Commission Regulation (EC) No 1353/2000
of 26 June 2000
concerning the permanent authorisation of an additive and the provisional authorisation of new additives, new additive uses and new 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 Directive 1999/20/CE(2) and in particular Article 3 thereof,
Whereas:
(1) Directive 70/524/EEC provides that new additives or new uses of additives shall be authorised, taking account of advances in scientific and technical knowledge.
(2) A permanent authorisation of a preparation belonging to the group of enzymes shall be given if all conditions laid down in Article 3(a) of Directive 70/524/EEC are met.
(3) Data were submitted for the permanent authorisation of the 3-phytase (EC 3.1.3.8) produced by Aspergillus niger (CBS 114.94), which is described in the Annex.
(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 product, if its presence in feedingstuffs can be controlled, and it is reasonable to assume, in view of the available results, that it has favourable effect on the characteristics of those feedingstufffs or on livestock production when incorporated in such feedingstuffs.
(5) Data were submitted for the provisional authorisations of new enzymes and micro-organisms, of new uses of enzymes and for the replacement of authorised preparations of enzymes by new preparations of the same enzymes.
(6) Council Directive 89/391/EEC(3) on the introduction of measures to encourage improvements in the safety and health of workers at work and its relevant individual directives, in particular Council Directive 90/679/EC(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.
(7) The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the harmlessness of these enzyme and micro-organism preparations and with regard to the favourable effect on animal production of the enzyme preparation for which an authorisation without a time limit is proposed.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,
The preparation belonging to the group "Enzymes" listed in Annex I 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 Annex.
The conditions for the authorisation of the preparations No 16 and No 17 belonging to the group "Enzymes" listed in Annex II to the present Regulation are hereby replaced by those set out in the said Annex according to Directive 70/524/EEC.
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.
The preparation belonging to the group "Micro-organisms" listed in Annex IV 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 twentieth 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.