Commission Implementing Regulation (EU) 2018/1568 of 18 October 2018 concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) as a feed additive for all pigs and all poultry species (Text with EEA relevance.)
Commission Implementing Regulation (EU) 2018/1568of 18 October 2018concerning the authorisation of a preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) as a feed additive for all pigs and all poultry species(Text with EEA relevance) 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 nutritionOJ L 268, 18.10.2003, p. 29., 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 a preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159). 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 a preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) as a feed additive for pigs and poultry, to be classified in the additive category "technological additives".(4)The European Food Safety Authority ("the Authority") in its opinion of 17 April 2018EFSA Journal 2018; 16(5):5269. concluded that, under the proposed conditions of use, the preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) does not have adverse effect on animal health, human health or the environment. It also concluded that it has the capability to degrade fumonisins in feed. 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.(5)The assessment of the preparation of fumonisin esterase produced by Komagataella phaffii (DSM 32159) shows that the conditions for authorisation, as 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 Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION:
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