Information on Health Canada's approach to the General Prohibitions under the Canada Consumer Product Safety Act

Introduction

Under the Canada Consumer Product Safety Act (CCPSA), the Government of Canada, regulated parties – those who manufacture, import, advertise, sell or distribute consumer products in Canada – and consumers, all play important roles in addressing dangers to human health or safety posed by consumer products. The intent of this page is to inform regulated parties of Health Canada's approach to the General Prohibitions (GPs) under the CCPSA. Health Canada may revisit certain aspects of this approach when warranted.

On this page

• General prohibitions on consumer products
  • Health Canada's approach to consumer product prohibitions
• Table 1: Identification of hazards of concern
• Table 2: Comment period for danger to human health or safety assessments
• Table 3: Determination of notice of danger to human health or safety
• Industry responsibilities
• Useful links

General prohibitions on consumer products

Paragraphs 7(a) and 8(a) of the CCPSA set out the GPs for consumer products that pose a danger to human health or safety.

Generally, the GPs:

• Prohibit the manufacturing, importing, advertising or selling of a consumer product that is a danger to human health or safety; and
• Prohibit the advertising or selling of a consumer product that a regulated party knows is a danger to human health or safety.

The CCPSA defines 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.

For more information on when a hazard associated with a class of consumer products poses a danger to human health or safety, please see:

Industry Guidance - "Danger to Human Health or Safety" Posed by Consumer Products.

Regulated parties are responsible for the safety of their products. They are responsible for making sure that their products do not pose a danger to human health or safety, without waiting for communication from Health Canada.

Health Canada's approach to consumer product prohibitions

Health Canada regularly monitors the marketplace to verify whether consumer products comply with the CCPSA and do not pose a danger to human health or safety. The Department uses the following 3-step process to determine whether a class of consumer products poses a danger to human health or safety:

• Identification (Hazards of Concern);
• Comment Period (Danger to Human Health or Safety Assessments); and
• Determination (Notice of Danger to Human Health or Safety)

When identifying hazards of concern and assessing whether a hazard poses a danger to human health or safety, Health Canada may consider, among other things, if the product meets nationally or internationally recognized performance criteria for the hazard of concern, such as:

• voluntary safety standards for that class of consumer product or other products with the same or similar hazards;
• Canadian legislation for other products with the same or similar hazards; and
• laws enacted in other countries for that class of consumer product or other products with the same or similar hazards.

While Health Canada may consider a number of options to mitigate a danger to human health or safety, regulated parties are responsible for assessing their consumer products for dangers to human health or safety and implementing effective hazard mitigation measures. A regulated party must ensure that they are compliant with the CCPSA.

Health Canada's GPs approach:

• provides regulated parties with general information about their roles and responsibilities;
• engages regulated parties and other stakeholders to communicate and explain the process (described above);
• uses evidence-based decision making, and;
• is designed in such a manner that:
  • enforcement actions are applied in a reasonable manner and are proportional to the level of risk presented by the consumer product based on its seriousness and likelihood of occurring, and
  • risk mitigation may involve multiple measures and is designed to address hazards and help protect consumers.

The details below outline the various steps of Health Canada's process for determining whether a hazard associated with a class of consumer product poses a danger to human health or safety. Transparency, openness and communication of information are key elements in achieving the objectives sought by this approach.

Health Canada will notify regulated parties when a change is made to Tables 1, 2 or 3 via the News and Updates email service.

Figure 1 - Text description

A process flow showing the hazard identification and danger determination approach through the general prohibition tables 1, 2, and 3.

Table 1 – Identification – Hazards of concern

Hazard(s) of concern are identified with class of consumer products and listed on Table 1. Health Canada monitors product class and conducts further assessment, as necessary. Industry is also encouraged to mitigate the hazard.

Table 2 – Assessment & comment period – Danger to human health or safety

If assessment provides sufficient reason to believe that there is a danger to human health or safety, then the product class and associated hazard(s) are listed on Table 2. The danger to human health and safety assessment will be posted to Table 2 and open for comment from stakeholders.

Once the comment period is closed, Health Canada will review comments and determine if a danger to human health or safety exists. If the conclusion is that there is a danger to human health or safety, the class of consumer products moves to Table 3, if not, the class of consumer products will be moved back to Table 1 for monitoring.

Table 3 – Determination – Danger to human health or safety

Health Canada concludes the hazard(s) associated with a class of consumer products to be a danger to human health or safety and lists the class of consumer products, associated hazards and completed assessment on Table 3. The manufacture, import, advertisement or sale of consumer products that pose a danger to human health or safety is prohibited. Health Canada can take enforcement actions such as seizure, orders to take measures, orders to recall, or prosecution concerning consumer products that do not comply with the CCPSA.

The tables are linked by a dotted line underneath and it states "Please note, that at any time in the process, Health Canada may take enforcement actions if there is a reason to believe that a consumer product is a danger to human health or safety."

Table 1: Identification of hazards of concern

Table 1 lists hazards of concern associated with classes of consumer products identified by Health Canada. In deciding to publish a hazard of concern on Table 1, Health Canada uses a variety of information sources, including:

• Incident reports and trends in Canada or other jurisdictions;
• Development and adoption of safety standards;
• Actions taken in other jurisdictions, and;
• Other information on hazards associated with consumer products.

Hazards associated with classes of consumer products that are listed on Table 1 have not yet undergone an assessment to determine whether they pose a danger to human health or safety. However, the listing of a hazard on Table 1 indicates that it may pose a danger to human health or safety. Regulated parties are encouraged to take steps to mitigate the identified hazards if they have not already.

Health Canada will monitor and collect information on the hazard. A hazard may remain on Table 1 for an extended period due to a number of reasons. These reasons include a lack of sufficient information to further assess the possible danger to human health or safety, or Health Canada's concerns about the hazard even if some regulated parties have taken hazard mitigation measures.

Once Health Canada completes a danger to human health or safety assessment for an identified hazard of concern and considers that it may pose a danger to human health or safety, the hazard of concern associated with a class of consumer products is moved from Table 1 to Table 2 for stakeholder feedback. If, following stakeholder input, there is insufficient information to conclude that a hazard associated with a class of consumer products posted on Table 2 poses a danger to human health or safety and Health Canada still has concerns, then it may be moved back to Table 1 for continued monitoring. Hazards of concern may be removed from Table 1 if Health Canada later concludes that they do not pose a danger to human health or safety or the hazard no longer exists.

What is included on Table 1?

• Identified hazards of concern associated with a class of consumer products. Entries on Table 1 include those that have not yet undergone a danger to human health or safety assessment.
• Performance criteria (i.e., existing voluntary standards, international rules or regulatory requirements) known to Health Canada that may mitigate the hazard.

What should a regulated party do about classes of consumer products listed on Table 1?

• Take measures necessary to mitigate the hazards identified.
• Provide Health Canada (CCPSA-LCSPC@hc-sc.gc.ca) with information they have on the hazards or any mitigation measures.

Table 2: Comment period for danger to human health or safety assessments

Table 2 lists hazards associated with classes of consumer products for which Health Canada has conducted a danger to human health or safety assessment. In deciding to move a hazard of concern from Table 1 to Table 2, Health Canada takes into account a number of factors, including:

• the severity of the hazard;
• the risk level;
• number of incidents;
• whether disproportionately impacted populations^{Footnote 1} are affected by the hazard;
• number of units sold; and,
• effectiveness of existing hazard mitigation tools.

Once an entry is added to Table 2, Health Canada invites stakeholders to provide comments on the danger to human health or safety assessment by a set date. Health Canada will consider these comments when making a determination on whether there is a danger to human health or safety.

Upon completion of this determination, Health Canada may conclude the hazard of concern is a danger to human health or safety and add the class of consumer products to Table 3. If there is insufficient information to conclude that there is a danger to human health or safety, the assessment documents will remain in the Closed for Comment section of Table 2 and it will be labelled as not currently being considered for Table 3. Health Canada will continue monitoring the hazard.

What is included on Table 2?

• Danger to human health or safety assessments that are open for comment, including the due date to submit comments to Health Canada.
• Danger to human health or safety assessments for which the comment period has closed and Health Canada is reviewing the comments received before making its determination.

Both listings will include:

• Hazards associated with a class of consumer products for which Health Canada has completed a danger to human health or safety assessment.
• Hazards associated with a class of consumer products that Health Canada is evaluating to determine if they are dangers to human health or safety.
• Performance criteria (i.e., existing voluntary standards, international rules or regulatory requirements) that may be sufficient to mitigate the hazard.

What should a regulated party do about classes of consumer products listed on Table 2?

• Take measures necessary to mitigate the hazards identified.
• Provide Health Canada (CCPSA-LCSPC@hc-sc.gc.ca) with any information or comments they may have relevant to Health Canada's danger to human health or safety assessment or identified performance criteria.
• Be aware that Health Canada will consider all information received by the due dates set out on Table 2 in reviewing its assessment and identified performance criteria.

There is no coming into force or transition period when a class of consumer products moves from Table 2 to Table 3 because paragraphs 7(a) and 8(a) of the CCPSA are already in force. Once the class of consumer products is added to Table 3, Health Canada can take immediate enforcement actions such as seizure, orders to take measures, orders to recall, or prosecution for the manufacture, import, advertisement, or sale of consumer products that do not comply with the CCPSA.

For more information and specific details of Table 2, please see the Information on Health Canada's Approach to General Prohibitions under the Canada Consumer Product Safety Act.

Table 3: Determination of dangers to human health or safety

Table 3 displays hazards associated with classes of consumer products that Health Canada has determined to be dangers to human health or safety. The manufacture, import, advertisement or sale of consumer products that are a danger to human health or safety is prohibited under the CCPSA and may be subject to compliance and enforcement actions.

What is included on Table 3?

• Classes of consumer products that Health Canada has determined to have hazards that pose a danger to human health or safety.
• Performance criteria (i.e., existing voluntary standards, international rules or regulatory requirements) that Health Canada has identified to be sufficient to mitigate the danger to human health or safety. Note - performance criteria that are equivalent in addressing the danger but are not listed on the table may also be acceptable.
• Final danger to human health or safety assessments (may contain updates to address comments received while open for comment), notices of dangers to human health or safety, and descriptions of the danger to human health or safety and the assessed performance criteria.

What should a regulated party do about classes of consumer products listed on Table 3?

• Do not manufacture, import, advertise, or sell products listed on Table 3 that do not meet the performance criteria set out on Table 3, or their equivalent.
• Take measures necessary to mitigate the danger to human health or safety identified.
• Review Health Canada's danger to human health or safety assessment for additional information about the scope of affected consumer products.
• Be aware Health Canada can take enforcement actions such as seizure, orders to take measures, orders to recall, administrative monetary penalties, or prosecution for the manufacture, import, advertisement, or sale of consumer products that do not comply with the CCPSA. There is no coming into force or transition period when a class of consumer products is added to Table 3 because paragraphs 7(a) and 8(a) of the CCPSA are already in force.

For more information and specific details of Table 3, please see the Information on Health Canada's Approach to General Prohibitions under the Canada Consumer Product Safety Act.

Industry responsibilities

Manufacturers, importers, advertisers and sellers of consumer products in Canada are responsible for ensuring their products are safe and comply with the CCPSA and its regulations. These regulated parties are expected to:

• regularly assess their products for potential dangers;
• review and apply relevant performance criteria, including requirements under laws enacted in other countries for a similar class of products, credible safety standards and world class best practices;
• mitigate any dangers in a timely fashion;
• report health or safety incidents to Health Canada;
• provide Health Canada with relevant information related to the dangers identified in the tables described above, along with any relevant performance criteria to mitigate them, and;
• regularly consult the tables linked to in this approach.

This document aims to describe the process by which Health Canada identifies, assesses, consults and determines that a hazard poses a danger to human health or safety. It also aims to describe the enforcement of the GPs under the CCPSA after identifying a danger to human health or safety. Transparency, openness and communication of information are key elements in achieving the objectives sought by this approach.

To ask questions about this approach please feel free to contact Health Canada at CCPSA-LCSPC@hc-sc.gc.ca or by telephone at 1-866-662-0666 (toll-free within Canada and the United States).

Useful links

• Subscribe for email updates about the Canada Consumer Product Safety Act
• Canada Consumer Product Safety Act Quick Reference Guide
• Industry Guidance – "Danger to Human Health or Safety" Posed by Consumer Products
• Industry Guide on Mandatory Reporting under the Canada Consumer Product Safety Act - Section 14 "Duties in the Event of an Incident"
• Report an Incident Involving a Consumer Product