# L_2014203EN.01009101.xml

| 11.7.2014 | EN | Official Journal of the European Union | L 203/91 |
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11.7.2014

EN

Official Journal of the European Union

L 203/91

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COMMISSION IMPLEMENTING REGULATION (EU) No 750/2014

of 10 July 2014

on protection measures in relation to porcine epidemic diarrhoea as regards the animal health requirements for the introduction into the Union of porcine animals

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (1), and in particular Article 18(1) and (7) thereof,

Whereas:

| (1) | Directive 91/496/EEC provides, inter alia, that if a disease or any other phenomenon liable to present a serious threat to animal or human health occurs or spreads in the territory of a third country, or if any other serious animal health reason so warrants, the Commission, acting on its own initiative or at the request of a Member State, is permitted to adopt measures without delay, including special conditions in respect of animals coming from all or part of the third country concerned. |
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(1)

Directive 91/496/EEC provides, inter alia, that if a disease or any other phenomenon liable to present a serious threat to animal or human health occurs or spreads in the territory of a third country, or if any other serious animal health reason so warrants, the Commission, acting on its own initiative or at the request of a Member State, is permitted to adopt measures without delay, including special conditions in respect of animals coming from all or part of the third country concerned.

| (2) | Commission Regulation (EU) No 206/2010 (2) lays down, inter alia, the veterinary certification requirements for the introduction into the Union of certain consignments of live animals. It provides that consignments of ungulates are to be introduced into the Union only if they comply with certain requirements and they are accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model set out in Part 2 of Annex I to that Regulation. |
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(2)

Commission Regulation (EU) No 206/2010 (2) lays down, inter alia, the veterinary certification requirements for the introduction into the Union of certain consignments of live animals. It provides that consignments of ungulates are to be introduced into the Union only if they comply with certain requirements and they are accompanied by the appropriate veterinary certificate, drawn up in accordance with the relevant model set out in Part 2 of Annex I to that Regulation.

| (3) | The animal health requirements set out in the model veterinary certificates provide for guarantees regarding animal diseases which may endanger the Union animal health status. The fulfilment of such requirements is therefore essential in order to protect the Union from outbreaks of exotic diseases. |
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(3)

The animal health requirements set out in the model veterinary certificates provide for guarantees regarding animal diseases which may endanger the Union animal health status. The fulfilment of such requirements is therefore essential in order to protect the Union from outbreaks of exotic diseases.

| (4) | A notification by the United States to the World Organization for Animal Health (OIE) (3) shows that Novel Swine Enteric Coronavirus Disease caused by emerging porcine alphacoronaviruses including porcine epidemic diarrhoea virus and a new Porcine deltacoronavirus has emerged in North America. Canada informed the Commission about positive results of tests for the presence of the both the alpha and the deltacoronavirus carried out in Canadian pig holdings. |
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(4)

A notification by the United States to the World Organization for Animal Health (OIE) (3) shows that Novel Swine Enteric Coronavirus Disease caused by emerging porcine alphacoronaviruses including porcine epidemic diarrhoea virus and a new Porcine deltacoronavirus has emerged in North America. Canada informed the Commission about positive results of tests for the presence of the both the alpha and the deltacoronavirus carried out in Canadian pig holdings.

| (5) | Porcine epidemic diarrhoea caused by the emerging alphacoronavirus and the new porcine deltacoronavirus may constitute a risk for the animal health status of the Union. It affects pigs and the clinical disease is more evident in piglets in which it has caused high percentages of mortalities. |
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(5)

Porcine epidemic diarrhoea caused by the emerging alphacoronavirus and the new porcine deltacoronavirus may constitute a risk for the animal health status of the Union. It affects pigs and the clinical disease is more evident in piglets in which it has caused high percentages of mortalities.

| (6) | Therefore it is necessary to review the animal health requirements for the entry of consignments of porcine animals into the Union from the areas in which the disease caused by these viruses is present in order to provide the necessary guarantees at the holding of origin and avoid the introduction of porcine epidemic diarrhoea caused by those viruses in the Union. |
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(6)

Therefore it is necessary to review the animal health requirements for the entry of consignments of porcine animals into the Union from the areas in which the disease caused by these viruses is present in order to provide the necessary guarantees at the holding of origin and avoid the introduction of porcine epidemic diarrhoea caused by those viruses in the Union.

| (7) | Due to the need to protect animal health in the Union and the serious threat posed by the introduction into the Union of live pigs for breeding and/or production the Commission should adopt provisional safeguard measures for consignments of those animals from affected third countries listed in Annex I to this Regulation. Accordingly, consignments of those animals should be accompanied by a health certificate in accordance with the model set out in Annex II to this Regulation which provides for specific guarantees in regard of porcine epidemic diarrhoea caused by the emerging alphacoronavirus and the new porcine deltacoronavirus |
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(7)

Due to the need to protect animal health in the Union and the serious threat posed by the introduction into the Union of live pigs for breeding and/or production the Commission should adopt provisional safeguard measures for consignments of those animals from affected third countries listed in Annex I to this Regulation. Accordingly, consignments of those animals should be accompanied by a health certificate in accordance with the model set out in Annex II to this Regulation which provides for specific guarantees in regard of porcine epidemic diarrhoea caused by the emerging alphacoronavirus and the new porcine deltacoronavirus

| (8) | Due to the serious risk to animal health posed by those consignments, those provisional safeguard measures should enter into force on the day following that of the publication of this Regulation and apply for a period of 6 months. |
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(8)

Due to the serious risk to animal health posed by those consignments, those provisional safeguard measures should enter into force on the day following that of the publication of this Regulation and apply for a period of 6 months.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

By way of derogation from point (b) of Article 3 and Parts 1and 2 of Annex I to Regulation (EU) No 206/2010, consignments of live pigs for breeding and production, covered by the model veterinary certificate ‘POR-X’ set out in that Annex, from third countries listed in Annex I to this Regulation, shall be accompanied by a veterinary certificate in accordance with the model set out in the Annex II to this Regulation.

Article 2

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

It shall apply until 12 January 2015.

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

Done at Brussels, 10 July 2014.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 268, 24.9.1991, p. 56.

1

(2)  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 (OJ L 73, 20.3.2010, p. 1).

2

(3)  http://www.oie.int/wahis_2/public/wahid.php/Reviewreport/Review?page_refer=MapFullEventReport&reportid=15133

3

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ANNEX I

CA — Canada

US — United States

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ANNEX II

Model POR-X -PED

Image 1

COUNTRY

Veterinary certificate to EU

Part I: Details of dispatched consignment

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name Approval number

Address

I.12.

I.13. Place of loading

Address Approval number

I.14. Date of departure

I.15. Means of transport

Aeroplane Ship Railway wagon

Road vehicle Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17.

I.18. Description of commodity

I.19. Commodity code (HS code)

01.03

I.20. Quantity

I.21.

I.22. Number of packages

I.23. Identification of container/seal number

I.24.

I.25. Commodities certified for:

Breeding

I.26.

I.27. For import or admission into EU

I.28. Identification of the commodities

Species Identification system Identification number Age Sex

(scientific name)

Image 2

COUNTRY

Model POR-X

II. Health information

II.a. Certificate reference number

II.b.

II.1. Public Health Attestation

I, the undersigned official veterinarian, hereby certify, that the animals described in this certificate:

II.1.1. come from holdings which have been free from any official prohibition on health grounds, for the last 42 days in the case of brucellosis, for the last 30 days in the case of anthrax and for the past 6 months in the case of rabies and, the animals have not been in contact with animals from holdings which did not satisfy these conditions;

II.1.2. have not received:

— any stilbene or thyrostatic substances,

— oestrogenic, androgenic, gestagenic or β-agonist substances for purposes other than therapeutic or zootechnic treatment (as defined in Council Directive 96/22/EC (OJ L 125, 23.5.1996, p. 3)).

II.2. Animal Health attestation

I, the undersigned official veterinarian, hereby certify, that the animals described above meet the following requirements:

II.2.1. they come from the territory with code: (1) which, at the date of issuing this certificate:

(2) either [(a) has been free for 24 months from foot-and-mouth disease, for 12 months from rinderpest, African swine fever, classical swine fever, swine vesicular disease and vesicular exanthema, and]

(2) or [(a) (i) has been free [for 24 months from foot-and-mouth disease] (2), for 12 months from rinderpest, African swine fever, vesicular exanthema, [classical swine fever] (2) and [swine vesicular disease] (2), and

(ii) has been considered free from [foot-and-mouth disease] (2), [classical swine fever] (2) and [swine vesicular disease] (2), since (dd/mm/yyyy), without having had cases/outbreaks from that date, and authorised to export these animals by Commission Regulation (EU) No/, of (dd/mm/yyyy), and]

(2) either [(b) for 6 months from vesicular stomatitis, and]

(2) (9) or [(b) the animals have been kept for the 21 days, or since birth if younger than 21 days of age, prior to entering the pre-export quarantine in a holding in which no case of vesicular stomatitis was officially reported during that period and during the pre-export quarantine of not less than 30 days prior to shipment in a quarantine station protected from vector insects where they were subjected with negative results at a serum dilution of 1 in 32 to a virus neutralisation test for vesicular stomatitis carried out as referred to in Part 6 of Annex I to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010, p. 1) on samples taken at least 21 days after commencement of the quarantine; and]

(c) they have been kept for the 40 days before dispatch in a holding in which no case of porcine epidemic diarrhoea was confirmed or suspected and they were subjected to an agent identification test (PCR) to detect Porcine Epidemic Diarrhoea virus and Porcine Deltacoronavirus on faecal samples taken within 7 days prior to dispatch, with negative results and they have not been vaccinated against those viruses, and

(d) where during the last 12 months, no vaccination against the diseases listed in point (a) has been carried out and imports of domestic cloven-hoofed animals vaccinated against these diseases are not permitted;

II.2.2. they have remained in the territory described under point II.2.1 since birth, or for at least the last 6 months before dispatch to the Union and without contact with imported cloven-hoofed animals for the last 30 days;

II.2.3. they have remained in the holding(s) described under box reference I.11 since birth, or for at least 40 days prior to dispatch, and, during this period, in the holding(s) and in an area with a 10 km radius around the holding(s) of origin, there has been no case/outbreak of the diseases referred to in point II.2.1;

Part II: Certification

Image 3

COUNTRY

Model POR-X

II. Health information

II.a. Certificate reference number

II.b.

II.2.4. A they are not animals to be killed under a national programme for the eradication of diseases, nor have they been vaccinated against the diseases referred to in point II.2.1;

(2) (3) [II.2.4. B they have been subjected within the past 30 days to a test for swine vesicular disease antibodies and a test for classical swine fever antibodies with negative results in both cases;]

(2) (4) [II.2.4. C they have been subjected within the past 30 days to a buffered Brucella antigen test for porcine brucellosis with negative results;]

II.2.5. they come from herds which are not restricted under the national brucellosis eradication programme;

II.2.6. they are/were (2) dispatched from their holding(s) of origin, without passing through any market,

(2) either [directly to the Union,]

(2) or [to the officially authorised assembly centre described under box reference I.13 situated within the territory described under point II.2.1,]

and, until dispatched to the Union:

(a) they did not come in contact with other cloven-hoofed animals not complying with the health requirements as described in this certificate, and

(b) they were not at any place where, or around which within a 10 km radius, during the previous 40 days there has been a case/outbreak of any of the diseases referred to in point II.2.1, and

(c) in the case the country has not been free for 6 months of vesicular stomatitis, they were transported to the place of loading protected from vector insects;

II.2.7. any transport vehicles or containers in which they were loaded were cleaned and disinfected before loading with an officially authorised disinfectant;

II.2.8. they were examined by an official veterinarian within 24 hours of loading and showed no clinical sign of disease;

II.2.9. they have been loaded for dispatch to the Union on (dd/mm/yyyy) (5) in the means of transport described under box reference I.15 that were cleaned and disinfected before loading with an officially authorised disinfectant and so constructed that faeces, urine, litter or fodder could not flow or fall out of the vehicle or container during transportation.

II.3. Animal transport attestation

I, the undersigned official veterinarian, hereby certify, that the animals described above have been treated before and at the time of loading in accordance with the relevant provisions of Council Regulation (EC) No 1/2005 (OJ L 3, 5.1.2005, p. 1), in particular as regards watering and feeding, and they are fit for the intended transport.

(2) (6) [II.4. Specific requirements

II.4.1. Aujeszky’s disease is notifiable in the country referred to in box reference I.7;

II.4.2. according to official information, no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded for the last 12 months in the holding(s) of origin referred to in box reference I.11, and in those holdings situated in its vicinity within 5 km;

II.4.3. the animals referred to in box reference I.28:

(a) prior to dispatch for exportation, have remained since birth in the holding(s) of origin referred to in box reference I.11 or they have remained in this(ese) holdings(s) for the last 3 months and in others of equivalent status since birth,

(b) have been isolated in accommodation approved by the competent authority for the last 30 days immediately prior to dispatch for export, without direct or indirect contact with other suidae animals,

Image 4

COUNTRY

Model POR-X

II. Health information

II.a. Certificate reference number

II.b.

(c) have been subjected to an ELISA test for the presence of Ig (7) on sera taken at least 21 days after entry into isolation, with negative results; and, all animals in isolation have also given negative results to this test, and

(d) have not been vaccinated against Aujeszky’s disease and have not been in contact with vaccinated animals and the herd of origin has not been vaccinated during the previous 12 months.]

(2) (8) [II.4.4 (further requirements and/or tests)

]

Notes

This certificate is meant for live domestic porcine animals (Sus scrofa) intended for breeding or production.

After importation the animals must be conveyed without delay to the holding of destination where they shall remain for a minimum period of 30 days before further movement outside the holding, except in the case of animals dispatched directly to a slaughterhouse or of animals transiting the Union from one third country to another third country.

Part I:

— Box reference I.8: Provide the code of territory as appearing in Part 1 of Annex I to Regulation (EU) No 206/2010.

— Box reference I.13: The assembly centre, if any, must fulfil the conditions for its approval, as laid down in Part 5 of Annex I to Regulation (EU) No 206/2010.

— Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided. In case of unloading and reloading, the consignor must inform the BIP of entry into the Union.

— Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) should be included.

— Box reference I.28: Identification system: the animals must bear:

An individual number which permits tracing of their premises of origin. Specify the identification system (such as tag, tattoos, brand, chip, transponder).

An ear tag that includes the ISO code of the exporting country. The individual number must permit tracing of their premises of origin.

— Box reference I.28: Age: months.

— Box reference I.28: Sex (M = male, F = female, C = castrated).

Part II:

(1) Code of the territory as it appears in Part 1 of Annex I to Regulation (EU) No 206/2010.

(2) Keep as appropriate.

(3) Supplementary guarantees to be provided when required in column 5 ‘SG’ of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry ‘B’.

(4) Supplementary guarantees to be provided when required in column 5 ‘SG’ of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry ‘C’.

(5) Date of loading. Imports of these animals shall not be allowed when the animals were loaded either prior to the date of authorisation for exportation to the Union of the third country, territory or part thereof referred to in boxes I.7 and I.8, or during a period where restrictive measures have been adopted by the Union against imports of these animals from this third country, territory or part thereof.

(6) When required by the EU Member State of destination or Switzerland, in accordance with Commission Decision 2008/185/EC (OJ L 59, 4.3.2008, p. 19) and the Agreement between the Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132) except for those countries with ‘IX’ in column 6 ‘Specific conditions’ of Part 1 of Annex I to Regulation (EU) No 206/2010.

(7) To be carried out according to the standards laid down in Annex III to Decision 2008/185/EC. In the case of pigs aged over 4 months, the test used shall be the whole virus ELISA.

(8) Further requirements requested by Finland in respect of transmissible gastro-enteritis.

(9) Supplementary guarantees to be provided when required in column 5 ‘SG’ of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry ‘D’.

Image 5

COUNTRY

Model POR-X

II. Health information

II.a. Certificate reference number

II.b.

Official veterinarian

Name (in capital letters): Qualification and title:

Date: Signature:

Stamp:

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