(Utkast) Kommisjonens gjennomføringsforordning om godkjenningen av preparatet av Bacillus subtilis C-3102 (DSM 15544) som et fôrtilsetningsstoff for slaktegriser (innehaver av godkjenningen Asahi Calpis Wellness Co. Ltd, representert av Asahi Calpis Wellness Co. Ltd Europe Representative Office)
(Draft) Commission Implementing Regulation concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office)
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 5.7.2018
BAKGRUNN (fra kommisjonsforordningen, engelsk utgave)
(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) The preparation of Bacillus subtilis C-3102 (DSM 15544), belonging to the additive category of ‘zootechnical additives’, was authorised for ten years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 , for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds by Commission Regulation (EC) No 184/2011 , for weaned piglets by Commission Regulation (EC) No 333/2010 , for laying hens and ornamental fish by Commission Implementing Regulation (EU) 2016/897 .for sows, suckling piglets and dogs by Commission Implementing Regulation (EU) 2017/2312 .
(3) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) for pigs for fattening, requesting that the additive be classified in the additive category ‘zootechnical additives’.
(4) The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(5) The European Food Safety Authority ('the Authority') concluded in its opinion of 6 March 2018 that, under the proposed conditions of use, the preparation of Bacillus subtilis C-3102 (DSM 15544) does not have an adverse effect on animal health, human health and the environment and that it has the potential to improve the zootechnical performance of pigs for fattening. 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.
(6) The assessment of the preparation of Bacillus subtilis C-3102 (DSM 15544) 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.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed
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