Commission Implementing Regulation (EU) 2015/46 of 14 January 2015 concerning the authorisation of diclazuril as a feed additive for chickens for fattening, for turkeys for fattening and for guinea fowl for fattening and breeding (holder of authorisation Huvepharma NV) Text with EEA relevance

• CELEX: Implementing Regulation (EU) 2015/46
• Articles: 3

Article 1 Authorisation

Diclazuril, CAS number 101831-37-2, belonging to the additive category ‘coccidiostats and histomonostas’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

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

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Coccidiostats and histomonostats

51775

Huvepharma NV.

Diclazuril 0,5 g/100 g (Coxiril)

Additive composition

Diclazuril: 5 g/kg.

Starch: 15 g/kg.

Wheat meal: 700 g/kg.

Calcium carbonate: 280 g/kg.

Characterisation of the 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.

Impurity D  ( 1 ) : ≤ 0,1 %.

Any other single impurity: ≤ 0,5 %.

Total impurities: ≤ 1,5 %.

Analytical method

( 2 )

For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Regulation (EC) No 152/2009)  ( 3 ) .

Chickens for fattening

Turkeys for fattening

Guinea fowl for fattening and for breeding

—

0,8

1,2

1.

The additive shall be incorporated in compound feed in the form of a premixture.

2.

Diclazuril 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 programme concerning the resistance to bacteria and Eimeria spp. shall be carried out by the holder of authorisation.

4 February 2025

Regulation (EU) No 37/2010  ( 4 )

—

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.

( 1 )   European Pharmacopoeia monograph 1718 (Diclazuril for Veterinary use).

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

( 3 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).

( 4 )   Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin ( OJ L 15, 20.1.2010, p. 1 ).