Q. Are the number of recalls in Canada expected to increase under the 
Canada Consumer Product Safety Act?
A. The number of recalls in Canada has increased every year for the last several years. Health Canada expects that the rate of increase will likely remain more or less the same.
Health Canada has a long history of working collaboratively with industry to have unsafe consumer products removed from the marketplace. It is expected that recalls – when necessary – would likely continue to be undertaken on a voluntary basis by industry in most cases.
Q. Where can I find the text of the Canada Consumer Product Safety Act?
A. The text of the 
Canada Consumer Product Safety Act can be found on the Justice Laws Website.
Q. Does my product fall under the Canada Consumer Product Safety Act?
A. Under the Canada Consumer Product Safety Act (CCPSA) 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.
Section 4 of the Act outlines the consumer products to which the CCPSA does not apply, including those listed in Schedule I. These include products that are covered under other legislation such as food, cosmetics, medical devices, drugs, natural health products, pest control products, fertilizers and vehicles. Tobacco products are also excluded, except with respect to their ignition propensity – i.e., their flammability properties.
Q. Is Health Canada considering adding certain products to the list of products to which the Canada Consumer Product Safety Act does not apply?
A. Section 4 of the Canada Consumer Product Safety Act (CCPSA) outlines the consumer products to which the CCPSA does not apply, including those listed in Schedule I. These include products that are covered under other legislation such as food, cosmetics, medical devices, drugs, natural health products, pest control products, fertilizers and vehicles. Tobacco products are also excluded, except with respect to their ignition propensity – i.e., their flammability properties.
At this time, Health Canada is not considering adding more consumer products to Schedule I of the Act.
Q. What is the policy on the acceptability of test reports and test labs? What about tests already done?
A. Suppliers of consumer products are responsible for ensuring the products they place on the Canadian market comply with the Canada Consumer Product Safety Act (CCPSA).
There are no specific certification requirements under the CCPSA for laboratories that conduct tests on consumer products. However, the following practices are recommended to help ensure that test results, if requested, will provide the necessary information for the purposes of the CCPSA:
- testing should be to the Canadian requirements for the consumer product as described in regulations, policies and guidelines;
- testing should be conducted on a representative sample of the product available in the Canadian market; and
- testing should be carried out at laboratories that have demonstrated competency in that testing area, preferably through accreditation to ISO/IEC 17025:2005 – General Requirements for the Competence of Testing and Calibration Laboratories, by a full member of the International Laboratory Accreditation Cooperation – Mutual Recognition Arrangement (“ILAC-MRA“).
Testing that was carried out prior to coming into force of the CCPSA may be acceptable if it meets the criteria above and can be traced to the products under review.
Q. Under the Canada Consumer Product Safety Act, how does Health Canada determine whether a recall is necessary, and the scope of the recall?
A. The Canada Consumer Product Safety Act (CCPSA) introduced a new provision relating to recalls under subsection 31(1), which grants the Minister the authority to order a recall if he or she “believes on reasonable grounds that a consumer product is a danger to human health or safety”.
Consumer product recalls are one of several measures that can be taken to address a danger in the marketplace. In the event that a danger must be addressed, product safety officers will work directly with industry to determine what corrective measures are appropriate for industry to achieve compliance. Each incident will be evaluated on a case-by-case basis, taking into account factors such as the nature of the hazard, the severity of reported or potential incidents and the number of products sold to consumers.
Health Canada will work to achieve industry compliance with the CCPSA, including ordering recalls where appropriate. It is expected that recalls – when necessary – would continue to be undertaken on a voluntary basis by industry.
General prohibition
Q: What is the general prohibition?
A: The general prohibition (GP) is set out in sections 7(a) and 8(a) of the Canada Consumer Product Safety Act (CCPSA). It applies to all consumer products to which the CCPSA applies and is fundamental to the purpose of the Act, which is to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada.
The GP prohibits manufacturers or importers from manufacturing, importing, advertising or selling a consumer product that is a danger to human health or safety, and prohibits any person from advertising or selling a consumer product that they know is a danger to human health or safety.
Definitions
Q. Does the definition of “import” include the importation of consumer products by an individual for personal use?
A. Yes. Any person who imports a consumer product for personal use would fall under the definition of “import” and would be required to comply with certain provisions of the Canada Consumer Product Safety Act (CCPSA).
For example, any person who imports, whether for commercial or personal use, must comply with sections 5 and 6 of the CCPSA. These provisions prohibit any person from importing into Canada consumer products listed in Schedule 2 of the CCPSA or consumer products that do not meet the requirements as set out in regulations.
However, there are certain provisions in the Act that apply to the import of consumer products only when the import is done for commercial purposes. Therefore, provisions such as those respecting preparing and maintaining documents ( section 13) and mandatory incident reporting ( section 14) do not apply to individuals importing consumer products for personal use.
Q. Does the Canada Consumer Product Safety Act apply to automotive tires?
A. No. Schedule 1 of the Canada Consumer Product Safety Act includes a list of consumer products that are not subject to the CCPSA. One of the items lists vehicles as defined in section 2 of the Motor Vehicle Safety Act as well as vehicle parts that are integral to the vehicle, including a vehicle part that replaces or alters such a part.
Q. Am I required to meet the requirements of the Canada Consumer Product Safety Act if I distribute consumer products for promotional purposes (i.e. free giveaways) or in exchange for loyalty points?
A. Yes. A person who distributes consumer products for promotional purposes or in exchange for loyalty points is considered a person who “sells” under the Canada Consumer Product Safety Act. The definition of “sell” under the Act includes the distribution of a consumer product even when the distribution is not made for consideration, i.e., when the product is donated or given away at no cost. Therefore, anyone who distributes consumer products for no cost or in exchange for loyalty points is required to comply with those provisions of the Act that apply to the sale of consumer products.
In this context it is useful to remember that persons who sell consumer products for commercial purposes are required to keep certain documents.
Q. Are construction materials/plumbing components in a residential setting that are installed by professionals – and not available for direct sale to consumers – captured under the definition of a “consumer product”?
A. Generally, yes. Products that are obtained by an individual through professional installation can meet the definition of a “consumer product” under the Act.
Consultations
Q. Which stakeholders were included in consultations for the Canada Consumer Product Safety Act (CCPSA)?
A. Health Canada carried out extensive consultations during the development of the Canada Consumer Product Safety Act (CCPSA) and its implementation. These stakeholders have included industry representatives, consumer groups, children’s organizations, other levels of government and the general public.
Since the summer of 2010, Health Canada has consulted with the public on the following:
- Mandatory Reporting Policy for the Proposed Canada Consumer Product Safety Act
- Proposal for the making of Exemptions Regulations respecting
- Consumer Products Non-Compliant with Requirements in Regulations
- Preparing and Maintaining Documents
- Proposal for the Making of Administrative Monetary Penalties (AMP) Regulations under the proposed Canada Consumer Product Safety Act
- Preparing and Maintaining Documents under the Canada Consumer Product Safety Act
- Mandatory Incident Reporting under the Canada Consumer Product Safety Act
The department continues to work closely with stakeholders to ensure a smooth transition to the new legislation.
If you are interested in participating in future consultations or in receiving information updates regarding the CCPSA, you can subscribe for email updates.
Implementation plan
Q. What about the reporting burden placed on small business? Has Health Canada considered how they are going to deal with all the procedures involved?
A. Health Canada has consulted broadly with stakeholders, including small businesses in order that concerns such as those associated with new reporting requirements were taken into consideration during the development of the Canada Consumer Product Safety Act and its subsequent implementation.
The department has also developed guidance and tools to help support industry’s ability to comply with the Act. For example, Health Canada has developed a web-based incident reporting form for use when submitting incident reports as required under section 14. The department has also developed guidance documents for industry on mandatory reporting and preparing and maintaining documents provisions of the CCPSA. In addition, every effort has been made to align requirements under the Act with existing legislative requirements for business.
For example, under section 13 persons must keep certain documents for six years after the end of the year to which they relate. This timeframe aligns with standard record keeping requirements for business as part of their normal book keeping practices (i.e., documents for GST requirements or income tax purposes).
Q. Is industry required to establish new processes – such as an international surveillance system to track recalls – to ensure compliance with the new Act?
A. The Canada Consumer Product Safety Act does not mandate companies to establish formal new surveillance systems. However, it is recommended that industry have, as part of good business practices, the necessary mechanisms to ensure that they are able to gather knowledge of their products in the marketplace.
Orders
Q. Does the review of orders process apply to all types of orders that could be issued under the Canada Consumer Product Safety Act?
A. No. Only orders made under sections 31 or 32 of the Canada Consumer Product Safety Act are eligible for review. These include orders for recall and orders to take measures (i.e. stopping the manufacturing, importation, packaging, storing, advertising, selling, labelling, testing, or transportation of the consumer product, or any other measure the Minister considers necessary to remedy non-compliance).
Q. Who can request the review of an order and how is this done?
A. The person who is subject to an order can request a review. In addition, a review officer can independently initiate the review of an order. Section 35 of the Canada Consumer Product Safety Act (CCPSA) outlines the process for requesting a review, including:
- The request must be provided to the Minister in writing within 7 days after the day on which the order was provided unless the order specifies another time period.
- The written request must state the grounds for review, set out the evidence that supports those grounds and specify the decision that is sought.
Subsection 35(3) of the CCPSA states that a review is not to be done if the request does not comply with the requirements specified in subsection 35(2) or if the request is frivolous, vexatious, or not in good faith.
The review officer has 30 days after the day on which the request is provided to the Minister to complete the review. The review officer may extend this period by up to an additional 30 days and may do so more than once. The requester must be notified in writing of any extension and of the reason for the extension.
The requestor will be notified in writing of the reasons for the review officer’s decision on the outcome of the review. Note that the order continues to apply during the review period unless the review officer decides otherwise.
Q. On what grounds can the review of an order be requested?
A. An order may only be reviewed on grounds that involve questions of fact alone or questions of mixed law and fact. An example would be if you become aware of new or additional evidence that may affect the context under which the order was issued.
Note that subsection 35(3) of the Canada Consumer Product Safety Act states that a review is not to be done if the request does not comply with the requirements specified in subsection 35(2) or if the request is frivolous, vexatious, or not in good faith.
Q. What does it mean in practice for the Minister to have the authority to order a recall?
A. Under subsection 31(1) of the Canada Consumer Product Safety Act the Minister has the authority to order a recall if he or she “believes on reasonable grounds that a consumer product is a danger to human health or safety”. As is the case with many ministerial authorities, an appropriate departmental official may be designated to exercise this authority.
An order for recall must be issued in writing and must include a statement of the reasons for the recall and the time and manner in which the recall is to be carried out.
Health Canada will continue to work with industry to resolve incidents of non-compliance through effective voluntary actions prior to using stronger compliance and enforcement measures. It is expected that recalls – when necessary – would likely continue to be undertaken on a voluntary basis by industry.
Advisory committees
Q. How will advisory committees work? Is there a timeline for inviting members to participate?
A. Section 67 of the Canada Consumer Product Safety Act states that the Minister shall establish a committee to provide him or her with advice on matters in connection with the administration of the Act, including the labelling of consumer products. The advice provided to the Minister will be made public. The Minister may strike one or more committees to provide him or her with advice on any issue related to the administration of the Act at any point after the Act comes into force.
Mandatory reporting
Health Canada has developed industry guidance to provide information regarding the mandatory incident reporting requirements under section 14 of the Canada Consumer Product Safety Act (CCPSA). You are also able to subscribe for email updates on the CCPSA so that you can keep informed of developments as they arise.
Q. Subsection 14(2) of the Canada Consumer Product Safety Act requires that sellers, manufacturers or importers of a product report to the Minister any information regarding any incident related to their product within two days. What does “relate” mean with respect to the determination of an incident?
A. When evaluating an event, the Canada Consumer Product Safety Act requires a person to determine if the product involved (including its components, parts or accessories and its packaging) is related to a consumer product that they manufacture, import or sell in Canada for commercial purposes.
The event need not directly involve the same consumer product that is exactly identical to the product the person manufactures, imports or sells in Canada. This may be the case, for instance, if the consumer product the person supplies shares a component, accessory or part with the product involved in the incident.
An additional consideration for the aspect of “relate” requires a person to determine if the consumer product is connected with the event.
Q. When making a determination of whether there is a reportable incident, one of the considerations pertains to “normal or foreseeable use”. What are the factors that should be taken into account when assessing normal or foreseeable use?
A. In assessing whether an “incident” has occurred under paragraphs 14(1)(a) to (c) consideration may be given to whether it indicates an unreasonable hazard posed by the normal or foreseeable use of the product, including the foreseeable misuse of the product.
Experience and judgment need to guide whether the consumer product involved in a suspected incident was being used as it was originally intended to be used or in a manner that was foreseeable but unintended.
What constitutes normal or foreseeable use or foreseeable misuse of a consumer product will depend on factors such as the particular product involved, the circumstances surrounding the event and the totality of information available to the supplier.
Q. How should an unreasonable hazard be considered in the determination of an incident?
A. The requirement in the definition of “danger to human health or safety” that hazards be “unreasonable” takes into account the fact that some consumer products (e.g. chain saws, power tools and kitchen knives) may by their very nature be hazardous in normal use, but those hazards are commonly accepted in order to have the benefit of the product. Such hazards would not be “unreasonable hazards” and would thereby not be captured by the general prohibition of the Canada Consumer Product Safety Act (sections 7 and 8).
On the other hand, hazards that are not commonly expected and accepted in these circumstances may constitute an “unreasonable hazard”.
The determination of whether a hazard is “unreasonable” will involve the use of standard risk assessment principles. Several factors must be taken into account, including:
- the overall utility of the product
- the utility of the aspect of the product that may pose a hazard
- the nature and severity of the hazard posed by the product
- the likelihood of the hazard materializing
- the availability of a safer design
Q. What happens with the information received through the section 14 reporting requirements?
A. The information generated as a result of mandatory reporting will help inform a broad range of Health Canada’s activities in the realm of consumer product safety. By requiring that incidents be reported to Health Canada and up the supply chain, Health Canada can monitor responses to dangers posed by consumer products. The information received may in some instances help inform the requirement for corrective actions or it may more generally contribute to an understanding of trends and in turn be the basis for communications with the public. For example, Health Canada may use the information to identify areas in which it would be of benefit to promote the safe use of consumer products to Canadians.
While the information received through mandatory reporting can be used in many ways to help protect the health and safety of Canadians, not every report will result in a follow-up action on the part of Health Canada.
Q. What is the definition of “day” for the purposes of submitting an incident report?
A. Where a report is to be submitted within a number of days after the day on which a person becomes aware of the incident, the day on which a person becomes aware of an incident is not included (see Interpretation Act at subsection 27(5)).
As per the Interpretation Act, where the due date for providing information to Health Canada falls on a holiday (which includes a Sunday), the provision of information is due on the next day that is not a holiday. “Holiday” is defined in subsection 35(1) of the Interpretation Act to include a “Sunday” and other identified holidays.
Q. How do mandatory reporting requirements under the Canada Consumer Product Safety Act compare to requirements in other jurisdictions?
A. Canada recognizes that aligning reporting requirements across jurisdictions reduces the regulatory impact on industry. That is why Health Canada has taken into account the product safety regimes developed by its principal trading partners, specifically the United States and the European Union, to establish a strengthened and more effective product safety regime for Canadians.
Information gathered through mandatory reporting can be used to support early detection of dangers posed by consumer products, and allows for proactive and efficient means for responding to those dangers. Some of the key elements of Canada’s mandatory requirements align with its major trading partners. For example, similar to the United States, section 14 of the Act requires the manufacturer, importer or seller to provide an initial notification once they become aware of an incident, and requires the higher level of trade to provide a follow up report with subsequent information and mitigation measures.
While mandatory reporting requirements in Canada share a common purpose with other jurisdictions, which is to gather information on how consumer products are being used with respect to human health and safety, the approach to mandatory reporting may differ in each jurisdiction.
Q. What is Mandatory Reporting?
A. Section 14 of the Canada Consumer Product Safety Act requires that persons who manufacture, import or sell a consumer product for commercial purposes in Canada report incidents related to their products to Health Canada and, if applicable, to the person from whom they received the product. Manufacturers and importers must also provide more detailed information on the incident to Health Canada, including information about any measures they propose be taken with respect to those products.
Q. How do I determine what is considered as a reportable incident?
A. Companies must undertake an evaluation to determine if a possible incident meets the requirements to report to Health Canada.
The following questions can assist in the determination of whether an event is a reportable incident:
- Does the event relate to a consumer product that I sell, manufacture or import in Canada for commercial purposes (including its components, parts or accessories or packaging)?
- Does it meet the criteria of an incident in either one of paragraphs 14(1) (a) through (d)?
- Does it indicate an unreasonable hazard posed by the normal or foreseeable use of the product or the foreseeable misuse of the product?
Health Canada has developed industry guidance to provide information regarding the mandatory incident reporting requirements. This includes guidance on determining what constitutes a reportable incident.
Q. When do I need to provide information to Health Canada?
A. The timelines for providing information are set out in the Canada Consumer Product Safety Act. Once you have information from which one may reasonably conclude that a reportable incident has occurred, you are considered to be “aware” of an incident. You must report to Health Canada and, if applicable, to the person from whom you received the product within two days after the day you become aware of the incident. Manufacturers and importers also have additional reporting requirements.
For further information, Health Canada has developed industry guidance to provide information regarding the mandatory incident reporting requirements. This includes guidance on determining when to provide information to Health Canada.
Q. How do I report an incident?
A. Health Canada has developed web-based incident report forms for industry and for consumers, which can be submitted directly online. These incident report forms are currently available on Health Canada’s Web site.
Q. If a product falls under the purview of both the Canada Consumer Product Safety Act and another statute, such as a provincial one, will Health Canada be the primary reporting body that will distribute the incident report information to the other regulatory body?
A. No. Health Canada will not serve as a single window for other reporting bodies and their regulatory requirements.
A report to Health Canada does not constitute a report to any other jurisdiction. Not providing information to the other jurisdiction may be deemed a failure to report to that other jurisdiction.
Q. Does a recall undertaken in another country need to be reported in Canada as well?
A.Paragraph 14(1)(d) of the Canada Consumer Product Safety Act includes a recall initiated by a foreign jurisdiction for human health or safety reasons as an incident. A recall in a foreign jurisdiction is one of the considerations that must be taken into account when determining whether an event meets the criteria for a reportable incident. Under subsection 14(2), once a person who manufactures, imports or sells a consumer product for commercial purposes in Canada becomes aware of an incident related to the product, they are responsible for reporting to Health Canada and, if applicable, to the person from whom they received the product.
Q. As a consumer, how and when should I report an incident?
A. Consumers are encouraged to report incidents with respect to health or safety concerns with a consumer product directly to the retailer or manufacturer. The Canada Consumer Product Safety Act requires suppliers of consumer products to provide Health Canada – and the person from whom they received the consumer product – with all the information in their control regarding any incidents related to their products that they become aware of.
Health Canada has also developed an online reporting form that consumers can use to report incidents directly to Health Canada.
Q. Can a corporate head office submit mandatory incident reports on behalf of its franchisees?
A. A person who manufactures, imports or sells consumer products in Canada for commercial purposes has mandatory reporting obligations under section 14 of the Canada Consumer Product Safety Act.
Given the variety in ownership structure and sourcing of inventory, industry will organize itself in different ways to achieve compliance with the requirements for mandatory reporting of consumer product incidents. It is expected that companies will put in place the appropriate mechanisms to make the determination of whether an event is a reportable incident.
Q. As a company operating in Canada with global operations, am I required to report an incident to Health Canada once I learn that an occurrence relating to one of my consumer products has occurred in a foreign jurisdiction?
A. Yes. Regardless of where an occurrence involving a consumer product takes place, companies operating in Canada that sell, distribute, manufacture or import the same product must determine if the occurrence involving the consumer product meets requirements to report to Health Canada. Action taken on a consumer product in a foreign jurisdiction for health and safety reasons may meet the criteria for an incident as described in section 14 of the Canada Consumer Product Safety Act (CCPSA).
If the determination is made that the occurrence in a foreign jurisdiction meets the criteria for an incident as described in section 14 of the CCPSA then the company must report to Health Canada and, if applicable, to the person from whom they received the product within two (2) days of becoming aware of that incident.
Q. Would a company that concludes that an incident is not reportable to Health Canada, be fined or penalized if Health Canada determined that the incident should have been reported
A. Experience and judgment need to guide industry when determining whether an incident must be reported. Health Canada will take a balanced, risk-based approach to compliance and enforcement to address safety in the marketplace. Generally, Health Canada will continue to work with industry to resolve incidents of non-compliance through effective voluntary actions prior to using stronger compliance and enforcement measures.
Failure to provide the information required by section 14 of the Canada Consumer Product Safety Act is a contravention and is subject to compliance and enforcement action. Persons are therefore encouraged to report an event when in doubt as to whether the event constitutes an incident.
Q. I am a service agent involved in installation/repair/removal of goods. Does the mandatory reporting obligation apply to me?
A. Mandatory reporting requirements are set out in section 14 of the Act. The mandatory reporting requirements apply to “a person who manufactures, imports or sells a consumer product for commercial purposes.” To help determine whether your activities are subject to section 14 of the Act, consult the definitions of “manufacture,” “import” and “sell” in the Act, as well as the Mandatory Reporting guidance document.
If you are a service agent employed by the company that sells the product you are installing or servicing, then you as an individual may not be considered “a person who manufactures, imports or sells a consumer product for commercial purposes” for the purposes of section 14. The obligations would rest with the company rather than you as an individual.
Of relevance to this question is the scope of the products captured by the Canada Consumer Product Safety Act (CCPSA). Section 2 of the CCPSA defines a consumer product 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. Therefore, components, parts or accessories provided as part of an installation or repair can also themselves be consumer products, consistent with the definition.
Preparing and maintaining documents
Health Canada has developed industry guidance to provide information regarding the requirements for preparing and maintaining documents under section 13 of the Canada Consumer Product Safety Act (CCPSA). You may wish to subscribe for email updates on the CCPSA so that you can keep informed of developments as they arise.
Q. As a retailer operating nationwide, do I have the option to maintain all records in one location at the corporate head office?
A. Section 13 of the Canada Consumer Product Safety Act (CCPSA) requires any person who imports, manufactures, sells, tests or advertises a consumer product for commercial purposes to prepare and maintain documents. This is important for the purposes of implementing product safety measures such as product recalls and providing documents to Health Canada inspectors upon request.
Subsection 13(3) requires that documents be kept at the person’s place of business in Canada, or at any prescribed place. Anyone who is required under the CCPSA to prepare and maintain documents has the discretion to determine the business location where it makes sense to keep those records. Whether records are stored at the corporate head office location or at the location of each individual retailer, it is important that the person be able to provide documents to Health Canada upon request and that those records can be used to put in place corrective measures.
Q. The Canada Consumer Product Safety Act has provisions requiring industry to prepare and maintain documents. What is meant by “the prescribed documents” in section 13(1)(b) of the Act?
A. The reference to “prescribed documents” in paragraph 13(1)(b) refers to regulations under the Canada Consumer Product Safety Act (CCPSA) that have requirements for preparing and maintaining documents separate from those required under paragraph 13(1)(a) of the Act. A list of such regulations is available in Appendix A of the Guidance on Preparing and Maintaining Documents under the CCPSA. For example, the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) require manufacturers and importers to keep records with respect to specifications regarding child-resistant characteristics of the container.
Q. Does the requirement to keep records at my “place of business in Canada” mean that all documents must be physically located in Canada (ie: servers)?
A. The intent of section 13 of the Act is to ensure the traceability of consumer products throughout the supply chain in the event that a danger must be addressed. Under these circumstances it is important for these documents to be readily available to Health Canada officials and for industry to make timely mandatory reports, put in place effective product recalls, and produce documents as part of routine inspections.
Whether records are stored in paper or electronic format, it is expected that all records will be physically located at your place of business in Canada. For example, if you have a server that stores electronic files which is located outside of Canada, those files must be easily and readily accessible on a computer terminal in Canada. In cases where it is not possible to maintain records in Canada in this way, you must apply for an exemption from this requirement.
Q. How do I get an exemption from keeping records in Canada?
A. The legislation allows for persons to request an exemption from the requirement to keep records in Canada. In cases where the Minister of Health considers it unnecessary or impractical for records to be kept at a place of business in Canada, persons may be granted an exemption.
Any person seeking an exemption from this requirement should speak directly with a Health Canada inspector in their region.
Q. Section 13 of the Act allows persons to request an exemption from the requirement to keep records in Canada. Under what circumstances might the Minister consider it “unnecessary or impractical” for a company to keep records in Canada?
A. The purpose of the requirement to prepare and maintain documents is to help improve the traceability of consumer products in the event that a danger must be addressed. In the case where a person cannot meet the requirement to keep records in Canada, a request for an exemption may be made to the Minister. Requests will be reviewed on a case-by-case basis to determine whether the circumstances meet the “unnecessary or impractical” threshold. The review will take into account several factors including the ability of the requestor to provide documents to Health Canada within a reasonable timeframe.
Q. Do I need to keep copies of my records electronically?
A. Documents may be kept in any format – electronic or paper – as long as those documents can be accessed in a timely manner, and they are legible.
For the purposes of submitting records to Health Canada it is recommended that records be maintained and provided in a compiled format, such as a spreadsheet.
It is expected that all documents provided to Health Canada will clearly identify the required information, are legible, and are provided in French or English.
Q. How quickly do I need to produce records for Health Canada inspectors?
A. Persons who are required to prepare and maintain documents under the Canada Consumer Product Safety Act (CCPSA) should be prepared to produce records upon request, or within the time period as set out in the CCPSA or regulations. A list of such regulations is available in Appendix A of the Guidance on Preparing and Maintaining Documents under the CCPSA.
For example, the time period prescribed in the Consumer Chemicals and Containers Regulations (CCCR) requires that persons responsible for a chemical product required to be packaged in a child-resistant container must provide documents within 15 days after receipt of a request from an inspector.
As with other aspects of the administration of the Act, a balanced, risk-based approach to compliance and enforcement can be expected to address safety in the marketplace while allowing for the free flow of goods in a post-market regime.
Q. Is Health Canada planning to require traceability of components of consumer products?
A. The requirement to prepare and maintain documents under Section 13 of the Canada Consumer Product Safety Act is intended to facilitate traceability of products along the supply chain and will apply to consumer products as defined in the Act. The definition includes components, parts and accessories of consumer products.
Q. Are consumer products used in a commercial setting, such as in daycare facilities or hotels, regulated under the Canada Consumer Product Safety Act?
A. Under the Canada Consumer Product Safety Act (CCPSA) 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.
Section 4 of the Act outlines the consumer products to which the CCPSA does not apply, including those listed in Schedule I.
A product that meets the definition of consumer product is not necessarily excluded from the scope of the CCPSA when used in a commercial setting. For example, cribs that are used in daycare facilities or hotels may meet the requirements of the definition as, in many circumstances, they can reasonably be expected to be obtained by an individual to be used for non-commercial purposes.
Q. As a person who tests consumer products, am I required to keep test results under section 13 of the Canada Consumer Product Safety Act?
A. The purpose of the provision to prepare and maintain documents is to ensure the traceability of consumer products throughout the supply chain in the event that a danger must be addressed. The record keeping requirements for persons who import, manufacture, advertise, sell or test a consumer product for commercial purposes as set out in subparagraph 13(1)(a)(ii), include documents that indicate the name and address of the person from whom they obtained the product, or to whom they sold it, or both as applicable.
Section 13 does not require persons to keep test results, unless this requirement is specified in regulations as referred to in paragraph 13(1)(b) of the Canada Consumer Product Safety Act (CCPSA). The regulations also set out the time period required for keeping those test results. For example, the Carbonated Beverage Containers Regulations currently require manufacturers and importers to keep test results for a period of two years.
Note that, under section 12 of the CCPSA, a person who manufactures or imports a consumer product for commercial purposes may be ordered by the Minister to conduct tests or studies, compile information and provide the Minister with documents that contact the results of the tests or studies.
Q. As a manufacturer, must I prepare and maintain documents respecting the components or parts that I obtain in order to assemble the final consumer product that I sell?
A. Yes. The Canada Consumer Product Safety Act (CCPSA) definition of a consumer product includes its components, parts, accessories and packaging. Therefore, any person who imports, manufactures, advertises, sells or tests a consumer product or its components, parts, accessories or packaging is responsible for complying with the Act.
The requirement to prepare and maintain documents under section 13 of the CCPSA is intended to facilitate traceability of products through the supply chain and applies to any person who manufactures, imports, advertises, sells or tests a consumer product for commercial purposes.
Activities for Commercial Purposes
Q. The Canada Consumer Product Safety Act (CCPSA) places special obligations on persons carrying out activities for commercial purposes, including preparing and maintaining documents (section13), mandatory incident reporting (section 14) and the requirement to provide tests or studies upon request (section 12). These persons are also responsible for carrying out recalls when ordered to do so (section 31). How do I know if my activities are considered to be for commercial purposes?
A.Establishing whether a person carries out activities for commercial purposes will have to be determined on a case-by-case basis. Various indicators and factors may be considered in making that determination.
For example, if you are a business, and as a business, you are engaging in the supply or distribution of a consumer product within an organized supply chain (at any point from manufacture or import through to selling to the consumer), you are likely engaging in activities for commercial purposes. This applies to the supply of consumer products for no consideration (for example, donations or promotional giveaways).
The level of your involvement in an organized supply chain for a consumer product and the use of business-like practices in supplying consumer products are good indicators of activities considered to be for commercial purposes. Business-like practices would include managing inventory, record keeping (including issuing receipts or invoices) and receiving payments in a commercial manner (including through invoices, business accounts or credit card terminals).
For example, small businesses that sell products from a recurring flea market stall, rotating fairs or bazaars or an online storefront (including those found on online auction websites or online classified ad websites) may be carrying out activities for a commercial purpose. Further, a business that provides products for no consideration (for example for donation) to a non-profit organization may also be considered to be carrying out activities for commercial purposes.
On the other hand, personal sales (in other words, individuals who are not considered to be small business who sell their own second-hand items) would not normally be considered to be undertaking activities for commercial purposes pursuant to the Canada Consumer Product Safety Act (CCPSA). This would include someone having a personal garage sale or selling an unwanted item through a classified ad either on-line or in print. Therefore, the requirements of the CCPSA that apply to activities carried out for commercial purposes would not apply.
Components, raw materials and ingredients
Q. Are suppliers of raw materials and ingredients subject to the requirements of the Canada Consumer Product Safety Act?
A. The supply of most raw materials and ingredients to manufacturers of consumer products is not normally considered to fall under the scope of the Canada Consumer Product Safety Act (CCPSA). However, the answer to this question will depend on the particular facts at hand, including whether the raw material or ingredient meets the definition of “consumer product” in the CCPSA. This definition includes a product’s components, parts, accessories and packaging.
Q. Is a person who manufactures a component, part or accessory of a consumer product considered a “manufacturer” under the Canada Consumer Product Safety Act?
A. The definition of “consumer product” includes its “components, parts or accessories.” Therefore, any person who imports, manufactures, advertises, sells or tests components, parts or accessories of a consumer product as defined in section 2 of the Canada Consumer Product Safety Act (CCPSA), must comply with the requirements under the Act and Regulations.
Manufacturing
Q. Does the definition of “manufacture” apply to consumer products that are finished and prepared for sale by a retailer? If so, would the retailer be required to report an incident and/or keep records as both the manufacturer and the retailer?
A. The definition of “manufacture” in the Canada Consumer Product Safety Act (CCPSA) refers to products that are produced, formulated, repackaged, prepared and reconditioned for sale. If you are a retailer that engages in activities that meet the definition of manufacture, you may be required to comply with the provisions of the CCPSA that apply to manufacturers as well.
Retail assembly, however, such as the fitting together of component parts of manufactured products, would not generally meet the definition of manufacture. Examples may include, where a hardware store assembles a barbeque or a sports store assembles a bicycle for its retail customers.
When in doubt, submit a report or keep records as required at each level of trade.
Real property
Q: Is a house or other real property considered to be a consumer product to which the CCPSA applies?
A. No, houses and other real property are not consumer products to which the CCPSA applies. However, many construction materials and household items are consumer products under the Act.
Regulations
Q. To what extent is the Consumer Chemicals and Containers Regulations, 2001 affected under the Canada Consumer Product Safety Act?
A. The Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) did not change once they were transferred to the CCPSA.
Regulations made under Part I of the Hazardous Products Act (HPA) were transferred to the Canada Consumer Product Safety Act (CCPSA) at the time of coming into force of the Act on June 20, 2011. Due to the differences in how the CCPSA and HPA are structured, the direct transfer of certain Regulations would have resulted in regulatory gaps. In order to maintain the same requirements respecting chemical products and containers, the CCCR, 2001 was amended to replace the authorization sections (e.g., 2, 45 and 53) and re-introduce the prohibition of very toxic products (section 38).
For more information about this regulatory transfer, please see the Regulations Amending the Consumer Chemicals and Containers Regulations, 2001.
Q. When can we expect to see new regulations under the Canada Consumer Product Safety Act?
A. The Canada Consumer Product Safety Act (CCPSA) includes provisions for a wide range of regulation-making authorities. Under the CCPSA, the new Administrative Monetary Penalties (Consumer Products) Regulations were developed and came into force in May 2013. Health Canada is also planning to make Exemption Regulations. Preliminary regulatory consultations for the making of Exemption Regulations under the CCPSA concluded in the fall of 2010. Further opportunity to provide comments on these proposed regulations will be provided as part of the regulatory development process.
Existing regulations that were developed under Part I of the Hazardous Products Act were transferred to the CCPSA at the time of coming into force of the Act on June 20, 2011. For more information about this regulatory transfer, please go to section two of the document.
Updates to the status of these regulations will be posted to the Health Canada website. You can subscribe for email updates on the CCPSA to stay informed of developments as they arise.
Q. What is the Government of Canada’s process for developing regulations?
A. For more information regarding the regulatory development process, please reference the Cabinet Directive on Regulatory Management. Government officials are responsible for abiding by the Directive at all stages of the regulatory life cycle-planning, development, implementation, evaluation and review, including regulatory management. This includes the requirement to identify interested and affected parties, and to provide them with opportunities to take part in open, meaningful, and balanced consultations at all stages of the regulatory process.
Exemption Regulations
Q. Will certain organizations be exempt from the Canada Consumer Product Safety Act?
A. Health Canada is developing regulatory proposals to exempt consumer products, classes of consumer products or classes of persons from certain provisions of the Canada Consumer Product Safety Act (CCPSA) relating to non-compliant consumer products and to preparing and maintaining documents. Preliminary consultations for the making of Exemption Regulations under the Act concluded in the fall of 2010. The department is proceeding through the established regulatory process.
In the meantime, the Department will focus its compliance promotion and enforcement resources on areas where they will be most effective in addressing or preventing dangers to the health and safety of Canadians.
Updates to the status of these regulations will be posted to the Health Canada website. You can subscribe for email updates on the CCPSA to stay informed of developments as they arise.
Federal/provincial/territorial and international matters
Q. Is Canada considering introducing a public database, much like the one recently launched by the United States Consumer Product Safety Commission?
No. Health Canada is not considering introducing a public database of consumer complaints at this time.
Q. Does the Canada Consumer Product Safety Act include electronics, which are regulated by the Electrical Safety Authority in Ontario?
A. Yes. Electrical products fall within the scope of the Canada Consumer Product Safety Act (CCPSA) insofar as they meet the definition of “consumer product” in the Act and the consumer product in question is not excluded.
The Electrical Safety Authority (ESA) is responsible for public electrical safety in Ontario and will continue to receive incident reports and issue recalls on consumer products relating to their mandate.
Work is being undertaken to determine whether and how any duplicate reporting requirements may be addressed. However, at this time persons are required to report to both Health Canada and to the ESA as required under the respective legislation.
Q. Under the Canada Consumer Product Safety Act will I be required to continue reporting to the Electrical Safety Authority in Ontario in addition to reporting directly to Health Canada?
A. A report to Health Canada does not constitute a report to any other jurisdiction. Not providing information to the other jurisdiction may be deemed a failure to report to that other jurisdiction. Similarly, incident reports required under the Canada Consumer Product Safety Act must be provided to the Minister of Health.
Work is being undertaken to determine whether and how any duplicate reporting requirements may be addressed. However, at this time persons are required to report to both Health Canada and to the Electrical Safety Authority as required under the respective legislation.
Q. With new requirements introduced in the United States what are the implications for Canadian businesses selling to the USA (and within Canada)?
A. The Canada Consumer Product Safety Act applies to those who manufacture, import, advertise, sell, test, package or label consumer products in Canada. For more information on requirements for conducting business in the USA, please refer to the United States Consumer Product Safety Commission.
Privacy and Confidential Business Information
Q. What safeguards are in place to protect Confidential Business Information submitted to Health Canada?
A. The Privacy Act and section 15 of the Canada Consumer Product Safety Act (CCPSA) govern the collection, use and disclosure of personal information; sections 16 and 17 of the CCPSA govern the disclosure of Confidential Business Information (CBI) and the Access to Information Act (ATIA) applies to the disclosure of CBI if a request for access to the information is made.
Confidential business information submitted to Health Canada under the CCPSA will be subject to the confidentiality requirements under sections 16 and 17 of the Act. However, it is important to note that the Minister may disclose information under certain circumstances.
If a person who manufacturers, imports or sells a consumer product in Canada believes that information provided to Health Canada falls within the definition of CBI under the CCPSA, then they can indicate this to Health Canada at the time they provide the information.
To be considered CBI under the CCPSA, information respecting a person’s business or affairs must meet all of the following criteria:
- it is not publicly available
- it is information in respect to which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available
- it has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors
Sections 16 and 17 of the CCPSA provide authority for the Minister to disclose CBI in specific circumstances. Under section 16, the Minister may disclose CBI in relation to a consumer product without the consent of, or notice to, the person whose business or affairs the information relates if (a) the disclosure is made to a person or government that carries out functions relating to the protection of human health or safety or the environment; and (b) the person or government to whom the information is to be provided agrees in writing to maintain its confidentiality and to use it only for the purpose of carrying out functions relating to the protection of human health or safety or the environment.
Under section 17, the Minister may disclose CBI in relation to a consumer product without the consent of the person to whose business or affairs the information relates and without notifying that person beforehand, if the consumer product is a serious and imminent danger to human health or safety or the environment if the disclosure of the information is essential to address the danger. Subsection 17(2) requires that notification of the disclosure be provided to the person to whose business or affairs the information relates no later than the next business day following the disclosure.
The Access to Information Act (ATIA) allows Canadians access to federal government records. Such records may be made available through the ATIA only in response to an access request. While provisions of the Act specify what can be disclosed or exempt from disclosure, exceptions to this right of access are to be limited and specific.
If a request is made under the ATIA, information will be dealt with in accordance with the Act, including in section 20 which addresses third party information.
Q. What if my records contain Personal Information?
A. The Privacy Act governs the collection, use and disclosure of all personal information under the control of a government institution, such as Health Canada. In addition, under section15 of the Canada Consumer Product Safety Act (CCPSA) the Minister of Health may disclose personal information only if the disclosure of that information is necessary to identify or address a serious danger to human health or safety. However, this provision does not affect the provisions of the Privacy Act. It is, in fact, an additional safeguard to the protections that currently exist for the disclosure of personal information under the Privacy Act.
Any disclosure without the consent of the individual to whom the information relates must be done in accordance with section 8 of the Privacy Act.
In particular, paragraph 8(2)(b) states that personal information under the control of a government institution may be disclosed “for any purpose in accordance with any Act of Parliament or any regulation made there under that authorizes its disclosure.”
Subsection 15(1) of the CCPSA, provides the Minister with the authority to disclose personal information without the consent of the individual to whom the information relates if the disclosure of such information:
- is to a person or government that carries out functions relating to the protection of human health or safety; and
- is necessary to identify or address a serious danger to human health or safety.
The ability to disclose personal information in those rare and serious circumstances helps enable rapid response to serious dangers to human health or safety.
Food packaging
Q. Do the requirements under section 14 of the Canada Consumer Product Safety Act apply to food contact material and other food packaging?
A. In some cases. The definition of “consumer product” in the Canada Consumer Product Safety Act (CCPSA) includes the packaging of a consumer product. “Food” within the meaning of section 2 of the Food and Drugs Act (FDA) is excluded from the CCPSA. The FDA definition does not refer to food packaging. Food packaging may therefore be subject to the provisions of the CCPSA and its regulations.
There are different ways in which food packaging can pose a risk to human health or safety. It could fail to adequately protect the food from its environment or leach substances into the contained food products. There could also be a health or safety risk posed directly by the packaging, rather than through the effects of the package on the food, for example if the packaging caused lacerations when handling it due to defects or sharp parts.
The FDA generally (but not exclusively) regulates the packaging of food insofar as it impacts or addresses the food contained therein. The Canadian Food Inspection Agency (CFIA) administers various Acts and regulations that pertain to food packaging.
Events respecting a risk to the health and safety of the user posed directly by the package itself (e.g. a laceration hazard from handling the package), must be reported to Health Canada pursuant to section 14 of the CCPSA if they meet the criteria in that section. Events respecting injury or potential injury via the manner in which packaging affects the food should be referred to the CFIA. Note that there may be circumstances in which an event reported pursuant to section 14 of the CCPSA should also be reported to the CFIA.
Health Canada will work to help those who manufacture and supply materials such as food packaging materials understand the new legislation and how the requirements may affect them.
Q. Does the Canada Consumer Product Safety Act apply to other retail products intended for use with food? Examples of such products include plastic or glass food containers or bottles, zip-top or other style plastic baggies, cling film, aluminum foil, dishes or cutlery (including single-use), etc.?
A. Generally, yes. Items that are sold to consumers without food but which are intended to be used to store or eat food, are generally considered consumer products to which the Canada Consumer Product Safety Act (CCPSA) applies. A person who manufactures, imports, or sells consumer products of this nature for commercial purposes must report any incidents that may be related to their products (including their components, parts, accessories, or packaging) to Health Canada as required under section 14 of the CCPSA. For more details on incident reporting, consult Information regarding the “incident” from the document Guidance on Mandatory Incident Reporting under the Canada Consumer Product Safety Act – Section 14 Duties in the Event of an Incident.
Pet grooming products
Q. Do pet grooming products fall within the scope of the Canada Consumer Product Safety Act?
A. Effective June 20, 2011, most pet grooming products intended for use on animals came under the scope of the Canada Consumer Product Safety Act (CCPSA).
A grooming product that meets the definition of a “consumer product” under the CCPSA and that is intended for use on animals only is no longer considered to be a cosmetic under the Cosmetic Regulations or the Food and Drugs Act (FDA).
Where an animal grooming product meets the definition of a consumer product, it may also be subject to the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001), depending on its properties and attributes. For example, if the product is classified as having toxic, corrosive, flammable, explosive, or quick skin-bonding properties, it would then need to be packaged and labelled in accordance with the CCCR, 2001.
This change in classification does not apply to any animal/pet grooming products that meet the definition of a cosmetic under the FDA and that are intended for use on both animals and humans. This change also does not affect the classification of therapeutic animal products that are regulated under the Food and Drugs Act, or pest control products regulated under the Pest Control Products Act.