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Commission Regulation (EC) No 2437/2000 of 3 November 2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives in feedingstuffs (Text with EEA relevance) Official Journal L 280 , 04/11/2000 P. 0028 - 0036

Commission Regulation (EC) No 2437/2000 of 3 November 2000 concerning the permanent authorisation of an additive and the provisional authorisation of new additives in feedingstuffs (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(1), as last amended by Commission Regulation (EC) No 1887/2000(2), and in particular Article 3 thereof, Whereas: (1) Directive 70/524/EEC provides that new additives shall be authorised, taking account of advances in scientific and technical knowledge. (2) Article 9d of the Directive provides that an additive of a type listed in Part II of Annex C to the Directive shall be authorised, where, following an evaluation of the dossier, all the conditions laid down in Article 3a of the Directive are met. (3) Article 9e of the Directive provides that an additive of the same type may be provisionally authorised for a period of up to four years where, following an evaluation of the dossier referred to above, the conditions of Article 3a(b) to (e) of the Directive are satisfied and if it is reasonable to assume, in view of the available results, that the conditions laid down in Article 3a(a) are also met. (4) The assessment of the dossier submitted shows that the micro-organism preparation described in Annexes I and II to this Regulation satisfies the conditions of Article 3a(b) to (e) of the Directive. Further, it satisfies the conditions of Article 3a(a) when used in relation to piglets. (5) It is also reasonable to assume, in view of the available results, that the conditions laid down in Article 3a(a) are met in relation to the use of the same micro-organism preparation for the categories of animals listed in Annex II to the Regulation. (6) The assessment of the dossiers submitted shows that the enzyme preparations described in Annex III to this Regulation satisfy the conditions for preliminary authorisation specified in Article 9e of the Directive, when used in relation to the categories of animal, and in accordance with the other provisions, specified in Annex III to this Regulation. (7) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(3) and its relevant individual directives, in particular Council Directive 90/679/EEC(4), as last amended by Commission Directive 97/65/EC(5), on the protection of workers from risks related to exposure to biological agents at work, are fully applicable to the use and manipulation by workers of the additives in feedingstuffs. (8) The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of the enzyme and micro-organism preparations and with regard to the favourable effect on piglets of the micro-organism preparation. (9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs, HAS ADOPTED THIS REGULATION: Article 1 The preparation belonging to the group "micro-organisms" listed in Annexes I and II to the present Regulation shall be authorised according to Directive 70/524/EEC as additive in animal nutrition under the conditions laid down in the said Annexes. Article 2 The preparations belonging to the group "enzymes" listed in Annex III to the present Regulation shall be authorised according to Directive 70/524/EEC as additives in animal nutrition under the conditions laid down in the said Annex. Article 3 This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 3 November 2000. For the Commission David Byrne Member of the Commission (1) OJ L 270, 14.12.1970, p. 1. (2) OJ L 227, 7.9.2000, p. 13. (3) OJ L 183, 29.6.1989, p. 1. (4) OJ L 374, 31.12.1990, p. 1. (5) OJ L 335, 6.12.1997, p. 17. ANNEX I >TABLE> ANNEX II >TABLE> ANNEX III >TABLE>

Commission Regulation (EC) No 2437/2000

of 3 November 2000

concerning the permanent authorisation of an additive and the provisional authorisation of new additives in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(1), as last amended by Commission Regulation (EC) No 1887/2000(2), and in particular Article 3 thereof,

Whereas:

(1) Directive 70/524/EEC provides that new additives shall be authorised, taking account of advances in scientific and technical knowledge.

(2) Article 9d of the Directive provides that an additive of a type listed in Part II of Annex C to the Directive shall be authorised, where, following an evaluation of the dossier, all the conditions laid down in Article 3a of the Directive are met.

(3) Article 9e of the Directive provides that an additive of the same type may be provisionally authorised for a period of up to four years where, following an evaluation of the dossier referred to above, the conditions of Article 3a(b) to (e) of the Directive are satisfied and if it is reasonable to assume, in view of the available results, that the conditions laid down in Article 3a(a) are also met.

(4) The assessment of the dossier submitted shows that the micro-organism preparation described in Annexes I and II to this Regulation satisfies the conditions of Article 3a(b) to (e) of the Directive. Further, it satisfies the conditions of Article 3a(a) when used in relation to piglets.

(5) It is also reasonable to assume, in view of the available results, that the conditions laid down in Article 3a(a) are met in relation to the use of the same micro-organism preparation for the categories of animals listed in Annex II to the Regulation.

(6) The assessment of the dossiers submitted shows that the enzyme preparations described in Annex III to this Regulation satisfy the conditions for preliminary authorisation specified in Article 9e of the Directive, when used in relation to the categories of animal, and in accordance with the other provisions, specified in Annex III to this Regulation.

(7) Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work(3) and its relevant individual directives, in particular Council Directive 90/679/EEC(4), as last amended by Commission Directive 97/65/EC(5), on the protection of workers from risks related to exposure to biological agents at work, are fully applicable to the use and manipulation by workers of the additives in feedingstuffs.

(8) The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of the enzyme and micro-organism preparations and with regard to the favourable effect on piglets of the micro-organism preparation.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group "micro-organisms" listed in Annexes I and II to the present Regulation shall be authorised according to Directive 70/524/EEC as additive in animal nutrition under the conditions laid down in the said Annexes.

Article 2

The preparations belonging to the group "enzymes" listed in Annex III to the present Regulation shall be authorised according to Directive 70/524/EEC as additives in animal nutrition under the conditions laid down in the said Annex.

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

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

Done at Brussels, 3 November 2000.

For the Commission

David Byrne

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.

(2) OJ L 227, 7.9.2000, p. 13.

(3) OJ L 183, 29.6.1989, p. 1.

(4) OJ L 374, 31.12.1990, p. 1.

(5) OJ L 335, 6.12.1997, p. 17.

ANNEX I

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ANNEX II

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ANNEX III

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