
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, 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, 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, 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, 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, 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, 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, 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 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 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, 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 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, 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.

(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 and Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations 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 lays down the animal health and certification conditions for imports of bees from certain third countries. In the interest of simplification of Union legislation, the measures laid down in that Decision should be included in this Regulation. Consequently, Decision 2003/881/EC should be repealed.

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

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

CHAPTER I
            

               SUBJECT MATTER, SCOPE AND DEFINITIONS
            

                  Subject matter and scope
               

                     Article 1
                   


                           1. 
                              This Regulation lays down the veterinary certification requirements for the introduction into  Great Britain  of consignments containing the following live animals or fresh meat:
                           
(a) 
                                    ungulates;
                                 
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) 
                                    fresh meat intended for human consumption, excluding meat preparations, of ungulates and equidae.
                                 

                           2. 
                              This Regulation lays down the lists of third countries,  and makes provision for the specification for the purposes of this Regulation by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), of territories or parts thereof,  from which the consignments referred to in paragraph 1 may be introduced into  Great Britain.
                           
3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

                  Definitions
               

                     Article 2
                   

                        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  2009/156/EC;
                              
((d)) 
                                 ‘holding’
                                  means a farm or other officially supervised agricultural, industrial or commercial undertaking, including zoos, amusement parks and wildlife or hunting reserves where live animals are regularly kept or bred.
((e)) ‘appropriate authority’ means the Secretary of State (in relation to England), the Welsh Ministers (in relation to Wales) and the Scottish Ministers (in relation to Scotland); but the  ‘appropriate authority’ is the Secretary of State if consent is given by:
((i)) in relation to Wales, the Welsh Ministers;
((ii)) in relation to Scotland, the Scottish Ministers;
((f)) ‘approved body, institute or centre’ means any permanent, geographically limited establishment, where one or more species of animal are habitually kept or bred, whether or not for commercial ends, for one or more of the following purposes:
((i)) display of the animals and education of the public;
((ii)) conservation of the species;
((iii)) basic or applied scientific research or breeding of animals for the purposes of such research,and where the establishment concerned is approved by, or registered with, the competent authority (in relation to a third country) or the appropriate authority (in relation to Great Britain);
((g)) ‘competent authority’ means the central authority of the country of destination or transit competent to carry out veterinary checks, or any authority to which that central authority has delegated that competence;
((h)) ‘third country’ means any country or territory other than the British Islands.
((i)) “specific condition” has the meaning given in Article 2c;
((j)) “supplementary guarantee”—
(i) in relation to ungulates, means the guarantee given under paragraph 2 of Article 2d;
(ii) in relation to fresh meat, means the guarantee given under paragraph 2 of Article 13b.
Publication of code representing country or part thereof
Article 2a 
The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article a system of words, letters or numbers representing, for the purposes of a veterinary certificate under this Regulation, a third country listed in Annex 1 or Annex 2, or a territory or part thereof.
Publication of closing date and opening date
Article 2b 

(1.) The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article a “closing date” or an “opening date” in relation to a third country listed in Annex 2, or a territory or part thereof.
(2.) Meat from animals slaughtered on or before a closing date may be imported into Great Britain from the country or territory to which the closing date relates for 90 days from that date. Consignments carried on vessels on the high seas may be imported into Great Britain from the country or territory to which the closing date relates if certified before the closing date for 40 days from that date.
(3.) Where an opening date has been specified in relation to a third country or territory or part thereof under paragraph 1, only meat slaughtered on or after that opening date may be imported into Great Britain from that country or part.
Specific conditions – live ungulates and fresh meat
Article 2c 

(1.) The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose a specific condition on the introduction of an ungulate into Great Britain, or on the importation of fresh meat of an ungulate intended for human consumption into Great Britain.
(2.) The Secretary of State must publish any specific condition required under this Article in a document published for the purposes of this Article.
(3.) “Specific condition” means one of the conditions published under paragraph 2 by the Secretary of State, imposed with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales).
Supplementary guarantees – live ungulates
Article 2d 

(1.) The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose conditions relating to the protection of public health, animal health or food safety in Great Britain on the import of an ungulate into Great Britain from a third country listed in column 1 of Annex 1, or a territory or part thereof.
(2.) The person exporting the ungulate from the third country to Great Britain, or another person acting on their behalf, must provide evidence that any condition imposed under paragraph 1 in relation to the ungulate is satisfied by giving a supplementary guarantee in accordance with the veterinary certificate for the ungulate concerned.
(3.) The Secretary of State must publish any conditions imposed under paragraph 1 in a document published for the purposes of this Article.
CHAPTER II
            

               CONDITIONS FOR THE INTRODUCTION OF LIVE ANIMALS INTO  GREAT BRITAIN

                  General conditions for the introduction of ungulates into  Great Britain

                     Article 3 
Consignments of ungulates shall only be introduced from third countries  into  Great Britain  if they comply with the following conditions:
                     

((a)) they come from  such of the third countries  listed in  column 1  of the table set out in Part 1 of Annex I or a territory or part of any such third country, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article  for which there is a model veterinary certificate corresponding to the consignment concerned listed in column 4 of the table in Part 1 of Annex I;
((b)) they are accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model veterinary certificate  , in the form published by the appropriate authority from time to time, taking into account  any specific conditions that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 2c, and completed and signed by an official veterinarian of the exporting third country;
((c)) they comply with the requirements set out in the veterinary certificate referred to in point (b), including:

((i)) any supplementary guarantees laid down in that certificate that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 2d;
((ii)) any additional veterinary certification requirements that the  appropriate authority may include  in the certificate.
Conditions for the introduction of ungulates intended for an approved body, institute or centre
               

                     Article 3a
                   


                           1. By way of derogation from Article 3,  the appropriate authority  may authorise the introduction into its territory of consignments of ungulates of the species listed in Tables 1, 2 and 3 of Part 1 of Annex VI where those consignments are destined for an approved body, institute or centre, provided that the following conditions are complied with:
(a) an assessment has been carried out by the  appropriate authority of the animal health risks that each of the consignments may present for  Great Britain;
(b) the consignments concerned come from ...:
((i)) such of the third countries included in one of the lists set out in Part 1 of Annex I or in Part 1 of Annex II to this Regulation , or territories or parts thereof, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales) may specify in a document published for the purposes of this Article,
((ii)) a third country, territory or part thereof which is included in one of the lists set out in, or specified by the Secretary of State in accordance withRegulation (EU) 2018/659, Decision 2007/777/EC
                                             , Regulation (EC) No 798/2008
                                             , Regulation (EC) No 119/2009
                                             , Regulation (EU) No 605/2010
                                             ,
(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  Great Britain;
(f) the ungulates are accompanied by an appropriate veterinary certificate,  in the form published by the appropriate authority from time to time;
(g) the ungulates comply with the requirements set out in the ... veterinary certificate referred to in point (f)....

                           2. Where exceptional circumstances render compliance with points (c) and (d) of paragraph 1 impossible, the  appropriate authority  may authorise the introduction, into its territory, of ungulates of the species listed in Tables 1, 2 and 3 of Part 1 of Annex VI from 
                              
                                 other holdings
                              
                               which do not comply with the requirements laid down in those points, provided that the requirements laid down in points (a), (b) and (e) to (g) of paragraph 1 are complied with and that the following additional conditions are met:
(a) a prior application for a permit has been made by the owner, or a natural person representing that owner, and the  appropriate authority  has granted such permit after having carried out a risk assessment that has indicated that the introduction of the ungulates concerned ... does not constitute an animal health risk ...;
(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  appropriate  veterinary certificate referred to in point (f):
((i)) at a place approved by the competent authority of the third country, territory or part thereof of origin of the animals;
((ii)) in accordance with the arrangements prescribed in the permit that shall provide at least the same guarantees as those laid down in points (a), (b) and (e) to (g) of paragraph 1.Where ungulates are introduced into Great Britain pursuant to the first subparagraph, they shall be quarantined in an approved body, institute or centre of destination for at least six months from the time of introduction into Great Britain, during which period the requirements provided for in Article 67 of Regulation (EU) 2017/625 may be applied, and protective measures may be put in place, by the appropriate authority.
3. The appropriate authority authorising the introduction of ungulates into its territory pursuant to paragraph 1 or 2 shall inform the other appropriate authorities of such authorisation prior to the introduction of the ungulates concerned into Great Britain.
Conditions for the entry and transit of ungulates intended for an approved body, institute or centre through one country of Great Britain to another country of Great Britain

                     Article 3b
                   
The transit of the ungulates referred to in Article 3a through one country of Great Britain to another country of Great Britain shall be permitted only subject to the authorisation of the appropriate authority of the country of transit. Such authorisation may be granted only on the basis of a risk assessment by that appropriate authority.
List of approved bodies, institutes or centres in third countries, territories and parts thereof
               

                     Article 3c
                   

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

                           2. 
                              A body, institute or centre in a third country, territory or part thereof shall only be included in the list referred to in paragraph 1 where the following conditions are complied with:
                           
(a) 
                                    the body, institute or centre complies with the requirements set out in Part 3 of Annex VI;
                                 
(b) 
                                    the body, institute or centre is approved by the competent authority of the third country, territory or part thereof where that body, institute or centre is situated;
                                 
(c) 
                                    the competent authority of the third country, territory or part thereof provides sufficient guarantees that the conditions concerning the approval of bodies, institutes or centres set out in Part 4 of Annex VI are complied with.
                                 
3. The appropriate authority may include in the list referred to in paragraph 1 approved bodies, institutes or centres in any country outside Great Britain which are already included in such a list established by another appropriate authority without having assessed compliance with the conditions laid down in paragraph 2.

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

                           5. The appropriate authority must make available to the public, by means of internet-based information pages, the lists referred to in paragraph 1, and must keep those internet-based information pages up to date.
6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
Conditions for the assembly centres for certain consignments of ungulates
               

                     Article 4
                   


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

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

                  Protocols for the standardisation of materials and sampling and testing procedures for ungulates
               

                     Article 5
                   

                        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  Great Britain  of consignments of ungulates, such sampling and testing shall be carried out by or under the control of the competent authority of the third country of origin in accordance with the Protocols for the standardisation of materials and testing procedures set out in Part 6 of that Annex.
                     

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

                     Article 6
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

                  General conditions for the introduction into  Great Britain  of certain species of bees
               

                     Article 7
                   


                           1. Consignments of  queen bees (Apis mellifera and Bombus spp.) and bumble bees (Bombus spp.) shall only be introduced into Great Britain  from ...:
(a) such third countries listed in Part 1 of Annex II , or territories or parts thereof, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this paragraph;
(b) third countries or territories where the presence of the American foulbrood, the small hive beetle (
                                    
                                       Aethina tumida
                                    
                                    ) and the Tropilaelaps mite (
                                    
                                       Tropilaelaps
                                    
                                     spp.) is subject to compulsory notification throughout the whole territory of the third country or territory concerned.

                           2. By way of derogation from paragraph 1(a), consignments of bees may be introduced into  Great Britain  from a part of a third country or territory listed in Part 1 of Annex II and specified by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), in a document published for the purposes of this paragraph,  which is:
(a) a geographically and epidemiologically isolated part of the third country or territory
(b) listed in the third column of the table in Section 1 of Part 1 of Annex IV.
When that derogation is applied, the introduction into  Great Britain  of consignments of bees shall be prohibited from all other parts of the third country or territory concerned not listed in the third column of the table in Section 1 of Part 1 of Annex IV.

                           3. Consignments of bees of the species  referred to in paragraph 1  shall consist of either:
(a) 
                                    cages of queen bees (
                                    
                                       Apis mellifera
                                    
                                     and 
                                    
                                       Bombus
                                    
                                     spp.), each containing one single queen bee with a maximum of 20 accompanying attendants; or
                                 
(b) 
                                    containers of bumble bees (
                                    
                                       Bombus
                                    
                                     spp.), each containing a colony of a maximum of 200 adult bumble bees.
                                 

                           4. 
                              Consignments of bees of the species  referred to in paragraph 1  shall:
                           
(a) 
                                    be accompanied by the appropriate veterinary certificate,  in the form published by the appropriate authority from time to time, and completed and signed by an official inspector of the exporting third country;
                                 
(b) 
                                    comply with the veterinary requirements set out in the veterinary certificate referred to in point (a).

                  General conditions concerning the transport of live animals to  Great Britain

                     Article 8
                   

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

((a)) 
                                 transported together with live animals that:
                              

((i)) 
                                          are not intended for introduction into  Great Britain; or
                                       
((ii)) 
                                          are of a lower health status;
                                       
((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  Great Britain.

                  Time limit for the period of transport to  Great Britain  of live animals
               

                     Article 9
                   

                        Consignments of live animals shall only be introduced  from third countries into Great Britain  where the consignment arrives at the  border control post... 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  the form required for the declaration, as published by the appropriate authority from time to time,  and attached in its original form to the veterinary certificate.
                     

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

                     Article 10
                   

                        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  the form required for the declaration, as published by the appropriate authority from time to time,  and attached in its original form to the veterinary certificate.
                     

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

                     Article 11
                   

1. 
                              Following their introduction into  Great Britain, consignments of ungulates, other than those referred to in Article 3a shall be conveyed in a vector-protected means of transport without delay to the holding of destination.
                           
                              Those ungulates shall remain on that holding for a period of at least 30 days, unless they are dispatched directly to a slaughterhouse.

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

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

                     Article 12
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


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

                     Article 12a
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

                  Conditions to be applied following the introduction into  Great Britain  of consignments of bees referred to in Article 7
               

                     Article 13
                   


                           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  Great Britain  until the end of the lifespan of the colony.
                           
                              That container and the material that accompanied the bumble bees from the third country of origin shall be destroyed at the end of the lifespan of the colony at the latest.
                           
Conditions to be applied following the introduction of consignments of ungulates intended for approved bodies, institutes or centres
               

                     Article 13a
                   


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

                           2. 
                              The animals shall be kept in quarantine in vector-protected facilities on the premises of the approved body, institute or centre ... 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  Great Britain, and
                                 
(b) the movement is carried out in accordance with the requirements of the competent authority concerned, in order to ensure no risk of possible spread of disease.

                           4. 
                              By way of derogation from paragraph 3, animals may leave an approved body, institute or centre before the end of the six-month period provided for in that paragraph, only where the following conditions are complied with:
                           
(a) 
                                    the animals are exported to a third country, territory or part thereof;
                                 
(b) 
                                    for the purpose of their export as referred to in a) the animals are transported in means of transport that are vector-protected and so constructed that the animals cannot escape and faeces, urine, litter, fodder, waste or any other material cannot flow or fall out from the vehicle or container during transportation.
CHAPTER III
            

               CONDITIONS FOR THE INTRODUCTION OF FRESH MEAT INTO  GREAT BRITAIN  

                  General conditions for the importation of fresh meat
               

                     Article 14
                   

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

((a)) 
                                 they come from  such of the third countries  listed in  column 1  of the table in Part 1 of Annex II or a territory or part of any such third country, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article  for which there is a  veterinary certificate, in the form published by the appropriate authority from time to time,  corresponding to the consignment concerned listed in column 4 of the table in Part 1 of Annex II;
                              
((b)) 
                                 they are presented at the  border control post of introduction into  Great Britain accompanied by the appropriate veterinary certificate, in the form published by the appropriate authority from time to time, taking into account  any specific conditions that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 2c, and completed and signed by an official veterinarian of the exporting third country;
                              
((c)) 
                                 they comply with the requirements set out in the veterinary certificate referred to in point (b), including:
                              

((i)) any supplementary guarantees that the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may require under Article 14b(2);
((ii)) 
                                          any additional veterinary certification requirements that the  appropriate authority may include  in the certificate.
Supplementary guarantees, fresh meat
Article 14b 

(1.) The Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may impose conditions relating to the protection of public health, animal health or food safety in Great Britain on the import into Great Britain of a consignment of meat intended for human consumption from a third country listed in column 1 of Annex 2, or a territory or part thereof.
(2.) The person exporting the consignment from the third country to Great Britain, or another person acting on their behalf, must provide evidence that any condition imposed under paragraph 1 in relation to the consignment is satisfied by giving a supplementary guarantee in accordance with the veterinary certificate for the consignment concerned.
(3.) The Secretary of State must publish any conditions imposed under paragraph 1 in a document published for the purposes of this Article.

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

                     Article 15
                   

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

                  Transit and storage of fresh meat
               

                     Article 16
                   
The introduction into  Great Britain  of consignments of fresh meat not intended for importation into  Great Britain  but destined for a third country either by immediate transit or after storage in  Great Britain  in accordance with  Commission Delegated Regulation (EU) 2019/2124, shall only be authorised if the consignments comply with the following conditions:

((a)) they come from  such of the third countries  listed in  column 1  of the table in Part 1 of Annex II or territory or part of any such third country, as the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), may specify in a document published for the purposes of this Article, for which there is   an appropriate veterinary certificate, in the form published by the appropriate authority from time to time;
((b)) they comply with the specific animal health requirements for the consignment concerned, as set out in the  appropriate  veterinary certificate referred to in point (a);
((c)) they are accompanied by a veterinary certificate, drawn up in accordance with the model veterinary certificate  , in the form published by the appropriate authority from time to time, and completed and signed by an official veterinarian of the exporting third country;
((d)) they are certified as acceptable for transit, including storage as appropriate, on the common health entry document referred to in Article 2(3) of Commission Implementing Regulation (EU) 2019/2130, signed by the official veterinarian of the border control post of introduction into Great Britain.

                  Derogation for transit through Latvia, Lithuania and Poland
               

                     Article 17
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

                     Article 17a
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER IV
            

               GENERAL, TRANSITIONAL AND FINAL PROVISIONS
            
Matters relating to the exercise of powers under this Regulation
Article 17b 

(1.) The powers exercisable by the Secretary of State, with the consent of the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), under the provisions listed in paragraph 2 are exercisable only where it is necessary or appropriate to do so in the light of an assessment of the risk to animal or public health in the United Kingdom, taking into account the public health criteria and matters specified in paragraph 3.
(2.) The provisions are—
(a)) Article 2b (specification of closing date and opening date);
(b)) Article 2c (specific conditions – live ungulates and fresh meat);
(c)) Article 2d (supplementary guarantees – live ungulates);
(d)) in Article 3 (specification of third country, territory or part thereof from which ungulates may be imported into Great Britain), paragraph 1;
(e)) in Article 3a (specification of third country, territory or part thereof from which ungulates may be imported into Great Britain for an approved body, institute or centre), paragraph 1(b)(i);
(f)) in Article 7, (specification of third country or part thereof from which certain species of bees may be imported into Great Britain), paragraph 1(a) and paragraph 2;
(g)) in Article 14 (general conditions for the import into Great Britain of fresh meat), point (a);
(h)) in Article 14b (supplementary guarantees – fresh meat), paragraph 1;
(i)) Article 16 (specification of third countries and parts thereof authorised for the transit and storage of fresh meat).
(3.) Any assessment which is relied on for the purposes of paragraph 1 with regard to imports of ungulate animals listed in Annex 1 to Council Directive 2004/68/EC2 must be appropriate to the circumstances and have been approved by the Secretary of State, the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales), taking into account—
(a)) the health status of livestock, other domestic animals and wildlife and the environmental situation in the third country, with particular regard to the general situation as regards animal health in the third country and any animal disease that is exotic, notifiable or reportable in the United Kingdom that may pose a risk to the health and environmental situation of the United Kingdom;
(b)) the legislation of the third country in relation to animal health and welfare;
(c)) the organisation of the competent veterinary authority and its inspection services in the third country, the powers available to undertake those services, the supervision to which they are subject, and the means at their disposal, including staff and laboratory capacity, to apply the third country’s legislation effectively;
(d)) the assurances which the competent veterinary authority of the third country can give regarding compliance with legislation in that country that is of relevance to protection of animal health in the United Kingdom;
(e)) whether the third country is a member of the OIE, and the regularity and rapidity of the information supplied by the third country relating to the existence of infectious or contagious animal diseases in its territory, in particular those diseases listed by the OIE;
(f)) the assurances given by the third country to inform the United Kingdom within 24 hours of the confirmation of the occurrence of any diseases of ungulates listed in Annex 2 to Council Directive 2004/68/EC and of any change in the vaccination policy concerning such diseases, or any proposed changes in the national health rules concerning live ungulate animals, in particular regarding importation;
(g)) any experience of previous imports of live animals from the third country and the results of any import controls carried out;
(h)) the animal health requirements applying to the production, manufacture, handling, storage and dispatch of products of animal origin intended for Great Britain;
(i)) the results of inspections or audits carried out in the third country, in particular the results of the assessment of the competent authorities of those inspections or audits;
(j)) the rules on the prevention and control of infectious or contagious animal diseases in force in the third country and their implementation, including rules on importation from other third countries.
(4.) Any assessment which is relied upon for the purposes of paragraph 1 with regard to the imports of fresh meat in accordance with Council Directive 2002/99/EC must be appropriate to the circumstances and must have been approved by the Secretary of State the Scottish Ministers (in relation to Scotland) and the Welsh Ministers (in relation to Wales).
(5.) Where the Scottish Ministers or the Welsh Ministers request that the Secretary of State exercise a power under a provision listed in paragraph 2, the Secretary of State must have regard to that request.
(6.) In this Article—
 “the OIE” means the World Organisation for Animal Health;
 “public health criteria” means the criteria set out in Schedule 2 to the Trade in Animals and Animal Products (Legislative Functions) and Veterinary Surgeons (Amendment) (EU Exit) Regulations 2019.

                  Certification
               

                     Article 18
                   

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

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

                  Transitional provisions
               

                     Article 19
                   
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

                  Repeal
               

                     Article 20
                   

                        Decision 2003/881/EC is repealed.
                     

                  Entry into force
               

                     Article 21
                   

                        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 ....
ANNEX I
            

                  UNGULATES
               
PART 1
                  



                              List of third countries ...
                                    ISO code and name of third country
                                  ...
                                  ... 
                                    Veterinary certificate
                                  ...

                                    Model(s)
                                  ... 
                                 

                                    1
                                  
                                    2
                                  
                                    3
                                  
                                    4
                                  
                                    5
                                  
                                    6
                                 

CA — Canada
                                    
                                    POR-X, BOV-X, OVI-X, OVI-Y, RUM  

                                    CH – Switzerland
                                    BOV-X, BOV-Y, OVI-X, OVI-Y, POR-X, POR-Y, RUM, SUI  

                                    CL – Chile
                                    
                                    BOV-X,OVI-X, RUM
                                   

                                    POR-X, SUI
                                  
EU member States, Liechtenstein and Norway  . . .   BOV-X, BOV-Y, OVI-X, OVI-Y, POR-X, POR-Y, RUM, SUI  

                                    GL – Greenland
                                    
                                    OVI-X, RUM
                                   


                                    IS – Iceland
                                    
                                    BOV-X, BOV-Y RUM, OVI-X, OVI-Y
                                   

                                    POR-X, POR-Y
                                  

                                    ME – Montenegro
                                      
MK-The Republic of North Macedonia     
NZ – New Zealand
                                    
                                          BOV-X, BOV-Y,
                                       
                                          RUM,
                                       
                                          POR-X, POR-Y
                                       
                                          OVI-X, OVI-Y  
. . .     

                                    RS – Serbia
                                    
                                      

                                    RU – Russia
                                      
    
  . . .  
US – United States
                                    
                                    POR-X  
. . .
. . .
. . .
. . .


. . .

... 




                     PART 2
                  

                        Models of Veterinary Certificates
                     

                     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.)
                  
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


                     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.)
                  
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


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

((a)) 
                                          without coming into contact with cloven-hoofed animals other than animals which fulfil the health conditions established for the introduction of the relevant category of animal into  Great Britain;
                                       
((b)) 
                                          segregated into consignments so that no consignment contains both animals for breeding or production and animals for immediate slaughter;
                                       
((c)) 
                                          in transport vehicles or containers which have first been cleansed and disinfected with a disinfectant officially authorised in the exporting country as effective for the control of foot-and-mouth disease and which are so constructed that faeces, urine, litter or fodder cannot flow or fall out during transportation.
                                       
IX.. 
                                 Where the conditions for the export of animals to  Great Britain  require that a test is carried out within a specified period before loading, that period must include any period of assembly, up to six days, from the date of arrival of the animals at the approved assembly centre.
                              
X.. 
                                 The exporting third country must designate the centres which are approved for animals for breeding and production and those centres which are approved for animals for slaughter and must notify the  appropriate authority  of the names and addresses of such premises. That information must be updated regularly.
                              
XI.. 
                                 The exporting third country shall determine the procedure for official supervision of approved assembly centres and shall ensure that such supervision is carried out.
                              
XII.. 
                                 The approved assembly centres must be regularly inspected by the competent authority of the third country in order to check that the requirements for approval set out in points I to XI continue to be fulfilled.
                              

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


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

                        Brucellosis (Brucella melitensis) (BRL)
                      


                           Tests shall be carried out  in a manner equivalent to the standards in  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  in a manner equivalent to the standards in  paragraphs A and C of Chapter II of Annex D to Directive 64/432/EEC.
                        

                        Bluetongue (BTG)
                      
 
                           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 H
                                          
                                             2
                                          
                                           O
                                          
                                             2
                                          
                                           per 10 ml OPD). (
                                          
                                             Handle OPD with care - wear rubber gloves - suspected mutagen
                                          
                                          ).
                                       
7.. 
                                          1 Molar sulphuric acid: 26,6 ml of acid added to 473,4 ml of distilled water. (
                                          
                                             Remember Acid must be added to water, never water to acid
                                          
                                          .)
                                       
8.. 
                                          Orbital shaker.
                                       
9.. 
                                          ELISA plate reader (
                                          
                                             the test may be read visually
                                          
                                          ).
                                       

                              Test format
                            


                                 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
                              
                              .
                           

                        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 CO
                                          
                                             2
                                          
                                           or liquid nitrogen. Samples are obtained by the use of a specially-designed sputum collector or ‘probang’. To obtain a sample the probang cup is passed through the mouth, over the dorsum of the tongue and down into the upper part of the oesophagus. Attempts are made to scrape the surface epithelium of the upper oesophagus and pharynx by movements directed laterally and dorsally. The probang is then withdrawn, if possible after the animal has swallowed. The cup must be full and contain a mixture of mucus, saliva, oesophageal fluid and cellular debris. Care must be taken to ensure that each specimen contains some visible cellular material. Very rough handling which causes bleeding must be avoided. Samples from some animals may be heavily contaminated with ruminal contents. Such samples must be discarded and the mouth of the animal flushed with water, or preferably physiological saline, before repeat sampling.
                                       
                                    Treatmentof samples:
                                 
                                          Each sample collected in the probang cup is examined for quality and 2 ml added to an equal volume of transport medium in a container which can withstand freezing. The containers are tightly closed, sealed, disinfected and labelled. The samples are kept cool (+ 
                                          4
                                           °C) and examined within three to four hours or placed over dry ice (- 
                                          69
                                           °C) or liquid nitrogen and kept frozen until examined. Between animals the probang is disinfected and washed in three changes of clean water.
                                       
                                    Testing for FMD virus:
                                 
                                          Samples are inoculated into cultures of primary bovine thyroid cell cultures using at least three tubes per sample. Other susceptible cells such as primary bovine or porcine kidney cells can be used but it must be kept in mind that for some strains of FMD virus they are less sensitive. The tubes are incubated at 37 °C on a roller apparatus and examined daily for 48 hours for the presence of a cytopathic effect (CPE). If negative, cultures are blind passaged onto new cultures and re-examined for 48 hours. The specificity of any CPE must be confirmed.
                                       

                              Recommended transport media:
                           

1.. 
                                       0,08M phosphate buffer pH 7,2 containing 0,01 % bovine serum albumin, 0,002 % phenol red and antibiotics.
                                    
2.. 
                                       Tissue culture medium (such as Eagle's MEM) containing 0,04 M Hepes buffer, 0,01 % bovine serum albumin and antibiotics, pH 7,2.
                                    
3.. 
                                       Antibiotics (per ml final) must be added to the transport medium such as penicillin 
                                       1 000
                                        IU, neomycin sulphate100 IU, polymyxin B sulphate50 IU, mycostatin100 IU.
                                    
 
                           B.
                         
                              The virus neutralisation test shall be carried out according to the following protocol:
                           

                                    Reagents
                                 
                                          Stock FMDV antigen is prepared in cell cultures or on cattle tongues and stored at - 
                                          70
                                           °C or less or at - 
                                          20
                                           °C after the addition of 50 % glycerol. This is the stock antigen. FMDV is stable under these conditions and titres vary little over a period of months.
                                       
                                    Procedure
                                 
                                          The test is carried out in flat-bottomed tissue culture grade microtitre plates using susceptible cells such as IB-RS-2, BHK-21 or calf kidney cells. Sera for the test are diluted 1/4 in serum-free cell culture medium with the addition of 100 IU/ml neomycin or other suitable antibiotics. Sera are inactivated at 56 °C for 30 minutes and 0.05 ml amounts are used to prepare a twofold series on microtitre plates using 0,05 ml diluting loops. Pre-titrated virus also diluted in serum-free culture medium and containing 100 TCID50/0.05 ml is then added to each well. Following incubation at 37 °C for one hour to allow neutralisation to take place, 0,05 ml of suspension cells containing 0,5 to 1.0 × 10
                                          
                                             6
                                          
                                           cells per 1 ml in cell culture medium containing serum free of FMD antibody is added to each well and the plates are sealed. Plates are incubated at 37 °C. Monolayers are normally confluent within 24 hours. CPE is usually sufficiently advanced at 48 hours for a microscopic reading of the test. At this time a final microscopic reading may be made or the plates may be fixed and stained for macroscopic reading, for instance using 10 % formol-saline and 0,05 % methylene blue.
                                       
                                    Controls
                                 
                                          Controls in each test include homologous antiserum of known titre, a cell control, a serum toxicity control, a medium control, and a virus titration from which the actual amount of virus in the test is calculated.
                                       
                                    Interpretation
                                 
                                          Wells with evidence of CPE are considered to be infected and neutralisation titres are expressed as the reciprocal of the final dilution of serum present in the serum/virus mixtures at the 50 % end point estimated according to the Spearman-Karber method. (Karber, G., 1931, Archiv fuer Experimentelle Pathologie und Pharmokologie, 162, 480.). Tests are considered to be valid when the actual amount of virus used per well in the test is between 101,5 and 102,5 TCID50 and when the titre of the reference serum is within twofold of its expected titre, estimated from the mode of previous titrations. When the controls are outside these limits the tests are repeated. An end point titre of 1/11 or less is taken as negative.
                                       
 
                           C.
                         
                              The detection and quantification of antibody by ELISA shall be carried out according to the following protocol:
                           


                                       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 % H
                                          
                                             2
                                          
                                          O
                                          
                                             2
                                          
                                           (30 %) w/v is added to each well.
                                       
8.. 
                                          The reaction is stopped after 15 minutes with 1,25M H
                                          
                                             2
                                          
                                          SO
                                          
                                             4
                                          
                                          .
                                       


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


                                       Controls
                                    
                                             For each antigen used 40 wells contain no serum but contain antigen diluted in PBST. A duplicated twofold dilution series of homologous bovine reference antiserum. A duplicate twofold dilution series of negative bovine serum.
                                          
                                       Interpretation
                                    
                                             Antibody titres are expressed as the final dilution of tests serum giving 50 % of the mean OD value recorded in the virus control wells where test serum is absent. Titres in excess of 1/40 are considered positive.
                                          
                                       References
                                    
                                             Hamblin C, Barnett ITR and Hedger RS (1986) 
                                             ‘
                                             A new enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies against foot-and-mouth disease virus. I. Development and method of ELISA.
                                             ’
                                              Journal of Immunological Methods, 93, 115 to 121.11.
                                          

                        Aujeszky's disease (AJD)
                      
 
                           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
                              
                              .
                           

                        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
                           
                           .
                        

                        Classical swine fever (CSF)
                      


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


                           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.
                        
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.


                     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
                      
 
                           CHAPTER 1
                         
                           Residence and quarantine
                         
 
                              1.
                            . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                              2.
                            . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                           CHAPTER 2
                         
                           Animal health tests
                         
 
                              1.
                            
                                 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                              2.
                            
                                 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                 2.1
                               
                                 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.1
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.2
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.3
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.4
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.5
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.6
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.7
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.8
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.9
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.10
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.11
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.12
                                  
                                       . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
 
                                    2.1.13
                                  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


               ANNEX II
            

                  FRESH MEAT
               
PART 1
                  



                              List of third countries ...
                           
                                    ISO code and name of third country
                                  ... ... 
                                    Veterinary certificate
                                  ...
                                  ...
                                    
                                  ...
                                    
                                 

                                    Model(s)
                                  ...
                                 

                                    1
                                  
                                    2
                                  
                                    3
                                  
                                    4
                                  
                                    5
                                  
                                    6
                                  
                                    7
                                  
                                    8
                                 

                                    AL – Albania
                                    
                                    —
                                     
AR-Argentina
                                    
                                    EQU
                                       
BOV, OVI, RUF, RUW
 . . .      
 . . .      
 . . .      
 . . .      

                                    AU – Australia
                                    
                                    BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
                                     
BA – Bosnia and Herzegovina
                                       
                                    BOV
                                     

                                    BH – Bahrain
                                    
                                    —
                                     
BR — BRAZIL
                                    
                                    EQU
                                     
BOV
. . .      
. . .      
. . .      
. . .      
BW — Botswana
                                    
                                    EQU, EQW
                                     
BOV, OVI, RUF, RUW
. . .      
. . .      
. . .      
. . .      
. . .      

                                    BY – Belarus
                                    
                                    —
                                     

                                    BZ – Belize
                                    
                                    BOV, EQU
                                     

                                    CA – Canada
                                    
                                    BOV, OVI, POR, EQU, SUF, SUW, RUF, RUW
                                     

                                    CH – Switzerland
                                    BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW, EQW    

                                    CL – Chile
                                    
                                    BOV, OVI, POR, EQU, RUF, RUW, SUF
                                     

                                    CN – China
                                    
                                    —
                                     

                                    CO – Colombia
                                    
                                    EQU
                                     

                                    CR – Costa Rica
                                    
                                    BOV, EQU
                                     

                                    CU – Cuba
                                    
                                    BOV, EQU
                                     

                                    DZ – Algeria
                                    
                                    —
                                     
EU member States, Liechtenstein and Norway ...    BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW , EQW    

                                    ET – Ethiopia
                                    
                                    —
                                     

                                    FK – Falkland Islands
                                    
                                    BOV, OVI, EQU
                                     

                                    GL – Greenland
                                    
                                    BOV, OVI, EQU, RUF, RUW
                                     

                                    GT – Guatemala
                                    
                                    BOV, EQU
                                     

                                    HK – Hong Kong
                                    
                                    —
                                     

                                    HN – Honduras
                                    
                                    BOV, EQU
                                     
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 
IL – Israel
                                       
                                    —
                                     

                                    IN – India
                                    
                                    —
                                     

                                    IS – Iceland
                                    
                                    BOV, OVI, EQU, RUF, RUW
                                  , POR, SUF, SUW, EQW    
JP — Japan
                                    
                                    BOV    

                                    KE – Kenya
                                    
                                    —
                                     

                                    MA – Morocco
                                    
                                    EQU
                                     

                                    ME – Montenegro
                                    
                                    BOV, OVI, EQU
                                     

                                    MG – Madagascar
                                    
                                    —
                                     
MK-The Republic of North Macedonia
                                    
                                    BOV, OVI, EQU    

                                    MU – Mauritius
                                    
                                    —
                                     

                                    MX – Mexico
                                    
                                    BOV, EQU
                                     

                                    NA – Namibia
                                    
                                    EQU, EQW
                                     
BOV, OVI, RUF, RUW
. . .      

                                    NC – New Caledonia
                                    
                                    BOV, RUF, RUW
                                     

                                    NI – Nicaragua
                                    
                                    —
                                     

                                    NZ – New Zealand
                                    
                                    BOV, OVI, POR, EQU, RUF, RUW, SUF, SUW
                                     

                                    PA – Panama
                                    
                                    BOV, EQU
                                     
PY – Paraguay
                                    
                                    EQU
                                     
BOV
. . .      

                                    RS – Serbia
                                       
                                    BOV, OVI, EQU
                                     

                                    RU – Russia
                                    RUF    
. . .      
SG — Singapore
                                       
                                    NZ-TRANSIT-SG    

                                    SV – El Salvador
                                    
                                    —
                                     

                                    SZ – Swaziland
                                    
                                    EQU, EQW
                                     
BOV, RUF, RUW
. . .      
. . .      

                                    TH – Thailand
                                    
                                    —
                                     

                                    TN – Tunisia
                                    
                                    —
                                     

                                    TR – Turkey
                                    EQU    
. . .      

                                    UA – Ukraine
                                    
                                    —
                                     

                                    US – United States
                                    
                                    BOV, OVI, POR, EQU,SUF, SUW, RUF, RUW
                                     
UY – Uruguay
                                    
                                    EQU
                                     
BOV, OVI
. . .    
. . .    
ZA – South Africa
                                    
                                    EQU, EQW    
...

                                    ZW – Zimbabwe
                                    
                                    —
                                     
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .
. . .


                     PART 2
                  

                        Models of veterinary certificates
                     
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


               ANNEX III
            

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


               ANNEX IV
            

                  ANIMALS REFERRED TO IN ARTICLE 1(1)(b)
               

                     PART 1
                  

                     Lists of third countries, territories or parts thereof
                  

                        SECTION 1
                     

                        Parts of third countries or territories referred to in Article 7(2)
                     


                                       Country/territory
                                     
                                       Code of part of the country/territory
                                     
                                       Description of part of the country/territory
                                    

                                       US – United States
                                     
                                       US-A
                                     
                                       The State of Hawaii



                     PART 2
                  

                     Tables of animals and the corresponding model veterinary certificates
                  
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .


               ANNEX V
            

                  Explanatory notes for completing the veterinary certificates
               

                  (referred to in Article 18)
               

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

ANNEX VI
            

                     PART 1
                  


                                       Table 1
                                     
‘RUM-A’Model veterinary certificate, in the form published by the appropriate authority from time to time,  for animals of the species listed below that are originating from and intended for an approved body, institute or centre.
                                                

                                       Order
                                     
                                       Family
                                     
                                       Genera/species
                                    

                                    Artiodactyla
                                  
                                    Antilocapridae
                                  
                                       Antilocapra
                                    
                                     ssp.
                                 

                                    Bovidae
                                  
                                       Addax
                                    
                                     ssp., 
                                    
                                       Aepyceros
                                    
                                     ssp., 
                                    
                                       Alcelaphus
                                    
                                     ssp., 
                                    
                                       Ammodorcas
                                    
                                     ssp., 
                                    
                                       Ammotragus
                                    
                                     ssp., 
                                    
                                       Antidorcas
                                    
                                     ssp., 
                                    
                                       Antilope
                                    
                                     ssp., 
                                    
                                       Bison
                                    
                                     ssp., 
                                    
                                       Bos
                                    
                                     ssp. 
                                    
                                       (including Bibos, Novibos, Poephagus), Boselaphus
                                    
                                     ssp., 
                                    
                                       Bubalus
                                    
                                     ssp. 
                                    
                                       (including anoa), Budorcas
                                    
                                     ssp., 
                                    
                                       Capra
                                    
                                     ssp., 
                                    
                                       Cephalophus
                                    
                                     ssp., 
                                    
                                       Connochaetes
                                    
                                     ssp., 
                                    
                                       Damaliscus
                                    
                                     ssp. 
                                    
                                       (including Beatragus), Dorcatragus
                                    
                                     ssp., 
                                    
                                       Gazella
                                    
                                     ssp., 
                                    
                                       Hemitragus
                                    
                                     ssp., 
                                    
                                       Hippotragus
                                    
                                     ssp., 
                                    
                                       Kobus
                                    
                                     ssp., 
                                    
                                       Litocranius
                                    
                                     ssp., 
                                    
                                       Madoqua
                                    
                                     ssp., 
                                    
                                       Naemorhedus
                                    
                                     ssp. 
                                    
                                       (including Nemorhaedus and Capricornis), Neotragus
                                    
                                     ssp., 
                                    
                                       Oreamnos
                                    
                                     ssp., 
                                    
                                       Oreotragus
                                    
                                     ssp., 
                                    
                                       Oryx
                                    
                                     ssp., 
                                    
                                       Ourebia
                                    
                                     ssp., 
                                    
                                       Ovibos
                                    
                                     ssp., 
                                    
                                       Ovis
                                    
                                     ssp., 
                                    
                                       Patholops
                                    
                                     ssp., 
                                    
                                       Pelea
                                    
                                     ssp., 
                                    
                                       Procapra
                                    
                                     ssp., 
                                    
                                       Pseudois
                                    
                                     ssp., 
                                    
                                       Pseudoryx
                                    
                                     ssp., 
                                    
                                       Raphicerus
                                    
                                     ssp., 
                                    
                                       Redunca
                                    
                                     ssp., 
                                    
                                       Rupicapra
                                    
                                     ssp., 
                                    
                                       Saiga
                                    
                                     ssp., 
                                    
                                       Sigmoceros-Alecelaphus
                                    
                                     ssp., 
                                    
                                       Sylvicapra
                                    
                                     ssp., 
                                    
                                       Syncerus
                                    
                                     ssp., 
                                    
                                       Taurotragus
                                    
                                     ssp., 
                                    
                                       Tetracerus
                                    
                                     ssp., 
                                    
                                       Tragelaphus
                                    
                                     ssp. (
                                    
                                       including Boocerus
                                    
                                    ).
                                 

                                    Camelidae
                                  
                                       Camelus
                                    
                                     ssp., 
                                    
                                       Lama
                                    
                                     ssp., 
                                    
                                       Vicugna
                                    
                                     ssp.
                                 

                                    Cervidae
                                  
                                       Alces
                                    
                                     ssp., 
                                    
                                       Axis-Hyelaphus
                                    
                                     ssp., 
                                    
                                       Blastocerus
                                    
                                     ssp., 
                                    
                                       Capreolus
                                    
                                     ssp., 
                                    
                                       Cervus-Rucervus
                                    
                                     ssp., 
                                    
                                       Dama
                                    
                                     ssp., 
                                    
                                       Elaphurus
                                    
                                     ssp., 
                                    
                                       Hippocamelus
                                    
                                     ssp., 
                                    
                                       Hydropotes
                                    
                                     ssp., 
                                    
                                       Mazama
                                    
                                     ssp., 
                                    
                                       Megamuntiacus
                                    
                                     ssp., 
                                    
                                       Muntiacus
                                    
                                     ssp., 
                                    
                                       Odocoileus
                                    
                                     ssp., 
                                    
                                       Ozotoceros
                                    
                                     ssp., 
                                    
                                       Pudu
                                    
                                     ssp., 
                                    
                                       Rangifer
                                    
                                     ssp.
                                 

                                    Giraffidae
                                  
                                       Giraffa
                                    
                                     ssp., 
                                    
                                       Okapia
                                    
                                     ssp.
                                 

                                    Moschidae
                                  
                                       Moschus
                                    
                                     ssp.
                                 

                                    Tragulidae
                                  
                                       Hyemoschus
                                    
                                     ssp., 
                                    
                                       Tragulus-Moschiola
                                    
                                     ssp.
                                 



                                       Table 2
                                     
‘SUI-A’Model veterinary certificate, in the form published by the appropriate authority from time to time,  for animals of the species listed below that are originating from and intended for an approved body, institute or centre.
                                                

                                       Order
                                     
                                       Family
                                     
                                       Genera/species
                                    

                                    Artiodactyla
                                  
                                    Suidae
                                  
                                       Babyrousa
                                    
                                     ssp., 
                                    
                                       Hylochoerus
                                    
                                     ssp., 
                                    
                                       Phacochoerus
                                    
                                     ssp., 
                                    
                                       Potamochoerus
                                    
                                     ssp., 
                                    
                                       Sus
                                    
                                     ssp.
                                 

                                    Tayassuidae
                                  
                                       Catagonus
                                    
                                     ssp., 
                                    
                                       Pecari-Tayassu
                                    
                                     ssp.
                                 
 
                                    Hippopotamidae
                                  
                                       Hexaprotodon-Choeropsis
                                    
                                     ssp., 
                                    
                                       Hippopotamus
                                    
                                     ssp.
                                 



                                       Table 3
                                     
‘TRE-A’Model veterinary certificate, in the form published by the appropriate authority from time to time,  for animals of the species listed below that are originating from and intended for an approved body, institute or centre.
                                                

                                       Order
                                     
                                       Family
                                     
                                       Genera/species
                                    

                                    Perissodactyla
                                  
                                    Tapiridae
                                  
                                       Tapirus
                                    
                                     ssp.
                                 
 
                                    Rhinocerotidae
                                  
                                       Ceratotherium
                                    
                                     ssp., 
                                    
                                       Dicerorhinus
                                    
                                     ssp., 
                                    
                                       Diceros
                                    
                                     ssp., 
                                    
                                       Rhinoceros
                                    
                                     ssp.
                                 

                                    Proboscidea
                                  
                                    Elephantidae
                                  
                                       Elephas
                                    
                                     ssp., 
                                    
                                       Loxodonta
                                    
                                     ssp.
                                 


                     PART 2
                  

                     PART 3
                  

                        Requirements concerning bodies, institutes or centres in third countries
                     

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


((a)) 
                                 be clearly demarcated and separated from its surroundings;
                              
((b)) 
                                 have adequate means for catching, confining and isolating animals, and have available adequate quarantine facilities and approved standard operating procedures for animals coming from unknown origin;
                              
((c)) 
                                 have a vector-protected structure complying with the following requirements:
                              

((i)) 
                                          it has appropriate physical barriers at entry and exit points;
                                       
((ii)) 
                                          the openings of the vector-protected structure are vector-screened with mesh of appropriate gauge impregnated regularly with an approved insecticide according to the instructions of the manufacturer;
                                       
((iii)) 
                                          vector surveillance and control are carried out within and around the vector-protected structure;
                                       
((iv)) 
                                          measures are taken to limit or eliminate breeding sites for vectors in the vicinity of the vector-protected structure;
                                       
((v)) 
                                          standard operating procedures are in place, including descriptions of back-up and alarm systems, for the operation of the vector-protected structure and for the transport of the animals from that structure to the place of loading;
                                       
((d)) 
                                 keep, for a minimum period of ten years, up-to-date records indicating:
                              

((i)) 
                                          the number and identity (age, sex, species and individual identification, where appropriate) of the animals of each species present on their premises;
                                       
((ii)) 
                                          the number and identity (age, sex, species and individual identification where appropriate) of animals arriving in or leaving their premises, together with information on their origin or destination, the means of transport, and the health status of those animals;
                                       
((iii)) 
                                          the results of blood tests or any other diagnostic procedures carried out on the animals on their premises;
                                       
((iv)) 
                                          cases of disease and, where appropriate, the treatment administered;
                                       
((v)) 
                                          the results of the post-mortem examinations on animals that have died on their premises, including still-born animals;
                                       
((vi)) 
                                          observations made during any isolation or quarantine period;
                                       
((e)) 
                                 be free from the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species  , in the form published by the appropriate authority from time to time, for at least the previous three years, as evidenced by the records kept pursuant to point (d) and the results of the clinical and laboratory tests carried out on the animals on their premises;
                              
((f)) 
                                 either have an arrangement with a laboratory approved 
                                 
                                    by the competent authority
                                 
                                  to perform post-mortem examinations, or have one or more appropriate premises where these examinations may be performed under the authority of the approved veterinarian;
                              
((g)) 
                                 ensure disposal of the carcasses of animals which die of a disease or are euthanised;
                              
((h)) 
                                 secure, by contract or legal instrument, the services of a veterinarian approved by and acting under the control of the competent authority, who must perform at least the following tasks:
                              

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

— 
                                                   an annual disease surveillance plan including appropriate control measures concerning zoonoses in the animals present on the premises,
                                                
— 
                                                   clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases and zoonoses,
                                                
— 
                                                   vaccination of susceptible animals against infectious diseases and zoonoses;
                                                
((ii)) 
                                          ensure that any suspect deaths or the presence of any other symptom suggesting that animals have contracted one or more of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species  , in the form published by the appropriate authority from time to time,  are notified without delay to the competent authority, where that particular disease is notifiable in the third country, territory or part thereof concerned;
                                       
((iii)) 
                                          ensure that incoming animals have been quarantined as necessary, in accordance with the instructions given by the competent authority;
                                       
((iv)) 
                                          ensure compliance with the animal health requirements which the animals must fulfil in order to be introduced into  Great Britain.
                                       


                     PART 4
                  

                        Conditions concerning the approval of bodies, institutes or centres in third countries
                     

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


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


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


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


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


((i)) 
                                    inspect the premises of the body, institute or centre at least once per year;
                                 
((ii)) 
                                    audit the activity of the veterinarian referred to in point (h) of Part 3 and the implementation of the annual disease surveillance plan referred to in the first indent of point (h)(i);
                                 
((iii)) 
                                    ensure that the provisions laid down in Parts 3 and 4 are met;
                                 
((iv)) 
                                    verify ...:
                                 

— 
                                             compliance with the animal health requirements which the animals must fulfil in order to be introduced into  Great Britain;
                                          
— that the results of the clinical, post-mortem and laboratory tests on the animals have revealed no occurrence of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species  , in the form published by the appropriate authority from time to time.
                                          


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


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


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


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


((a)) 
                                    the disease and the source of infection were eradicated on the premises of the body, institute or centre concerned;
                                 
((b)) 
                                    the premises of the body, institute or centre concerned were appropriately cleaned and desinfected;
                                 
((c)) 
                                    the body, institute or centre concerned complies with the requirements set out in points (a) to (d) and (f) to (h) of Part 3.
                                 


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