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Document 02011R0532-20131112
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 Zoetis Belgium SA ) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004 (Text with EEA relevance)
Consolidated text: 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 Zoetis Belgium SA ) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004 (Text with EEA relevance)
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 Zoetis Belgium SA ) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004 (Text with EEA relevance)
No longer in force
02011R0532 — EN — 12.11.2013 — 002.001
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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 ►M2 Zoetis Belgium SA ◄ ) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004 (OJ L 146 1.6.2011, p. 7) |
Amended by:
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Official Journal |
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No |
page |
date |
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COMMISSION IMPLEMENTING REGULATION (EU) No 118/2012 of 10 February 2012 |
L 38 |
36 |
11.2.2012 |
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COMMISSION IMPLEMENTING REGULATION (EU) No 1014/2013 of 22 October 2013 |
L 281 |
1 |
23.10.2013 |
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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 ►M2 Zoetis Belgium SA ◄ ) and amending Regulations (EC) No 2430/1999 and (EC) No 1800/2004
(Text with EEA relevance)
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
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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 |
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mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
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Coccidiostats and histomonostats |
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5 1 758 |
►M2 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 % |
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 kidney 100 μg /kg wet weight for all other tissues |
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Rabbits for fattening |
50 |
66 |
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(1)
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
(2)
OJ L 54, 26.2.2009, p. 1. |
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ANNEX II
The Annex to Regulation (EC) No 1800/2004 is replaced by the following:
‘ANNEX
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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 |
►M1 Maximum residue limits (MRLs) in the relevant foodstuffs of animal origin ◄ |
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mg of active substance/kg of complete feedingstuff |
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Coccidiostats and other medicinal substances |
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E 758 |
Alpharma Belgium BVBA |
Robenidine hydrochloride 66 g/kg ►M1 (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 |
Use is prohibited at least 5 days before slaughter. |
29 October 2014 |
►M1 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. ◄ |
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Turkeys |
30 |
36 |
Use is prohibited at least 5 days before slaughter. |
29 October 2014 |
►M1 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. ◄ ’ |
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( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 296, 17.11.1999, p. 3.
( 4 ) OJ L 317, 16.10.2004, p. 37.
( 5 ) EFSA Journal 2011;9(3):2102.