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Commission Implementing Regulation (EU) No 532/2011 of 31 May 2011 concerning the authorisation of robenidine hydrochloride as a feed additive for rabbits for breeding and rabbits for fattening (holder of authorisation Alpharma Belgium BVBA) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004 Text with EEA relevance

Type Implementing Regulation

Publication 2011-06-01

Last updated 2013-11-12

State Repealed

Department European Commission

Source EUR-Lex

articles 5

Reform history JSON API

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.

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
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	mg of active substance/kg of complete feedingstuff with a moisture content of 12 %	mg of active substance/kg of complete feedingstuff with a moisture content of 12 %	Other provisions	End of period of authorisation	Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
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	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats	Coccidiostats and histomonostats
5 1 758	Zoetis Belgium SA	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 [^E0006] 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 [^E0007].	Rabbits for breeding	—	50	66	Other provisions	End of period of authorisation	Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin	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 kidney 100 μg /kg wet weight for all other tissues
5 1 758	Zoetis Belgium SA	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 [^E0006] 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 [^E0007].	Rabbits for fattening	—	50	66

Details of the analytical methods are available at the following address of the European Union Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

OJ L 54, 26.2.2009, p. 1.

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 Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin

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 mg of active substance/kg of complete feedingstuff mg of active substance/kg of complete feedingstuff Other provisions End of period of authorisation Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin

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 Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances Coccidiostats and other medicinal substances

E 758 Alpharma Belgium BVBA Robenidine hydrochloride 66 g/kg (Robenz 66 G) 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 Other provisions End of period of authorisation Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin Use is prohibited at least 5 days before slaughter. 29 October 2014 800 μg robenidine hydrochloride/kg of wet liver. 350 μg robenidine hydrochloride/kg of wet kidney. 200 μg robenidine hydrochloride/kg of wet muscle. 1 300 μg robenidine hydrochloride/kg of wet skin/fat.

E 758 Alpharma Belgium BVBA Robenidine hydrochloride 66 g/kg (Robenz 66 G) 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 % Turkeys — 30 36 Use is prohibited at least 5 days before slaughter. 29 October 2014 400 μg robenidine hydrochloride/kg of skin/fat. 400 μg robenidine hydrochloride/kg of wet liver. 200 μg robenidine hydrochloride/kg of wet kidney. 200 μg robenidine hydrochloride/kg of wet muscle.’

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	Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
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	mg of active substance/kg of complete feedingstuff	mg of active substance/kg of complete feedingstuff	Other provisions	End of period of authorisation	Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin
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	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances	Coccidiostats and other medicinal substances
E 758	Alpharma Belgium BVBA	Robenidine hydrochloride 66 g/kg (Robenz 66 G)	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	Other provisions	End of period of authorisation	Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin	Use is prohibited at least 5 days before slaughter.	29 October 2014	800 μg robenidine hydrochloride/kg of wet liver. 350 μg robenidine hydrochloride/kg of wet kidney. 200 μg robenidine hydrochloride/kg of wet muscle. 1 300 μg robenidine hydrochloride/kg of wet skin/fat.
E 758	Alpharma Belgium BVBA	Robenidine hydrochloride 66 g/kg (Robenz 66 G)	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 %	Turkeys	—	30	36	Use is prohibited at least 5 days before slaughter.	29 October 2014	400 μg robenidine hydrochloride/kg of skin/fat. 400 μg robenidine hydrochloride/kg of wet liver. 200 μg robenidine hydrochloride/kg of wet kidney. 200 μg robenidine hydrochloride/kg of wet muscle.’

OJ L 268, 18.10.2003, p. 29.

OJ L 270, 14.12.1970, p. 1.

OJ L 296, 17.11.1999, p. 3.

OJ L 317, 16.10.2004, p. 37.

[^E0005]: (⁵) EFSA Journal 2011;9(3):2102.

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