(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)

Robenidine hydrochloride, CAS number 25875-50-7, was authorised for 10 years in accordance with Directive 70/524/EEC as a coccidiostat for use on rabbits for breeding by Commission Regulation (EC) No 2430/1999 (3) and for use on turkeys, chickens for fattening and rabbits for fattening by Commission Regulation (EC) No 1800/2004 (4). The additive was subsequently entered in the Register of Feed Additives as an existing product, 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 of that Regulation, an application was submitted for the re-evaluation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening, requesting that additive to be classified in the additive category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (the Authority) concluded in its opinion of 7 March 2011 that, under the proposed conditions of use, robenidine hydrochloride does not have an adverse effect on animal health, human health or the environment, and that the additive is effective in controlling coccidiosis in rabbits for fattening and for breeding (5). It also verified the report on the method of analysis of the feed additive in feed submitted by the European Union Reference Laboratory for Feed Additives set up by Regulation (EC) No 1831/2003.

(5)

The assessment of robenidine hydrochloride shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

(6)

As a consequence of a new authorisation being granted by this Regulation, the entry in Regulation (EC) No 2430/1999 concerning robenidine hydrochloride for rabbits for breeding purposes is deleted.

(7)

As a further consequence of this new authorisation, the entry for robenidine hydrochloride in the Annex to Regulation (EC) No 1800/2004 should be amended.

(8)

Since the modifications to the conditions of authorisation are not related to safety reasons, it is appropriate to allow a transitional period for the disposal of existing stocks of pre-mixtures and compound feed containing this preparation, as authorised by Regulation (EC) No 2430/1999 for use on rabbits for breeding purposes and by Regulation (EC) No 1800/2004 for use on rabbits for fattening.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,