(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 such an authorisation. 

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of 4-hydroxy-2,5-dimethylfuran-3(2H)-one. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 

(3) The application concerns the authorisation of 4-hydroxy-2,5-dimethylfuran-3(2H)-one, as a feed additive for all animal species, except cats and dogs, requesting that additive to be classified in the category ‘sensory additives’ and in the functional group ‘flavouring compounds’. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 24 June 2025 that, under the proposed conditions of use, 4-hydroxy-2,5-dimethylfuran3(2H)-one is safe for the target species as well as for consumers and the environment. The Authority also concluded that the additive is irritant to the skin, eyes and respiratory tract and is a dermal a respiratory sensitiser. Any exposure of users to 4- hydroxy-2,5-dimethylfuran-3(2H)-one is considered a risk. In addition, the Authority concluded that since 4-hydroxy-2,5-dimethylfuran-3(2H)-one is used in food as a flavouring in feed for cats and dogs, no further demonstration of efficacy is necessary. It did not consider that there is a need for specific requirements of post-market monitoring. 

(5) he Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 23 July 2012 are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005, an evaluation report of the Reference Laboratory was therefore not required. 

(6) In view of the above, the Commission considers that 4-hydroxy-2,5-dimethylfuran3(2H)-one satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for all animal species, except cats and dogs. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. 

(7) The Commission considers that safety reasons do not require the setting of maximum contents for 4-hydroxy-2,5-dimethylfuran-3(2H)-one. In order to allow better control, the recommended maximum content should be indicated on the label of the additive. Where the recommended maximum content is exceeded, certain information should be indicated on the label of the premixtures concerned. 

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