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Council Directive 87/486/EEC of 22 September 1987 amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever Official Journal L 280 , 03/10/1987 P. 0021 - 0023 Finnish special edition: Chapter 3 Volume 24 P. 0151 Swedish special edition: Chapter 3 Volume 24 P. 0151

***** COUNCIL DIRECTIVE of 22 September 1987 amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever (87/486/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Decision 87/230/EEC of 7 April 1987 amending Directive 80/1095/EEC and Decisions 80/1096/EEC and 82/18/EEC with regard to the duration and the financial means of measures for the eradication of classical swine fever (1), and in particular Article 2 thereof, Having regard to the proposal from the Commission (2), Having regard to the opinion of the European Parliament (3), Having regard to the opinion of the Economic and Social Committee (4), Whereas, pursuant to Article 2 of Decision 87/230/EEC, the Council is to decide in particular on the necessary measures which must be implemented by the Member States in order to achieve the eradication of classical swine fever in the Community; whereas such measures are likely to have repercussions on the entire set of Community regulations adopted to date with regard to animal health policy problems in the trade of animals and meat; whereas in order to guarantee the effectiveness of these measures, the provisions of these regulations should be amended as appropriate; Whereas Directive 80/217/EEC (5), as last amended by Regulation (EEC) No 3768/85 (6), laid down the measures to be applied in the event of an outbreak of swine fever and more particularly the arrangements for emergency preventive vaccination where recourse to such vaccination is decided on; Whereas pigs vaccinated in such an event and the meat obtained therefrom threaten to give rise to the propagation of the disease in areas where such vaccination is not carried out, with consequent reduced productivity in pig herds and a fall in the income of those working in this sector; whereas restrictive national measures should therefore be applied in this respect, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 80/217/EEC is hereby amended as follows: 1. In Article 9 (2) (a), the first indent is replaced by the following: '- the movement and transport of pigs on public or private roads shall be prohibited other than for transport in transit through the zone by rail or motorway, and, where the need is duly established, by other major roads,'. 2. Article 14 is replaced by the following: 'Article 14 1. Member States shall ensure that: - the use of specific immune-serum or sero-vaccination is prohibited, - the manufacture, sale for any purpose, distribution and use of swine fever vaccine are placed under official control. 2. Member States which practise vaccination in the context of a plan for the eradication of the disease approved by the Commission, pursuant to Directive 80/1095/EEC, shall ensure that the following requirements are observed: (a) vaccines must have been produced under official control and conform to the provisions of the European Pharmacopoeia; (b) requirements relating to swine fever vaccine and the means of distribution, sale in any form, storage and use must be established in accordance with the procedure laid down in Article 16; (c) swine fever vaccines imported from third countries must be subject to the same conditions as those laid down in subparagraphs (a) and (b). The first subparagraph shall also apply where vaccination is decided on as a matter of urgency in accordance with paragraphs 4 to 6. 3. Where swine fever is detected on one or more holdings or in one or more production units, and without prejudice to national provisions, where the latter provide for preventive vaccination of pigs against swine fever either on part or all of the territory, the measures to control the disease may be supplemented by the prompt vaccination under official control of pigs in other holdings or production units threatened with contamination in a territorial vaccination area or a production branch demarcated, in each case, by the competent authority. The vaccinated pigs shall be permanently marked in accordance with the instructions issued by the competent authority. 4. Where the competent authority decides on systematic vaccination in a specific region of all the pigs in that region, the following measures shall be applied for a period ending six months after completion of the first vaccination; they may be extended by the competent authority: (a) all pigs kept inside the vaccination area shall be vaccinated as soon as possible; throughout these vaccination operations, all pigs kept on holdings inside the vaccination area must remain there; (b) without prejudice to subparagraph (a), vaccinated pigs may not leave a holding until seven days efter vaccination in the case of pigs for breeding and production and then only if they are transferred to a holding situated in an area where vaccination has been carried out, under official control, or, in the case of pigs for immediate slaughter to one or more slaughterhouses situated within the protection zone or, failing that, to a slaughterhouse which is close to that zone and which has been designated by the competent authority; (c) all pigs born on or transferred to a holding inside the vaccination area must be vaccinated in accordance with the procedure laid down by the competent authority; (d) after their transfer to a holding, vaccinated pigs for production may not leave that holding except to be transported for immediate slaughter to one or more slaughterhouses situated within the protection zone or, failing that, to a slaughterhouse which is close to that zone and which has been designated by the competent authority. 5. By way of derogation from paragraph 4, the competent authorities may, however, exempt herds of pigs of very great genetic value from systematic vaccination provided that all necessary steps are taken to ensure protection of their health and to subject them to periodic serological checks. 6. Where a Member State decides on vaccination of pigs for production in a specific region, the following measures shall be applied for a period of six months following completion of the first vaccination; they may be extended by the competent authority: (a) vaccination must be carried out as soon as possible; (b) by way of derogation from paragraph 4 (a), pigs for production fattened on the holding where they were born may be exempted from vaccination. Such pigs may not leave that holding except to be slaughtered at one or more slaughterhouses situated within the vaccination area or, failing that, at the nearest slaughterhouse designated by the competent authority; (c) piglets may not be vaccinated until they are old enough for effective immunity to develop; (d) vaccinated pigs for production may not leave a holding until seven days after vaccination and then only if they are transferred to a holding situated inside a vaccination area; (e) pigs for production transferred to a holding inside the vaccination area must be vaccinated in accordance with the procedure laid down by the competent authority; (f) after their arrival in the receiving holding, the pigs referred to in points (c), (d) and (e) may not leave that holding except to be transported for immediate slaughter to one or more slaughterhouses situated within the vaccination area or, failing that, to the nearest slaughterhouse designated by the competent authority; (g) where non-vaccinated pigs for breeding coming from holdings inside the vaccination area are moved to holdings outside the vaccination area, no pigs shall be allowed to leave the latter holdings, except for immediate slaughter, for 30 days following the arrival of the pigs from the vaccination area; in the case of gestating sows, the 30-day period shall commence on farrowing. 7. Moreover, Member States which practise emergency vaccination pursuant to paragraphs 4 to 6 shall ensure that there is a prohibition on: - live pigs leaving a vaccination area except to be transported to another vaccination area in the same Member State or for immediate slaughter in a slaughterhouse designated by the competent authority and situated close to the vaccination area; in the latter case, the meat obtained shall be stamped in accordance with the second indent, - fresh pigmeat intended for another Member State; such meat shall bear either the national stamp or the stamp provided for in Article 5a of Directive 72/461/EEC. This prohibition shall apply during vaccination operations and for a minimum period of: - three months following completion of these operations in the affected area, or - three months after the last outbreak of the disease has been recorded in the affected area, in the event of the disease appearing in that area within three months of the end of vaccination operations. The prohibition referred to in the first indent of the first subparagraph shall not, however, apply to live pigs from holdings covered by the derogation in paragraph 5. In accordance with the procedure provided for in Article 16a, the provisions of this paragraph may, following a critical analysis of the epidemiological data and on the basis of well-founded conclusions, be extended to an area or part of an area in which vaccination is carried out under a plan approved by the Commission pursuant to Directive 80/1095/EEC, where there are several outbreaks of classical swine fever in that area.' 3. In Article 14a: - in paragraph 2, second line, 'Article 14 (3) and (4)' is replaced by 'Article 14 (4) and (5)', - in paragraph 3, fifth line, 'Article 14 (3) and (4)' is replaced by 'Article 14 (4) and (5)'. Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1987. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Brussels, 22 September 1987. For the Council The President L. TOERNAES (1) OJ No L 99, 11. 4. 1987, p. 16. (2) OJ No C 295, 21. 11. 1986, p. 5. (3) OJ No C 76 23. 3. 1987, p. 169. (4) OJ No C 83, 30. 3. 1987, p. 3. (5) OJ No L 47, 21. 2. 1980, p. 11. (6) OJ No L 362, 31. 12. 1985, p. 8.

*****

COUNCIL DIRECTIVE

of 22 September 1987

amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever

(87/486/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community,

Having regard to Council Decision 87/230/EEC of 7 April 1987 amending Directive 80/1095/EEC and Decisions 80/1096/EEC and 82/18/EEC with regard to the duration and the financial means of measures for the eradication of classical swine fever (1), and in particular Article 2 thereof,

Having regard to the proposal from the Commission (2),

Having regard to the opinion of the European Parliament (3),

Having regard to the opinion of the Economic and Social Committee (4),

Whereas, pursuant to Article 2 of Decision 87/230/EEC, the Council is to decide in particular on the necessary measures which must be implemented by the Member States in order to achieve the eradication of classical swine fever in the Community; whereas such measures are likely to have repercussions on the entire set of Community regulations adopted to date with regard to animal health policy problems in the trade of animals and meat; whereas in order to guarantee the effectiveness of these measures, the provisions of these regulations should be amended as appropriate;

Whereas Directive 80/217/EEC (5), as last amended by Regulation (EEC) No 3768/85 (6), laid down the measures to be applied in the event of an outbreak of swine fever and more particularly the arrangements for emergency preventive vaccination where recourse to such vaccination is decided on;

Whereas pigs vaccinated in such an event and the meat obtained therefrom threaten to give rise to the propagation of the disease in areas where such vaccination is not carried out, with consequent reduced productivity in pig herds and a fall in the income of those working in this sector; whereas restrictive national measures should therefore be applied in this respect,

HAS ADOPTED THIS DIRECTIVE:

Directive 80/217/EEC is hereby amended as follows:

1. In Article 9 (2) (a), the first indent is replaced by the following:

'- the movement and transport of pigs on public or private roads shall be prohibited other than for transport in transit through the zone by rail or motorway, and, where the need is duly established, by other major roads,'.

2. Article 14 is replaced by the following:

'Article 14

1. Member States shall ensure that:

- the use of specific immune-serum or sero-vaccination is prohibited,

- the manufacture, sale for any purpose, distribution and use of swine fever vaccine are placed under official control.

2. Member States which practise vaccination in the context of a plan for the eradication of the disease approved by the Commission, pursuant to Directive 80/1095/EEC, shall ensure that the following requirements are observed:

(a) vaccines must have been produced under official control and conform to the provisions of the European Pharmacopoeia;

(b) requirements relating to swine fever vaccine and the means of distribution, sale in any form, storage and use must be established in accordance with the procedure laid down in Article 16;

(c) swine fever vaccines imported from third countries must be subject to the same conditions as those laid down in subparagraphs (a) and (b).

The first subparagraph shall also apply where vaccination is decided on as a matter of urgency in accordance with paragraphs 4 to 6.

3. Where swine fever is detected on one or more holdings or in one or more production units, and without prejudice to national provisions, where the latter provide for preventive vaccination of pigs against swine fever either on part or all of the territory, the measures to control the disease may be supplemented by the prompt vaccination under official control of pigs in other holdings or production units threatened with contamination in a territorial vaccination area or a production branch demarcated, in each case, by the competent authority. The vaccinated pigs shall be permanently marked in accordance with the instructions issued by the competent authority.

4. Where the competent authority decides on systematic vaccination in a specific region of all the pigs in that region, the following measures shall be applied for a period ending six months after completion of the first vaccination; they may be extended by the competent authority:

(a) all pigs kept inside the vaccination area shall be vaccinated as soon as possible; throughout these vaccination operations, all pigs kept on holdings inside the vaccination area must remain there;

(b) without prejudice to subparagraph (a), vaccinated pigs may not leave a holding until seven days efter vaccination in the case of pigs for breeding and production and then only if they are transferred to a holding situated in an area where vaccination has been carried out, under official control, or, in the case of pigs for immediate slaughter to one or more slaughterhouses situated within the protection zone or, failing that, to a slaughterhouse which is close to that zone and which has been designated by the competent authority;

(c) all pigs born on or transferred to a holding inside the vaccination area must be vaccinated in accordance with the procedure laid down by the competent authority;

(d) after their transfer to a holding, vaccinated pigs for production may not leave that holding except to be transported for immediate slaughter to one or more slaughterhouses situated within the protection zone or, failing that, to a slaughterhouse which is close to that zone and which has been designated by the competent authority.

5. By way of derogation from paragraph 4, the competent authorities may, however, exempt herds of pigs of very great genetic value from systematic vaccination provided that all necessary steps are taken to ensure protection of their health and to subject them to periodic serological checks.

6. Where a Member State decides on vaccination of pigs for production in a specific region, the following measures shall be applied for a period of six months following completion of the first vaccination; they may be extended by the competent authority:

(a) vaccination must be carried out as soon as possible;

(b) by way of derogation from paragraph 4 (a), pigs for production fattened on the holding where they were born may be exempted from vaccination. Such pigs may not leave that holding except to be slaughtered at one or more slaughterhouses situated within the vaccination area or, failing that, at the nearest slaughterhouse designated by the competent authority;

(c) piglets may not be vaccinated until they are old enough for effective immunity to develop;

(d) vaccinated pigs for production may not leave a holding until seven days after vaccination and then only if they are transferred to a holding situated inside a vaccination area;

(e) pigs for production transferred to a holding inside the vaccination area must be vaccinated in accordance with the procedure laid down by the competent authority;

(f) after their arrival in the receiving holding, the pigs referred to in points (c), (d) and (e) may not leave that holding except to be transported for immediate slaughter to one or more slaughterhouses situated within the vaccination area or, failing that, to the nearest slaughterhouse designated by the competent authority;

(g) where non-vaccinated pigs for breeding coming from holdings inside the vaccination area are moved to holdings outside the vaccination area, no pigs shall be allowed to leave the latter holdings, except for immediate slaughter, for 30 days following the arrival of the pigs from the vaccination area; in the case of gestating sows, the 30-day period shall commence on farrowing. 7. Moreover, Member States which practise emergency vaccination pursuant to paragraphs 4 to 6 shall ensure that there is a prohibition on:

- live pigs leaving a vaccination area except to be transported to another vaccination area in the same Member State or for immediate slaughter in a slaughterhouse designated by the competent authority and situated close to the vaccination area; in the latter case, the meat obtained shall be stamped in accordance with the second indent,

- fresh pigmeat intended for another Member State; such meat shall bear either the national stamp or the stamp provided for in Article 5a of Directive 72/461/EEC.

This prohibition shall apply during vaccination operations and for a minimum period of:

- three months following completion of these operations in the affected area, or

- three months after the last outbreak of the disease has been recorded in the affected area, in the event of the disease appearing in that area within three months of the end of vaccination operations.

The prohibition referred to in the first indent of the first subparagraph shall not, however, apply to live pigs from holdings covered by the derogation in paragraph 5.

In accordance with the procedure provided for in Article 16a, the provisions of this paragraph may, following a critical analysis of the epidemiological data and on the basis of well-founded conclusions, be extended to an area or part of an area in which vaccination is carried out under a plan approved by the Commission pursuant to Directive 80/1095/EEC, where there are several outbreaks of classical swine fever in that area.'

3. In Article 14a:

- in paragraph 2, second line, 'Article 14 (3) and (4)' is replaced by 'Article 14 (4) and (5)',

- in paragraph 3, fifth line, 'Article 14 (3) and (4)' is replaced by 'Article 14 (4) and (5)'.

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1987. They shall forthwith inform the Commission thereof.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 22 September 1987.

For the Council

The President

L. TOERNAES

(1) OJ No L 99, 11. 4. 1987, p. 16.

(2) OJ No C 295, 21. 11. 1986, p. 5.

(3) OJ No C 76 23. 3. 1987, p. 169.

(4) OJ No C 83, 30. 3. 1987, p. 3.

(5) OJ No L 47, 21. 2. 1980, p. 11.

(6) OJ No L 362, 31. 12. 1985, p. 8.