Industry Guidance - "Danger to Human Health or Safety" Posed by Consumer Products
Under sections 7 and 8 of the Canada Consumer Product Safety Act (CCPSA), industry is responsible for making sure that the products they manufacture, import, advertise or sell on the Canadian market do not pose a "danger to human health or safety".
Under the Act, a "consumer product" is defined as "a product, including its components, parts or accessories, that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging."
This document provides industry with general information on factors that Health Canada will consider when determining whether a consumer product poses a "danger to human health or safety"; how this determination affects actions taken by Health Canada; and, measures industry members should consider to help reduce these dangers. This document contains a summary of relevant concepts and powers under the CCPSA. It is not intended to substitute for, supersede or limit the requirements under the applicable legislation. In case of any discrepancy between this summary and the legislation, the legislation will prevail.
"Danger to human health or safety" is a key principle of the Canada Consumer Product Safety Act (CCPSA)
The CCPSA defines a "danger to human health or safety" as:
any unreasonable hazard - existing or potential - that is posed by a consumer product during or as a result of its normal or foreseeable use and that may reasonably be expected to cause the death of an individual exposed to it or have an adverse effect on that individual's health - including an injury - whether or not the death or adverse effect occurs immediately after the exposure to the hazard, and includes any exposure to a consumer product that may reasonably be expected to have a chronic adverse effect on human health.
Factors affecting "danger to human health or safety" are interrelated and have to be considered as a whole when determining whether a product poses a "danger to human health or safety". They can be further described as follows:
- Unreasonable hazard
- A number of factors can influence whether a hazard is unreasonable. For example, some consumer products can be inherently hazardous under normal conditions of use. Those hazards are commonly known to the public and are accepted in order to have the benefit of the product (for example, heat from a stove). Such hazards are less likely to be considered unreasonable. On the other hand, hazards from the use of a consumer product that are not commonly known, expected or accepted by the public are more likely to be considered unreasonable.
The notion of a product posing an unreasonable hazard can change over time. Technological innovation or emerging and evolving usage patterns could result in a hazard previously considered reasonable becoming unreasonable. For example, in the context of road safety, where it was once acceptable to have children in a car without a restraint system, safety regulations now require that approved restraints be used.
- Existing or potential
- A product can pose a danger, even if there is no death or injury, or complaints or incidents actually related to its use.
- Normal or foreseeable use (includes foreseeable misuse)
- This includes any use or misuse of the product that could be reasonably predicted.
Foreseeable misuse may include:
- Uses other than the manufacturer's intended use (e.g., children using small powerful magnets from magnet sets to mimic mouth piercings or mistaking them for candy);
- Incorrect use of the product that could be reasonably anticipated (e.g., when a consumer incorrectly puts together a piece of furniture);
- A reasonably predictable product modification (e.g., a person removing the child resistant closure of a chemical product and not replacing it).
This will often exclude gross negligence or criminal activity.
- Adverse effect on health
- There is no precise adverse health effect threshold for determining when a product could pose a "danger to human health or safety". This determination could be made regardless of the severity of the adverse health effect, but may be more likely if the existing or potential effect on health is more serious.
What Health Canada may do to determine if consumer products pose a "danger to human health or safety"
Health Canada uses a variety of information and analyses to determine whether a consumer product poses a "danger to human health or safety". These may include:
- Contacting the company for further information on the product, including risk assessments or results of safety tests where appropriate.
- Ordering the company to carry out tests or studies, and compiling and providing information related to the safety of the product.
- Conducting a risk assessment, which is a systematic process of estimating the level of risk posed by a product. It is based on the probability and consequences of exposure to the hazard, with consideration given to usage/exposure scenarios as well as the exposed population variability and vulnerability, and foreseeable uses or misuses. This process may result in a determination of the level of the risk posed to product users, and the risk to the larger population for whom the product is intended, or who may be exposed to the product hazard.
- Consideration of human factors, such as risk tolerance of the public for the product, or ability of consumers to identify and mitigate the hazard themselves.
- Specific market information, such as product design characteristics, availability of safer designs, or product compliance with any relevant consensus-based safety standards/guidelines.
What Health Canada may do when it has determined that a consumer product poses a "danger to human health or safety"
Should Health Canada determine the need to address "danger to human health or safety" posed by consumer products in Canada, the corrective action chosen depends on a number of factors, including the nature and severity of the risk as well as the level of cooperation from industry in promptly addressing the danger.
If information suggests that a product may pose a "danger to human health or safety", Health Canada may take one or more actions, depending on the circumstances, including:
- Contacting the company for further information on the product, including risk assessments or results of tests or studies where appropriate;
- Ordering the company to carry out tests or studies, or to compile and provide information relating to the safety of the product (section 12);
- Requesting voluntary actions by the company, such as removal of the product(s) from sale, and/or distribution and the issuing of a voluntary recall;
- Seizing and detaining product to control distribution (section 21);
- Ordering a mandatory recall of the product(s) (section 31);
- Other orders (section 32); and/or
- Referring the matter for a prosecution.
What you can do to reduce the risk of "danger to human health or safety" that might be posed by your products
Industry is responsible for taking proactive measures to ensure the safety of consumer products that they manufacture, import, advertise or sell in Canada. As a manufacturer and/or importer, you should consider the following:
- Designing products with due consideration for all the ways in which people may use them, including foreseeable misuse;
- Being aware of all hazards associated with your product and the potential adverse health effects that they may cause early in the development process, which will allow you to subsequently address these potential hazards;
- Making sure your product meets at minimum the safety requirements of applicable regulations, standards, or guidelines;
- Making sure you source your components from reputable / trusted suppliers;
- Establishing an appropriate quality control system for the production of your product;
- Providing clear directions for the installation, maintenance and use of the product;
- Providing sufficient warnings for hazards that cannot otherwise be mitigated in the product;
- Appropriately monitoring your product in the marketplace, including complaints and reports of injury or other adverse health effects;
- Taking prompt appropriate corrective action where needed.
This is not an exhaustive list and industry should continuously assess the safety of products it supplies.
For additional information about the Canada Consumer Product Safety Act (CCPSA), visit the Health Canada website. For the complete text of the Act, visit the Department of Justice website.