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Consumer Product Safety

Industry Guide on Mandatory Reporting under the Canada Consumer Product Safety Act - Section 14 "Duties in the Event of an Incident"

Table of Contents

Introduction

The purpose of this guide is to help industry understand its obligations under section 14 of the Canada Consumer Product Safety Act (referred to in this guide as "the Act").

Under the Act, industry is responsible for making sure its products are safe.

Under section 14 of the Act, industry MUST report to Health Canada after they become aware of a health or safety incident involving its consumer product.

Some products intended for use by a consumer are not subject to the Act. They include cosmetics, drugs, medical devices, food, pest-control products and vehicles, which are all covered by other laws in Canada. Please refer to the Act or the Quick Reference Guide listed in Appendix A for a complete listing.

This document is an unofficial summary of, and guidance respecting, the requirements under section 14 of the Act. It is not intended to substitute for, supersede or limit the requirements under the Canada Consumer Product Safety Act. In case of any discrepancy between this summary and the legislation, the legislation will prevail. For further information, contact a Health Canada Consumer Product Safety Office via email (cps-spc@hc-sc.gc.ca) or telephone at 1-866-662-0666 (toll-free within Canada and the United States).

This document may be updated from time to time. For the most recent version, consult Health Canada's website.

How does Health Canada define "industry"?

While there is no definition of "industry" in the Act, there are definitions of the activities of selling, importing and manufacturing. Obligations under section 14 apply to people and companies who manufacture, import, or sell consumer products in Canada.

  • If you sell consumer products, you are part of "industry."
  • If you distribute consumer products, you are part of "industry."
  • If you import consumer products into Canada, you are part of "industry."
  • If you manufacture consumer products, you are part of "industry."

Wording from the Act

Section 2 of the Act defines these terms, as follows:

  • "consumer product" is 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.
  • "import" means to import into Canada.
  • "manufacture" includes produce, formulate, repackage and prepare, as well as recondition for sale.
  • "sell" includes offer for sale, expose for sale or have in possession for sale - or distribute to one or more persons, whether or not the distribution is made for consideration - and includes lease, offer for lease, expose for lease or have in possession for lease.

What are industry's responsibilities under section 14 of the Act?

Industry must report any incidents related to their consumer products to

  1. Health Canada; and
  2. the person who supplied them with the product (if applicable).

Sometimes, a person in the supply chain may have more than one role. For example, as part of industry, you may both manufacture and sell consumer products in Canada. Someone else who is part of industry may both import and sell consumer products in Canada.

If you have one role, you will report at that level of trade. If you have more than one role, Health Canada expects reports for only your highest role in the supply chain for that product. For example, if you both sell and import the product, you will submit reports as an importer. If you both sell and manufacture the product, you will submit reports as a manufacturer.

What is an "incident"?

An incident related to a consumer product is:

  1. Something that happened in Canada or somewhere else that resulted or may reasonably have been expected to result in death or serious negative impacts on health.
  2. A defect or characteristic of the product that may reasonably have been expected to result in death or serious negative impacts on health.
  3. Incorrect or not enough information on a label or instructions--or the lack of a label or instructions--that may reasonably have been expected to result in death or serious negative impacts on health.
  4. A recall or other action taken in Canada or elsewhere based on concerns about human health or safety.

Wording from the Act

Section 14 of the Act defines "incident" as follows:

  • (a) An occurrence in Canada or elsewhere that resulted or may reasonably have been expected to result in an individual's death or in serious adverse effects on their health, including a serious injury;
  • (b) A defect or characteristic that may reasonably be expected to result in an individual's death or in serious adverse effects on their health, including a serious injury;
  • (c) Incorrect or insufficient information on a label or in instructions - or the lack of a label or instructions - that may reasonably be expected to result in an individual's death or in serious adverse effects on their health, including a serious injury; or
  • (d) A recall or measure that is initiated for human health or safety reasons by
    • i. A foreign entity,
    • ii. A provincial government,
    • iii. A public body that is established under an Act of the legislature of a province,
    • iv. An aboriginal government as defined in subsection 13(3) of the Access to Information Act, or
    • v. An institution of an entity referred to in subparagraphs (ii) to (iv).

When is something an incident?

When industry learns about something that has occurred with any of its consumer products, this is called an "event." Some events are incidents. Some are not. You should take steps to ensure you are kept informed of any issues or concerns related to your consumer products. Including information-sharing requirements in your agreements or contracts can help.

It is industry's responsibility to determine if an event involving their product is an incident that must be reported to Health Canada. You need to be ready to meet your obligations under section 14 of the Act. This section includes information to help you make this decision.

Keep in mind that an event may meet the definition of an incident even without an actual death or serious injury having occurred. Under the Act, the reasonable potential for death or serious adverse health effects also meets the criteria for an incident. Industry is responsible for considering whether a death or serious adverse effect may reasonably have been expected to result from the event when determining whether an incident occurred.

When you learn about an event...

A person who manufactures, imports, or sells a consumer product in Canada may learn about an event through various sources, such as:

  • directly from a consumer, through product returns and complaints, or through product liability lawsuits or claims
  • directly from other levels of the supply chain
  • reports from experts, test reports, or information from scientific and other studies
  • directly from governments (including Health Canada) or from bodies that set standards or certify products

...then you need to decide if the event is an incident

To decide whether an event is an incident, ask yourself this question: does the event meet one of the four criteria set out in section 14 of the Act? The following provides further explanation of some concepts within the four criteria. Note that for the first three criteria, the event must have resulted in or had the potential to result in death or a serious adverse impact on health.

1. An occurrence

The first criterion under section 14 is "[a]n occurrence in Canada or elsewhere that resulted or may reasonably have been expected to result in an individual's death or in serious adverse effects on their health, including a serious injury".  It is industry's responsibility to determine whether a negative health impact (actual or potential) associated with an event is serious. 

A serious health impact includes a harmful effect that brings about a change to health. The change may be permanent or temporary. It includes damage to the body, chronic health effects, or any injury that sends a person to hospital or requires medical treatment. Some examples of this include:

  • threats to breathing such as choking, strangling, suffocation, asphyxiation, aspiration, or other respiratory problems
  • external physical harm, such as a serious burn or cut
  • internal harm, such as internal bleeding, injury to an organ, broken bones
  • poisoning
  • allergic reactions (including anaphylaxis)
  • loss of consciousness
  • convulsions
  • loss of sight or hearing

Deciding whether an injury is serious may depend on other factors, such as the person's age and the part of the body that is harmed. For example, a cut on an infant may be seen as more serious than a cut of the same size on an adult. A cut on the face may be deemed more serious than a similar cut on the person's leg.

Health Canada expects that industry will report to Health Canada on any death or serious injury related to a consumer product; however, if the death or serious injury happens due to the illegal use of a product or because the person wanted to harm himself, industry may decide, within reason, that this is not an incident. You must have a strong case for deciding NOT to report an incident. Be prepared to state your reasons if a Health Canada Product Safety Officer questions your decision.

Example

A mother is pushing a stroller with her baby buckled inside. Suddenly, the front wheel shaft breaks. The stroller veers off the sidewalk, the mother falls, and the stroller tips over on the road. The mother twists her ankle and the baby's head comes within one inch of hitting the pavement. Although no one is seriously hurt, there was potential for serious injury to the baby. If the company learns of this event, Health Canada would expect them to report it as an incident.

2. Defect or characteristic of the product

This refers to a problem with the product that causes weakness or failure in the product's form or how it works. In order to meet this criterion, the defect or characteristic must have the reasonable potential to cause death or serious negative impacts on health. This can occur when the product does not comply with regulations, certification requirements or standards for health or safety. It can also be the result of an error when the product was made in the factory. Sometimes, the way a product is designed or the materials used to make it can create a defect.

Example

A father is going out for a run with his toddler strapped in their new jogging stroller. This jogging stroller has large, easily accessible wheels with multiple spokes as a characteristic of its design, and these wheels can cause injury if they are accessible by the child while sitting in the stroller. During the run, the child put her hands into the spinning wheels. Whether the child was actually hurt or not, if the company learns of this event, Health Canada would expect them to report it as an incident.

3. Incorrect or not enough information

Industry must ensure that a product's label or instructions are correct and have enough detail so that consumers can use the product safely. The label and instructions must help people use the product the way it is intended to be used. To be an incident, the fact that the label is incorrect or does not contain sufficient information must have the potential to result in death or serious negative impacts on health.

Incorrect or not enough information on a product's label, instructions, or packaging may include:

  • precaution or warning statements that are not adequate
  • pictures that may show or encourage unsafe use (even if written instructions are correct)
  • statements about how to use the product that may contradict each other
  • warnings or directions for safe use that appear in only one official language
  • instructions for assembly or use that are misleading or incorrect

Examples

  • Photos on the package that show the product being used unsafely (e.g., a photo of a stroller designed for one child carrying two children).
  • Missing pages from the user manual that comes with the product (e.g., missing information on how to install and use the stroller brake).
  • Incorrect translations on labels or instructions of health or safety information (e.g., the French and English instructions on attaching the stroller seat to the frame are different).

4. Recall

When industry learns about a product recall in Canada or elsewhere for health or safety reasons, it is an incident under section 14.

Other Considerations

Many consumer products pose hazards. Industry can assess whether a hazard is reasonable or unreasonable when deciding whether to report something as an incident. Be aware that you should consider hazards from the consumer's viewpoint. You should not look at hazard from the viewpoint of product designers or engineers who are more familiar with the product. 

As an example, a knife that needs to be sharp enough to cut vegetables is also sharp enough to cut fingers. Most adult consumers understand when they use a knife that there is a chance they may cut themselves. Other hazards are less common and not expected by consumers. For example, if a knife handle breaks while someone is cutting vegetables and the knife slips, it could cut the person's hand. This is a hazard the person does not expect when using a knife.

Remember that the definition of a consumer product includes its components, parts, or accessories. If an event is determined to be an incident due to a component, part, or accessory, other products that are made with that same component should be included in the report.

When is someone "aware" of an incident?

"Awareness" of an incident does not mean that industry needs to be fully certain of all aspects or details of an event. If you are not certain whether an incident occurred, you should report to Health Canada on a precautionary basis. Once you decide that an incident has occurred, this establishes awareness.

Under the Act, industry's responsibility for reporting to Health Canada begins as soon as you have awareness of an incident. Industry should NOT wait until further details are received or absolute certainty (for example, through a formal risk assessment) is established that an incident has occurred.

As soon as industry becomes aware of an incident that could lead to a recall, it should report to Health Canada. By the time a company is considering a recall or announcement about a product for health or safety reasons, in most cases it would already have submitted an incident report to Health Canada.

Industry must report incidents. This is required by section 14 of the Act. Not reporting an incident is an offence.

There are two kinds of incident reports. The next section of this guide provides details on what they are and when industry must submit them.

When must industry report incidents and what information should it include?

Subsection 14(2) - Industry must report on the incident

Within two (2) days after the day you become aware of an incident, you must provide all available information about the incident to Health Canada and to the person from whom you received the consumer product. Communicating up the supply chain will ensure that companies that manufacture and import products are kept informed on any possible health or safety concerns regarding their products. The next section, "How should industry provide its incident reports to Health Canada?", contains further detail on the process for submitting your reports.

Wording from the Act

Subsection 14(2):
A person who manufactures, imports or sells a consumer product for commercial purposes shall provide the Minister and, if applicable, the person from whom they received the consumer product with all the information in their control regarding any incident related to the product within two days after the day on which they become aware of the incident.

Here is the kind of information to include in a 14(2) report:

  • all information about the product (name, model number, UPC, serial number)
  • description of how the incident happened
  • detail of injuries (body part, age of victim, kind of treatment they needed)
  • details on where the product is sold
  • complete name and contact information of the manufacturer or importer, as it appears on the product label
  • complete name and contact information of who supplied the product to you
  • information on any other known events related to the product
  • information on any other known incidents with this product reported in the past to Health Canada
  • information on products that share the same parts (components) as the one involved in the incident

If using the online incident report form, discussed in the section "How should industry provide its incident reports to Health Canada?", complete all but section 7 of the form with the information available at the time.

Table 1: Due Dates for 14(2) Reports (within 2 days after day of awareness)
If a person who manufactures, imports or sells a consumer product becomes aware of an incident on: You must provide information to Health Canada under subsection 14(2) by 11:59 p.m. of the next:
Note 1: The report becomes overdue after 11:59 p.m. in the person's time zone. This means if you are reporting from British Columbia to Health Canada in Ottawa, the report is overdue after 11:59 PT.

Note 2: If your report is due on a statutory holiday, your report is due on the day immediately following.
Friday Monday
Saturday Monday
Sunday Tuesday
Monday Wednesday
Tuesday Thursday
Wednesday Friday
Thursday Saturday

Industry updates Health Canada as it learns more over time. If you later find out that an event you reported is NOT an incident, your update can inform Health Canada of this.

Subsection 14(3) - Manufacturers and importers must submit an additional report to Health Canada

Those who manufacture or import products must also provide another written report within ten (10) days after the day on which they become aware of an incident.

According to subsection 14(3) of the Act, this report must contain:

  • any new information about the incident,
  • details about the consumer product involved,
  • details of any consumer products you manufacture or import that may be involved in a similar incident, and
  • any actions you have taken or propose to take to address health or safety concerns.

This report would usually include:

  • New details about the incident gathered from the consumer or through examination of the product involved in the incident (such as the root cause).
  • More information about the product, such as:
    • the number of products distributed
    • other incidents related to the same or similar product, with numbers of products distributed and a description
    • standards to which the product is certified and any Canadian Certification Records that exist
    • test reports, if you did testing on the product or similar products
    • warning labels and instructions on the product
    • pictures and diagrams of the product, as needed
    • steps the company took or will take to ensure safety
  • Other products that may be affected (such as products that share the same component involved in the incident).
  • Information about corrective action, including:
    • proposed corrective action(s) and an explanation of how the corrective measure will address the issue, or
    • the reasons corrective actions are not needed.

If using the online incident report form, discussed in the section "How should industry provide its incident reports to Health Canada?", complete ALL sections of the form and provide any attachments such as images, distribution lists and/or test results as additional documents.

Wording from the Act

Subsection 14(3):
The manufacturer of the consumer product, or if the manufacturer carries on business outside Canada, the importer, shall provide the Minister with a written report - containing information about the incident, the product involved in the incident, any products that they manufacture or import, as the case may be, that to their knowledge could be involved in a similar incident and any measures they propose be taken with respect to those products - within 10 days after the day on which they become aware of the incident or within the period that the Minister specifies by written notice.

Table 2: Due Dates for 14(3) Reports (within 10 days after day of awareness)
If a person who manufactures, imports or sells a consumer product becomes aware of an incident on: You must provide information to Health Canada under subsection 14(3) by 11:59 p.m. of the second:
Note 1: The report becomes overdue after 11:59 p.m. in the person's time zone. This means if you are reporting from British Columbia to Health Canada in Ottawa, the report is overdue after 11:59 PT.

Note 2: If your report is due on a statutory holiday, your report is due on the day immediately following.
Friday Monday
Saturday Tuesday
Sunday Wednesday
Monday Thursday
Tuesday Friday
Wednesday Saturday
Thursday Monday

Corrective actions may include consumer advisories, voluntary recall of the product, design changes, stop sale or distribution, product correction, and design or materials changes, among others. Not every 14(3) report will need to state corrective actions. If industry decides that no action is required in response to the incident, it should be prepared to explain its reasoning to Health Canada. Industry should update Health Canada as it learns more over time.

If a manufacturer or importer expects they will not be able to file a 14(3) report within 10 days, they must request an extension from Health Canada well before the deadline for the report. This request must:

  • state the reasons why they cannot meet the deadline;
  • include actions taken to date; and
  • provide a date when they expect to provide the report(s).

If an extension is granted by Health Canada, it will be communicated in a written notice. See the section "Contact Information for Health Canada" for information on how to get in touch with the department to request an extension.

Figure 1: Supply Chain Reporting

Providing other notices to Health Canada

Industry may want to send Health Canada a report about an event it has decided is not an incident. This is welcome. This report should contain clear reasons why you have decided the event is not an incident under the Act. When filling out the online form, check the box that says: "Notification - evaluated as not an incident."

How should industry provide its incident reports to Health Canada?

There are different ways that industry can report to Health Canada.

To submit reports under section 14, you may:

  • use the online form at www.healthcanada.gc.ca/reportaproduct
  • submit via email at CPSR-RSPC@hc-sc.gc.ca OR
  • submit via regular mail at:
    • National Capital Region Consumer Product Safety Office
      Consumer Product Safety Programme
      Health Canada
      269 Laurier Avenue West
      Ottawa, ON K1A 0K9
      AL 4907E

We strongly encourage industry to use the incident report form on our website:
www.healthcanada.gc.ca/reportaproduct

An automated reporting process is also available using Web Services Description Language (WSDL) for an Extensible Markup Language (XML) dropbox. Contact your IT support or Health Canada for further information.

If you do not wish to submit the form online, you can save the form and email it to us. You may also print the form and send it by regular mail. DO NOT submit your reports via courier as there may not be a departmental representative available to receive your report and there is a risk it will be returned to you.

Confidential Business Information and Private Information under the Act

Confidential Business Information (CBI)

Sections 16 and 17 of the Act expressly allow Health Canada to disclose confidential business information (CBI) in order to protect human health or safety, or the environment. 

Information about a person's business or affairs must meet ALL of the following conditions for it to meet the definition of CBI in the Act:

  • it is not publicly available;
  • the person has taken reasonable steps to ensure it remains not publicly available; and
  • it has actual or potential economic value to the person or their competitors (because it is not publicly available and making its disclosure would mean financial loss to the person or a financial gain to their competitors).

Under section 16 of the Act, the Minister may disclose CBI without the consent (or notice to) the person (or establishment) if certain conditions are met: the CBI must relate to a consumer product, and the CBI can only be disclosed to a person or government that carries out functions relating to the protection of human health or safety, or the environment. Those who receive the CBI must agree in writing to keep it confidential and to only use it for functions relating to the protection of human health or safety, or the environment.

Under section 17 of the Act, the Minister may disclose CBI to the public without the consent of (or prior notice to) the person if a consumer product poses a serious and imminent danger to human health or safety, or the environment. Disclosing the CBI must be essential to addressing the danger. Subsection 17(2) requires that Health Canada notify the person the next business day after the CBI is made public.

It is often possible to deal with health or safety concerns without disclosing CBI. Health Canada will consider relevant factors when determining whether to disclose CBI in a particular case.

Personal Information

Industry must comply with all laws that normally apply to the disclosure of personal information it controls.

Health Canada does not routinely require personal information when it assesses incident reports submitted under section 14. When in doubt, industry should leave out personal information about a consumer. If Health Canada requires personal information about a consumer in a specific case in order to follow up on a section 14 report, Health Canada will request the information.

The Privacy Act applies to Health Canada and will govern how the Department manages any personal information that is submitted.

Under section 15 of the Act, the Minister of Health may disclose personal information without the individual's consent based on two conditions:

  1. The information may be disclosed only to a person or government that carries out functions related to the protection of human health or safety.
  2. The disclosure must be necessary to identify or address a serious danger to human health or safety.

In addition, section 8 of the Privacy Act sets out instances where Health Canada may disclose personal information.

Appendix A - Information Resources

NOTICE: For further information visit the resources below or contact a Health Canada Consumer Product Safety Office via email (cps-spc@hc-sc.gc.ca) or telephone at 1-866-662-0666 (toll-free within Canada and the United States).