COMMISSION REGULATION (EC) No 2316/98 of 26 October 1998 concerning authorisation of new additives and amending the conditions for authorisation of a number of additives already authorised 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 Directive 98/19/EC (2), and in particular Articles 9j and 3 thereof,
Whereas Directive 70/524/EEC provides that new additives or uses of additives may be authorised, taking account of advances in scientific and technical knowledge;
Whereas Council Directive 96/51/EC of 23 July 1996 amending Directive 70/524/EEC concerning additives in feedingstuffs (3) lays down a new procedure for the authorisation of additives by Regulation, which will be fully applicable from 1 October 1999; whereas during the transitional period the Member States must be able to adopt legal provisions to prevent any confusion as to the legislation in force; whereas the Member States must ensure that all legislation not complying with this Regulation is repealed;
Whereas new additives belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments` have been successfully tested in certain Member States; whereas the new additives should be provisionally authorised;
Whereas, in order to distinguish a new additive belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments` from another additive belonging to the same group which has already been authorised, the name of the latter should be changed;
Whereas new additives belonging to the group 'Trace elements`, and more specifically to the elements 'Copper-Cu`, 'Manganese-Mn` and 'Zinc-Zn`, have been widely tested in some Member States; whereas, on the basis of the studies carried out, it appears that these new additives can be authorised;
Whereas, to prevent any negative effects on dogs, the maximum permitted level in a complete feedingstuff of the additive Ethoxyquin, belonging to the group 'Antioxidants`, should be reduced;
Whereas a new use for an additive belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments` which has already been authorised has been successfully tested in some Member States; whereas the new use should be provisionally authorised;
Whereas a new use for the additive 3-phytase belonging to the group 'Enzymes` which has already been authorised has been successfully tested in some Member States; whereas the new use should be provisionally authorised;
Whereas, in the interests of transparency, the Annexes to this Regulation include, where appropriate, other additives belonging to the same group or other authorised uses of the additive; whereas it is appropriate to extend by a specific period the deadline for authorisation of additives, which are already authorised at national level but study of which has not been completed, belonging to the same groups of additives as the substances newly authorised by this Regulation;
Whereas the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Feedingstuffs,
1. Beta-carotene, belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments`, may be authorised in accordance with Directive 70/524/EEC as additive E 160a in feedingstuffs under the conditions laid down in Annex I to this Regulation.
2. Astaxanthin-rich Phaffia rhodozyma (ATCC 74219), belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments`, may be authorised in accordance with Directive 70/524/EEC as additive 12 in feedingstuffs under the conditions laid down in Annex I to this Regulation.
3. The substance 'cupric chelate of amino acids hydrate`, belonging to the group 'Trace elements`, element E4 'Copper-Cu`, shall be authorised in accordance with Directive 70/524/EEC as an additive in feedingstuffs under the conditions laid down in Annex II to this Regulation.
4. The substance 'manganese chelate of amino hydrate`, belonging to the group 'Trace elements`, element E5 'Manganese-Mn`, shall be authorised in accordance with Directive 70/524/EEC as an additive in feedingstuffs under the conditions laid down in Annex II to this Regulation.
5. The substance 'zinc chelate of amino acids hydrate`, belonging to the group 'Trace elements`, element E6 'Zinc-Zn`, shall be authorised in accordance with Directive 70/524/EEC as an additive in feedingstuffs under the conditions laid down in Annex II to this Regulation.
1. The conditions for authorisation of the additive E 324 Ethoxyquin, belonging to the group 'Antioxidants`, shall be replaced in accordance with Directive 70/524/EEC by the conditions laid down in Annex III to this Regulation.
2. Additive E161g Canthaxanthin, belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments` for the category of 'Pet and ornamental birds`, may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in Annex I to this Regulation.
3. Additive 3-phytase (EC 3.1.3.8), belonging to the group 'Enzymes`, may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in Annex IV to this Regulation.
4. Additive 11, Astaxanthin-rich Phaffia rhodozyma, belonging to Part 1 'Carotenoids and xanthophylls` of the group 'Colouring matters including pigments` for the category of animal 'Salmon, trout`, may be authorised in accordance with Directive 70/524/EEC under the conditions laid down in Annex I to this Regulation.
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.
It shall apply from 15 December 1998.
This Regulation shall be binding in its entirety and directly applicable in all Member States.