EN Official Journal of the European Union L 209/53

COMMISSION IMPLEMENTING DECISION

of 16 August 2011

concerning certain protection measures relating to classical swine fever in Lithuania

(notified under document C(2011) 5798)

(Text with EEA relevance)

(2011/508/EU)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (1), and in particular Article 9(4) thereof,

Having regard to Council Directive 90/425/EEC of 26 June 1990 concerning veterinary and zootechnical checks applicable in intra-Community trade in certain live animals and products with a view to the completion of the internal market (2), and in particular Article 10(4) thereof,

Having regard to Council Directive 2001/89/EC of 23 October 2001 on Community measures for the control of classical swine fever (3) and in particular Article 11(1)(f) thereof,

Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (4), and in particular the first subparagraph of Article 4(3) thereof,

Whereas:

(1) Outbreaks of classical swine fever have occurred in Lithuania.

(2) In view of the trade in live pigs and certain pig products, those outbreaks are liable to endanger the herds of other Members States.

(3) It is necessary to reinforce the measures taken by Lithuania in the framework of Directive 2001/89/EC.

(4) Commission Decision 2002/106/EC of 1 February 2002 approving a Diagnostic Manual establishing diagnostic procedures, sampling methods and criteria for evaluation of the laboratory tests for the confirmation of classical swine fever (5) provides for risk adapted surveillance protocols.

(5) The animal health conditions and the certification requirements for trade in live pigs are laid down in Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (6).

(6) The animal health conditions and certification requirements for trade in porcine semen are laid down in Council Directive 90/429/EEC of 26 June 1990 laying down the animal health requirements applicable to intra-Community trade in and imports of semen of domestic animals of the porcine species (7).

(7) Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (8) concerns, amongst others, trade in embryos of porcine animals.

(8) The model health certificates for trade within the Union in semen, ova and embryos of animals of the ovine and caprine species and in ova and embryos of animals of the porcine species are laid down in Commission Decision 2010/470/EU of 26 August 2010 laying down model health certificates for trade within the Union in semen, ova and embryos of animals of the equine, ovine and caprine species and in ova and embryos of animals of the porcine species (9).

(9) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (10) concerns, amongst others, the health conditions for the production and marketing of fresh meat, minced meat, mechanically separated meat, meat preparations, farmed game meat, meat products, including treated stomachs, bladders and intestines, and dairy products.

(10) Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (11) concerns, amongst others, the health marking of food of animal origin.

(11) It is necessary to complete the certificate provided for in Commission Regulation (EC) No 599/2004 of 30 March 2004 concerning the adoption of a harmonised model certificate and inspection report linked to intra-Community trade in animals and products of animal origin (12) with an official animal health attestation which should be set up in an Annex to this Decision.

(12) Article 6 of Commission Decision 2007/275/EC of 17 April 2007 concerning lists of animals and products to be subject to controls at border inspection posts under Council Directives 91/496/EEC and 97/78/EC (13) provides for a derogation from the veterinary checks for certain products containing animal products. It is appropriate to allow dispatch from areas under restrictions of such products under a simplified certification regime.

(13) Council Directive 92/118/EEC (14) lays down animal health and public health requirements governing trade in and imports into the Community of products not subject to the said requirements laid down in specific Community rules referred to in Annex A (I) to Directive 89/662/EEC and, as regards pathogens, to Directive 90/425/EEC.

(14) Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (15), provides animal health conditions for the processing of animal byproducts derived from animals in restricted areas.

(15) In so far as medicinal products defined in Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (16), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (17), and Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (18) no longer fall under the scope of Regulation (EC) No 1069/2009 they should be excluded from animal health-related restrictions set up by this Decision.

(16) Based on the information provided by Lithuania it is appropriate to establish protective measures relating to classical swine fever in Lithuania for a period sufficient to complete the necessary investigations.

(17) It is also necessary to establish the measures so as to minimise contacts to and between pig holdings in certain parts of Lithuania and to require a regional limitation of certain services related to pigs so as to prevent spread of the virus.

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

HAS ADOPTED THIS DECISION:

Article 1

Lithuania shall ensure that no pigs are dispatched to other Member States and to third countries from:

(a) the areas listed in Annex I;

(b) holdings on its territory located outside the areas listed in Annex I that have received pigs since 1 March 2011 from a holding located in the areas listed in Annex I.

Article 2

Lithuania shall ensure that:

(a) no pigs are transported from holdings within the areas listed in Part A of Annex I;

(b) the transport of slaughter pigs coming from holdings situated outside the areas listed in Part A of Annex I to slaughterhouses located within those areas and the transit of pigs through those areas is only allowed: (i) via major roads or railways; and (ii) in accordance with the detailed instructions provided for by the competent authority to prevent such pigs coming into direct or indirect contact with other pigs during transport and in the slaughterhouse;

(c) no pigs are dispatched from the areas listed in Part B of Annex I to other areas in Lithuania, except for the direct transport of: (i) slaughter pigs to a slaughterhouse for immediate slaughter, provided that the pigs originate from one single holding; (ii) breeding and production pigs to a holding, provided that the pigs have been resident for at least 30 days, or since birth if less than 30 days of age, on a single holding: — which has not received live pigs during the 30-day period immediately prior to the date of dispatch of the pigs, and — on which the clinical examinations carried out in accordance with Chapter IV(D)(2) of the Annex to Decision 2002/106/EC have been completed with negative results.

Article 3

1. By way of derogation from Article 2(a), the competent authority may authorise the transport of pigs from a holding situated within the areas listed in Part A of Annex I but outside a protection or surveillance zone:

(a) directly to a slaughterhouse situated within those areas, or in exceptional cases, to designated slaughterhouses in Lithuania located outside those areas, for immediate slaughter, provided that the pigs are dispatched from a holding on which the clinical examinations carried out in accordance with Chapter IV(D)(3) of the Annex to Decision 2002/106/EC have been completed with negative results;

(b) to a holding situated within those areas, provided that the pigs have been resident for at least 45 days, or since birth if less than 45 days of age, on a single holding of origin: (i) which has not received live pigs during the 45-day period immediately prior to the date of dispatch of the pigs; (ii) on which the clinical examinations carried out in accordance with Chapter IV(D)(2) and the second to fourth paragraph of Chapter IV(D)(4) of the Annex to Decision 2002/106/EC have been completed with negative results;

(c) to a holding situated within those areas, provided that the pigs have been resident for at least 45 days, or since birth if less than 45 days of age, on a single holding of origin: (i) which has not received live pigs during the 20-day period immediately prior to the date of dispatch of the pigs, provided that during the six-month period immediately prior to the date of dispatch of the pigs the holding of origin has not received any other pigs than gilts from one and the same single holding; (ii) on which the clinical examinations carried out in accordance with Chapter IV(D)(2) and the second to fourth paragraph of Chapter IV(D)(4) of the Annex to Decision 2002/106/EC have been completed with negative results;

(d) to a holding situated within those areas, provided that the pigs have been resident for at least 45 days, or since birth if less than 45 days of age, on a single holding of origin and that: (i) the holding of origin has not received any other pigs than gilts, which have been subjected to laboratory tests, carried out on samples taken within 10 days of the date of dispatch, with negative results for the following: — a test for the detection of antibodies, — two consecutive tests at seven days interval for the detection of the classical swine fever virus genome (RT-PCR) carried out in the national reference laboratory; (ii) the clinical examinations carried out in that holding of origin in accordance with Chapter IV(D)(2) and the second to fourth paragraph of Chapter IV(D)(4) of the Annex to Decision 2002/106/EC have been completed with negative results.

2. By way derogation from Article 2(a), the competent authority may authorise the direct transport of pigs from a holding situated within a surveillance zone to a designated holding in which no pigs are present and which is situated within the same surveillance zone, provided that:

(a) the conditions in Article 11(1)(f) and Article 11(2) of Directive 2001/89/EC are applied at the designated holding of destination;

(b) the examinations provided for in Chapter IV(D)(2) of the Annex to Decision 2002/106/EC have been completed with negative results on the holding from which the pigs are dispatched.

3. By way derogation from Article 2(a), the competent authority may authorise the direct transport of pigs from a holding situated within a surveillance zone to a designated holding in the protection zone, provided that:

(a) the designated holding of destination is situated at least 10 km from the national border with another Member State or third country and no pigs have been present on that holding for at least 21 days following the date of completion of the cleaning and disinfection in accordance with Article 12 of Directive 2001/89/EC;

(b) the designated holding of destination has undergone a third cleansing and disinfection under veterinary supervision prior to the introduction of the pigs;

(c) all the pigs arrive at the designated holding of destination within a period of 20 days;

(d) pigs in the designated holding of destination are subjected to a serological examination in accordance with Chapter IV(E) of the Annex to Decision 2002/106/EC, carried out on samples taken not earlier than 40 days following the date of the arrival of the last pigs at that holding;

(e) no pigs leave the designated holding of destination except if moved for direct slaughter in a slaughterhouse situated in the areas listed in Part A of Annex I, provided that the examinations referred to in point (d) have been completed with negative results.

4. The competent authority shall record the transports of pigs referred to in paragraphs 1 to 3 and notify the Commission thereof in the Standing Committee on the Food Chain and Animal Health.

Article 4

Lithuania shall ensure that no consignments of the following commodities are dispatched to other Member States or to third countries:

(a) porcine semen, unless the semen originates from boars kept at a collection centre referred to in Article 3(a) of Directive 90/429/EEC and situated outside the areas listed in Annex I;

(b) ova and embryos of animals of the porcine species, unless the ova and embryos originate from porcine animals kept at a holding situated outside the areas listed in Annex I.

Article 5

Lithuania shall ensure that:

1. the health certificate provided for in Annex F (Model 2) to Directive 64/432/EEC accompanying animals of the porcine species dispatched from Lithuania to other Member States includes the words: ‘Animals in accordance with Commission Implementing Decision 2011/508/EU of 16 August 2011 concerning certain protection measures relating to classical swine fever in Lithuania’;

2. the animal health certificate provided for in Annex D to Directive 90/429/EEC accompanying semen from boars dispatched from Lithuania to other Member States includes the words: ‘Semen in accordance with Commission Implementing Decision 2011/508/EU of 16 August 2011 concerning certain protection measures relating to classical swine fever in Lithuania’;

3. the health certificates provided for in Annex V to Decision 2010/470/EU accompanying ova and embryos of animals of the porcine species dispatched from Lithuania to other Member States include the words: ‘Ova/Embryos (delete as appropriate) in accordance with Commission Implementing Decision 2011/508/EU of 16 August 2011 concerning certain protection measures relating to classical swine fever in Lithuania’.

Article 6

1. By way of derogation from the fourth indent of Article 10(3)(f) of Directive 2001/89/EC, Lithuania may apply the health marking laid down in Article 5(2) of Regulation (EC) No 854/2004 and may permit that fresh meat not be submitted to a subsequent treatment in accordance with Article 4(1) of Directive 2002/99/EC, in the case of pigmeat which is obtained from pigs that comply with the following requirements:

(a) they have been slaughtered within 12 hours of arrival at the slaughterhouse;

(b) they originate from a holding: (i) situated in a surveillance zone established in accordance with Article 9(1) of Directive 2001/89/EC in the areas listed in Part A of Annex I to this Decision, and around a protection zone where: — no outbreak of classical swine fever has been detected during a period of 21 days prior to the movement of the pigs to the slaughterhouse and where at least 21 days have elapsed following the disinfection of the infected holdings, — clinical examinations for classical swine fever have been carried out in all holdings in those protection and surveillance zones following the detection of classical swine fever, with negative results; (ii) which has been authorised by the competent authority to remove pigs to a designated slaughterhouse, and: — which had no contact with an infected holding, following the epidemiological inquiry, — which has been subject to regular inspections by a veterinarian following the establishment of the surveillance zone and that inspection has included all pigs kept on the holding, — where all pigs have been submitted to clinical and laboratory examinations in accordance with paragraphs 1, 3, 4 and 5 of Chapter IV(D) of the Annex to Decision 2002/106/EC.

2. Lithuania shall ensure that the slaughterhouse referred to in paragraph 1(a):

(a) is located within the areas listed in Part A of Annex I;

(b) does not on the same day, accept pigs for slaughter, other than the pigs referred to in paragraph 1.

3. Lithuania shall ensure that the vehicles used for the transport of the pigs referred to in paragraph 1 are cleaned and disinfected twice following each transport.

Article 7

1. Lithuania shall ensure that pigmeat referred to in Article 6 is accompanied by a certificate issued in accordance with the Annex to Regulation (EC) No 599/2004 and completed by the official veterinarian with the animal health attestation as set out in Annex II to this Decision.

2. Lithuania shall ensure that the Commission and the Member States are provided with the following information concerning the pigs referred to in Article 6:

(a) before the slaughtering of the pigs, the name and location of the slaughterhouses designated to receive the pigs for slaughter;

(b) after the slaughtering of the pigs, on a weekly basis, a report which contains information on: (i) the number of the pigs slaughtered at the designated slaughterhouses; (ii) the identification system and movement controls applied in order to ensure compliance with Article 11(1)(f) of Directive 2001/89/EC.

Article 8

1. Lithuania shall not dispatch to other Member States or to third countries consignments of:

(a) products of animals of the porcine species not referred to in Articles 6 and 7 coming from the areas listed in Part A of Annex I;

(b) products obtained from animals of the porcine species originating in the areas listed in Part A of Annex I;

(c) dung and manure of animals of the porcine species from the areas listed in Part A of Annex I.

2. The prohibition set out in paragraph 1(a) and (b) shall not apply to:

(a) products derived from animals of the porcine species which: (i) have been subjected to a heat treatment: — in a hermetically sealed container with a Fo value of 3,00 or more, or — in which the centre temperature is raised to at least 70 °C; or (ii) were produced outside the areas listed in Annex I in accordance with the conditions laid down in Regulation (EC) No 1069/2009, and which since introduction into Lithuania have been stored and transported separately from animal products not eligible for dispatch in accordance with paragraph 1;

(b) blood and blood products as defined in points 2 and 4 of Annex I to Commission Regulation (EU) No 142/2011 (19) which have been subjected to at least one of the treatments provided for in point 3.1 of Section 2 of Chapter II of Annex XIV to Regulation (EU) No 142/2011, followed by an effectiveness check, or have been imported in accordance with Section 2 of Chapter II of Annex XIV to Regulation (EU) No 142/2011;

(c) lard and rendered fats which have been processed by processing method 1 (pressure sterilisation) or in accordance with one of the other processing methods referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011;

(d) petfood conforming to the requirements of points 3(a) and 3(b)(i), (ii) and (iii) of Chapter II of Annex XIII to Regulation (EU) No 142/2011;

(e) game trophies in accordance with point C.2 of Chapter VI of Annex XIII to Regulation (EU) No 142/2011;

(f) pigs bristles which have undergone factory washing or have been obtained from tanning and unprocessed pigs bristles which are securely enclosed in packaging and dry;

(g) packed animal products intended for use as in-vitro diagnostic, laboratory reagents;

(h) medicinal products as defined in Directive 2001/83/EC, medical devices manufactured utilising animal tissue which is rendered non-viable as referred to in Article 1(5)(g) of Council Directive 93/42/EEC (20), veterinary medicinal products as defined in Directive 2001/82/EC, and investigational medicinal products as defined in Directive 2001/20/EC;

(i) animal casings complying with the conditions in Part A of Chapter 2 of Annex I to Directive 92/118/EEC and which have been cleaned, scraped and then either salted, bleached or dried, followed by steps to prevent the recontamination of the casings;

(j) composite products which are not subject to further treatment containing products of animal origin, on the understanding that the treatment was not necessary for finished products, the ingredients of which comply with the respective animal health conditions laid down in this Decision.

3. Lithuania shall ensure that the animal products referred to in paragraph 2 which are dispatched to other Member States are accompanied by an official certificate which includes the following words:

‘Animal products conforming to Commission Implementing Decision 2011/508/EU of 16 August 2011 concerning certain protection measures against classical swine fever in Lithuania’.

Article 9

By way of derogation from Article 8(3), it shall be sufficient, in the case of:

(a) products referred to in paragraph 2(a) to (d) and (i) of Article 8 that compliance with the conditions for the treatment stated in the commercial document required in accordance with the respective Union legislation is endorsed in accordance with Article 10;

(b) products referred to in paragraph 2(f) of Article 8 to be accompanied by a commercial document stating that they: (i) have undergone factory washing; or (ii) have been obtained from tanning; or (iii) comply with the conditions set out in point A.1 of Chapter VII of Annex XIII to Regulation (EU) No 142/2011;

(c) products referred to in paragraph 2(g) and (h) of Article 8, to be accompanied by a commercial document stating that the products are for use as in-vitro diagnostic, laboratory reagents, medical products or medical devices, provided that the products are clearly labelled ‘for in-vitro diagnostic use only’ or ‘for laboratory use only’, as ‘medicinal products’ or as ‘medical devices’;

(d) products referred to in paragraph 2(j) of Article 8 which have been produced in an establishment operating HACCP and an auditable standard operating procedure which ensures that pre-processed ingredients comply with the respective animal health conditions laid down in this Decision, that this is stated on the commercial document accompanying the consignment, endorsed in accordance with Article 10;

(e) composite products that fulfil the conditions laid down in Article 6(1) of Decision 2007/275/EC that they are accompanied by a commercial document, which includes the following words: ‘These composite products are shelf stable at ambient temperature or have clearly undergone in their manufacture a complete cooking or heat-treatment process throughout their substance, so that any raw material is de-natured’.

Article 10

1. Where reference is made to this Article, the competent authority shall ensure that the commercial document required by Union legislation for trade between Member States is endorsed by the attachment of a copy of an official certificate stating that:

(a) the products concerned have been produced: (i) in a production process that has been audited and found in compliance with the appropriate requirements in Union animal health legislation and suitable to destroy the classical swine fever virus; or (ii) from pre-processed materials which had been certified accordingly to comply with the requirements laid down in Articles 8 and 9; and

(b) provisions are in place to avoid possible re-contamination with the classical swine fever virus after treatment.

2. The certificate referred to in paragraph 1 shall:

(a) include a reference to this Decision;

(b) be valid for 30 days;

(c) include a mention of its date of expiry;

(d) be renewable after an inspection of the establishment.

Article 11

1. The competent authority shall define risk based zones in the areas listed in Annex I.

2. The services provided by persons in direct contact to pigs or requiring entry into the housing areas for pigs shall be limited to those risk based zones and shall not be shared with other parts of the Union. The same shall apply to services requiring the use of vehicles for the transport of feed, manure or dead animals to and from pig holdings situated in the areas listed in Annex I.

3. Paragraph 2 shall not apply to services provided that the following conditions are complied with:

(a) the vehicles, equipment and any other fomites have been cleansed and disinfected;

(b) the persons, vehicles and equipment were not in direct contact with pigs or pig holdings for at least three days.

4. Lithuania shall ensure that:

(a) the following surveillance measures are carried out in the areas listed in Annex I: (i) any case of a contagious disease in pig holdings for which a treatment with antibiotic or other antibacterial drugs is indicated, shall be reported to the competent authority without delay and before treatment is commenced; (ii) in the pig holdings referred to in (a), the clinical examinations and sampling procedures laid down in Chapter IV(A) of the Annex to Decision 2002/106/EC are carried out by a veterinarian without delay;

(b) preventive disease control measures are applied as necessary, in accordance with Article 4(3)(a) of Directive 2001/89/EC;

(c) an appropriate information campaign is addressed to pig farmers.

Article 12

Lithuania shall ensure that in the areas listed in Part A of Annex I:

(a) the measures in the protection and surveillance zones continue to apply until at least 40 days have elapsed following the completion of preliminary cleaning and disinfection measures on the infected holdings;

(b) pigs on all holdings in the surveillance zones have, in addition to the examinations referred to in Article 11(3)(b) of Directive 2001/89/EC and before the measures provided for in Directive 2001/89/EC are withdrawn in the surveillance zone, undergone clinical and laboratory examinations carried out in accordance with Chapter IV(F) of the Annex to Decision 2002/106/EC; those examinations must not take place before 30 days have elapsed following the completion of preliminary cleaning and disinfection measures on the infected holdings.

Article 13

1. Member States other than Lithuania shall not send pigs to slaughterhouses in the areas listed in Part A of Annex I.

2. Member States shall ensure that:

(a) vehicles which have been used for the transport of pigs in Lithuania are cleaned and disinfected twice after each transport in that Member State and do not transport pigs for at least three days following disinfection;

(b) vehicles which have entered a holding where pigs are kept in Lithuania are cleaned and disinfected twice after leaving that holding and do not transport pigs for at least three days following disinfection;

(c) the transporters furnish proof to the competent authority of such cleaning and disinfection.

Article 14

Member States shall amend the measures they apply to trade so as to bring them into compliance with this Decision and they shall give immediate appropriate publicity to the measures adopted. They shall immediately inform the Commission thereof.

Article 15

This Decision shall apply until 31 October 2011.

Article 16

This Decision is addressed to the Member States.

Done at Brussels, 16 August 2011. For the Commission John DALLI Member of the Commission

(1) OJ L 395, 30.12.1989, p. 13.

(2) OJ L 224, 18.8.1990, p. 29.

(3) OJ L 316, 1.12.2001, p. 5.

(4) OJ L 18, 23.1.2003, p. 11.

(5) OJ L 39, 9.2.2002, p. 71.

(6) OJ 121, 29.7.1964, p. 1977/64.

(7) OJ L 224, 18.8.1990, p. 62.

(8) OJ L 268, 14.9.1992, p. 54.

(9) OJ L 228, 31.8.2010, p. 15.

(10) OJ L 139, 30.4.2004, p. 55.

(11) OJ L 139, 30.4.2004, p. 206.

(12) OJ L 94, 31.3.2004, p. 44.

(13) OJ L 116, 4.5.2007, p. 9.

(14) OJ L 62, 15.3.1993, p. 49.

(15) OJ L 300, 14.11.2009, p. 1.

(16) OJ L 311, 28.11.2001, p. 1.

(17) OJ L 311, 28.11.2001, p. 67.

(18) OJ L 121, 1.5.2001, p. 34.

(19) OJ L 54, 26.2.2011, p. 1.

(20) OJ L 169, 12.7.1993, p. 1.

ANNEX I Part A The district of Jonava, Kaišiadorys, Kaunas and Kėdainiai in Kaunas county and the districts of Ukmergė and Širvintos in Vilnius county. Part B The whole of the territory of Lithuania, except the part included in Part A.