Decision on passionflower extract as a supplemental ingredient in foods

Health Canada's Food and Nutrition Directorate has assessed passionflower extract (i.e., extracts of Passiflora incarnata aerial parts) for use as a supplemental ingredient. This 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.^{Footnote 1}

The assessment considered publicly available information, and found the data insufficient to establish acceptable conditions for its use as a supplemental ingredient in supplemented foods.

Consequently, Health Canada is not acceding to the use of passionflower extract as a supplemental ingredient. While aerial parts of passionflower and extracts of aerial parts of passionflower have a history of use as a food ingredient (e.g., use as a flavouring), the available information is insufficient to assess the safety of passionflower extract for use as a supplemental ingredient. The food seller is responsible for ensuring that the sale of a food containing passionflower extract does not contravene section 4 of the Food and Drugs Act.

Health Canada is prepared to accept a request to reconsider this decision under the regulations for supplemented foods. The Appendix of this letter identifies the information required to support reconsideration.

For more information on Health Canada's decision on passionflower extract, 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 Passionflower Extract" in the subject line of your e-mail.

Appendix 1 – Information to support a request for Health Canada to reconsider the decision on the use of passionflower extract as a supplemental ingredient

General guidance

1. Characterise in detail the passionflower extract that is requested for use.
2. Clearly demonstrate that the toxicological and nutritional safety information apply to use of the requested passionflower extract as a supplemental ingredient in supplemented foods. For example, explain why the results of toxicity testing of a particular passionflower extract apply to such use of the requested passionflower extract.
3. Provide full study reports of safety tests, not summaries. The reports should provide clear, detailed characterisation of the passionflower extract test material and a full description of the study design, including methods used, the type and number of animals treated, the doses administered and the end-points Studies should also provide detailed documentation of the test results.

Toxicological information

1. Repeated dose toxicity testing of orally administered passionflower extract at doses that would provide adequate evidence of safety to support its use as an ingredient in foods suitable for consumption by the general population.
2. Mutagenicity and clastogenicity testing of passionflower extract.

3. Reproductive and developmental toxicity testing of orally administered passionflower extract at doses that would provide adequate evidence of safety to support its use as an ingredient in foods suitable for consumption by the general population, including foods that could be consumed by children and individuals who are pregnant or who are trying to become pregnant.

   In the absence of results from such toxicity testing, Health Canada will also consider a scientifically sound rationale why foods containing passionflower extract would not pose a significant health concern if they were to be consumed by these sensitive population sub-groups.

Nutritional information

1. Information on constituents in the passionflower extract that may affect digestion or absorption of other nutrients, especially in the intestines, and/or information on whether these constituents could pose nutritional safety concerns if foods containing passionflower extract were to be consumed frequently over a long period of time in different food matrices.

This information is required to address the safety of passionflower extract for use as a supplemental ingredient in supplemented foods, not to demonstrate efficacy or to support specific health claims. For substantiation of food health claims, please see Health Canada's guidance Substantiation of Health Claims (Scientific Evidence).^{Footnote 2}