Any food that does not have a “history of safe use as a food”, or a food that has undergone new processes, changes or modifications is required to be notified to Health Canada’s Food Directorate for review and approval prior to being sold in Canada. The novel food notification procedure allows the Food Directorate to assess the safety of the novel food prior to approving its sale in Canada.
A “novel food” can be a substance that does not have a history of safe use as a food, a food that has been manufactured, prepared, preserved or packaged by a process that has not been previously applied to that food or that causes the food to undergo a major change or a food that is derived from a genetically modified plant, animal or microorganism that causes changes in characteristics. Regulations pertaining to novel foods are described in Division 28 of the Food and Drug Regulations. Novel foods can be permitted sale in Canada, but Health Canada
Health Canada controls the sale of novel foods through a mandatory pre-market notification procedure, with the Food Directorate conducting the novel food safety assessments. The novel food notification procedure is potentially a two-stage process. The first stage is to determine if, in fact, any ingredients are in fact “novel”, and (assuming it is) the safety of the novel ingredient(s) are reviewed by the Food Directorate.
This first step is the submission of a novel food notification which must include the common name of the novel food, the name and address of the manufacturer and importer, the estimated level of consumption and label text as well as a description of the novel food which includes details on its development, manufacturing method, major changes, intended usage and preparation directions, history of use and safety evidence. This notification is reviewed and if there is no objection to the sale of the novel food for consumption, a letter of no objection will be sent out.
Where the second stage may be required is if the information provided in the novel food notification is not considered adequate to determine the safety of the novel food. In this case, after review of the notification, additional data supporting the safety of the food will be requested. An additional review period is initiated at this point to assess the new information. If the additional information is deemed adequate and the there is no objection to the sale of the novel food for consumption, a letter of no objection will be sent out at this point.
NHP Consulting has experience with novelty food determinations and can help determine if your food is a novel food and, if a novel food notification is required, our expert consultants can guide you through this process.