Are Your Supplemental Ingredients Compliant? Canada’s New Rules Explained
If your business sells supplemented foods in Canada, major regulatory updates are on the horizon. Health Canada has introduced new compliance rules for supplemental ingredients declared on product labels, with full enforcement set for December 31, 2025.
These updates impact how your products are labelled and tested, and failing to comply could mean product recalls, fines, or even removal from the market.
Understanding and implementing these changes is crucial to keeping your products on store shelves and maintaining consumer trust. But what do these new rules mean for your business? How can you ensure compliance without disrupting operations?
Keep reading to learn exactly what’s changing, how it affects you, and the steps you need to take now to stay ahead.
What’s Changing? New Compliance Rules for Supplemented Foods
In July 2022, Health Canada introduced the Supplemented Foods Regulations, a risk-based framework that governs how supplemented foods must be labelled and tested. These products must now use a Supplemented Food Facts table instead of a traditional Nutrition Facts table, ensuring transparency and consistency in labelling.
The goal of these updates is to prevent misleading claims and establish clearer compliance requirements for supplemental ingredients. As a business owner, you need to be aware of how these changes impact ingredient testing, rounding rules, and compliance limits.
Key Compliance Factors You Need to Know
New Testing Requirements for Supplemental Ingredients
- The declared amount of a supplemental ingredient on a label must match lab-tested results within strict compliance limits.
- Some ingredients must meet minimum required levels, while others can have a slight variation below the declared value.
Rounding Rules Impact Labelling Compliance
- Health Canada enforces specific rounding rules for supplemented food labels.
- The percentage daily value for vitamins and minerals must be calculated using rounded figures to align with regulatory standards.
Compliance Limits for Supplemental Ingredients
Health Canada applies different compliance limits based on ingredient type:
- Minimum compliance limits apply to vitamins, minerals, and amino acids. These ingredients must be at least 50% of the declared value after rounding.
- Maximum compliance limits apply to certain supplemental ingredients like caffeine, which cannot exceed 150% of the declared value to protect consumer safety.
Overages and Flexibility for Manufacturers
- Previously, Health Canada proposed a strict 150% overage limit, but after industry feedback, this restriction was removed.
- Manufacturers can now use Good Manufacturing Practices (GMPs) to determine acceptable overages based on processing needs.
Why Compliance Matters for Your Business
Failing to meet these new regulations could lead to product recalls, fines, and market restrictions. Compliance ensures your products remain eligible for sale in Canada and meet consumer expectations for transparency and safety.
At Quality Smart Solutions, we help businesses navigate Health Canada’s regulatory landscape with ease. Whether you need guidance on labelling, compliance assessments, or regulatory consulting, our experts are here to support you.
Fill out the form below or contact us to schedule a consultation with one of our regulatory specialists.
