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 such an authorisation.

(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445. 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 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445, 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’. The applicant also requested the additive to be authorised for use in water for drinking.

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022 (2) that, under the proposed conditions of use, riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445 is safe for all animal species, consumers and the environment. It also concluded that is not a skin/eye irritant, and it is not considered a respiratory sensitiser and that riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The Authority further concluded that riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445 is effective in covering the animals’ requirements for vitamin B2, when administered via feed and/or water for drinking. 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 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445 satisfies the conditions for authorisation 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 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,