(Utkast) Kommisjonens gjennomføringsforordning om godkjenningen av et preparat av Saccharomyces cerevisiae CNCM I-1079 som fôrtilsetningsstoff til smågris og avlspurker og om endring av forordning (EF) nr. 1847/2003 og (EF) nr. 2036/2005 (innehaver av godkjenningen Danstar Ferment AG representert av Lallemand SAS)
(Draft) Commission Implementing Regulation concerning an authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for sows and piglets and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)
Utkast til kommisjonsforordning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.2.2018
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. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.
(2) The preparation of Saccharomyces cerevisiae CNCM I-1079 was authorised without a time limit as feed additive for piglets by Commission Regulation (EC) No 1847/2003 and for sows by Commission Regulation (EC) 2036/2005 . That additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.
(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as feed additive for sows and piglets. The applicant requested that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 20 April 2016 and 4 July 2017 that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1079 does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive is efficacious in sows in order to have a benefit in suckling piglets and in weaned piglets in order to have a significant improvement of feed to gain ratio. 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 Saccharomyces cerevisiae CNCM I-1079 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) Regulations (EC) No 1847/2003 and (EC) No 2036/2005 should be amended accordingly.
(7) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
(8) 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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