Cosmetic regulation in Canada is evolving, and enforcement is catching up. A Cosmetic Notification Form alone is no longer enough.
In the past two years, Environment and Climate Change Canada (ECCC) has issued over $1 million in fines against cosmetic companies for violations of the Canadian Environmental Protection Act, 1999 (CEPA). The government, through agencies like ECCC, enforces compliance orders when violations are found. These enforcement actions signal a clear shift: cosmetic compliance in Canada now extends well beyond labels and notification submissions. ECCC issued compliance orders and penalties to companies for failing to manage chemicals in consumer products, highlighting the risk of adverse effects on health and the environment. The Food and Drugs Act (FDA) also regulates the safety of cosmetic products in Canada by ensuring that all cosmetics sold in the country are safe for human use, properly labeled, and free from harmful substances.
Yet many brands continue to rely on regulatory reviews that focus primarily on Cosmetic Notification Forms, without a structured assessment of CEPA obligations or broader federal requirements. Compliance reviews must consider the full range of chemicals present in cosmetics and other consumer products.
If your cosmetic regulatory support does not include a CEPA review, your compliance strategy may be incomplete.
Cosmetic Compliance in Canada Is Broader Than Many Think
Most cosmetic companies are familiar with Health Canada’s Cosmetic Regulations, ingredient hotlists, and notification requirements. However, cosmetic products are also subject to additional federal legislation, including CEPA and other environmental and product safety measures.
Recent regulatory developments highlight this broader compliance landscape:
- Microbeads ban: Plastic microbeads are prohibited in toiletries under CEPA due to environmental concerns. Even small formulation changes can trigger compliance issues if this assessment is overlooked.
- Animal testing ban: Canada’s amendments to the Food and Drugs Act prohibit cosmetic animal testing and restrict the sale of cosmetics that rely on new animal testing data, with limited exceptions.
- Fragrance allergen disclosure requirements: Updates to the Cosmetic Regulations require expanded disclosure of certain fragrance allergens on cosmetic labels, increasing formulation transparency obligations.
- CEPA substance controls: Ingredients used in cosmetics may be subject to Significant New Activity (SNAc) requirements, reporting obligations, or other risk management measures under CEPA.
CEPA is a comprehensive federal law in Canada aimed at pollution prevention and protecting the environment and human health.
Individually, each requirement may appear manageable. Collectively, they create a layered regulatory framework that requires coordination across environmental, safety, and labelling obligations. The Chemical Management Plan (CMP) is Canada’s strategy for assessing, monitoring, and managing chemicals that may pose risks to human health or the environment. Manufacturers are required to inform regulatory authorities and consumers about ingredient safety and compliance, ensuring that all products meet Health Canada’s standards.
Why CEPA Matters for Cosmetics
CEPA applies to substances used in cosmetic products, including ingredients that may trigger:
- Substance usage tracking and import tracking
- Significant New Activity (SNAc) notification requirements
- Environmental reporting obligations
- Restrictions or risk management measures
Manufacturers must check if ingredients are listed as ‘toxic’ under CEPA Schedule 1 or as restricted substances before importation or use, and determine if they are new substances requiring assessment.
ECCC is increasingly verifying whether cosmetic products meet their environmental compliance obligations, not just whether they have been notified to Health Canada. Routine inspection and review of scientific data, including new scientific data, are used to assess compliance and long-term health risks, such as endocrine disruption or carcinogenicity, rather than only immediate effects.
A product can be properly notified and still be non-compliant under CEPA or other federal requirements.
This distinction is critical.
Regulatory Framework: How CEPA Governs Cosmetics in Canada
The Canadian Environmental Protection Act (CEPA) is a cornerstone of environmental and product safety regulation in Canada, and its reach extends directly into the cosmetic industry. While many cosmetic companies are familiar with Health Canada’s Cosmetic Regulations under the Food and Drugs Act, it’s essential to recognize that compliance doesn’t stop there. CEPA, administered by both Health Canada and Environment and Climate Change Canada (ECCC), governs the assessment and management of toxic substances and chemical substances found in cosmetic products.
Under this regulatory framework, every cosmetic product sold in Canada must meet the requirements of both the Cosmetic Regulations and CEPA. The Cosmetic Regulations focus on product safety, labelling, and sanitary conditions, while CEPA addresses broader environmental risks and the use of certain substances that may pose a threat to human health or the environment. The Domestic Substances List (DSL) is a key tool under CEPA, cataloguing chemical substances that are permitted for use in Canada, while the Cosmetic Ingredient Hotlist identifies restricted or prohibited ingredients for cosmetics. Health Canada maintains the Cosmetic Ingredient Hotlist, which identifies prohibited and restricted substances in cosmetics. The Hotlist is a science-based document that is reviewed and updated periodically when new scientific data becomes available. It consists of two distinct tables: one for ingredients identified as being prohibited and another for those identified as being restricted. Ingredients in the Hotlist are typically listed under their INCI name (International Nomenclature of Cosmetic Ingredients), which standardizes ingredient identification for regulatory compliance.
Cosmetic companies must ensure compliance with all applicable legislation, including the Food and Drugs Act and CEPA, to avoid enforcement actions. This means not only assessing product formulations for safety and efficacy but also evaluating environmental impacts and the presence of restricted or toxic substances. By understanding and navigating this layered regulatory landscape, companies can better assess risks, comply with regulations, and ensure that their cosmetics meet the highest standards for both consumer safety and environmental protection.
Role of Health Canada in Cosmetic Regulation
Health Canada is at the forefront of cosmetic regulation in Canada, playing a pivotal role in safeguarding both consumer health and the environment. As the primary regulatory authority, Health Canada enforces the Food and Drugs Act and Cosmetic Regulations, which set the standards for cosmetic products sold in the Canadian market. The department is responsible for evaluating cosmetic ingredients, monitoring for adverse effects, and ensuring that all cosmetic companies comply with established safety guidelines.
A key aspect of Health Canada’s mandate is the ongoing assessment of cosmetic ingredients using the latest scientific data. When new scientific evidence emerges about potential health risks, Health Canada updates its regulations and guidance to reflect these findings. This proactive approach helps to minimize risks associated with restricted substances and ensures that only safe products reach Canadian consumers.
Health Canada also leads enforcement actions when companies fail to comply with regulations, which can include product recalls, compliance orders, or other corrective measures. By maintaining rigorous oversight and updating the Cosmetic Ingredient Hotlist as new risks are identified, Health Canada helps cosmetic companies navigate the complex regulatory landscape and meet their obligations under the Food and Drugs Act. For companies, working closely with Health Canada and adhering to its guidelines is essential to ensure compliance, avoid enforcement actions, and protect both human health and the environment.
The Risk of “Notification-Only” Compliance
Many cosmetic companies assume that once a Cosmetic Notification Form has been submitted, regulatory risk is minimal. That assumption no longer reflects today’s enforcement reality.
If CEPA or related federal obligations are missed:
- Inspections may escalate quickly
- Products may be pulled from distribution
- Enforcement orders and monetary penalties may follow
- Issuance of an environmental protection compliance order may occur, requiring specific corrective actions to meet legal standards
- Reputational risk may increase
Regulatory gaps are often discovered after products are already on the market, when the cost and complexity of corrective action are highest.
Proactive compliance is significantly less disruptive than reactive remediation.
Dell Tech’s Integrated Cosmetic Compliance Approach
Dell Tech recognized this regulatory shift early and incorporated structured CEPA compliance reviews into our cosmetic evaluation process.
Our cosmetic regulatory support includes:
- Cosmetic label review
- Cosmetic Notification Form preparation and submission
- CEPA substance and SNAc assessment
- Review of microbeads restrictions
- Consideration of animal testing prohibitions and supporting documentation
- Assessment of fragrance allergen disclosure requirements
- Review of applicable VOC concentration limits under CEPA, where products may fall within the scope of the Volatile Organic Compound (VOC) Concentration Limits for Certain Products Regulations
- Search and identification of ingredients on the Cosmetic Ingredient Hotlist using INCI names and international nomenclature to ensure regulatory compliance and proper identification of chemicals of concern
Certain cosmetic products, particularly sprays, hair products, nail products, and other aerosolized formulations, may fall within the scope of Canada’s VOC Regulations. These regulations set concentration limits for specific volatile organic compounds in certain product categories and can apply alongside Cosmetic Regulations and CEPA substance requirements. Overlooking VOC classification or concentration thresholds can create unintended compliance gaps. In addition, it is important to monitor for the presence of heavy metals and polyfluoroalkyl substances (PFAS) in product formulations, as these impurities and persistent chemicals are subject to increasing regulatory scrutiny.
This integrated approach reflects how regulators now assess cosmetic products. Instead of viewing cosmetic compliance through a single regulatory lens, we evaluate products holistically across applicable federal requirements. All cosmetic products must be manufactured under sanitary conditions and meet safety standards for human health.
The result is a more defensible compliance position and reduced enforcement risk.
Free Download: CEPA Compliance Checklist for Cosmetic Products in Canada
Not sure whether your current cosmetic review covers CEPA and related federal requirements?
This checklist can help you identify potential gaps.
What’s Included in the Checklist
- Key CEPA questions every cosmetic company should be able to answer
- Common CEPA blind spots in cosmetic compliance reviews
- Considerations related to microbeads, animal testing restrictions, and fragrance allergen disclosures
- Practical prompts to assess whether your regulatory support is complete
CEPA Compliance Checklist for Cosmetics
Use this checklist to assess whether CEPA and broader federal requirements have been adequately addressed for your cosmetic products.
Product and Ingredient Assessment
- Have all cosmetic ingredients been reviewed for CEPA applicability, not just Health Canada acceptability?
- Have all ingredients been checked against the Domestic Substances List (DSL) and Non-Domestic Substances List (NDSL)?
- Has a New Substances Notification been submitted for any ingredient not on the DSL?
- Has the presence of substances subject to CEPA controls, SNAc requirements, or reporting obligations been assessed?
- Have PFAS or other environmentally persistent substances been specifically evaluated?
- Has the product been assessed for compliance with Canada’s microbeads prohibition?
- Has the formulation been evaluated against applicable VOC concentration limits where the product category may fall under the VOC Regulations?
- Has the product been reviewed for overlap with natural health products and other consumer products?
The Cosmetic Ingredient Hotlist: What You Need to Know
The Cosmetic Ingredient Hotlist is an indispensable resource for cosmetic companies operating in Canada. Maintained by Health Canada, the Hotlist identifies prohibited and restricted substances that must not be used, or can only be used under specific conditions, in cosmetic products. This list is regularly updated to reflect new scientific evidence and to address emerging health and environmental risks associated with cosmetic ingredients.
Cosmetic companies are required to review their product formulations against the Hotlist to ensure compliance before introducing new substances or products to the Canadian market. The Hotlist covers a wide range of toxic substances, including polyfluoroalkyl substances (PFAS), heavy metals, and other chemicals known to cause adverse effects on human health or the environment. When a new ingredient is proposed for use, companies must notify Health Canada through a Cosmetic Notification Form and provide supporting safety information.
Staying current with the Cosmetic Ingredient Hotlist is crucial for compliance and risk management. Failure to comply can result in enforcement actions, such as product recalls or penalties, and can jeopardize a company’s reputation in the competitive cosmetic industry. By proactively monitoring updates to the Hotlist and ensuring that all product formulations meet Health Canada’s requirements, cosmetic companies can minimize regulatory risks, protect consumer safety, and maintain their standing in the Canadian market.
Significant New Activity (SNAc) Considerations
- Has it been confirmed whether any ingredient triggers a SNAc notification requirement?
- If a SNAc applies, has the required notification been submitted before import or sale?
- Has the assessment considered changes in use, concentration, or annual volume that could trigger a SNAc?
VOC Classification and Formulation Review
- Has the product category been assessed to determine whether it falls within the scope of the VOC Concentration Limits for Certain Products Regulations?
- Have applicable VOC concentration limits been calculated based on the final formulation?
- Are records available to demonstrate compliance with VOC limits during an inspection?
- Have reformulations been evaluated to ensure VOC compliance is maintained?
Animal Testing and Safety Substantiation
- Has compliance with Canada’s cosmetic animal testing ban been verified?
- Are safety substantiation records aligned with current prohibitions on new animal testing data?
- Are supplier assurances supported by appropriate documentation?
Fragrance Allergen and Labelling Requirements
- Has the formulation been reviewed against current and upcoming fragrance allergen disclosure requirements?
- Have labelling updates been planned to meet regulatory timelines?
- Is there a system in place to monitor future ingredient disclosure changes?
Importer and Supply Chain Obligations
- Has the importer of record been clearly identified for CEPA purposes?
- Are CEPA responsibilities clearly assigned between brand owner, importer, and manufacturer?
- Has reliance on foreign supplier assurances been independently verified?
Documentation and Recordkeeping
- Is there written documentation showing that CEPA compliance was assessed?
- Are records sufficient to demonstrate compliance during an ECCC inspection?
- Have compliance assumptions been validated against current enforcement trends?
Ongoing Compliance
- Is CEPA compliance reassessed when formulations change?
- Are regulatory updates monitored for substances used in existing products?
- Is CEPA considered during product expansions, reformulations, or supplier changes?
If you answered “no” or “not sure” to any of these questions, your cosmetic compliance review may require additional evaluation.
Penalties for Non-Compliance: What’s at Stake for Cosmetic Brands
Failing to comply with CEPA and the Cosmetic Regulations can have serious consequences for cosmetic companies operating in the Canadian market. Enforcement actions are becoming more frequent and more severe, as demonstrated by recent high-profile cases. For example, the Ontario Court of Justice imposed a $750,000 fine on Estée Lauder Cosmetics Ltd. for violating CEPA by failing to notify ECCC about the use of perfluorononyl dimethicone—a restricted ingredient—in their eyeliner products. This case underscores the importance of notifying ECCC and Health Canada about new substances and providing accurate safety information.
Penalties for non-compliance can include substantial fines, product recalls, seizures, and the issuance of environmental protection compliance orders. Companies found violating CEPA may also be listed on Canada’s Environmental Offenders Registry, which can significantly damage brand reputation and erode consumer trust. Beyond financial penalties, non-compliance exposes companies to risks related to human health and environmental safety, especially when toxic substances or restricted ingredients are involved.
To avoid these risks, cosmetic companies must ensure that their products and processes comply with all applicable guidelines, legislation, and safety requirements. This includes proactively notifying ECCC about new substances, maintaining up-to-date safety documentation, and adhering to restrictions on certain ingredients. By prioritizing compliance and staying informed about evolving regulations, companies can protect their reputation, safeguard human health and the environment, and maintain their standing in the competitive Canadian cosmetics market.
Take the Next Step
Download the CEPA Compliance Checklist for Cosmetics to better understand your regulatory risk and determine whether further review is needed.
If helpful, Dell Tech can also:
- Perform a CEPA compliance review of your existing cosmetic portfolio
- Integrate CEPA and federal environmental assessments into your cosmetic notification process
- Evaluate compliance with microbeads restrictions, animal testing prohibitions, and fragrance allergen requirements
- Support proactive regulatory strategies aligned with current enforcement trends
For direct assistance or guidance with CEPA compliance and cosmetic regulations in Canada, contact Dell Tech today.
Cosmetic compliance in Canada has evolved. Your regulatory strategy should evolve with it.
