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

(2)

The preparation of robenidine hydrochloride (Robenz 66G) was authorised, in accordance with Directive 70/524/EEC, as a feed additive for chickens for fattening by Commission Regulation (EC) No 1800/2004 (3). That preparation 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 thereof, an application was submitted for the re-evaluation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening. The applicant requested 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 24 January 2019 (4) that, under the proposed conditions of use, robenidine hydrochloride (Robenz 66G) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to effectively control coccidiosis in chickens for fattening. The Authority considered that there is a need for a field post-market monitoring of Eimeria spp., preferably during the latter part of the period of the authorisation. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of robenidine hydrochloride (Robenz 66G) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

(6)

As a consequence of this re-evaluation, Regulation (EC) No 1800/2004 should be amended accordingly.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, 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,

(1)

Article 2 is deleted;

(2)

the Annex is deleted.