Consumer Product Safety Program policy on compliance verification projects: Industry guide

Table of contents

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:

The diagram below provides a graphic representation of the current division of CV projects:

Figure 1

Current division of CV projects

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:

In addition to regulated products, CE projects may also be undertaken to assess compliance with specific prohibitions under the Acts including:

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:

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.

These statistics help to narrow the focus of a CV project to ensure that resources are used effectively and efficiently to address imminent risks.

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.

Execution of CV projects

Once CV projects are confirmed for a fiscal year, they will be conducted in the following stages:

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:

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

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