Commission Implementing Regulation (EU) 2024/231 of 12 January 2024 concerning the authorisation of a preparation of halofuginone hydrobromide (Stenorol) as a feed additive for chickens for fattening, turkeys for fattening and turkeys reared for breeding (holder of authorisation: Huvepharma NV)

• CELEX: Implementing Regulation (EU) 2024/231
• Articles: 4

Article 1 Authorisation

The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Transitional measures

1.   The preparation specified in the Annex and premixtures containing that preparation, which are produced and labelled before 4 August 2024 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the preparation specified in the Annex, which are produced and labelled before 4 February 2025 in accordance with the rules applicable before 4 February 2024 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 3 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

ANNEX

Identification number of the 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

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 %

Category: coccidiostats and histomonostats

51764

Huvepharma NV

Halofuginone hydrobromide (Stenorol)

Additive composition

Preparation of:

—

halofuginone hydrobromide: 0,6 %

—

povidone (polyvinylpyrrolidone): 1 %,

—

castor oil (macrogol glycerol ricinoleate): 2 %,

—

corn cobs: 96,4 %.

Solid form.

Characterisation of the active substance

Halofuginone hydrobromide:

—

C 16 H 17 BrClN 3 •HBr

—

CAS number: 64924-67-0

—

trans -(±)-7-bromo-6-chloro-3-[3-(3-hydroxy-2-piperidyl)-2-oxopropyl]-4(3H)-quinazolinone hydrobromide

—

Produced by chemical synthesis.

Impurities: cis -isomer of

halofuginone hydrobromide, cebrazolone, methoxy cebegine and melylcebegine: ≤ 0,5 % each.

Total impurities: ≤ 1 %.

Analytical methods

( 1 )

For the determination of halofuginone hydrobromide in the feed additive and premixtures: high performance liquid chromatography coupled with photometric detection (HPLC-UV).

For the determination of halofuginone hydrobromide in compound feed:

—

High performance liquid chromatography coupled with photometric detection (HPLC-UV) – Commission Regulation (EC) No 152/2009  ( 2 ) or

—

High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) – EN 17299.

For the determination of halofuginone hydrobromide in tissues: high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).

Chickens for fattening

—

2

3

1.

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

2.

Use prohibited at least 3 days before slaughter.

3.

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

4.

Halofuginone hydrobromide shall not be mixed with other coccidiostats.

5.

A post-market monitoring program on the resistance of Eimeria spp. to halofuginone hydrobromide shall be planned and executed by the holder of authorisation, in accordance with Commission Regulation (EC) No 429/2008  ( 3 ) .

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

4 February 2034

50 μg halofuginone/kg of wet liver;

40 μg halofuginone/kg of wet kidney;

3 μg halofuginone/kg of wet muscle;

10 μg halofuginone/kg of wet skin/fat.

Turkeys for fattening

12 weeks

Turkeys reared for breeding

12 weeks

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 2 )   Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed ( OJ L 54, 26.2.2009, p. 1 ).

( 3 )   Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives ( OJ L 133, 22.5.2008, p. 1 ).