Address https://gelex.eu/eli/EU/regulation/2004/1465@2004-08-17/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX 1.2.3.1.2.3.1.2.3.1.2.3.4.1.2.3.1.2.3.

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, and in particular Article 3 and Article 9d(1) thereof,

Whereas:

(1) Directive 70/524/EEC provides that no additive may be put into circulation unless a Community authorisation has been granted. The additives referred to in Part II of Annex C to that Directive may be authorised without a time limit subject to certain conditions being satisfied.

(2) The use of the enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 11857) was provisionally authorised, for the first time, for chickens for fattening, laying hens, turkeys for fattening, piglets and pigs for fattening by Commission Regulation (EC) No 1353/2000, and for sows by Commission Regulation (EC) No 261/2003.

(3) New data were submitted in support of the application for authorisation without a time limit of that preparation. The assessment shows that the conditions laid down in Directive 70/524/EEC for such an authorisation have been satisfied.

(4) Accordingly, the use of that preparation, under the conditions set out in the Annex, should be authorised without a time limit.

(5) The assessment of that preparation shows that certain procedures should be required to protect workers from exposure to the additive set out in the Annex. Such protection should 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.

(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group Enzymes, as set out in the Annex, is authorised for use without a time limit as an additive in animal nutrition under the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the third 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, 17 August 2004. For the Commission David Byrne Member of the Commission

ANNEX

(1) Solid form: 2500 FYT/g (2) Liquid form: 5000 FYT/g Anx. annex. EC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Units of activity/kg of complete feedingstuff Enzymes E 1614 6-phytase EC 3.1.3.26 Preparation of 6-phytase produced by Aspergillus oryzae (DSM 11857) having a minimum activity of: Chickens for fattening — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Laying hens — 300 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pellleting. Recommended dose per kg of complete feedingstuff: 450-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Turkeys for fattening — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Piglets — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. For use in weaned piglets until approximately 35 kg. Without a time limit Pigs for fattening — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Sows — 750 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 750-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit

ANNEX 1.2.3.1.2.3.1.2.3.1.2.3.4.1.2.3.1.2.3.

EC No Additive Chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Units of activity/kg of complete feedingstuff Enzymes E 1614 6-phytase EC 3.1.3.26 Preparation of 6-phytase produced by Aspergillus oryzae (DSM 11857) having a minimum activity of: Chickens for fattening — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Laying hens — 300 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pellleting. Recommended dose per kg of complete feedingstuff: 450-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Turkeys for fattening — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Piglets — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. For use in weaned piglets until approximately 35 kg. Without a time limit Pigs for fattening — 250 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 500-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit Sows — 750 FYT — In the directions for use of the additive and premixture, indicate the storage temperature, storage life and stability to pelleting. Recommended dose per kg of complete feedingstuff: 750-1000 FYT. For use in compound feed containing more than 0,25 % phytin-bound phosphorus. Without a time limit (1) Solid form: 2500 FYT/g (2) Liquid form: 5000 FYT/g

Solid form: 2500 FYT/g

Liquid form: 5000 FYT/g

Versions

1. 2004-08-17

Cited by

• Commission Regulation (EC) No 255/2005 of 15 February 2005 concerning the permanent authorisations of certain additives in feedingstuffs (Text with EEA relevance) Regulation · Grade B

  The use of the enzyme preparation of 6-phytase produced by Aspergillus oryzae (DSM 11857) was provisionally authorised, for the first time, for chickens for fattening, laying hens, turkeys for fattening, piglets and pigs for fattening by Commission Regulation (EC) No 1353/2000, and for sows by Commission Regulation (EC) No 261/2003. The use of this enzyme preparation was authorised without a time limit for these animal categories by Commission Regulation (EC) No 1465/2004.