
Article 1 
The preparation specified in the Annex I, belonging to the additive category ‘coccidiostats and histomonostats’ is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2 
In Annex I to Regulation (EC) No 2430/1999, the entry under registration number of additive E 758 concerning robenidine hydrochloride for rabbits for breeding purposes is deleted.
Article 3 
The Annex to Regulation (EC) No 1800/2004 is amended in accordance with Annex II to this Regulation.
Article 4 
Premixtures and compound feed labelled in accordance with Directive 70/524/EEC and containing robenidine hydrochloride, 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, may continue to be placed on the market and used until the existing stocks are exhausted.
Article 5 
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 31 May 2011.
For the Commission
The President
José Manuel BARROSO
ANNEX I

Identification number of the additive Name of the holder of authorisation Additive(Trade name) Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Coccidiostats and histomonostats
5 1 758 Alpharma Belgium BVBA Robenidine hydrochloride 66g/kg(Cycostat 66G) 
 Additive composition
 Robenidine hydrochloride: 66 g/kg
 Lignosulfonate: 40 g/kg
 Calcium sulphate dihydrate: 894 g/kg
 Active substance
Robenidine hydrochloride,
C15H13Cl2N5 . HCl,
CAS number: 25875-50-7,
1,3-bis [(p-chlorobenzylidene) amino]-guanidine hydrochloride: > 97 %
Related impurities:
 N,N',N''-Tris[(p-Cl-benzylidene)amino]guanidine (TRIS): ≤ 0,5 %
 Bis-4[4-Cl-benzylidene]hydrazine (AZIN): ≤ 0,5 %
 Analytical methods
Determination of robenidine hydrochloride in feed: reverse phase high performance liquid chromatography coupled to ultraviolet spectrometry (HPLC/UV) in accordance with Method E in Annex IV to Commission Regulation (EC) No 152/2009. Rabbits for breeding — 50 66 
1. The additive shall be incorporated in compound feed in the form of a pre-mixture.

2. Robenidine hydrochloride shall not be mixed with other coccidiostats.

3. For safety: breathing protection, glasses and gloves shall be used during handling.

4. A post-market monitoring program on the resistance to Eimeria spp. shall be planned and executed by the holder of authorisation.

5. Use is prohibited at least 5 days before slaughter.
 21 June 2021 200 μg/kg wet weight for liver and kidney100 μg /kg wet weight for all other tissues
Rabbits for fattening 50 66


ANNEX II

The Annex to Regulation (EC) No 1800/2004 is replaced by the following:

ANNEX 
Registration number of the additive Name and the registration number of the person responsible for putting additive into circulation Additive(Trade name) Composition, chemical formula, description Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation
mg of active substance/kg of complete feedingstuff
Coccidiostats and other medicinal substances
E 758 Alpharma Belgium BVBA Robenidine hydrochloride 66 g/kg(Cycostat 66G) 
 Additive composition
 Robenidine hydrochloride: 66 g/kg
 Lignosulfonate: 40 g/kg
 Calcium sulphate dihydrate: 894 g/kg
 Active substance
Robenidine hydrochloride,
C15H13Cl2N5. HCl,
1,3-bis [(p-chlorobenzylidene) amino]-guanidine hydrochloride CAS number: 25875-50-7,
Related impurities:
 N,N',N''-Tris[(p-Cl-benzylidene)amino]guanidine (TRIS): ≤ 0,5 %
 Bis-4[4-Cl-benzylidene]hydrazine (AZIN): ≤ 0,5 % Chickens for fattening — 30 36 Use is prohibited at least 5 days before slaughter. 29 October 2014
Turkeys 30 36 Use is prohibited at least 5 days before slaughter. 29 October 2014
