Learn how Health Canada regulates the safety requirements for cosmetics.
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Under the Food and Drugs Act (FDA) a cosmetic includes any substance or mixture of substances manufactured, sold or represented for use in:
- cleansing, improving or altering:
- masking odours, such as:
- cosmetics used for professional esthetic services
- bulk institutional products, such as hand soap in school restrooms
- handmade cosmetics sold at craft sales or by home-based businesses
In line with our major regulatory partners, Health Canada does not have legislative powers to approve cosmetics before they are sold in Canada. However, section 16 of the FDA prohibits manufacturers from selling cosmetics with ingredients that may cause injury to the user when the product is used either:
- according to directions
- during customary use
The FDA also requires sanitary conditions for cosmetics while products are:
The Cosmetic Ingredient Hotlist communicates to manufacturers and others that certain ingredients may go against:
- section 16 of the FDA
- one or more provisions of the Cosmetic Regulations
The Hotlist includes approximately 500 entries of ingredients which are considered:
- prohibited and must not be used at all
- restricted, meaning they have:
- concentration limits
- labelling requirements
Other requirements for cosmetics are set out in the Cosmetic Regulations.
Notifying Health Canada
Manufacturers and importers are required to submit a Cosmetic Notification Form to Health Canada within 10 days of the first sale of their product in Canada. Submission of a notification is not a product evaluation nor approval of the cosmetic. The form includes specific formulation information about the product, such as ingredients and their concentrations.
Once the form is received, Health Canada:
- screens the information in the notification against the Hotlist
- works with companies to address potential concerns
- takes appropriate enforcement actions where necessary
Health Canada takes a risk-based approach to manage the safety of cosmetics. This means that we identify, assess and manage risks to human health or safety of cosmetics and communicate these risks to Canadians.
We have published the Consumer Product Safety Program Risk Assessment Framework to:
- outline principles and processes Health Canada uses in assessing risk related to consumer product safety, including cosmetics
- establish a risk-based approach to determine where the Department should focus its attention
Promoting and enforcing compliance
Health Canada takes steps to help protect you from health or safety risks related to cosmetics by:
- monitoring the marketplace for potentially dangerous cosmetic products
- conducting routine sampling and testing of cosmetics in the marketplace to verify compliance with the FDA and Cosmetic Regulations
- assessing and managing the health risks and safety hazards associated with cosmetics
- providing importers, manufacturers and distributors with information and guidance to help them meet regulatory requirements
In cases where a product is non-compliant with the FDA or Cosmetic Regulations, Health Canada may:
- work with the company to bring the affected product into compliance
- take further action to protect the health and safety of Canadians, including issuing public communications
- seize products or prosecute the company for failure to comply with regulatory requirements
Collaborating with partners
Health Canada works closely with the Canada Border Services Agency to target specific cosmetics or companies at the border if imported products are identified as a risk.
In addition, Canada's Chemicals Management Plan addresses risks to health and the environment from chemical substances. Health Canada works with Environment and Climate Change Canada to conduct risk assessments on these substances in various products used by consumers, such as cosmetics. If necessary, concerns are followed up with appropriate risk management action.
Health Canada is also a member of the International Cooperation on Cosmetics Regulation (ICCR). The purpose of ICCR is to:
- maintain the highest level of global consumer protection
- discuss common issues on the safety of cosmetics
- enter into a constructive dialogue with the relevant cosmetics industry trade associations
- minimize barriers to international trade
Engaging and informing Canadians
Health Canada engages and informs Canadians on important issues by:
As the consumer, you play an important role in maintaining and protecting your health and safety. Read product labels and follow instructions carefully. Look for new public information about safety risks. Report all health or safety concerns related to cosmetics to Health Canada.
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