Health Canada’s Proposed Food Additives, Infant Formula and Novel Foods Pre-Market Submission Management Process

December 8, 2014 By

The Food Directorate of Health Canada is proposing a new scheme of management for pre-market submissions of Food Additives, Infant Formulas and Novel Foods. Timelines and activities are being proposed, influencing the time to market and other food marketing considerations.

On October 7th 2014, the Food Directorate of Health Canada opened a consultation period for their proposal on how they intend to manage Pre-Market Submissions for Food Additives, Infant Formulas, and Novel Foods pursuant to the requirements of the Food & Drug Regulations in the future. The Food Directorate’s aim is to increase improve the timeliness, predictability and transparency of the submission process through the proposed management of pre-submission process. The timelines and activities of the proposed Pre-Market Submission Management process are outlined in a Consultation Document which has to be requested directly from the Food Directorate to view. The Food Directorate is hoping through having an open consultation to acquire feedback from industry on their proposed management process.

All Pre-Market Submissions for Food Additives, Infant Formulas and Novel Food Review Process are structured with the same three steps:

1. Administrative Verification

  • Confirmation that submission contains the necessary administrative information.

2. Scientific Review

  • Evaluation determining the risk to human health for food additive, infant formula or novel food. Food additives may also be evaluated for efficacy. Where applicable, the Food Directorate’s evaluation may consider other aspects (international status; consultation with industry/public/other government groups).

3. Decision

  • The Outcome of the Scientific Review and its resulting recommendation is presented to Food Directorate Senior Management. The Food Directorate’s Decisions is then communicated to applicant. The type of positive outcomes for the three products covered by this process are as follows:
  • For Food Additives: The appropriate List of Permitted Food Additives must be modified to be legally sold in Canada.
  • For Infant Formulas: Applicants receive a “Letter of No Further Questions”
  • For Novel Foods: Applicants receive a “Letter of No Objection”.

The Pre-Market Submission Management Process also includes Performance Standards for increased accountability. The Food Directorate is aiming to have a decision to applicants within 410 calendar days of receiving a food additive, infant formula or novel food submission 90% of the time. The other 10% of the time when a licensing decision could not be reached with 410 calendar days may be attributed to complexity or quality of the submission, but not limited to those, according to the Food Directorate. Please note the Food Directorate state that the 410 day performance standard does not include the time the submission is with the applicant to address deficiencies.

The Consultation period for comments and feedbacks is open from October 7, 2014 to December 5, 2014.

dicentra can assist in your product development by proper classification of which food category your food product and its ingredients fit into. dicentra can prepare food additive, infant formula and novel foods on your behalf in the most expedient manner possible with its true compliant marketing potential.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of foods, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or