How to Determine if Your Product or Ingredient is a Novel Food

How to Determine if Your Product or Ingredient is a Novel Food

December 11, 2019 By

Novel foods are defined as “foods that have not been historically consumed or have been produced using new processes” and are becoming more common in the food industry. Advances in genetics and science have paved the way for new methods in food production and the ongoing spread of globalization has brought more diverse food(s) to the Canadian market. Health Canada is responsible for regulatory due diligence to ensure that all food products marketed to Canadians are safe for consumption. All novel foods must meet the requirements outlined in the Food and Drugs Act and the Food and Drug Regulations.

If you have a suspected novel food or ingredient that you wish to seek approval from Health Canada, depending on the ingredient, there are varying steps that you must take. The general process is summarized below:

  • The first step is to contact Health Canada to find out if a determination has been made on the ingredient. If no determination has been made yet, you have the option to submit a History of Safe Use (HOSU). The HOSU is a document detailing the history of the food, proving that it has been consumed in the past with no negative health effects.
    • For simple ingredients: a decision may be made quickly as the food is known to be used in food or is supported by other governing bodies, such as EFSA. If the ingredient is deemed acceptable, an official Letter of Non-Novelty or Approval will be sent from the Food Directorate as proof that this ingredient is allowed to be sold in Canada.
    • For more complicated ingredients: the evidence will be evaluated by a panel of specialists and you will be notified once a decision has been made on the ingredient. If the HOSU provides sufficient evidence to prove the safety of the ingredient, a Letter of Non-Novelty or Approval will be sent by the Food Directorate. If not, you will need to proceed to Step 2.
  • If the HSOU has been deemed insufficient to support the safety of the ingredient then a Novel Food Notification (NFN) will be required.
    • At this point, you may choose to either reformulate and remove the ingredient or move forward with the NFN. The NFN will provide a detailed analysis on the safety of the ingredient including toxicology, nutritional, and allergenicity considerations.

Our Services for Novel Food Notifications and Food Additive Submissions Include:

  • Review your product for regulatory strategy (to determine if product or ingredient is novel or can be established to be non-novel)
  • Arrange pre-submission meetings with the Food Directorate
  • Prepare a safety data package for notification submission, such as: history of use, dietary exposure, detail of novel process, history of organism(s), characterization, genetic modification considerations, nutritional considerations, toxicology considerations, allergen considerations, chemical considerations, and microbiological considerations
  • Prepare statutory requirements for submissions on food additives, such as: description of the food additive, including chemical properties, purpose and level of use, efficacy, residue data and proposed maximum level of use, analytical method, safety data, and label content
  • Prepare other supporting information, such as: consumer benefits and food quality considerations, and compiling information on evaluations, approvals, and authorizations of other health authorities
  • Correspond with Food Directorate regarding novel food approval
  • Respond to government clarification requests (CRs) and information request notices (IRNs)

Handling novel food ingredients requires a substantial amount of time and effort. The dicentra team has ample experience and is well-equipped in preparing novel food submissions, so if you require assistance or have any questions about the approval process with Health Canada contact one of our consultants today!