Start by reviewing your product to determine its regulatory strategy. Assess whether your additive is novel or can be classified as non-novel to plan your submission approach.
A Food Additive Submission is a mandatory process where manufacturers seek Health Canada’s approval before introducing any new or modified additives into food products. This submission ensures that the additive meets stringent safety and regulatory standards before reaching consumers and is suitable for its intended use.
There are two primary scenarios requiring a Food Additive Submission:
Start by reviewing your product to determine its regulatory strategy. Assess whether your additive is novel or can be classified as non-novel to plan your submission approach.
Gather and prepare all required documents. This includes a detailed description of the additive, its chemical properties, and its intended use, along with efficacy, residue data, and safety information.
Schedule pre-submission meetings with the Food Directorate. These meetings help clarify requirements, address potential issues, and ensure your application is on the right track.
Submit your food additive application to Health Canada. Ensure all statutory requirements are met, including the submission of scientific data and labeling information.
Health Canada will review your submission and may request additional information. Once they are satisfied with the data, they will issue a decision on your food additive’s approval.
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