Commission Regulation (EC) No 976/2008 of 6 October 2008 amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive Clinacox , belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)

Regulation (EC) No 976/2008 · Regulation · 7 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

In Annex I to Regulation (EC) No 2430/1999 the line for E 771 is replaced by the text in Annex I to this Regulation.

Article 2

Annex III to Regulation (EC) No 418/2001 is replaced by the text in Annex II to this Regulation.

Article 3

The Annex to Regulation (EC) No 162/2003 is replaced by the text in Annex III to this Regulation.

Article 4

This Regulation shall enter into force on the 20th day following that of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEX ISupplementary provisions

ANNEX I Registration number of additive Name and registration number of 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 mg of active substance/kg of complete feedingstuff Coccidiostats and other medicinal substances ‘E 771 Janssen Pharmaceutica nv Diclazuril 0,5 g/100 g (Clinacox 0,5 % Premix) Diclazuril 0,2 g/100 g (Clinacox 0,2 % Premix) Additive composition : Diclazuril: 0,5 g/100 g Soybean meal: 99,25 g/100 g Polyvidone K 30: 0,2 g/100 g Sodium hydroxide: 0,0538 g/100 g Diclazuril: 0,2 g/100 g Soybean meal: 39,7 g/100 g Polyvidone K 30: 0,08 g/100 g Sodium hydroxide: 0,0215 g/100 g Wheat middling: 60 g/100 g Active substance : Diclazuril C 17 H 9 Cl 3 N 4 O 2 , (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, CAS number: 101831-37-2 Related impurities : Degradation compound (R064318): ≤ 0,2 % Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually Total impurities: ≤ 1,5 % Chickens for fattening — 1 1 — 30.9.2009 1 500 μg diclazuril/kg of wet liver 1 000 μg diclazuril/kg of wet kidney 500 μg diclazuril/kg of wet muscle 500 μg diclazuril/kg of wet skin/fat’

ANNEX IISupplementary provisions

ANNEX II ‘ANNEX III Registration number of additive Name and registration number of 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 mg of active substance/kg of complete feedingstuff Coccidiostats and other medicinal substances E 771 Janssen Pharmaceutica nv Diclazuril 0,5 g/100 g (Clinacox 0,5 % Premix) Diclazuril 0,2 g/100 g (Clinacox 0,2 % Premix) Additive composition: Diclazuril: 0,5 g/100 g Soybean meal: 99,25 g/100 g Polyvidone K 30: 0,2 g/100 g Sodium hydroxide: 0,0538 g/100 g Diclazuril: 0,2 g/100 g Soybean meal: 39,7 g/100 g Polyvidone K 30: 0,08 g/100 g Sodium hydroxide: 0,0215 g/100 g Wheat middling: 60 g/100 g Active substance: Diclazuril C 17 H 9 Cl 3 N 4 O 2 , (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, CAS number: 101831-37-2 Related impurities: Degradation compound (R064318): ≤ 0,2 % Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually Total impurities: ≤ 1,5 % Turkeys for fattening 12 weeks 1 1 — 28.2.2011 1 500 μg diclazuril/kg of wet liver 1 000 μg diclazuril/kg of wet kidney 500 μg diclazuril/kg of wet muscle 500 μg diclazuril/kg of wet skin/fat’

ANNEX IIISupplementary provisions

ANNEX III ‘ANNEX Registration number of additive Name and registration number of 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 mg of active substance/kg of complete feedingstuff Coccidiostats and other medicinal substances E 771 Janssen Pharmaceutica nv Diclazuril 0,5 g/100 g (Clinacox 0,5 % Premix) Diclazuril 0,2 g/100 g (Clinacox 0,2 % Premix) Additive composition: Diclazuril: 0,5 g/100 g Soybean meal: 99,25 g/100 g Polyvidone K 30: 0,2 g/100 g Sodium hydroxide: 0,0538 g/100 g Diclazuril: 0,2 g/100 g Soybean meal: 39,7 g/100 g Polyvidone K 30: 0,08 g/100 g Sodium hydroxide: 0,0215 g/100 g Wheat middling: 60 g/100 g Active substance: Diclazuril C 17 H 9 Cl 3 N 4 O 2 , (±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile, CAS number: 101831-37-2 Related impurities: Degradation compound (R064318): ≤ 0,2 % Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually Total impurities: ≤ 1,5 % Chickens reared for laying 16 weeks 1 1 — 20.1.2013 1 500 μg diclazuril/kg of wet liver 1 000 μg diclazuril/kg of wet kidney 500 μg diclazuril/kg of wet muscle 500 μg diclazuril/kg of wet skin/fat’

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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