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Decision on calcium fructoborate as a supplemental ingredient in foods

Calcium fructoborate is one of the ingredients the Food and Nutrition Directorate identified for further assessment as set out in Health Canada's Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food. However, the Food and Nutrition Directorate did not fully assess this ingredient for use as a supplemental ingredient.

In 2016, a draft screening assessment was published in Canada Gazette, Part I that proposed boric acid, including its salts and precursors, meet the criteria under paragraphs 64(a) and (c) of the Canadian Environmental Protection Act (CEPA). Specifically:

  • they are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity (paragraph 64(a)); and
  • as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health (paragraph (c)).

Given the aforementioned CEPA proposal, and the fact that calcium fructoborate hydrolyzes into boric acid, additional sources of exposure should be minimized. Therefore, calcium fructoborate is not appropriate for addition to foods, and the Food and Nutrition Directorate will not be considering calcium fructoborate as a potential supplemental ingredient at this time.

For more information on Health Canada's decision on calcium fructoborate, please contact the Food and Nutrition Directorate's Submission Management and Information Unit (SMIU) (E-mail: smiu-ugdi@hc-sc.gc.ca). Please use the words "Decision on Calcium Fructoborate" in the subject line of your e-mail.

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2024-08-15

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