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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 an authorisation. In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation. The application concerns the authorisation of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 as a feed additive for all animal species, to be classified in the additive category 'nutritional additives', functional group 'amino acids, their salts and analogues'. The European Food Safety Authority ('the Authority') concluded in its opinion of 17 March 2021 that, under the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 7.366, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer safety or the environment. With respect to the safety of the user of that additive, the Authority could neither exclude a risk by inhalation, nor that L-valine might be irritant to skin or eyes, or a dermal sensitiser. 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. Further, the Authority concluded that it is considered an efficacious source of the essential amino acid L-valine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. The assessment of L-valine produced by Corynebacterium glutamicum CGMCC 7.366 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.
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