Address https://gelex.eu/eli/EU/regulation/2010/879@2010-10-06/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX 1.2.3.4.5.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 13(3) thereof,

Whereas:

(1) The use of 6-phytase (EC 3.1.3.26) (Quantum Phytase) as a feed additive for chickens for fattening, laying hens, ducks for fattening, turkeys for fattening and weaned piglets was authorised for 10 years by Commission Regulation (EC) No 554/2008 of 17 June 2008 concerning the authorisation of 6-phytase (EC 3.1.3.26) (Quantum Phytase) as a feed additive.

(2) In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has submitted an application with which it requests changing the terms of authorisation of that feed additive when used in laying hens by reducing the minimum recommended dose of 6-phytase (EC 3.1.3.26) (Quantum Phytase) from 2000 FTU/kg to 250 FTU/kg. That application was accompanied by the relevant data supporting the request for the change.

(3) The European Food Safety Authority concluded in its opinion of 10 March 2010 that the additive 6-phytase (EC 3.1.3.26) (Quantum Phytase) is efficacious in laying hens at the requested minimum dose of 250 FTU/kg of complete feed.

(4) The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

(5) Regulation (EC) No 554/2008 should therefore be amended accordingly.

(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 Annex to Regulation (EC) No 554/2008 is replaced by the text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 6 October 2010. For the Commission The President José Manuel Barroso

ANNEX

ANNEX 1.2.3.4.5.

Identification number of the additive Name of the holder of authorisation Additive (Trade name) Composition, chemical formula, description, analytical method 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 with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a5 AB Enzyme GmbH 6-phytase EC 3.1.3.26 (Quantum Phytase 2500 D Quantum Phytase 5000 L) Chickens for fattening — 500 FTU — In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. Recommended dose per kilogram of complete feedingstuff: For use in compound feed containing more than 0,25 % phytin-bound phosphorus. For use in weaned piglets up to approximately 35 kg. For safety: breathing protection glasses and gloves shall be used during handling. 8.7.2018 Laying hens — 250 FTU — Ducks for fattening — 250 FTU — Turkeys for fattening — 1000 FTU — Piglets (weaned) — 100 FTU —

Additive composition Preparation of 6-phytase produced by Pichia pastoris (DSM 15927) having a minimum activity of:

Solid form: 2500 FTU/g

Liquid form: 5000 FTU/ml

Characterisation of the active substance 6-phytase produced by Pichia pastoris (DSM 15927)

Analytical method Colorimetric method based on reaction of vanadomolybdate on organic phosphate produced by reaction on a phytate-containing substrate (sodium phosphate) at pH 5,5 and 37 °C.

chickens for fattening: 500-2500 FTU,

laying hens: 250 FTU,

ducks for fattening: 250-2000 FTU,

turkeys for fattening: 1000-2700 FTU,

piglets (weaned): 100-2500 FTU.

Versions

1. 2010-10-06