Commission Implementing Regulation (EU) 2021/709 of 29 April 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/709of 29 April 2021concerning the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 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 authorisation.(2)In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-histidine monohydrochloride monohydrate. 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-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 as a feed additive for all animal species, to be classified in the category "nutritional additives".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 30 September 2020EFSA Journal 2020;18(11):6287. that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212, when supplemented at levels appropriate to the requirements of the target species, does not have an adverse effect on animal health, consumer health or the environment. With respect to the safety of the user of the additive, the Authority stated that L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 is a skin sensitiser and that there is a risk from exposure to endotoxins by inhalation. 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 L-histidine monohydrochloride monohydrate produced by Escherichia coli KCCM 80212 is an efficacious source of the essential amino acid L-histidine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. The Authority considered that there is no 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 that substance 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 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 Feed,HAS ADOPTED THIS REGULATION: