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.

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.

Top
We use cookies

We use cookies on our website. Some of them are essential for the operation of the site, while others help us to improve this site and the user experience (tracking cookies). You can decide for yourself whether you want to allow cookies or not. Please note that if you reject them, you may not be able to use all the functionalities of the site.