This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability  
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official 
Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links 
embedded in this document  
►B ►C1 COMMISSION REGULATION (EU) No 206/2010  
of 12 March 2010  
laying down lists of third countries, territories or parts thereof authorised for the introduction into 
the European Union of certain animals and fresh meat and the veterinary certification 
requirements  
(Text with EEA relevance) ◄ 
(OJ L 73, 20.3.2010, p. 1)  
Amended by:  
Official Journal  
No page  date  
►M1 Commission Regulation (EU) No 810/2010 of 15 September 2010  L 243  1 6  16.9.2010  
►M2 Commission Regulation (EU) No 144/2011 of 17 February 2011  L  4 4  7  18.2.2011  
►M3 Commission Implementing Regulation (EU) No 342/2011 of 8 April  
2011  L 96  1 0  9.4.2011  
►M4 Commission Implementing Regulation (EU) No 801/2011 of 9 Augus t 
2011  L 205  2 7  10.8.2011  
►M5 Commission Implementing Regulation (EU) No 1112/2011 of 3 
November 2011  L 287  3 2  4.11.2011  
►M6 Commission Implementing Regulation (EU) No 497/2012 of 7 June 
2012  L 152  1  13.6.2012  
►M7 Commission Implementing Regulation (EU) No 546/2012 of 25 June  
2012  L 165  2 5  26.6.2012  
►M8 Commission Implementing Regulation (EU) No 644/2012 of 16 July  
2012  L 187  1 8  17.7.2012  
►M9 Commission Implementing Regulation (EU) No 1036/2012 of 7 
November 2012  L 308  1 3  8.11.2012  
►M10  Commission Implementing Regulation (EU) No 1160/2012 of 7 
December 2012  L 336  9  8.12.2012  
►M11  Commission Implementing Regulation (EU) No 71/2013 of 25 Janua ry 
2013  L 26  7  26.1.2013  
►M12  Commission Implementing Regulation (EU) No 102/2013 of 4 
February 2013  L 34  4  5.2.2013  
►M13  Commission Implementing Regulation (EU) No 191/2013 of 5 March  
2013  L 62  2 2  6.3.2013  
►M14  Commission Implementing Regulation (EU) No 196/2013 of 7 March  
2013  L 65  1 3  8.3.2013  
►M15  Commission Implementing Regulation (EU) No 482/2013 of 24 May 
2013  L 139  6  25.5.2013  
►M16  Commission Regulation (EU) No 519/2013 of 21 February 2013  L 158  7 4  10.6.2013  
►M17  Commission Implementing Regulation (EU) No 556/2013 of 14 June  
2013  L 164  1 3  18.6.2013  02010R0206 — EN — 01.01.2021 — 027.001 — 1
 
►M18  Commission Implementing Regulation (EU) No 780/2013 of 14 Augu st 
2013  L 219  1  15.8.2013  
►M19  Commission Implementing Regulation (EU) No 854/2013 of 4 
September 2013  L 237  1  5.9.2013  
►M20  Commission Implementing Regulation (EU) No 1044/2013 of 25 
October 2013  L 284  1 2  26.10.2013  
►M21  Commission Implementing Regulation (EU) No 1218/2014 of 13 
November 2014  L 329  2 0  14.11.2014  
►M22  Commission Implementing Regulation (EU) 2015/604 of 16 April 2 015 L 100  6 0  17.4.2015  
►M23  Commission Implementing Regulation (EU) 2015/917 of 15 June 20 15 L 149  1 1  16.6.2015  
►M24  Commission Implementing Regulation (EU) 2016/535 of 5 April 20 16 L  8 9  8  6.4.2016  
►M25  Commission Implementing Regulation (EU) 2016/922 of 10 June 20 16 L 154  2 1  11.6.2016  
►M26  Commission Implementing Regulation (EU) 2016/1248 of 28 July 2 016 L 204  112  29.7.2016  
►M27  Commission Implementing Regulation (EU) 2016/1832 of 17 Octobe r 
2016  L 280  1 3  18.10.2016  
►M28  Commission Implementing Regulation (EU) 2017/384 of 2 March 20 17 L  5 9  3  7.3.2017  
►M29  Commission Implementing Regulation (EU) 2017/731 of 25 April 2 017 L 108  7  26.4.2017  
►M30  Commission Implementing Regulation (EU) 2019/1162 of 1 July 20 19 L 182  1  8.7.2019  
►M31  Commission Delegated Regulation (EU) 2019/2124 of 10 October 2 019 L 321  7 3  12.12.2019  
►M32  Commission Implementing Regulation (EU) 2020/386 of 9 March 20 20 L  7 3  1  10.3.2020  
►M33  Commission Implementing Regulation (EU) 2020/2204 of 22 
December 2020  L 438  7  28.12.2020  
Corrected by:  
►C1 Corrigendum, OJ L 146, 11.6.2010, p. 1 (206/2010)  
►C2 Corrigendum, OJ L 49, 24.2.2011, p. 53 (144/2011)  
►C3 Corrigendum, OJ L 63, 10.3.2011, p. 28 (144/2011)  
►C4 Corrigendum, OJ L 238, 6.9.2013, p. 23 (780/2013)  
►C5 Corrigendum, OJ L 29, 5.2.2015, p. 16 (780/2013)  
►C6 Corrigendum, OJ L 146, 3.6.2016, p. 37 (2016/535)  02010R0206 — EN — 01.01.2021 — 027.001 — 2
▼C1 
COMMISSION REGULATION (EU) No 206/2010  
of 12 March 2010  
laying down lists of third countries, territories or parts thereof 
authorised for the introduction into the European Union of 
certain animals and fresh meat and the veterinary certification 
requirements  
(Text with EEA relevance)  
CHAPTER I  
SUBJECT MATTER, SCOPE AND DEFINITIONS  
Article 1  
Subject matter and scope  
1. This Regulation lays down the veterinary certification 
requirements for the introduction into the Union of consignment s 
containing the following live animals or fresh meat:  
(a) ungulates;  
(b) the animals listed in Part 2 of Annex IV;  
(c) fresh meat intended for human consumption, excluding meat p rep­
arations, of ungulates and equidae.  
2. This Regulation lays down the lists of third countries, terr itories or 
parts thereof from which the consignments referred to in paragr aph 1 
may be introduced into the Union.  
▼M18  __________  
▼C1 
4. This Regulation shall apply without prejudice to any specifi c 
certification requirements laid down in other Union acts or in 
agreements concluded by the Union with third countries.  
Article 2  
Definitions  
For the purposes of this Regulation, the following definitions shall 
apply:  
(a) ‘ungulates’ means ungulates as defined in Article 2(d) of D irective 
2004/68/EC;  ▼B 02010R0206 — EN — 01.01.2021 — 027.001 — 3
 
(b) ‘fresh meat’ means fresh meat as defined in point 1.10 of A nnex I 
to Regulation (EC) No 853/2004;  
(c) ‘equidae’ means equidae as defined in Article 2(b) of Counc il 
Directive 90/426/EEC (  1 ); 
(d) ‘holding’ means a farm or other officially supervised agric ultural, 
industrial or commercial undertaking, including zoos, amusement  
parks and wildlife or hunting reserves where live animals are 
regularly kept or bred.  
CHAPTER II  
CONDITIONS FOR THE INTRODUCTION OF LIVE ANIMALS INTO 
THE UNION  
Article 3  
General conditions for the introduction of ungulates into the Union  
Consignments of ungulates shall only be introduced into the Uni on if 
they comply with the following conditions:  
(a) they come from the third countries, territories or parts th ereof listed 
in columns 1, 2 and 3 of the table set out in Part 1 of Annex I  for 
which there is a model veterinary certificate corresponding to the 
consignment concerned listed in column 4 of the table in Part 1  of 
Annex I;  
(b) they are accompanied by the appropriate veterinary certific ate, 
drawn up in accordance with the relevant model veterinary 
certificate set out in Part 2 of Annex I, taking into account t he 
specific conditions indicated in column 6 of the table in Part 1 of 
that Annex, and completed and signed by an official veterinaria n of 
the exporting third country;  
(c) they comply with the requirements set out in the veterinary  
certificate referred to in point (b), including:  
(i) the supplementary guarantees laid down in that certificate,  
where indicated in column 5 of the table in Part 1 of Annex I;  
(ii) any additional veterinary certification requirements that the 
Member State of destination may impose in accordance with 
Union veterinary legislation and which are included in the 
certificate.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 4  
( 1 ) OJ L 224, 18.8.1990, p. 42.
 Article 3a  
Conditions for the introduction of ungulates intended for an 
approved body, institute or centre  
1. By way of derogation from Article 3, the competent authority  of a 
Member State may authorise the introduction into its territory of 
consignments of ungulates of the species listed in Tables 1, 2 and 3 
of Part 1 of Annex VI where those consignments are destined for  an 
approved body, institute or centre, provided that the following  
conditions are complied with:  
(a) an assessment has been carried out by the competent authori ty of 
the Member State of destination of the animal health risks that  each 
of the consignments may present for the Union;  
(b) the consignments concerned come from a third country, terri tory or 
part thereof which is included in one of the lists set out in:  
(i) Part 1 of Annex I or in Part 1 of Annex II to this Regulati on, 
(ii) Decision 2004/211/EC (  1 ), Decision 2007/777/EC (  2 ), 
Regulation (EC) No 798/2008 (  3 ), Regulation (EC) 
No 119/2009 (  4 ), Regulation (EU) No 605/2010 (  5 ), 
(c) the ungulates originate from a body, institute or centre in  a third 
country, territory or part thereof, referred to in point (a), w hich is 
included in a list established in accordance with Article 3c;  
(d) the ungulates have been quarantined in a vector-protected f acility at 
the premises of the body, institute or centre referred to in po int (c) 
for the period provided for in the relevant certificates;  
(e) the ungulates are conveyed directly to an approved body, in stitute 
or centre in the Member State of destination;  
(f) the ungulates are accompanied by an appropriate veterinary 
certificate, drawn up in accordance with the relevant model of 
veterinary certificate referred to in Tables 1, 2 and 3 in Part  1 of 
Annex VI and set out in Part 2 of that Annex;  
(g) the ungulates comply with the requirements set out in the m odel of 
veterinary certificate referred to in point (f).  
The Member State of destination shall inform the Commission and  the 
other Member States in the Standing Committee on the Food Chain  and 
Animal Health of the authorisation granted pursuant to the firs t subpara­
graph, prior to the introduction of the ungulates into their te rritory.  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 5  
( 1 ) OJ L 73, 11.3.2004, p. 1. 
( 2 ) OJ L 312, 30.11.2007, p. 49. 
( 3 ) OJ L 226, 23.8.2008, p. 1. 
( 4 ) OJ L 39, 10.2.2009, p. 12. 
( 5 ) OJ L 175, 10.7.2010, p. 1.'
 2. Where exceptional circumstances render compliance with point s 
(c) and (d) of paragraph 1 impossible, the competent authority of the 
Member State of destination may authorise the introduction, int o its 
territory, of ungulates of the species listed in Tables 1, 2 an d 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 par agraph 
1 are complied with and that the following additional condition s are 
met: 
(a) a prior application for a permit has been made by the owner , or a 
natural person representing that owner, and the Member State of  
destination has granted such permit after having carried out a risk 
assessment that has indicated that the introduction of the ungu lates 
concerned into its territory does not constitute an animal heal th risk 
for the Union;  
(b) the ungulates have been quarantined in the third country, t erritory or 
part thereof of origin under official supervision for the time 
necessary for them to meet the animal health conditions set out  in 
the model of veterinary certificate referred to in point (f):  
(i) at a place approved by the competent authority of the third  
country, territory or part thereof of origin of the animals;  
(ii) in accordance with the arrangements prescribed in the perm it 
that shall provide at least the same guarantees as those laid 
down in points (a), (b) and (e) to (g) of paragraph 1.  
Where ungulates are introduced into the Union pursuant to the f irst 
subparagraph, they shall be quarantined in an approved body, in stitute 
or centre  of destination  for at least six months from the time of intro­
duction into the Union, during which period the requirements pr ovided 
for in Article 8(1)(a) of Council Directive 90/425/EEC may be a pplied 
by the competent authorities.  
The Member State authorising the introduction of ungulates purs uant to 
the first subparagraph shall inform the Commission and the othe r 
Member States in the Standing Committee on the Food Chain and 
Animal Health of such authorisation, prior to the introduction of the 
ungulates into its territory.  
Article 3b  
Conditions for the entry and transit of ungulates intended for an 
approved body, institute or centre through the territory of Member 
States other than the Member State of destination  
The transit of the ungulates referred to in Article 3a through a Member 
State other than the Member State of destination shall be permi tted only 
subject to the authorisation of the competent authority of the Member 
State of transit. Such authorisation may be granted only on the  basis of 
a risk assessment by that competent authority, in view of the 
information submitted to it by the Member State of destination.  
The Member State of destination shall inform the Commission and  the 
other Member States in the Standing Committee on the Food Chain  and 
Animal Health, prior to the transit, when authorising the intro duction of 
animals under the conditions provided for in Article 3a.  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 6
 
Article 3c  
List of approved bodies, institutes or centres in third countries, 
territories and parts thereof  
1. Following an assessment of compliance with the conditions la id 
down in paragraph 2, each Member State may establish a list of bodies, 
institutes and centres from which the introduction of ungulates  into its 
territory may be authorised pursuant to Article 3a(1).  
2. A body, institute or centre in a third country, territory or  part 
thereof shall only be included in the list referred to in parag raph 1 
where the following conditions are complied with:  
(a) the body, institute or centre complies with the requirement s 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 t he 
approval of bodies, institutes or centres set out in Part 4 of 
Annex VI are complied with.  
3. A Member State may include in the list referred to in paragr aph 
(1) bodies, institutes or centres in third countries which are already 
included in such a list established by another Member State, wi thout 
having assessed compliance with the conditions laid down in par agraph 
2. 
4. Member States shall keep the lists referred to in paragraph (1) up 
to date, taking into account in particular any suspension or wi thdrawal 
of the approval granted by the competent authority of a third c ountry, 
territory or part thereof to the bodies, institutes or centres situated 
therein and included in those lists.  
5. Member States shall make available to the public, by means o f 
Internet-based information pages, the lists referred to in para graph 1 and 
shall keep those Internet-based information pages up to date.  
6. Member States shall communicate the Internet address of thei r 
Internet-based information pages to the Commission.  
Article 4  
Conditions for the assembly centres for certain consignments of 
ungulates  
1. Consignments of ungulates which contain live animals from mo re 
than one holding shall only be introduced into the Union if the y are 
assembled in assembly centres approved by the competent authori ty of 
the third country, territory or part thereof of origin of the a nimals in 
accordance with the requirements set out in Part 5 of Annex I.  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 7
 
2. Consignments of ungulates introduced into the Union in 
accordance with Article 3a or Article 6 shall not originate fro m more 
than one holding and shall not be assembled in assembly centres . 
▼C1 
Article 5  
Protocols for the standardisation of materials and sampling and 
testing procedures for ungulates  
Where sampling and testing is required by the veterinary certif icates 
listed in column 4 of the table in Part 1 of Annex I for the di seases 
listed in Part 6 of that Annex, for the introduction into the U nion of 
consignments of ungulates, such sampling and testing shall be c arried 
out by or under the control of the competent authority of the t hird 
country of origin in accordance with the Protocols for the stan dard­
isation of materials and testing procedures set out in Part 6 o f that 
Annex.  
Article 6  
Special conditions for certain consignments of ungulates imported 
into St Pierre and Miquelon and introduced into the Union  
Consignments of ungulates of the species listed in the table in  Part 7 of 
Annex I which were introduced into St Pierre and Miquelon less than 
six months prior to the date of shipment from St Pierre and Miq uelon to 
the Union shall only be introduced into the Union if:  
(a) they comply with the residence and quarantine requirements set out 
in Chapter 1 of that Part;  
(b) they have been tested in accordance with the animal health test 
requirements set out in Chapter 2 of that Part.  
Article 7  
General conditions for the introduction into the Union of certain 
species of bees  
1. Consignments of bees of the species listed in table 1 of Par t 2 of 
Annex IV shall only be introduced into the Union from third cou ntries 
or territories:  
(a) listed in Part 1 of Annex II;  
(b) where the presence of the American foulbrood, the small hiv e beetle 
(Aethina tumida ) and the Tropilaelaps mite ( Tropilaelaps  spp.) is 
subject to compulsory notification throughout the whole territo ry of 
the third country or territory concerned.  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 8
 
2. By way of derogation from paragraph 1(a), consignments of be es 
may be introduced into the Union from a part of a third country  or 
territory listed in Part 1 of Annex II which is:  
(a) a geographically and epidemiologically isolated part of the  third 
country or territory  
(b) listed in the third column of the table in Section 1 of Par t 1 of 
Annex IV.  
When that derogation is applied, the introduction into the Unio n of 
consignments of bees shall be prohibited from all other parts o f the 
third country or territory concerned not listed in the third co lumn of 
the table in Section 1 of Part 1 of Annex IV.  
3. Consignments of bees of the species listed in table 1 of Par t 2 of 
Annex IV shall consist of either:  
(a) cages of queen bees ( Apis mellifera  and  Bombus  spp.), each 
containing one single queen bee with a maximum of 20 accom­
panying attendants; or  
(b) containers of bumble bees ( Bombus  spp.), each containing a colony 
of a maximum of 200 adult bumble bees.  
4. Consignments of bees of the species listed in table 1 of Par t 2 of 
Annex IV shall:  
(a) be accompanied by the appropriate veterinary certificate, d rawn up 
in accordance with the relevant model veterinary certificate se t out 
in Part 2 of Annex IV, and completed and signed by an official 
inspector of the exporting third country;  
(b) comply with the veterinary requirements set out in the vete rinary 
certificate referred to in point (a).  
Article 8  
General conditions concerning the transport of live animals to the 
Union  
During the period after loading in the third country of origin and before 
arrival at the border inspection post of introduction into the Union, 
consignments of live animals shall not be:  
(a) transported together with live animals that:  
(i) are not intended for introduction into the Union; or  
(ii) are of a lower health status;  
▼M18  
(b) unloaded in, or when transported by air, moved to another a ircraft, 
or transported by road, by rail, or moved on foot through a thi rd 
country, territory or part thereof which is not authorised for imports 
of the animals concerned into the Union.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 9
 
Article 9  
Time limit for the period of transport to the Union of live animals  
Consignments of live animals shall only be introduced into the Union 
where the consignment arrives at the border inspection post of intro­
duction into the Union within 10 days of the date of issue of t he 
appropriate veterinary certificate.  
In the case of transport by sea, that period of 10 days shall b e extended 
by an additional period corresponding to the duration of the jo urney by 
sea, as certified by a signed declaration of the master of the ship, drawn 
up in accordance with Part 3 of Annex I and attached in its ori ginal 
form to the veterinary certificate.  
Article 10  
Special conditions regarding the spraying of consignments of live 
animals transported by air to the Union  
Where consignments of live animals, excluding consignments of b ees, 
are transported by air, the crate or container in which they ar e trans­
ported and the surrounding area shall be sprayed with an approp riate 
insecticide.  
That spraying shall be carried out immediately prior to the clo sing of 
the aircraft doors after loading, and after any subsequent open ing of the 
doors in a third country, until the aircraft reaches its final destination.  
The captain of the aircraft shall certify that the spraying has  been carried 
out by signing a declaration, drawn up in accordance with Part 4 of 
Annex I and attached in its original form to the veterinary cer tificate.  
Article 11  
Conditions to be applied following the introduction into the Union 
of certain consignments of ungulates 
▼M18  
1. Following their introduction into the Union, consignments of  
ungulates, other than those referred to in Article 3a shall be conveyed 
in a vector-protected means of transport without delay to the h olding 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.  
▼C1 
2. Following their introduction into the Union, consignments of  
ungulates intended for immediate slaughter shall be conveyed wi thout 
delay to the slaughterhouse of destination where they shall be 
slaughtered within five working days from the date of arrival a t the 
slaughterhouse.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 10
 
Article 12  
Specific conditions concerning the transit through third countries of 
certain consignments of ungulates  
Where specific condition I of Part 1 of Annex I applies, in ord er to 
allow consignments of the ungulates referred to in that conditi on orig­
inating in one Member State and destined for another Member Sta te, to 
transit through a third country, territory or part thereof whic h is listed in 
the table in Part 1 of Annex I but for which there is no corres ponding 
model veterinary certificate for consignments of the ungulates concerned 
indicated in column 4 of that table, the following conditions s hall apply:  
(a) for bovine animals for fattening:  
(i) the holdings of final destination must be designated in adv ance 
by the competent authority of the final destination;  
(ii) the live animals comprised in the consignment must not be 
moved from the holding of final destination unless for 
immediate slaughter;  
(iii) all movements of live animals into and out of the holding  of 
final destination must be carried out under the control of the 
competent authority as long as the animals comprising the 
consignment are kept at the holding.  
(b) for ungulates for immediate slaughter, Article 11(2) shall apply.  
▼M8 
Article 12a  
Derogation for the transit of certain consignments of live bovine 
animals for breeding and production through Lithuania  
1. The transit by road through Lithuania of consignments of liv e 
bovine animals for breeding and production coming from the Russ ian 
region of Kaliningrad and consigned to a destination outside th e Union 
shall be authorised subject to compliance with the following co nditions:  
(a) the animals enter Lithuania at the border inspection post a t Kybartai 
road and exit Lithuania at the border inspection post of Medini nkai;  
(b) the animals are transported in containers on road vehicles sealed 
with a serially numbered seal at the border inspection post of intro­
duction into the Union at Kybartai road, by the veterinary serv ices 
of the competent authority of Lithuania;  
(c) the documents referred to in the third indent of Article 7 (1) of 
Council Directive 91/496/EEC, including the duly completed 
veterinary certificate in accordance with the model veterinary 
certificate ‘BOV-X-TRANSIT-RU’ set out in Part 2 of Annex I 
to this Regulation, accompanying the animals from the border 
inspection post Kybartai road to the border inspection post Med i­
ninkai are stamped ‘ONLY FOR TRANSIT FROM THE RUSSIAN 
REGION OF KALININGRAD VIA LITHUANIA’ on each page by 
the official veterinarian of the competent authority responsibl e for 
the border inspection post at Kybartai road;  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 11
 
__________  
▼M8 
(f) the animals are accompanied by a health certificate that al lows 
unhindered entry into Belarus and a veterinary certificate issu ed 
for the place of destination of the animals in Russia.  
▼M31  __________  
▼M8 
3. In case of any irregularity or emergency during the transit,  the 
Member State of transit shall apply the measures provided for i n the 
second indent of Article 8(1) (b) of Directive 90/425/EEC (  1 ) as appro­
priate.  
▼M31  __________  
▼C1 
Article 13  
Conditions to be applied following the introduction into the Union 
of consignments of bees referred to in Article 7  
1. Consignments of queen bees referred to in Article 7(3)(a) sh all be 
conveyed without delay to the designated place of final destina tion 
where the hives shall be placed under the control of the compet ent 
authority and the queen bees transferred to new cages before be ing 
introduced to local colonies.  
2. The cages, attendants, and other material that accompanied t he 
queen bees from the third country of origin shall be sent to a laboratory 
designated by the competent authority for examination for the p resence 
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 th e 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 designat ed 
place of destination.  ▼M31  02010R0206 — EN — 01.01.2021 — 027.001 — 12  
( 1 ) OJ L 224, 18.8.1990, p. 29.
 Those bumble bees may stay in the container in which they were 
introduced into the Union until the end of the lifespan of the colony.  
That container and the material that accompanied the bumble bee s from 
the third country of origin shall be destroyed at the end of th e lifespan 
of the colony at the latest.  
▼M18  
Article 13a  
Conditions to be applied following the introduction of consignments 
of ungulates intended for approved bodies, institutes or centres  
1. Following their introduction into the Union, consignments of  
ungulates intended for approved bodies, institutes or centres s hall be 
transported without delay to the approved body, institute or ce ntre of 
destination in means of transport that are vector-protected and  so 
constructed that the animals cannot escape and faeces, urine, l itter, 
fodder, waste or any other material cannot flow or fall out fro m 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 c entre of 
the Member State of destination for a minimum of 30 days. After  the 30 
days quarantine period the animals may be moved to another appr oved 
body, institute or centre.  
3. Animals introduced into an approved body, institute or centr e can 
only be moved to a destination other than an approved body, ins titute or 
centre provided that:  
(a) at least six months have elapsed from the time of introduct ion into 
the Union, and  
(b) the movement is carried out in accordance with paragraph 4 of 
Annex C to Directive 92/65/EEC.  
4. By way of derogation from paragraph 3, animals may leave an 
approved body, institute or centre before the end of the six-mo nth 
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 p art thereof;  
(b) for the purpose of their export as referred to in a) the an imals are 
transported in means of transport that are vector-protected and  so 
constructed that the animals cannot escape and faeces, urine, l itter, 
fodder, waste or any other material cannot flow or fall out fro m the 
vehicle or container during transportation.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 13
 
CHAPTER III  
CONDITIONS FOR THE INTRODUCTION OF FRESH MEAT INTO 
THE UNION  
Article 14  
General conditions for the importation of fresh meat  
Consignments of fresh meat intended for human consumption shall  only 
be imported into the Union if they comply with the following 
conditions:  
(a) they come from the third countries, territories or parts th ereof listed 
in columns 1, 2 and 3 of the table in Part 1 of Annex II for wh ich 
there is a model veterinary certificate corresponding to the 
consignment concerned listed in column 4 of the table in Part 1  
of Annex II;  
(b) they are presented at the border inspection post of introdu ction into 
the Union accompanied by the appropriate veterinary certificate , 
drawn up in accordance with the relevant model veterinary 
certificate set out in Part 2 of Annex II, taking into account the 
specific conditions indicated in column 6 of the table in Part 1 of 
that Annex, and completed and signed by an official veterinaria n of 
the exporting third country;  
(c) they comply with the requirements set out in the veterinary  
certificate referred to in point (b), including:  
(i) the supplementary guarantees laid down in that certificate,  
where indicated in column 5 of the table in Part 1 of Annex II;  
(ii) any additional veterinary certification requirements that the 
Member State of destination may impose in accordance with 
Union veterinary legislation and which are included in the 
certificate.  
Article 15  
Conditions to be applied following the importation of unskinned 
carcases of wild cloven-hoofed game  
In accordance with Article 8(2) of Council Directive 97/78/EC (  1 ), 
consignments of unskinned carcases of wild cloven-hoofed game f or 
human consumption after further processing shall be conveyed 
without delay to the processing establishment of destination.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 14  
( 1 ) OJ L 24, 30.1.1998, p. 9.
 Article 16  
Transit and storage of fresh meat  
The introduction into the Union of consignments of fresh meat n ot 
intended for importation into the Union but destined for a thir d 
country either by immediate transit or after storage in the Uni on in 
accordance with Article 12(4) and Article 13 of Directive 97/78 /EC, 
shall only be authorised if the consignments comply with the 
following conditions:  
(a) they come from the third countries, territories or parts th ereof listed 
in columns 1, 2 and 3 of the table in Part 1 of Annex II, for w hich 
there is a model veterinary certificate corresponding to the 
consignment concerned listed in column 4 of the table in Part 1  
of Annex II;  
(b) they comply with the specific animal health requirements fo r the 
consignment concerned, as set out in the relevant model veterin ary 
certificate referred to in point (a);  
(c) they are accompanied by a veterinary certificate, drawn up in 
accordance with the model veterinary certificate set out in 
Annex III, and completed and signed by an official veterinarian  
of the exporting third country;  
(d) they are certified as acceptable for transit, including for  storage as 
appropriate, on the common veterinary entry document referred t o 
in Article 2(1) of Commission Regulation (EC) No 136/2004 (  1 ), 
signed by the official veterinarian of the border inspection po st of 
introduction into the Union.  
Article 17  
Derogation for transit through Latvia, Lithuania and Poland  
1. By way of derogation from Article 16 the transit by road or by rail 
through the Union, between the designated border inspection pos ts in 
Latvia, Lithuania and Poland listed in Commission Decision 
2009/821/EC (  2 ), of consignments coming from and destined to Russia 
directly or via another third country shall be authorised provi ded that 
the following conditions are complied with:  
(a) the consignment is sealed with a serially numbered seal at the 
border inspection post of introduction into the Union by the 
veterinary services of the competent authority.  
▼M31  __________  
__________  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 15  
( 1 ) OJ L 21, 28.1.2004, p. 11. 
( 2 ) OJ L 296, 12.11.2009, p. 1.
 Article 17a  
Derogation for transit through Croatia of consignments coming 
from Bosnia and Herzegovina and destined to third countries  
1. By way of derogation from Article 16, the direct transit by road 
through the Union, between the border inspection post of Nova S ela and 
the border inspection post of Ploče, of consignments coming fro m 
Bosnia and Herzegovina and destined to third countries shall be  auth­
orised provided that the following conditions are complied with : 
(a) the consignment is sealed with a serially numbered seal by the 
official veterinarian at the border inspection post of entry.  
▼M31  __________  
__________  
▼C1 
CHAPTER IV  
GENERAL, TRANSITIONAL AND FINAL PROVISIONS  
Article 18  
Certification  
The veterinary certificates required by this Regulation shall b e 
completed in accordance with the explanatory notes set out in A nnex V.  
However, that requirement shall not preclude the use of electro nic 
certification or of other agreed systems, harmonised at Union l evel.  
Article 19  
Transitional provisions 
▼M1 
For a transitional period those consignments of live animals, e xcept bees 
coming from the State of Hawaii, and fresh meat intended for hu man 
consumption certified before 30 November 2010 in accordance wit h 
Decisions 79/542/EEC and 2003/881/EC may continue to be introdu ced 
into the Union until 31 May 2011.  
▼C1 
Article 20  
Repeal  
Decision 2003/881/EC is repealed.  
Article 21  
Entry into force  
This Regulation shall enter into force on the twentieth day fol lowing 
that of its publication in the  Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly a pplicable in 
all Member States.  ▼M17  02010R0206 — EN — 01.01.2021 — 027.001 — 16
 
ANNEX I  
UNGULATES  
▼M8 
PART 1  
List of third countries, territories or parts thereof  (*) 
ISO code and name of 
third country Code of 
Territory Description of third country, territory or part 
thereof Veterinary certificate Specific 
conditions  Model(s) SG  
1 2 3 4 5 6  
▼M28  
__________  
CA — Canada CA-0 Whole country POR-X, BOV-X, 
OVI-X, OVI-Y, 
RUM (**)  IVb 
IX 
V 
XIII  
(******)  
▼M8 
CH – Switzerland CH-0 Whole country (***)  
CL – Chile CL-0 Whole country BOV-X,OVI-X, RUM  
POR-X, SUI  B  
▼M33  
GB – United King­
dom (*******) GB-0 Whole country  
GB-1 England and Wales BOV-X, BOV-Y, 
OVI-X, OVI-Y, 
POR-X, POR-Y, 
RUM, SUI  III, IVa, 
V, IX, 
XI 
GB-2 Scotland BOV-X, BOV-Y, 
OVI-X, OVI-Y, 
POR-X, POR-Y, 
RUM, SUI  II, III, 
IVa, V, 
IX, XI  
GG – Guernsey GG-0 Whole country BOV-X, OVI-X, 
POR-X 
RUM  V, IX  
▼M8 
GL – Greenland GL-0 Whole country OVI-X, RUM  V  
▼M33  
IM – Isle of Man IM-0 Whole country BOV-X, BOV-Y, 
OVI-X, OVI-Y  II, III, 
IVa, V, 
IX 
▼M16  
__________  
▼M8 
IS – Iceland IS-0 Whole country BOV-X, BOV-Y 
RUM, OVI-X, OVI-Y  
POR-X, POR-Y  B  
▼M33  
JE – Jersey JE-0 Whole country BOV-X, BOV-Y  IVa  
▼M8 
ME – Montenegro ME-0 Whole country  I  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 17
 
ISO code and name of 
third country Code of 
Territory Description of third country, territory or part 
thereof Veterinary certificate Specific 
conditions  Model(s) SG  
1 2 3 4 5 6  
▼M30  
MK-The Republic of 
North Macedonia MK-0 Whole country  I  
▼M22  
NZ – New Zealand NZ-0 Whole country BOV-X, BOV-Y, 
RUM, 
POR-X, POR-Y 
OVI-X, OVI-Y  III 
V 
XII 
▼M8 
PM – St Pierre and 
Miquelon PM-0 Whole country BOV-X, BOV-Y, 
RUM, OVI-X, OVI-Y 
CAM  
RS – Serbia (*****) RS-0 Whole country  I  
RU – Russia RU-0 Whole country  
RU-1 Whole country except the region of 
Kaliningrad  
RU-2 Region of Kaliningrad BOV-X-TRANSIT- 
RU X 
▼M12  
US – United States US-0 Whole country POR-X D  
▼M8 
(*) Without prejudice to specific certification requirements pr ovided for by any relevant agreement between the Union and thir d 
countries. 
(**) Exclusively for live animals other than animals belonging to the cervidae species. 
(***) Certificates in accordance with the Agreement between the  European Community and the Swiss Confederation on trade in 
agricultural products (OJ L 114, 30.4.2002, p. 132).  
►M30 __________  ◄ 
(*****) Not including Kosovo under UNSCR 1244/99.  
►M30  (******) Canada: seasonally free period for bluetongue and epi zootic haemorrhagic disease is between 1 November and 15 
May, in accordance with the OIE Terrestrial Animal Health Code.  ◄ 
►M28 __________  ◄ 
►M33  (*******) In accordance with the Agreement on the withdrawal o f the United Kingdom of Great Britain and Northern Ireland 
from the European Union and the European Atomic Energy Communit y, and in particular Article 5(4) of the Protocol on 
Ireland/Northern Ireland in conjunction with Annex 2 to that Pr otocol, for the purposes of this Annex, references to the Unite d 
Kingdom do not include Northern Ireland. ◄  
Specific Conditions (see footnotes in each certificate)  
‘I’: for transit through the territory of a third country of live a nimals for 
immediate slaughter or live bovine animals for fattening which are 
consigned from a Member State and destined to another Member 
State in lorries which have been sealed with a serially numbere d seal.  
The seal number must be entered on the health certificate issue d in 
accordance with the model laid down in Annex F to Directive 
64/432/EEC (  1 ) for live bovine animals for slaughter and fattening 
and in accordance with Model I of Annex E to Directive 
91/68/EEC (  2 ) for ovine and caprine animals for slaughter.  
In addition, the seal must be intact on arrival at the designat ed border 
inspection post of entry into the Union and the seal number rec orded in 
the integrated computerised veterinary system of the Union (TRA CES).  
▼M30  
The certificate must be stamped at the exit point of the Union by the 
competent veterinary authority prior to transiting one or more third 
countries, with the following wording ‘ONLY FOR TRANSIT 
BETWEEN DIFFERENT PARTS OF THE EUROPEAN UNION 
VIA THE REPUBLIC OF NORTH MACEDONIA/MONTENEGRO/ 
SERBIA (*) (**)’.  ▼M8 02010R0206 — EN — 01.01.2021 — 027.001 — 18  
( 1 ) OJ 121, 29.7.1964, p. 1977/64. 
( 2 ) OJ L 46, 19.2.1991, p. 19.
 Bovine animals for fattening must be transported directly to th e holding 
of destination designated by the competent veterinary authority  of desti­
nation. Those animals must not be moved from that holding unles s for 
immediate slaughter.  
___________  
(*) Delete country as applicable.  
(**) Serbia, not including Kosovo under UNSCR 1244/99.  
‘II’: territory recognised as having an official tuberculosis-free s tatus for the 
purposes of exports to the Union of live animals certified acco rding to 
the model of certificate BOV-X.  
‘III’:  territory recognised as having an official brucellosis-free st atus for the 
purposes of exports to the Union of live animals certified acco rding to 
the model of certificate BOV-X.  
‘IVa’:  territory recognised as having an official enzootic-bovine-leu kosis 
(EBL) free status for the purposes of exports to the Union of l ive 
animals certified according to the model of certificate BOV –X.  
‘IVb’:  recognised as having officially enzootic-bovine-leukosis (EBL) -free 
herds equivalent to the requirements set out in Annex D to Dire ctive 
64/432/EEC for the purposes of exports to the Union of live ani mals 
certified according to the model of certificate BOV–X.  
‘V’: territory recognised as having an official brucellosis-free st atus for the 
purposes of exports to the Union of live animals certified acco rding to 
the model of certificate OVI-X.  
‘VI’:  Geographical constraints:  
‘VII’:  territory recognised as having an official tuberculosis-free s tatus for the 
purposes of exports to the Union of live animals certified acco rding to 
the model of certificate RUM.  
‘VIII’:  territory recognised as having an official brucellosis-free st atus for the 
purposes of exports to the Union of live animals certified acco rding to 
the model of certificate RUM.  
‘IX’:  territory recognised as having an official Aujeszky’s disease -free status 
for the purposes of exports to the Union of live animals certif ied 
according to the model of certificate POR-X.  
‘X’: Only for transit through Lithuania of bovine animals for breed ing 
and/or production from the Kaliningrad region to other regions of 
Russia.  
▼M33  
‘XI’:  unweaned domestic swine less than five weeks of age are exempt  from  
Trichinella  testing.  
▼M22  
‘XII’:  territory recognised as having officially tuberculosis-free bo vine herds 
equivalent to those recognised based on the conditions laid dow n in 
paragraphs 1 and 2 of Annex A.I to Directive 64/432/EEC, for th e 
purposes of exports to the Union of live animals certified acco rding 
to the model of veterinary certificate BOV-X or BOV-Y.  
▼M30  
‘XIII’:  territory recognised as having an official bluetongue and epiz ootic 
haemorrhagic disease seasonally free status, for the purpose of  
exports to the Union of live animals certified according to the  model 
of veterinary certificate BOV-X, OVI-X, OVI-Y or RUM.  
▼M8 
PART 2  
Models of Veterinary Certificates  
Models  
‘BOV-X’: Model of veterinary certificate for domestic bovine 
animals (including Bubalus and Bison species and 
their cross-breeds) intended for breeding and/or 
production after importation.  ▼M8 02010R0206 — EN — 01.01.2021 — 027.001 — 19
 
‘BOV-Y’: Model of veterinary certificate for domestic bovine 
animals (including Bubalus and Bison species and 
their cross-breeds) intended for immediate slaughter 
after importation.  
‘BOV-X-TRANSIT-RU’: Model of veterinary certificate for domesti c bovine 
animals (including Bubalus and Bison species and 
their cross-breeds) intended for transit from the 
region of Kaliningrad to other regions of Russia via 
the territory of Lithuania.  
‘OVI-X’: Model of veterinary certificate for domestic ovine 
animals (Ovis aries) and domestic caprine animals 
(Capra hircus) intended for breeding and/or 
production after importation.  
‘OVI-Y’: Model of veterinary certificate for domestic ovine 
animals (Ovis aries) and domestic caprine animals 
(Capra hircus) intended for immediate slaughter after 
importation.  
▼M12  
‘POR-X’: Model of veterinary certificate for domestic porcine 
animals (Sus scrofa) intended for breeding and/or 
production after importation or intended for transit 
through the Union from one third country to another 
third country.  
▼M8 
‘POR-Y’: Model of veterinary certificate for domestic porcine 
animals (Sus scrofa) intended for immediate 
slaughter after importation.  
‘RUM’: Model of veterinary certificate for animals of the 
order Artiodactyla (excluding bovine animals 
(including Bubalus and Bison species and their 
cross-breeds), Ovis aries, Capra hircus, Suidae and 
Tayassuidae), and of the families Rhinocerotidae and 
Elephantidae.  
‘SUI’: Model of veterinary certificate for non-domestic 
Suidae, Tayassuidae and Tapiridae.  
‘CAM’: Model of specific attestation for animals imported 
from St Pierre and Miquelon under the conditions 
provided for in Part 7 of Annex I.  
SG (Supplementary guarantees)  
▼M28  
‘A’: guarantees regarding Bluetongue and 
Epizootic-haemorrhagic-disease tests on animals 
certified according to the model of veterinary 
certificates BOV-X (point II.2.1.(d)), OVI-X (point 
II.2.1.(d)) and RUM (point II.2.1.(c)).  
▼M8 
‘B’: guarantees regarding Swine-vesicular-disease and 
Classical-swine-fever tests on animals certified 
according to the model of veterinary certificates 
POR-X (point II.2.4 B) and SUI (point II.2.4 B).  
‘C’: guarantees regarding Brucellosis test on animals 
certified according to the model of veterinary 
certificates POR-X (point II.2.4 C) and SUI (point 
II.2.4 C).  
▼M12  
‘D’: guarantees regarding vesicular stomatitis test on 
animals certified according to the model of veterinary 
certificate POR-X (point II.2.1(b)).  ▼M8 02010R0206 — EN — 01.01.2021 — 027.001 — 20
 
Model BOV-X
  ▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 21
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 22
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 23
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 24
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 25
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 26
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 27
 
▼M22  02010R0206 — EN — 01.01.2021 — 027.001 — 28
 
► (1) M29 ▼M22  02010R0206 — EN — 01.01.2021 — 027.001 — 29
 
▼M22  02010R0206 — EN — 01.01.2021 — 027.001 — 30
 
► (1) M29 ▼M22  02010R0206 — EN — 01.01.2021 — 027.001 — 31
 
▼M22  02010R0206 — EN — 01.01.2021 — 027.001 — 32
 
Model BOV-X-TRANSIT-RU
  ▼M10  02010R0206 — EN — 01.01.2021 — 027.001 — 33
 
▼M10  02010R0206 — EN — 01.01.2021 — 027.001 — 34
 
▼M10  02010R0206 — EN — 01.01.2021 — 027.001 — 35
 
Model OVI-X
  ▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 36
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 37
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 38
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 39
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 40
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 41
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 42
 
Model OVI-Y
  ▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 43
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 44
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 45
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 46
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 47
 
Model POR-X
  ▼M12  02010R0206 — EN — 01.01.2021 — 027.001 — 48
 
► (1) M21 ▼M12  02010R0206 — EN — 01.01.2021 — 027.001 — 49
 
▼M12  02010R0206 — EN — 01.01.2021 — 027.001 — 50
 
► (1) M21 ▼M12  02010R0206 — EN — 01.01.2021 — 027.001 — 51
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 52
 
► (1) M21 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 53
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 54
 
► (1) M21 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 55
 
Model RUM
  ▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 56
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 57
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 58
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 59
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 60
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 61
 
▼M30  02010R0206 — EN — 01.01.2021 — 027.001 — 62
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 63
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 64
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 65
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 66
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 67
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 68
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 69
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 70
 
PART 3  
Addendum for transport of animals by sea  
(To be completed and attached to the veterinary certificate whe n transport to the Union frontier 
includes, even for part of the journey, transportation by ship. ) 
Declaration by the master of the ship  
I, the undersigned, master of ship (name ................. ), d eclare that the animals referred to in the 
attached veterinary certificate No ......... have remained on b oard the ship during the voyage 
from ........... in ............ ( exporting country ) to ....... in the Union and that the ship did not call 
at any place outside ..... ( exporting country ) en route to the Union other than: ........................ 
(Ports of call en route ). Moreover, during the journey, these animals have not been in  contact 
with other animals on board of a lower health status. 
Done at ....................................................... .......... on ................................................. ............. ...  
(Port of arrival) (Date of arrival)  
(stamp) (signature of master)  
(name in capital letters and title)  
PART 4  
Addendum for transport of animals by air  
(To be completed and attached to the veterinary certificate whe n transport to the Union frontier 
includes, even for part of the journey, transportation by air.)  
Declaration by the captain of the aircraft  
I, the undersigned, captain of the aircraft (name ......... ), declare that the crate or container and 
the area around the crate or container containing the animals r eferred to in the attached veterinary 
certificate No .......... has been sprayed with insecticide bef ore departure. 
Done at ....................................................... .......... on ................................................. ............. ...  
(Airport of departure) (Date of departure)  
(stamp) (signature of captain)  
(name in capital letters and title)  
PART 5  
Conditions for the approval of assembly centres (referred to in Article 4)  
In order to be approved, assembly centres must meet the followi ng requirements:  
I. They must be supervised by an official veterinarian.  
II. They must each be situated at the centre of an area of at l east 20 km in 
diameter in which, according to official findings, there has be en no case of 
foot-and-mouth disease for at least a period of 30 days prior t o their use as 
approved assembly centres.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 71
 
III. They must, before each use as approved assembly centres, b e cleansed and 
disinfected with a disinfectant officially authorised in the ex porting 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 cen tre; 
(b) appropriate facilities, that are easy to clean and disinfec t, for loading, 
unloading and adequate housing of a suitable standard for the a nimals, 
for watering and feeding them, and for giving them any necessar y 
treatment;  
(c) appropriate facilities for inspection and isolation;  
(d) appropriate equipment for cleaning and disinfecting rooms a nd 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 c arry out all 
duties set out in Part 5;  
VI. They must only admit animals that are individually identifi ed 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 anim als are 
properly identified and accompanied by health documents or cert ificates 
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 entr y 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 fulfi l the health 
conditions established for the introduction of the relevant cat egory of 
animal into the Union.  
VIII. Animals to be introduced into the Union which pass throug h 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 othe r than 
animals which fulfil the health conditions established for the intro­
duction of the relevant category of animal into the Union;  
(b) segregated into consignments so that no consignment contain s both 
animals for breeding or production and animals for immediate 
slaughter;  
(c) in transport vehicles or containers which have first been c leansed and 
disinfected with a disinfectant officially authorised in the ex porting 
country as effective for the control of foot-and-mouth disease and 
which are so constructed that faeces, urine, litter or fodder c annot 
flow or fall out during transportation.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 72
 
IX. Where the conditions for the export of animals to the Union  require that a 
test is carried out within a specified period before loading, t hat period must 
include any period of assembly, up to six days, from the date o f 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 Commissi on and 
the competent central authorities of the Member States of the n ames and 
addresses of such premises. That information must be updated re gularly.  
XI. The exporting third country shall determine the procedure f or official 
supervision of approved assembly centres and shall ensure that such super­
vision 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 c omplied 
with, the approval of the centre must be suspended. The approva l may 
be restored only when the competent authority of the third coun try is 
satisfied that the centre fully complies with the conditions se t out in 
points I to XI.  
PART 6  
Protocols for the standardisation of materials and testing procedures  
(referred to in Article 5)  
T u b e r c u l o s i s ( T B L )  
The single intradermal tuberculin test using bovine tuberculin shall be carried out 
according to Annex B to Directive 64/432/EEC. In the case of Su idae animals, 
the single intradermal tuberculin test using avian tuberculin s hall be carried out 
according to Annex B to 64/432/EEC, except that the site of inj ection shall be 
the loose skin at the base of the ear.  
▼M2 
B r u c e l l o s i s (  B r u c e l l a a b o r t u s  ) ( B R L )  
The serum agglutination test, complement fixation test, buffere d brucella antigen 
test, enzyme-linked immunosorbent assays (ELISA) and fluorescen ce polarisation 
assay (FPA) shall be carried out according to Annex C to Direct ive 64/432/EEC.  
▼C1 
B r u c e l l o s i s ( B r u c e l l a m e l i t e n s i s ) (  B R L )  
Tests shall be carried out according to Annex C to Directive 91 /68/EEC.  
E n z o o t i c B o v i n e L e u k o s i s ( E B L )  
The agar gel immuno-diffusion test and the enzyme linked immuno -absorbent 
assay test (ELISA) shall be carried out according to paragraphs  A and C of 
Chapter II of Annex D to Directive 64/432/EEC.  
B l u e t o n g u e ( B T G )  
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 capa ble of 
identifying antibodies to all known serotypes of bluetongue vir us (BTV).  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 73
 
The principle of the test is the interruption of the reaction b etween BTV 
antigen and a group-specific monoclonal antibody (3-17-A3) by t he addition 
of test serum. Antibodies to BTV present in the test serum bloc k the reac­
tivity of the monoclonal antibody (Mab) and result in a reducti on in the 
expected colour development after the addition of enzyme labell ed 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 (se rum titration – 
Appendix 2) to give dilution end-point. Inhibition values highe r 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-c ulture 
supernatant) directed against the group-specific polypeptide VP 7, 
stored at - 20 °C or freeze-dried and diluted 1/100 with blocki ng 
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-chromog en) 
at a final concentration of 0,4 mg/ml in sterile distilled wate r. Hydrogen 
peroxide (30 %w/v-substrate) 0,05 % v/v added immediately befor e 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-: ne gative 
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  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 74
 
Controls Test Sera  
1 2 3 4 5 6 7 8 9 10 11 12  
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, mono­
clonal 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.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 75
 
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, son icate briefly 
to disperse aggregated virus (if sonicator is not available, pi pette vigor­
ously) 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 a nd blot 
dry on absorbent paper.  
3. Control wells: Add 100 μl of blocking buffer to Cc wells. Ad d 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 μ l blocking 
buffer),  
or 
Serum titration method: Prepare a two-fold dilution series of e ach 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 immedi ately 
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 fo r approxi­
mately 10 minutes and stop the reaction with 1 Molar sulphuric acid (50 
μl per well). Colour should develop in the Mab control wells an d in those 
wells containing sera with no antibody to BTV.  
9. Examine and record the plates either visually or using a spe ctrophoto­
metric reader.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 76
 
Analysis of results:  
Using the software package print out the optical density (OD) v alues, and the 
percentage inhibition (PI) for test and control sera based on t he 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 wit hin 
acceptable limits. The upper control limits (UCL) and lower con trol limits 
(LCL) for the Mab control (antigen plus Mab in the absence of t est 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 O D 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 e ach sample.  
Percentage inhibition (PI) value = 100 – (OD of each test contr ol/Mean OD 
of Cm) × 100.  
The duplicate negative control serum wells and the duplicate bl ank wells 
must record PI values between + 25 % and – 25 %, and between + 95 % 
and + 105 %, respectively. Failure to be within these limits do es 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 5 0 %). 
Samples recording PI values >50 % are recorded negative. Sample s that 
record PI values above and below the threshold for the duplicat e 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 discer nible by eye; 
weakly positive or strong negative samples may be more difficul t to interpret 
by eye.  
Preparation of BTV ELISA antigen:  
1. Wash 40-60 roux of confluent BHK-21 cells three times with s erum-free 
Eagle's medium and infect with bluetongue virus serotype 1 in s erum- 
free Eagle's medium.  
2. Incubate at 37 °C and examine daily for cytopathic effect (C PE). 
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 fro m 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 approxim ately 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: phen ylme­
thylsulphonyl fluoride is harmful - handle with extreme caution .) ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 77
 
6. Disrupt the cells for 60 seconds using an ultrasonic probe a t 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 P BS) 
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. Two fold 
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 mic rotitre 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 horser adish 
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 th e 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 ex cess, 
therefore a dilution of antigen is chosen which falls on the ti tration curve 
(not on the plateau region) which gives approximately 0,8 OD af ter 10 
minutes.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 78
 
B. The agar gel immuno-diffusion test shall be carried out acco rding to the 
following protocol:  
Antigen:  
Precipitating antigen is prepared in any cell culture system th at supports the 
rapid multiplication of a reference strain of bluetongue virus.  BHK or Vero 
cells are recommended. Antigen is present in the supernatant fl uid 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 proc edure; virus 
in the antigen may be inactivated by the addition of 0,3 % (v/v ) beta-propiol­
actone.  
Known positive control serum:  
Using the international reference serum and antigen a national standard 
serum is produced, standardised for optimal proportion against the inter­
national reference serum, freeze-dried and used as the known co ntrol 
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.  
E p i z o o t i c h a e m o r r h a g i c d i s e a s e ( E H D  ) 
The agar gel immuno-diffusion test shall be carried out accordi ng to the 
following protocol:  
Antigen:  
Precipitating antigen is prepared in any cell culture system th at supports the rapid 
multiplication of the appropriate serotype(s) of epizootic haem orrhagic 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 co ncentration to be 
effective. This may be achieved by any standard protein concent ration 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 inter national reference 
serum, freeze-dried and used as the known control serum in each  test. ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 79
 
Test serum  
Procedure: 1 % agarose prepared in borate or sodium barbitol bu ffer, 
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.  
I n f e c t i o u s b o v i n e r h i n o t r a c h e i t i s (  I B R ) / i n f e c t i o u s 
p u s t u l a r v u l v o - v a g i n i t i s ( I P V )  
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 cont rols, 
(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 (  1 ). 
F o o t - a n d - m o u t h d i s e a s e ( F M D )  
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  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 80  
( 1 ) OJ L 249, 23.7.2004, p. 20.
 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 me dium such as 
penicillin 1 000 IU, neomycin sulphate100 IU, polymyxin B sulph ate50 
IU, mycostatin100 IU.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 81
 
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 cult ure 
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 Phar­
mokologie, 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.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 82
 
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 foo t- 
and-mouth disease virus (FMDV) used at a prede­
termined 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 immunog­
lobulin 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 tes t serum starting 
at 1/4 are prepared in U-bottomed multiwell plates (carrier pla tes). Fifty 
microlitres of a constant dose of antigen are added to each wel l and the 
mixtures are left overnight at 4 °C. The addition of the antige n 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 transfe rred from the 
carrier plates to the rabbit-serum-coated ELISA plates and incu bated 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 im munog­
lobulin conjugated to horseradish peroxidase is added to each w ell. 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 co ntaining 
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 ELIS A reader 
linked to a microcomputer.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 83
 
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 dilu tion 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.  
A u j e s z k y ' s d i s e a s e ( A J D )  
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 cont rols, 
(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 (  1 ). 
T r a n s m i s s i b l e g a s t r o - e n t e r i t i s ( T G  E ) 
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 be fore 
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  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 84  
( 1 ) OJ L 59, 4.3.2008, p. 19.
 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 cont rols, (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 incu­
bation 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.  
S w i n e v e s i c u l a r d i s e a s e ( S V D )  
Tests for swine vesicular disease (SVD) shall be carried out ac cording to 
Decision 2000/428/EC (  1 ). 
C l a s s i c a l s w i n e f e v e r ( C S F )  
Tests for classical swine fever (CSF) shall be carried out acco rding to Decision 
2002/106/EC (  2 ). 
The performance of tests for CSF must follow the guidelines set  out in the 
relevant chapter of the OIE Manual of Diagnostic Tests and Vacc ines for 
Terrestrial Animals.  
The evaluation of sensitivity and specificity of the serologica l test for CSF must 
be carried out in a national laboratory with a quality assuranc e scheme in place. 
Tests employed must be shown to recognise a range of weak and s trong positive 
reference sera and allow detection of antibody in early phase a nd convalescence.  
▼M12  
V e s i c u l a r s t o m a t i t i s ( V S )  
The virus neutralisation (VN) test shall be carried out in acco rdance 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.  
▼C1 
PART 7  
Import and quarantine animal health conditions for animals imported into 
St. Pierre and Miquelon within a period of less than six months prior to 
introduction into the Union  
(referred to in Article 6)  
Animal species covered  
Taxon  
ORDER FAMILY GENUS AND SPECIES  
Artiodactyla Camelidae  Camelus  spp.,  Lama  spp.,  Vicugna  spp. ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 85  
( 1 ) OJ L 167, 7.7.2000, p. 22. 
( 2 ) OJ L 39, 9.2.2002, p. 71.
 CHAPTER 1  
Residence and quarantine  
1. Animals imported into St. Pierre and Miquelon must reside in  an authorised 
quarantine station for a minimum period of 60 days before being  dispatched 
for introduction into the Union. This period may be increased d ue to testing 
requirements for individual species. In addition the animals mu st comply 
with the following requirements:  
(a) Separate consignments may enter the quarantine station. How ever, upon 
entry in the quarantine station all animals of the same species  in the 
quarantine facility must be considered as a single group, and r eferred to 
as such. The quarantine period must commence for the whole grou p at 
the time when the last animal entered the quarantine facility.  
(b) Within the quarantine station each specific group of animal s must be 
maintained in isolation, with no direct or indirect contact wit h any other 
animals, including those from other consignments that may be pr esent.  
Each consignment must be kept in the approved quarantine statio n and 
protected from vector insects.  
(c) If, during the period of quarantine, the isolation of a gro up of animals is 
not maintained and contact is made with other animals, the quar antine 
period must begin again for the same duration as initially pres cribed on 
entry into the quarantine station.  
(d) Animals to be introduced into the Union which pass through the quar­
antine station must be loaded and dispatched directly to the Un ion: 
(i) without coming into contact with animals other than animals  which 
fulfil the health conditions established for the introduction o f the 
relevant category of animal into the Union;  
(ii) segregated into consignments so that no consignment can ca me in 
contact with animals not eligible for importation into the Unio n; 
(iii) in transport vehicles or containers which have first been  cleansed 
and disinfected with a disinfectant officially authorised in St . Pierre 
and Miquelon as effective in the control of the diseases referr ed to 
in Chapter 2 and which are so constructed that faeces, urine, l itter or 
fodder cannot flow or fall out of the vehicle or container duri ng 
transportation.  
2. The quarantine premises must at least meet the minimum stand ards laid 
down in Annex B to Directive 91/496/EEC (  1 ), and the following conditions:  
(a) they must be supervised by an official veterinarian;  
(b) they must be situated at the centre of an area of at least 20 km in 
diameter in which, according to official findings, for at least  30 days 
prior to their use as a quarantine station there has been no ca se of foot- 
and-mouth disease;  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 86  
( 1 ) OJ L 268, 24.9.1991, p. 56.
 (c) they must, before being used as a quarantine station, be cl eansed and 
disinfected with a disinfectant officially authorised in St Pie rre et 
Miquelon as effective in the control of the diseases referred t o in 
Chapter 2;  
(d) they must operate, taking into account their animal capacit y: 
(i) a facility dedicated exclusively for the quarantine of anim als, 
including adequate housing to a suitable standard for the anima ls; 
(ii) appropriate facilities, that:  
— are easy to thouroughly clean and disinfect,  
— include facilities for safe loading and unloading,  
— are able to fulfil all watering and feeding requirements for the 
animals,  
— allow any necessary veterinary treatment to be easily adminis ­
tered;  
(iii) appropriate facilities for inspection and isolation;  
(iv) appropriate equipment for cleaning and disinfecting rooms and 
transport vehicles;  
(v) an appropriate storage area for fodder, litter and manure;  
(vi) an appropriate system for collecting waste water;  
(vii) an office for the official veterinarian;  
(e) when operating, they must have sufficient veterinarians to carry out all 
duties;  
(f) they must only admit animals that are individually identifi ed so as to 
guarantee traceability. To this end, when animals are admitted the owner 
or the person in charge of the quarantine station must ensure t hat the 
animals are properly identified and accompanied by health certi ficates for 
the species and categories involved. In addition, the owner or the person 
in charge of the quarantine station must record on a register o r in a data 
base, and retain for at least three years, the name of the owne r, the origin 
of the animals in the consignment, the dates of entry and exit of the 
animals in the consignment, the identification number of the an imals in 
the consignment and their place of destination;  
(g) the competent authority must determine the procedure for of ficial super­
vision of the quarantine station and must ensure that such supe rvision is 
carried out; this supervision must include regular inspections in order to 
ascertain that the requirements for approval continue to be ful filled. In 
case of failure and suspension, the approval may only be restor ed when 
the competent authority is satisfied that the quarantine premis es are in 
full compliance with all the conditions set out in points (a) t o (g).  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 87
 
CHAPTER 2  
Animal health tests  
1. GENERAL REQUIREMENTS  
The animals must be subjected to the following tests carried ou t on 
samples of blood taken, if not specified otherwise, not earlier  than 21 
days from the date of commencement of the isolation period.  
The laboratory tests must be carried out in an approved laborat ory in the 
Union and all laboratory tests and their results, vaccinations and 
treatments must be enclosed with the health certificate.  
In order to keep animal interventions to a minimum, sampling, t ests and 
any vaccinations must be grouped as far as is possible whilst r especting 
the minimum time intervals required by the testing protocols se t out in 
Part 2 of this Chapter.  
2. SPECIFIC REQUIREMENTS  
2.1 CAMELIDAE  
2.1.1  Tuberculosis  
(a) Test to be used : comparative intradermal reaction test using Bovine 
purified protein derivative (PPD) and Avian PPD conforming to t he 
standards for the manufacture of bovine and avian tuberculins a s 
described in point 2.1.2 of Annex B of Directive 64/432/EEC.  
The test must be executed in the area behind the shoulder (axil lary 
region) following the technique described in point 2.2.4 of Ann ex B 
of Directive 64/432/EEC.  
(b) Timing : the animals must be tested within two days from the date of 
arrival in the quarantine station and 42 days from the date of the first 
test. 
(c) Interpretation of tests:  
the reaction shall be considered:  
— negative if the increased skin thickness is less than 2 mm.  
— positive if the increased skin thickness is more than 4 mm.  
— inconclusive if the increased skin thickness to the bovine PP D is 
between 2mm and 4 mm, or more than 4 mm but less then the 
reaction to the avian PPD.  
(d) Options for action following testing:  
If an animal presents a positive result to the intradermal-reac tion to 
the bovine PPD, that animal shall be excluded from the group an d 
the other animals shall be re-tested starting at least 42 days from the 
date of the first positive test was administered and this shall  be 
considered as the first test described in (b).  
If more than one animal of the group presents a positive result , the 
whole group shall be rejected for exportation to the Union.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 88
 
If one or more animals of the same group present an inconclusiv e 
reaction, the whole group shall be re-tested starting at least 42 days 
from the date of the first test was administered and it shall b e 
considered as the first test described in (b).  
2.1.2  Brucellosis  
(a) Test to be used:  
(i) Brucella abortus : Rose Bengal test (RBT) and Serum aggluti­
nation test (SAT) as described respectively in points 2.5 and 2 .6 
of Annex C to Directive 64/432/EEC. In the case of a positive 
result, a complement-fixation test shall be performed for confi r­
mation as described in Part 6 of Annex I to Regulation (EU) 
No 206/2010.  
(ii) Brucella melitensis : RBT and SAT as described respectively in 
points 2.5 and 2.6 of Annex C to Directive 64/432/EEC. In the 
case of a positive result, a complement-fixation test following  
the method described in Annex C to Directive 91/68/EEC shall 
be performed for confirmation.  
(iii) Brucella ovis : Complement fixation test as described in Annex 
D to Directive 91/68/EEC  
(b) Timing : the animals have to be tested within two days from the date 
of their arrival in the quarantine station and 42 days from the  date of 
the first test.  
(c) Interpretation of tests:  
A positive reaction to the tests shall be as defined in Annex C  to 
Directive 64/432/EEC.  
(d) Options for action following testing:  
Animals tested positive to one of the tests shall be excluded f rom the 
group and the other animals shall be re-tested starting at leas t 42 
days from the date the first positive test was performed: this shall be 
considered as the first test described in (b).  
Only the animals that tested negative to two consecutive tests 
performed as described in (b) shall be allowed for the introduc tion 
to the Union.  
2.1.3  Bluetongue and Epizootic haemorrhagic disease (EHD)  
(a) Test to be  used: agar gel immunodiffusion (AGID) test as described 
in Part 6 of Annex I to Regulation (EU) No 206/2010.  
In case of a positive reaction the animals shall be tested with  
competitive ELISA test as described in Part 6 of Annex I to Reg u­
lation (EU) No 206/2010 to discriminate between the two disease s. 
(b) Timing:  
The animals must be tested with negative result to two tests: t he first 
within two days from the date of their arrival in the quarantin e 
station and the second at least 21 days from date of the first test. ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 89
 
(c) Options for action following testing:  
(i) Bluetongue  
If one or more animals tested positive to the ELISA as describe d 
in Part 6 of Annex I to Regulation (EU) No 206/2010, the 
positive animal/animals shall be excluded from the group, and 
all the remaining animals in the group must be quarantined for 
100 days starting from the date on which the samples for the 
positive test were collected. The group shall only be considere d 
free of the bluetongue disease if regular checks carried out by  
official veterinarians throughout the duration of the quarantin e 
period fail to reveal clinical symptoms of disease, and the qua r­
antine station remains free of bluetongue vectors ( Culicoides ). 
If a further animal presents clinical symptoms of bluetongue 
disease during the quarantine period as described in the first 
subparagraph, all the animals in the group shall be rejected fo r 
introduction into the Union.  
(ii) Epizootic haemorrhagic disease (EHD)  
If one or more animals tested positive reveal the presence of 
antibodies to the EHD virus during confirmatory ELISA 
testing, the animal(s) shall be considered positive and shall b e 
excluded from the group, and the whole group shall be subject t o 
repeat testing beginning at least 21 days from the date of the 
initial positive diagnosis and again at least 21 days from the date 
of the repeat test, both with negative results.  
If any additional animals are tested positive during either or both 
of the two tests carried out for repeat testing, the whole grou p of 
animals shall be rejected for introduction into the Union.  
2.1.4  Foot-and-Mouth Disease (FMD)  
(a) Test to be used : Diagnostic tests (probang and serology) using 
ELISA and (Virus Neutralisation) (VN) techniques in accordance 
with the Protocols described in Part 6 of Annex I to Regulation  
(EU) No 206/2010.  
(b) Timing : the animals shall be tested with negative results to two test s: 
the first within two days from the date of their arrival in the  quar­
antine station and the second at least 42 days from the date of  the 
first test.  
(c) Options for action following testing : If any animal tests positive for 
the FMD virus, then none of the animals present in the quaranti ne 
station shall be considered as eligible for introduction into t he Union.  
Note : Any detection of antibodies to structural or not structural 
proteins of FMD virus shall be considered as a result of previo us 
infection of FMD irrespective of the vaccination status.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 90
 
2.1.5  Rinderpest  
(a) Test to be used : The competitive ELISA test as described in the OIE 
Manual of Diagnostic Tests and Vaccines for Terrestrial Animals , 
latest version, is the prescribed test for international trade and is test 
of choice. Serum neutralisation test, or other recognised tests  in 
accordance with the protocols described in relevant sections of  the 
OIE manual may also be used.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : If any animal tests positive for 
the Rinderpest virus, then none of the animals present in the q uar­
antine station shall be considered as eligible for introduction  into the 
Union.  
2.1.6  Vesicular stomatitis  
(a) Test to be used : ELISA, virus neutralisation test, or other recognised 
test in accordance with the protocols described in the relevant  
sections of the OIE manual.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : If any animal tests positive for 
vesicular stomatitis virus, then none of the animals present in  the 
quarantine station shall be considered as eligible for introduc tion into 
the Union.  
2.1.7  Rift valley fever  
(a) Test to be used : ELISA, virus neutralisation test, or other recognised 
test in accordance with the protocols described in relevant sec tions of 
the OIE manual.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : If any animal displays 
evidence of exposure to rift valley fever agent, then none of t he 
animals present in the quarantine station shall be considered a s 
eligible for introduction into the Union.  
2.1.8  Lumpy skin disease  
(a) Test to be used : Serology using ELISA, virus neutralisation test, or 
other recognised test in accordance with the protocols describe d in 
relevant sections of the OIE manual.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 91
 
(c) Options for action following testing : If any animal displays 
evidence of exposure to lumpy skin disease, then none of the 
animals present in the quarantine station shall be considered a s 
eligible for introduction into the Union.  
2.1.9  Crimean congo haemorrhagic fever  
(a) Test to be used : ELISA, virus neutralisation test, Immunofluor­
escence test or other recognised test.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : If any animal displays 
evidence of exposure to crimean congo haemorrhagic fever agent,  
then none of the animals present in the quarantine station shal l be 
considered as eligible for introduction into the Union.  
2.1.10  Surra  (Trypanosoma evansi (T. evansi))  
(a) Test to be used : The parasitic agent can be identified in concentrated 
blood samples in accordance with the protocols described in rel evant 
sections of the OIE manual.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : If T. evansi  is detected in any 
animal in the consignment, then that animal shall be considered  not 
eligible for introduction into the Union. The remaining animals  of the 
group shall then undergo internal and external antiparasitic tr eatment 
using suitable agents that are effective against  T. evansi . 
2.1.11  Malignant catarrhal fever  
(a) Test to be used : Detection of viral DNA based on identification by 
immunofluorescence or immunocytochemistry using the protocols 
described in relevant sections of the OIE manual.  
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : If any animal displays 
evidence of exposure to MCF, then none of the animals present i n 
the quarantine station shall be considered as eligible for intr oduction 
into the Union.  
2.1.12  Rabies  
Vaccination : Rabies vaccination may be carried out when requested by 
the Member State of destination and the animal shall be blood s ampled 
and a serum neutralisation test for antibodies carried out.  
2.1.13  Enzootic bovine leucosis . (only in the case where the animals are 
destined for an officially enzootic-bovine-leucosis free Member  State or 
region, as referred to in Article 2(2)(k) of Directive 64/432/E EC) 
(a) Test to be used : AGID or blocking ELISA, in accordance with the 
protocols described in the OIE manual, latest version.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 92
 
(b) Timing : the animals shall be tested twice: the first within two days 
from the date of their arrival in the quarantine station and th e second 
at least 42 days from the date of the first test.  
(c) Options for action following testing : animals tested positive to the 
test described in (a) shall be excluded from the group of anima ls in 
the quarantine facility and the other animals shall be re-teste d starting 
at least 21 days from the date of the first positive test was p erformed: 
this shall be considered as the first test described in (b).  
Only the animals that tested negative to two consecutive tests 
performed as described in (b) shall be considered eligible for intro­
duction into the Union.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 93
 02010R0206 — EN — 01.01.2021 — 027.001 — 94
 ▼C1 
ANNEX II  
FRESH MEAT  
▼M2 
PART 1  
List of third countries, territories and parts thereof  ( 1 ) 
ISO code and name of 
third country Code of Territory Description of third country, territory or pa rt thereof Veterinary certificate Specific 
conditions Closing date (  2 ) Opening date (  3 ) 
Model(s) SG  
1 2 3 4 5 6 7 8  
AL – Albania AL-0 Whole country — 
▼M30  
AR-Argentina AR-0 Whole country EQU  
AR-1 The provinces of: 
Part of Buenos Aires (excluding territory included in 
AR-4), 
Catamarca, 
Corrientes, 
Entre Ríos, 
La Rioja, 
Mendoza, 
Misiones, 
San Juan, 
San Luis, 
Santa Fe, 
Tucuman, 
Cordoba, 
La Pampa, 
Santiago del Estero, 
Chaco, 
Formosa, 
Jujuy, 
Salta (excluding territory included in AR-3). BOV 
RUF 
RUW A 1 1 August 2010
 02010R0206 — EN — 01.01.2021 — 027.001 — 95
 ▼M30  
1 2 3 4 5 6 7 8  
AR-2 The provinces of: 
Chubut, 
Santa Cruz, 
Tierra del Fuego, 
Part of Neuquén (excluding territory included in AR-4), 
Part of Río Negro (excluding territory included in AR-4) BOV 
OVI 
RUW 
RUF 1 August 2008  
AR-3 Part of Salta: the area of 25 km from the border with 
Bolivia and Paraguay that extends from the Santa 
Catalina District in the Province of Jujuy, to the Laishi 
District in the Province of Formosa (the former 
high-surveillance buffer area) BOV 
RUF 
RUW A 1 1 July 2016  
AR-4 The provinces of: 
Part of Neuquén (in Confluencia the zone located east of 
the Provincial road 17, and in Picun Leufú the zone located 
east of the Provincial road 17) 
Part of province of Río Negro (in Avellaneda the zone 
located north of the Provincial road 7 and east of the 
Provincial road 250, in Conesa the zone located east of 
the Provincial road 2, in El Cuy the zone located north 
of the Provincial road 7 from its intersection with the 
Provincial road 66 to the border with the Department of 
Avellaneda, and in San Antonio the zone located east of 
the Provincial roads 250 and 2) 
Part of Buenos Aires (Partido (district) de Patagones). BOV 
OVI 
RUW 
RUF 8 July 2019  
▼M2 
AU – Australia AU-0 Whole country BOV, OVI, POR, 
EQU, RUF, 
RUW, SUF, 
SUW  
▼M28  
BA – Bosnia and 
Herzegovina (  8 ) BA-0 Whole country BOV  
▼M2 
BH – Bahrain BH-0 Whole country —
 02010R0206 — EN — 01.01.2021 — 027.001 — 96
 ▼M2 
1 2 3 4 5 6 7 8  
▼M25  
BR – Brazil BR-0 Whole country EQU  
BR-1 State of Minas Gerais, 
State of Espírito Santo, 
State of Goiás, 
State of Mato Grosso, 
State of Rio Grande Do Sul, 
State of Mato Grosso Do Sul (excluding territory included 
in BR-4). BOV A and H 1 1 December 2008  
BR-2 State of Santa Catarina BOV A and H 1 31 January 2008  
BR-3 States of Paraná and São Paulo BOV A and H 1 1 August 2008  
BR-4 Part of State of Mato Grosso Do Sul: The area of 15 km 
from the external borders in the municipalities of Porto 
Murtinho, Caracol, Bela Vista, Antônio João, Ponta Porã, 
Aral Moreira, Coronel Sapucaia, Paranhos, Sete Quedas, 
Japorã, and Mundo Novo and the area in the municipalities 
of Corumbá and Ladário (the former designated 
high-surveillance area) BOV A and H 1 1 July 2016  
▼M26  
BW – Botswana BW-0 Whole country EQU, EQW  
BW-1 The veterinary disease control zones 3c, 4b, 5, 8, 9 and 1 8 BOV, OVI, RUF, 
RUW F 1 11 May 2011 26 June 2012  
BW-2 The veterinary disease control zones 10, 11, 13 and 14 BOV, OVI, RUF, 
RUW F 1 7 March 2002  
BW-3 The veterinary disease control zone 12 BOV, OVI, RUF, 
RUW F 1 20 October 
2008 20 January 2009  
BW-4 The veterinary disease control zone 4a, except the intensi ve 
surveillance buffer zone of 10 km along the boundary with 
the foot-and-mouth disease vaccination zone and wildlife 
management areas BOV F 1 28 May 2013 18 February 2011  
BW-5 The veterinary disease control zones 6a and 6b BOV, OVI, RUF, 
RUW F 1 28 May 2013 18 August 2016  
▼M2 
BY – Belarus BY-0 Whole country — 
BZ – Belize BZ-0 Whole country BOV, EQU
 02010R0206 — EN — 01.01.2021 — 027.001 — 97
 ▼M2 
1 2 3 4 5 6 7 8  
CA – Canada CA-0 Whole country BOV, OVI, POR, 
EQU, SUF, SUW, 
RUF, RUW G 
CH – Switzerland CH-0 Whole country * 
CL – Chile CL-0 Whole country BOV, OVI, POR, 
EQU, RUF, 
RUW, SUF  
CN – China CN-0 Whole country — 
CO – Colombia CO-0 Whole country EQU  
CR – Costa Rica CR-0 Whole country BOV, EQU  
CU – Cuba CU-0 Whole country BOV, EQU  
DZ – Algeria DZ-0 Whole country — 
ET – Ethiopia ET-0 Whole country — 
FK – Falkland 
Islands FK-0 Whole country BOV, OVI, EQU  
▼M33  
GB – United King­
dom (***) GB-0 Whole country BOV, OVI, POR, 
EQU, RUF, 
RUW, SUF, 
SUW K 
GG – Guernsey GG-0 Whole country  
▼M2 
GL – Greenland GL-0 Whole country BOV, OVI, EQU, 
RUF, RUW  
GT – Guatemala GT-0 Whole country BOV, EQU  
HK – Hong Kong HK-0 Whole country — 
HN – Honduras HN-0 Whole country BOV, EQU  
▼M16  __________  
▼M22  
IL – Israel (  6 ) IL-0 Whole country — 
▼M33  
IM – Isle of Man IM-0 Whole country BOV, OVI, POR  
▼M2 
IN – India IN-0 Whole country —
 02010R0206 — EN — 01.01.2021 — 027.001 — 98
 ▼M2 
1 2 3 4 5 6 7 8  
IS – Iceland IS-0 Whole country BOV, OVI, EQU, 
RUF, RUW  
▼M33  
JE – Jersey JE-0 Whole country  
▼M14  
JP – Japan JP Whole country BOV 28 March 2013  
▼M2 
KE – Kenya KE-0 Whole country — 
MA – Morocco MA-0 Whole country EQU  
ME – Montenegro ME-0 Whole country BOV, OVI, EQU  
MG – Madagascar MG-0 Whole country — 
▼M30  
MK-The Republic of 
North Macedonia MK-0 Whole country BOV, OVI, EQU  
▼M2 
MU – Mauritius MU-0 Whole country — 
MX – Mexico MX-0 Whole country BOV, EQU  
NA – Namibia NA-0 Whole country EQU, EQW  
NA-1 South of the cordon fences which extend from Palgrave 
Point in the west to Gam in the east BOV, OVI,RUF, 
RUW F and J 1  
NC – New Caledonia NC-0 Whole country BOV, RUF, 
RUW  
NI – Nicaragua NI-0 Whole country — 
NZ – New Zealand NZ-0 Whole country BOV, OVI, POR, 
EQU, RUF, 
RUW, SUF, 
SUW  
PA – Panama PA-0 Whole country BOV, EQU
 02010R0206 — EN — 01.01.2021 — 027.001 — 99
 ▼M2 
1 2 3 4 5 6 7 8  
▼M22  
PY – Paraguay PY-0 Whole country EQU  
PY-0 Whole country BOV A 1 17 April 2015  
▼M2 
RS – Serbia (  5 ) RS-0 Whole country BOV, OVI, EQU  
RU – Russia RU-0 Whole country — 
RU-1 Region of Murmansk, Yamolo-Nenets autonomous area RUF 
▼M24  
SG – Singapore (*) SG-0 Whole country NZ-TRANSIT- 
SG (**)  
▼M2 
SV – El Salvador SV-0 Whole country — 
SZ – Swaziland SZ-0 Whole country EQU, EQW  
SZ-1 Area west of the ‘red line’ fences which extends 
northwards from the river Usutu to the frontier with 
South Africa west of Nkalashane, BOV, RUF, 
RUW F 1  
SZ-2 The veterinary foot and mouth disease surveillance and 
vaccination control areas as gazetted as a Statutory 
Instrument under legal notice number 51 of 2001 BOV, RUF, 
RUW F 1 4 August 2003  
TH – Thailand TH-0 Whole country — 
TN – Tunisia TN-0 Whole country — 
TR – Turkey TR-0 Whole country — 
TR-1 The provinces of Amasya, Ankara, Aydin, Balikesir, 
Bursa, Cankiri, Corum, Denizli, Izmir, Kastamonu, 
Kutahya, Manisa, Usak, Yozgat and Kirikkale EQU  
UA – Ukraine UA-0 Whole country —
 02010R0206 — EN — 01.01.2021 — 027.001 — 100
 ▼M2 
1 2 3 4 5 6 7 8  
US – United States US-0 Whole country BOV, OVI, POR, 
EQU,SUF, SUW, 
RUF, RUW G 
▼M11  
UY – Uruguay UY-0 Whole country EQU  
BOV A and J 1 1 November 2001  
OVI A 1  
▼M3 
ZA – South Africa ZA-0 Whole country EQU, EQW  
▼M32  __________  
▼M2 
ZW – Zimbabwe ZW-0 Whole country — 
Footnotes:  
( 1 ) Without prejudice to specific certification requirements prov ided for in Union agreements with third countries. 
( 2 ) Meat from animals slaughtered on or before the date set out i n column 7 may be imported into the Union for 90 days from that  date. Consignments carried on vessels on the high seas may be imported into the 
Union if certified before the date set out in column 7 for 40 d ays from that date.(N.B.: no date in column 7 means that there are no time restrictions). 
( 3 ) Only meat from animals slaughtered on or after the date set o ut in column 8 may be imported into the Union (no date in colum n 8 means that there are no time restrictions).  
►M30 __________  ◄ 
( 5 ) Not including Kosovo which is at present under international administration pursuant to United Nations Security Council Reso lution 1244 of 10 June 1999.  
►M22  ( 6 ) Hereafter understood as the State of Israel, excluding the te rritories under Israeli administration since June 1967, namely the Golan Heights, the Gaza Strip, East Jerusalem and the rest of the West Bank. ◄  
►M30 __________  ◄ 
►M28  ( 8 ) Only for transit of consignments of fresh meat of domestic bo vine animals via Bulgaria into Turkey. ◄  
►M24  (*) Only for fresh meat originating from New Zealand, for whic h New Zealand is authorised for introduction into the Union, wh ich is accompanied by the appropriate model of veterinary certi ficate issued by the 
competent authority of New Zealand, destined to the Union and b eing unloaded, with or without storage and reloaded in an appro ved establishment during transit through Singapore. 
(**) Upon entry into the Union, the consignments should be acco mpanied both by this model of veterinary certificate issued in TRACES by the competent authority of Singapore and by the appro priate model of 
veterinary certificate for import of fresh meat issued by the c ompetent authority of New Zealand, which may be attached in TRA CES by the competent authority of Singapore. ◄  
►M33  (***) In accordance with the Agreement on the withdrawal of th e United Kingdom of Great Britain and Northern Ireland from the  European Union and the European Atomic Energy Community, and i n 
particular Article 5(4) of the Protocol on Ireland/Northern Ire land in conjunction with Annex 2 to that Protocol, for the purp oses of this Annex references to the United Kingdom do not incl ude Northern Ireland. ◄ 
* = Requirements as in accordance with the Agreement between th e European Community and the Swiss Confederation on trade in ag ricultural products (OJ L 114, 30.4.2002, p. 132). 
— = No certificates are laid down and fresh meat imports are pr ohibited (except for those species where indicated in the line comprising the entry for the whole country).  
‘1’ Category restrictions:  
No offal is authorised for introduction into the Union (except,  in the case of bovine species, diaphragm and masseter muscles) .
 PART 2  
Models of veterinary certificates  
Model(s):  
‘BOV’: Model of veterinary certificate for fresh meat, includin g 
minced meat, of domestic bovine animals (including  
Bison  and Bubalus  species and their cross-breeds).  
‘OVI’: Model of veterinary certificate for fresh meat, includin g 
minced meat, of domestic ovine animals ( Ovis aries ) and 
domestic caprine animals ( Capra hircus ). 
‘POR’: Model of veterinary certificate for fresh meat, includin g 
minced meat, of domestic porcine animals ( Sus scrofa ). 
‘EQU’: Model of veterinary certificate for fresh meat, excludin g 
minced meat, of domestic solipeds ( Equus caballus , 
Equus asinus  and their cross-breeds).  
‘RUF’: Model of veterinary certificate for fresh meat, excludin g 
offal and minced meat, of farmed non-domestic animals 
of the order Artiodactyla (excluding bovine animals 
(including  Bison  and  Bubalus  species and their cross- 
breeds),  Ovis aries , Capra hircus , Suidae and Tayas­
suidae), and of the families Rhinocerotidae and Eleph­
antidae.  
‘RUW’: Model of veterinary certificate for fresh meat, excludin g 
offal and minced meat, of wild non-domestic animals of 
the order Artiodactyla (excluding bovine animals 
(including  Bison  and  Bubalus  species and their cross- 
breeds),  Ovis aries, Capra hircus , Suidae and Tayas­
suidae), and of the families Rhinocerotidae and Eleph­
antidae.  
‘SUF’: Model of veterinary certificate for fresh meat, excludin g 
offal and minced meat, of farmed non-domestic animals 
belonging to the Suidae, Tayassuidae, or Tapiridae 
families.  
‘SUW’: Model of veterinary certificate for fresh meat, excludin g 
offal and minced meat, of wild non-domestic animals 
belonging to the Suidae, Tayassuidae, or Tapiridae 
families.  
‘EQW’: Model of veterinary certificate for fresh meat, excludin g 
offal and minced meat, of wild solipeds belonging to the 
subgenus  Hippotigris  (zebra).  
▼M24  
‘NZ-TRANSIT-SG’: Model of veterinary certificate only for trans it through 
Singapore with unloading, possible storage and reloading 
of fresh meat originating from New Zealand, for which 
New Zealand is authorised for introduction into the 
Union, which is eligible for introduction and destined to 
the Union.  
▼M1 
SG (Supplementary guarantees)  
‘A’: guarantees regarding the maturation, pH measurement and 
boning of fresh meat, excluding offal, certified according 
to the models of veterinary certificates BOV (point II.2.6), 
OVI (point II.2.6), RUF (point II.2.7) and RUW (point 
II.2.4).  ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 101
 
‘C’: guarantees regarding the laboratory test for classical-swi ne- 
fever in the carcases from which fresh meat was obtained, 
certified according to the model of veterinary certificate 
SUW (point II.2.3 B).  
‘D’: guarantees regarding swill feed on holding(s) of animals 
from which fresh meat certified was obtained according to 
the model of veterinary certificate POR (point II.2.3 d).  
‘E’: guarantees regarding tuberculosis test in the animals from  
where fresh meat certified was obtained, according to the 
model of veterinary certificate BOV (point II.2.4 d).  
‘F’: guarantees regarding the maturation and de-boning of fresh  
meat, excluding offal, certified according to the models of 
veterinary certificates BOV (point II.2.6), OVI (point 
II.2.6), RUF (point II.2.6) and RUW (point II.2.7).  
‘G’: guarantees regarding 1, exclusion of offals and spinal cor d; 
and 2, testing and origin of cervid animals in relation to 
chronic wasting disease as referred to in the models of 
veterinary certificates RUF (point II.1.7) and RUW (point 
II.1.8).  
‘H’: supplementary guarantees required for Brazil. Concerning 
vaccination programmes, as the State of Santa Catarina in 
Brazil does not vaccinate against foot and mouth disease, 
the reference to a vaccination programme is not applicable 
for meat coming from animals originating and slaughtered 
in that State.  
‘J’: guarantees regarding the movement of bovine, ovine and 
caprine animals from holdings to the slaughterhouse, which 
allow them to pass via an assembly centre (including 
markets) before being transported directly to slaughter.  
▼M33  
‘K’: unweaned domestic swine less than five weeks of age are 
exempt from  Trichinella  testing.  ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 102
 
Model BOV
  ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 103
 
► (1) M29 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 104
 
► (1) M29 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 105
 
▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 106
 
► (1) M13 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 107
 
► (1) M13  
► (2) (3) M29 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 108
 
Model OVI
  ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 109
 
► (1) M29 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 110
 
► (1) M29 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 111
 
► (1) M13 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 112
 
► (1) M13  
► (2) M29 ▼M1 02010R0206 — EN — 01.01.2021 — 027.001 — 113
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 114
 
► (1) M21 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 115
 
► (1) M13 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 116
 
► (1) M13  
► (2) M21 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 117
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 118
 
► (1) M27 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 119
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 120
 
► (1) (2) M13 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 121
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 122
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 123
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 124
 
► (1) M13 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 125
 
► (1) M13 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 126
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 127
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 128
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 129
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 130
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 131
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 132
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 133
 
► (1) (2) M13 ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 134
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 135
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 136
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 137
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 138
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 139
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 140
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 141
 
▼M24  02010R0206 — EN — 01.01.2021 — 027.001 — 142
 
► (1) C6 ▼M24  02010R0206 — EN — 01.01.2021 — 027.001 — 143
 
▼M24  02010R0206 — EN — 01.01.2021 — 027.001 — 144
 
ANNEX III
  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 145
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 146
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 147
 
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)  
▼M1 
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 (  1 ) 
( 1 ) Suspended from 5 May 2010.  
▼C1 
PART 2  
Tables of animals and the corresponding model veterinary certificates 
Table 1  
‘QUE’: Model of veterinary certificate for consignments of quee n bees and queen bumble bees 
(Apis mellifera and Bombus  spp.), 
‘BEE’: Model of veterinary certificate for consignments of colo nies of bumble bees ( Bombus  
spp.)  
Order Family Genera/species  
Hymenoptera  Apidae Apis mellifera, Bombus  spp. ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 148
 
Model QUE
  ▼M20  02010R0206 — EN — 01.01.2021 — 027.001 — 149
 
▼M20  02010R0206 — EN — 01.01.2021 — 027.001 — 150
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 151
 
▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 152
 
ANNEX V  
Explanatory notes for completing the veterinary certificates  
(referred to in Article 18)  
(a) Veterinary certificates shall be issued by the exporting th ird country, based 
on the models set out in Part 2 of Annexes I, II and IV and Ann ex III 
according to the layout of the model that corresponds to the li ve animals/­
fresh meat concerned.  
They shall contain, in the numbered order that appears in the m odel, the 
attestations that are required for any third country and, as th e case may be, 
those supplementary guarantees that are required for the export ing third 
country or part thereof.  
If the Member State of destination imposes, for the live animal s/fresh meat 
concerned, additional certification requirements, attestations to certify that 
those requirements are fulfilled shall also be incorporated in the original 
form of the veterinary certificate.  
(b) Where the model certificate states that certain statements shall be kept as 
appropriate, statements which are not relevant, may be crossed out and 
initialled and stamped by the certifying officer, or completely  deleted from 
the certificate.  
(c) A separate and unique certificate must be provided for the live animals/fresh 
meat that are exported from a territory or territories of the s ame exporting 
country appearing in columns 2 and 3 of Part 1 of Annex I, II o r IV which 
are consigned to the same destination and transported in the sa me railway 
wagon, lorry, aircraft or ship.  
(d) The original of each certificate shall consist of a single sheet of paper, or, 
where more text is required it must be in such a form that all sheets of paper 
required are part of an integrated whole and indivisible.  
(e) The veterinary certificate shall be drawn up in at least on e of the official 
languages of the Member State of the border inspection post of introduction 
of the consignment into the Union and of the Member State of de stination. 
However, those Member States may authorise the certificate to b e drawn up 
in the official language of another Member State, and accompani ed, if 
necessary, by an official translation.  
(f) If for reasons of identification of the items of the consig nment (schedule in 
point I.28 of the model veterinary certificate), additional she ets of paper are 
attached to the certificate, those sheets of paper shall also b e considered as 
forming part of the original of the certificate by the applicat ion of the 
signature and stamp of the certifying officer, on each of the p ages.  
(g) When the certificate, including additional schedules referr ed to in (f), 
comprises more than one page, each page shall be numbered, (pag e 
number) of (total number of pages), at the end of the page and shall bear 
the certificate reference number that has been designated by th e competent 
authority at the top of the pages.  
(h) The original of the certificate must be completed and signe d by an official 
veterinarian or by another designated official inspector where this is provided 
for in the model veterinary certificate. In the case of live an imals, the 
certificate must be completed and signed within 24 hours prior to loading 
of the consignment for introduction into the Union. The compete nt auth­
orities of the exporting third country shall ensure that rules of certification 
equivalent to those laid down in Directive 96/93/EC (  1 ) are followed.  
The colour of the signature shall be different from that of the  printing. This 
requirement also applies to stamps other than those embossed or  water­
marked.  
(i) The certificate reference number referred to in boxes I.2 a nd II.a. must be 
issued by the competent authority.  ▼C1 02010R0206 — EN — 01.01.2021 — 027.001 — 153  
( 1 ) OJ L 13, 16.1.1997, p. 28.
 ANNEX VI  
PART 1  
Table 1  
‘RUM-A’: Model of veterinary certificate for animals of the spe cies listed below that are 
originating from and intended for an approved body, institute o r 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), Bose ­
laphus  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-Alece ­
laphus  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.,  Mega­
muntiacus  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 of veterinary certificate for animals of the spe cies listed below that are 
originating from and intended for an approved body, institute o r centre.  
Order Family Genera/species  
Artiodactyla Suidae  Babyrousa  ssp.,  Hylochoerus  ssp.,  Phacochoerus  ssp.,  Pota­
mochoerus  ssp.,  Sus ssp.  
Tayassuidae  Catagonus  ssp.,  Pecari-Tayassu  ssp.  
Hippopotamidae  Hexaprotodon-Choeropsis  ssp.,  Hippopotamus  ssp. ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 154
 
Table 3  
‘TRE-A’: Model of veterinary certificate for animals of the spe cies listed below that are 
originating from and intended for an approved body, institute o r centre.  
Order Family Genera/species  
Perissodactyla Tapiridae  Tapirus  ssp.  
Rhinocerotidae  Ceratotherium  ssp.,  Dicerorhinus  ssp.,  Diceros  ssp.,  
Rhinoceros  ssp.  
Proboscidea Elephantidae  Elephas  ssp.,  Loxodonta  ssp. ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 155
 
PART 2
  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 156
 
► (1) (2) C4 ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 157
 
► (1) C5 ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 158
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 159
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 160
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 161
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 162
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 163
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 164
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 165
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 166
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 167
 
▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 168
 
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 a nimals, 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 follow ing requirements:  
(i) it has appropriate physical barriers at entry and exit poin ts; 
(ii) the openings of the vector-protected structure are vector- screened with 
mesh of appropriate gauge impregnated regularly with an approve d 
insecticide according to the instructions of the manufacturer;  
(iii) vector surveillance and control are carried out within an d around the 
vector-protected structure;  
(iv) measures are taken to limit or eliminate breeding sites fo r vectors in the 
vicinity of the vector-protected structure;  
(v) standard operating procedures are in place, including descr iptions of 
back-up and alarm systems, for the operation of the vector-prot ected 
structure and for the transport of the animals from that struct ure 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 i dentification, 
where appropriate) of the animals of each species present on th eir 
premises;  
(ii) the number and identity (age, sex, species and individual identification 
where appropriate) of animals arriving in or leaving their prem ises, 
together with information on their origin or destination, the m eans of 
transport, and the health status of those animals;  
(iii) the results of blood tests or any other diagnostic proced ures carried out 
on the animals on their premises;  
(iv) cases of disease and, where appropriate, the treatment adm inistered;  
(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 perio d; 
(e) be free from the diseases listed in Annex A to Directive 92 /65/EEC or 
mentioned in the veterinary certificates for the relevant speci es set out in 
Part 2 of Annex VI to this Regulation, for at least the previou s three years, as 
evidenced by the records kept pursuant to point (d) and the res ults of the 
clinical and laboratory tests carried out on the animals on the ir premises;  
(f) either have an arrangement with a laboratory approved  by the competent 
authority  to perform post-mortem examinations, or have one or more appro ­
priate 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;  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 169
 
(h) secure, by contract or legal instrument, the services of a veterinarian 
approved by and acting under the control of the competent autho rity, who 
must perform at least the following tasks:  
(i) ensure that appropriate disease surveillance and control me asures are 
applied in that body, institute or centre. Such measures must b e 
approved by the competent authority of the third country, terri tory or 
part thereof where the body, institute or centre is situated, t aking into 
account the disease situation and must include at least the fol lowing 
elements:  
— an annual disease surveillance plan including appropriate con trol 
measures concerning zoonoses in the animals present on the 
premises,  
— clinical, laboratory and post-mortem testing of animals suspe cted to 
be affected by transmissible diseases and zoonoses,  
— vaccination of susceptible animals against infectious disease s and 
zoonoses;  
(ii) ensure that any suspect deaths or the presence of any othe r symptom 
suggesting that animals have contracted one or more of the dise ases 
listed in Annex A to Directive 92/65/EEC or mentioned in the ve terinary 
certificates for the relevant species set out in Part 2 of Anne x VI to this 
Regulation are notified without delay to the competent authorit y, where 
that particular disease is notifiable in the third country, ter ritory or part 
thereof concerned;  
(iii) ensure that incoming animals have been quarantined as nec essary, in 
accordance with the instructions given by the competent authori ty; 
(iv) ensure compliance with the animal health requirements whic h the 
animals must fulfil in order to be introduced into the Union.  
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 struc ture 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 verif y 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 protecti on 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 co nditions 
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 le ast once per 
year;  
(ii) audit the activity of the veterinarian referred to in poin t (h) of Part 3 and 
the implementation of the annual disease surveillance plan refe rred to in 
the first indent of point (h)(i);  
(iii) ensure that the provisions laid down in Parts 3 and 4 are  met;  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 170
 
(iv) verify that:  
— compliance with the animal health requirements which the anim als 
must fulfil in order to be introduced into the Union;  
— the results of the clinical, post-mortem and laboratory tests  on the 
animals have revealed no occurrence of the diseases listed in A nnex 
A to Directive 92/65/EEC or mentioned in the veterinary certifi cates 
for the relevant species set out in Part 2 of Annex VI to this Regu­
lation.  
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 occurren ce of one of the 
diseases listed in Annex A to Directive 92/65/EEC or mentioned in the 
veterinary certificates for the relevant species laid down in P art 2 of 
Annex VI to this Regulation, the competent authority must suspe nd the 
approval of the body, institute or centre, until the suspicion has been offi­
cially ruled out. Depending on the disease involved and the ris k of disease 
transmission, the suspension may relate to the the body, instit ute 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 di sease are 
taken.  
7. Where the suspected disease referred to in point 6 is confir med, the approval 
of the body, institute or centre must be withdrawn.  
8. Where the approval of a body, institute or centre has been w ithdrawn, it must 
be restored only where the following conditions are complied wi th: 
(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 wer e appropriately 
cleaned and desinfected;  
(c) the body, institute or centre concerned complies with the r equirements 
set out in points (a) to (d) and (f) to (h) of Part 3.  
9. The competent authority which approved the body, institute o r centre must 
inform the Member States that included the body, institute or c entre on their 
lists of approved bodies, institutes and centres of the suspens ion, withdrawal 
or restoration of that approval.  ▼M18  02010R0206 — EN — 01.01.2021 — 027.001 — 171