Commission Regulation (EC) No 1501/2007 of 18 December 2007 concerning the authorisation of a new use of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2007/1501@2007-12-18/en
Contents
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, 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 a new use of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X), as a feed additive for ducks, to be classified in the additive category zootechnical additives.
(4) The use of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1453/2004, without a time limit for turkeys for fattening by Commission Regulation (EC) No 943/2005, without a time limit for laying hens by Commission Regulation (EC) No 1810/2005 and for ten years for piglets (weaned) by Commission Regulation (EC) No 497/2007.
(5) New data were submitted in support of an application for authorisation for ducks. The European Food Safety Authority (the Authority) concluded in its opinion of 10 July 2007 that the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X) does not have an adverse effect on animal health, human health or the environment. It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation for this additional animal category. According to that opinion, the use of that preparation is efficacious in digestibility of feedingstuffs. 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.
(6) 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.
(7) 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 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, 18 December 2007. For the Commission Markos Kyprianou Member of the Commission
ANNEX
ANNEX 1.2.3.
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 Unit of activity/kg of complete feedingstuff with a moisture content of 12 % Category of zootechnical additives. Functional group: digestibility enhancers 4a1613 Société Industrielle Lesaffre Endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) Ducks — 700 IFP — 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: 2800 IFP. For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 50 % wheat. 8.1.2018
Additive composition: Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum activity of:
Powder form: 70000 IFP/g
Liquid form: 7000 IFP/ml
Characterisation of the active substance: endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W)
Analytical method: Reducing sugar assay for endo-1,4-beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield.