List of Prohibited and Restricted Cosmetic Ingredients ("Hotlist")
To help cosmetic manufacturers satisfy the requirements for sale of a cosmetic, Health Canada developed the Hotlist - an administrative list of substances that are restricted and prohibited in cosmetics.
Current Hotlist: March 2011
The 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 Health Canada considers inappropriate for cosmetic use, or which require avoidable hazard labelling. It is recommended to check the Cosmetics Program website regularly, or contact the Cosmetics Program directly to ensure the most accurate information.
This March 2011 Cosmetic Ingredient Hotlist replaces the June 2010 version. Please refer to the document entitled "March 2011 changes to the Cosmetic Ingredient Hotlist" to view the changes made.
Proposed Changes to the Hotlist
Health Canada welcomes stakeholders to submit comments on proposed changes to the Hotlist. Entries for ingredients are proposed to be added to the Cosmetic Ingredient Hotlist as a restriction or a prohibition via consultation process. Refer to the link below for any current or previous consultations.
The Hotlist takes its basis from the following sections of legislation:
- Section 2 of the Food and Drugs Act addresses the definitions of products regulated under the Act. Should an ingredient lack a cosmetic purpose (or functional purpose in a cosmetic formulation) it should not be used in a cosmetic product. For example, fluoride in oral care products has no cosmetic purpose to cleanse, improve or alter the appearance of the body. Its purpose is to prevent dental caries (a disease state), which is therapeutic in nature. It is subsequently classified as a drug (in this case, a natural health product) ingredient. Therefore, fluoride is inappropriate in cosmetic oral care products, and is indicated as such on the Hotlist.
- Section 16 of the Food and Drugs Act states, among other things, 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. Section 16 permits Health Canada to restrict or prohibit any ingredient it deems unsafe. Should an ingredient become of concern, it is not necessary for the substance to be indicated on the Hotlist in order for Health Canada to take action.
- Section 24 of the Cosmetic Regulations requires that the label of a cosmetic product presenting an avoidable hazard includes directions for safe use. This appears in the form of an ingredient restriction on the Hotlist, where a cautionary statement or direction for use associated with an ingredient mitigates the hazard of the product. Caution statements and directions for safe use must appear in both English and French.
- All individual prohibitions and restrictions for ingredients as outlined in the Cosmetic Regulations.
Note: The Hotlist is not exhaustive. It is the manufacturer's responsibility to ensure that the products meet the requirements for cosmetic products under the Food and Drugs Act and the Cosmetic Regulations.
Information for Manufacturers
If a cosmetic contains an ingredient which appears on the Hotlist, the manufacturer may be advised to:
- Remove the ingredient from the formulation;
- Reduce the concentration of the ingredient to an acceptable level;
- Consider marketing the product as a non-prescription drug or natural health product, with appropriate claims and application for a Drug Identification Number (DIN) or Natural Product Number (NPN);
- 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.
How to Read the Cosmetic Ingredient Hotlist
- 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.
- 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
- 0.3% in rinse-off preparations
- 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.
The Hotlist lists ingredients in alphabetical order. 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:
- Latin name
- International Non-Proprietary Names (INN) recommended by the World Health Organization
- European or U.S. Pharmacopoeia name
- International Union of Pure and Applied Chemistry (IUPAC) name or Chemical Abstracts Service (CAS) name
- Common name
Synonyms can be found by performing an internet search engine query. If in doubt, please contact the Cosmetics Program.