The United States and Canada are often considered similar markets for cosmetic products. However, regulatory requirements differ significantly between the two countries.
A product compliant in the US is not automatically compliant in Canada, and vice versa. Understanding these differences is essential for companies planning to market cosmetics across North America.
The United States: a framework under MoCRA
In the United States, cosmetic regulation is governed by the Modernization of Cosmetics Regulation Act (MoCRA).
MoCRA introduced several key obligations:
- Facility registration
- Product listing
- Safety substantiation
- Adverse event reporting
- Recordkeeping requirements
Unlike other markets, the US does not require pre-market approval for most cosmetic products. However, companies are responsible for ensuring product safety and compliance.
Canada: a notification-based system
In Canada, cosmetic products are regulated under the Food and Drugs Act and the Cosmetic Regulations.
Key requirements include:
- Submission of a Cosmetic Notification Form (CNF)
- Compliance with the Cosmetic Ingredient Hotlist
- Bilingual labeling (English and French)
- Ingredient disclosure requirements
Unlike the US, Canada requires notification shortly after placing a product on the market.
Key differences between the US and Canada
1. Registration vs notification
- US: facility registration and product listing (MoCRA)
- Canada: product notification via CNF
2. Ingredient restrictions
- US: no centralized “hotlist,” but safety must be demonstrated
- Canada: strict reference to the Cosmetic Ingredient Hotlist
3. Labeling requirements
- US: English labeling, flexible structure
- Canada: mandatory bilingual labeling and stricter format requirements
4. Fragrance allergens
- US: requirements still under development
- Canada: aligned with the EU, with defined thresholds and timelines
5. Regulatory classification
- US: cosmetics vs OTC drugs (e.g., sunscreen)
- Canada: cosmetics vs drugs or natural health products
Common mistakes companies make
Companies entering both markets often:
- Assume US compliance applies to Canada
- Underestimate labeling differences
- Fail to update CNF submissions
- Mismanage ingredient restrictions
- Overlook evolving requirements (e.g., allergens, MoCRA updates)
Practical implications for companies
To operate successfully in both markets, companies should:
- Review formulations against both regulatory frameworks
- Adapt labeling for each market
- Monitor regulatory updates continuously
- Structure regulatory data efficiently
A coordinated approach is essential to avoid duplication of work and compliance risks.
Key takeaway
The US and Canada may seem aligned, but their regulatory approaches differ in structure and execution.
Compliance in North America requires a market-specific strategy, not a one-size-fits-all approach.
Going further
If you need support navigating US and Canadian cosmetic regulations, our regulatory team can assist you.
👉 Contact us | 👉 Subscribe to the newsletter
The United States and Canada are often considered similar markets for cosmetic products. However, regulatory requirements differ significantly between the two countries.
A product compliant in the US is not automatically compliant in Canada, and vice versa. Understanding these differences is essential for companies planning to market cosmetics across North America.
The United States: a framework under MoCRA
In the United States, cosmetic regulation is governed by the Modernization of Cosmetics Regulation Act (MoCRA).
MoCRA introduced several key obligations:
- Facility registration
- Product listing
- Safety substantiation
- Adverse event reporting
- Recordkeeping requirements
Unlike other markets, the US does not require pre-market approval for most cosmetic products. However, companies are responsible for ensuring product safety and compliance.
Canada: a notification-based system
In Canada, cosmetic products are regulated under the Food and Drugs Act and the Cosmetic Regulations.
Key requirements include:
- Submission of a Cosmetic Notification Form (CNF)
- Compliance with the Cosmetic Ingredient Hotlist
- Bilingual labeling (English and French)
- Ingredient disclosure requirements
Unlike the US, Canada requires notification shortly after placing a product on the market.
Key differences between the US and Canada
1. Registration vs notification
- US: facility registration and product listing (MoCRA)
- Canada: product notification via CNF
2. Ingredient restrictions
- US: no centralized “hotlist,” but safety must be demonstrated
- Canada: strict reference to the Cosmetic Ingredient Hotlist
3. Labeling requirements
- US: English labeling, flexible structure
- Canada: mandatory bilingual labeling and stricter format requirements
4. Fragrance allergens
- US: requirements still under development
- Canada: aligned with the EU, with defined thresholds and timelines
5. Regulatory classification
- US: cosmetics vs OTC drugs (e.g., sunscreen)
- Canada: cosmetics vs drugs or natural health products
Common mistakes companies make
Companies entering both markets often:
- Assume US compliance applies to Canada
- Underestimate labeling differences
- Fail to update CNF submissions
- Mismanage ingredient restrictions
- Overlook evolving requirements (e.g., allergens, MoCRA updates)
Practical implications for companies
To operate successfully in both markets, companies should:
- Review formulations against both regulatory frameworks
- Adapt labeling for each market
- Monitor regulatory updates continuously
- Structure regulatory data efficiently
A coordinated approach is essential to avoid duplication of work and compliance risks.
Key takeaway
The US and Canada may seem aligned, but their regulatory approaches differ in structure and execution.
Compliance in North America requires a market-specific strategy, not a one-size-fits-all approach.
Going further
If you need support navigating US and Canadian cosmetic regulations, our regulatory team can assist you.
👉 Contact us | 👉 Subscribe to the newsletter
