Commission Implementing Regulation (EU) 2022/1492 of 8 September 2022 concerning the authorisation of L-valine produced by Escherichia coli CCTCC M2020321 as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2022/1492of 8 September 2022concerning the authorisation of L-valine produced by Escherichia coli CCTCC M2020321 as a feed additive for all animal species(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionOJ L 268, 18.10.2003, p. 29., and in particular Article 9(2) thereof,Whereas:(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 an authorisation.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-valine produced by Escherichia coli CCTCC M2020321 as a feed additive for all animal species. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.(3)The application concerns the authorisation of L-valine produced by Escherichia coli CCTCC M2020321 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".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 27 January 2022EFSA Journal 2022;20(2):7163. that, under the proposed conditions of use, L-valine produced by Escherichia coli CCTCC M2020321, when supplemented to diets in appropriate amounts, does not have an adverse effect on animal health, consumer safety or the environment. As regards the safety of the additive for the user, the Authority could not conclude on the potential of the additive to be toxic by inhalation, irritant to skin or eyes, or on its potential to be a dermal or a respiratory sensitiser, and noted that the endotoxin activity of the additive does not represent a hazard for users handling the additive. Furthermore, 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 did 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.(5)In view of the Authority’s opinion, the Commission therefore considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.(6)The assessment of L-valine produced by Escherichia coli CCTCC M2020321 shows that the conditions for authorisation set out in Article 5 of Regulation (EC) No 1831/2003, are fulfilled.(7)The use of this substance should therefore be authorised as specified in the Annex to this Regulation.(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,HAS ADOPTED THIS REGULATION: