Oil from the microalga Schizochytrium limacinum ATCC-20889 in infant formulae: DHA ≥ 32 %, p-anisidine value ≤ 10 added at EFSA’s request — the first five batches had 11.2–19.7
Commission Implementing Regulation (EU) 2025/1515, published on 29 July 2025, authorises oil from strain ATCC-20889 of the microalga Schizochytrium limacinum (BioPlus Life Sciences) as a novel food in infant formulae and follow-on formulae; data protected until 18 August 2030. The application was filed as an extension of the authorisation for “Schizochytrium sp. oil”, but EFSA assessed the specific species — so the Commission treated it as an authorisation of a novel food.
- Specification: acid value ≤ 0.5 mg KOH/g, peroxide value ≤ 5.0 meq/kg, moisture and volatiles ≤ 0.05 %, unsaponifiable matter ≤ 4.5 %, trans fatty acids ≤ 1.0 %, DHA ≥ 32 %, p-anisidine value ≤ 10. The p-anisidine limit (secondary oxidation products) was proposed by EFSA, based on the European Pharmacopoeia value for salmon oil. The applicant wanted to raise the minimum DHA content from 32 to 35 % — EFSA considered this unnecessary from a safety point of view.
- Methods in the applicant’s data: acid value AOCS Cd 3d-63, peroxide value AOCS Cd 8-53, moisture and volatiles AOCS Ca 2d-25, unsaponifiables AOCS Ca 6d-53, p-anisidine Ph. Eur. 2.5.36, fatty acids AOAC 2012.13 (GC-FID), sterols AOAC 994.10. In five batches DHA 40.7–43.2 % of fatty acids, DPA (n-6) 8.71–10.97 %, cholesterol 181–350 mg/100 g.
- p-Anisidine value: the first five batches (after addition of sunflower oil and deodorisation) 11.23–19.66; five further batches after deodorisation 9.07–12.50 (two above 10). After microencapsulation, in the stability study up to 10.5 after 36 months at 5 °C. EFSA considered the stability data sufficient.
- Marine biotoxins in five batches below the LOQ: domoic acid < 1 mg/kg; yessotoxins, azaspiracids, dinophysistoxins and okadaic acid < 5 µg/kg; pectenotoxins, saxitoxins and gonyautoxins < 20 µg/kg; cyanotoxins < 25 µg/kg. Glycidyl esters (as glycidol) and 3-MCPD < 100 µg/kg. On the label: “oil from the microalgae Schizochytrium limacinum”.