Commission Regulation (EC) No 270/2009

of 2 April 2009

concerning the authorisation of 6-phytase as a feed additive for chickens for fattening (holder of the authorisation DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o.)

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 [1], and in particular Article 9(2) thereof,

Whereas:

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

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3) The application concerns the authorisation of the enzyme preparation 6-phytase produced by Aspergillus oryzae (DSM 17594), as a feed additive for chickens for fattening to be classified in the additive category "zootechnical additives".

(4) From the Opinion of the European Food Safety Authority (the Authority) of 18 November 2008 and of 29 October 2008 [2] it results that, based on the data provided by the applicant, the enzyme preparation 6-phytase, produced by Aspergillus oryzae (DSM 17594), as produced by the applicant DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o., does not have an adverse effect on animal health, human health or the environment and that it is efficacious in improving the utilisation of phytate-bound phosphorus. The Authority does not consider that there is a need for specific requirements of post market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

(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 specified in the Annex, belonging to the additive category "zootechnical additives" and to the functional group "digestibility enhancers", is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following that of 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, 2 April 2009.

For the Commission

Androulla Vassiliou

Member of the Commission

[1] OJ L 268, 18.10.2003, p. 29.

[2] The EFSA Journal (2008) 871, 1-18.

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ANNEX

Identification number of the additive | Name of the holder of authorisation | Additive | 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.

4a6 | DSM Nutritional Products Ltd represented by DSM Nutritional products Sp. Z o.o. | 6-phytase EC 3.1.3.26 | Additive compositionPreparation of 6-phytase produced by Aspergillus oryzae (DSM 17594) having a minimum activity of:Solid form: 10000 FYT [1]/gLiquid form: 20000 FYT/gCharacterisation of the active substance6-phytase produced by Aspergillus oryzae (DSM 17594)Analytical method [2]Colorimetric method based on reaction of vanadomolybdate on inorganic phosphate produced by action of 6-phytase on a phytate-containing substrate (sodium phytate) at pH 5,5 and 37 °C, quantified against a standard curve from inorganic phosphate. | Chickens for fattening | - | 1500 FYT | - | 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 kilogram of complete feedingstuff:chickens for fattening: 1500-3000 FYT;3.For use in compound feed containing more than 0,23 % phytin-bound phosphorus.4.For safety: breathing protection, glasses and gloves shall be used during handling. | 22 April 2019 |

[1] One FYT is the amount of enzyme that releases 1 μmol of inorganic phosphate from phytate per minute under reaction conditions with a phytate concentration of 5,0 mM at pH 5,5 and a temperature of 37 °C during 30 minutes incubation.

[2] Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives

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