The Feed Additives (Authorisations) (Scotland) Regulations 2022 No. 288

Regulation 3(2)

SCHEDULE 11 S Authorisation of Decoquinate (Avi-Deccox® 60G) (identification number 51756ii) as a feed additive for chickens for fattening

Authorisation S

1.  The substance Decoquinate specified in the table in this schedule, 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 in this schedule(1).

Table

Column 1		Column 2
Additive		Decoquinate (Avi-Deccox® 60G)
Identification number of the additive		51756ii
Authorisation holder		Zoetis Belgium SA
Additive category		Coccidiostats and Histomonostats
Functional group		None
Additive composition		Decoquinate: 60.0 g/kg Colloidal silica: 0.6 g/kg Silicon dioxide: 4.0 g/kg Carboxymethylcellulose sodium: 30.0 g/kg Calcium sulphate dihydrate: q.s. ad 1,000 g
Characterisation of the active substance(s)		Decoquinate: (Ethyl 6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate)
		Chemical Formula: C24H35NO5 CAS No: 185-7-89-6(2)
		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(3)		1. For the quantification of Decoquinate in the feed additive, premixtures and feed:
		Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) in accordance with European standard EN 16162:2012 entitled “Animal feeding stuffs – Determination of decoquinate by HPLC with fluorescence detection”
		2. For quantification of Decoquinate in tissues:
		Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any other analytical method complying with the requirements set by Retained EU Decision 2002/657/EC(4)
Species or category of animal		Chickens for fattening
Maximum age		Not applicable
Content of Decoquinate (Avi-Deccox®) in mg/kg of complete feed with a moisture content of 12%	Minimum content	30 mg/kg
	Maximum content	40 mg/kg
Other provisions		1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated. 2. The 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. Post-market monitoring programmes must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031.

Commencement Information

I1 Sch. 11 para. 1 in force at 24.11.2022, see reg. 1(1)

(1)

This authorisation is for a modified form of decoquinate (Deccox®), which was previously authorised under Regulation (EC) No. 1289/2004, and now authorised under schedule 10 of these Regulations.

(2)

This is a reference to the CAS Registry Number assigned to this substance by the Chemical Abstracts Service https://cas.org/cas-data/cas-registry.

(3)

Details of the analytical methods are set out in the document referenced “Ares(2014)2704635 – 18/08/2014” and “JRC.D.5/SFB/CvH/MGH/mds/Ares” and last updated on 6 June 2016. The document is available at the following address: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports/fad-2014-0014.

(4)

EUD 2002/657 as amended by S.I. 2020/1461.