Health Canada monitors hazards and risks posed by consumer products. Health Canada has recently added lithium-ion batteries (including products containing lithium-ion batteries), water beads, and infant bath seats to its watch-list for products that may pose a danger to human health and safety.1 After Health Canada identifies a "hazard of concern" the agency adds that class of consumer products to Table 1 of the General Prohibitions List.
The General Prohibitions List allows Health Canada to monitor hazards, existing or potential, in the Canadian marketplace. The Canada Consumer Product Safety Act ("CCPSA") prohibits the manufacture, import, advertising, or sale of consumer products that pose a danger to human health or safety. Consumer products that are found to pose a danger to human health or safety are prohibited (subject to meeting the identified performance criteria) and published on Table 3 of the General Prohibition List.
Once a product is placed on Table 3, it must meet certain mandatory safety standards or an equivalent safety standard. A consumer product listed on Table 1 is not yet prohibited, however, industry is encouraged to proactively mitigate the hazards associated with those products by testing and certifying products to an approved standard.
What is the General Prohibitions List?
Health Canada follows a three-step process to determine whether a consumer product poses a threat to human health or safety. Consumer products under review by Health Canada are published and categorized into three tables:
- Table 1 "Hazards of Concern": Products under assessment by Health Canada. Table 1 lists the performance criteria and safety standards Health Canada is considering for that product type. Once a product is on Table 1, it is recommended to meet the recommended performance criteria.
- Table 2 "Assessment and Comment": Products that have undergone Health Canada's danger to human health or safety assessment and are open for stakeholder comment on the assessment.
- Table 3 "Determination of Danger to Human Health or Safety": Products Health Canada has determined are a danger to human health and safety and which are therefore prohibited in Canada unless the products meet certain performance criteria. Industry is prohibited from manufacturing, importing, advertising, or selling these consumer products unless they meet the performance criteria.
Health Canada identifies hazards of concern associated with consumer products by looking at mandatory incident reports, trends and actions taken in other jurisdictions, and the development and adoption of safety standards.2
New Products identified as "Hazards of Concern" are added to Table 1 of the General Prohibition List
Lithium-ion batteries, water beads, and infant bath seats were added to Table 1 of the General Prohibitions List, meaning Health Canada views these products as potentially posing a danger to health or safety.
(i) Lithium-ion batteries and consumer products that contain lithium-ion batteries
Health Canada has identified that lithium-ion batteries may pose burn, fire, and explosion hazards. The following standards are currently listed in Table 1 as the performance criteria to mitigate the risks posed by lithium-ion batteries:
- CSA C22.2 No. 62133-2:20 – Secondary cells and batteries containing alkaline or other non-acid electrolytes — Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications — Part 2: Lithium systems (Bi-national standard with UL 62133-2, harmonized with IEC 62133-2); or
- UL 1642, 6th edition – Lithium Batteries; or
- UL 2054, 3rd edition – Household and Commercial Batteries; or
- the equivalent.
As you will note, Health Canada takes a flexible approach: once listed in Table 3, a company need only demonstrate that their products meet one of the standards cited in the table. There is an additional requirement for lithium-ion batteries contained in another product that they meet:
- any requirements for the Battery Management System (BMS) that may be specified within a consumer product's associated safety standard; or
- the equivalent.
Health Canada's concern with the dangers posed by lithium-ion batteries is consistent with international trends, including the US Consumer Product Safety Commission, which has also identified concerns with lithium-ion batteries.3
(ii) Water Beads (superabsorbent polymer balls, water-absorbing beads)
For water beads, the hazards of concern identified by Health Canada are ingestion hazards leading to obstruction of the gastrointestinal tract, insertion into ear or nose, and aspiration. Health Canada is monitoring the development of new performance criteria such as ASTM F963 Standard Consumer Safety Specification for Toy Safety for water beads.4 Health Canada is also considering other requirements such as prohibiting water beads that fit within the small parts cylinder as set out in the Toys Regulations.5
(iii) Infant bath seats (products that support an infant in a seated position during bathing, excluding products that retain water for bathing)
Health Canada has also identified that infant bath seats may pose a drowning hazard. Health Canada reviewed the performance criteria in ASTM F1967-19 Standard Consumer Safety Specification for Infant Bath Seats and EN 17022:2018 Childcare articles bathing aids but determined that neither standard sufficiently mitigated the hazard. Health Canada will continue to investigate alternative performance criteria.6
Actions for Industry and Best Practices
Companies that manufacture any of the products listed on Table 1 should consider whether their products currently meet the contemplated safety standards. A proactive approach to these hazards may involve testing and certifying all products to an approved standard in anticipation of the products being moved to Table 3.
Products assessed by Health Canada as potentially posing a danger to human health or safety will move from Table 1 to Table 2 and be open for stakeholder feedback. Companies interested in Health Canada's assessment outcomes should ensure that they submit their feedback during the comment period for Table 2. It is anticipated that Health Canada will host a series of workshops on lithium-ion batteries in the next 6-12 months.
If Health Canada moves a product to Table 3, companies are prohibited from manufacturing, importing, advertising, or selling that product in Canada unless it meets the risk mitigation criteria set in the General Prohibitions list. Health Canada can take immediate enforcement actions such as seizure, orders to take measures, orders to recall, and impose monetary penalties on persons who contravene the general prohibitions.
Footnotes
1 "Information on Health Canada's approach to the General Prohibitions under the Canada Consumer Product Safety Act" Health Canada (July 10, 2024).
2 "Information on Health Canada's approach to the General Prohibitions under the Canada Consumer Product Safety Act" Health Canada (July 10, 2024).
3 CPSC, "At CPSC's Lithium-Ion Battery Fire Forum, Experts Call On The Agency To Implement A Strong Mandatory Safety Standard"; CPSC "CPSC Issues Consumer Safety Warning: Serious Injury or Death Can Occur if Lithium-Ion Battery Cells Are Separated from Battery Packs and Used to Power Devices"; CPSC "CPSC Warns Consumers to Stop Using Unit Pack Power (UPP) E-bike Batteries Due to Fire and Burn Hazards; Risk of Serious Injury and Death".
4 "Information on Health Canada's approach to the General Prohibitions under the Canada Consumer Product Safety Act" Health Canada (July 10, 2024).
5 "Information on Health Canada's approach to the General Prohibitions under the Canada Consumer Product Safety Act" Health Canada (July 10, 2024).
6 "Information on Health Canada's approach to the General Prohibitions under the Canada Consumer Product Safety Act" Health Canada (July 10, 2024).
The foregoing provides only an overview and does not constitute legal advice. Readers are cautioned against making any decisions based on this material alone. Rather, specific legal advice should be obtained.
© McMillan LLP 2024
