Novel food correction: 3-fucosyllactose from E. coli K-12 DH1 added for food for special medical purposes for infants and young children (up to 1.75 g/L or g/kg), Schizochytrium sp. oil — in food supplements for children aged 18 months to 18 years up to 250 mg DHA and EPA per day
Commission Implementing Regulation (EU) 2025/1549, published on 31 July 2025, corrects Implementing Regulations (EU) 2023/2210 and (EU) 2022/1365, restoring two uses of novel foods that had been omitted by mistake from the Union list: 3-FL produced by a derivative strain of E. coli K-12 DH1 in food for special medical purposes for infants and young children, and Schizochytrium sp. oil rich in DHA and EPA in food supplements for children.
- 3-FL (Annex II, applicant Glycom A/S, data protection until 12 November 2028): recital 7 — the applicant had requested use in food for special medical purposes for infants and young children and EFSA assessed it, but the entry was not included. The new table adds it with a limit “not higher than 1.75 g/L or 1.75 g/kg” in the final product ready for use; other limits: infant formula and follow-on formula 1.75 g/L, milk-based drinks 2.0 g/L, cereal bars 25.0 g/kg, flavoured drinks (pH ≥ 5) 1.25 g/L, food for special medical purposes for other groups up to 4.0 g/L or g/kg, food supplements 4.0 g per day (not for children under 3).
- Schizochytrium sp. oil (Annex I): in 2012 a UK authority authorised it inter alia in food supplements for the “normal population” at 250 mg/day and for pregnant and lactating women at 450 mg/day; Decision (EU) 2015/546 raised the limit for adults to 3 000 mg/day. When the list was established by Regulation (EU) 2017/2470 and when it was amended by Regulation (EU) 2022/1365, food supplements for children aged 18 months to 18 years were omitted — they are now included with a limit of 250 mg/day of combined DHA and EPA. Other limits in the new wording of the table are, e.g., 600 mg/100 g for cheese and spreadable fats, 80 mg/100 g for non-alcoholic beverages.
- Data from the EFSA opinion on 3-FL (e8026, adopted on 27 April 2023): the novel food comes from fermentation with the genetically modified strain E. coli K-12 DH1 MDO MAP1834 and besides 3-FL contains D-lactose, L-fucose, 3-fucosyllactulose and a small fraction of other saccharides; identity was confirmed inter alia by HPAEC-PAD against a standard. In eight batches (crystalline and non-crystalline) 3-FL accounted for 92.1–97.5 % of dry matter (HPAEC-PAD, validated internal method).
- Exposure according to EFSA: at 1.75 g/L in infant formula the high intake of 3-FL is 455 mg/kg bw per day, which does not exceed the mean highest intake from human milk — 460 mg/kg bw per day. The Panel considered the novel food safe under the proposed conditions, including in food for special medical purposes, whose levels should not exceed those for the corresponding food categories for this population. A corrigendum R(01) to the act was published on 28 September 2026 in Italian only.