The European Commission authorised the following three milk oligosaccharides as novel food in January 2023:
- Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3),
- 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) and
- 3’-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3).
In all 3 cases the applicant only is authorised to place on the market within the Union the novel food, for a period of 5 years from the date of entry into force of this Regulation, unless a subsequent applicant obtains an authorisation for that novel food without reference to the scientific data protected pursuant to Article 3 or with the agreement of the applicant.
Furthermore, in all 3 cases authorisation includes, that the labelling of food supplements containing the novel food shall bear a statement, that
- they should not be consumed by children under 3 years of age and
- they should not be used if other foods containing the novel food are consumed the same day.
Further details, such as specified food categories, maximum levels and specifications can be found in the Commission Implementing Regulation (EU) 2023/7 (Lacto-N-tetraose), in the Commission Implementing Regulation (EU) 2023/52 (3-Fucosyllactose) and in the Commission Implementing Regulation (EU) 2023/113 (3’-Sialyllactose sodium salt) respectively.
