Health Canada's Regulation Standards: Not Just Cosmetic Details

If you are a cosmetics manufacturer or importer already selling to the United States and planning to target Canada, it would be natural to assume a certain shared sense of regulatory cooperation and harmonization of standards between the two countries.

Indeed, on the surface, the United States and Canada may appear alike, being geographical neighbors with immense cultural similarities. However, examining the two countries' approach to consumer product regulation, especially when it comes to cosmetics, shows that in some ways, the US and Canada could not be farther apart.

Therefore, if you intend to expand your market from the United States to Canada, you must be aware of the different - and often stricter - requirements imposed by Health Canada, the governing body which oversees cosmetics manufacturing and import into the country.

Here are some important considerations to keep in mind when targeting the Canadian cosmetics market.

Does Canada Consider Your Product to be 'Cosmetics'?

To know whether or not your product will be strictly regulated as cosmetics, you should refer to Canada's Food and Drugs Act as well as its cosmetic regulations law. The Food and Drugs Act offers the specifics about what constitutes a 'cosmetic product', and the cosmetic regulations law will describe the governing rules pertaining to cosmetics manufactured or sold in Canada.

Similar to most countries, certain aspects or ingredients of your product may cross over into the medicinal product category, which is governed by a separate set of rules.

Health Canada may find your product to have both qualities, thus defining it as a "Product at the Cosmetic-Drug Interface" (PCDI). A PCDI label is applied to any cosmetic-like product intended to affect the internal processes of the human body and is governed by Canada's natural health product legislation instead of the cosmetic regulations law.

Canada Upholds a Stronger Government-Imposed Risk Assessment

One key difference between the FDA and Health Canada is how much more oversight responsibility is given to Canadian authorities when it comes to assessing the risk a cosmetic product may pose to consumers. In comparison, the US market places a greater responsibility on the individual manufacturer or importer for maintaining technical records that prove their product’s safety.

To enter the Canadian market, your product must undergo risk assessment as per Health Canada's consumer product safety program to show that said product will not cause harm under foreseeable use.

Banned and Restricted Substances

Canada's growing list of banned chemicals more closely resembles that of the EU than the US. There are hundreds of banned or restricted substances on Canada's cosmetic ingredient hotlist, while the United States has only banned about a dozen substances from inclusion in cosmetics.

This fact can make an important difference in your manufacturing approach for certain products. For example, in the US, facial skin cream is still permitted to contain hydroquinone, a skin-lightening substance. However, hydroquinone is now considered to be cytotoxic (may cause cell death) and possibly carcinogenic (may induce cancer), and many countries around the world - including Canada - have disallowed the use of hydroquinone in most cosmetics products.

Product Notification for Manufacturers and Importers

In order to market cosmetics in Canada, every business without exception must notify Health Canada about their intentions within 10 days of their first product sale, by completing and submitting a Cosmetic Notification Form (CNF).


While Canadian requirements for cosmetics labeling are similar to US ingredients, intended use, warnings, and potential product risks), it is important to realize that Canada has two official languages - English and French. Therefore, individual labeling laws could vary from province to province, which is something that can be easily overlooked during packaging design.

Wading Through Regulatory Differences

When expanding your business to new countries like Canada, where regulatory differences may cause you to significantly adjust your production methods, it is a good idea to engage a full spectrum lab testing and inspection service, which can help you ensure that your products are safe and compliant.

QIMA's quality assurance service offers expertise and guidance through your target market requirements from the very beginning and can continue to help you stay on course throughout the production process with on-site inspections that will keep your supply chain on top of the job.

Don't let regulation differences restrict you from entering any market with confidence! At QIMA, we will take care of every detail, allowing your business to continue unimpeded.

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