Health Canada regulates cosmetics under the Cosmetic Regulations of the Federal Drug Act. Cosmetic products in Canada do not require approval prior to marketing, however they must be notified once they enter the market. Some products on the Cosmetic-Drug Interface may actually be Non-Prescription Drugs or Natural Health Products. EcoMundo can help you classify your products.

Comprendre les réglementations cosmétiques au Canada

Definitions

A cosmetic is any product “manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.” (Food and Drugs Act).

A drug is any product “manufactured, sold or represented for use in the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state, or its symptoms” or for use in “restoring, correcting or modifying organic functions in human beings or animals” (Food and Drugs Act).

A Natural Health Product (NHP) is made from naturally occurring substances that are used to restore or maintain good health. These products can be made from plants, animals, microorganisms or marine sources. NHPs include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (such as traditional Chinese medicine or Ayurvedic medicine), and probiotics.

How do I know if my product is a cosmetic, a non-prescription drug, or a natural health product?

Products in Canada are classified based on 2 key factors:

  1. Representations made about the product: The main consideration for classifying a product is its proposed claims. A claim can be a word, sentence, picture, symbol, paragraph or implication on the product’s labels, package inserts or advertisements. These claims come together to create a net impression of what the product does. Products with a therapeutic claim cannot be classified as Cosmetics.

  2. The composition of the product: 2. The composition of the product: While a product’s composition 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. Monographs define how an active ingredient is used in Non-Prescription Drugs or Natural Health Products.

Cosmetic product registration in Canada

Do I have to register my cosmetic product in Canada?

Yes! Cosmetic products in Canada have to be notified to Health Canada. Unlike the United States’ Voluntary Cosmetic Registration Program, Canada’s notification process is not voluntary. While Canada’s notification is not as extensive as the European CPNP system, it is mandatory.

How do I register my cosmetic product in Canada?

Cosmetic products in Canada do not require pre-market approval. However, Health Canada does require that cosmetic products be notified post-marketing. Cosmetic products are notified to Health Canada with the Cosmetic Notification Form (CNF). The CNF is an online form filled out by the manufacturer, a Canadian importer, or a notifier, such as a consultant, acting on behalf of the manufacturer or importer. The CNF provides Health Canada with information about the product, its ingredients, and the manufacturer and distributor.

When do I register my product in Canada?

Cosmetic products are notified post-marketing in Canada. However, the notification must be submitted within 10 days of the product entering the market.

Are there banned ingredients in Canadian cosmetic products?

Health Canada maintains a list of Restricted or Prohibited ingredients for Cosmetic products. The ingredients on this “Hotlist” are either completely banned, or are limited in how they are used. For example, Chloroform is an ingredient that appears on the Prohibited portion of the Hotlist, and is therefore not permitted for use. Glycerin, on the other hand, is on the Restricted portion of the Hotlist, and can be used as long as the manufacturers of any oral or leave-on products containing glycerin ensures the raw material follows the specifications of an accepted pharmacopoeia when it comes to diethylene glycol (DEG) impurities.

In addition, ingredients in Canadian products must be a part of the Domestic Substance List (DSL). Any ingredients that are new to Canada must be notified through a New Substance Notification.

Want to know more about registering your products in Canada?

For more information on EcoMundo's services and software for your compliance in North America, do not hesitate to contact our expert, Mr. Michaël Sommeil by phone at : +1 (514) 575-6085 or even send him an email at [email protected]

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