Commission Implementing Regulation (EU) No 667/2013 of 12 July 2013 concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003 Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 667/2013
• Articles: 5

Article 1

The preparation specified in the Annex, 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

Regulation (EC) No 162/2003 is repealed.

Article 3

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 2 February 2014 in accordance with the rules applicable before 2 August 2013 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

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

(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

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

Coccidiostats and histomonostats

51771

Eli Lilly and Company Ltd

Diclazuril 0,5 g/100 g

(Clinacox 0,5 %)

Additive composition

Diclazuril: 0,50 g/100 g

Protein-poor soybean meal: 99,25 g/100 g

Polyvidone K 30: 0,20 g/100 g

Sodium hydroxide: 0,05 g/100 g

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

Related impurities:

Degradation compound (R064318): ≤ 0,1 %

Other related impurities (T001434, R066891, R068610, R070156, R070016): ≤ 0,5 % individually

Total impurities: ≤ 1,5 %

Analytical method

( 1 )

For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Commission Regulation (EC) No 152/2009  ( 2 ) ).

For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two diagnostic product ions.

Chickens reared for laying

16 weeks

1

1

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.

2 August 2023

Commission Regulation (EU) No 37/2010  ( 3 )

( 1 )   Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

( 2 )

OJ L 54, 26.2.2009, p. 1 .

( 3 )

OJ L 15, 20.1.2010, p. 1 .