Commission Regulation (EC) No 418/2001
of 1 March 2001
concerning the authorisations of new additives and uses of 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 2697/2000(2), and in particular Article 4 thereof,
Whereas:
(1) Directive 70/524/EEC provides that new additives or uses of additives may be authorised following the review of an application made in accordance with article 4 of the Directive.
(2) Article 9e(1) of the Directive provides that provisional authorisation of new additives or uses of additives may be given if the conditions of Articles 3a(b) to (e) of Directive 70/524/EEC are satifisfied and if its reasonable to assume, in view of the available results, that when used in animal nutrition it has one of the effects referred to in Article 2(a). Such provisional authorisation may be given for a period up to four years in the case of additives referred to in Part II of Annex C to the Directive.
(3) The assessment of dossiers submitted shows that the new micro-organism and enzyme preparations and the new uses of the micro-organism and enzyme preparations described in Annex I and II satisfy the abovementioned conditions and may therefore be authorised on a provisional basis for a four-year period.
(4) Article 2(aaa) of Directive 70/524/EEC requires authorisations for coccidiostats to be linked to the person responsible for putting them into circulation.
(5) Article 9b of Directive 70/524/EEC provides that the authorisations of such substances shall be given for a period of 10 years from the date on which final authorisation takes effect, if all conditions laid down in Article 3a of Directive 70/524/EEC are met.
(6) The assessment of the dossier submitted shows that the coccidiostat described in Annex III satisfies all the requirements of Article 3a, when used in the anidmal category and under the conditions described in the said Annex.
(7) The assessment of the dossiers shows that certain procedures may be required to protect workers from exposure to the additives. Such protection should however be assured by the application of 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 the Directives made under it.
(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 of the coccidiostat, and with regard to the favourable effect on animal production of the latter, under the conditions described in the said Annexes.
(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,
The preparations belonging to the group "Micro-organisms" listed in Annex I to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.
The preparations belonging to the group "Enzymes" listed in Annex II to the present Regulation are authorised for use as additives in animal nutrition under the conditions laid down in that Annex.
The additive belonging to the group "Coccidiostats and other medicinal substances" listed in Annex III to the present Regulation is authorised for use as additive in animal nutrition under the conditions laid down in that Annex.
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.
It shall apply from 1 March 2001.
This Regulation shall be binding in its entirety and directly applicable in all Member States.