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Council Directive 91/266/EEC of 21 May 1991 amending Directive 72/461/EEC on health problems affecting intra- Community trade in fresh meat and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine and fresh meat or meat products from third countries Official Journal L 134 , 29/05/1991 P. 0045 - 0046 Finnish special edition: Chapter 3 Volume 37 P. 0195 Swedish special edition: Chapter 3 Volume 37 P. 0195

COUNCIL DIRECTIVE of 21 May 1991 amending Directive 72/461/EEC on health problems affecting intra-Community trade in fresh meat and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine and fresh meat or meat products from third countries (91/266/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 72/461/EEC (4), as last amended by Directive 89/662/EEC (5), lays down the health requirements which must be fulfilled by animals from which fresh meat is obtained for intra-Community trade; whereas Directive 72/462/EEC (6), as last amended by Directive 91/69/EEC (7), lays down health and veterinary inspection requirements applicable to imports of bovine, ovine and caprine animals and swine and fresh meat or meat products from third countries; Whereas glands and organs, including blood, are within the scope of the abovementioned Directives; whereas they are required in large quantity by the pharmaceutical manufacturing industries of the Member States to ensure the availability of extracts and enzymes for human and veterinary medicine; Whereas this means that Member States should be afforded the possibility of authorizing on a more liberal basis the importation from third countries of glands and organs, including blood, for pharmaceutical manufacturing purposes; whereas, with a view to ensuring the proper and specific use of such raw materials, authorization should be granted only when certain conditions, to be determined in accordance with a Community procedure, are fulfilled; Whereas, in order to maintain Community preference, the same facilities should be applied in intra-Community trade in glands and organs, including blood, for pharmaceutical manufacturing purposes under certain minimum conditions which ensure the proper and specific use of such raw materials; Whereas by its Judgment of 16 November 1989 in Case 131/87 the Court of Justice declared void Directive 87/64/EEC (8) which covered the aforementioned matters; whereas it is therefore necessary to adopt a new Directive on the appropriate legal basis; Whereas, given this situation, the deadline for transposition laid down by Directive 87/64/EEC may be maintained, HAS ADOPTED THIS DIRECTIVE: Article 1 The following paragraph shall be added to Article 3 of Directive 72/461/EEC: '(d) However, until 31 December 1996, in their compliance with (a), (b) and (c), but by way of derogation from Article 8a, the Member States may, subject to an authorization granted by their veterinary authorities, authorize the introduction in their territory of glands and organs, including blood, as raw materials for the pharmaceutical processing industry. Such authorization shall, moreover, be subject to compliance with the provisions concerning the identity of the materials in question, their packaging, transportation, storage, handling and processing and with those concerning the disposal of packaging, wrapping and residual matter following processing so that all public and animal health risks are eliminated.' Article 2 The present text of Article 16 of Directive 72/462/EEC shall become paragraph 1 and the following paragraph shall be added: '2. However, Member States may, until 31 December 1996, authorize imports of glands and organs, including blood, as raw materials for the pharmaceutical processing industry, from third countries which appear on the list drawn up under Article 3 (1) and are not the subject of a ban. The general conditions to be complied with for the said imports shall be laid down in accordance with the procedure provided for in Article 30. In accordance with the procedure provided for in Article 29, Member States may be authorized to import the said raw materials from third countries which do not appear on the list referred to in the first subparagraph under conditions which take account of the specific health situation of the third countries concerned. The conditions relating to the said imports, established in accordance with the procedures referred to in the second and third subparagraphs, must in no case be more favourable than those governing intra-Community trade. Article 3 The Council, on the basis of a report by the Commission - together with any appropriate proposals - with re-examine, before 1 July 1995, the derogations provided for in Article 3 (d) of Directive 72/461/EEC and in Article 16 (2) of Directive 72/462/EEC. Article 4 The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1988. They shall forthwith inform the Commission thereof. Article 5 This Directive is addressed to the Member States. Done at Brussels, 21 May 1991. For the Council The President R. STEICHEN (1) OJ No C 154, 23. 6. 1990, p. 4. (2) OJ No C 129, 20. 5. 1991. (3) OJ No C 332, 31. 12. 1990, p. 27. (4) OJ No L 302, 31. 12. 1972, p. 24. (5) OJ No L 395, 30. 12. 1989, p. 13. (6) OJ No L 302, 31. 12. 1972, p. 28. (7) OJ No L 46, 19. 2. 1991, p. 37. (8) OJ No L 34, 5. 2. 1987, p. 52.

COUNCIL DIRECTIVE of 21 May 1991 amending Directive 72/461/EEC on health problems affecting intra-Community trade in fresh meat and Directive 72/462/EEC on health and veterinary inspection problems upon importation of bovine, ovine and caprine animals and swine and fresh meat or meat products from third countries (91/266/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 72/461/EEC (4), as last amended by Directive 89/662/EEC (5), lays down the health requirements which must be fulfilled by animals from which fresh meat is obtained for intra-Community trade; whereas Directive 72/462/EEC (6), as last amended by Directive 91/69/EEC (7), lays down health and veterinary inspection requirements applicable to imports of bovine, ovine and caprine animals and swine and fresh meat or meat products from third countries;

Whereas glands and organs, including blood, are within the scope of the abovementioned Directives; whereas they are required in large quantity by the pharmaceutical manufacturing industries of the Member States to ensure the availability of extracts and enzymes for human and veterinary medicine;

Whereas this means that Member States should be afforded the possibility of authorizing on a more liberal basis the importation from third countries of glands and organs, including blood, for pharmaceutical manufacturing purposes; whereas, with a view to ensuring the proper and specific use of such raw materials, authorization should be granted only when certain conditions, to be determined in accordance with a Community procedure, are fulfilled;

Whereas, in order to maintain Community preference, the same facilities should be applied in intra-Community trade in glands and organs, including blood, for pharmaceutical manufacturing purposes under certain minimum conditions which ensure the proper and specific use of such raw materials;

Whereas by its Judgment of 16 November 1989 in Case 131/87 the Court of Justice declared void Directive 87/64/EEC (8) which covered the aforementioned matters; whereas it is therefore necessary to adopt a new Directive on the appropriate legal basis;

Whereas, given this situation, the deadline for transposition laid down by Directive 87/64/EEC may be maintained,

HAS ADOPTED THIS DIRECTIVE: Article 1

The following paragraph shall be added to Article 3 of Directive 72/461/EEC:

'(d) However, until 31 December 1996, in their compliance with (a), (b) and (c), but by way of derogation from Article 8a, the Member States may, subject to an authorization granted by their veterinary authorities, authorize the introduction in their territory of glands and organs, including blood, as raw materials for the pharmaceutical processing industry.

Such authorization shall, moreover, be subject to compliance with the provisions concerning the identity of the materials in question, their packaging, transportation, storage, handling and processing and with those concerning the disposal of packaging, wrapping and residual matter following processing so that all public and animal health risks are eliminated.' Article 2 The present text of Article 16 of Directive 72/462/EEC shall become paragraph 1 and the following paragraph shall be added:

'2. However, Member States may, until 31 December 1996, authorize imports of glands and organs, including blood, as raw materials for the pharmaceutical processing industry, from third countries which appear on the list drawn up under Article 3 (1) and are not the subject of a ban.

The general conditions to be complied with for the said imports shall be laid down in accordance with the procedure provided for in Article 30.

In accordance with the procedure provided for in Article 29, Member States may be authorized to import the said raw materials from third countries which do not appear on the list referred to in the first subparagraph under conditions which take account of the specific health situation of the third countries concerned.

The conditions relating to the said imports, established in accordance with the procedures referred to in the second and third subparagraphs, must in no case be more favourable than those governing intra-Community trade. Article 3

The Council, on the basis of a report by the Commission - together with any appropriate proposals - with re-examine, before 1 July 1995, the derogations provided for in Article 3 (d) of Directive 72/461/EEC and in Article 16 (2) of Directive 72/462/EEC. Article 4

The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1988. They shall forthwith inform the Commission thereof. Article 5

This Directive is addressed to the Member States. Done at Brussels, 21 May 1991. For the Council

The President

R. STEICHEN (1) OJ No C 154, 23. 6. 1990, p. 4. (2) OJ No C 129, 20. 5. 1991. (3) OJ No C 332, 31. 12. 1990, p. 27. (4) OJ No L 302, 31. 12. 1972, p. 24. (5) OJ No L 395, 30. 12. 1989, p. 13. (6) OJ No L 302, 31. 12. 1972, p. 28. (7) OJ No L 46, 19. 2. 1991, p. 37. (8) OJ No L 34, 5. 2. 1987, p. 52.