(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. In particular, Article 10(2), in conjunction with Article 10(7) of that Regulation, provides for specific procedures for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Council Directive 82/471/EEC (3).

(2)

Butylated hydroxyanisole was authorised without a time limit as a feed additive for all animal species in accordance with Council Directive 70/524/EEC. This additive has been subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) 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 butylated hydroxyanisole as a feed additive for all animal species. The applicant has later withdrawn the application with regard to cats, due to the adoption by EFSA on 12 November 2019 (4) of a non-favourable opinion concerning the safety of the additive for use for cats. The re-evaluation of butylated hydroxyanisole resulted in the authorisation thereof as a feed additive for all animal species except cats, by Commission Implementing Regulation (EU) 2020/1399 (5).

(4)

Article 10(5) of Regulation (EC) No 1831/2003 requires the adoption of a Regulation withdrawing from the market feed additives for which no application in accordance with Article 10(2) and (7) of that Regulation was submitted before the deadline set in those provisions, or for which an application was submitted but subsequently withdrawn.

(5)

Since the applicant has withdrawn the application with regard to cats, butylated hydroxyanisole (E 320) should be withdrawn from the market as a feed additive for cats.

(6)

In accordance with Article 7 of Regulation (EC) No 1831/2003, a new application was submitted for the authorisation of butylated hydroxyanisole as a feed additive for cats, to be classified in the category ‘technological additives’ and in the functional group ‘antioxidants’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(7)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 June 2021 (6) that, under the proposed conditions of use, butylated hydroxyanisole does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive should be considered as a skin and eye irritant and a potential skin 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 also concluded that since butylated hydroxyanisole is authorised as an antioxidant for use in food at comparable use levels, no studies are required to demonstrate the efficacy of butylated hydroxyanisole as an antioxidant in feed for cats. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(8)

The assessment of butylated hydroxyanisole shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of butylated hydroxyanisole should be authorised as specified in the Annex to this Regulation.

(9)

As butylated hydroxyanisole as a feed additive for cats is ready to be newly authorised simultaneously to the adoption of a measure requiring a withdrawal from the market of the additive under the previous conditions of authorisation in accordance with Article 10(5) of Regulation (EC) No 1831/2003, such withdrawal from the market should not prevent the effective application of the new authorisation. The terms of the new authorisation differ from the previous ones in particular in that they provide for a more specific description of the additive and for the related methods of analysis, a new identification number of the additive and other provisions related to the directions of use and users’ safety for the additive and premixture concerned.

(10)

Since there is no safety reason requiring the immediate withdrawal from the market of butylated hydroxyanisole as a feed additive for cats under the previous conditions of authorisation, it is appropriate to allow a limited transitional period for interested parties, within which existing stocks of butylated hydroxyanisole as a feed additive for cats, premixtures, feed materials and compound feed produced with that additive may be used up, in order to meet the new requirements resulting from the authorisation.

(11)

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