2013R0780 — EN — 04.09.2013 — 000.001

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►B COMMISSION IMPLEMENTING REGULATION (EU) No 780/2013 of 14 August 2013 amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (Text with EEA relevance) (OJ L 219, 15.8.2013, p.1)





Corrected by:









▼B

COMMISSION IMPLEMENTING REGULATION (EU) No 780/2013

of 14 August 2013

amending Commission Regulation (EU) No 206/2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements

(Text with EEA relevance)







THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Union of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC ( 1 ), and in particular the first and second subparagraphs of Article 3(1), the first subparagraph of Article 6(1), Article 7(e), Article 8(c) and Article 13(1) thereof, Whereas: (1) Commission Regulation (EU) No 206/2010 ( 2 ) lays down the requirements for the introduction into the Union of, amongst others, certain ungulates. That Regulation does not apply to non-domesticated animals intended for an approved body, institute or centre as defined in Article 2(1)(c) of Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC ( 3 ). (2) The lack of specific animal health requirements for the introduction of ungulates intended for an approved body, institute or centre into the Union causes practical problems for such structures and strongly limits their activities, because of their need to introduce those animals. (3) It is appropriate to lay down animal health requirements for the introduction of ungulates intended for an approved body, institute or centre into the Union, which would take account of the specific situation of such animals. In the interest of simplification of Union law, it is appropriate that such rules be laid down in Regulation (EU) No 206/2010. The scope of that Regulation should therefore be amended accordingly. (4) Regulation (EU) No 206/2010 provides that consignments of ungulates may only be introduced into the Union if they come from the third countries, territories or parts thereof listed in Part 1 of Annex I to that Regulation. (5) Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption ( 4 ) provides for the adoption by the Commission of lists of the third countries or regions of third countries from which imports of specified products of animal origin are permitted. (6) Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae ( 5 ) provides that the importation of equidae into the Union is to be authorised only from third countries that appear on a list to be drawn up or amended in accordance with the procedure laid down in that Directive. (7) Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs ( 6 ) provides that poultry and hatching eggs imported into the Union must have originated in a third country or part of a third country included on a list drawn up by the Commission in accordance with the procedure laid down in that Directive. (8) The introduction of ungulates intended for an approved body, institute or centre into the Union should, in particular, fulfil the general requirements for the introduction of live animals into the Union and further specific animal health requirements and offer specific guarantees ensuring that the animals introduced into the Union do not endanger the animal health status of the Union. (9) The general requirements for the introduction of live animals into the Union, consisting of an effective system of veterinary services in charge of the control of animal health, are currently fulfilled by those third countries, territories and parts thereof listed pursuant to Directives 2002/99/EC, 2009/156/EC and 2009/158/EC. (10) However, the general requirements for the introduction of live animals into the Union do not guarantee that ungulates are free of diseases. Individual animals may still carry infectious diseases that could spread into the Union and consequently consitute a danger to animal health in the Union. Ungulates intended for an approved body, institute or centre should therefore only be introduced into the Union directly from a body, institute or centre which complies with certain requirements and is approved by the competent authority of the third country, territory or part thereof in which it is situated. (11) It is appropriate that the list of such bodies, institutes or centres be established by the Member State of destination, following an assessment of all relevant information. (12) In order to protect the animal health in the Union, it is crucial that consignments of ungulates introduced into the Union and destined to approved bodies, institutes or centres be transported directly and without delay to their destination in sealed containers and that further movement of such animals within the Union be restricted. (13) In order to address exceptional circumstances such as situations concerning animal welfare problems, conservation of endangered species, sudden natural disasters or political unrest, in which it is not possible to apply all the animal health requirements and especially those related with the approval of the body, institute or centre of origin, Member States should be able to introduce into their territory certain ungulates destined to an approved body, institute or centre, under specific conditions. However, even in such cases, a permit should be required in order to ensure sufficient reduction of the animal health risk. (14) Regulation (EU) No 206/2010 should therefore be amended accordingly. (15) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, Whereas: HAS ADOPTED THIS REGULATION:







Article 1

Regulation (EU) No 206/2010 is amended as follows:

(1) In Article 1, paragraph 3 is deleted.

(2) The following Article 3a is inserted: 'Article 3a Conditions for the introduction of ungulates intended for an approved body, institute or centre 1. By way of derogation from Article 3, the competent authority of a Member State may authorise the introduction into its territory of consignments of ungulates of the species listed in Tables 1, 2 and 3 of Part 1 of Annex VI where those consignments are destined for an approved body, institute or centre, provided that the following conditions are complied with: (a) an assessment has been carried out by the competent authority of the Member State of destination of the animal health risks that each of the consignments may present for the Union; (b) the consignments concerned come from a third country, territory or part thereof which is included in one of the lists set out in: (i) Part 1 of Annex I or in Part 1 of Annex II to this Regulation, (ii) Decision 2004/211/EC ( 7 ), Decision 2007/777/EC ( 8 ), Regulation (EC) No 798/2008 ( 9 ), Regulation (EC) No 119/2009 ( 10 ), Regulation (EU) No 605/2010 ( 11 ), (c) the ungulates originate from a body, institute or centre in a third country, territory or part thereof, referred to in point (a), which is included in a list established in accordance with Article 3c; (d) the ungulates have been quarantined in a vector-protected facility at the premises of the body, institute or centre referred to in point (c) for the period provided for in the relevant certificates; (e) the ungulates are conveyed directly to an approved body, institute or centre in the Member State of destination; (f) the ungulates are accompanied by an appropriate veterinary certificate, drawn up in accordance with the relevant model of veterinary certificate referred to in Tables 1, 2 and 3 in Part 1 of Annex VI and set out in Part 2 of that Annex; (g) the ungulates comply with the requirements set out in the model of veterinary certificate referred to in point (f). The Member State of destination shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health of the authorisation granted pursuant to the first subparagraph, prior to the introduction of the ungulates into their territory. 2. Where exceptional circumstances render compliance with points (c) and (d) of paragraph 1 impossible, the competent authority of the Member State of destination may authorise the introduction, into its territory, of ungulates of the species listed in Tables 1, 2 and 3 of Part 1 of Annex VI from other holdings which do not comply with the requirements laid down in those points, provided that the requirements laid down in points (a), (b) and (e) to (g) of paragraph 1 are complied with and that the following additional conditions are met: (a) a prior application for a permit has been made by the owner, or a natural person representing that owner, and the Member State of destination has granted such permit after having carried out a risk assessment that has indicated that the introduction of the ungulates concerned into its territory does not constitute an animal health risk for the Union; (b) the ungulates have been quarantined in the third country, territory or part thereof of origin under official supervision for the time necessary for them to meet the animal health conditions set out in the model of veterinary certificate referred to in point (f): (i) at a place approved by the competent authority of the third country, territory or part thereof of origin of the animals; (ii) in accordance with the arrangements prescribed in the permit that shall provide at least the same guarantees as those laid down in points (a), (b) and (e) to (g) of paragraph 1. Where ungulates are introduced into the Union pursuant to the first subparagraph, they shall be quarantined in an approved body, institute or centre of destination for at least six months from the time of introduction into the Union, during which period the requirements provided for in Article 8(1)(a) of Council Directive 90/425/EEC may be applied by the competent authorities. The Member State authorising the introduction of ungulates pursuant to the first subparagraph shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health of such authorisation, prior to the introduction of the ungulates into its territory.

(3) The following Article 3b is inserted: 'Article 3b Conditions for the entry and transit of ungulates intended for an approved body, institute or centre through the territory of Member States other than the Member State of destination The transit of the ungulates referred to in Article 3a through a Member State other than the Member State of destination shall be permitted only subject to the authorisation of the competent authority of the Member State of transit. Such authorisation may be granted only on the basis of a risk assessment by that competent authority, in view of the information submitted to it by the Member State of destination. The Member State of destination shall inform the Commission and the other Member States in the Standing Committee on the Food Chain and Animal Health, prior to the transit, when authorising the introduction of animals under the conditions provided for in Article 3a.'

(4) The following Article 3c is inserted: 'Article 3c List of approved bodies, institutes or centres in third countries, territories and parts thereof 1. Following an assessment of compliance with the conditions laid down in paragraph 2, each Member State may establish a list of bodies, institutes and centres from which the introduction of ungulates into its territory may be authorised pursuant to Article 3a(1). 2. A body, institute or centre in a third country, territory or part thereof shall only be included in the list referred to in paragraph 1 where the following conditions are complied with: (a) the body, institute or centre complies with the requirements set out in Part 3 of Annex VI; (b) the body, institute or centre is approved by the competent authority of the third country, territory or part thereof where that body, institute or centre is situated; (c) the competent authority of the third country, territory or part thereof provides sufficient guarantees that the conditions concerning the approval of bodies, institutes or centres set out in Part 4 of Annex VI are complied with. 3. A Member State may include in the list referred to in paragraph (1) bodies, institutes or centres in third countries which are already included in such a list established by another Member State, without having assessed compliance with the conditions laid down in paragraph 2. 4. Member States shall keep the lists referred to in paragraph (1) up to date, taking into account in particular any suspension or withdrawal of the approval granted by the competent authority of a third country, territory or part thereof to the bodies, institutes or centres situated therein and included in those lists. 5. Member States shall make available to the public, by means of Internet-based information pages, the lists referred to in paragraph 1 and shall keep those Internet-based information pages up to date. 6. Member States shall communicate the Internet address of their Internet-based information pages to the Commission.'

(5) Article 4 is replaced by the following: 'Article 4 Conditions for the assembly centres for certain consignments of ungulates 1. Consignments of ungulates which contain live animals from more than one holding shall only be introduced into the Union if they are assembled in assembly centres approved by the competent authority of the third country, territory or part thereof of origin of the animals in accordance with the requirements set out in Part 5 of Annex I. 2. Consignments of ungulates introduced into the Union in accordance with Article 3a or Article 6 shall not originate from more than one holding and shall not be assembled in assembly centres.'

(6) In Article 8, point (b) is replaced by the following: '(b) unloaded in, or when transported by air, moved to another aircraft, or transported by road, by rail, or moved on foot through a third country, territory or part thereof which is not authorised for imports of the animals concerned into the Union.'

(7) In Article 11, paragraph 1 is replaced by the following: '1. Following their introduction into the Union, consignments of ungulates, other than those referred to in Article 3a shall be conveyed in a vector-protected means of transport without delay to the holding of destination. Those ungulates shall remain on that holding for a period of at least 30 days, unless they are dispatched directly to a slaughterhouse.'

(8) The following Article 13a is inserted: 'Article 13a Conditions to be applied following the introduction of consignments of ungulates intended for approved bodies, institutes or centres 1. Following their introduction into the Union, consignments of ungulates intended for approved bodies, institutes or centres shall be transported without delay to the approved body, institute or centre of destination in means of transport that are vector-protected and so constructed that the animals cannot escape and faeces, urine, litter, fodder, waste or any other material cannot flow or fall out from the vehicle or container during transportation. 2. The animals shall be kept in quarantine in vector-protected facilities on the premises of the approved body, institute or centre of the Member State of destination for a minimum of 30 days. After the 30 days quarantine period the animals may be moved to another approved body, institute or centre. 3. Animals introduced into an approved body, institute or centre can only be moved to a destination other than an approved body, institute or centre provided that: (a) at least six months have elapsed from the time of introduction into the Union, and (b) the movement is carried out in accordance with paragraph 4 of Annex C to Directive 92/65/EEC. 4. By way of derogation from paragraph 3, animals may leave an approved body, institute or centre before the end of the six-month period provided for in that paragraph, only where the following conditions are complied with: (a) the animals are exported to a third country, territory or part thereof; (b) for the purpose of their export as referred to in a) the animals are transported in means of transport that are vector-protected and so constructed that the animals cannot escape and faeces, urine, litter, fodder, waste or any other material cannot flow or fall out from the vehicle or container during transportation.'

(9) Annex VI, the text of which is set out in the Annex to this Regulation, is added.

Article 2

Entry into force

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

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









ANNEX









‘ANNEX VI

PART 1







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







Table 2 "SUI-A": Model of veterinary certificate for animals of the species listed below that are originating from and intended for an approved body, institute or centre. Order Family Genera/species Artiodactyla Suidae Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp., Potamochoerus ssp., Sus ssp. Tayassuidae Catagonus ssp., Pecari-Tayassu ssp. Hippopotamidae Hexaprotodon-Choeropsis ssp., Hippopotamus ssp.







Table 3 "TRE-A": Model of veterinary certificate for animals of the species listed below that are originating from and intended for an approved body, institute or centre. Order Family Genera/species Perissodactyla Tapiridae Tapirus ssp. Rhinocerotidae Ceratotherium ssp., Dicerorhinus ssp., Diceros ssp., Rhinoceros ssp. Proboscidea Elephantidae Elephas ssp., Loxodonta ssp.

PART 2

►(2) C1

►(2) C1

PART 3

Requirements concerning bodies, institutes or centres in third countries

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

(a) be clearly demarcated and separated from its surroundings;

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

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

(d) keep, for a minimum period of ten years, up-to-date records indicating: (i) the number and identity (age, sex, species and individual identification, where appropriate) of the animals of each species present on their premises; (ii) the number and identity (age, sex, species and individual identification where appropriate) of animals arriving in or leaving their premises, together with information on their origin or destination, the means of transport, and the health status of those animals; (iii) the results of blood tests or any other diagnostic procedures carried out on the animals on their premises; (iv) cases of disease and, where appropriate, the treatment administered; (v) the results of the post-mortem examinations on animals that have died on their premises, including still-born animals; (vi) observations made during any isolation or quarantine period;

(e) be free from the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species set out in Part 2 of Annex VI to this Regulation, for at least the previous three years, as evidenced by the records kept pursuant to point (d) and the results of the clinical and laboratory tests carried out on the animals on their premises;

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

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

(h) secure, by contract or legal instrument, the services of a veterinarian approved by and acting under the control of the competent authority, who must perform at least the following tasks: (i) ensure that appropriate disease surveillance and control measures are applied in that body, institute or centre. Such measures must be approved by the competent authority of the third country, territory or part thereof where the body, institute or centre is situated, taking into account the disease situation and must include at least the following elements: — an annual disease surveillance plan including appropriate control measures concerning zoonoses in the animals present on the premises, — clinical, laboratory and post-mortem testing of animals suspected to be affected by transmissible diseases and zoonoses, — vaccination of susceptible animals against infectious diseases and zoonoses; (ii) ensure that any suspect deaths or the presence of any other symptom suggesting that animals have contracted one or more of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species set out in Part 2 of Annex VI to this Regulation are notified without delay to the competent authority, where that particular disease is notifiable in the third country, territory or part thereof concerned; (iii) ensure that incoming animals have been quarantined as necessary, in accordance with the instructions given by the competent authority; (iv) ensure compliance with the animal health requirements which the animals must fulfil in order to be introduced into 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 structure as vector-protected must be granted only if the criteria in point (c) of Part 3 are met. In order to grant the approval, the competent authority must verify at least three times during the required protection period (at the beginning, during and at the end of the period) the effectiveness of the vector protection measures, by means of a vector trap inside the vector protected structure.

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

4. Approval must be maintained only as long as the following conditions continue to be met: the premises are under the control of an official veterinarian, who must perform at least the following tasks: (i) inspect the premises of the body, institute or centre at least once per year; (ii) audit the activity of the veterinarian referred to in point (h) of Part 3 and the implementation of the annual disease surveillance plan referred to in the first indent of point (h)(i); (iii) ensure that the provisions laid down in Parts 3 and 4 are met; (iv) verify that: — compliance with the animal health requirements which the animals 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 Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species set out in Part 2 of Annex VI to this Regulation.

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

6. Where notification is given of the suspicion of the occurrence of one of the diseases listed in Annex A to Directive 92/65/EEC or mentioned in the veterinary certificates for the relevant species laid down in Part 2 of Annex VI to this Regulation, the competent authority must suspend the approval of the body, institute or centre, until the suspicion has been officially ruled out. Depending on the disease involved and the risk of disease transmission, the suspension may relate to the the body, institute or centre as a whole or only to certain categories of animals susceptible to the disease in question. The competent authority must ensure that the measures necessary to confirm or rule out the suspicion and to avoid any spread of disease are taken.

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

8. Where the approval of a body, institute or centre has been withdrawn, it must be restored only where the following conditions are complied with: (a) the disease and the source of infection were eradicated on the premises of the body, institute or centre concerned; (b) the premises of the body, institute or centre concerned were appropriately cleaned and desinfected; (c) the body, institute or centre concerned complies with the requirements set out in points (a) to (d) and (f) to (h) of Part 3.

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