Cosmetic Ingredient Hotlist: Prohibited and Restricted Ingredients
The Cosmetic Ingredient Hotlist is an administrative tool that helps industry satisfy the requirements for sale of a cosmetic, by providing a list of substances that are restricted or prohibited in cosmetics. The listed substances may contravene the general prohibition found in section 16 of the Food and Drugs Act or a section of the Cosmetic Regulations.
The Hotlist is a science-based document that is reviewed and updated as new scientific data becomes available. The Hotlist serves to keep the cosmetic industry aware of new substances Health Canada considers inappropriate for cosmetic use, or which require hazard labelling. It is recommended to check the Cosmetics website regularly, or contact the Cosmetics Unit directly to ensure the most accurate information.
For assistance on the Ingredient Hotlist, please refer to "How to read the Cosmetic Ingredient Hotlist"
How Changes are Made 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.
Proposed changes to the Hotlist are put forward as needed. Conclusions are based on weight of evidence. Information is gathered through a review of recognized scientific journals, as well as opinions or decisions made by national or international counterparts and expert panel groups. The proposed changes to the Hotlist are posted for consultation on Health Canada's website for a 60-day comment period. In addition, a notice is sent to all notifiers who have submitted a Cosmetic Notification Form that includes any of the affected ingredients. Refer to the links below for any changes to the Hotlist, and current or previous consultations.
How the Legislation Applies to the Hotlist
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. 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 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 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.
- Specific 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 cosmetics 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
- 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 this case:
- appropriate compliance action may be taken
- the product may be referred to the Health Products and Food Branch (HPFB) Inspectorate
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