Address https://gelex.eu/eli/EU/regulation/2014/291@2014-03-21/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
3. ANNEX
4. ANNEX

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 13(3) thereof,

Whereas:

(1) Regulation (EC) No 1831/2003 provides for the possibility to modify the authorisation of a feed additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority).

(2) The use of decoquinate belonging to the group of coccidiostats and other medicinal substances was authorised for 10 years in accordance with Council Directive 70/524/EEC as a feed additive for the use on chickens for fattening by Commission Regulation (EC) No 1289/2004.

(3) The holder of the authorisation submitted an application requesting a reduction in the authorised withdrawal time from three days to zero days before slaughter and the introduction of maximum residues limits (MRLs) for liver (1,0 mg/kg), kidney (0,8 mg/kg), muscle (0,5 mg/kg) and skin/fat (1,0 mg/kg) from animals fed with the additive. The holder of the authorisation submitted the relevant data to support its request.

(4) The Authority concluded in its opinion of 12 September 2013 that the modification from three days to zero days of withdrawal time does not compromise consumer safety and the new data submitted confirm that no MRLs are necessary.

(5) However, for the purpose of the feasibility of controls, it was considered appropriate to established MRLs as proposed by the applicant.

(6) The conditions provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

(7) Regulation (EC) No 1289/2004 should therefore be amended accordingly.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 1289/2004 is amended in accordance with the Annex to this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 21 March 2014. For the Commission The President José Manuel Barroso

ANNEX

ANNEX

The Annex to Regulation (EC) No 1289/2004 is replaced as follows:

ANNEX

Registration number of additive Name and registration number of person responsible for putting the additive into circulation Additive (Trade name) Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin mg of active substance/kg of complete feedingstuff with a moisture content of 12 % Coccidiostats and other medicinal substances E756 Zoetis Belgium SA Decoquinate (Deccox) Chickens for fattening 20 40 — 17 July 2014 1000 μg of decoquinate/kg of wet liver and wet skin+fat; 800 μg of decoquinate/kg of wet kidney; 500 μg of decoquinate/kg wet muscle.

Additive composition Decoquinate: 60,6 g/kg Refined deodorised soya oil: 28,5 g/kg Wheat middling: q.s. 1 kg

Active substance Decoquinate C24H35NO5 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: < 0,5 %

Analytical method 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 For the determination of decoquinate in tissues: Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS)

Versions

1. 2014-03-21

Cited by

• Commission Regulation (EU) 2017/2229 of 4 December 2017 amending Annex I to Directive 2002/32/EC of the European Parliament and of the Council as regards maximum levels for lead, mercury, melamine and decoquinate (Text with EEA relevance) Regulation · Grade B

  Commission Implementing Regulation (EU) No 291/2014 reduced the withdrawal time for decoquinate from three days to zero days. Therefore the provision for the unavoidable carry-over of decoquinate in withdrawal feed for chickens for fattening should be deleted.