Risk Assessment Framework Summary

Consumer Products, Cosmetics and Risk Assessment

Health Canada's Consumer Product Safety Program (the Program) identifies, assesses, manages, and communicates risks to human health or safety of consumer products^{Footnote 1} and cosmetics^{Footnote 2} after they reach the consumer market. As part of its risk assessment functions, the Program gathers information from a variety of sources, including:

• incident reports from industry, fire safety authority or consumers; and
• reports of activities (e.g. recalls) in other jurisdictions, actions proposed by manufacturers or importers aimed at reducing the risk to the public; and
• monitoring of science, information from health and safety professionals, media and other web-based news sources that may identify health or safety issues regarding consumer products and cosmetics.

The Risk Assessment Process

When the Program identifies an emerging trend or becomes aware of an incident involving a consumer product or cosmetic, it will review the information related to the case and determine whether the seriousness of the incident warrants a risk assessment. A risk assessment is not carried out in all situations.

If the Program determines that a risk assessment is not warranted, the issue may be tracked and monitored.

In assessing whether a risk assessment is warranted, the Program may consider several factors including:

• How severe is the actual or potential injury?
• Is it reasonable to attribute the injury, if any, to the use of a product?
• Have there been other incidents involving the product?
• What is the age of the user affected?
• Would the user have been aware of a potential hazard?
• Did the product's foreseeable use or misuse have the potential to pose a serious adverse health effect or death? Is further information required from the supplier or other sources?
• Is there information to suggest that a specific demographic of the population is more likely to be affected?

If a risk assessment is carried out, the Program would:

• identify and characterize the various properties of the potential hazard and the link between the hazard and reported health outcomes;
• estimate the likelihood that the hazard will occur when the consumer uses the product; and
• determine the overall risk with the product given the hazard and likelihood that the hazard will occur.

In gathering this information, the Program may consult subject-matter experts within or outside of government. Manufacturers and importers may provide, or in some cases may be required to provide, information to inform the risk assessment process of their product. They may also be given an opportunity to review the risk assessment report, where appropriate in the circumstances of specific cases.

If a risk is identified, it will be considered for potential risk management. Risk management officials will consider the risk assessment, among other considerations, to determine how to respond to the issue.

Risk Assessment Characterization

Risk assessment is a structured process used to evaluate the potential for a product to pose risks to human health or safety. The two steps—hazard identification and exposure assessment— interact to build a complete picture of risk. Hazard identification identifies potential severity of the injury, whereas exposure assessment estimates the likelihood of specific incidents based on defined use patterns and potential pathways of harm. The final step, risk characterization, may include both quantitative and qualitative analyses, incorporating factors such as injury severity, likelihood of occurrence, and population-level versus individual-level risk. A risk matrix is employed to assign an overall risk level. An uncertainty rating is also applied to reflect gaps in the data and assumptions used. This approach ensures that risk assessments are as robust and evidence based as possible, considering all sources of information available at the time of the assessment.

Guiding Principles

The goal of the Program is to carry out its risk assessment responsibilities in a manner that is consistent, systematic, structured, and based on the best available evidence.

In doing so, the Program is guided by the following principles:

1. The priority and level of effort given to conducting a risk assessment are determined by the potential risk to the health or safety of people in Canada.
2. A risk assessment is based on evidence and professional judgement.
3. A risk assessment considers foreseeable use and misuse.
4. The risk assessment process is as transparent as possible.
5. A risk assessment identifies uncertainties.
6. A risk assessment appropriately considers intersectionality and population variability.

1. The Priority and Level of Effort Given to Conducting a Risk Assessment Are Determined by the Potential Risk to the Health or Safety of People in Canada

The Program evaluates product safety concerns based on the level of risk they pose to the public and focuses on the most urgent and serious threats to consumer health and safety first. Incident reports, consumer complaints and emerging trends are subject to an initial screening and triage process to determine the urgency of the response and priority for risk assessment. The Program then looks at such factors as the severity of the reported or potential injury, the extent of wear and age of the product being considered, the number or pattern of incident reports, whether the hazard was present during foreseeable use or misuse of the product, the age of the person affected, how available the product is on the Canadian market, or whether risks have been identified by another authority inside or outside Canada. To stay informed, the Program gathers information from a wide range of sources, including health professionals, poison centres, government agencies, media, and international authorities.

2. A Risk Assessment is Based on Evidence and Professional Judgement

Risk assessments conducted by the Program are grounded in scientific evidence available at the time. Professional judgment is used to interpret scientific evidence and identify data gaps to make the most informed decision. Risk Assessments are carried out independent of risk management decisions and follow established methods that are appropriate to the product hazard under consideration. The Program considers the weight and relevance of available information, drawing from a range of sources including subject matter experts, industry, product safety testing, and other regulatory jurisdictions. To promote consistency and objectivity, the Program uses a risk characterization framework, unconscious bias mitigation tools, expert consultations, and peer reviews. Even if information is lacking for a specific product, professional judgment will be used to assess a risk based on other information sources, such as information on similar products and similar incident reports. Risk assessments may be updated as new information becomes available.

3. A Risk Assessment Considers Foreseeable Use and Misuse

Risk assessments consider both the intended use of a product and foreseeable use or misuse, including scenarios that a reasonable person might engage in, even if they differ from the manufacturer's instructions. The Program evaluates risks to human health or safety from consumer products or cosmetics used in normal or foreseeable ways, while typically excluding cases involving gross negligence, addiction behaviours, or criminal activity. Examples include incorrect assembly or tampering by a consumer, improper storage, or use of the product by children when not designed for use by children. Risk assessments also consider factors like the product's intended purpose, foreseeable users, potential modifications, clarity of instructions, and emerging trends from incident reports.

4. The Risk Assessment Process is Transparent

The Program promotes transparency in its risk assessment process by publicly sharing the principles and framework that guide assessments. This allows companies to anticipate the kind of information they will be expected to provide and helps ensure consistency. Where appropriate, risk assessments can be shared with affected companies where further action is being considered. Risk assessments can also be shared with other regulators or stakeholders to help improve consistency in risk assessment decision making across jurisdictions.

If the Program finds that a product poses a Danger to Human Health or Safety, a summary of the risk assessment findings is published during regulatory consultations, and full copies of the risk assessments can be shared with the public upon request. This approach ensures stakeholders are treated consistently and provides opportunities to submit relevant information for consideration.

5. A Risk Assessment Identifies Uncertainties

Risk assessments identify and describe uncertainties that may influence the understanding and estimation of risk. These uncertainties can arise from limited or incomplete information, assumptions, gaps in scientific knowledge, or limitations in assessment methods. Recognizing and understanding the nature and potential impact of these uncertainties is essential to support informed risk management decisions. While some uncertainties can be reduced through consultation with subject matter experts or additional data, this is not always feasible. When uncertainty cannot be reduced, it is clearly documented to help determine their influence on the overall risk and the need for further action.

6. Risk Assessments Appropriately Consider Intersectionality and Population Variability

Aligned with federal anti-racism and equity initiatives, the risk assessment approach incorporates an intersectional lens to reflect the diversity and variability of populations who use or may be affected by a product. This includes the consideration of age, sex, gender, as well as other diverse identity factors. Populations who may be disproportionately impacted^{Footnote 3}, such as children, seniors, pregnant individuals, and persons with disabilities, may be more susceptible to harm or less equipped to understand or respond to risks. It is important to note that data on specific parts of the population is not always available. The collection of disaggregated data is an essential step for informed decision-making since its analysis can be used to uncover risks to specific subpopulations. By incorporating intersectionality, risk assessments can better identify and address the needs of people in Canada, supporting more inclusive and comprehensive safety evaluations.

Conclusion

In summary, Health Canada's Consumer Product Safety Program applies a risk-based approach to setting priorities and carrying out risk assessment work. This approach follows the principles and processes outlined in the Program's Risk Assessment Framework. Risk assessments inform risk management actions which could result in the application of a range of different tools such as enforcement, regulation, outreach to consumers, or monitoring. For a copy of the full Consumer Product Safety Program Risk Assessment Framework, please contact CCPSA-LCSPC@hc-sc.gc.ca.