Summary |
: 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. 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 7.358 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 30 September 2020 that, under the proposed conditions of use, L-valine produced by Corynebacterium glutamicum CGMCC 7.358, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer health or the environment. With respect to the safety of the user of L-valine produced by Corynebacterium glutamicum CGMCC 7.358, the Authority could neither exclude a risk by inhalation, nor that the substance it is irritant to skin or eyes, or a dermal sensitiser. Therefore, appropriate protective measures should be taken for this additive to prevent adverse effects on human health, in particular as regards the users of the additive. Furthermore, the Authority concluded that the substance is considered an efficacious source of the essential amino acid L-valine for animal nutrition and that, in order to be efficacious in ruminants, it 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 7.358 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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