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Council Directive 84/645/EEC of 11 December 1984 amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever Official Journal L 339 , 27/12/1984 P. 0033 - 0035 Spanish special edition: Chapter 03 Volume 33 P. 0056 Portuguese special edition Chapter 03 Volume 33 P. 0056 Finnish special edition: Chapter 3 Volume 18 P. 0089 Swedish special edition: Chapter 3 Volume 18 P. 0089

COUNCIL DIRECTIVE of 11 December 1984 amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever (84/645/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof, Having regard to the proposal from the Commission (1), Having regard to the opinion of the European Parliament (2), Having regard to the opinion of the Economic and Social Committee (3), Whereas Directive 80/217/EEC (4), as last amended by Directive 81/476/EEC (5), introduced Community measures to be applied in the event of suspected or confirmed cases of classical swine fever; Whereas, in view of the way in which the disease has developed, the measures implemented should be stepped up; Whereas the conditions for carrying out the protective vaccination of herds threatened with contamination and the conditions for controlling the movement of livestock should be specified; Whereas, in the event of the disease assuming serious epizootic proportions, it must be possible to make regional measures, in particular preventive vaccination, compulsory ; whereas, to this end, provision should be made for a rapid procedure for initiating close cooperation between the Member States and the Commission; Whereas, in order to increase the effectiveness of Community recommendations regarding the intensification of measures to combat swine fever, it seems necessary to provide for the suspension of Community financial aid by way of derogation from Decision 80/1096/EEC (6), HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 80/217/EEC is hereby amended as follows: 1. In the seventh indent of Article 5 (1), "15 days" is replaced by "30 days". 2. Article 9 is amended as follows: (i) in paragraph 1, "2 kilometres" is replaced by "3 kilometres"; (ii) the second indent of paragraph 2 (a) is replaced by the following: "- the pigs may not be removed from the holding on which they are kept during the first 15 days. Between the 15th day and the 30th day the pigs may not be removed from the said holding except to be transported under official supervision directly to a slaughterhouse for the purpose of immediate slaughter. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all pigs on the holding and confirmed that none of the pigs is suspected of being infected with swine fever,"; (iii) in paragraph 2 (b), "15 days" is replaced by "30 days". 3. Article 14 is replaced by the following: "Article 14 1. Member States shall ensure that in general the following measures are applied: - 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, - requirements relating to swine fever vaccine established in accordance with the procedure laid down in Article 16 are observed, - swine fever vaccines imported from third countries are authorized and checked by the (1) OJ No C 19, 26.1.1984, p. 6. (2) OJ No C 127, 14.5.1984, p. 186. (3) OJ No C 206, 6.8.1984, p. 44. (4) OJ No L 47, 21.2.1980, p. 11. (5) OJ No L 186, 8.7.1981, p. 20. (6) OJ No L 325, 1.12.1980, p. 5. competent authority in the importing Member State and are subject to the same conditions in respect of sale, distribution and use as apply to vaccine produced in the Member States. 2. 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. 3. Where the competent authority decides on vaccination in a specific region, such vaccination shall be carried out systematically on all the pigs in the vaccination area. In this case, the following measures shall be applied within a period of six months of the completion of the vaccination operations, which period may be extended for a further six month: (i) all pigs kept on holdings inside the vaccination area shall be vaccinated as soon as possible; (ii) all pigs kept on holdings inside the vaccination area must remain there throughout the vaccination operations stipulated in point (i); (iii) any pigs born on or transferred to a holding inside the vaccination area shall have been vaccinated. However, in the herds referred to in paragraph 4, piglets born after six months may be exempted from the vaccination operations; (iv) in order to be allowed to leave the vaccination area, live vaccinated pigs must be intended for immediate slaughter and have been vaccinated at least 15 days beforehand. However, three months after completion of the vaccination operations referred to in (i), the competent authority may authorize the departure of vaccinated pigs intended for fattening, provided they are transferred under official control and the receiving holding contains only pigs for fattening and is kept under official surveillance until the vaccinated pigs are slaughtered. 4. By way of derogation from paragraph 3, 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. 5. However, by way of derogation from paragraphs 3 and 4 a Member State may authorize vaccination to be confined to pigs for fattening in the vaccination area, subject to the condition that vaccinated pigs may not leave the holding on which they are kept except to be taken to a slaughter house for slaughter. In such a case, the following measures shall be applied for a period of six months, which period may be extended for a further six months: (i) vaccination must be carried out as soon as possible; (ii) during the vaccination operations and for 15 days following completion of these operations, live pigs for fattening must remain in the vaccination area; (iii) all pigs for fattening brought to holdings in the vaccination area shall be vaccinated; (iv) piglets coming from herds in which vaccination has taken place may only be transferred to holdings situated within the vaccination area for fattening; (v) where live pigs for breeding or for fattening coming from non-vaccinated herds are moved to holdings situated 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." 4. The following Article is inserted: "Article 14a 1. Where, in a given region, an epizootic of swine fever is exceptionally serious and is tending to spread, the Member State concerned shall declare a demarcated territorial area including at least all the protection zones in that area "a high health-risk area" in accordance with Article 9 (1). 2. Where the Member State in question does not intend to have recourse to Article 14 (3) and (4) it shall apply the measures provided for in Article 9 in the "high health-risk area" and stipulate the following in particular: (a) no live pig may leave the "high health-risk" area; (b) live pigs leaving a holding situated in the protection zone shall do so in accordance with the conditions laid down in Article 9 (2) (a), second indent, while live pigs from a holding situated in the remainder of the "high health-risk area" may be introduced into another holding in that area provided that no pig leaves the latter holding, except for immediate slaughter, for 30 days either after the arrival of the pigs or, in the case of gestating sows from such a holding, for 30 days after farrowing. 3. If the alarming situation continues, all the measures to be taken by the Member States concerned, in particular determination of the high-risk area and recourse to the provisions of Article 14 (3) and (4), may be the subject of a recommendation in accordance with the procedure laid down in Article 16a. If a Member State decides not to apply this recommendation, the Community financial assistance provided for under Decision 80/1096/EEC shall be suspended for the area by way of derogation from Article 1 of the Decision. 4. The measures laid down in the preceding paragraphs shall be discontinued after the elimination of the last protection zone in the "high health-risk area"." 5. The following Article shall be inserted: "Article 16a 1. Where the procedure laid down in this Article is to be followed, the matter shall without delay be referred to the Committee by its chairman, either on his own initiative or at the request of a Member State. 2. Within the Committee, the votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote. 3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on these measures within two days. Opinions shall be delivered by a majority or 45 votes. 4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit a proposal to the Council on the measures to be taken. The Council shall adopt the measures by a qualified majority. 5. If the Council has not adopted any measures within 15 days of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately unless the Council has voted against the measures by a simple majority." Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 March 1985. They shall forthwith inform the Commission thereof. Article 3 This Directive is addressed to the Member States. Done at Brussels, 11 December 1984. For the Council The President A. DEASY

COUNCIL DIRECTIVE of 11 December 1984 amending Directive 80/217/EEC introducing Community measures for the control of classical swine fever (84/645/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas Directive 80/217/EEC (4), as last amended by Directive 81/476/EEC (5), introduced Community measures to be applied in the event of suspected or confirmed cases of classical swine fever;

Whereas, in view of the way in which the disease has developed, the measures implemented should be stepped up;

Whereas the conditions for carrying out the protective vaccination of herds threatened with contamination and the conditions for controlling the movement of livestock should be specified;

Whereas, in the event of the disease assuming serious epizootic proportions, it must be possible to make regional measures, in particular preventive vaccination, compulsory ; whereas, to this end, provision should be made for a rapid procedure for initiating close cooperation between the Member States and the Commission;

Whereas, in order to increase the effectiveness of Community recommendations regarding the intensification of measures to combat swine fever, it seems necessary to provide for the suspension of Community financial aid by way of derogation from Decision 80/1096/EEC (6),

HAS ADOPTED THIS DIRECTIVE:

Directive 80/217/EEC is hereby amended as follows: 1. In the seventh indent of Article 5 (1), "15 days" is replaced by "30 days".

2. Article 9 is amended as follows: (i) in paragraph 1, "2 kilometres" is replaced by "3 kilometres";

(ii) the second indent of paragraph 2 (a) is replaced by the following:

"- the pigs may not be removed from the holding on which they are kept during the first 15 days. Between the 15th day and the 30th day the pigs may not be removed from the said holding except to be transported under official supervision directly to a slaughterhouse for the purpose of immediate slaughter. Such transport may be authorized by the competent authority only after the official veterinarian has carried out an examination of all pigs on the holding and confirmed that none of the pigs is suspected of being infected with swine fever,";

(iii) in paragraph 2 (b), "15 days" is replaced by "30 days".

3. Article 14 is replaced by the following:

"Article 14

1. Member States shall ensure that in general the following measures are applied: - 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,

- requirements relating to swine fever vaccine established in accordance with the procedure laid down in Article 16 are observed,

- swine fever vaccines imported from third countries are authorized and checked by the (1) OJ No C 19, 26.1.1984, p. 6. (2) OJ No C 127, 14.5.1984, p. 186. (3) OJ No C 206, 6.8.1984, p. 44. (4) OJ No L 47, 21.2.1980, p. 11. (5) OJ No L 186, 8.7.1981, p. 20. (6) OJ No L 325, 1.12.1980, p. 5. competent authority in the importing Member State and are subject to the same conditions in respect of sale, distribution and use as apply to vaccine produced in the Member States.

2. 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.

3. Where the competent authority decides on vaccination in a specific region, such vaccination shall be carried out systematically on all the pigs in the vaccination area. In this case, the following measures shall be applied within a period of six months of the completion of the vaccination operations, which period may be extended for a further six month: (i) all pigs kept on holdings inside the vaccination area shall be vaccinated as soon as possible;

(ii) all pigs kept on holdings inside the vaccination area must remain there throughout the vaccination operations stipulated in point (i);

(iii) any pigs born on or transferred to a holding inside the vaccination area shall have been vaccinated. However, in the herds referred to in paragraph 4, piglets born after six months may be exempted from the vaccination operations;

(iv) in order to be allowed to leave the vaccination area, live vaccinated pigs must be intended for immediate slaughter and have been vaccinated at least 15 days beforehand. However, three months after completion of the vaccination operations referred to in (i), the competent authority may authorize the departure of vaccinated pigs intended for fattening, provided they are transferred under official control and the receiving holding contains only pigs for fattening and is kept under official surveillance until the vaccinated pigs are slaughtered.

4. By way of derogation from paragraph 3, 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.

5. However, by way of derogation from paragraphs 3 and 4 a Member State may authorize vaccination to be confined to pigs for fattening in the vaccination area, subject to the condition that vaccinated pigs may not leave the holding on which they are kept except to be taken to a slaughter house for slaughter. In such a case, the following measures shall be applied for a period of six months, which period may be extended for a further six months: (i) vaccination must be carried out as soon as possible;

(ii) during the vaccination operations and for 15 days following completion of these operations, live pigs for fattening must remain in the vaccination area;

(iii) all pigs for fattening brought to holdings in the vaccination area shall be vaccinated;

(iv) piglets coming from herds in which vaccination has taken place may only be transferred to holdings situated within the vaccination area for fattening;

(v) where live pigs for breeding or for fattening coming from non-vaccinated herds are moved to holdings situated 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."

4. The following Article is inserted:

"Article 14a

1. Where, in a given region, an epizootic of swine fever is exceptionally serious and is tending to spread, the Member State concerned shall declare a demarcated territorial area including at least all the protection zones in that area "a high health-risk area" in accordance with Article 9 (1).

2. Where the Member State in question does not intend to have recourse to Article 14 (3) and (4) it shall apply the measures provided for in Article 9 in the "high health-risk area" and stipulate the following in particular: (a) no live pig may leave the "high health-risk" area;

(b) live pigs leaving a holding situated in the protection zone shall do so in accordance with the conditions laid down in Article 9 (2) (a), second indent, while live pigs from a holding situated in the remainder of the "high health-risk area" may be introduced into another holding in that area provided that no pig leaves the latter holding, except for immediate slaughter, for 30 days either after the arrival of the pigs or, in the case of gestating sows from such a holding, for 30 days after farrowing.

3. If the alarming situation continues, all the measures to be taken by the Member States concerned, in particular determination of the high-risk area and recourse to the provisions of Article 14 (3) and (4), may be the subject of a recommendation in accordance with the procedure laid down in Article 16a.

If a Member State decides not to apply this recommendation, the Community financial assistance provided for under Decision 80/1096/EEC shall be suspended for the area by way of derogation from Article 1 of the Decision.

4. The measures laid down in the preceding paragraphs shall be discontinued after the elimination of the last protection zone in the "high health-risk area"."

5. The following Article shall be inserted:

"Article 16a

1. Where the procedure laid down in this Article is to be followed, the matter shall without delay be referred to the Committee by its chairman, either on his own initiative or at the request of a Member State.

2. Within the Committee, the votes of the Member States shall be weighted as laid down in Article 148 (2) of the Treaty. The chairman shall not vote.

3. The representative of the Commission shall submit a draft of the measures to be adopted. The Committee shall deliver its opinion on these measures within two days. Opinions shall be delivered by a majority or 45 votes.

4. The Commission shall adopt the measures and shall implement them immediately, where they are in accordance with the opinion of the Committee. Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay submit a proposal to the Council on the measures to be taken. The Council shall adopt the measures by a qualified majority.

5. If the Council has not adopted any measures within 15 days of the date on which the matter is referred to it, the Commission shall adopt the proposed measures and shall implement them immediately unless the Council has voted against the measures by a simple majority."

Article 2

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 March 1985. They shall forthwith inform the Commission thereof.

Article 3

This Directive is addressed to the Member States.

Done at Brussels, 11 December 1984.

For the Council

The President

A. DEASY