(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 authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) were authorised as sources of vitamin B2 without a time limit as feed additives for all animal species in accordance with Directive 70/524/EEC. Those additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, two applications were submitted for the re-evaluation of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) for all animal species, requesting those additives to be classified in the additive category ‘nutritional additives’. One application concerns riboflavin produced by Ashbya gossypii (DSM 23096) and the other application concerns riboflavin and riboflavin 5′-phosphate ester monosodium salt, both produced by Bacillus subtilis (DSM 17339 and/or DSM 23984). Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

In accordance with Article 7 of Regulation (EC) No 1831/2003, one of the two applications also requested the authorisation of riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) as feed additives for all animal species for use in water for drinking. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003 for the use in water for drinking.

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 3 December 2015 (3) and 13 June 2018 (4) that, under the proposed conditions of use, riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) do not have adverse effects on animal health, consumer safety or the environment. It also concluded that the additives containing riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) are not irritant to skin and eyes. In the absence of data, the Authority cannot conclude on skin sensitisation. Riboflavin is a recognised as photosensitiser, which may elicit skin and eye photoallergic reactions. Workers might be exposed to a respirable dust when handling riboflavin and riboflavin 5′-phosphate sodium salt; in the absence of data on inhalation toxicity, the Authority cannot conclude on a possible risk by inhalation. Therefore, the Commission consider that appropriate protective measures should be taken to prevent effects on human health, in particular as regards the users of the additive. The Authority further concluded that riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) are effective sources of vitamin B2 in covering the animal's nutritional requirements. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis in feed and, where applicable, in water, submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(6)

The assessment of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied for the use in feed and for riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) also for the use in water for drinking. Accordingly, the use of those additives should be authorised as specified in the Annex to this Regulation.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substances concerned, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

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