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

AuthorisationI11

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 schedule54.

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: 185-7-89-655

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 methods56

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/EC57

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.