Cosmetic Ingredient Hotlist: Prohibited and Restricted Ingredients
List of substances that are restricted or prohibited in cosmetics.
On this page
- About the Cosmetic Ingredient Hotlist
- How to read the Cosmetic Ingredient Hotlist
- Responsibilities of manufacturers and importers
- Updating the Hotlist
- Hotlist compliance and enforcement
About the Cosmetic Ingredient Hotlist
In order for a cosmetic product to be sold in Canada, it must meet the requirements of the Food and Drugs Act (FDA) and the Cosmetic Regulations(CR). Section 16 of the FDA stipulates that cosmetics manufactured, imported or offered for sale in Canada must be safe for use.
- The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances may be prohibited or restricted for use in cosmetics.
Entries on the Hotlist can be linked to particular legislative provisions, including the following:
- Section 16 of the FDA (the general prohibition)
- Section 24 of the CR (avoidable hazard labelling)
- Section 2 of the FDA (definitions for the purpose of product classification)
- Specific individual prohibitions and restrictions for substances as outlined in the CR
The Hotlist is a science-based document that is reviewed and updated periodically (i.e. when new scientific data becomes available). Health Canada can take actions at any time to enforce the FDA and CR, regardless of whether a substance is included on the Hotlist.
When information becomes available to industry that a substance in a product may be harmful to the user, an appropriate review and corresponding safety assessment should be undertaken to determine any potential risks. Pending the outcomes of this review, risk mitigation measures can be considered where appropriate. These could include but are not limited to: monitoring, reformulation, or removal of product from the market. Industry must not wait for a regulatory or Hotlist update in order to comply with the general prohibition. Sale of a cosmetic should stop as soon as industry knows the cosmetic may cause injury.
How to read the Hotlist
The Cosmetic Ingredient Hotlist consists of two distinct tables, one for ingredients identified as being prohibited and another for those identified as being restricted.
- Prohibited ingredients, including synonyms, salts and related compounds, should not be present in cosmetic products sold in Canada.
- Restricted ingredients are permitted only if the conditions of use and/or cautionary statement(s) are met as outlined.
- If the ingredient has a concentration restriction, providing the exact concentration used in the product at the time of notification will help expedite processing of the Cosmetic Notification Form.
Limits are to be read as having 3 significant figures, regardless of how they are expressed on the Hotlist. The concentration limits listed on the Hotlist should not be exceeded, within the experimental errors presented by analytical test methods or instruments.
The Hotlist pertains to substances that are intentionally added to cosmetics. It is not meant to cover common and pervasive impurities and/or contaminants (e.g. heavy metals) that may be present at trace levels in a finished product.
Example: Benzethonium Chloride
Not permitted in:
- Products to be applied to mucous membranes.
- Leave-on products, at a concentration equal to or less than 0.2%
- Rinse-off products, at a concentration equal to or less than 0.3%
With three significant figures, the limit for Benzethonium chloride in rinse-off products would be a concentration equal to or less than 0.300%. This limit should not be exceeded, within the experimental errors presented by analytical test methods or instruments. For example:
- 0.300% ± 0.005%: this concentration is considered to meet the Hotlist limit
- 0.302% ± 0.005%: this concentration is considered to meet the Hotlist limit
- 0.299% ± 0.002%: this concentration is considered to meet the Hotlist limit
- 0.304% ± 0.002%: this concentration is considered in excess of the Hotlist limit
Health Canada considers cosmetics with ingredient concentrations exceeding the Hotlist limits to not comply with section 16 of the Food and Drugs Act or another section of the FDA or CR and may be subject to compliance and enforcement actions.
Ingredients on the Hotlist are set out 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 your closest Regional Product Safety Office.
Responsibilities of manufacturers and importers
In order to determine whether a cosmetic is safe for use, it is the manufacturer’s and importer’s responsibility to be aware of emerging science and risks related to substances in the cosmetics they sell. They are also expected to:
- monitor scientific literature and post-market data both domestically and internationally (as available); and
- take appropriate corrective measures as soon as available safety information suggests the need for action (i.e. product may no longer be compliant with the FDA and the CR).
Sources to help stay informed include (but are not limited to):
- tests, studies, or research related to substances in their products
- regulatory decisions or actions put forward by other jurisdictions
- research and conclusions related to similar product areas
- positions taken by other relevant authoritative organizations outside of government (review panels, advisory groups, associations, etc.)
- adverse events, injuries or trends with respect to a product
Other members of the supply chain are encouraged to discuss safety monitoring activities with manufacturers and importers, as anyone who sells a cosmetic is responsible for the safety of products available to consumers.
While the Hotlist is an administrative tool used to communicate that certain substances may cause injury when used in cosmetics, it is not exhaustive. The general prohibition applies as soon as the potential to cause injury is identified.
Updating the Hotlist
Proposed updates to the Hotlist take into account and reflect information gathered through a review of:
- recognized scientific journals and other scientific evidence;
- decisions rendered under the Chemicals Management Plan (CMP);
- market survey data; and,
- other actions, opinions or decisions made by international counterparts and expert panel groups, etc.
Although other approaches may be used when appropriate, the general approach for updates to the Hotlist includes the following:
- Notice to Stakeholders: The notice provides an early indication to industry about the substances that Health Canada is currently reviewing and considering for inclusion in the next Hotlist update. This notice is not a formal consultation process. This notice will be posted on the canada.ca website approximately three months prior to the consultation on proposed updates to the Hotlist (see below). During this time, Health Canada expects that affected industry will start to determine which of their products could be impacted by the possible updates, and begin to think about the necessary changes to product formulations, distribution and sale. Although stakeholders will be invited to provide any safety information or other considerations about the proposed substances that may further inform the department’s decisions, Health Canada will not provide a detailed response to the comments or information received at this stage.
- Consultation: The proposed updates to the Hotlist will be posted on the canada.ca website. Feedback from stakeholders will be solicited during a 60-day comment period. The consultation document could include information on specific concentration limits (if applicable), recommended wording for cautionary labelling (if applicable), or if the substance is proposed to be described as prohibited (altogether or for a certain category of products).
- Evaluation period: Prior to publication of the final revised Hotlist, Health Canada will review any information provided during the consultation and respond to comments received. This evaluation period may last several months.
- Hotlist update and Communication: Following the evaluation period, the final revised Hotlist will be posted on the Consumer Product Safety section of the canada.ca website and a notice will be sent to stakeholders.
- Compliance promotion and enforcement: Following the posting of the Hotlist update, Health Canada will prioritize compliance and enforcement in response to the level of risk posed by a product and any complaints/incidents received.
Efforts will be made to contact all notifiers who have previously submitted a cosmetic notification form when a Notice to Stakeholders, consultation opportunity or updated Hotlist is available. An email will also be sent through the cosmetics mailing list to all subscribers.
If at any time Health Canada receives information that indicates the potential for a serious risk concerning a product in this process, the Program will bypass this approach and take any immediate action necessary.
To stay informed of the next Notice to Stakeholders or consultation, subscribe to the Cosmetics Mailing List.
Information is available on previous changes to the Cosmetic Ingredient Hotlist, as well as Notices to Stakeholders and consultations.
Information on compliance and enforcement
Section 16 of the FDA states that no person shall sell a cosmetic that has in it any substance that may injure the health of the user according to the directions for use or as customarily used.
Regardless of whether or how a cosmetic ingredient is described on the Hotlist, Health Canada may take action to enforce the FDA and the CR at any time, including the following activities:
- Request product labelling to confirm a product meets legislative requirements;
- Request an establishment commitment to bring a product into compliance;
- Request evidence of safety to demonstrate that a product is safe as used;
- Stop sale or distribution of a product;
- Post a consumer alert or advisory; and
- Request that the company voluntarily recall a product
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