Consumer Product Safety Program policy on compliance verification projects: Industry guide
Table of contents
- Purpose
- Introduction
- Division CV projects
- Selection of CV projects
- Execution of CV projects
- References
Purpose
This document does not constitute part of the Canada Consumer Product Safety Act (CCPSA) or its Regulations, or the Food and Drugs Act (FDA) or the Cosmetic Regulations. In the event of any inconsistency or conflict between these Acts or Regulations and this document, the applicable legislation will take precedence.
This guidance document was created to provide industry with a better understanding of the Consumer Product Safety Program's (CPSP) approach to verifying compliance with the Acts and Regulations. It includes general information about Compliance Verification (CV) projects for cosmetics and consumer products conducted by Health Canada inspectors under the applicable legislation. The types of CV projects undertaken by Health Canada are described and an overview of annual CV project planning, scheduling, implementation, and reporting are provided.
Should you require assistance in interpreting your obligations with respect to this topic, please contact your regional Consumer Product Safety office or your legal advisor.
Introduction
The CCPSA and the FDA do not provide the authority to require pre-market authorization for consumer and cosmetic products. Therefore, the CPSP establishes its regulatory regime on post-market surveillance.
Industry's compliance with the legislative and regulatory requirements under the CCPSA and FDA are evaluated through CV projects, which are targeted to find non-compliance, as opposed to reflect the overall market compliance. These projects are conducted in line with a strategic, risk-based approach to monitor regulated products, prohibited products and unregulated products on the Canadian market, and establishments' capacity to meet the legislated health or safety requirements for consumer and cosmetic products.
CV projects also support the Government of Canada's Food and Consumer Safety Action Plan (FCSAP) by improving industry oversight and responding more quickly to risks through inspections and sampling.
Division of CV projects
CV projects are divided into product-based and establishment-based verification projects targeted at certain requirements within the applicable legislation. They are as follows:
- Product-based verification projects consist of:
- Planned Cyclical Enforcement (CE) projects involving products for which compliance is verified on cyclical basis;
- General Prohibition (GP) projects involving products or hazards that are not specifically regulated and are not on any defined project frequency; and
- Establishment-based verification projects focus on assessing the compliance of establishments to an administrative requirement or their capacity to comply with legislative requirements.
The diagram below provides a graphic representation of the current division of CV projects:
Figure 1
Figure 1 - Text Description
In the hierarchy chart, Compliance Verification projects is the overarching concept that governs the different projects that are conducted within the CPSP. Compliance Verification projects are split into two main focuses, Product-based Verification and Establishment-based Verification. Product-based Verification consists of CE (Cyclical Enforcement) Projects or GP (General Prohibition) Projects. Examples of CE projects include those involving regulated products or regulated hazards, or those involving prohibited products. Examples of GP projects include those involving unregulated products or unregulated hazards. Establishment-based Verification consists only of Establishment compliance verification projects. An example of this is the Mandatory Incident Reporting Project.
Product-based Verification
Cyclical Enforcement Projects
Regulated products refer to consumer and cosmetic products for which a product-specific regulation exists. The CPSP administers numerous product-specific regulations under the CCPSA and the Cosmetic Regulations under the FDA. Depending on the scope and the complexity of a product-specific regulation, CE projects may be used to verify compliance of a product with all or only certain sections of a regulation. All CE projects for regulated products follow an enforcement cycle of one to six years.
The enforcement cycle determines the frequency of reviews or how often a project is conducted. The following factors are considered when establishing cyclical enforcement cycles:
- Type of product;
- Characteristics of industry and compliance history;
- Vulnerability of the product users;
- Incident and injury data; and
- Severity of the hazard(s).
In addition to regulated products, CE projects may also be undertaken to assess compliance with specific prohibitions under the Acts including:
- Section 5 of the CCPSA, which prohibits the manufacture, import, advertisement and sale of specific consumer products listed in Schedule 2 of the Act; and
- Section 16 of the FDA, which prohibits the sale of cosmetics that contain substances that are filthy or decomposed or that may cause injury to human health, or cosmetics that were manufactured, prepared, preserved, packaged or stored under unsanitary conditions.
Prohibited consumer products are specifically listed within the CCPSA, whereas for cosmetics, the Cosmetic Ingredient Hotlist is used as an administrative tool to communicate to industry that certain substances, when present in a cosmetic, may contravene section 16 of the FDA or a provision of the Cosmetic Regulations. In addition, the Hotlist communicates that certain substances, with no known function in a cosmetic formulation, make it unlikely for the product to meet the definition of a cosmetic under the FDA. As such, some cosmetic cyclical enforcement projects are developed around Hotlist conditions.
General Prohibition Projects under the CCPSA
The term "unregulated products" is used to refer to consumer products without specific regulations under the CCPSA. Similarly, the term "unregulated hazards" is used to refer to regulated products with hazards that are not addressed by specific provisions of existing regulations.
Paragraphs 7(a) and 8(a) of the CCPSA prohibit the manufacture, import, advertisement or sale of consumer products that pose a danger to human health or safety. Together, these provisions are more commonly referred to as the "general prohibition".
General prohibition projects are designed to effectively assess the hazards posed by unregulated products or unregulated hazards that pose a danger to human health or safety.
When evaluating whether a product poses a danger to human health or safety, Health Canada may conduct a risk assessment as well as consider whether a product meets national or internationally recognized performance standards, voluntary industry performance standards, international regulations, and regulatory requirements for similar products. These standards support the goals of FCSAP – Active Prevention, Targeted Oversight and Rapid Response – by addressing the safety of unregulated consumer products.
Establishment-based Verification
Establishment compliance verification projects are designed to help the Canadian industry achieve their role in complying to with their obligations under the CCPSA. As the requirements pertaining to cosmetics under the FDA focus primarily on ingredients and products, establishment-based verification projects are not routinely conducted in relation to industry's obligations under the FDA.
These projects may assess the following:
- The establishment's ability to prepare and maintain documents for the purposes of traceability in the event of a recall, as required under Section 13 of the CCPSA
- The establishment's ability to identify and report incidents to Health Canada as per the mandatory reporting requirements under Section 14 of the CCPSA
During establishment compliance verification projects, consumer products are not generally inspected for compliance. However, should a non-compliance with a consumer product be identified during the project (e.g., through reviewing the establishment's incidents), corrective actions would be taken to control the product and bring the product into compliance. Product compliance issues and subsequent follow-up are documented and actioned by the CPSP outside of the CV process.
Selection of CV projects
Various CV projects are scheduled, planned, and implemented every year by the CPSP and are captured in a CV Project Plan.
Principles for developing CV project plan
The CPSP takes several factors into consideration when developing a CV project plan for the coming year. The timeframe in which consumer and cosmetic products will be verified is determined by factors such as industry's compliance history and its awareness of the requirements, the complexity of implementing a project, resource availability, the level of risk a product poses, and emerging trends at the national and international level.
- The CE cycle schedule – Since CE projects are conducted on a cyclical basis, as described in the "Cyclical Enforcement Projects" section, CE projects to be conducted in a given fiscal year are predetermined in the annual CV project plan.
- The characteristics of industry and compliance history – As CV projects are targeted to find non-compliance, the CSPS considers industry members' past compliance rates against the various legislative requirements and their level of cooperation when planning the distribution of resources for a coming year. Where repeated non-compliance and lack of industry cooperation are identified, CV projects may be undertaken to address these issues. Conversely, industry members with a strong compliance history who offer a high level of cooperation may not be subjected to CV projects as frequently.
- The vulnerability of the product users – Protecting the health and safety of vulnerable sub-populations who may be at greater risk than the general population is a key consideration in developing the annual CV project plan. For example, children are naturally curious but do not easily recognize hazards, and therefore, they require extra protection and care. As a result, CV projects that assess the compliance of products intended for use by children, or in caring for children, may receive higher priority than those focused on products intended for use by the general population.
- The data on incidents and injuries – The CPSP can identify current or emerging risks by monitoring and reviewing:
- incident and injury reports related to consumer and cosmetic products in our case management system,
- data on product safety issues from other sources (e.g., media, hospitals, poison control centers).
These statistics help to narrow the focus of a CV project to ensure that resources are used effectively and efficiently to address imminent risks.
- The severity of hazard(s) – An understanding of the level of severity posed by hazards and non-compliance in regulated and unregulated products can help in identifying those products that would pose the greatest risk to consumers. This, in turn, helps prioritize those projects that must take place on a more frequent basis, or those that may require more samples. For example, non-compliance to labelling requirements (e.g. wrong font size, inexact wording of a cautionary statement) could be considered as a lower risk than non-compliance to performance requirements that may result in a severe injury or death. Therefore, a project may be conducted more frequently for products or hazards where the consequences of non-compliance are more severe.
- The summary of recommendations from past CV projects – The completion of each project is accompanied by an activity report, which lays out the actions taken, results, and lessons learned, which are then collated, discussed within CPSP, and applied to future projects. These activity reports may also include recommendations to:
- increase/decrease the frequency of a project based on level of compliance,
- develop a policy to facilitate interpretation of regulatory provisions, or
- develop industry guidance to improve awareness and promote compliance.
Recommendations from past CV projects are reviewed on an ongoing basis to ensure that CV projects continue to be effective and efficient in addressing risks to Canadians.
Factors that may affect the planning and scheduling of the CV projects
Despite careful planning and preparation, the CV project plan may be impacted by unforeseen circumstances that require a shift in the CPSP's priorities and direction, and thereby impact the CPSP's annual CV project plan.
- Identification of an emerging consumer or cosmetic product risk that requires a rapid response from the CPSP – The existing CV project plan may be modified if a new risk is identified in the marketplace that requires immediate risk management action. In those situations, CPSP will re-evaluate priorities to ensure that Canadians are adequately protected.
- New regulations or amendments to legislation – If new regulations or amendments to the CCPSA, its regulations, the FDA, or the Cosmetic Regulations are introduced, compliance promotion and education activities will be prioritized to inform industry of the new or amended requirements prior to implementing a CV project. For product categories subject to changes in regulations, CV projects are conducted based on the factors mentioned in this document. This may result in a project carried out soon after implementation of the new regulation or in consecutive years to assess industry's level of compliance. Based on the findings, a recommendation will be made on the cycle length for the product.
- Available resources – If there is a significant shift in resource availability, the CPSP will determine how best to continue delivering on the CV project plan in light of those changes.
- A shift in departmental priorities – Departmental priorities may shift for a variety of reasons, including but not limited to an incident report resulting in a death, the introduction of a new product, or new trends found in media surveillance, which may impact the delivery or progression of a CV project.
Execution of CV projects
Once CV projects are confirmed for a fiscal year, they will be conducted in the following stages:
- Execute the project work plan and assess product or establishment compliance;
- Address compliance issues with the establishment;
- Post Consumer Product Enforcement Summary Reports; and
- Conclude the CV project.
Execution of the project work plan and assessment of product or establishment compliance
The CPSP inspectors conduct inspections to assess compliance for confirmed CV projects. Inspections may be conducted in-person, or off-site via email or telecommunications. Inspections can involve sampling and testing products and obtaining records to demonstrate product compliance, or reviewing records to verify the establishment's compliance to its obligations under the Act or its regulations.
Products that are sampled may be evaluated for compliance by the inspector on-site and/or sent for testing to Health Canada laboratories.
Documents provided to the CPSP by persons responsible at inspected establishments are assessed to determine product compliance and to verify establishment compliance under the CCPSA for document retention and mandatory incident reporting requirements.
Addressing compliance issues
Products or establishments that do not comply with the CCPSA and its regulations or the FDA and the Cosmetic Regulations, may be subject to enforcement actions. When compliance issues are identified, the CPSP follows a progressive and proportionate enforcement approach, where voluntary compliance by industry is usually encouraged as the most efficient way to control an unsafe product. When an establishment refuses to take appropriate voluntary action, delays taking action within reasonable timeframes, or has repeatedly displayed non-compliant behaviour, or where an inspector has any grounds to believe that voluntary compliance will not suffice, the compliance and enforcement measures are escalated further along the compliance and enforcement continuum to address the risk to the public. Some enforcement actions include stop sales, recalls, or Ministerial Orders.
Consumer Product Enforcement Summary Reports
As part of the Government of Canada's Regulatory Transparency and Openness Framework, the results of each CV project are posted online as Consumer Product Enforcement Summary Reports. Beyond informing Canadians as to which products met or did not meet safety standards, these reports provide information to industry and consumers on products reviewed by Health Canada, and include:
- A description of the scope of each project;
- The names of the products reviewed;
- The source where the sample was taken;
- The compliance determination; and
- The corrective actions.
Concluding the CV project
CV projects are concluded with an activity report, which describes the observations made during inspections and provides recommendations for future planning of inspections, compliance promotion, and potential future risk management considerations. The recommendations may suggest a frequency to repeat inspections, different approaches to methodology, education and compliance promotion activities targeted at industry, program updates, and regulatory changes for consideration.
References
- Health Canada: The Food and Consumer Safety Action Plan, August 30, 2012 https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/strategies-initiatives/health-canada-food-consumer-safety-action-plan.html
- Compliance and enforcement policy framework https://www.canada.ca/en/health-canada/corporate/mandate/regulatory-role/what-health-canada-does-as-regulator/compliance-enforcement-framework.html
- Open Government initiative http://data.gc.ca/eng/canadas-action-plan-open-government
- Regulatory transparency and openness framework https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness.html
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