Canthaxanthin from Yarrowia lipolytica CBS 146148 fermentation as a new production route (2a161gi): spectrophotometry at 426 nm and NP-HPLC-VIS at 466 nm, dichloromethane ≤ 80 mg/kg in the fermentation preparation (≤ 600 mg/kg for the synthetic one)
Commission Implementing Regulation (EU) 2025/2046, published on 13 October 2025, replaces the annex to Regulation (EU) 2015/1486 and, alongside synthetic canthaxanthin (2a161g), authorises canthaxanthin produced by fermentation with the genetically modified yeast Yarrowia lipolytica CBS 146148 (2a161gi) — only as a preparation with at least 10 % canthaxanthin — for poultry for fattening and laying, ornamental fish and ornamental birds. The expiry date of the authorisation in the new annex is 23.9.2025 — earlier than the publication date of the act.
- Methods (the same for both production routes): canthaxanthin in the additive — spectrophotometry at 426 nm; in premixtures and feed — normal-phase high-performance liquid chromatography with visible detection (NP-HPLC-VIS, 466 nm). The EURL considered that the conclusions of the previous method evaluation remain valid. Purity of the active substance: at least 96 % of total colouring matters (as canthaxanthin), other carotenoids ≤ 5 %.
- EFSA data (opinion of 26 November 2024): five batches of fermentation-derived active substance — on average 99 % canthaxanthin (98–100 %); five batches of an example preparation (10 % canthaxanthin, 4.4 % BHT, dextrin, maize starch, 60.6 % lignosulfonate) — 10.3–11.5 % canthaxanthin, dichloromethane 25–66 mg/kg against a limit of 80 mg/kg. For synthetic canthaxanthin, dichloromethane ≤ 600 mg/kg and triphenylphosphine oxide (TPPO) ≤ 100 mg/kg still apply; TPPO is not required for the fermentation route. Dusting potential of the preparation 0.45–1.43 g/m³.
- Stability: after 12 months at 25 °C recovery 95 % (fermentation) and 90 % (synthetic); in a premixture with 5.4 % choline chloride on average 67 % after 6 months at 25 °C; pelleting at 90 °C without losses, 82–102 % after 3 months of feed storage. Homogeneity: CV 5.3 % in mash, 6.2–7.0 % in pelleted feed.
- Unchanged: maximum contents of 25 mg/kg (chickens for fattening), 8 mg/kg (laying poultry, ornamental breeder hens), 100 mg/kg (ornamental fish and birds) and the MRLs of 15 mg/kg liver and 2.5 mg/kg skin/fat in poultry and 30 mg/kg egg yolk. Following EFSA’s recommendation, the provision on mixtures now refers to the total carotenoid concentration — at most 80 mg/kg (100 mg/kg for ornamental fish and birds). In the absence of data on preparations, EFSA did not conclude on user safety.