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European Union

European Commission Approves Increased Use of 3-Fucosyllactose in Infant Formula and Food Supplements

Strategic Insights

— 2 min read

The European Commission has adopted a new regulation, COMMISSION IMPLEMENTING REGULATION (EU) 2025/1537, amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food '3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21 (DE3)'. The regulation increases the maximum authorised use levels of 3-Fucosyllactose in infant formula, follow-on formula, and foods for special medical purposes for infants and young children, as well as in food supplements for the general population.

Chr. Hansen A/S, the applicant, submitted an application to the Commission in April 2024, requesting to increase the maximum authorised use levels of 3-Fucosyllactose in these food categories. The European Food Safety Authority (Authority) consulted on the application and adopted a scientific opinion on the safety of the proposed changes in March 2025. The Authority concluded that the proposed change is safe under the proposed conditions of use, and the Commission has approved the changes.

Key Takeaways:

  • The European Commission has approved the increased use levels of 3-Fucosyllactose in infant formula, follow-on formula, and foods for special medical purposes for infants and young children from 0.9 g/L to 1.75 g/L for all three food categories.
  • The Commission has also approved the increase of the maximum authorised use level of 3-Fucosyllactose in food supplements for the general population from 3.0 g/day to 4.0 g/day.
  • The application was submitted by Chr. Hansen A/S in April 2024 and was consulted with the European Food Safety Authority in June 2024.
  • The Authority adopted a scientific opinion in March 2025, concluding that the proposed changes are safe under the proposed conditions of use.
  • The new regulation amends Implementing Regulation (EU) 2017/2470 and will enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Statistics:

  • Current maximum authorised use levels of 3-Fucosyllactose in infant formula and follow-on formula: 0.9 g/L
  • New maximum authorised use levels of 3-Fucosyllactose in infant formula, follow-on formula, and foods for special medical purposes for infants and young children: 1.75 g/L
  • Current maximum authorised use level of 3-Fucosyllactose in food supplements: 3.0 g/day
  • New maximum authorised use level of 3-Fucosyllactose in food supplements: 4.0 g/day

Sources:

  • COMMISSION IMPLEMENTING REGULATION (EU) 2025/1537
  • Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods
  • Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods
  • Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements
  • EFSA Journal, https://doi-org.sdpl.idm.oclc.org/10.2903/j.efsa.2025.9370

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