Kommisjonens gjennomføringsforordning (EU) 2019/764 av 14. mai 2019 om godkjenning av et preparat av Lactobacillus hilgardii (CNCM I-4785) og Lactobacillus buchneri CNCM I-4323/NCIMB 40788 som et tilsetningsstoff til fôrvarer til alle dyrearter
Commission Implementing Regulation (EU) 2019/764 of 14 May 2019 concerning the authorisation of a preparation of Lactobacillus hilgardii (CNCM I-4785) and Lactobacillus buchneri CNCM I-4323/NCIMB 40788 as a feed additive for all animal species.
Kommisjonsforordning publisert i EU-tidende 15.5.2019
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 Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchneri CNCM I-4323/NCIMB 40788. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of a preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchneri CNCM I-4323/NCIMB 40788 as a feed additive for all animal species to be classified in the additive category ‘technological additives’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 October 2018 that, under the proposed conditions of use, the preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchneri CNCM I-4323/NCIMB 40788 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is considered a potential respiratory sensitiser and that no conclusion could be drawn on skin or eyes sensitisation or irritation by the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation concerned has the potential to improve the production of silage from easy and moderately difficult to ensile forage materials. 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 Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchneri CNCM I-4323/NCIMB 40788 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 Fee
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