Novel food: Schizochytrium sp. oil (ATCC PTA-9695) in food supplements up to 1 g DHA per day for persons over 3 years, including pregnant and lactating women (previously 250 and 450 mg) — without a new EFSA assessment, on the basis of the opinion on strain FCC-3204
Commission Implementing Regulation (EU) 2025/2245, published on 10 November 2025, amends the conditions of use of the novel food “Schizochytrium sp. (ATCC PTA-9695) oil” in the Union list (Regulation 2017/2470). At the request of DSM Nutritional Products Europe of 4 March 2025, the maximum DHA level in food supplements rises from 250 mg per day for the general population and 450 mg for pregnant and lactating women to 1 g per day for the general population over 3 years; 250 mg remains for children under 3.
- Justification without EFSA assessment: the Commission considered an assessment by the Authority unnecessary, because the same level of 1 g DHA per day had already been authorised by Regulation 2021/1326 for oil from another strain, FCC-3204, and EFSA concluded in its 2012 opinion on the tolerable upper intake level of EPA, DHA and DPA that supplemental intakes of DHA alone up to about 1 g per day do not raise safety concerns for the general population. Labels of food supplements containing more than 250 mg DHA per day must state that they should not be consumed by children under 3; the novel food is labelled as “oil from the micro-algae Schizochytrium sp.”.
- Opinion on FCC-3204 (EFSA, adopted 24 November 2020): the applicant (Fermentalg) sought 3 g DHA per day for adults excluding pregnant and lactating women; the NDA Panel found the evidence insufficient and concluded on safety at a maximum of 1 g DHA per day for that target population — adults excluding pregnant and lactating women. Recital 6 of Regulation 2025/2245 states that FCC-3204 was authorised for the general population over 3 years; the new entry for PTA-9695 also covers pregnant and lactating women — both facts side by side.
- Analytical data from the opinion on FCC-3204 (another strain, same type of product): the oil is almost entirely fat (at least 94 %), protein below the LOQ of 0.25 %, EPA:DHA ratio 0.008:1 to 0.017:1, total sterols 9 087–13 375 mg/kg, p-anisidine value 1.6–7.3, peroxide value 0.5–2.1 meq/kg. Marine biotoxins in three batches below the LOQ (DSP toxins and pectenotoxins 20 μg/kg; PSP toxins, azaspiracids, yessotoxins, saxitoxin and okadaic acid 5 μg/kg; domoic acid 1 mg/kg), glycidyl esters and 3-MCPD below the limits for edible oils.
- Other conditions of the PTA-9695 entry unchanged, including: dairy products (except drinks) 200 mg/100 g, cheese products 600 mg/100 g, spreadable fats and dressings 600 mg/100 g, breakfast cereals and cereal bars 500 mg/100 g, bakery products 200 mg/100 g, cooking fats 360 mg/100 g, non-alcoholic beverages 80 mg/100 g, fruit and vegetable purées 100 mg/100 g, meal replacements for weight control 250 mg/meal. The oil was first authorised by Decision 2015/545 and its uses extended by Regulation 2019/387.