The Feed Additives (Authorisations) (Wales) Regulations 2022

Regulation 3(1)

SCHEDULE 10 Authorisation of decoquinate (Deccox^®) (identification number 51756i) as a feed additive for chickens for fattening

The substance decoquinate specified in the table, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition subject to the conditions set out in the table(1).

(1) CAS Registry Number® assigned to this preparation by the Chemical Abstracts Service https://www.cas.org/cas-data/cas-registry.
(2) Details of the analytical methods set out in the document referenced “Ares(2013)3639174 - 04/12/2013 ” and last updated 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2013-0034.
(3) Under reference BS EN 16162:2012 “Animal feeding stuffs. Determination of decoquinate by HPLC with fluorescence detection”. Published by the British Standards Institution on 31 March 2012 (ISBN 978 0 580 67002 2). Available from the British Standards Institution https://knowledge.bsigroup.com.
(4) “Safety and efficacy of Deccox® (decoquinate) for chickens for fattening”. Published by the European Food Safety Authority (EFSA) in the EFSA Journal, Volume 17, Issue 1 on 14 January 2019. This document is available at the following address: https://www.efsa.europa.eu/en/efsajournal/pub/5541.
(5) Content of decoquinate (Deccox®) in mg/kg of complete feed with a moisture content of 12%.
Additive	Decoquinate (Deccox®)
Identification number of the additive	51756i
Authorisation holder	Zoetis Belgium SA
Additive category	Coccidiostats and Histomonostats
Functional group	None
Additive composition	Decoquinate, 60.0 g/kg Refined deodorised soya oil, 28.5 g/kg Colloidal silica, 0.6 g/kg Wheat middlings, q.s. 1kg
Characterisation of the active substance(s)	Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate) Chemical formula: C24H35NO5 CAS number(1): 18507-89-6
	Related impurities: Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate: < 1.0% 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: < 0.5% Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate: < 0.5%
Analytical methods(2)	For quantification of decoquinate in the feed additive, premixtures, feed materials and compound feed: Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) (BS EN 16162:2012(3)).
	For quantification of decoquinate in tissues: Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS(4)).
Species or category of animal	Chickens for fattening
Maximum age	None
Minimum content(5)	30 mg/kg
Maximum content(5)	40 mg/kg
Other provisions	1. In the directions for use of the feed additive and premixtures, the storage conditions and stability to heat treatment must be indicated.
	2. The feed additive must be incorporated in compound feed in the form of a premixture.
	3. Decoquinate must not be mixed with other coccidiostats.
	4. Decoquinate must not be used in feed containing bentonite.
	5. A post-market monitoring programme must be carried out by the holder of authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of that programme must be submitted to the Welsh Ministers by the end of 23 November 2031.

(1)

This authorisation replaces the authorisation of decoquinate (Deccox^®) under Commision Regulation (EC) No 1289/2004. That Regulation is revoked by regulation 8 of these Regulations but see the transitional provision in regulation 11. See also Schedule 11 to these Regulations, which contains a separate re-authorisation of decoquinate (Deccox^®), but in a modified form - decoquinate (Avi-Deccox^® 60G).