Commission Implementing Regulation (EU) 2024/265 of 17 January 2024 concerning the authorisation of zinc(II)– betaine complex as a feed additive for all animal species except aquatic animals farmed in marine aquaculture systems
Commission Implementing Regulation (EU) 2024/265of 17 January 2024concerning the authorisation of zinc(II)– betaine complex as a feed additive for all animal species except aquatic animals farmed in marine aquaculture systems(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 zinc(II)– betaine complex. That 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 zinc(II)– betaine complex as a feed additive for all animal species, to be classified in the additive category "nutritional additives" and in the functional group "compounds of trace elements".(4)The European Food Safety Authority ("the Authority") concluded in its opinion of 11 January 2023EFSA Journal 2023;21(2):7819 that, under the proposed conditions of use, zinc(II)– betaine complex is safe for all animal species and consumers, provided that the maximum authorised levels for total zinc in feed are not exceeded. As regards the safety of zinc(II)– betaine complex for the environment, the available data do not allow to conclude on its safety for the marine sediment when that substance is used in sea cages. The Authority further concluded that zinc(II)– betaine complex is considered a skin and respiratory sensitiser, due to the presence of nickel. It is an eye irritant, but it is non-irritant to skin. The Authority concluded that the substance is efficacious as a source of zinc in covering the animals’ requirements The Authority did 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)In view of the above, the Commission considers that zinc(II)– betaine complex satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.(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: