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The Feed Additives (Authorisations) (Scotland) Regulations 2022

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Authorisation

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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 (Avi-Deccox® 60G)
Identification number of the additive51756ii
Authorisation holderZoetis Belgium SA
Additive categoryCoccidiostats and Histomonostats
Functional groupNone
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 animalChickens for fattening
Maximum ageNot applicable
Content of Decoquinate (Avi-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 the authorisation for resistance to bacteria and Eimeria spp and submitted to the Scottish Ministers by the end of 23 November 2031.

(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.

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