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Commission Regulation (EC) No 971/2008 of 3 October 2008 concerning a new use of a coccidiostat as additive in feedingstuffs (Text with EEA relevance)

In forceVersion 2008-10-03from 2008-10-24
Grade B

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Contents
  1. Preamble
    1. Article 1
    2. Article 2
  3. ANNEX
  4. ANNEX

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 feedingstuffs, and in particular Articles 3 and 9 thereof,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 25 thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition.

(2) Article 25 of Regulation (EC) No 1831/2003 lays down transitional measures for applications for the authorisation of feed additives submitted in accordance with Directive 70/524/EEC before the date of application of Regulation (EC) No 1831/2003.

(3) The application for authorisation of the additive set out in the Annex to this Regulation was submitted before the date of application of Regulation (EC) No 1831/2003.

(4) Initial comments on that application, as provided for in Article 4(4) of Directive 70/524/EEC, were forwarded to the Commission before the date of application of Regulation (EC) No 1831/2003. That application is therefore to continue to be treated in accordance with Article 4 of Directive 70/524/EEC.

(5) The additive diclazuril (Clinacox 0,5 % Premix) is already authorised by Commission Regulations (EC) No 2430/1999 for chickens for fattening, (EC) No 418/2001 for turkeys for fattening and (EC) No 162/2003 for chickens reared for laying.

(6) New data were submitted by the holder of the authorisation of the additive in support of an application for authorisation for ten years as coccidiostat for rabbits. The European Food Safety Authority (the Authority) delivered two opinions on the safety of the use of that coccidiostat for humans, animals and environment, under the conditions set out in the Annex to this Regulation. The assessment shows that the conditions laid down in Article 3a of Directive 70/524/EEC for such authorisation are satisfied. Accordingly, the use of this preparation, as specified in Annex, should be authorised for ten years.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation belonging to the group Coccidiostats and other medicinal substances, as specified in the Annex, is authorised for use for ten years as additive in animal nutrition under the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the 20th day following that of 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, 3 October 2008. For the Commission Androulla Vassiliou Member of the Commission

ANNEX

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) Additive composition: Active substance: Related impurities: Rabbits — 1 1 Use prohibited at least one day before slaughter. 24 October 2018 2500 g diclazuril/kg of wet liver 1000 g diclazuril/kg of wet kidney 150 g diclazuril/kg of wet muscle 300 g diclazuril/kg of wet fat

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 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

Degradation compound (R064318): < 0,2 %

Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): < 0,5 % individually

Total impurities: < 1,5 %

Versions

  1. 2008-10-03

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