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Commission Regulation (EC) No 654/2000 of 29 March 2000 concerning the authorisation of new additives, new additive uses and new additive preparations in feedingstuffs (Text with EEA relevance) Official Journal L 079 , 30/03/2000 P. 0026 - 0035

Commission Regulation (EC) No 654/2000 of 29 March 2000 concerning the authorisation of new additives, new additive uses and new additive preparations 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 2690/1999(2) and in particular Article 3 thereof, Whereas: (1) Directive 70/524/EEC provides that new additives or new additive uses shall be authorised, taking account of advances in scientific and technical knowledge. (2) Council Directive 93/113/EC of 14 December 1993 concerning the use and the marketing of enzymes, micro-organisms and their preparations in animal nutrition(3), as last amended by Directive 97/40/EC(4), by derogation from Directive 70/524/EEC, authorised Member States to permit provisionally the use and marketing of enzymes, micro-organisms and their preparations. (3) New data were submitted for the replacement of authorised preparations of enzymes by new preparations of the same enzymes. (4) A provisional authorisation of new additives or new uses of additives shall be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock products, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs. (5) 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(5) and its relevant individual directives, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work(6), as last amended by Commission Directive 75/65/EC(7), are fully applicable to the use and manipulation by workers of the additives in feedingstuffs. (6) The examination of the dossiers, submitted by the Member States in accordance with Article 3 of Directive 93/113/EC, indicates that a certain number of preparations belonging to the groups of enzymes and micro-organisms can be provisionally authorised. (7) The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of these enzyme(8) and micro-organism(9) preparations. (8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Feedingstuffs, HAS ADOPTED THIS REGULATION: Article 1 The preparations belonging to the group "Enzymes" listed in Annex I 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 2 The particulars concerning the composition of the enzymes authorised under Nos "7" and "8" are modified, as indicated in Annex I, under the heading "Chemical formula, description". Article 3 The preparations belonging to the group "Micro-organisms" listed in Annex II 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 4 This Regulation shall enter into force on the third day following 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, 29 March 2000. For the Commission David Byrne Member of the Commission (1) OJ L 270, 14.12.1970, p. 1. (2) OJ L 326, 18.12.1999, p. 33. (3) OJ L 334, 31.12.1993, p. 17. (4) OJ L 180, 9.7.1997, p. 21. (5) OJ L 183, 29.6.1989, p. 1. (6) OJ L 374, 31.12.1990, p. 1. (7) OJ L 335, 6.12.1997, p. 17. (8) Report of the Scientific Committee for Animal Nutrition on the use of certain enzymes as additives in feedingstuffs, adopted on 4 June 1998, updated on 21 October 1999. (9) Report of the Scientific Committee for Animal Nutrition on the use of certain micro-organismes as additives in feedingstuffs, adopted on 26 September 1997, updated on 22 October 1999. ANNEX I >TABLE> ANNEX II >TABLE>

Commission Regulation (EC) No 654/2000

of 29 March 2000

concerning the authorisation of new additives, new additive uses and new additive preparations 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 2690/1999(2) and in particular Article 3 thereof,

Whereas:

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

(2) Council Directive 93/113/EC of 14 December 1993 concerning the use and the marketing of enzymes, micro-organisms and their preparations in animal nutrition(3), as last amended by Directive 97/40/EC(4), by derogation from Directive 70/524/EEC, authorised Member States to permit provisionally the use and marketing of enzymes, micro-organisms and their preparations.

(3) New data were submitted for the replacement of authorised preparations of enzymes by new preparations of the same enzymes.

(4) A provisional authorisation of new additives or new uses of additives shall be given if, at the level permitted in feedingstuffs, it does not adversely affect human or animal health or the environment, nor harm the consumer by altering the characteristics of livestock products, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has a favourable effect on the characteristics of those feedingstuffs or on livestock production when incorporated in such feedingstuffs.

(5) 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(5) and its relevant individual directives, in particular Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work(6), as last amended by Commission Directive 75/65/EC(7), are fully applicable to the use and manipulation by workers of the additives in feedingstuffs.

(6) The examination of the dossiers, submitted by the Member States in accordance with Article 3 of Directive 93/113/EC, indicates that a certain number of preparations belonging to the groups of enzymes and micro-organisms can be provisionally authorised.

(7) The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of these enzyme(8) and micro-organism(9) preparations.

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparations belonging to the group "Enzymes" listed in Annex I 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 2

The particulars concerning the composition of the enzymes authorised under Nos "7" and "8" are modified, as indicated in Annex I, under the heading "Chemical formula, description".

The preparations belonging to the group "Micro-organisms" listed in Annex II 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 4

This Regulation shall enter into force on the third day following 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, 29 March 2000.

For the Commission

David Byrne

Member of the Commission

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

(2) OJ L 326, 18.12.1999, p. 33.

(3) OJ L 334, 31.12.1993, p. 17.

(4) OJ L 180, 9.7.1997, p. 21.

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

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

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

(8) Report of the Scientific Committee for Animal Nutrition on the use of certain enzymes as additives in feedingstuffs, adopted on 4 June 1998, updated on 21 October 1999.

(9) Report of the Scientific Committee for Animal Nutrition on the use of certain micro-organismes as additives in feedingstuffs, adopted on 26 September 1997, updated on 22 October 1999.

ANNEX I

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ANNEX II

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