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Council Directive 90/422/EEC of 26 june 1990 amending Directive 64/432/EEC as regards enzootic bovine leukosis Official Journal L 224 , 18/08/1990 P. 0009 - 0012 Finnish special edition: Chapter 3 Volume 33 P. 0125 Swedish special edition: Chapter 3 Volume 33 P. 0125

COUNCIL DIRECTIVE of 26 June 1990 amending Directive 64/432/EEC as regards enzootic bovine leukosis (90/422/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 88/406/EEC (4), which amends Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (5), as last amended by Directive 89/662/EEC (6), lays down common health guarantees regarding enzootic bovine leukosis as applicable to certain categories of bovine animals intended for intra-Community trade which will apply from 1 July 1990; Whereas Article 4 of Directive 88/406/EEC requires that proposals be made to lay down the criteria permitting a Member State or part of the territory of a Member State to be recognized as being free from enzootic bovine leukosis, the conditions to be implemented to guarantee the maintenance of such status and the rules applicable to trade conducted from such regions; Whereas, from surveys carried out to date, it would appear that certain Member States and regions are free from enzootic bovine leukosis whereas it is necessary to define, on a Community basis, how these areas shall be defined and the conditions under which they shall be maintained as being free from enzootic bovine leukosis and the conditions in relation to trade; Whereas it appears necessary that Member States be granted an additional period of time in order to conform to the requirements of Directive 64/432/EEC as thus amended, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 64/432/EEC is hereby amended as follows: 1. Article 2 (s) is replaced by the following: '(s) "Enzootic bovine leukosis free herd" shall mean a herd which satisfies the conditions laid down in Annex G, Chapter I, section A.' 2. The following is added to Article 2: '(t) "enzootic bovine leukosis free Member State or region" shall mean a region or Member State which meets the requirements laid down in Annex G, Chapter I, section B.' 3. Article 3 (3) (e) is replaced by the following: '(e) in addition to the condition under (d), where they are over 12 months of age and come from a region or Member State which does not have enzootic bovine leukosis free status, have reacted negatively to an individual test carried out in accordance with Annex G, Chapter II, during the 30 days before they were loaded;' 4. The following paragraph is added to Article 3: '15. By way of derogation from the requirements laid down in Annex G, Chapter I, section B (2), a Member State or region of a Member State declared enzootic bovine leukosis free within the meaning of Article 2 (t) may be authorized, in accordance with the procedure laid down in Article 12, to lower the inspection level in respect of animals more than two years of age provided that tests have shown that the following requirements are met: - no case of enzootic bovine leukosis has been recorded in a proportion of one herd out of 10 000 for at least three years, - all cattle which have reacted positively to an immuno-diffusion test have been slaughtered and the herd has remained subject to restrictions until re-establishment of its status pursuant to Annex G, Chapter I, C (1) or (2), - all cattle slaughtered within the territory of that Member State or region have been submitted to a post mortem examination by an official veterinarian who must issue notification of all tumours with a view to laboratory examination. If one of the conditions provided for in the first subparagraph ceases to be fulfilled - especially in the case provided for in Annex G, Chapter I, section C (3) - the Commission, after assessing the circumstances of the recrudescence of enzootic bovine leukosis, and if its assessment gives grounds for so doing, shall adopt a decision in accordance with the same procedure to rescind the derogation decision taken in respect of that Member State or region(s) of that Member State.' 5. In Article 8 (2), the second sentence of the second subparagraph is replaced by the following: 'However, such guarantees shall not be required upon the introduction of animals from an enzootic bovine leukosis free Member State, region or holding.' 6. The following subparagraph is added to Article 8a (1) (b): 'This test shall not be required in respect of animals from an enzootic bovine leukosis free Member State or region or holding.' 7. The present wording of Annex G becomes Chapter II of the said Annex; section A (2) (j) of Chapter II is replaced by the following: '(j) Spain: Subdirrección general de sanidad animal. Laboratorio de sanidad y producción animal ALGETE (Madrid);' 8. The Annex to this Directive is incorporated as Chapter I of Annex G. Article 2 In Articles 2 and 5 of Directive 88/406/EEC, '1 July 1990' is replaced by '1 July 1991'. However, from 1 July 1990 to 30 June 1991, Member States which have thus qualified all or part of their herds are authorized - in order to maintain that qualification - to make introduction into enzootic bovine leukosis free herds subject, in respect of animals of the bovine species other than slaughter animals, to the following conditions: (a) the animals must come from an enzootic bovine leukosis free herd; or (b) the animals must have been born and raised in a herd in which all the bovine animals over 24 months of age at the time of the test and forming part of the bovine herd from which the animals come have reacted negatively during the last 12 months to a test carried out pursuant to Annex G. Article 3 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1990 as far as Article 2 is concerned and not later than 1 October 1990 as concerns the other provisions. They shall forthwith inform the Commission thereof. Article 4 This Directive is addressed to the Member States. Done at Luxembourg, 26 June 1990. For the Council The President M. O'KENNEDY (1) OJ No C 17, 24. 1. 1990, p. 11. (2) OJ No C 113, 7. 5. 1990, p. 205. (3) OJ No C 112, 7. 5. 1990, p. 31. (4) OJ No L 194, 22. 7. 1988, p. 1. (5) OJ No 121, 29. 7. 1964, p. 1977/64. (6) OJ No L 395, 30. 12. 1989, p. 13. ANNEX 'CHAPTER I ENZOOTIC BOVINE LEUKOSIS FREE HERDS, MEMBER STATES AND REGIONS A. "Enzootic bovine leukosis free herd" means: 1. a herd in which: ii(i) there is no evidence, either clinical or as a result of a test carried out in accordance with Chapter II, of any case of enzootic bovine leukosis and in which no such case has been confirmed in the previous two years, and i(ii) all animals over 24 months of age have previously reacted negatively during the preceding 12 months to two tests carried out in accordance with this Annex, at intervals of at least four months, and (iii) following the tests referred to in (ii), there are only animals born in the herd, or which have come from an enzootic bovine leukosis free herd and in which, after qualification, the animals over 24 months of age have continued to react negatively to one of the tests carried out in accordance with Chapter II at intervals of three years and the conditions provided for in (i) and (iii) continue to be fulfilled; 2. a herd situated in an enzootic bovine leukosis free Member State or region. B. "Enzootic bovine leukosis free Member State or region" means: A Member State or a region, within the meaning of Article 2 (o), of that Member State 1. in which: (a) at least 99,8 % of the bovine herds are enzootic bovine leukosis free herds within the meaning of subparagraph (s), or (b) on the one hand, no case of enzootic bovine leukosis has been notified or confirmed in any way whatever in the five years preceding the date of notification of this Directive or in the last three years after that date, and, on the other hand, in the last two years: i(i) random checks on a national scale carried out in accordance with Chapter II have been conducted over a period of two years on all the animals over 24 months of age in at least 10 % of herds, with negative results, and (ii) all animals over 24 months of age have undergone a test as provided for in Chapter II at least once, with negative results; 2. in which, having satisfied the conditions provided for in 1, i(i) every year either a random sample with a confidence rating of 99 % has established that less than 0,2 % of the herds were infected or not less than 20 % of bovine animals over two years of age have reacted negatively to a test carried out in accordance with Chapter II, and (ii) the conditions set in A (1) continue to be fulfilled. C. Suspension of leukosis free status after an outbreak of the disease 1. If an animal in an enzootic bovine leukosis free herd has reacted positively to one of the tests referred to in (ii), the enzootic bovine leukosis free status of the herd shall be suspended until the following measures have been taken: ii(i) the animal which has reacted positively, and, in the case of a cow, any calf it may have produced, must have left the herd for slaughter under the supervision of the veterinary authorities; i(ii) the remaining animals have reacted negatively to a serological test carried out in accordance with Chapter II three months at least after elimination of the positive animal and any possible progeny thereof; (iii) an epidemiological enquiry must be conducted and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in (ii); However, the competent authority may grant a derogation from the obligation to slaughter the calf of an infected cow where it was separated from its mother after calving. In this case, the calf must be made subject to the requirements provided for in 2 (ii). 2. Where more than one animal from an enzootic bovine leukosis free herd has reacted positively, the leukosis free status of the herd shall be suspended until the following measures have been taken: ii(i) the infected animals and, in the case of an infected cow, except in the event of a derogation granted by the competent authority pursuant to the second subparagraph of 1 (iii), their calves must be removed for slaughter under the supervision of the veterinary authorities; i(ii) the remaining animals - including, where such is the case, the calves of infected animals - of less than six months of age must, after identification, remain on the holding until they have satisfied the tests referred to in A (1) (ii); (iii) the herd must remain under official supervision until the conditions provided for under A (1) (ii) and (iii) are again fulfilled; (iv) an epidemiological enquiry must be conducted, and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in A (1) (ii); 3. If enzootic bovine leukosis is detected and confirmed in more than 0,2 % of herds in the region or Member State, leukosis free status of that region or Member State shall be suspended and, in addition to the measures provided for in paragraph 1 or 2, 20 % of the other herds in the region or Member State must, within the time limits stipulated in A (1) (ii), undergo one of the tests referred to in Chapter II. Leukosis free status shall be re-established if, on completion of the measures provided for in the preceding points, the tests provided for therein have proved negative.'

COUNCIL DIRECTIVE of 26 June 1990 amending Directive 64/432/EEC as regards enzootic bovine leukosis (90/422/EEC)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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 88/406/EEC (4), which amends Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (5), as last amended by Directive 89/662/EEC (6), lays down common health guarantees regarding enzootic bovine leukosis as applicable to certain categories of bovine animals intended for intra-Community trade which will apply from 1 July 1990;

Whereas Article 4 of Directive 88/406/EEC requires that proposals be made to lay down the criteria permitting a Member State or part of the territory of a Member State to be recognized as being free from enzootic bovine leukosis, the conditions to be implemented to guarantee the maintenance of such status and the rules applicable to trade conducted from such regions;

Whereas, from surveys carried out to date, it would appear that certain Member States and regions are free from enzootic bovine leukosis whereas it is necessary to define, on a Community basis, how these areas shall be defined and the conditions under which they shall be maintained as being free from enzootic bovine leukosis and the conditions in relation to trade;

Whereas it appears necessary that Member States be granted an additional period of time in order to conform to the requirements of Directive 64/432/EEC as thus amended,

HAS ADOPTED THIS DIRECTIVE:

Directive 64/432/EEC is hereby amended as follows:

1. Article 2 (s) is replaced by the following:

'(s) "Enzootic bovine leukosis free herd" shall mean a herd which satisfies the conditions laid down in Annex G, Chapter I, section A.'

2. The following is added to Article 2:

'(t) "enzootic bovine leukosis free Member State or region" shall mean a region or Member State which meets the requirements laid down in Annex G, Chapter I, section B.'

3. Article 3 (3) (e) is replaced by the following:

'(e) in addition to the condition under (d), where they are over 12 months of age and come from a region or Member State which does not have enzootic bovine leukosis free status, have reacted negatively to an individual test carried out in accordance with Annex G, Chapter II, during the 30 days before they were loaded;'

4. The following paragraph is added to Article 3:

'15. By way of derogation from the requirements laid down in Annex G, Chapter I, section B (2), a Member State or region of a Member State declared enzootic bovine leukosis free within the meaning of Article 2 (t) may be authorized, in accordance with the procedure laid down in Article 12, to lower the inspection level in respect of animals more than two years of age provided that tests have shown that the following requirements are met:

- no case of enzootic bovine leukosis has been recorded in a proportion of one herd out of 10 000 for at least three years,

- all cattle which have reacted positively to an immuno-diffusion test have been slaughtered and the herd has remained subject to restrictions until re-establishment of its status pursuant to Annex G, Chapter I, C (1) or (2),

- all cattle slaughtered within the territory of that Member State or region have been submitted to a post mortem examination by an official veterinarian who must issue notification of all tumours with a view to laboratory examination.

If one of the conditions provided for in the first subparagraph ceases to be fulfilled - especially in the case provided for in Annex G, Chapter I, section C (3) - the Commission, after assessing the circumstances of the recrudescence of enzootic bovine leukosis, and if its assessment gives grounds for so doing, shall adopt a decision in accordance with the same procedure to rescind the derogation decision taken in respect of that Member State or region(s) of that Member State.'

5. In Article 8 (2), the second sentence of the second subparagraph is replaced by the following:

'However, such guarantees shall not be required upon the introduction of animals from an enzootic bovine leukosis free Member State, region or holding.'

6. The following subparagraph is added to Article 8a (1) (b):

'This test shall not be required in respect of animals from an enzootic bovine leukosis free Member State or region or holding.'

7. The present wording of Annex G becomes Chapter II of the said Annex; section A (2) (j) of Chapter II is replaced by the following:

'(j) Spain: Subdirrección general de sanidad animal. Laboratorio de sanidad y producción animal ALGETE (Madrid);'

8. The Annex to this Directive is incorporated as Chapter I of Annex G.

Article 2

In Articles 2 and 5 of Directive 88/406/EEC, '1 July 1990' is replaced by '1 July 1991'.

However, from 1 July 1990 to 30 June 1991, Member States which have thus qualified all or part of their herds are authorized - in order to maintain that qualification - to make introduction into enzootic bovine leukosis free herds subject, in respect of animals of the bovine species other than slaughter animals, to the following conditions:

(a) the animals must come from an enzootic bovine leukosis free herd; or

(b) the animals must have been born and raised in a herd in which all the bovine animals over 24 months of age at the time of the test and forming part of the bovine herd from which the animals come have reacted negatively during the last 12 months to a test carried out pursuant to Annex G.

Article 3

Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1990 as far as Article 2 is concerned and not later than 1 October 1990 as concerns

the other provisions. They shall forthwith inform the Commission thereof.

Article 4

This Directive is addressed to the Member States.

Done at Luxembourg, 26 June 1990.

For the Council

The President

M. O'KENNEDY

(1) OJ No C 17, 24. 1. 1990, p. 11.

(2) OJ No C 113, 7. 5. 1990, p. 205.

(3) OJ No C 112, 7. 5. 1990, p. 31.

(4) OJ No L 194, 22. 7. 1988, p. 1.

(5) OJ No 121, 29. 7. 1964, p. 1977/64.

(6) OJ No L 395, 30. 12. 1989, p. 13.

ANNEX

'CHAPTER I ENZOOTIC BOVINE LEUKOSIS FREE HERDS, MEMBER STATES AND REGIONS A. "Enzootic bovine leukosis free herd" means:

1. a herd in which:

ii(i) there is no evidence, either clinical or as a result of a test carried out in accordance with Chapter II, of any case of enzootic bovine leukosis and in which no such case has been confirmed in the previous two years, and

i(ii) all animals over 24 months of age have previously reacted negatively during the preceding 12 months to two tests carried out in accordance with this Annex, at intervals of at least four months, and

(iii) following the tests referred to in (ii), there are only animals born in the herd, or which have come from an enzootic bovine leukosis free herd

and in which, after qualification, the animals over 24 months of age have continued to react negatively to one of the tests carried out in accordance with Chapter II at intervals of three years and the conditions provided for in (i) and (iii) continue to be fulfilled;

2. a herd situated in an enzootic bovine leukosis free Member State or region.

B.

"Enzootic bovine leukosis free Member State or region" means:

A Member State or a region, within the meaning of Article 2 (o), of that Member State

1. in which:

(a) at least 99,8 % of the bovine herds are enzootic bovine leukosis free herds within the meaning of subparagraph (s),

or

(b) on the one hand, no case of enzootic bovine leukosis has been notified or confirmed in any way whatever in the five years preceding the date of notification of this Directive or in the last three years after that date, and, on the other hand, in the last two years:

i(i) random checks on a national scale carried out in accordance with Chapter II have been conducted over a period of two years on all the animals over 24 months of age in at least 10 % of herds, with negative results, and

(ii)

all animals over 24 months of age have undergone a test as provided for in Chapter II at least once, with negative results;

2. in which, having satisfied the conditions provided for in 1,

i(i) every year either a random sample with a confidence rating of 99 % has established that less than 0,2 % of the herds were infected or not less than 20 % of bovine animals over two years of age have reacted negatively to a test carried out in accordance with Chapter II, and

(ii) the conditions set in A (1) continue to be fulfilled.

C.

Suspension of leukosis free status after an outbreak of the disease

1. If an animal in an enzootic bovine leukosis free herd has reacted positively to one of the tests referred to in (ii), the enzootic bovine leukosis free status of the herd shall be suspended until the following measures have been taken:

ii(i) the animal which has reacted positively, and, in the case of a cow, any calf it may have produced, must have left the herd for slaughter under the supervision of the veterinary authorities;

i(ii) the remaining animals have reacted negatively to a serological test carried out in accordance with Chapter II three months at least after elimination of the positive animal and any possible progeny thereof;

(iii) an epidemiological enquiry must be conducted and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in (ii);

However, the competent authority may grant a derogation from the obligation to slaughter the calf of an infected cow where it was separated from its mother after calving. In this case, the calf must be made subject to the requirements provided for in 2 (ii).

2. Where more than one animal from an enzootic bovine leukosis free herd has reacted positively, the leukosis free status of the herd shall be suspended until the following measures have been taken:

ii(i) the infected animals and, in the case of an infected cow, except in the event of a derogation granted by the competent authority pursuant to the second subparagraph of 1 (iii), their calves must be removed for slaughter under the supervision of the veterinary authorities;

i(ii) the remaining animals - including, where such is the case, the calves of infected animals - of less than six months of age must, after identification, remain on the holding until they have satisfied the tests referred to in A (1) (ii);

(iii) the herd must remain under official supervision until the conditions provided for under A (1) (ii) and (iii) are again fulfilled;

(iv) an epidemiological enquiry must be conducted, and the herds linked epidemiologically to the infected herd must be subjected to the measures laid down in A (1) (ii);

3. If enzootic bovine leukosis is detected and confirmed in more than 0,2 % of herds in the region or Member State, leukosis free status of that region or Member State shall be suspended and, in addition to the measures provided for in paragraph 1 or 2, 20 % of the other herds in the region or Member State must, within the time limits stipulated in A (1) (ii), undergo one of the tests referred to in Chapter II.

Leukosis free status shall be re-established if, on completion of the measures provided for in the preceding points, the tests provided for therein have proved negative.'