Risk Assessment Framework Summary
Consumer products, cosmetics and risk assessment
Health Canada's Consumer Product Safety Program identifies, assesses, manages, and communicates risks to human health or safety of consumer productsFootnote 1 and cosmeticsFootnote 2 after they reach the consumer market. The Consumer Product Safety Program, in carrying out its risk-assessment functions, gathers information from a variety of sources, including:
- incident reports from industry or consumers,
- reports of activities (e.g. recalls) in other jurisdictions, such as the United States,
- 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 Consumer Product Safety 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 or not the seriousness of the incident warrants doing 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 is still tracked and monitored.
In addressing whether or not a risk assessment is needed, the Program may consider a number of 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 person affected?
- Would the user have been aware of a potential hazard?
- Was the product involved in the incident new or expired?
- Did the product's normal or foreseeable use have the potential to pose a serious adverse health effect or death?
- Would the harm only occur if the user used the product in an unreasonable manner?
- Is further information required from the supplier or other sources?
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 materialize when the consumer uses the product; and
- make a determination on 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 steps in 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.
All of this information is fed into the next level--risk management. Risk management officials will consider the risk assessment, among other considerations, to determine how to respond to the issue.
The goal of the Consumer Product Safety 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:
- The priority and level of effort given to conducting a risk assessment will be determined by the potential risk to health or safety.
- A risk assessment will be based on evidence and professional judgement.
- The risk assessment process will be as transparent as possible.
- A risk assessment will identify uncertainties.
- A risk assessment will consider population variability and vulnerability.
- A risk assessment will consider foreseeable use and foreseeable misuse of a product.
1. The priority and level of effort given to conducting a risk assessment will be determined by the potential risk to health or safety.
The risk assessment effort must be proportional to the potential risk. Incident reports, consumer complaints and emerging trends will be subject to an initial screening process to determine the urgency of the response and priority for risk assessment. The Program will look 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. For example, the Program will attribute greater priority to reported incidents that involve risk to young children.
2. A risk assessment will be based on evidence and professional judgment.
Once the Consumer Product Safety Program determines that a risk assessment is required, the assessment must be conducted in accordance with the methods and standards of the specific discipline involved, taking into account the scientific evidence available at the time. Even if information is lacking, professional judgment will be used to assess a risk based on other information sources, information on similar products, and similar incident reports.
3. The risk assessment process will be as transparent as possible.
Both the process involved in risk assessment and the principles that guide those assessments have been described and shared with the Canadian public and industry stakeholders. This transparency allows companies to anticipate the kind of information and cooperation they will be expected to provide and assures them that they are being treated consistently. In some situations, the level of transparency is limited by rules dealing with the confidentiality of business and personal information.
4. A risk assessment will identify uncertainties.
Uncertainties can arise from not having enough information and also from not having information that is complete. Identifying both these types of uncertainties is part of the risk assessment process. The process will also address how to reduce and communicate these uncertainties.
5. A risk assessment will consider population variability and vulnerability.
A risk assessment will look at and reflect the variability in populations and groups who use or may be impacted by the use of a consumer product or cosmetic. An estimate of the risks of a product may consider many potential sources of variability, such as:
- whether the product poses risks to a vulnerable sub-population,
- whether there are any aggregate risks that could be present when a product is used in conjunction with another product, or
- the likely circumstances surrounding the foreseeable product use or misuse.
In considering variability, an assessment will consider a range of characteristics in a population such as size, age, strength, and skill. As well, personal, cultural, behavioral or professional factors may lead to greater than average use or exposure to a product.
A vulnerable group is any group that may be more susceptible to impacts of exposure to a product or less resilient or able to cope with or understand impacts than the general public. Examples of vulnerable groups are children, seniors, pregnant women or the disabled. In considering vulnerability, an assessment would consider the risks posed to the vulnerable group, the increased risk, if any, and other likely circumstances surrounding product use in relation to that subgroup. In general, children are the vulnerable group of greatest concern for the Program due to their unique physiology and behaviours, as well as their lack of awareness of and control over hazards to which they may be exposed. The other vulnerable groups identified are also of concern to the Program and will be considered in the risk assessment when applicable.
6. A risk assessment will consider foreseeable use and foreseeable misuse of a product
The Program works to address and prevent risks to human health or safety posed by consumer products or cosmetics when they are used in a normal or foreseeable manner. A risk assessment will not be limited, however, to what a company may identify as the intended use of a product but will also consider hazards that result from foreseeable misuse. For instance, a company may warn consumers that a product should not be used in a certain way. If it is foreseeable that a reasonable person might use the product in that way, a risk assessment might consider this to be a foreseeable use of the product despite the company warning. Factors to be considered in applying this principle are the nature of the product, foreseeable users, and how obvious product hazards are.
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.
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