Annual Compliance and Enforcement Report, Fiscal Year: 2015-2016

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. We gather information, both domestically and internationally, about injuries, emerging issues and new science related to consumer product safety. We also conduct routine sampling and testing of products in the marketplace and work 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 us 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. We monitor issues that do not require immediate attention so that we are prepared to take action if the risk changes over time.

Finally, the 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

The Program’s compliance and enforcement activities focus on promoting and verifying compliance, as well as correcting non-compliances with regulatory obligations, prohibitions, product standards, and reporting and notification requirements.

1.5 How Compliance and Enforcement Activities Are Done

The Program uses a post-market approach to regulate the safety of consumer products and cosmetics in Canada. This means that there is no pre-approval required for industry members to sell their products in Canada;  industry is responsible for ensuring their compliance with the legislation, including that the consumer products and cosmetics that they manufacture, import, sell or advertise in Canada do not pose a danger to human health or safety.
The 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 the Program to identify and manage these risks include:

• Targeted inspections;
• Sampling and testing products;
• Following up on incidents and complaints involving consumer products;
• Risk communications;
• 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 Canada Border Services Agency (CBSA) and the United States Consumer Product Safety Commission (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, 2015 to March 31, 2016, CPSP conducted the following compliance and enforcement (C&E) activities:

• carried out 324 planned inspections across 13 different product categories;
• inspected 618 second-hand establishments;
• responded to 2,600 referrals from the Canada Border Services Agency (CBSA) leading to the refusal of 654 shipments;
• reviewed 1,693 consumer complaints and incident reports; and
• identified and took corrective action on 842 different non-compliant products, 258 of which resulted in a recall.

Key highlights included:

• the outdoor seasonal light project, which resulted in over 3 million products being recalled;
• the establishment inspection approach, which focuses on evaluating and improving industry’s compliance to both record-keeping and reporting requirements as well as the effectiveness of a company’s product safety regime; and
• the joint US-Canada recall initiative, which led to 114 jointly posted recalls with the US and also included 6 recalls jointly posted with Mexico. This initiative aims to increase the overall number of joint recalls posted concurrently across North America.

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 they become aware of a health or safety incident involving their 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 the Program, they are reviewed by program staff 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 2015-2016, 1,693 reports were received by the program: 738 from consumers and 955 from industry. The figure below shows the most frequently reported product categories for those submitted reports:

Of the 1693 reports received, 223 (13%) resulted in the posting of a recall. The figure below shows the most frequently recalled product categories:

There are no incident reporting requirements 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 2015-2016, the Program received 40,222 cosmetic notifications. 

3.2 Collaboration with the United States

Canada actively collaborates with the US Consumer Product Safety Commission (US CPSC) on consumer product safety as both countries share similar distribution networks, general approaches to consumer product health and safety standards, and enforcement. Information gathered on products of concern in the US 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 2015-2016, 114 joint recalls were posted by Health Canada and the US CPSC. The most frequent product types jointly recalled and their relative percentages are shown below in Figure 3.

Collaboration between Canada and the United States has been steadily increasing as is apparent in the overall number of joint recalls, which is almost 50% higher than the previous year. Figure 4 below illustrates the overall number of joint recalls over the past 4 fiscal years and shows an increasing trend indicating that more and more recalls and taking place at the same time on the same products in both Canada and the US.

CPSP and the US CPSC are also working towards posting more recalls jointly with Mexico’s Consumer Protection Federal Agency (Profeco). In 2015-2016, six recalls were posted jointly by all three regulators. This is an improvement from 2014-2015 where only one recall was 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.  The 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 compliance with record-keeping, mandatory reporting, and other legislative requirements. The results of these inspections also help CPSP evaluate how well a company’s internal product safety quality system is functioning and also how to more effectively focus the Program’s resources. 

In 2015/16, CPSP piloted this approach with inspections of 15 establishments. We 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. The program intends to continue to expand the use of this approach nationally over the next two years to allow for the inspection of more establishments.

3.3.2 Product Inspections

In addition to establishment inspections, the Program conducts inspections targeted to specific product types to monitor and verify industry compliance with the CCPSA and 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 and the vulnerability of product users.

In 2015-2016, projects for 13 different product categories were completed resulting in 324 inspections. Those inspections led to 87 separate findings of non-compliance which led to 35 product recalls. Figure 5 describes those 13 different targeted inspection product categories and also gives details on the means by which compliance determinations were made. 

Charcoal, household chemical products, seasonal lights, and strollers ranked among those categories with the highest levels of non-compliance. It is worth noting that while all stroller samples were non-compliant, none posed a significant enough risk to warrant a product recall; many of those non-compliances were related to low-risk testing failures that would not result in a danger to human health or safety . Conversely, the majority of the non-compliances seen in the seasonal lights did pose a significant risk and the products were subsequently recalled from the marketplace. From October 2015 to January 2016 over 3 million strings of lights were recalled. While working with industry to address all non-compliance, the Program focuses its more serious enforcement actions, such as recalls on issues where non-compliance is of high risk, as was seen with seasonal lights.

In 2015-2016 CPSP inspectors also visited retail establishments that sell second-hand goods. 63,990 products were inspected in 618 different locations. Those inspections resulted in 532 enforcement actions carried out at 383 locations. The most frequent non-compliant products that were identified through this project were:

Product inspections at second-hand stores are critical because old products tend to resurface that may not meet current requirements. This project is repeated at regular intervals to identify and remove non-compliant products and educate the establishments on their obligations under the CCPSA.

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 Regulatory Transparency and Openness Framework.

3.3.4 Border Admissibility Recommendations

The CPSP works with the CBSA to identify non-compliant products being shipped into the country. By stopping non-compliant products at the border, the Program is able to prevent these products from reaching the market and thus reduce the potential for risk to Canadians. In 2015/16, CPSP received approximately 2,600 referrals from the CBSA for shipments that were flagged as being potentially non-compliant and requiring input from the Program, almost half of which were cosmetics. Of these referrals, 654 were recommended for refusal. 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, the 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. All product categories that were examined during 2015/16, and the reports received, will be used in the planning of next year’s activities.  This data serves 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 brought to the attention of the Program by contacting cps-spc@hc-sc.gc.ca.

Appendix A – Description of “Product Categories”

• Appliances: Kitchen appliances; heating and cooling appliances; laundry and cleaning appliances.
• Children’s Products: Nursery products; baby gear; toys.
• Clothing, Textiles & Accessories: Clothing; household textiles; footwear.
• Electronics: Televisions and home theatres; electronic cables, batteries and chargers; computers and peripherals; cellphones and accessories.
• Home & 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 & Accessories: Beauty and body care; beauty accessories; oral care.
• Sports, Recreation & Hobby: Sports and outdoor activities; play structures; hobby or crafts.