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

Regulation 3

The substance of Decoquinate (Avi-Deccox® 60G), belonging to the additive ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition in accordance with the specifications in the following table19.

Additive

Decoquinate (Avi-Deccox® 60G)

Identification number of the additive

51756ii

Authorisation holder

Zoetis Belgium SA

Additive category

Coccidiostats and Histomonostats

Functional group

Not applicable

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: 18507-89-6(1)

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-ethoxyanilinomethylene-malonate: < 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) in accordance with 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)) or any other analytical method complying with the requirements set by Commission Decision 2002/657/EC20.

Species or category of animal

Chickens for fattening

Maximum age

Not applicable

Minimum content(5)

30 mg/kg

Maximum content(5)

40 mg/kg

Other provisions

  1. 1

    In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment must be indicated.

  2. 2

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

  3. 3

    Decoquinate must not be mixed with other coccidiostats.

  4. 4

    Decoquinate must not be used in feed containing bentonite.

  5. 5

    A post-market monitoring programme must be carried out by the holder of the authorisation for resistance to bacteria and Eimeria spp. A report containing the outcome of the post market monitoring programme must be submitted to the Secretary of State before 25th November 2031.

(1)

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.

(2)

Details of the analytical methods set out in the document referenced “Ares(2013)3639174 - 04/12/2013 ” and last updated 6th 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)

BS EN 16162:2012. “Animal feeding stuffs. Determination of decoquinate by HPLC with fluorescence detection”. Published by the British Standards Institution on 31st 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 in the EFSA Journal, Volume 17, Issue 1 on 14th January 2019. This document is available at the following address https://www.efsa.europa.eu/en/efsajournal/pub/5541.

(5)

Content of Decoquinate (Avi-Deccox®): mg/kg of complete feed with a moisture content of 12%.