List of Prohibited and Restricted Cosmetic Ingredients (The Cosmetic Ingredient "Hotlist")

May, 2005

Proceed to the Hotlist

This May 2005 Cosmetic Ingredient "Hotlist" replaces the December 2004 version. Click here to view the changes made.

Section 16 of the Food and Drugs Act states that no person shall sell a cosmetic product that has in it any substance that may injure the health of the user when the cosmetic is used according to its customary method. To help cosmetic manufacturers satisfy this requirement, Health Canada has developed the Cosmetic Ingredient Hotlist - a list of substances which are restricted and prohibited in cosmetics.

The Cosmetic Ingredient Hotlist is a science-based document that is reviewed and updated a few times per year as new scientific data becomes available. In this way, the Hotlist serves to keep the cosmetic industry aware of new substances of concern. It is recommended to check the Cosmetics Program website regularly, or contact the Cosmetics Division directly to ensure the most accurate information.

If a cosmetic contains an ingredient which appears on the Hotlist, the manufacturer may be advised to:

• Remove the substance from the formulation;
• Reduce the concentration of the ingredient to an acceptable level;
• Consider marketing the product as a drug, with appropriate claims and apply for a Drug Identification Number (DIN);
• Provide evidence that the product is safe for its intended use;
• Confirm that the product is labelled as required;
• Confirm that the product is sold in a child-resistant package.

Depending on the response of the manufacturer, the cosmetic may be found to be unacceptable for sale in Canada. In such a case, the product would be:

• Referred to a regional Product Safety Officer for appropriate action;
• Referred to the Health Products and Food Branch (HPFB) Inspectorate.

The Hotlist lists ingredients in alphabetical order. Substances are designated as prohibited unless followed by a condition of use, in which case they are restricted.

Caution statements and directions for safe use must appear on the label in English and French.

Note:

1. If a cosmetic contains a restricted ingredient, the notifying company must indicate, in their cosmetic notification form, the exact concentration at which it is present in the product.
   
   
2. Unless otherwise stated, substances listed on the Cosmetic Ingredient Hotlist are prohibited in cosmetic products. Substances listed with specific condition(s) outlined are restricted in cosmetic products.

Example: 8 - Hydroxyquinoline and its sulfate

Permitted as stabilizers for hydrogen peroxide in hair-care preparations, with a concentration equal to or less than

1. 0.3% in rinse-off preparations
2. 0.03% in leave-on preparations

This means that 8-Hydroxyquinoline and its sulfate are prohibited in cosmetics unless used as a stabilizer in a hair product at the indicated concentrations.

Please be aware of discrepancies between nomenclature, as one substance may have several synonyms. Whenever possible, ingredients on the Hotlist will appear under International Nomenclature of Cosmetic Ingredients (INCI) form, followed by a Chemical Abstracts Service number (CAS #). In the case that an INCI name or CAS # does not exist, ingredients may be listed by one of the following:

1. Latin name
2. International Non-Proprietary Names (INN) recommended by the World Health Organization
3. European or U.S. Pharmacopoeia name
4. International Union of Pure and Applied Chemistry (IUPAC) name or Chemical Abstracts Service (CAS) name
5. Common name

Synonyms can be found by performing an internet search engine query. If in doubt, please contact the Cosmetics Division.

Cosmetics Division
Consumer Product Safety Bureau
Health Canada
MacDonald Bldg, A.L. 3504D
123 Slater Street
Ottawa, ON K1A 0K9
Tel: (613) 946-6452
Fax: (613) 952-3039
email: cosmetics@hc-sc.gc.ca
Website: www.hc-sc.gc.ca/cosmetics