Commission Implementing Regulation (EU) 2021/2094 of 29 November 2021 concerning the authorisation of decoquinate (Deccox and Avi-Deccox 60G) as a feed additive for chickens for fattening (holder of authorisation Zoetis Belgium SA) and repealing Regulation (EC) No 1289/2004 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/2094
• Articles: 6

Article 1 Authorisation

The substance decoquinate specified in the Annexes, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, subject to the conditions laid down in those Annexes.

Article 2 Repeal

Regulation (EC) No 1289/2004 is repealed.

Article 3 Transitional measures

The substance specified in Annex I and feed containing that substance, which are produced and labelled before 20 June 2022 in accordance with the rules applicable before 20 December 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4 Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX I

ANNEX I

Identification number of additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Additive category: coccidiostats and histomonostats

51756i

Zoetis Belgium SA

Decoquinate

(Deccox)

Additive composition:

Decoquinate: 60,0 g/kg

Soybean oil: 28,5 g/kg

Colloidal silica: 0,6 g/kg

Wheat middling: q.s. 1 kg

Characterisation of the active substance

Decoquinate

C 24 H 35 NO 5

Ethyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate

CAS number: 18507-89-6

Related impurities:

6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: < 0,5 %

Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate: < 1,0 %

Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate (aniline compound) < 0,5 %

Analytical method

( 1 )

For the determination of decoquinate in feed additive, premixtures and feedingstuffs:

Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162

Chickens for fattening

30

40

1.

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

2.

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

3.

The additive shall not be mixed with other coccidiostats.

4.

Post-market monitoring programmes shall be carried out by the holder of authorisation for: resistance to bacteria and Eimeria spp.

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.

20.12.2031

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

ANNEX II

ANNEX II

Identification number of additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Additive category: coccidiostats and histomonostats

51756ii

Zoetis Belgium SA

Decoquinate

(Avi-Deccox 60G)

Additive composition

Decoquinate: 60,0 g/kg

Colloidal silica: 0,6 g/kg

Silicon dioxide: 4,0 g/kg

Carboximethylcellulose sodium 30,0 g/kg

Calcium sulphate dihydrate q.s. ad 1 000,0  g

Characterisation of the active substance

Decoquinate

C 24 H 35 NO 5

Ethyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate

CAS number: 18507-89-6

Related impurities:

6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylic acid: < 0,5 %

Methyl-6-decycloxy-7-ethoxy-4-hydroxyquinoline-3-carboxylate: < 1,0 %

Diethyl-4-decycloxy-3-ethoxyanilinomethylenemalonate (aniline compound) < 0,5 %

Analytical method

( 1 )

For the determination of decoquinate in feed additive, premixtures and feedingstuffs:

—

Reversed-Phase High Performance Liquid Chromatography with fluorescence detection (RP-HPLC-FL) – EN 16162

Chickens for fattening

30

40

1.

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

2.

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

3.

The additive shall not be mixed with other coccidiostats.

4.

Post-market monitoring programmes shall be carried out by the holder of authorisation for: resistance to bacteria and Eimeria spp.

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks of their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.

20.12.2031

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports