Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/2046 13.10.2025 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 (Text with EEA relevance) THE EUROPEAN COMMISSION, Having...
Official Journal EN of the European Union L series 2025/2046 13.10.2025 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 (Text with EEA relevance) 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(1), and in particular Article 9(2) and Article 13(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and modifying such an authorisation.
(2) Canthaxanthin was authorised for 10 years as a feed additive for certain categories of poultry, ornamental fish and ornamental birds by Commission Implementing Regulation (EU) 2015/1486(2).
(3) In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority (‘the Authority’) to issue an opinion on whether the authorisation of canthaxanthin as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, if the terms of that authorisation were modified. The modification consists of the addition of a new production route by fermentation with Yarrowia lipolytica CBS 146148. The applicant stated that canthaxanthin, either synthetic or produced by fermentation, will only be placed on the market as a preparation. The request was accompanied by the relevant supporting data.
(4) The Authority concluded in its opinion of 26 November 2024(3)that the preparation of canthaxanthin produced by fermentation with Yarrowia lipolyticaCBS 146148 is safe for the target species, consumer and environment under the current authorised conditions of use. It also concluded that, in the absence of data with the preparation of canthaxanthin, no conclusions could be reached regarding its safety for the user. The Authority further concluded that canthaxanthin produced by fermentation with Yarrowia lipolyticaCBS 146148 is efficacious as a colouring agent in feed for chickens for fattening and minor poultry species for fattening, laying poultry and poultry reared for laying, ornamental fish and ornamental birds. Finally, it recommended adjusting the wording of the provision of the current authorisation regarding the mixture of the preparation of canthaxanthin with other carotenoids.
(5) In view of the above, the Commission considers that the preparation of canthaxanthin still satisfies the conditions, as
provided for in Article 5 of Regulation (EC) No 1831/2003, when modifying the terms of the authorisation with the addition of a new production route by fermentation with Yarrowia lipolyticaCBS 146148. In addition, the provision of Implementing Regulation (EU) 2015/1486 regarding the mixture of the preparation of canthaxanthin with other carotenoids should be adjusted in accordance with the recommendation of the Authority. Implementing Regulation
(EU) 2015/1486 should therefore be amended accordingly.
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) Commission 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 (OJ L 229, 3.9.2015, p. 5, ELI: http://data.europa.eu/ eli/reg_impl/2015/1486/oj).
(3) EFSA Journal, 23(1), e9134. https://doi.org/10.2903/j.efsa.2025.9134.
ELI: http://data.europa.eu/eli/reg_impl/2025/2046/oj 1/6EN OJ L, 13.10.2025
(6) In order to allow better control, a new identification number should be granted to canthaxanthin produced by fermentation with Yarrowia lipolyticaCBS 146148.
(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1 Amendment to Implementing Regulation (EU) 2015/1486 The Annex to Implementing Regulation (EU) 2015/1486 is replaced by Annex to this Regulation.
Article 2 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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 October 2025.
For the Commission The President Ursula VON DER LEYEN 2/6 ELI: http://data.europa.eu/eli/reg_impl/2025/2046/ojANNEX Minimum Maximum Maximum Identifica content content residue levels End of tion Species or Composition, chemical formula, Maximum period of number of Additive category of mg active substance/kg Other provisions description, analytical method age authorisa the feed animal complete feedingstuff tion additive 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 Chickens for - - 25 1. Canthaxanthin may be Poultry 23.9.2025 fattening and placed on the market and 15 mg Canthaxanthin minor poultry used as an additive canthaxan Triphenylphosphine oxide (TPPO) species for consisting of a preparation. thin/kg liver ≤ 100 mg/kg fattening (wet tissue)
2. The mixture of this additive and 2,5 mg Dichloromethane ≤ 600 mg/kg with other additives canthaxan containing canthaxanthin thin/kg skin/ Characterisation of the active substance Laying poultry - - 8 and other carotenoids is fat (wet — Canthaxanthin and poultry allowed provided that the tissue) — C H O reared for total concentration of the — CA40 S n52 um2 ber: 514-78-3 laying mixture does not exceed Laying 80 mg total carotenoids/kg poultry — Canthaxanthin, solid form, of complete feed. 30 mg produced by chemical synthesis.
canthaxan
3. For users of the additive and
Purity: thin/kg egg premixtures, feed business
Assay: min. 96 % yolk (wet operators shall establish tissue)
Carotenoids other than canthaxanthin: operational procedures and not more than 5 % of total colouring organisational measures to matters. address potential risks resulting from their use.
Method of analysis(1) Where those risks cannot be eliminated by such For the quantification of canthaxanthin procedures and measures,
in the feed additive: spectrophotometry the additive and premixtures at 426 nm. shall be used with personal For the quantification of canthaxanthin skin, eye and breathing
in the premixtures and feedingstuffs: protective equipment.
Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 466 nm).
ELI:
http://data.europa.eu/eli/reg_impl/2025/2046/oj 3/6 OJ L,
13.10.2025 ENMinimum Maximum Maximum Identifica content content residue levels End of tion Species or Composition, chemical formula, Maximum period of number of Additive category of mg active substance/kg Other provisions description, analytical method age authorisa the feed animal complete feedingstuff tion additive with 12 % moisture content 2a161gi Canthaxanthin Additive composition Chickens for - - 25 1. The mixture of this additive Poultry 23.9.2025 fattening and with other additives 15 mg Preparation containing minimum 10 % minor poultry containing canthaxanthin canthaxan of canthaxanthin species for and other carotenoids is thin/kg liver Dichloromethane ≤ 80 mg/kg fattening allowed provided that the (wet tissue) total concentration of the and 2,5 mg Characterisation of the active substance mixture does not exceed canthaxan 80 mg total carotenoids/kg thin/kg skin/ — Canthaxanthin, solid form, Laying poultry - - 8 of complete feed. fat (wet produced with Yarrowia lipolytica and poultry tissue) CBS 146148. reared for 2. For users of the additive and — C 40H 52O 2 laying premixtures, feed business Laying — CAS number: 514-78-3 operators shall establish poultry operational procedures and 30 mg
Purity: organisational measures to canthaxan
Assay: min. 96 % of total colouring address potential risks thin/kg egg matters (expressed as canthaxanthin) resulting from their use. yolk (wet
Carotenoids other than canthaxanthin: Where those risks cannot be tissue) not more than 5 % of total colouring eliminated by such matters. procedures and measures, the additive and premixtures Method of analysis (1) shall be used with personal skin, eye and breathing For the quantification of canthaxanthin protective equipment.
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).
(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.
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ELI:
http://data.europa.eu/eli/reg_impl/2025/2046/oj EN OJ L,
13.10.2025Minimum Maximum Maximum content content residue levels Identifica End of Species or tion number Composition, chemical formula, Maximum period of Additive category of mg active substance/kg Other provisions of the feed description, analytical method age authorisa animal complete feedingstuff additive tion 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 Ornamental - - 100 1. Canthaxanthin may be 23.9.2025 fish and placed on the market and Canthaxanthin ornamental used as an additive Triphenylphosphine oxide (TPPO) birds except consisting of a ≤ 100 mg/kg ornamental preparation.
breeder hens Dichloromethane ≤ 600 mg/kg 2. The mixture of this additive with other Characterisation of the active substance additives containing Ornamental - - 8 canthaxanthin and other — Canthaxanthin breeder hens carotenoids is allowed — C H O 40 52 2 provided that the total — CAS number: 514-78-3 concentration of the — Canthaxanthin, solid form, mixture does not exceed produced by chemical synthesis.
100 mg total carotenoids/
Purity: kg of complete feed.
Assay: min. 96 %
3. For users of the additive Carotenoids other than and premixtures, feed
canthaxanthin: business operators shall not more than 5 % of total colouring establish operational matters. procedures and organisational measures Method of analysis(1) to address potential risks resulting from their use.
For the quantification of Where those risks cannot
canthaxanthin in the feed additive: be eliminated by such spectrophotometry at 426 nm. procedures and measures, For the quantification of the additive and canthaxanthin in the premixtures premixtures shall be used
and feedingstuffs: Normal Phase High with personal skin, eye Performance Liquid Chromatography and breathing protective coupled to visible detection equipment. (NP-HPLC-VIS, 466 nm).
ELI:
http://data.europa.eu/eli/reg_impl/2025/2046/oj 5/6 OJ L,
13.10.2025 ENMinimum Maximum Maximum content content residue levels Identifica End of Species or tion number Composition, chemical formula, Maximum period of Additive category of mg active substance/kg Other provisions of the feed description, analytical method age authorisa animal complete feedingstuff additive tion with 12 % moisture content 2a161gi Canthaxanthin Additive composition Ornamental - - 100 1. The mixture of this 23.9.2025 fish and additive with other Preparation containing minimum ornamental additives containing 10 % of canthaxanthin birds except canthaxanthin and other Dichloromethane ≤ 80 mg/kg ornamental carotenoids is allowed breeder hens provided that the total Characterisation of the active substance concentration of the Ornamental - - 8 — Canthaxanthin, solid form, mixture does not exceed breeder hens produced with Yarrowia lipolytica 100 mg total carotenoids/ CBS 146148. kg of complete feed.
— C H O 40 52 2 2. For users of the additive — CAS number: 514-78-3 and premixtures, feed
Purity: business operators shall establish operational
Assay: min. 96 % of total colouring procedures and matters (expressed as canthaxanthin) organisational measures Carotenoids other than to address potential risks
canthaxanthin: resulting from their use. not more than 5 % of total colouring Where those risks cannot matters. be eliminated by such procedures and measures, Method of analysis(1) the additive and For the quantification of premixtures shall be used
canthaxanthin in the feed additive: with personal skin, eye spectrophotometry at 426 nm. and breathing protective equipment.
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).
(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.
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ELI:
http://data.europa.eu/eli/reg_impl/2025/2046/oj EN OJ L,
13.10.2025