Commission Implementing Regulation (EU) 2021/506 of 23 March 2021 concerning the authorisation of methanethiol as a feed additive for all animal species (Text with EEA relevance)
Commission Implementing Regulation (EU) 2021/506of 23 March 2021concerning the authorisation of methanethiol 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. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EECCouncil Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1)..(2)Methanethiol was authorised without a time limit, in accordance with Directive 70/524/EEC, as a feed additive for all animal species. This additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.(3)In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of methanethiol as a feed additive for all animal species.(4)The applicant requested the additive to be classified in the additive category "sensory additives" and in the functional group "flavouring compounds". That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.(5)The European Food Safety Authority ("the Authority") concluded in its opinions of 17 April 2013EFSA Journal 2013;11(5):3208. and 30 September 2020EFSA Journal 2020;18(11):6288. that, under the proposed conditions of use, methanethiol does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive should be considered as irritant to skin and eyes and to the respiratory tract and no conclusions could be drawn on skin sensitisation. 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 does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.(6)The assessment of methanethiol shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of methanethiol should be authorised as specified in the Annex to this Regulation.(7)Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.(8)The fact that the use of the substance concerned in water for drinking is not authorised does not preclude its use in compound feed which is administered via water.(9)Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of methanethiol, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.(10)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: