Diario Oficial de la Unión Europea del 8/2/2023 - Sección Legislación
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Source: Diario Oficial de la Unión Europea - Sección Legislación
EN
8.2.2023
Official Journal of the European Union
L 37/1
II
Non-legislative acts
REGULATIONS
COMMISSION IMPLEMENTING REGULATION EU 2023/263
of 7 February 2023
concerning the authorisation of sepiolitic clay as a feed additive for dairy ruminants, weaned and fattening Suidae, salmonids and chickens for fattening 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 nutrition 1, and in particular Article 92 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 an authorisation. Article 102 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC 2.
2
The substance sepiolitic clay was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species, belonging to the functional group binders, anticaking agents and coagulants. That substance was subsequently included in the Register of feed additives as an existing product, in accordance with Article 101, point b, of Regulation EC No 1831/2003.
3
In accordance with Article 102 of Regulation EC No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of sepiolitic clay as a feed additive for all animal species, requesting the additive to be classified in the additive category technological additives and in the functional groups binders and anticaking agents. That application was accompanied by the particulars and documents required under Article 73 of Regulation EC No 1831/2003.
4
The European Food Safety Authority the Authority concluded in its opinion of 4 May 2022 3 that, under the proposed conditions of use, sepiolitic clay is safe for dairy ruminants, weaned piglets, pigs for fattening and other growing Suidae at a level of 20 000 mg per kilo of complete feed, for salmonids at a level of 17 600 mg per kilo of complete feed and for chickens for fattening at a level of 10 000 mg per kilo of complete feed, and does not have an adverse effect on consumer safety or the environment. It could not conclude on the safety of the additive for other animal species and categories. The Authority also concluded that the additive poses a risk by inhalation for the user, in particular due to the presence of crystalline silica and of nickel in the additive, and that it is not irritant to the skin or eyes but should be considered as skin and respiratory sensitiser. The Authority concluded that the additive is efficacious as a binder and as an anticaking agent. It also verified the report on the method of analysis in feed submitted by the Reference Laboratory set up by Regulation EC No 1831/2003.
1 OJ L 268, 18.10.2003, p. 29.
2 Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs OJ L 270, 14.12.1970, p. 1.
3 EFSA Journal 2022;205:7344.
