Commission Implementing Regulation (EU) 2025/2046 of 10 October 2025 amending Implementing Regulation (EU) 2015/1486 as regards the terms of the authorisation of canthaxanthin as a feed additive for certain categories of poultry, ornamental fish and ornamental birds

Amendment to Implementing Regulation (EU) 2015/1486

Article 1

The Annex to Implementing Regulation (EU) 2015/1486 is replaced by Annex to this Regulation.

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 the feed additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions Maximum residue levels End of period of authorisation mg active substance/kg complete feedingstuff with 12 % moisture content   Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin 2a161g Canthaxanthin Additive composition Canthaxanthin Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Dichloromethane ≤ 600 mg/kg Characterisation of the active substance — Canthaxanthin — C 40 H 52 O 2 — CAS number: 514-78-3 — Canthaxanthin, solid form, produced by chemical synthesis. Purity: Assay: min. 96 % Carotenoids other than canthaxanthin: not more than 5 % of total colouring matters. Method of analysis  ( 1 ) For the quantification of canthaxanthin in the feed additive: spectrophotometry at 426 nm. For the quantification of canthaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 466 nm). Chickens for fattening and minor poultry species for fattening - - 25 1. Canthaxanthin may be placed on the market and used as an additive consisting of a preparation. 2. The mixture of this additive with other additives containing canthaxanthin and other carotenoids is allowed provided that the total concentration of the mixture does not exceed 80 mg total carotenoids/kg of complete feed. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. Poultry 15 mg canthaxanthin/kg liver (wet tissue) and 2,5 mg canthaxanthin/kg skin/fat (wet tissue) Laying poultry 30 mg canthaxanthin/kg egg yolk (wet tissue) 23.9.2025 Laying poultry and poultry reared for laying - - 8 2a161gi Canthaxanthin Additive composition Preparation containing minimum 10 % of canthaxanthin Dichloromethane ≤ 80 mg/kg Characterisation of the active substance — Canthaxanthin, solid form, produced with Yarrowia lipolytica CBS 146148. — C 40 H 52 O 2 — CAS number: 514-78-3 Purity: Assay: min. 96 % of total colouring matters (expressed as canthaxanthin) Carotenoids other than canthaxanthin: not more than 5 % of total colouring matters. Method of analysis  ( 1 ) For the quantification of canthaxanthin in the feed additive: spectrophotometry at 426 nm. For the quantification of canthaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 466 nm). Chickens for fattening and minor poultry species for fattening - - 25 1. The mixture of this additive with other additives containing canthaxanthin and other carotenoids is allowed provided that the total concentration of the mixture does not exceed 80 mg total carotenoids/kg of complete feed. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. Poultry 15 mg canthaxanthin/kg liver (wet tissue) and 2,5 mg canthaxanthin/kg skin/fat (wet tissue) Laying poultry 30 mg canthaxanthin/kg egg yolk (wet tissue) 23.9.2025 Laying poultry and poultry reared for laying - - 8 Identification number of the feed additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions Maximum residue levels End of period of authorisation mg active substance/kg complete feedingstuff with 12 % moisture content   Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds 2a161g Canthaxanthin Additive composition Canthaxanthin Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Dichloromethane ≤ 600 mg/kg Characterisation of the active substance — Canthaxanthin — C 40 H 52 O 2 — CAS number: 514-78-3 — Canthaxanthin, solid form, produced by chemical synthesis. Purity: Assay: min. 96 % Carotenoids other than canthaxanthin: not more than 5 % of total colouring matters. Method of analysis  ( 2 ) For the quantification of canthaxanthin in the feed additive: spectrophotometry at 426 nm. For the quantification of canthaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 466 nm). Ornamental fish and ornamental birds except ornamental breeder hens - - 100 1. Canthaxanthin may be placed on the market and used as an additive consisting of a preparation. 2. The mixture of this additive with other additives containing canthaxanthin and other carotenoids is allowed provided that the total concentration of the mixture does not exceed 100 mg total carotenoids/kg of complete feed. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.   23.9.2025 Ornamental breeder hens - - 8 2a161gi Canthaxanthin Additive composition Preparation containing minimum 10 % of canthaxanthin Dichloromethane ≤ 80 mg/kg Characterisation of the active substance — Canthaxanthin, solid form, produced with Yarrowia lipolytica CBS 146148. — C 40 H 52 O 2 — CAS number: 514-78-3 Purity: Assay: min. 96 % of total colouring matters (expressed as canthaxanthin) Carotenoids other than canthaxanthin: not more than 5 % of total colouring matters. Method of analysis  ( 2 ) For the quantification of canthaxanthin in the feed additive: spectrophotometry at 426 nm. For the quantification of canthaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 466 nm). Ornamental fish and ornamental birds except ornamental breeder hens - - 100 1. The mixture of this additive with other additives containing canthaxanthin and other carotenoids is allowed provided that the total concentration of the mixture does not exceed 100 mg total carotenoids/kg of complete feed. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment.   23.9.2025 Ornamental breeder hens - - 8 ( 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 )   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 .