Commission Regulation (EC) No 162/2003 of 30 January 2003 concerning the authorisation of an additive in feedingstuffs (Text with EEA relevance)
Modified by
  • Commission Regulation (EC) No 1519/2007of 19 December 2007amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of certain additives in feedingstuffs belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance), 307R1519, December 20, 2007
Commission Regulation (EC) No 162/2003of 30 January 2003concerning the authorisation of an additive in feedingstuffs(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffsOJ L 270, 14.12.1970, p. 1., as last amended by Council Regulation No 1756/2002OJ L 265, 3.10.2002, p. 1., and in particular Article 9 thereof, Whereas: (1)Under Article 2(aaa) of Directive 70/524/EEC authorisations for putting coccidiostats into circulation are to be linked to the person responsible for putting them into circulation. Such authorisations may be given for a period of 10 years provided all the conditions laid down in Article 3a of that Directive are met. (2)The assessment of the request for authorisation submitted in respect of the coccidiostat preparation specified in the Annex to this Regulation, shows that the conditions referred to in Article 3a of Directive 70/524/EEC are satisfied. The coccidiostat preparation may therefore be authorised and included in Chapter I of the list of authorised additives in feedingstuffs referred to in Article 9t(b) of that Directive. (3)The Scientific Committee for Animal Nutrition has delivered a favourable opinion with regard to the safety and the favourable effects on animal productions of the coccidiostat preparation under the conditions set out in the Annex to this Regulation. (4)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Food Chain and Animal Health, HAS ADOPTED THIS REGULATION:
Article 1 The additive belonging to the group "Coccidiostats and other medicinal substances" listed in the Annex to this Regulation is authorised for use as additive in animal nutrition under the conditions laid down in the Annex.
Article 2 This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States. ANNEX
Coccidiostats and other medicinal substances
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 mg of active substance/kg of complete feedingstuff Other provisions End of period of authorisation
Minimum content Maximum content
E 771 Janssen Pharmaceutica NV Diclazuril 0,5 g/100 g(Clinacox 0,5 % 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 Chickens reared for laying 16 weeks 1 1 — 20.1.2013
Diclazuril 0,2 g/100 g(Clinacox 0,2 % Premix) 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 middlings: 60 g/100 g
Active substance: Diclazuril, C17H9Cl3N4O2 (±)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 (RO64318): ≤ 0,2 % other related impurities (RO66891, RO66896, (RO68610, RO70156, RO68584, RO70016): ≤ 0,5 % individually Total impurities: ≤ 1,5 %