Annual Compliance and Enforcement Report Fiscal Year: 2016-2017

Table of Contents

• Acronyms
• 1. What we do
• 2. Executive Summary
• 3. Compliance and Enforcement Key Activities
• 4. Conclusion
• 5. Contact Information
• Appendix A - Description of "Product Categories"

Acronyms

CBSA

Canada Border Services Agency

CCPSA

Canada Consumer Product Safety Act

CPSP

Consumer Product Safety Program

FDA

Food and Drugs Act

US CPSC

United States Consumer Product Safety Commission

1. What we do

1.1 Mission

To identify, assess, manage, and communicate health or safety risks to Canadians associated with consumer products and cosmetics.

1.2 Vision

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:

• 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

The Consumer Product Safety Program (CPSP) of Health Canada helps protect Canadians by assessing the health risks and safety hazards associated with consumer products and cosmetics. From April 1, 2016 to March 31, 2017, CPSP conducted the following compliance and enforcement (C&E) activities:

• Carried out 247 planned product-based inspections across 13 different product categories;
• Carried out 78 planned establishment-based inspections (69 compliance verification inspections and 9 mandatory incident reporting inspections);
• Responded to nearly 3,000 referrals from the Canada Border Services Agency (CBSA) leading to the refusal of 828 (28%) shipments;
• Reviewed 2,125 consumer complaints and incident reports;
• Identified and took corrective action on a total of 289 different non-compliant products, 238 of which resulted in a recall (219 recalls being a result of reported incidents and 19 recalls being a result of CPSP product inspections); and
• Received and processed 43,789 cosmetic notifications.

Key highlights included:

• Increased the scope of the establishment inspection approach, which focuses on evaluating and improving industry's record-keeping and reporting requirements, as well as the effectiveness of a company's product safety regime, to include importers, distributors, and retailers.
• Compared to 2015-2016, CPSP saw increases in the following areas:
  • consumer (about 100 more) and industry (about 300 more) reports received;
  • cosmetic notifications (about 3,500 more) received;
  • customs referrals (about 400 more) received; and
  • seasonal lights project compliance increased from 44% to 79%.

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 2016-2017, 2,125 reports were received by the program: 843 from consumers and 1,282 from industry. Table 1 shows the most frequently reported product categories for those submitted reports.

Table 1. Most frequent product categories reported and their percentage of the total for 2016-2017

Product Category	Percent
Housewares	25%
Appliances	21%
Electronics	15%
Children's Products	14%
Home and Automotive Maintenance	8%
Grooming Products and Accessories	5%
Outdoor Living	5%
Clothing, Textiles and Accessories	4%
Sports, Recreation and Hobby	3%

Of the 2,125 reports received, 219 (10%) resulted in the posting of a recall ^{Footnote 1}. Table 2 shows the most frequently recalled product categories.

Table 2. Most frequent product categories recalled as a result of complaints and incident reports and their percentage of the total for 2016-2017

Product Category	Percent
Sports, Recreation and Hobby	18%
Children's Products	16%
Housewares	16%
Home and Automotive Maintenance	13%
Clothing, Textiles and Accessories	10%
Appliances	9%
Electronics	8%
Outdoor Living	8%
Grooming Products and Accessories	2%

Of note, is that while the category of 'Sports, Recreation and Hobby' provides the lowest number of reports received by CPSP, they amount to the highest number of recalls. The reason being that for the reports under this category, the vast majority lead to recalls whereas for the other product categories, recall was not required, but other measures may have been taken. Bicycles and bicycle accessories are the most common products recalled in this category.

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 2016-2017, the Program received 43,789 cosmetic notifications, which is an increase from the 40,222 received in 2015-2016.

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 2016-2017, 100 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.

Table 3. Most frequent product categories recalled jointly with the US CPSC and their percentage of the total for 2016-2017

Product Category	Percent
Housewares	23%
Children's Products	21%
Sports, Recreation and Hobby	17%
Appliances	10%
Home and Automotive Maintenance	10%
Electronics	9%
Outdoor Living	7%
Clothing, Textiles and Accessories	3%
Grooming Products and Accessories	0%

While the trend for collaboration between Canada and the United States has been steadily increasing, this fiscal year showed a plateau. Figure 1 illustrates the overall number of joint recalls over the past 5 fiscal years showing the general trend.

Figure 1. Joint Canada-US recall totals for the past 5 fiscal years. - Text Equivalent

Graphic showing the number of joint Canada-US recalls from fiscal years 2012 to 2017. In 2012-2013 there were 45 recalls, in 2013-2014 there were 76 recalls, in 2014-2015 there were 63 recalls, in 2015-2016 there were 112 recalls and in 2016-2017 there were 100 recalls.

Health Canada and the US CPSC continue to work towards posting more recalls with Mexico's Consumer Protection Federal Agency (Profeco). In 2016-2017, 7 recalls were posted jointly by all three regulators and 1 recall was posted by Health Canada and Profeco only, compared to 2015-2016, where 6 recalls were posted jointly by all three regulators.

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 this 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. 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 expand the use of this approach nationally over the next two years to allow for the inspection of more establishments, including manufacturers.

Also in 2016-2017, a specific establishment inspection project looking only at mandatory incident reporting targeted 9 establishments. This project will be repeated in 2017-2018 to determine if this targeted review with respect to reporting requirements is useful or if it can be incorporated into the broader establishment inspections outlined above.

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 and the FDA. 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 2016-2017, projects for 13 different product categories were completed resulting in 247 unique inspections. Note that establishments inspected during the liquid-filled teethers and rattles projects had some products, if appropriate, that were also tested under the phthalates and lead (contact with mouth) projects. In total, the 247 inspections led to 71 separate findings of non-compliance which led to 70 enforcement actions, including 19 product recalls. One of the non-compliant products was not sold in Canada, so no enforcement action was taken. The product in question was believed to be available for sale in Canada but when following up with the non-compliance, it was determined that no sales in Canada were made. Table 4 describes those 13 different targeted inspection product categories and also gives details on the means by which compliance determinations were made.

Table 4. Summary of the 13 product inspection activities for 2016-2017

Project	Number of Inspections	Evaluation Means (and applicable legislation)	Number of Samples Assessed	Findings of Non-compliance	Recall	Stop Sale	Stop Distribution	Trader Commitment
Overall safety of corded window coverings	21	Document review and visual examination of labels (Corded Window Covering Products Regulations)	21	16	3	4	0	9
Presence of methyl-isothiazolinone (MI) / methylchloro-isothiazolinone (MCI) in cosmetics	19	Sampling and testing (Cosmetic Regulations)	42	10	1	0	1	8
Overall safety of cribs	19	Sampling and testing (Cribs, Cradles and Bassinets Regulations)	23	18	5	0	8	5
Overall safety of non-luxury lighters	15	Sampling and testing (Lighters Regulations)	7	4	0	1	1	2
Overall safety of matches	18	Document review and sampling and testing (Matches Regulations)	8	7	0	2	3	2
Presence of microbes in liquid-filled teethers (LFT)	20	Sampling and testing (Item 4, Schedule 2, CCPSA)	10	0	0	0	0	0
Mechanical safety of rattles	32	Sampling and testing (Toys Regulations)	14	5	4	0	1	0
Presence of phthalates in liquid-filled teethers and rattles (those with soft plastic)	0Footnote 2	Sampling and testing (Phthalates Regulations)	14 (10 LFT) (4 rattles)	0	0	0	0	0
Presence of lead in liquid-filled teethers, rattles and foodware	22Footnote 3	Sampling and testing Consumer Products Containing Lead (Contact with Mouth Regulations)	43 (10 LFT) (10 rattles) (23 foodware)	1 (determined not to be sold in Canada so no action taken)	0	0	0	0
Overall safety of high chairs	21	Document review (Sections 7 & 8, CCPSA)	21	1	0	1	0	0
Performance safety of winter snow helmets	16	Document review (Sections 7 & 8, CCPSA)	18	0	0	0	0	0
Flammability safety of carpets	25	Sampling and testing (Textile Floor Coverings Regulations)	20	5		1	0	0
Compliance of seasonal lights with Canadian Electrical Code	19	Sampling and testing (Sections 7 & 8, CCPSA)	25	4	2	1	1	0
Total	247		266	71 (70 actions)	19	10	15	26

Based on the inspections that were done, matches, cribs, corded window coverings and non-luxury lighters ranked among those categories with the highest levels of non-compliance. With respect to matches and lighters, these product categories saw a number of samples that were non-compliant, but none posed a significant enough risk to warrant a product recall; many of those non-compliances were related to low-risk failures that would not result in a danger to human health or safety. Conversely, high risk violations, among other non-compliances, were identified in the corded window coverings and cribs projects and product recalls were required. While working with industry to address all non-compliance, CPSP focuses its more serious enforcement actions, such as recall, on products where a high risk has been identified.

Given the poor compliance rate of 44% for seasonal light products in 2015-2016, the project was repeated in 2016-2017 and saw an improved compliance rate of 79%.

3.3.3 Enforcement Summary Reports

The results of the assessment of product compliance are posted online as Enforcement Summary Reports on an ongoing basis, as part of the Government of Canada's commitment to regulatory transparency and openness.

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 2016-2017, CPSP received approximately 3,000 referrals from the CBSA for shipments that were flagged as being potentially non-compliant and requiring input from CPSP, almost half of which were cosmetics. Of these referrals, 828 were recommended for refusal and more than one-half of those refusals were also cosmetics. Shipments may be refused for a variety of reasons, including that the products are prohibited, or do not meet specific regulatory requirements.

4. Conclusion

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 2015-2016, CPSP saw increases in the following areas in 2016-2017:

• Consumer (about 100 more) and industry (about 300 more) reports received;
• Cosmetic notifications (about 3,500 more) received; and
• Customs referrals (about 400 more) received.

With respect to the establishment inspection approach, the scope was expanded from retail head offices to include importers, distributors and retailers in 2016-2017. This approach focused on evaluating industry's ability to identify and report incidents to CPSP and assessing record-keeping practices, as well as the effectiveness of a company's product safety regime. The expansion to include other levels of industry led to a total of 69 inspections in 2016-2017 versus the 15 inspections completed in 2015-2016.

With respect to product inspections carried out in 2016-2017, there were 266 products assessed which resulted in a 27% non-compliance rating. This is the same non-compliance rating as seen in 2015-2016. A systematic bias is applied during inspection and sampling. That being, products are not randomly selected but are chosen because they are deemed by the inspector to be more likely to not meet health and safety requirements due to characteristics that are observed.

All information gathered from compliance and enforcement activities during 2016-2017, 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 cps-spc@hc-sc.gc.ca.

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.