2′-fucosyllactose (2′-FL) from Escherichia coli K-12 (DH1) MDO MAP1001d strain
In 2021, Health Canada received a submission to allow the sale of 2′-fucosyllactose (2′-FL) oligosaccharide from a genetically modified bacterial strain. This carbohydrate is expected to be placed on the Canadian market to be used as an ingredient in term infant formulas and nutritional supplements (toddler formulas) intended for children 1 to 3 years of age.
In order to determine whether this 2′-FL carbohydrate could be sold in Canada as an ingredient in term infant formulas and toddler formulas, the scientists at Health Canada conducted a scientific assessment to ensure that it is safe for consumption. Our scientists also assessed how this carbohydrate was developed and 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 did not pose a risk to human health when used as an ingredient in infant formulas and toddler formulas. In addition, Health Canada concluded that there are no allergy concerns associated with the 2′-FL ingredient and that there were no differences in the nutritional value of this 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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