Navigating through food regulatory requirements
Access resources that help industry navigate the relevant regulatory approval processes, including scientific substantiation, for innovative food products.
The food regulatory environment plays an important role in supporting industry innovation and competitiveness, enabling market access and attracting investment while protecting the health and safety of Canadians. Industry needs to consider the regulatory requirements when making decisions on investment, product development and marketing.
- Regulatory Readiness: A Decision Model for Canadian Food Products
This tool leads food product developers, researchers and marketers through a logical step-by-step approach to promote compliance with food regulatory requirements. The model is based on six key questions to consider prior to launching a new food product.
- Canada's Regulatory System for Foods with Health Benefits - An Overview for Industry
This fact sheet is a starting point for companies wanting to bring innovative food products to market and promote the health benefits of their products. It will help them better understand and navigate Canada's food regulatory system and point them to important resources.
- Best Practices for Food-Based Clinical Trials
This practical manual describes how to plan, conduct and report on data from human nutrition research required to substantiate health claims for food in Canada. It provides guidance that addresses the criteria used by Health Canada to evaluate a food health claim submission.
- An Example of a Systematic Literature Review
This resource illustrates how to present the findings of a systematic scientific literature review according to the specifications outlined in the Health Canada Guidance Document for Preparing a Submission for Food Health Claims.
- Not-for-Profit Food Processing Facilities Offering Food Product Development Expertise for the Reduction of Sodium and/or Trans Fat
This is a list of Canadian not-for-profit food processing development centres that are able to assist food producers in reformulating their food products to reduce or eliminate sodium and/or trans fats, and/or to develop food products with little or no sodium and/or trans fats.
Health Canada resources
- Guidance Documents from Health Canada
Guidance to assist industry in the interpretation of policies, governing statutes and regulations, and to assist in preparing submissions when seeking approval for food products, processes and packaging materials.
- About Natural Health Product Regulation in Canada
- Natural and Non-prescription Health Products Directorate
Regulations (including health claims) for natural health products.
- Foods Marketed as Natural Health Products
Includes guidance that explains the four basic principles used in determining whether products are regulated as a food or as a natural health product.
- Temporary Marketing Authorization for Foods:
- Submission Management and Information Unit (SMIU)
The SMIU processes food additive, infant formula, novel food and health claim submissions.
- Food and Drugs Act Liaison Office
A resource for those with questions, concerns, inquiries or problems on matters pertaining to the Act.
Canadian Food Inspection Agency (CFIA) resources
- Industry Food Labelling Tool
A tool to help industry interpret food labelling and advertising requirements as well as policies that apply to statements and claims made for foods. This tool has replaced the Guide to Food Labelling and Advertising.
- Guidance Documents from Canadian Food Inspection Agency
Guidance for regulated parties to help ensure compliance with legal requirements.
- Pre-market Application Submissions Office (PASO)
PASO processes applications for livestock feeds, Plant Breeder’s Rights, fertilizers, variety registration, plants with novel traits, and veterinary biologics.
- My CFIA
Industry’s point of entry to secure online services including licences, permits, registrations and export certificates.
- Ask CFIA
A service that provides industry with one point of entry to ask questions to help in understanding and complying with regulatory requirements.
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