In 2020, Health Canada received a submission to allow the sale of enzymatically synthesized D-tagatose for use as food ingredient and sweetening ingredient in order to fully or partially replace existing added sugars.
In order to determine whether D-tagatose could be sold in Canada, the scientists at Health Canada conducted a scientific assessment that ensured this substance is safe for consumption. Our scientists also needed to assess how D-tagatose was developed, the manufacturing process and specifications, and whether D-tagatose poses a nutritional safety issue as well as the potential for D-tagatose to 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 proposed use of D-tagatose did not pose a nutritional, microbiological, toxicological or allergenic risk to consumers.
The assessment revealed that gastrointestinal symptoms such as bloating, belching, flatulence, and laxation may be experienced by excessive consumption of products containing D-tagatose, e.g., 30 grams per serving. These gastrointestinal effects are well documented internationally, are characterized as mild, transient, and not experienced by all consumers. In consequence, they were not considered to pose a significant health or safety concern.
Furthermore, D-tagatose may be unsuitable for individuals with Hereditary Fructose Intolerance (HFI) for whom consumption of fructose leads to a variety of adverse effects due to similarities in metabolic pathways between D-tagatose and fructose. D-tagatose will be declared in the list of ingredients on product labels, which would be sufficient to allow consumers to avoid D-tagatose in foods based on dietary counselling.
Health Canada's assessment of D-tagatose 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.
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