Beta-carotene in feed for another 10 years: the previously recommended 50 mg/kg in calf milk replacers becomes a maximum content, triphenylphosphine oxide up to 100 mg/kg — Regulation (EU) 2026/1148
Commission Implementing Regulation (EU) 2026/1148 of 28 May 2026, published on 29 May, renews until 18 June 2036 the authorisation of beta-carotene (3a160) and a beta-carotene preparation containing at least 10% of the substance (3a160i) as nutritional additives for all animal species and repeals Regulation (EU) 2015/1103. For calves (milk replacers) it sets a maximum content of 50 mg/kg complete feed.
- According to EFSA (opinion of 25 June 2025), beta-carotene produced by chemical synthesis remains safe for animals, consumers and the environment, but in the absence of an acceptable daily intake supplementation should not significantly add to consumer exposure, and consumption of liver from veal calves may cause such additional exposure. The previous 2015 authorisation only recommended a maximum of 50 mg beta-carotene per kg in calf milk replacers; it is now a binding value.
- Specification of both additives: beta-carotene (CAS 7235-40-7) in solid form from chemical synthesis, at least 96% total colouring matters on a dry basis expressed as beta-carotene, carotenoids other than beta-carotene ≤ 3% of total colouring matters, triphenylphosphine oxide (TPPO) ≤ 100 mg/kg additive. In the data from five companies submitted to EFSA, the preparations contained on average 10.2% to 12.6% beta-carotene.
- Methods: beta-carotene in the additive is determined spectrophotometrically (for 3a160 according to the Food Chemicals Codex “β-Carotene” monograph), and in premixtures and compound feed by reversed-phase HPLC with UV detection according to EN 17550. The reference laboratory considered the conclusions of the method evaluation from the previous authorisation still valid, so no new report was required.
- Beta-carotene is not a skin or eye irritant or a skin sensitiser; one of the 10% preparations assessed was not a sensitiser, but no conclusions on user safety could be drawn for the other preparations, hence the requirement for eye, skin and respiratory protection with the preparation. Additives and premixtures labelled before 18 December 2026 may be used up; compound feed if labelled before 18 June 2027 (food-producing animals) or 18 June 2028 (others).