Health Canada has launched a new national consultation that could reshape how infant foods for special dietary purposes are assessed and authorized in Canada. This marks an important moment for manufacturers and importers of infant formula, human milk fortifiers, and medical infant foods, as the department is considering a more modern and risk-based approach to product review.
If your company works with products regulated under Division 25 of the Food and Drug Regulations, this consultation matters. It may influence future requirements and could change the level of evidence needed when submitting new or reformulated products for authorization.
Why Health Canada Is Updating This Framework
Infant foods are held to some of the highest regulatory standards in Canada because they support a vulnerable population.
Current requirements were built at a time when fewer product types existed, and scientific understanding was less advanced. Health Canada’s proposed framework aims to:
- modernize how products are assessed
- introduce a tiered, risk-based review model
- improve clarity around evidence expectations
- streamline the evaluation of lower risk products
For businesses, this could mean clearer pathways, more predictable timelines, and a better alignment between product risk and evidence burden.
What Types of Products May Be Affected
The consultation focuses on infant foods that require specific nutritional composition and safety controls. These include:
- Infant formula sold in Canada
- Human milk fortifiers
- Medical foods intended for specialized dietary management
Products in these categories often require detailed evidence to demonstrate safety, nutritional adequacy, and intended use. As Health Canada reviews how risk should be assessed, companies may need to adapt how they prepare scientific and regulatory documentation.
What the Proposed Risk Based Approach Means
The proposed model introduces a structured way of assessing product risk, which may include factors such as:
Intended population and use
Products designed for infants with medical conditions may be classified at a higher risk level.
Complexity of formulation
Ingredients, nutrient modifications, and functional components may influence evidence needs.
Scientific justification
Higher risk categories may require more robust safety and nutritional data. This approach could help reduce unnecessary delays for lower risk products, while ensuring higher scrutiny for products that require more specialized validation.
Steps Businesses Can Take Now
Even though the framework is still in consultation, you can begin preparing by reviewing your current processes. Start by assessing:
- scientific evidence supporting your product
- nutritional composition and intended uses
- documentation practices
- current compliance with Division 25
Preparing early allows you to adapt quickly once Health Canada finalizes its updated approach.
How to Participate in the Consultation
The consultation is open until January 25, 2026. Health Canada encourages industry stakeholders to provide feedback, especially regarding operational challenges and evidence expectations.
You can participate by reviewing the questions in Section 6.0 of the proposal and submitting your input to bns-bsn@hc-sc.gc.ca.
This is an opportunity to ensure that the final framework reflects practical realities for manufacturers, importers, and distributors.
Key Takeaways
- Health Canada has opened a consultation on a risk-based framework for authorizing infant foods for special dietary purposes.
- The proposal focuses on infant formula, human milk fortifiers, and medical infant foods.
- A tiered review model may change evidence expectations and streamline lower risk submissions.
- Businesses can prepare by reviewing Division 25 compliance and scientific documentation.
- Stakeholders can participate until January 25, 2026.
FAQ
Will the new framework take effect immediately?
No. The proposal is still in the consultation stage, and the current rules remain in place.
Does this mean every infant food will undergo a different authorization proce
Not necessarily. The framework aims to match evidence requirements with actual product risk, which may reduce the burden for some products.
Is labelling part of this consultation?
Labelling is not the focus of this proposal, although changes to authorization requirements could inform future guidance.
Can manufacturers influence the final direction of the framework?
Yes. Health Canada actively reviews stakeholder feedback before finalizing regulatory updates.
Next Steps
As Health Canada considers updates to the way infant foods are authorized, staying informed and preparing early can help you maintain compliance and avoid delays. If you need support reviewing your product portfolio, assessing documentation, or preparing submissions, our team is here to help. Contact our regulatory experts today.
