Description - Figure 3: Decision tree for guidance on regulations or safety assessment guidelines for novel foods or similar products - Guidelines for the Safety Assessment of Novel Foods

When a petitioner has a product that they think is regulated under the Food and Drugs Act, they can answer the following series of questions to determine what regulations (if any) their product may be subject to.

The first question to answer is: Is this product a food or food ingredient as defined in the Food and Drugs Act? If the answer is no, a novel food notification is not required under part B of the Food and Drugs Regulations. However, a petitioner should then consider whether their product is a drug, for which a petitioner should refer to Part C of the Food and Drugs Regulations entitled “Drugs”. If the product is not a drug, a petitioner should then consider whether their product is a natural health product and therefore subject to the Natural Health Products Regulations.

If the answer to the first question is yes, the second question to answer is: Is this food or food ingredient a food additive as defined in B.01.001 of the Food and Drugs Regulations? If the answer is yes, a petitioner should refer to B.16.002 (a) of the Food and Drugs Regulations which addresses food additives.

If the answer is no, the third question to answer is: Is this food or food ingredient intended to be a dietary fibre source? If the answer is yes, a petitioner should refer to the novel fibre guidelines.

If the answer is no, the fourth question to answer is: Is this food or food ingredient intended to fortify foods with vitamins, minerals, or amino acids? If the answer is yes, a petitioner should refer to Part D of the Food and Drugs Regulations entitled “Vitamins, Minerals and Amino Acids”.

If the answer is no, the fifth question to answer is: Is this a food or food ingredient produced by, and/or containing an organism (to the species level) not previously used in food in Canada? If the answer is yes, a petitioner should refer to the Guidelines for the Safety Assessment of Novel Foods, particularly sections 4.1.1 and 4.2.1 which discuss plants and microorganisms with no history of safe use, respectively.

If the answer is no, the sixth question to answer is: Is the source organism from which the food or food ingredient is derived genetically modified as defined in B.28.001 of the Food and Drugs Regulations? If the answer is yes, a petitioner should refer to the Guidelines for the Safety Assessment of Novel Foods, particularly sections 4.1.3 and 4.2.3 which discuss genetically modified plants and microorganisms, respectively.

If the answer is no, the seventh question to answer is: Is the food or food ingredient the result of a process not previously used on that food or food ingredient and has this process in a major change to the food or food ingredient? For the complete definition of a “major change”, please refer to B.28.001 of the Food and Drugs Regulations. If the answer is yes, a petitioner should refer to the Guidelines for the Safety Assessment of Novel Foods, particularly sections 4.1.2 and 4.2.2 which discuss the novel processing of plants and microorganisms, respectively.

Lastly, if a petitioner has identified their product as a food or food ingredient as defined in the Food and Drugs Act, but has answered “no” to the other six questions, a novel food notification is not required for the sale of that food or food ingredient in Canada.