The human milk oligosaccharide, lacto-N-tetraose, has been authorized for use in a wide number food categories, including food supplements. Lacto-N-tetraose is a substance naturally present in human breast milk which is replicated by microbial fermentation with a genetically modified strain of Escherichia coli. The authorisation is based on proprietary data providing the applicant protection for 5 years for lacto-N-tetraose as characterized in the application.
For the use of lacto-N-tetraose in food supplements, it is required that a warning statement is included indicating that lacto-N-tetraose should not be used if breast milk or other foods containing added lacto-N-tetraose are consumed the same day.
The specified food categories to which lacto-N-tetraose may be added and the use limits amount to:
- Food supplements, with a maximum limit of 2 g/day for young children, children, adolescents, and adults
- Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products and Beverages (flavoured drinks), with a maximum level of 1 g/l;
- Unflavoured fermented milk-based products and Flavoured fermented milk-based products including heat-treated products, with a maximum level of 1 g/l for beverages and 10 g/kg for products other than beverages;
-, with a maximum level of 1 g/l for beverages and 10 g/kg for products other than beverages;
- Cereal bars, with a maximum level of 10 g/kg;
- Infant formula (maximum 0,8 g/l) and Follow-on formula (maximum 0,6 g/l) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer;
- Processed cereal-based food, baby food for infants and young and Milk based drinks and similar products intended for young children, with a maximum level of 0,6 g/l or 5 g/kg for products other than beverages;
- Total diet replacement foods for weight control, with a maximum level of 2 g/l for beverages and 20 g/kg for products other than beverages; and
- Food for special medical purpsoses, in accordance with the particular nutritional requirements of the persons for whom the products are intended.
Commission Implementing Regulation (EU) 2020/484 of 2 April 2020 authorising the placing on the market of lacto-N-tetraose as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470) - link