When a Cosmetic Complaint Becomes an Incident  

Cosmetic Product Safety  

Product safety is a shared responsibility that protects the health and well-being of consumers. It means ensuring that products such as cosmetics are free from harmful ingredients, properly labeled, manufactured under hygienic conditions, and safe for use as intended. It involves proactive risk management to prevent adverse health effects such as allergic reactions, skin irritation, or more serious harm. 

The Canada Consumer Product Safety Act (CCPSA) defines the obligations of industry, empowers consumers to make informed choices, and provides the government with tools to respond to potential risks. Under Section 14 of the CCPSA, Mandatory Reporting serves as a key mechanism for Health Canada to monitor and assess health or safety-related incidents involving consumer products, including cosmetics. This broad reporting requirement helps the department identify emerging risks and take timely action. 

As part of their regulatory obligations, cosmetic manufacturers, importers, and sellers must report to Health Canada when they become aware of an incident involving a human health or safety concern related to their product. Timely and accurate reporting is not only a legal requirement- it is an essential part of ensuring public safety and maintaining consumer trust. 

Who Needs to Report an Incident?  

Mandatory Reporting obligations apply to people or companies who manufacture, import, sell or distribute cosmetics. 

In some cases, a company may occupy multiple roles within the supply chain. For example, a business may both manufacture and sell cosmetics in Canada, or it may import and sell them. When a company fulfills only one role, it is expected to report incidents at that specific level of trade. However, if a company holds more than one role, Health Canada requires reporting to be conducted at the highest level of responsibility for that product. 

For instance, if a company both imports and sells a cosmetic product, it must report as an importer. Similarly, if a company manufactures and sells a product, it must report as a manufacturer. This approach ensures accountability aligns with the point in the supply chain with the greatest ability to address and mitigate potential risks. 

When industry learns about something that has occurred with any of its cosmetics, this is called an event. Some events are incidents. Some are not.  

It is your responsibility to determine if an event involving your product is an incident that must be reported to Health Canada. 

What is an Incident? 

To decide whether an event is an incident, the event must meet one of the four criteria set out in Section 14 of the Canada Consumer Product Safety Act: 

1. An incident occurred, either within or outside of Canada, that resulted—or could reasonably be expected to result—in death or serious adverse effects on health. 

2. A defect or characteristic in the product that could reasonably be expected to lead to death or serious health effects. 

3. Inaccurate, insufficient, or missing information or instructions on the cosmetic product label, or lack of label, that could reasonably be expected to result in death or serious health consequences. 

4. A recall or other corrective action initiated in Canada or another jurisdiction due to concerns related to human health or safety. 

Once industry has determined that an event meets one of those 4 criteria, they are aware of an incident. 

Incident Reporting Timeline 

There are timelines outlined in the Act for reporting an incident. 

• A company must report to Health Canada, and the company from whom they received the product, within 2 days after the day they became AWARE of the incident. 

• Manufacturers and importers have an additional reporting obligation to provide a follow-up report to Health Canada within 10 days after the day upon which they became AWARE, with further information, including proposed corrective measures. 

• These reports contribute to Health Canada’s unique, national perspective on consumer product safety across a wide range of products. They also help assess and identify possible or emerging hazards with consumer products. 

• Companies are encouraged to use the online form to report an incident involving a consumer product, as it includes specific sections for all necessary information. When in doubt, report! 

For more information about Mandatory Reporting, including guidance on how to report an incident, reach out to Dell Tech. Our team of experts can provide support in quality assurance, development of Standard Operating Procedures (SOPs), product label review for regulatory compliance, and comprehensive documentation to help ensure your cosmetic products meet all applicable safety and regulatory standards, and are ready for market. 

DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.