21.4.2022
EN
Official Journal of the European Union
L 119/85
(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,
HAS ADOPTED THIS REGULATION:
Article 1
Authorisation The substance specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Article 2
Withdrawal from the market Butylated hydroxyanisole (E 320) shall be withdrawn from the market as a feed additive for cats to the extent that it does not meet the conditions laid down in the authorisation referred to in Article 1.
(6) EFSA Journal 2021;19(7):6714.