Commission Regulation (EC) No 1743/2006

of 24 November 2006

concerning the permanent authorisation of an additive 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], and in particular Articles 3, and 9d(1) thereof,

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 [2], and in particular Article 25 thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

(2) Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for the authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003.

(3) The application for authorisation of the additive listed in the Annex to this Regulation was submitted before the date of application of Regulation (EC) No 1831/2003.

(4) Initial comments on this application, as provided for in Article 4(4) of Directive 70/524/EEC, was forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. This application is therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.

(5) Data were submitted in support of this application for authorisation without a time limit of the enzyme preparation of 6-phytase EC 3.1.3.26 produced by Schizosaccharomyces pombe (ATCC 5233) for chickens for fattening. On 20 April 2006 the European Food Safety Authority delivered its opinion on the safety and efficacy of that preparation.

(6) The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of that enzyme preparation, as specified in Annex to this Regulation, should be authorised without a time limit.

(7) The assessment of this application 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 [3].

(8) 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 specified in the Annex, is authorised without a time limit as an additives in animal nutrition under the conditions laid down in that Annex.

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, 24 November 2006.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).

[2] OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

[3] OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

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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 1640 | 6-Phytase EC 3.1.3.26 | Preparation of 6-Phytase produced by Schizosaccharomyces pombe (ATCC 5233) having a minimum activity of: Liquid form: 6-Phytase: 5000 FTU [1]/ml | Chickens for fattening | | 250 FTU | | 1.In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.2.Recommended dose per kg of complete feedingstuff: 250-750 FTU3.For use in compound feed containing more than 0,23 % phytin-bound phosphorus. | Without a time limit |

[1] One FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5.5 and 37 掳C.

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