Cosmetics Regulations

Act: Food and Drugs Act, R.S.C. 1985, c. F-27
Regulation: Cosmetic Regulations, C.R.C., Vol. VIII, c. 869, p. 5949

To Whom Does This Apply?

Manufacturers and importers of cosmetics.

Summary

A "cosmetic" is, defined in the Food and Drugs Act as, "any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes."

Cosmetics therefore include:

• lipsticks
• mascara
• eyeshadows
• nail polish
• shampoos
• conditioners
• moisturizers
• cleansers
• hair dyes
• hair permanents
• epilatories and depilatories
• foundations

However, products such as sunscreens, acne treatments, anti-dandruff shampoos, anti-cavity toothpastes and antiperspirants are considered to be drugs.

Notification

Manufacturers and importers must submit a cosmetic notification form to the address below within 10 days of the first sale of a cosmetic in Canada. There is no fee for notification.

Cosmetic notification is not a product evaluation or approval procedure, and acceptance of the completed form or labelling by Health Canada does not constitute, in any way, agreement that the product meets all regulatory requirements. The manufacturer has the responsibility of ensuring that a cosmetic meets Canadian regulatory requirements, including those of the Food and Drugs Act and Cosmetics Regulations, and the Consumer Packaging and Labelling Act and Regulations. Manufacturers who need help in this area should contact an association or consultant who is familiar with Canadian requirements.

Labelling

The labelling of cosmetics is regulated by the Cosmetic Regulations of the Food and Drugs Act and by the Consumer Packaging and Labelling Act.

Manufacturers of cosmetics must print certain information on the labels of each product, that include:

• the identity of the product;
• the net quantity in metric units;
• any warnings or cautions necessary for the safe use of the product;
• the name and address of the manufacturer or distributor;
• the list of ingredients. 

With the exception of the last two points, this information must be in both English and French. All inserts and brochures are considered part of the labelling. Ingredients must be listed on the outer label using the International Nomenclature for Cosmetic Ingredients (INCI) system as found in the most current edition of the International Cosmetic Ingredient.

To help manufacturers and others in the interpretation of regulatory requirements, Health Canada produces a Guideline titled "Labelling of Cosmetics " (H46-2/05-410; ISBN: 0-662-68882-1) that provides detailed information on cosmetic labelling. This may be obtained from the Publications Office of Health Canada.

For more information on labelling, please see the documents Labelling - Packaging Consumer Products (Non-Food) and Labelling Fact Sheet.

Cosmetic Claims

Claims on cosmetics must not imply actions that are therapeutic in nature, as these are considered to be drug claims. Manufacturers who make such claims must remove them from the label if they wish to continue to sell the product as a cosmetic. If the manufacturers wish to retain the claims they will be required to apply for a Drug Identification Number (DIN) or Natural Health Product Number (NPN) and cannot sell the product until a DIN or NPN has been issued.

Claims that are fraudulent and mislead the public may contravene the provisions of the Consumer Packaging and Labelling Act and/or the Competition Actand associated Regulations. Industry Canada should be contacted for further information.

Safety

The Act and the Regulations also set safety requirements for all cosmetics sold in Canada. For instance, it is prohibited to sell a cosmetic that is either prepared under unsanitary conditions or is unsafe when used as directed. It is the manufacturer's responsibility to ensure that the cosmetics are safe for their intended use. Health Canada has the authority under the Act and the Regulations to test and analyse all products marketed for sale in Canada.

Health Canada maintains the Cosmetic Ingredient Hotlist: A List of Prohibited and Restricted Cosmetic Ingredients in Canada. This list should be verified prior to manufacture or import of cosmetics in Canada. Ingredients in cosmetics may also be subject to the New Substances Notification Regulation under the Canadian Environmental Protection Act.

Import

All cosmetics imported for sale into Canada must comply with the Food and Drugs Act, and the Cosmetic Regulations.

Information

On the Web site of Health Canada's Cosmetics Program you will find:

• a copy of the cosmetic notification form and the guide to completing the form;
• a list of ingredients that should not be used in cosmetics (The Hotlist);
• guidelines for the labelling of cosmetics;
• guidelines for cosmetic advertising and labelling claims; and
• links to the applicable legislation for cosmetics in Canada.

These documents can also be obtained by contacting the local office of the Healthy Environments and Consumer Safety Branch at the address listed below (also listed in the Blue Pages of the telephone directory).

DISCLAIMER
Information contained in this section is of a general nature only and is not intended to constitute advice for any specific fact situation. For particular questions, the users are invited to contact their lawyer. For additional information, see contact(s) listed below.

Quebec Contact(s):
Product Safety Officer
Health Canada
1001 St-Laurent Street West
Longueuil, Quebec  J4K 1C7
Telephone: 450-646-1353 (Longueuil); 514-283-5488 (Montréal)
Fax: 450-928-4066
Toll-free (information): 1-866-662-0666
E-mail: Quebec_Prod@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html

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National Contact(s):
Head, Cosmetics Division
Consumer Product Safety Bureau
Healthy Environments and Consumer Safety Branch
Health Canada
A.L. 3504D, 4th Floor, MacDonald Building
123 Slater Street
Ottawa, Ontario  K1A 0K9
Telephone: 613-946-6452
Fax: 613-952-3039
Toll-free (information): 1-866-225-0709
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: cosmetics@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html

Publications
Health Canada
A. L. 0900C2
Ottawa, Ontario  K1A 0K9
Telephone: 613-954-5995
Fax: 613-941-5366
Toll-free (information): 1-866-225-0709
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: info@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html