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May 04, 2020

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

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