Kommisjonens gjennomføringsforordning (EU) 2023/649 av 20. mars 2023 om godkjenningen av L-arginin fremstilt av Corynebacterium glutamicum CGMCC 20516 for alle dyrearter
Commission Implementing Regulation (EU) 2023/649 of 20 March 2023 concerning the authorisation of L-arginine produced by Corynebacterium glutamicum CGMCC 20516 for all animal species
Kommisjonsforordning publisert i EU-tidende 21.3.2023
BAKGRUNN (fra kommisjonsforordningen)
(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 L-arginine produced by Corynebacterium glutamicum CGMCC 20516. 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 L-arginine produced by Corynebacterium glutamicum CGMCC 20516 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 29 June 2022 that, under the proposed conditions of use, L-arginine produced by Corynebacterium glutamicum CGMCC 20516 does not have an adverse effect on consumer safety or the environment, or on animal health when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species and when nutritional imbalances caused by the simultaneous administration of L-arginine via water for drinking and feed are prevented.
(5) The Authority further concluded that exposure of users by inhalation is possible. The applicant provided the safety data sheet required in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council which demonstrates that the additive may cause eyes and skin irritation.
(6) The Authority concluded that the additive has the potential to be efficacious for all animal species. 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.
(7) The assessment of L-arginine produced by Corynebacterium glutamicum CGMCC 20516 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 substance should be authorised. 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.
(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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