BAKGRUNN (fra kommisjonsforordningen)

(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 or modifying such authorisation. 

(2) The substance 4-hydroxy-2,5-dimethylfuran-3(2H)-one was authorised by Commission Implementing Regulation (EU) 2022/1452 as a feed additive for cats and dogs. 

(3) In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority (‘the Authority’) to issue an opinion on whether the authorisation of 4-hydroxy-2,5-dimethylfuran-3(2H)-one as a feed additive for cats and dogs would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, if the terms of that authorisation were modified. The modification relates to the increase of the maximum recommended content from 5 to 25 mg/kg complete feed for cats and dogs. The request was accompanied by the relevant supporting data. 

(4) The Authority concluded in its opinion of 13 March 2024 that 4-hydroxy-2,5- dimethylfuran-3(2H)-one is safe for dogs at the maximum recommended level of 25 mg/kg complete feed and for cats at 18 mg/kg complete feed. It also concluded that the additive is irritant to skin, eyes and to the respiratory tract and is a skin sensitiser. The Authority concluded that since 4-hydroxy-2,5-dimethylfuran-3(2H)-one is used in food as a flavouring and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

(5) The Commission considers that the authorisation of 4-hydroxy-2,5-dimethylfuran3(2H)-one still meets the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, when modifying the terms thereof as regards an increase of the maximum recommended level to 25 mg/kg complete feed for dogs and at 18 mg/kg complete feed for cats. In addition, 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. 

(6) Implementing Regulation (EU) 2022/1452 should therefore be amended accordingly. 

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