2′-Fucosyllactose, 3-Fucosyllactose, Lacto-N-Tetraose, 3′-Sialyllactose and 6′-Sialyllactose Blend Produced by Escherichia coli BL21(DE3) Strains

In 2022, Health Canada received a submission to allow the sale of a blend comprising 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-tetraose (LNT), 3′-sialyllactose sodium salt (3′-SL) and 6′-sialyllactose sodium salt (6′-SL) produced by genetically modified bacterial strains. This blend is expected to be placed on the Canadian market as an ingredient in infant and toddler formulas.

In order to determine whether this blend could be sold in Canada as infant and toddler formula ingredients, the scientists at Health Canada conducted a scientific assessment that ensured that they are safe for consumption. Our scientists also assessed how these carbohydrates were developed, produced and whether they can be toxic or cause allergic reactions.

Scientists with expertise in molecular biology, microbiology, toxicology, chemistry and nutrition conducted a thorough analysis of the data and the protocols provided by the applicant to ensure the validity of the results.

Following this assessment, it was determined that the 2′-FL, 3-FL, LNT, 3′-SL and 6′-SL blend produced by fermentation does not pose a risk to human health when used as an ingredient in infant and toddler formulas. In addition, Health Canada also concluded that these carbohydrates would have no impact on allergies, and that there were no differences in their nutritional value compared to other carbohydrates available for consumption.

Health Canada's assessment was conducted according to the Guidelines for the Safety Assessment of Novel Foods. The approach taken by Health Canada in the safety assessment of GM foods is based upon scientific principles developed through expert international consultation over the last 20 years with agencies such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), and the Organization for Economic Co-operation and Development (OECD). The approach taken by Canada is currently applied by regulatory agencies around the world in countries such as the European Union, Australia/New Zealand, Japan, and the United States.

Related content:

• Technical summary