Commission Implementing Regulation (EU) 2021/2047 of 23 November 2021 concerning the authorisation of amprolium hydrochloride (COXAM) as a feed additive for chickens for fattening and chickens reared for laying (holder of authorisation: HuvePharma NV) (Text with EEA relevance)

Authorisation

Article 1

The substance 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.

Entry into force

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.

ANNEXSupplementary provisions

ANNEX Identification number of additive Name of the holder 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 51777 HuvePharma NV Amprolium hydrochloride (COXAM) Additive composition Amprolium HCl: 250 g/kg Liquid paraffin: 30 g/kg Rice hulls q.s . to 1,000 g. Characterisation of the active substance Amprolium hydrochloride (> 97,5 %purity) C 14 H 19 ClN 4 .HCl, (1-[(4-amino-2-propyl-5-pyrimidinyl)methyl]-2-methylpyridinium chloride monohydrochloride, CAS Number: 137-88-2 Related impurities: 2-picoline < 0,52 % sulfated ash ≤ 0,1 % Analytical method  ( 1 ) For the quantification of amprolium in the feed additive: — Reversed-Phase High Performance Liquid Chromatography using Ultraviolet detection at 268 nm (RP-HPLC-UV). For the quantification of amprolium in premixtures and feedingstuffs: — Cation exchange High Performance Liquid Chromatography using Ultraviolet detection at 264 nm (IE-HPLC-UV) – Regulation (EC) No 152/2009. Chickens for fattening Chickens reared for laying - 125 125 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, including skin and breathing protection. 14.12.2031 ( 1 )   https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports