This article originally appeared in Food in Canada and is republished with the permission of the publisher.

Division 28 of the Food and Drug Regulations (FDR) prohibits the sale or advertisement of a “novel food” unless the manufacturer or importer of that food has submitted a pre-market notification to Health Canada and received confirmation that the food is safe for consumption.

What makes a food novel? For starters, a food is novel if it is derived from a plant, animal or microorganism that has been genetically modified (through intentional manipulation). A food is also novel if it has been manufactured, prepared, preserved or packaged by a “novel process” — a process that has not previously been applied to that food and causes the food to undergo a major change.

For the purposes of a novelty assessment, a major change is a change in the food that places the modified food outside the accepted limits of natural variations for that food with respect to: (a) composition, structure or nutritional quality of the food, or its physiological effects; (b) the manner in which the food is metabolized in the body; or (c) the microbiological safety, the chemical safety, or the safe use of the food.

Less commonly considered is that a substance may be a novel food if it does not have a history of safe use as a food. This can pose a challenge to companies looking to sell foods that include herbal substances and other ingredients that have a history of use in dietary supplements or cultural practices (for example, plants used for teas in herbal medicine) rather than as traditional foods.

A key consideration in a novelty determination is that history of safe use must be in a food context. Health Canada takes the position that use of a substance for a purpose other than satisfying hunger or thirst is not sufficient to create a history of food use. We do not consume foods with the same discretion that we do health products — when we eat foods, we don’t defer to recommended doses and directions of use.

So, what can be done if you have a (potentially) novel food or ingredient? Novel foods must be notified to Health Canada, with detailed information on history of use, dietary exposure, and nutritional, toxicological, allergen and chemical considerations.

It’s possible to request an initial novelty determination from Health Canada before preparing this notification, but unfortunately Health Canada does not have a published list of substances that they have considered and determined to be novel or not. Decisions are only published for substances that have undergone a full novel food notification process.

In February 2016, Health Canada published the Category Specific Guidance for Temporary Marketing Authorization:

Supplemented Food (the TMA Guidance), which identifies certain substances as novel. These substances were found in the earliest fortified food products during their transition from food-like natural health products (NHPs) to foods regulated under the FDR. While they have some history of use in NHPs, they are not currently authorized for use in foods.

Health Canada has undertaken to assess the novel substances in the TMA Guidance, rather than waiting for a company to submit a novel food notification. These safety assessments started with the substances found most frequently in early fortified foods, and decisions on this first batch of substances are expected within the next few months.

The remainder of the novel substances from the TMA Guidance will be assessed at a later date. Industry may be called on to provide information on certain ingredients to support Health Canada’s safety assessment.

In the push to develop new, innovative food products, novel foods can create unexpected challenges and delays, but the alternative is potential compliance action by the CFIA.