Regulation of Cosmetics in Canada

The legal authority that regulates cosmetics in Canada is the Health Canada.

Laws that Health Canada Enforces for Cosmetics:

• Cosmetic Regulations
• Food and Drugs Act

Definition of Cosmetic Product

Cosmetics are defined in Canada as "any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes". Personal care products may fall into one of three regulatory categories in Canada: cosmetics, drugs or natural health products.

The distinction between drugs and cosmetics

• Representation: The key consideration for the classification of a product is its proposed claim(s), defined in the Act as "representation for sale". A claim can be a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements. Together, these claims are used to create a net impression of what the product is and does. Health Canada Classification of Products at the Cosmetic-Drug Interface Guidance Document 1 " Puffery " is defined as "hyperbole about a product that does not contain factual claims of merit." This is consistent with the international use and understanding of the term. Further, representations may be explicit or implied.
• Composition: Although the composition of a product alone does not necessarily determine its classification, the presence of an ingredient, or its concentration, may make the product unsuitable for classification as a cosmetic or as a drug.While both factors are important, ultimately the intended purpose of the product takes precedence in the classification decision.A drug exhibits therapeutic or pharmacological activity, such as interacting with a receptor site to achieve a biological response. Modification of an organic function can range from minor to major, which falls within the definition of a drug as per the Act. This is determined by the mode of action, which is defined as the means by which a product achieves its intended effect. Some ingredients are inherently drugs. For example, corticosteroids are internationally recognized as drugs. On the other hand, an ingredient may have a cosmetic function until it reaches a certain threshold, at which point it has a therapeutic or pharmacological effect. In a case where a product makes a therapeutic representation, there is inherently one or more ingredients in the composition that contribute to this effect. As such, any substance supporting a therapeutic claim for a product is likely to be considered an active ingredient.
• Level of action: In order to be a cosmetic, the product must exhibit a lack of percutaneous absorption and should not have to be absorbed systemically to achieve the effect. Products that are administered through ingestion, inhalation, or by injection (intramuscular, subcutaneous, intravenous, etc), with the sole exception of tattoo ink, are not considered to be cosmetics.

Pre-market Approval and Notification of Products

All cosmetics sold in Canada must be approved by Health Canada and the cosmetic manufacturer is responsible for the safety of the product. According to Article 30 of the Cosmetics Regulations, manufacturers are also required to submit the Cosmetics Notification Form (CNF) within 10 days after the cosmetics market, which should include the address and contact information of the manufacturer, the function and form of the cosmetics, and the concentration of each ingredient. Upon approval, Health Canada will issue a Cosmetic number (CN).

• Notification: It should be noted here that each product should be notified, assuming that a mask series has 10 products, you need to handle 10 procedures. Unless each product differs only in non-active ingredients such as fragrance or color, it can be declared as one product only.

Component requirement

Canada has an available Cosmetic Ingredient Hotlist, which is a document that is reviewed and updated periodically and lists the substances that are prohibited or restricted for use in cosmetics. If cosmetics contain restricted ingredients, the amount must be within the prescribed limits. As for prohibited ingredients, they must not be included.

Labels, Packaging and Claims

According to Article 18 of Cosmetic Regulations, in addition to the International Nomenclature of Cosmetic Ingredients (INCI), Other necessary information shall be marked in both English and French. Regarding labelling requirements, the Ministry of Health has issued special guidelines, some of which are very detailed, including the size of the font, different regulations on internal and external packaging, and warnings about dangerous packaging such as pressure containers such as hairspray bottles. Also, as mentioned above, cosmetics should not contain any claims about therapeutic benefits. Therefore, when describing the function of a cosmetic product, terms such as "treat", "cure", "heal", "restores", "prevents" should always be avoided. There are also guidelines from the Ministry of Health on what effect claims and advertising are allowed for cosmetic products.

Cosmetics that meet the above requirements can be legally imported and sold in Canada. If the packaging and label of the product do not meet the above requirements, it is theoretically possible to apply to the customs for advance customs clearance, and then readjust and package in Canada to ensure compliance with relevant regulations before selling. However, considering the cost, it is better to ensure that the product meets the requirements before shipping.

For R&D and Further Manufacturing ONLY. Not for Personal Use.