Food Additive Submissions
A Food Additive submission is required to be completed to permit a new food additive or new uses of already approved food additives to be used in retail food in Canada. Health Canada specifically authorizes the use of certain food additives as per the ‘Lists of Permitted Food Additives’ which are incorporated by reference to Division 16 of the Food and Drug Regulations (FDR).
Our services in the Food Additive Submission process are:
- Initial product review for regulatory strategy (to determine if product or ingredient is novel or can be established to be non-novel)
- Pre-submission meetings with the Food Directorate
- Preparation of 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.
- Preparation of other supporting information: consumer benefits and food quality considerations, and compiling information on evaluations, approvals, and authorizations of other National and International bodies.
- Correspondence and advocacy with Food Directorate regarding food additive approval
- Responding to government clarification requests (CRs) and information request notices (IRNs)
Importantly, dicentra can utilize their established expertise and relationships with Health Canada to facilitate communication in order to ensure the food additive submission is reviewed in the most timely manner possible.