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

Authorisation

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 1Column 2
AdditiveDecoquinate (Deccox®)
Identification number of the additive51756i
Authorisation holderZoetis Belgium SA
Additive categoryCoccidiostats and Histomonostats
Functional groupNone
Additive composition

  • Decoquinate: 60.0g/kg

  • Refined deodorised soya oil: 28.5g/kg

  • Colloidal silica: 0.6g/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 No: 18507-89-6(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 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”(4)

2. For quantification of Decoquinate in tissues:

  • Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS)

Species or category of animalChickens for fattening
Maximum ageNot applicable
Content of Decoquinate (Deccox®) in mg/kg of complete feed with a moisture content of 12%Minimum content30 mg/kg
Maximum content40 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 authorisation for resistance to bacteria and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031.

(1)

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

(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(2013)3639174 – 04/12/2013” 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-2013-0034.

(4)

This standard was approved by the European Committee for Standardization (CEN) on 4 February 2012. Under reference BS EN 16162:2012, it was published as a UK standard by the British Standards Institution on 31 March 2012 (ISBN 978 0 580 67002 2).