Oil from the microalga Schizochytrium sp. (FCC-3204) authorised in protein products (excluding dairy analogues) up to 1 g DHA/100 g — for Fermentalg only until 30 April 2030; specification unchanged: DHA ≥ 32 %, peroxide value ≤ 5.0 meq/kg, anisidine value ≤ 10; EFSA — no viable cells, lower oxidation markers in extruded soy mass than in the control
Commission Implementing Regulation (EU) 2025/688, published on 10 April 2025, extends the conditions of use of the novel food ‘Schizochytrium sp. (FCC-3204) oil’, authorised in 2021 (Regulation 2021/1326), to protein products excluding dairy analogues, for the general population. The application was submitted by the French company Fermentalg (Libourne) — on 23 December 2023 according to the act, on 22 June 2023 according to the EFSA opinion. EFSA adopted its opinion on 24 September 2024: the novel food is safe under the new use.
- New entry in the Union list: infant formula and follow-on formula — in accordance with Regulation 609/2013; food supplements for the general population above 3 years — 1 g DHA/day; protein products excluding dairy analogues — 1 g DHA/100 g. Labelling: ‘Oil from the microalgae Schizochytrium sp.’, and on food supplements a statement that they should not be consumed by infants and children under 3. For 5 years from 30 April 2025 only Fermentalg may place the oil for protein products on the market, unless a subsequent applicant obtains authorisation without reference to the protected data.
- Protected data: the taxonomic analysis of the strain, the viable cell analysis (part of the production process description) and the certificates of analysis of protein products with the oil added — EFSA stated that without them it could not have assessed the application. S. limacinum has QPS status with the qualification ‘for production purposes only’; the data provided showed no viable cells in the oil.
- Specification in the Union list (unchanged): acid value ≤ 0.5 mg KOH/g, peroxide value ≤ 5.0 meq/kg, moisture and volatiles ≤ 0.05 %, unsaponifiables ≤ 4.5 %, trans fatty acids ≤ 1.0 %, DHA ≥ 32.0 %, p-anisidine value ≤ 10. The applicant proposed raising the DHA minimum to 55 % and lowering unsaponifiables to 3.5 % — EFSA considered this unnecessary from a safety point of view and the act does not change the specification. The oil is stored at −20 °C in airtight, light-proof containers; shelf life 2 years at ≤ −15 °C.
- Stability in the product (EFSA): extrusion (high temperature and moisture) can damage algal oils; in two extruded soy masses with 5 % and 10 % of the oil, peroxide and p-anisidine values were lower than in the control without oil. The data covered only the time point right after adding the oil, but given the oil’s stability for up to 113 weeks at 25 °C and 60 % relative humidity the Panel expects it to be stable in the products. The highest DHA intake from the new use (95th percentile) — 6.3 mg/kg bw per day in adolescents, very low compared with the already authorised categories.