(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 riboflavin produced from Eremothecium ashbyi CCTCCM 2019833, in the form of a dried inactivated fermentation product. 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 riboflavin produced from Eremothecium ashbyi CCTCCM 2019833, in the form of a dried inactivated fermentation product, as a feed additive for all animal species, requesting that additive to be classified in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 10 February 2021 (2) and 15 October 2024 (3) that, under the proposed conditions of use, riboflavin produced from Eremothecium ashbyi CCTCCM 2019833, in the form of a dried inactivated fermentation product, is safe for all animal species, consumers and the environment. It also concluded that it is not a skin/eye irritant nor a skin sensitiser, but it is considered a respiratory sensitiser. The Authority further concluded that riboflavin produced from Eremothecium ashbyi CCTCCM 2019833, in the form of a dried inactivated fermentation product, is effective in covering the animals’ requirements for vitamin B2, when administered via feed. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority 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.

(5) In view of the above, the Commission considers that riboflavin produced from Eremothecium ashbyi CCTCCM 2019833, in the form of a dried inactivated fermentation product, satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. 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.

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