Avis juridique important

Commission Regulation (EC) No 260/2003 of 12 February 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos (Text with EEA relevance) Official Journal L 037 , 13/02/2003 P. 0007 - 0011

Commission Regulation (EC) No 260/2003 of 12 February 2003 amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, 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(1), as last amended by Directive 92/118/EEC(2), and in particular Article 10 thereof, Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(3), as last amended by Commission Regulation (EC) No 1494/2002(4), and in particular Article 23 thereof, Whereas: (1) In its opinion of 4 and 5 April 2002 on safe sourcing of small ruminant materials the Scientific Steering Committee (SSC) recommended that where a case of scrapie is diagnosed in a small ruminant holding, the entire flock should be culled. The SSC indicated however that culling sheep of the ARR/ARR prion protein genotype would carry little risk-reducing benefit. In order to avoid discouraging the reporting of the disease and to safeguard breeds which may have a low level of resistance, this culling should be achieved gradually. (2) In the interests of consistency with such rules for the culling of sheep, the rules for intra-Community trade in breeding sheep should be amended to remove scrapie-related restrictions from trade in sheep of the ARR/ARR genotype. (3) In its opinion of 16 May 2002 on the safety of bovine embryos, the SSC concluded that there is no need for measures other than those prescribed by the International Embryo Transfer Society Protocols. In its general session of May 2002, the World Animal Health Organisation (Office International des Epizooties (OIE)) decided on similar scientific grounds to delete all trade conditions related to bovine embryos and ova. BSE-related trade conditions for bovine embryos and ova in Regulation (EC) No 999/2001 should therefore be deleted, and Commission Decision 92/290/EEC of 14 May 1992 concerning certain protection measures relating to bovine spongiform encephalopathy (BSE) in the United Kingdom(5), as amended by the Act of Accession of Austria, Finland and Sweden, should be repealed. (4) Regulation (EC) No 999/2001 should therefore be amended accordingly. (5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: Article 1 Annexes VII, VIII and XI to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation. Article 2 Decision 92/290/EEC is repealed. Article 3 This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union. Point 2(b) of Annex VII and point (a)(iii) of part I of Chapter A of Annex VIII shall apply from 1 October 2003. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 12 February 2003. For the Commission David Byrne Member of the Commission (1) OJ L 224, 18.8.1990, p. 29. (2) OJ L 62, 15.3.1993, p. 49. (3) OJ L 147, 31.5.2001, p. 1. (4) OJ L 225, 22.8.2002, p. 3. (5) OJ L 152, 4.6.1992, p. 37. ANNEX Annexes VII, VIII and XI are amended as follows: 1. Annex VII is replaced by the following: "ANNEX VII ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY 1. The inquiry referred to in Article 13(1)(b) must identify: (a) in the case of bovine animals: - all other ruminants on the holding of the animal in which the disease was confirmed, - where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease, - all animals of the cohort of the animal in which the disease was confirmed, - the possible origin of the disease, - other animals on the holding of the animal in which the disease was confirmed or on other holdings, which may have become infected by the TSE agent or been exposed to the same feed or contamination source, - the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question; (b) in the case of ovine and caprine animals: - all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed, - in so far as they are identifiable, the parents, all embryos, ova and the last progeny of the animal in which the disease was confirmed, - all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those mentioned in the second indent, - the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source, - the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the BSE agent to or from the holding in question. 2. The measures laid down in Article 13(1)(c) shall comprise at least: (a) in case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in point 1(a), first, second and third indent. The Member State may decide not to kill and destroy all bovine animals on the holding of the animal in which the disease was confirmed as referred to in the first indent of point 1(a), depending upon the epidemiological situation and traceability of the animals on that holding; (b) in the case of confirmation of TSE in an ovine or caprine animal, from 1 October 2003, according to the decision of the competent authority: (i) either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b); or (ii) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of: - breeding rams of the ARR/ARR genotype, - breeding ewes carrying at least 1 ARR allele and no VRQ allele, and - sheep carrying at least one ARR allele which are intended solely for slaughter, (iii) if the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed. In the case of land used for common grazing by more than one flock, Member States may decide to limit the application of the measures to a single flock, based on a consideration of all the epidemiological factors, (c) in case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b). 3.1. Only the following animals may be introduced to the holding(s) where destruction has been undertaken in accordance with point 2(b)(i) or (ii): (a) male sheep of the ARR/ARR genotype; (b) female sheep carrying at least 1 ARR allele and no VRQ allele; (c) Caprine animals, provided that: - no ovine animals other than those of the ARR/ARR genotype are present on the holding, - thorough cleaning and disinfection of all animal housing on the premises has been carried out following de-stocking, - the holding shall be subjected to intensified TSE monitoring, including the testing of all culled and dead-on-farm caprine animals over the age of 18 months. 3.2. Only the following ovine germinal products may be used in the holding(s) where destruction has been undertaken in accordance with point 2(b)(i) or (ii): (a) semen from rams of the ARR/ARR genotype; (b) embryos carrying at least 1 ARR allele and no VRQ allele. 4. During a transitional period until 1 January 2006 at the latest, and by way of derogation from the restriction set out in point 3(b), where it is difficult to obtain replacement ovine animals of a known genotype, Member States may decide to allow non-pregnant ewe lambs of an unknown genotype to be introduced to the holdings referred to in point 2(b)(i) and (ii). 5. Following the application on a holding of the measures referred to in point 2(b)(i) and (ii): (a) movement of ARR/ARR sheep from the holding shall not be subject to any restriction; (b) sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction; (c) sheep of other genotypes may only be moved from the holding for the purposes of destruction. 6. The restrictions referred to in points 3 and 5 shall continue to apply to the holding for a period of three years from: (a) the date of attainment of ARR/ARR status by all ovine animals on the holding; or (b) the last date when any ovine or caprine animal was kept on the premises; or (c) in the case of point 3.1(c), the date when the intensified TSE monitoring commenced. 7. Where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, a Member State may decide to: (a) delay the destruction of animals as referred to in point 2(b)(i) and (ii) for up to two breeding years; (b) allow ovine animals other than those specified in point 3 to be introduced to the holdings referred to in point 2(b)(i) and (ii), provided that they do not carry a VRQ allele. 8. Members States applying the derogations referred to in points 4 and 7 shall notify to the Commission an account of the conditions and criteria used for granting them." 2. The title of Chapter A of Annex VIII, and the text of Part I of Chapter A of Annex VIII, are replaced by the following: "CHAPTER A Conditions for intra-Community trade in live animals I. Conditions which apply irrespective of the category of the Member State or third country of origin or residence of the animal The following conditions shall apply to trade in ovine and caprine animals: (a) ovine and caprine animals for breeding shall either: (i) come from a holding which has satisfied the following requirements for at least three years: - it is subject to regular official veterinary checks, - the animals are marked, - no case of scrapie has been confirmed, - checking by sampling of old female animals intended for culling is carried out on the holding, - females are introduced into that holding only if they come from a holding which complies with the same requirements; or (ii) have been continuously kept on a holding or holdings complying with the requirements laid down in point (i) since birth or for the last three years; or (iii) from 1 October 2003, be animals of the ARR/ARR prion protein genotype, as defined in Annex I of Commission Decision 2002/1003/EC(1). If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c), they shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2); (b) a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory: (i) may submit the said program to the Commission, outlining in particular: - the distribution of the disease in the Member State, - the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio, - the geographical area in which the program will be implemented, - the status categories defined for holdings and the standards which must be attained in each such category, - the test procedures to be used, - the program monitoring procedures, - the action to be taken if, for any reason, a holding loses its status, - the measures to be taken if the results of checks carried out in accordance with the provisions of the program are positive, (ii) the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). The additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally, (iii) amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure, (c) where a Member State considers that its territory or part of its territory is free from scrapie: (i) it is to submit to the Commission appropriate supporting documentation, setting out in particular: - the history of the occurrence of the disease in its territory, - the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation, - the period over which the surveillance was carried out, - the arrangements for verifying the absence of the disease, (ii) the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally, (iii) the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2)." 3. In Part D, point 1 of Annex XI the following words are deleted: "Commission Decision 92/290/EEC of 14 May 1992 concerning certain protection measures relating to bovine embryos in respect of bovine spongiform encephalopathy (BSE) in the United Kingdom." (1) OJ L 349, 24.12.2002, p. 105.

Commission Regulation (EC) No 260/2003

of 12 February 2003

amending Regulation (EC) No 999/2001 of the European Parliament and of the Council as regards the eradication of transmissible spongiform encephalopathies in ovine and caprine animals and rules for the trade in live ovine and caprine animals and bovine embryos

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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(1), as last amended by Directive 92/118/EEC(2), and in particular Article 10 thereof,

Having regard to Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies(3), as last amended by Commission Regulation (EC) No 1494/2002(4), and in particular Article 23 thereof,

Whereas:

(1) In its opinion of 4 and 5 April 2002 on safe sourcing of small ruminant materials the Scientific Steering Committee (SSC) recommended that where a case of scrapie is diagnosed in a small ruminant holding, the entire flock should be culled. The SSC indicated however that culling sheep of the ARR/ARR prion protein genotype would carry little risk-reducing benefit. In order to avoid discouraging the reporting of the disease and to safeguard breeds which may have a low level of resistance, this culling should be achieved gradually.

(2) In the interests of consistency with such rules for the culling of sheep, the rules for intra-Community trade in breeding sheep should be amended to remove scrapie-related restrictions from trade in sheep of the ARR/ARR genotype.

(3) In its opinion of 16 May 2002 on the safety of bovine embryos, the SSC concluded that there is no need for measures other than those prescribed by the International Embryo Transfer Society Protocols. In its general session of May 2002, the World Animal Health Organisation (Office International des Epizooties (OIE)) decided on similar scientific grounds to delete all trade conditions related to bovine embryos and ova. BSE-related trade conditions for bovine embryos and ova in Regulation (EC) No 999/2001 should therefore be deleted, and Commission Decision 92/290/EEC of 14 May 1992 concerning certain protection measures relating to bovine spongiform encephalopathy (BSE) in the United Kingdom(5), as amended by the Act of Accession of Austria, Finland and Sweden, should be repealed.

(4) Regulation (EC) No 999/2001 should therefore be amended accordingly.

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

HAS ADOPTED THIS REGULATION:

Article 1

Annexes VII, VIII and XI to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.

Article 2

Decision 92/290/EEC is repealed.

Article 3

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union.

Point 2(b) of Annex VII and point (a)(iii) of part I of Chapter A of Annex VIII shall apply from 1 October 2003.

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

Done at Brussels, 12 February 2003.

For the Commission

David Byrne

Member of the Commission

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

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

(3) OJ L 147, 31.5.2001, p. 1.

(4) OJ L 225, 22.8.2002, p. 3.

(5) OJ L 152, 4.6.1992, p. 37.

ANNEX

Annexes VII, VIII and XI are amended as follows:

1. Annex VII is replaced by the following:

"ANNEX VII

ERADICATION OF TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY

1. The inquiry referred to in Article 13(1)(b) must identify:

(a) in the case of bovine animals:

- all other ruminants on the holding of the animal in which the disease was confirmed,

- where the disease was confirmed in a female animal, its progeny born within two years prior to, or after, clinical onset of the disease,

- all animals of the cohort of the animal in which the disease was confirmed,

- the possible origin of the disease,

- other animals on the holding of the animal in which the disease was confirmed or on other holdings, which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

- the movement of potentially contaminated feedingstuffs, of other material or any other means of transmission, which may have transmitted the TSE agent to or from the holding in question;

(b) in the case of ovine and caprine animals:

- all ruminants other than ovine and caprine animals on the holding of the animal in which the disease was confirmed,

- in so far as they are identifiable, the parents, all embryos, ova and the last progeny of the animal in which the disease was confirmed,

- all other ovine and caprine animals on the holding of the animal in which the disease was confirmed in addition to those mentioned in the second indent,

- the possible origin of the disease and the identification of other holdings on which there are animals, embryos or ova which may have become infected by the TSE agent or been exposed to the same feed or contamination source,

- the movement of potentially contaminated feedingstuffs, other material or any other means of transmission, which may have transmitted the BSE agent to or from the holding in question.

2. The measures laid down in Article 13(1)(c) shall comprise at least:

(a) in case of confirmation of BSE in a bovine animal, the killing and complete destruction of bovine animals identified by the inquiry referred to in point 1(a), first, second and third indent. The Member State may decide not to kill and destroy all bovine animals on the holding of the animal in which the disease was confirmed as referred to in the first indent of point 1(a), depending upon the epidemiological situation and traceability of the animals on that holding;

(b) in the case of confirmation of TSE in an ovine or caprine animal, from 1 October 2003, according to the decision of the competent authority:

(i) either the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b); or

(ii) the killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second and third indents of point 1(b), with the exception of:

- breeding rams of the ARR/ARR genotype,

- breeding ewes carrying at least 1 ARR allele and no VRQ allele, and

- sheep carrying at least one ARR allele which are intended solely for slaughter,

(iii) if the infected animal has been introduced from another holding, a Member State may decide, based on the history of the case, to apply eradication measures in the holding of origin in addition to, or instead of, the holding in which the infection was confirmed. In the case of land used for common grazing by more than one flock, Member States may decide to limit the application of the measures to a single flock, based on a consideration of all the epidemiological factors,

(c) in case of confirmation of BSE in an ovine or caprine animal, killing and complete destruction of all animals, embryos and ova identified by the inquiry referred to in the second to fifth indents of point 1(b).

3.1. Only the following animals may be introduced to the holding(s) where destruction has been undertaken in accordance with point 2(b)(i) or (ii):

(a) male sheep of the ARR/ARR genotype;

(b) female sheep carrying at least 1 ARR allele and no VRQ allele;

(c) Caprine animals, provided that:

- no ovine animals other than those of the ARR/ARR genotype are present on the holding,

- thorough cleaning and disinfection of all animal housing on the premises has been carried out following de-stocking,

- the holding shall be subjected to intensified TSE monitoring, including the testing of all culled and dead-on-farm caprine animals over the age of 18 months.

3.2. Only the following ovine germinal products may be used in the holding(s) where destruction has been undertaken in accordance with point 2(b)(i) or (ii):

(a) semen from rams of the ARR/ARR genotype;

(b) embryos carrying at least 1 ARR allele and no VRQ allele.

4. During a transitional period until 1 January 2006 at the latest, and by way of derogation from the restriction set out in point 3(b), where it is difficult to obtain replacement ovine animals of a known genotype, Member States may decide to allow non-pregnant ewe lambs of an unknown genotype to be introduced to the holdings referred to in point 2(b)(i) and (ii).

5. Following the application on a holding of the measures referred to in point 2(b)(i) and (ii):

(a) movement of ARR/ARR sheep from the holding shall not be subject to any restriction;

(b) sheep carrying only one ARR allele may be moved from the holding only to go directly for slaughter for human consumption or for the purposes of destruction;

(c) sheep of other genotypes may only be moved from the holding for the purposes of destruction.

6. The restrictions referred to in points 3 and 5 shall continue to apply to the holding for a period of three years from:

(a) the date of attainment of ARR/ARR status by all ovine animals on the holding; or

(b) the last date when any ovine or caprine animal was kept on the premises; or

(c) in the case of point 3.1(c), the date when the intensified TSE monitoring commenced.

7. Where the frequency of the ARR allele within the breed or holding is low, or where it is deemed necessary in order to avoid inbreeding, a Member State may decide to:

(a) delay the destruction of animals as referred to in point 2(b)(i) and (ii) for up to two breeding years;

(b) allow ovine animals other than those specified in point 3 to be introduced to the holdings referred to in point 2(b)(i) and (ii), provided that they do not carry a VRQ allele.

8. Members States applying the derogations referred to in points 4 and 7 shall notify to the Commission an account of the conditions and criteria used for granting them."

2. The title of Chapter A of Annex VIII, and the text of Part I of Chapter A of Annex VIII, are replaced by the following:

"CHAPTER A

Conditions for intra-Community trade in live animals

I. Conditions which apply irrespective of the category of the Member State or third country of origin or residence of the animal

The following conditions shall apply to trade in ovine and caprine animals:

(a) ovine and caprine animals for breeding shall either:

(i) come from a holding which has satisfied the following requirements for at least three years:

- it is subject to regular official veterinary checks,

- the animals are marked,

- no case of scrapie has been confirmed,

- checking by sampling of old female animals intended for culling is carried out on the holding,

- females are introduced into that holding only if they come from a holding which complies with the same requirements; or

(ii) have been continuously kept on a holding or holdings complying with the requirements laid down in point (i) since birth or for the last three years; or

(iii) from 1 October 2003, be animals of the ARR/ARR prion protein genotype, as defined in Annex I of Commission Decision 2002/1003/EC(1).

If they are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c), they shall comply with the additional guarantees, general or specific, which have been defined in accordance with the procedure referred to in Article 24(2);

(b) a Member State which has a compulsory or voluntary national scrapie control program for all or part of its territory:

(i) may submit the said program to the Commission, outlining in particular:

- the distribution of the disease in the Member State,

- the reasons for the program, taking into consideration the importance of the disease and the cost/benefit ratio,

- the geographical area in which the program will be implemented,

- the status categories defined for holdings and the standards which must be attained in each such category,

- the test procedures to be used,

- the program monitoring procedures,

- the action to be taken if, for any reason, a holding loses its status,

- the measures to be taken if the results of checks carried out in accordance with the provisions of the program are positive,

(ii) the program referred to in point (i) may be approved if it complies with the criteria laid down in that point, in accordance with the procedure referred to in Article 24(2). The additional guarantees, general or specific, which may be required in intra-Community trade, shall be defined at the same time or at the latest three months after approval of the program in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,

(iii) amendments or additions to the programmes submitted by Member States may be approved in accordance with the procedure referred to in Article 24(2). Amendments to the guarantees which have been defined in accordance with point (ii) may be approved in accordance with that procedure,

(c) where a Member State considers that its territory or part of its territory is free from scrapie:

(i) it is to submit to the Commission appropriate supporting documentation, setting out in particular:

- the history of the occurrence of the disease in its territory,

- the results of surveillance testing based on serological, microbiological, pathological or epidemiological investigation,

- the period over which the surveillance was carried out,

- the arrangements for verifying the absence of the disease,

(ii) the additional guarantees, general or specific, which may be required in intra-Community trade are to be defined in accordance with the procedure referred to in Article 24(2). Such guarantees must not exceed those which the Member State implements nationally,

(iii) the Member State concerned is to notify the Commission of any change in the details specified in point (i) which relate to the disease. The guarantees defined in accordance with point (ii) may, in the light of such notification, be amended or withdrawn in accordance with the procedure referred to in Article 24(2)."

3. In Part D, point 1 of Annex XI the following words are deleted:

"Commission Decision 92/290/EEC of 14 May 1992 concerning certain protection measures relating to bovine embryos in respect of bovine spongiform encephalopathy (BSE) in the United Kingdom."

(1) OJ L 349, 24.12.2002, p. 105.