Calanus finmarchicus oil: astaxanthin esters up to 0.25 % for all age groups, 0.9 / 2.2 / 3.1 g per day in food supplements (up to 2.25 / 5.5 / 7.75 mg astaxanthin) — without a new EFSA assessment, with reference to the ADI of 0.2 mg/kg bw
Commission Implementing Regulation (EU) 2025/1513, published on 29 July 2025, amends — at the request of Calanus A/S of 16 December 2024 — the conditions of use of the novel food Calanus finmarchicus oil in food supplements. Instead of two variants — oil with < 0.1 % astaxanthin esters at up to 1.0 g/day for the general population and oil with 0.1–0.25 % at up to 2.3 g/day from age 14 — three age-dependent doses now apply for oil with ≤ 0.25 % esters; the Commission found an EFSA assessment unnecessary.
- New levels: general population under 10 years excluding infants and young children — 0.9 g/day (≤ 2.25 mg astaxanthin); 10–14 years — 2.2 g/day (≤ 5.5 mg); over 14 years — 3.1 g/day (≤ 7.75 mg). Label: the name “Calanus finmarchicus oil (crustacean)”, a warning not to consume it on the same day as other supplements containing astaxanthin esters and — depending on the target group — not by children under 3, 10 or 14 years.
- The act’s arithmetic: 0.25 % of 0.9 g is 2.25 mg, of 2.2 g — 5.5 mg, of 3.1 g — 7.75 mg astaxanthin per day. Previously it was < 1.0 mg per day for the general population (< 0.1 % in 1.0 g) and ≤ 5.75 mg (≤ 0.25 % in 2.3 g) from age 14. According to recital 6, intake together with astaxanthin from the diet will not exceed the ADI of 0.2 mg/kg bw in any group; the previous warning for children under 14 at ≥ 0.1 % astaxanthin is dropped.
- The ADI of 0.2 mg/kg bw was set by the FEEDAP Panel in 2019, replacing 0.034 mg/kg bw from 2014; in its opinion of 18 December 2019 (e5993) the NDA Panel, counting 8 mg per day from supplements plus astaxanthin from fish and crustaceans, found that adults stay within the ADI, adolescents aged 14–18 reach it, children aged 10–14 exceed it by 28 % and infants aged 4–6 months by up to 524 %.
- The limits are expressed in grams of oil per day, and the act derives the milligrams of astaxanthin from the ester content (≤ 0.25 %) — for a laboratory the reference points are therefore the astaxanthin ester content of the oil and the declared daily portion for the age group. Supplements lawfully placed on the market before the act entered into force, including those in transit from third countries, may remain on the market until their date of minimum durability.