State of destination may impose in accordance with Union veterinary legislation and which are included in the certificate.

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Article 3a

Conditions for the introduction of ungulates intended for an approved body, institute or centre

1. By way of derogation from Article 3, the competent authority of a Member State 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 competent authority of the Member State of destination of the animal health risks that each of the consignments may present for the Union;

(b) the consignments concerned come from a third country, territory or part thereof which is included in one of the lists set out in: (i) Part 1 of Annex I or in Part 1 of Annex II to this Regulation, (ii) Decision 2004/211/EC ( 18 ), Decision 2007/777/EC ( 19 ), Regulation (EC) No 798/2008 ( 20 ), Regulation (EC) No 119/2009 ( 21 ), Regulation (EU) No 605/2010 ( 22 ),

(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 the Member State of destination;

(f) the ungulates are accompanied by an appropriate veterinary certificate, drawn up in accordance with the relevant model of veterinary certificate referred to in Tables 1, 2 and 3 in Part 1 of Annex VI and set out in Part 2 of that Annex;

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

The Member State of destination shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health of the authorisation granted pursuant to the first subparagraph, prior to the introduction of the ungulates into their territory.

2. Where exceptional circumstances render compliance with points (c) and (d) of paragraph 1 impossible, the competent authority of the Member State of destination 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 Member State of destination has granted such permit after having carried out a risk assessment that has indicated that the introduction of the ungulates concerned into its territory does not constitute an animal health risk for the Union;

(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 model of 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.

Where ungulates are introduced into the Union 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 the Union, during which period the requirements provided for in Article 8(1)(a) of Council Directive 90/425/EEC may be applied by the competent authorities.

The Member State authorising the introduction of ungulates pursuant to the first subparagraph shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health of such authorisation, prior to the introduction of the ungulates into its territory.

Article 3b

Conditions for the entry and transit of ungulates intended for an approved body, institute or centre through the territory of Member States other than the Member State of destination

The transit of the ungulates referred to in Article 3a through a Member State other than the Member State of destination shall be permitted only subject to the authorisation of the competent authority of the Member State of transit. Such authorisation may be granted only on the basis of a risk assessment by that competent authority, in view of the information submitted to it by the Member State of destination.

The Member State of destination shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health, prior to the transit, when authorising the introduction of animals under the conditions provided for in Article 3a.

Article 3c

List of approved bodies, institutes or centres in third countries, territories and parts thereof

1. Following an assessment of compliance with the conditions laid down in paragraph 2, each Member State may establish a list of bodies, institutes and centres from which the introduction of ungulates into its territory may be authorised pursuant to Article 3a(1).

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.

3. A Member State may include in the list referred to in paragraph (1) bodies, institutes or centres in third countries which are already included in such a list established by another Member State, without having assessed compliance with the conditions laid down in paragraph 2.

4. Member States 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.

5. Member States shall make available to the public, by means of Internet-based information pages, the lists referred to in paragraph 1 and shall keep those Internet-based information pages up to date.

6. Member States shall communicate the Internet address of their Internet-based information pages to the Commission.

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Article 4

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 the Union 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 the Union in accordance with Article 3a or Article 6 shall not originate from more than one holding and shall not be assembled in assembly centres.

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Article 5

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 the Union 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.

Article 6

Special conditions for certain consignments of ungulates imported into St Pierre and Miquelon and introduced into the Union

Consignments of ungulates of the species listed in the table in Part 7 of Annex I which were introduced into St Pierre and Miquelon less than six months prior to the date of shipment from St Pierre and Miquelon to the Union shall only be introduced into the Union if:

(a) they comply with the residence and quarantine requirements set out in Chapter 1 of that Part;

(b) they have been tested in accordance with the animal health test requirements set out in Chapter 2 of that Part.

Article 7

General conditions for the introduction into the Union of certain species of bees

1. Consignments of bees of the species listed in table 1 of Part 2 of Annex IV shall only be introduced into the Union from third countries or territories:

(a) listed in Part 1 of Annex II;

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

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

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

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

When that derogation is applied, the introduction into the Union 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 listed in table 1 of Part 2 of Annex IV 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 listed in table 1 of Part 2 of Annex IV shall:

(a) be accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model veterinary certificate set out in Part 2 of Annex IV, 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).

Article 8

General conditions concerning the transport of live animals to the Union

During the period after loading in the third country of origin and before arrival at the border inspection post of introduction into the Union, consignments of live animals shall not be:

(a) transported together with live animals that: (i) are not intended for introduction into the Union; or (ii) are of a lower health status;

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(b) unloaded in, or when transported by air, moved to another aircraft, or transported by road, by rail, or moved on foot through a third country, territory or part thereof which is not authorised for imports of the animals concerned into the Union.

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Article 9

Time limit for the period of transport to the Union of live animals

Consignments of live animals shall only be introduced into the Union where the consignment arrives at the border inspection post of introduction into the Union 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 Part 3 of Annex I and attached in its original form to the veterinary certificate.

Article 10

Special conditions regarding the spraying of consignments of live animals transported by air to the Union

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 Part 4 of Annex I and attached in its original form to the veterinary certificate.

Article 11

Conditions to be applied following the introduction into the Union of certain consignments of ungulates

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1. Following their introduction into the Union, 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.

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2. Following their introduction into the Union, 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.

Article 12

Specific conditions concerning the transit through third countries of certain consignments of ungulates

Where specific condition I of Part 1 of Annex I applies, in order to allow consignments of the ungulates referred to in that condition originating in one Member State and destined for another Member State, to transit through a third country, territory or part thereof which is listed in the table in Part 1 of Annex I but for which there is no corresponding model veterinary certificate for consignments of the ungulates concerned indicated in column 4 of that table, the following conditions shall apply:

(a) for bovine animals for fattening: (i) the holdings of final destination must be designated in advance by the competent authority of the final destination; (ii) the live animals comprised in the consignment must not be moved from the holding of final destination unless for immediate slaughter; (iii) all movements of live animals into and out of the holding of final destination must be carried out under the control of the competent authority as long as the animals comprising the consignment are kept at the holding.

(b) for ungulates for immediate slaughter, Article 11(2) shall apply.

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Article 12a

Derogation for the transit of certain consignments of live bovine animals for breeding and production through Lithuania

1. The transit by road through Lithuania of consignments of live bovine animals for breeding and production coming from the Russian region of Kaliningrad and consigned to a destination outside the Union shall be authorised subject to compliance with the following conditions:

(a) the animals enter Lithuania at the border inspection post at Kybartai road and exit Lithuania at the border inspection post of Medininkai;

(b) the animals are transported in containers on road vehicles sealed with a serially numbered seal at the border inspection post of introduction into the Union at Kybartai road, by the veterinary services of the competent authority of Lithuania;

(c) the documents referred to in the third indent of Article 7 (1) of Council Directive 91/496/EEC, including the duly completed veterinary certificate in accordance with the model veterinary certificate ‘BOV-X-TRANSIT-RU’ set out in Part 2 of Annex I to this Regulation, accompanying the animals from the border inspection post Kybartai road to the border inspection post Medininkai are stamped ‘ONLY FOR TRANSIT FROM THE RUSSIAN REGION OF KALININGRAD VIA LITHUANIA’ on each page by the official veterinarian of the competent authority responsible for the border inspection post at Kybartai road;

(d) the requirements provided for in Article 9 of Council Directive 91/496/EEC are complied with;

(e) the consignment is certified as acceptable for transit through Lithuania on the common veterinary entry document referred to in Article 1(1) of Commission Regulation (EC) No 282/2004 ( 23 ) and signed by the official veterinarian of the border inspection post at Kybartai road;

(f) the animals are accompanied by a health certificate that allows unhindered entry into Belarus and a veterinary certificate issued for the place of destination of the animals in Russia.

2. The consignment shall not be unloaded in the Union and shall be moved directly to the border inspection post of exit of Medininkai.

The official veterinarian at the border inspection post of Medininkai shall complete part 3 of the Common Veterinary Entry Document after the exit controls on the consignment have verified that it is the same consignment that entered Lithuania at the border inspection post at ‘Kybartai road’.

3. In case of any irregularity or emergency during the transit, the Member State of transit shall apply the measures provided for in the second indent of Article 8(1) (b) of Directive 90/425/EEC ( 24 ) as appropriate.

4. The competent authority of Lithuania shall verify regularly that the number of consignments entering and leaving the Union territory matches.

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Article 13

Conditions to be applied following the introduction into the Union 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 the Union 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.

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Article 13a

Conditions to be applied following the introduction of consignments of ungulates intended for approved bodies, institutes or centres

1. Following their introduction into the Union, 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 of the Member State of destination 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 the Union, and

(b) the movement is carried out in accordance with paragraph 4 of Annex C to Directive 92/65/EEC.

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.

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CHAPTER III

CONDITIONS FOR THE INTRODUCTION OF FRESH MEAT INTO THE UNION

Article 14

General conditions for the importation of fresh meat

Consignments of fresh meat intended for human consumption shall only be imported into the Union if they comply with the following conditions:

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

(b) they are presented at the border inspection post of introduction into the Union accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model veterinary certificate set out in Part 2 of Annex II, taking into account the specific conditions indicated in column 6 of the table in Part 1 of that Annex, and completed and signed by an official veterinarian of the exporting third country;

(c) they comply with the requirements set out in the veterinary certificate referred to in point (b), including: (i) the supplementary guarantees laid down in that certificate, where indicated in column 5 of the table in Part 1 of Annex II; (ii) any additional veterinary certification requirements that the Member State of destination may impose in accordance with Union veterinary legislation and which are included in the certificate.

Article 15

Conditions to be applied following the importation of unskinned carcases of wild cloven-hoofed game

In accordance with Article 8(2) of Council Directive 97/78/EC ( 25 ), 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.

Article 16

Transit and storage of fresh meat

The introduction into the Union of consignments of fresh meat not intended for importation into the Union but destined for a third country either by immediate transit or after storage in the Union in accordance with Article 12(4) and Article 13 of Directive 97/78/EC, shall only be authorised if the consignments comply with the following conditions:

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

(b) they comply with the specific animal health requirements for the consignment concerned, as set out in the relevant model veterinary certificate referred to in point (a);

(c) they are accompanied by a veterinary certificate, drawn up in accordance with the model veterinary certificate set out in Annex III, and completed and signed by an official veterinarian of the exporting third country;

(d) they are certified as acceptable for transit, including for storage as appropriate, on the common veterinary entry document referred to in Article 2(1) of Commission Regulation (EC) No 136/2004 ( 26 ), signed by the official veterinarian of the border inspection post of introduction into the Union.

Article 17

Derogation for transit through Latvia, Lithuania and Poland

1. By way of derogation from Article 16 the transit by road or by rail through the Union, between the designated border inspection posts in Latvia, Lithuania and Poland listed in Commission Decision 2009/821/EC ( 27 ), of consignments coming from and destined to Russia directly or via another third country shall be authorised provided that the following conditions are complied with:

(a) the consignment is sealed with a serially numbered seal at the border inspection post of introduction into the Union by the veterinary services of the competent authority;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC are stamped ‘ONLY FOR TRANSIT TO RUSSIA VIA THE EU’ on each page by the official veterinarian of the competent authority responsible for the border inspection post of introduction into the Union;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with;

(d) the consignment is certified as acceptable for transit on the common veterinary entry document signed by the official veterinarian of the border inspection post of introduction into the Union.

2. Unloading or storage, as defined in Article 12(4) or in Article 13 of Directive 97/78/EC, of such consignments on Union territory shall not be allowed.

3. Regular audits shall be made by the competent authority to ensure that the number of consignments and the quantities of products leaving the Union territory matches the number and quantities entering.

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Article 17a

Derogation for transit through Croatia of consignments coming from Bosnia and Herzegovina and destined to third countries

1. By way of derogation from Article 16, the direct transit by road through the Union, between the border inspection post of Nova Sela and the border inspection post of Ploče, of consignments coming from Bosnia and Herzegovina and destined to third countries shall be authorised provided that the following conditions are complied with:

(a) the consignment is sealed with a serially numbered seal by the official veterinarian at the border inspection post of entry;

(b) the documents accompanying the consignment and referred to in Article 7 of Directive 97/78/EC are stamped ‘ONLY FOR TRANSIT TO THIRD COUNTRIES VIA THE EU’ on each page by the official veterinarian at the border inspection post of entry;

(c) the procedural requirements provided for in Article 11 of Directive 97/78/EC are complied with;

(d) the consignment is certified as acceptable for transit on the Common Veterinary Entry Document referred to in Article 2(1) of Regulation (EC) No 136/2004 by the official veterinarian at the border inspection post of entry.

2. Unloading or storage, as defined in Article 12(4) or in Article 13 of Directive 97/78/EC, of such consignments on Union territory shall not be allowed.

3. Regular audits shall be made by the competent authority to ensure that the number of consignments and the quantities of products leaving the Union matches the number and quantities entering the Union.

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CHAPTER IV

GENERAL, TRANSITIONAL AND FINAL PROVISIONS

Article 18

Certification

The veterinary certificates required by this Regulation shall be completed in accordance with the explanatory notes set out in Annex V.

However, that requirement shall not preclude the use of electronic certification or of other agreed systems, harmonised at Union level.

Article 19

Transitional provisions

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For a transitional period those consignments of live animals, except bees coming from the State of Hawaii, and fresh meat intended for human consumption certified before 30 November 2010 in accordance with Decisions 79/542/EEC and 2003/881/EC may continue to be introduced into the Union until 31 May 2011.

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Article 20

Repeal

Decision 2003/881/EC is repealed.

Article 21

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

UNGULATES

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PART 1







List of third countries, territories or parts thereof (1) ISO code and name of third country Code of Territory Description of third country, territory or part thereof Veterinary certificate Specific conditions Model(s) SG 1 2 3 4 5 6 ▼M23 BD — Bangladesh (6) BD-0 The area covered by Chittagong Safari Park TRE-A (7) ▼M8 CA – Canada CA-0 Whole country POR-X IVb IX V CA-1 Whole country, except the Okanagan Valley region of British Columbia described as follows: — From a point on the Canada/United States border 120°15′ longitude, 49° latitude — Northerly to a point 119°35′ longitude, 50°30′ latitude — North-easterly to a point 119° longitude, 50°45′ latitude — Southerly to a point on the Canada/United States border 118°15′ longitude, 49° latitude BOV-X, OVI-X, OVI-Y RUM (2) A CH – Switzerland CH-0 Whole country (3) CL – Chile CL-0 Whole country BOV-X,OVI-X, RUM POR-X, SUI B GL – Greenland GL-0 Whole country OVI-X, RUM V ▼M16 ————— ▼M8 ISCIceland IS-0 Whole country BOV-X, BOV-Y RUM, OVI-X, OVI-Y POR-X, POR-Y B ME – Montenegro ME-0 Whole country I MK – The former Yugoslav Republic of Macedonia (4) MK-0 Whole country I ▼M22 NZ – New Zealand NZ-0 Whole country BOV-X, BOV-Y, RUM, POR-X, POR-Y OVI-X, OVI-Y III V XII ▼M8 PM – St Pierre and Miquelon PM-0 Whole country BOV-X, BOV-Y, RUM, OVI-X, OVI-Y CAM RS – Serbia (5) RS-0 Whole country I RU – Russia RU-0 Whole country RU-1 Whole country except the region of Kaliningrad RU-2 Region of Kaliningrad BOV-X-TRANSIT-RU X ▼M12 US – United States US-0 Whole country POR-X D ▼M8 (1) Without prejudice to specific certification requirements provided for by any relevant agreement between the Union and third countries. (2) Exclusively for live animals other than animals belonging to the cervidae species. (3) Certificates in accordance with the Agreement between the European Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132). (4) The former Yugoslav Republic of Macedonia: the definitive nomenclature for this country will be agreed following current negotiations at UN level. (5) Not including Kosovo under UNSCR 1244/99. (6) This entry applies until 17 August 2015. (7) Exclusively for live ungulates of the Elephas ssp. from an approved body, institute or centre in Bangladesh to an approved body, institute or centre in Cyprus.

Specific Conditions (see footnotes in each certificate)

‘I’ : for transit through the territory of a third country of live animals for immediate slaughter or live bovine animals for fattening which are consigned from a Member State and destined to another Member State in lorries which have been sealed with a serially numbered seal. The seal number must be entered on the health certificate issued in accordance with the model laid down in Annex F to Directive 64/432/EEC ( 28 ) for live bovine animals for slaughter and fattening and in accordance with Model I of Annex E to Directive 91/68/EEC ( 29 ) for ovine and caprine animals for slaughter. In addition, the seal must be intact on arrival at the designated border inspection post of entry into the Union and the seal number recorded in the integrated computerised veterinary system of the Union (TRACES). The certificate must be stamped at the exit point of the Union by the competent veterinary authority prior to transiting one or more third countries, with the following wording ‘ONLY FOR TRANSIT BETWEEN DIFFERENT PARTS OF THE EUROPEAN UNION VIA THE FORMER YUGOSLAV REPUBLIC OF MACEDONIA/MONTENEGRO/SERBIA ( 30 ) ( 31 )’. Bovine animals for fattening must be transported directly to the holding of destination designated by the competent veterinary authority of destination. Those animals must not be moved from that holding unless for immediate slaughter.

‘II’ : territory recognised as having an official tuberculosis-free status for the purposes of exports to the Union 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 the Union 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 the Union 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 the Union 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 the Union 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 the Union 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 the Union 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 the Union of live animals certified according to the model of certificate POR-X.

‘X’ : Only for transit through Lithuania of bovine animals for breeding and/or production from the Kaliningrad region to other regions of Russia.

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‘XI’ : holdings or compartments recognised as applying controlled housing conditions in accordance with Article 8 of Regulation (EC) No 2075/2005.

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

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PART 2

Models of Veterinary Certificates

Models

‘BOV-X’ : Model of veterinary certificate for domestic bovine animals (including Bubalus and Bison species and their cross-breeds) intended for breeding and/or production after importation.

‘BOV-Y’ : Model of veterinary certificate for domestic bovine animals (including Bubalus and Bison species and their cross-breeds) intended for immediate slaughter after importation.

‘BOV-X-TRANSIT-RU’ : Model of veterinary certificate for domestic bovine animals (including Bubalus and Bison species and their cross-breeds) intended for transit from the region of Kaliningrad to other regions of Russia via the territory of Lithuania.

‘OVI-X’ : Model of veterinary certificate for domestic ovine animals (Ovis aries) and domestic caprine animals (Capra hircus) intended for breeding and/or production after importation.

‘OVI-Y’ : Model of veterinary certificate for domestic ovine animals (Ovis aries) and domestic caprine animals (Capra hircus) intended for immediate slaughter after importation.

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‘POR-X’ : Model of veterinary certificate for domestic porcine animals (Sus scrofa) intended for breeding and/or production after importation or intended for transit through the Union from one third country to another third country.

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‘POR-Y’ : Model of veterinary certificate for domestic porcine animals (Sus scrofa) intended for immediate slaughter after importation.

‘RUM’ : Model of veterinary certificate for animals of the order Artiodactyla (excluding bovine animals (including Bubalus and Bison species and their cross-breeds), Ovis aries, Capra hircus, Suidae and Tayassuidae), and of the families Rhinocerotidae and Elephantidae.

‘SUI’ : Model of veterinary certificate for non-domestic Suidae, Tayassuidae and Tapiridae.

‘CAM’ : Model of specific attestation for animals imported from St Pierre and Miquelon under the conditions provided for in Part 7 of Annex I.

SG (Supplementary guarantees)

‘A’ : guarantees regarding Bluetongue and Epizootic-haemorrhagic-disease tests on animals certified according to the model of veterinary certificates BOV-X (point II.2.8 B), OVI-X (point II.2.6 D) and RUM (point II.2.6).

‘B’ : guarantees regarding Swine-vesicular-disease and Classical-swine-fever tests on animals certified according to the model of veterinary certificates POR-X (point II.2.4 B) and SUI (point II.2.4 B).

‘C’ : guarantees regarding Brucellosis test on animals certified according to the model of veterinary certificates POR-X (point II.2.4 C) and SUI (point II.2.4 C).

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‘D’ : guarantees regarding vesicular stomatitis test on animals certified according to the model of veterinary certificate POR-X (point II.2.1(b)).

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Model BOV-X-TRANSIT-RU

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Model OVI-X

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Model POR-X

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►(1) M21

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PART 3

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.)







Declaration by the master of the ship I, the undersigned, master of ship (name …), declare that the animals referred to in the attached veterinary certificate No … have remained on board the ship during the voyage from … in … (exporting country) to … in the Union and that the ship did not call at any place outside … (exporting country) en route to the Union other than: … (Ports of call en route). Moreover, during the journey, these animals have not been in contact with other animals on board of a lower health status. Done at … on … (Port of arrival) (Date of arrival) (stamp) (signature of master) (name in capital letters and title)

PART 4

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.)







Declaration by the captain of the aircraft I, the undersigned, captain of the aircraft (name …), declare that the crate or container and the area around the crate or container containing the animals referred to in the attached veterinary certificate No … has been sprayed with insecticide before departure. Done at … on … (Airport of departure) (Date of departure) (stamp) (signature of captain) (name in capital letters and title)

PART 5

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 the Union.

VIII. Animals to be introduced into the Union 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 the Union; (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 the Union 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 Commission and the competent central authorities of the Member States 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.

PART 6

Protocols for the standardisation of materials and testing procedures

(referred to in Article 5)

Tuberculosis (TBL)

The single intradermal tuberculin test using bovine tuberculin shall be carried out according to 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 according to Annex B to 64/432/EEC, except that the site of injection shall be the loose skin at the base of the ear.

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Brucellosis (Brucella abortus) (BRL)

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 according to Annex C to Directive 64/432/EEC.

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Brucellosis (Brucella melitensis) (BRL)

Tests shall be carried out according to Annex C to Directive 91/68/EEC.

Enzootic Bovine Leukosis (EBL)

The agar gel immuno-diffusion test and the enzyme linked immuno-absorbent assay test (ELISA) shall be carried out according to paragraphs A and C of Chapter II of Annex D to Directive 64/432/EEC.

Bluetongue (BTG)

A. The blocking or competitive ELISA test shall be carried out according to the following protocol: 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: 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 H2 O2 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 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: 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: 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: 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: 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: 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: Antigen: 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: 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 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)

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

Antigen:

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:

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

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)

A. 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 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 ( 32 ).

Foot-and-mouth disease (FMD)

A. Collecting oesophageal/pharyngeal samples and testing shall be carried out according to the following protocol: 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 CO2 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: 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 × 106 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: 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: 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 % H2O2 (30 %) w/v is added to each well. 8. The reaction is stopped after 15 minutes with 1,25M H2SO4. 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)

A. 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 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 ( 33 ).

Transmissible gastro-enteritis (TGE)

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)

Tests for swine vesicular disease (SVD) shall be carried out according to Decision 2000/428/EC ( 34 ).

Classical swine fever (CSF)

Tests for classical swine fever (CSF) shall be carried out according to Decision 2002/106/EC ( 35 ).

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.

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Vesicular stomatitis (VS)

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.

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PART 7

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)

Animal species covered







Taxon ORDER FAMILY GENUS AND SPECIES Artiodactyla Camelidae Camelus spp., Lama spp., Vicugna spp.

CHAPTER 1

Residence and quarantine

1. Animals imported into St. Pierre and Miquelon must reside in an authorised quarantine station for a minimum period of 60 days before being dispatched for introduction into the Union. This period may be increased due to testing requirements for individual species. In addition the animals must comply with the following requirements: (a) Separate consignments may enter the quarantine station. However, upon entry in the quarantine station all animals of the same species in the quarantine facility must be considered as a single group, and referred to as such. The quarantine period must commence for the whole group at the time when the last animal entered the quarantine facility. (b) Within the quarantine station each specific group of animals must be maintained in isolation, with no direct or indirect contact with any other animals, including those from other consignments that may be present. Each consignment must be kept in the approved quarantine station and protected from vector insects. (c) If, during the period of quarantine, the isolation of a group of animals is not maintained and contact is made with other animals, the quarantine period must begin again for the same duration as initially prescribed on entry into the quarantine station. (d) Animals to be introduced into the Union which pass through the quarantine station must be loaded and dispatched directly to the Union: (i) without coming into contact with animals other than animals which fulfil the health conditions established for the introduction of the relevant category of animal into the Union; (ii) segregated into consignments so that no consignment can came in contact with animals not eligible for importation into the Union; (iii) in transport vehicles or containers which have first been cleansed and disinfected with a disinfectant officially authorised in St. Pierre and Miquelon as effective in the control of the diseases referred to in Chapter 2 and which are so constructed that faeces, urine, litter or fodder cannot flow or fall out of the vehicle or container during transportation.

2. The quarantine premises must at least meet the minimum standards laid down in Annex B to Directive 91/496/EEC ( 36 ), and the following conditions: (a) they must be supervised by an official veterinarian; (b) they must be situated at the centre of an area of at least 20 km in diameter in which, according to official findings, for at least 30 days prior to their use as a quarantine station there has been no case of foot-and-mouth disease; (c) they must, before being used as a quarantine station, be cleansed and disinfected with a disinfectant officially authorised in St Pierre et Miquelon as effective in the control of the diseases referred to in Chapter 2; (d) they must operate, taking into account their animal capacity: (i) a facility dedicated exclusively for the quarantine of animals, including adequate housing to a suitable standard for the animals; (ii) appropriate facilities, that: — are easy to thouroughly clean and disinfect, — include facilities for safe loading and unloading, — are able to fulfil all watering and feeding requirements for the animals, — allow any necessary veterinary treatment to be easily administered; (iii) appropriate facilities for inspection and isolation; (iv) appropriate equipment for cleaning and disinfecting rooms and transport vehicles; (v) an appropriate storage area for fodder, litter and manure; (vi) an appropriate system for collecting waste water; (vii) an office for the official veterinarian; (e) when operating, they must have sufficient veterinarians to carry out all duties; (f) 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 quarantine station must ensure that the animals are properly identified and accompanied by health certificates for the species and categories involved. In addition, the owner or the person in charge of the quarantine station 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 in the consignment, the dates of entry and exit of the animals in the consignment, the identification number of the animals in the consignment and their place of destination; (g) the competent authority must determine the procedure for official supervision of the quarantine station and must ensure that such supervision is carried out; this supervision must include regular inspections in order to ascertain that the requirements for approval continue to be fulfilled. In case of failure and suspension, the approval may only be restored when the competent authority is satisfied that the quarantine premises are in full compliance with all the conditions set out in points (a) to (g).

CHAPTER 2

Animal health tests

1. GENERAL REQUIREMENTS

The animals must be subjected to the following tests carried out on samples of blood taken, if not specified otherwise, not earlier than 21 days from the date of commencement of the isolation period.

The laboratory tests must be carried out in an approved laboratory in the Union and all laboratory tests and their results, vaccinations and treatments must be enclosed with the health certificate.

In order to keep animal interventions to a minimum, sampling, tests and any vaccinations must be grouped as far as is possible whilst respecting the minimum time intervals required by the testing protocols set out in Part 2 of this Chapter.

2. SPECIFIC REQUIREMENTS

2.1 CAMELIDAE

2.1.1 Tuberculosis

(a) Test to be used: comparative intradermal reaction test using Bovine purified protein derivative (PPD) and Avian PPD conforming to the standards for the manufacture of bovine and avian tuberculins as described in point 2.1.2 of Annex B of Directive 64/432/EEC. The test must be executed in the area behind the shoulder (axillary region) following the technique described in point 2.2.4 of Annex B of Directive 64/432/EEC.

(b) Timing: the animals must be tested within two days from the date of arrival in the quarantine station and 42 days from the date of the first test.

(c) Interpretation of tests: the reaction shall be considered: — negative if the increased skin thickness is less than 2 mm. — positive if the increased skin thickness is more than 4 mm. — inconclusive if the increased skin thickness to the bovine PPD is between 2mm and 4 mm, or more than 4 mm but less then the reaction to the avian PPD.

(d) Options for action following testing: If an animal presents a positive result to the intradermal-reaction to the bovine PPD, that animal shall be excluded from the group and the other animals shall be re-tested starting at least 42 days from the date of the first positive test was administered and this shall be considered as the first test described in (b). If more than one animal of the group presents a positive result, the whole group shall be rejected for exportation to the Union. If one or more animals of the same group present an inconclusive reaction, the whole group shall be re-tested starting at least 42 days from the date of the first test was administered and it shall be considered as the first test described in (b).

2.1.2 Brucellosis

(a) Test to be used: (i) Brucella abortus: Rose Bengal test (RBT) and Serum agglutination test (SAT) as described respectively in points 2.5 and 2.6 of Annex C to Directive 64/432/EEC. In the case of a positive result, a complement-fixation test shall be performed for confirmation as described in Part 6 of Annex I to Regulation (EU) No 206/2010. (ii) Brucella melitensis: RBT and SAT as described respectively in points 2.5 and 2.6 of Annex C to Directive 64/432/EEC. In the case of a positive result, a complement-fixation test following the method described in Annex C to Directive 91/68/EEC shall be performed for confirmation. (iii) Brucella ovis: Complement fixation test as described in Annex D to Directive 91/68/EEC

(b) Timing: the animals have to be tested within two days from the date of their arrival in the quarantine station and 42 days from the date of the first test.

(c) Interpretation of tests: A positive reaction to the tests shall be as defined in Annex C to Directive 64/432/EEC.

(d) Options for action following testing: Animals tested positive to one of the tests shall be excluded from the group and the other animals shall be re-tested starting at least 42 days from the date the first positive test was performed: this shall be considered as the first test described in (b). Only the animals that tested negative to two consecutive tests performed as described in (b) shall be allowed for the introduction to the Union.

2.1.3 Bluetongue and Epizootic haemorrhagic disease (EHD)

(a) Test to be used: agar gel immunodiffusion (AGID) test as described in Part 6 of Annex I to Regulation (EU) No 206/2010. In case of a positive reaction the animals shall be tested with competitive ELISA test as described in Part 6 of Annex I to Regulation (EU) No 206/2010 to discriminate between the two diseases.

(b) Timing: The animals must be tested with negative result to two tests: the first within two days from the date of their arrival in the quarantine station and the second at least 21 days from date of the first test.

(c) Options for action following testing: (i) Bluetongue If one or more animals tested positive to the ELISA as described in Part 6 of Annex I to Regulation (EU) No 206/2010, the positive animal/animals shall be excluded from the group, and all the remaining animals in the group must be quarantined for 100 days starting from the date on which the samples for the positive test were collected. The group shall only be considered free of the bluetongue disease if regular checks carried out by official veterinarians throughout the duration of the quarantine period fail to reveal clinical symptoms of disease, and the quarantine station remains free of bluetongue vectors (Culicoides). If a further animal presents clinical symptoms of bluetongue disease during the quarantine period as described in the first subparagraph, all the animals in the group shall be rejected for introduction into the Union. (ii) Epizootic haemorrhagic disease (EHD) If one or more animals tested positive reveal the presence of antibodies to the EHD virus during c