Commission Implementing Regulation (EU) 2020/2116 of 16 December 2020 concerning the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids and its extension of use to other finfish, and repealing Regulation (EC) No 244/2007 (Text with EEA relevance)
Commission Implementing Regulation (EU) 2020/2116of 16 December 2020concerning the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids and its extension of use to other finfish, and repealing Regulation (EC) No 244/2007(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 and renewing such authorisation.(2)L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 was authorised for 10 years as a feed additive for salmonids by Commission Regulation (EC) No 244/2007Commission Regulation (EC) No 244/2007 of 7 March 2007 concerning the authorisation of L-histidine monohydrochloride monohydrate as feed additive (OJ L 73, 13.3.2007, p. 6.)..(3)In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive for salmonids. The application included a request to change the strain designation to Escherichia coli NITE SD 00268 and was accompanied by the particulars and documents required under Article 14(2) of that Regulation. In addition, in accordance with Article 7 of that Regulation, the application requested an extension of use to other finfish. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 18 March 2020EFSA Journal 2020;18(4):6072. that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE SD 00268, 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. The Authority also concluded that while the additive in question is not a skin irritant, it was not possible to conclude on the potential for the additive to be toxic if inhaled, an irritant to eyes or a skin 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. The Authority also concluded that the additive is an efficacious source of the amino acid histidine for fish species. 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.(5)The assessment of L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE SD 00268 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 additive should be authorised as specified in the Annex to this Regulation.(6)As a consequence of the renewal of the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 244/2007 should be repealed.(7)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for L-histidine monohydrochloride monohydrate produced by Escherichia coli ATCC 9637, it is appropriate to provide for a transitional period to allow interested parties to prepare to meet the new requirements resulting from the renewal of the authorisation.(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: