LegalizeCommission Implementing Regulation (EU) 2015/1486 of 2 September 2015 concerning the authorisation of canthaxanthin as feed additive for certain categories of poultry, ornamental fish and ornamental birds (Text with EEA relevance)
Article 1
The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’ is authorised as additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
1.
The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 23 March 2016 in accordance with the rules applicable before 23 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted.
2.
Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 23 September 2016 in accordance with the rules applicable before 23 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
3.
Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 23 September 2017 in accordance with the rules applicable before 23 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
Article 3
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.
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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg active substance/kg complete feedingstuff with 12 % moisture content | mg active substance/kg complete feedingstuff with 12 % moisture content | Other provisions | End of period of authorisation | |||||||
| Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | Category: sensory additives. Functional group: colourants: (ii) substances which, when fed to animals, add colours to food of animal origin | ||||||
| 2a161g | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Canthaxanthin | Additive composition Canthaxanthin Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Dichloromethane ≤ 600 mg/kg Characterisation of the active substance — Canthaxanthin — C40H52O2 — 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 [^E0001] 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). | Other provisions | Chickens for fattening and minor poultry species for fattening | End of period of authorisation | — | — | 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 |
| 2a161g | Laying poultry and poultry reared for laying | — | — | 8 | Canthaxanthin | Additive composition Canthaxanthin Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Dichloromethane ≤ 600 mg/kg Characterisation of the active substance — Canthaxanthin — C40H52O2 — 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 [^E0001] 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). | |||||||||
| 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. — C40H52O2 — 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 [^E0001] 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 | ||||||
| 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. — C40H52O2 — 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 [^E0001] 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). | Laying poultry and poultry reared for laying | — | — | 8 | 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 |
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.
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Identification number of the feed additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | mg active substance/kg complete feedingstuff with 12 % moisture content | mg active substance/kg complete feedingstuff with 12 % moisture content | Other provisions | End of period of authorisation | |||||||
| Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | Category: sensory additives. Functional group: colourants: (iii) substances which favourably affect the colour of ornamental fish or birds | ||||||
| 2a161g | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Canthaxanthin | Additive composition Canthaxanthin Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Dichloromethane ≤ 600 mg/kg Characterisation of the active substance — Canthaxanthin — C40H52O2 — 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 [^E0002] 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). | Other provisions | Ornamental fish and ornamental birds except ornamental breeder hens | End of period of authorisation | — | — | 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 | |
| 2a161g | Ornamental breeder hens | — | — | 8 | Canthaxanthin | Additive composition Canthaxanthin Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg Dichloromethane ≤ 600 mg/kg Characterisation of the active substance — Canthaxanthin — C40H52O2 — 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 [^E0002] 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). | |||||||||
| 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. — C40H52O2 — 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 [^E0002] 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 | |||||||
| 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. — C40H52O2 — 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 [^E0002] 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 breeder hens | — | — | 8 | 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 |
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.
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