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

Regulation 3(1)

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 table19.

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 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)) or any other analytical method complying with the requirements set by Commission Decision 2002/657/EC concerning the performance of analytical methods and the interpretation of results20.

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)

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(2014)2704635 - 18/08/2014” and “JRC.D.5/SFB/CvH/MGH /mds/Ares” 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-2014-0014.

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