(Utkast) Kommisjonens gjennomføringsforordning om godkjenningen av preparatet av Bacillus subtilis DSM 29784 som et fôrtilsetningsstoff til fjørfearter av mindre økonomisk betydning til slakt og verping (innehaver av godkjenningen Adisseo France SAS)
(Draft) Commission Implementing Regulation concerning the authorisation of the preparation of Bacillus subtilis DSM 29784 as a feed additive for minor poultry species for fattening and reared for laying (holder of authorisation Adisseo France SAS)
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) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Bacillus subtilis DSM 29784. 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 Bacillus subtilis DSM 29784 as a feed additive for minor poultry species for fattening and reared for laying, to be classified in the additive category 'zootechnical additives'.
(4) The preparation of Bacillus subtilis DSM 29784 belonging to the additive category of ‘zootechnical additives’, was authorised for ten years as a feed additive for chickens for fattening and chickens reared for laying by Commission Implementing Regulation (EU) 2018/328 .
(5) The European Food Safety Authority ('the Authority') concluded in its opinion of 21 February 2018 that, under the proposed conditions of use, the preparation of Bacillus subtilis DSM 29784 does not have an adverse effect on animal health, human health and the environment. The Authority also concluded that it can reasonably be assumed that the mode of action for minor poultry species is the same as for major poultry species (chickens for fattening). Consequently, the conclusion on efficacy for chickens for fattening can be extrapolated to minor poultry species for fattening and reared for laying. The Authority did 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 DSM 29784 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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