Commission Implementing Regulation (EU) 2021/1425 of 31 August 2021 concerning the authorisation of manganese chelate of lysine and glutamic acid as feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/1425of 31 August 2021concerning the authorisation of manganese chelate of lysine and glutamic acid as 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 manganese chelate of lysine and glutamic acid. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(3)The application concerns the authorisation of the preparation of manganese chelate of lysine and glutamic acid as a feed additive for all animal species to be classified in the additive category "nutritional additives" and the functional group "compounds of trace elements".(4)The European Food Safety Authority ("the Authority") concluded in its opinions of 10 January 2020EFSA Journal 2020;18(2):6001. and 27 January 2021EFSA Journal 2021;19(3):6454. that, under the proposed conditions of use, manganese chelate of lysine and glutamic acid does not have an adverse effect on animal health, consumer safety or the environment. The Authority concluded that the handling of the additive poses a risk to users by inhalation and that it should be considered as an eye irritant, skin and respiratory 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 concluded that the additive is efficacious in chickens for fattening; this conclusion can be extended to all other animal species. The Authority does not consider that there is a 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 manganese chelate of lysine and glutamic acid 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 preparation 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: