(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 10(2) 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 10(1), point (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 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 7(3) 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.

(5)

The assessment of sepiolitic clay 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 additive should be authorised for dairy ruminants, weaned and fattening Suidae, salmonids and chickens for fattening. Supplementary information has been requested by the Commission to the applicant concerning the safety of the additive for the other animal species and categories. 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. Those protective measures should comply with Union legislation on worker safety requirements.

(6)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,