3-Fucosyllactose from E. coli BL21(DE3): in infant formula 1.75 g/L instead of 0.9 g/L, in food supplements 4 g/day — according to EFSA, intake from formula alone (455 mg/kg bw) is below the highest from human milk (896 mg/kg bw)
Commission Implementing Regulation (EU) 2025/1537, published on 30 July 2025, amends the conditions of use of the novel food 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli BL21(DE3): in infant formula the maximum level rises from 0.9 to 1.75 g/L, in follow-on formula from 1.2 to 1.75 g/L, in food for special medical purposes for infants and young children to 1.75 g/L or g/kg (previously 0.9 up to 6 months of age and 1.2 thereafter), and in food supplements from 3 to 4 g/day. Chr. Hansen A/S applied on 25 April 2024; data protection runs until 25 January 2028.
- Levels in the final product ready for use (marketed as such or reconstituted as instructed by the manufacturer): infant and follow-on formula — 1.75 g/L; food for special medical purposes for infants and young children — not more than 1.75 g/L or 1.75 g/kg; unchanged — processed cereal-based food and baby food 1.20 g/L or g/kg, milk-based drinks for young children 1.20 g/L. Food supplements for the general population excluding infants and young children — 4 g/day, with a warning not to give them to children under 3 or on the same day as other foods with added 3-FL.
- EFSA’s calculation (opinion of 24 March 2025): with high formula consumption — 260 mL/kg bw per day in infants aged 0–16 weeks — and 1.75 g/L, intake of 3-FL from formula alone is 455 mg/kg bw per day. For human milk EFSA used 0.91 g/L (mean of means) and 5.00 g/L (highest mean) and 800 and 1200 mL per day at 6.7 kg bw — giving 109–896 mg/kg bw per day.
- Combined intake from all authorised uses (DietEx tool, all EU dietary surveys): in infants a mean of 43–182 mg/kg bw per day, at the 95th percentile 157–387; in young children (1–3 years) P95 up to 150, in adults up to 1 mg/kg bw. EFSA concluded that the extension does not change the safety assessment, also for medical foods and supplements.
- Earlier 3-FL concentrations in human milk used by EFSA: 1.24 and 1.44 g/L (Thurl et al., 2017), then 0.92 and 2.57 g/L (review by Soyyılmaz et al., 2021); the current 0.91 and 5.00 g/L come from a 2024 EFSA report following a literature review. Recital 4 of the act (in the Polish and English versions) gives the current levels as 0.9 g/L, 0.9 g/L and 1.2 g/L for infant formula, follow-on formula and medical foods, whereas Regulation (EU) 2023/52 and the EFSA opinion give 0.9 g/L for infant formula and 1.2 g/L for follow-on formula.