2′-fucosyllactose (2′-FL) from Escherichia coli BL21(DE3) Strain #1242

In 2021, Health Canada received a submission to allow the sale of 2′-fucosyllactose (2′-FL) derived from a genetically modified bacterial strain, as a food ingredient in infant and toddler formula.

In order to determine whether this 2′-FL carbohydrate could be sold in Canada as a food ingredient for infant and toddler formula, the scientists at Health Canada conducted a scientific assessment that ensured that it is safe for consumption. Our scientists also assessed how this carbohydrate was developed, produced and whether it 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 this carbohydrate does not pose a risk to human health when used as a food ingredient in infant and toddler formula. In addition, Health Canada also concluded that this carbohydrate would have no impact on allergies, and that there are no differences in the nutritional value of the 2′-FL carbohydrate compared to other carbohydrates available for consumption.

Health Canada’s assessment of 2′-FL was conducted according to the Guidelines for the Safety Assessment of Novel Foods. The approach taken by Health Canada in the safety assessment of novel 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.

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