Annual Compliance and Enforcement Report Fiscal Year: 2017-2018
Table of Contents
- What we do
- Executive Summary
- Compliance and Enforcement Key Activities
- Contact Information
- Canada Border Services Agency
- Canada Consumer Product Safety Act
- Consumer Product Safety Program
- Compliance Verification Inspection
- Food and Drugs Act
- US CPSC
- United States Consumer Product Safety Commission
1. What we do
To identify, assess, manage, and communicate health or safety risks to Canadians associated with consumer products and cosmetics.
A Canada where Canadians are confident that consumer products and cosmetics are safe or can be used safely and that is recognized as a world leader in the reduction of health risks posed by consumer products and cosmetics.
1.3 Program Description
The Consumer Product Safety Program (CPSP) is responsible for the administration and enforcement of the Canada Consumer Product Safety Act (CCPSA), and regulations made under it, as well as cosmetic-related provisions of the Food and Drugs Act (FDA) and the Cosmetic Regulations.
Health Canada promotes, monitors, verifies, and enforces compliance with the CCPSA and the FDA. CPSP reviews reports submitted by industry and consumers and regularly monitors the marketplace to look for potentially dangerous products. CPSP gathers information, both domestically and internationally, about injuries, emerging issues and new science related to consumer product safety. CPSP also conducts routine sampling and testing of products in the marketplace and works closely with the Canada Border Services Agency (CBSA) and other regulators domestically and internationally to verify the compliance of products being imported into Canada.
CPSP uses this information to identify possible risks to Canadians posed by consumer products or cosmetics. We conduct risk assessments to identify issues that may result in serious injury. This allows CPSP to target the Program's compliance and enforcement resources towards products that pose the greatest potential risk to Canadians. CPSP uses a triage-based approach to identify product-related health and safety issues for follow up compliance and enforcement activity. CPSP monitors issues that do not require immediate attention so that we are prepared to take action if the risk changes over time.
Finally, CPSP provides credible and reliable information that facilitates public education and provides tools for informed decision-making by the public.
CPSP's authorities do not include products excluded from the CCPSA in Schedule 1 such as explosives, drugs, food, medical devices, ammunition, natural health products, and tobacco products, nor do they include products regulated under the FDA beyond cosmetics.
1.4 What Compliance and Enforcement Activities We Do
CPSP's compliance and enforcement activities focus on promoting and verifying compliance, as well as on correcting non-compliances with regulatory obligations, prohibitions, product standards, and reporting and notification requirements.
1.5 How Compliance and Enforcement Activities Are Done
The safety of consumer products and cosmetics is regulated through a post-market approach in Canada. Despite the fact that there is no pre-approval required for industry members to sell their products in Canada, industry is still responsible for ensuring their compliance with the legislation, including that the consumer products and cosmetics they manufacture, import, sell, or advertise in Canada do not pose a danger to human health or safety.
CPSP directs its resources to where the human health risks are greatest. This approach is similar to risk-based approaches used by our major trading partners. Tools used by CPSP to identify and manage these risks include:
- Planning targeted inspections;
- Sampling and testing products;
- Following up on incidents and complaints involving consumer products;
- Communicating the risks to Canadians;
- Reviewing records from establishments, such as test reports;
- Negotiating and, if necessary, ordering corrective measures such as stopping sale and recalling a product; and
- Working with our other federal and foreign counterparts (such as the CBSA and the US CPSC, respectively) to prevent the importation of non-compliant consumer products and cosmetics into Canada.
2. Executive Summary
Health Canada's CPSP helps protect Canadians by assessing the health risks and safety hazards associated with consumer products and cosmetics. From April 1, 2017 to March 31, 2018, CPSP conducted the following compliance and enforcement (C&E) activities:
- Carried out 623 planned product-based inspections across 17 different product categories;
- Carried out 58 planned establishment-based compliance verification inspections (CVIs);
- Responded to 2,381 referrals from the CBSA leading to the refusal of 630 (26%) shipments;
- Reviewed 2,554 consumer complaints and incident reports from industry;
- Identified and took corrective action on a total of 448 different non-compliant products, 222 of which resulted in a recall (137 recalls being a result of reported incidents and 85 recalls being a result of CPSP product inspections);
- Carried out 4,606 monitoring inspections to ensure recalled products were not for sale; and
- Received and processed 56,612 cosmetic notifications.
Key highlights included:
- The online market sweep identified a low compliance rate of 31% and highlighted the enforcement challenges with this marketplace.
- Certain substances prohibited or restricted for use in cosmetics were tested, specifically those associated with fragrance ingredients and possibly hidden under the umbrella term “fragrance/parfum”. This was in follow-up to recommendations found in the 2016 Spring Reports of the Commissioner of the Environment and Sustainable Development. The various samples that were assessed resulted in a compliance rate of 99% indicating that industry does not appear to be using those terms to hide prohibited or restricted ingredients in their products.
- Inclusion of manufacturers in the CVI establishment inspection approach.
- Compared to 2016-2017, CPSP saw increases in the following areas:
- consumer (about 350 more) and industry (about 60 more) reports received; and
- cosmetic notifications (about 12,800 more) received.
3. Compliance and Enforcement Key Activities
3.1 Following-up on Consumer Complaints and Mandatory Incident Reports
CPSP reviews reports submitted by industry and consumers to look for potentially dangerous products. Under section 14 of the CCPSA, industry must report to Health Canada after it becomes aware of a health or safety incident involving its consumer product. An incident can include:
- An occurrence, a product defect, or incorrect or a lack of information that resulted or may result in death or serious negative impacts on health; or
- A product recall in another jurisdiction based on concerns about human health or safety.
When reports are received by CPSP, they are reviewed and triaged to determine if action is required to address the risk. Product returns or complaints from consumers will often trigger reporting requirements for industry, which leads to the submission of reports describing the incident and any corrective measure(s) that the company is implementing.
In 2017-2018, 2,554 reports were received by the program:1,205 from consumers and 1,349 from industry. Table 1 shows the most frequently reported product categories for those submitted reports.
|Grooming Products, and Accessories||8%|
|Home and Automotive Maintenance||7%|
|Clothing, Textiles, and Accessories||4%|
|Sports, Recreation, and Hobby||3%|
|Clothing, Textiles, and Accessories||15%|
|Sports, Recreation, and Hobby||12%|
|Grooming Products, and Accessories||8%|
|Home and Automotive Maintenance||6%|
Table 2 shows that the categories of ‘Housewares’, ‘Children’s Products’, and ‘Clothing, Textiles, and Accessories’ resulted in over half of the recalls resulting from complaints and incidents reported to CPSP. Of note, and similar to that seen in 2016-2017, the category of ‘Sports, Recreation, and Hobby’ comprised the least amount of reports received at 67, but there were 23 recalls associated with those reports. The ratio of recalls to reports highlights that when industry is reporting under this category, it tends to be for more serious hazards that warrant risk management action such as voluntary recall.
There is no incident reporting requirement for cosmetics under the FDA and Cosmetic Regulations, although the Program does encourage consumers and industry members to report when they have health or safety concerns related to a cosmetic. Under section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10 days after they first sell a cosmetic in Canada. Failure to notify may result in a product being denied entry into Canada or removed from sale. Over the course of 2017-2018, the Program received 56,612 cosmetic notifications, which is a significant increase from the 43,789 received in 2016-2017. This may be in part due to ongoing efforts to improve awareness of cosmetic notification requirements in Canada.
3.2 Collaboration with the United States
Canada actively collaborates with the US CPSC on consumer product safety as both countries share similar distribution networks, general approaches to consumer product health and safety standards, and enforcement activities. Information gathered on products of concern in the United States is used by CPSP to determine if compliance or enforcement activities should be initiated in Canada. When Canadian establishments are initiating a product recall and are present in both jurisdictions, CPSP reminds them of their reporting requirements to the US CPSC, and vice-versa.
In 2017-2018, 95 joint recalls were posted by Health Canada and the US CPSC. The most frequent product types jointly recalled and their relative percentages are shown in Table 3.
|Sports, Recreation, and Hobby||17%|
|Clothing, Textiles, and Accessories||9%|
|Home and Automotive Maintenance||2%|
|Grooming Products and Accessories||0%|
The overall trend for the past few years for collaboration on joint recalls between Canada and the United States is showing a plateau. Figure 1 illustrates the overall number of joint recalls over the past 6 fiscal years showing the general trend.
Health Canada and the US CPSC continue to work towards posting recalls with Mexico's Consumer Protection Federal Agency (Profeco). In 2017-2018, 5 recalls were posted jointly by all three regulators, compared to 2016-2017, where 7 recalls were posted jointly.
3.3 Targeted Inspections
One of the key tools that CPSP uses to support the goal of targeted oversight is planned, targeted inspections. CPSP uses a risk-based approach to monitor and verify industry compliance with the regulations for consumer and cosmetic products on a cyclical basis. Sampling and inspecting for compliance is targeted to those regulated product categories and establishments where CPSP intelligence indicates elevated levels of non-compliance. In many cases, inspectors can identify a higher probability of non-compliance based on previous market analysis or in the field using readily identifiable indicators, such labelling or packaging issues, missing certification marks, or design issues that may lead to regulatory violations. Due to this targeted approach, higher rates of non-compliance are expected than if sampling was random.
3.3.1 Establishment Inspections
The purpose of conducting establishment inspections is to evaluate industry's ability to identify and report incidents to CPSP and evaluate record-keeping practices. The results of these inspections also help CPSP assess how well a company's internal product safety quality system is functioning and also how to more effectively focus CPSP's resources.
In 2015-2016, CPSP piloted a CVI approach with inspections of 15 establishments at the retail head office level. In 2016-2017, this approach was repeated and expanded to 69 establishments at the importer, distributor and retail level. Similarly, in 2017-2018 this establishment inspection project was repeated and manufacturers were added with 58 establishment inspections at all levels being carried out. CPSP concluded that this approach can be effective in helping establishments comply, and in identifying establishments at higher risk of non-compliance. Higher-risk establishments will be more likely to be selected as targets for product inspections. CPSP intends to continue to use this national approach to allow for the inspection of more establishments.
While a specific establishment inspection project on mandatory incident reporting was expected to start in 2017-2018, it was deferred to 2018-2019 in an effort to improve the process and guidance to industry based on the lessons learned in 2016-2017.
3.3.2 Product Inspections
In addition to establishment inspections, CPSP conducts inspections targeted to specific product types to monitor and verify industry compliance with the CCPSA for consumer products and the FDA for cosmetics. Compliance is verified by either conducting product sampling and testing, or by requesting documents, such as test reports or safety information, to evaluate compliance with the relevant requirements. Projects are chosen every year depending on factors such as emerging trends, the level of risk a product poses, the type of product, industry's previous level of compliance, the hazards posed by the product and the vulnerability of product users.
In 2017-2018, projects for 17 different product categories were completed resulting in 623 inspections. In total, 957 products were assessed leading to 311 enforcement actions, including 85 product recalls. Table 4 describes those 17 different targeted inspection product categories and also gives details on the means by which compliance determinations were made. For more details on the results of the individual projects see the Enforcement Summary Reports published online. Publication of these reports is part of the Government of Canada's commitment to regulatory transparency and openness.
|Project||Number of Inspections||Evaluation Means (and applicable legislation)||Number of Samples Assessed||Findings of Non-compliance||Recall||Stop Sale||Stop Distribution||Trader Commitment||Other|
|Started in 2016-2017 and completed in 2017-2018|
|Overall safety of bassinets||31||Document review (Cribs, Cradles and Bassinets Regulations)||49||11||6||0||4||1||0|
|Presence of lead and cadmium in children's jewellery||35||Sampling and testing (Children's Jewellery Regulations)||25||3||3||0||0||0||0|
|Overall safety of children's sleepwear||84||Onsite assessment and sampling and testing (Children's Sleepwear Regulations)||151||51||24||9||16||2||0|
|Overall safety of consumer chemicals||16||Document review and sampling and testing (Consumer Chemicals and Containers Regulations, 2001)||49||33||12||0||7||12||2 products discontinued|
|Presence of methyl-isothiazolinone (MI) and/or methylchloro-isothiazolinone (MCI) in cosmetics||40||Onsite inspections and sampling and testing
(Food and Drugs Act and Cosmetic Regulations)
|Overall safety of expansion gates and expandable enclosures||11||Sampling and testing (Expansion Gates and Expandable Enclosures Regulations)||11||11||4||0||0||7||0|
|Mechanical requirements of pacifiers||20||Sampling and testing (Pacifiers Regulations)||17||4||3||0||0||1||0|
|Overall safety of toys||64||Onsite assessment and sampling and testing (Toys Regulations)||36||26||14||12||0||0||0|
|Presence of prohibited, non-compliant and unsafe consumer products sold online||104||Online inspections of e-commerce websites (Canada Consumer Product Safety Act)||199||133||1
(not published as all end users contacted)
|89||0||0||43 referrals for a CBSA port lookout|
|Started in 2017-2018 and completed in 2017-2018|
|Overall safety of corded window coverings||18||Sampling and testing (Corded Window Covering Products Regulations)||19||6||2||2||2||0||0|
|Presence of ingredients listed as “fragrance” in cosmetics||93||Sampling and testing (Food and Drugs Act and Cosmetic Regulations)||206||2||0||2||0||0||0|
|Tip-over requirements for furniture||12||Sampling and testing (Sections 7 and 8 of the Canada Consumer Product Safety Act)||12||2||2||0||0||0||0|
|Chemical requirements of glazed ceramics and glassware||7||Sampling and testing (Glazed Ceramics and Glassware Regulations)||5||0||0||0||0||0||0|
|Flammability requirements for Halloween costumes||20||Sampling and testing (Textile Flammability Regulations)||23||7||6
(1 recall involved 3 products)
|Flammability requirements of mattresses and futons||14||Sampling and testing (Mattresses Regulations)||9||0||0||0||0||0||0|
|Presence of boric acid in toys||33||Sampling and testing (Toys Regulations)||29||3||3||0||0||0||0|
|Presence of phthalates in toys||21||Sampling and testing (Toys Regulations)||27||3||3||0||0||0||0|
Based on the inspections that were done, the following projects ranked among those categories with the highest levels of non-compliance:
- Expansion gates and expandable enclosures with 100% non-compliance
- Toys (retail) with 72% non-compliance
- CCCR, 2001 with 67% non-compliance
- Children's sleepwear with 34% non-compliance
- Halloween costumes with 30% non-compliance.
With respect to these product categories high-risk violations, among other non-compliances, were identified and a number of product recalls were required. With respect to expansion gates, all the products sampled were found to be non-compliant but the majority of them were related to low-risk failures, such as labelling violations. Trader commitments to fix future products are in place with the responsible establishments. As noted in Table 4, a wide range of enforcement actions were taken with toys, products subject to the CCCR, 2001 and children's sleepwear. Given the broad type and volume of products available for sale within these product categories, these compliance projects continue to be done regularly to verify compliance and educate industry on the product requirements. With respect to Halloween costumes, all the enforcement actions taken were recalls related to the presence of feathers found on the products which highlighted an ongoing flammability concern regarding these products and the need for continued industry education regarding the hazard.
Overall, while working with industry to address all non-compliance, CPSP continues to focus its more serious enforcement actions, such as recall, on products where a high risk has been identified.
Other notable projects completed over 2017-2018 include the following.
- Online Market Sweep
Health Canada surveyed various online retailers and marketplaces, and found that a number of prohibited, non-compliant, and unsafe consumer products were available for sale to Canadians. The majority of enforcement actions taken during the project included requesting stop sales, which involved online retailers and marketplaces removing advertisements, and requesting online retailers to stop exporting certain products into Canada. Online retailers residing in foreign jurisdictions highlighted enforcement challenges with this evolving marketplace. One recall was undertaken, but not published on the Healthy Canadians Recalls and Alerts website as the online retailer was able to contact end users directly. Customs port lookouts were also used as a means of addressing challenges with enforcement of online vendors that are not located in Canada. In this way, products could be identified prior to entry into Canada and evaluated for compliance. Given the high non-compliance identified during this project an information update was published on the Healthy Canadians Recalls and Alerts website reminding consumers of the risks of buying certain products online.
- Corded Window Covering Products
In 2016-2017 a document review and visual examination of labels was done on corded window covering products which resulted in a low compliance rate of 24%. The project was repeated in 2017-2018 but included testing to certain sections of the Regulations. An improved compliance rate of 68% was achieved but it was identified that more work was needed in this product area.
- Cosmetics (Fragrances)
Certain substances prohibited or restricted for use in cosmetics were tested, specifically those associated with fragrance ingredients and possibly hidden under the umbrella term “fragrance/parfum”. This was in follow-up to recommendations found in the 2016 Spring Reports of the Commissioner of the Environment and Sustainable Development. The various samples that were assessed resulted in a compliance rate of 99% indicating that industry does not appear to be using those terms to hide prohibited or restricted ingredients in their products.
3.3.3 Recall Monitoring Inspections
Whether an establishment agrees to voluntarily recall a product or has been ordered to do so (for consumer products under the CCPSA only), they should contact their supply chain accounts to ensure that the product is no longer offered for sale. Through recall monitoring inspections, CPSP verifies that selected supply chain accounts have received the notification of the recall from the responsible establishment and have taken the necessary steps to remove the product from sale; further minimizing the hazard in the Canadian marketplace. In 2017-2018, 4,606 recall monitoring inspections were conducted.
3.3.4 Import Admissibility Recommendations
CPSP works with the CBSA to identify non-compliant products being shipped into the country. By stopping non-compliant products at the border, CPSP is able to prevent these products from reaching the market and thus reduce the potential for risk to Canadians. In 2017-2018, CPSP received 2,381 referrals from the CBSA for shipments that were flagged as being potentially non-compliant and requiring input from CPSP, half of which were cosmetics. Of these referrals, 630 were recommended for refusal and two-thirds of those refusals involved cosmetics. Shipments may be refused for a variety of reasons, including that the products are prohibited or do not meet specific regulatory requirements.
By continuing to implement its key compliance and enforcement activities, CPSP is able to quickly identify and act on product safety risks while keeping Canadians informed about health and safety issues related to consumer products and cosmetics.
Compared to 2016-2017, CPSP saw increases in the following areas in 2017-2018:
- Consumer (about 350 more) and industry (about 60 more) reports received. While there were particular events throughout the year that contributed to higher than usual reports, we still see a consistent rise in the overall number of reports received by the Program.
- Cosmetic notifications (about 12,000 more) received. The increase may be in part due to the continued efforts regarding industry awareness on the subject of cosmetics.
With respect to the establishment inspection approach, the scope was expanded to include manufacturers in 2017-2018. Including manufacturers was the result of an ongoing expansion of this project and an important one as now all three levels of trade in Canada, retailers/retailer head offices, importers/distributors, and manufacturers, are captured. This expansion to include another level of trade will further help in identifying establishments at a higher risk of non-compliance.
With respect to product inspections carried out in 2017-2018, there were 957 products assessed which resulted in a 32% non-compliance rating. This is a higher non-compliance rating than the 27% seen in 2016-2017. As mentioned in section 3.3, a systematic bias is applied during inspection and sampling.
All information gathered from compliance and enforcement activities during 2017-2018, and the reports received, will be used in the planning of future years' activities. These data serve as timely and relevant intelligence that helps in targeting existing and upcoming product safety risks as efficiently as possible.
5. Contact Information
Any questions or comments on this report should be directed to firstname.lastname@example.org.
Appendix A – Examples of Product Types in “Product Categories”
- Appliances: Kitchen appliances; heating and cooling appliances; laundry and cleaning appliances.
- Children's Products: Nursery products; baby gear; toys.
- Clothing, Textiles, and Accessories: Clothing; household textiles; footwear.
- Electronics: Televisions and home theatres; electronic cables, batteries and chargers; computers and peripherals; cellphones and accessories.
- Home and Automobile Maintenance: Construction materials; tools.
- Housewares: Furniture; home décor; lighting; household cleaning; kitchenware.
- Outdoor Living: Outdoor furniture and decorations; pools and accessories; lawn and garden.
- Grooming Products and Accessories: Beauty and body care; beauty accessories; oral care.
- Sports, Recreation, and Hobby: Sports and outdoor activities; play structures; hobby or crafts.
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