Cosmetic Safety Obligations are important in keeping consumers, the environment and the general population safe. In this series, we will delve into the safety obligations across the globe.
Safety Obligations of Cosmetic Products Series
To learn more about the differences in safety obligations across regional regulations, explore our safety obligations of cosmetic products series:
Food and Drugs Act Safety Obligations
The Food and Drugs Act (FDA) 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. The Act provides the legal framework for cosmetic safety, and its enforcement is supported by the Cosmetic Regulations under Health Canada.
Prohibition of Harmful Substances in Cosmetics
Section 16 of the Food and Drugs Act (FDA) is a fundamental regulation that prohibits the sale of any cosmetic product containing substances that may cause injury to the health of the user when applied as intended.
Section 16 stipulates:
- A cosmetic product must not contain any ingredient that may cause injury when used according to its instructions or customary use.
- Manufacturers are required to evaluate product formulations to ensure they meet safety standards before being introduced to the market.
- Health Canada monitors compliance through product testing, market surveillance, and consumer complaint investigations.
The Cosmetic Ingredient Hotlist
A major tool used in enforcing Section 16 is Health Canada’s Cosmetic Ingredient Hotlist, which serves as a reference document outlining substances that are prohibited or restricted in cosmetics.
Prohibited Ingredients
- These substances must not be used in cosmetics at any concentration due to their high toxicity, carcinogenic nature, or potential to cause severe health effects.
- Example: Mercury and its compounds – Mercury is a known neurotoxin and has been banned in cosmetic formulations in Canada due to its ability to accumulate in the body and cause poisoning.
Restricted Ingredients
- These substances are permitted in cosmetics only under specific conditions, such as a maximum allowable concentration or specific use instructions.
- Example: Formaldehyde – This preservative is permitted in certain cosmetics (e.g., nail hardeners) but only at regulated concentrations. Exposure limits ensure minimal risk to consumers, as formaldehyde is a known irritant and potential carcinogen.
- Example: Parabens – Certain parabens (such as propylparaben and butylparaben) are restricted due to potential links to endocrine disruption, with maximum allowable limits set to minimize risks.
Misleading or False Representation
Under Section 9 of the Food and Drugs Act (FDA), it is strictly prohibited for any individual or company to label, package, treat, process, sell, or advertise a cosmetic product in a manner that is false, misleading, or deceptive. This regulation ensures that consumers are not misled about the character, value, quantity, composition, merit, or safety of a cosmetic product.
The primary objective of this regulation is to protect consumers from fraudulent or exaggerated claims that may lead them to believe a product is more effective, safer, or has benefits that it does not actually provide. False advertising and misrepresentation can create unrealistic consumer expectations and, in some cases, pose health risks if a product is used improperly due to misleading claims.
Examples of Claims That Violate Section 9
- A moisturizer claiming to “heal eczema” – This would classify it as a drug, requiring approval from Health Canada.
- A shampoo advertised as “curing dandruff permanently” – While anti-dandruff shampoos exist, they must meet specific requirements and be registered as natural health products.
- A lip balm stating it has “SPF 50+ and protects against all UV damage” – SPF claims must be supported by scientific evidence and meet specific labeling guidelines.
- A whitening toothpaste claiming to “permanently alter the structure of enamel” – Any product affecting the physical structure of the body may be considered a drug or medical device.
GMP Safety Obligations
Although the Food and Drugs Act (FDA) does not impose the same stringent manufacturing regulations on cosmetics as it does for drugs, manufacturers must still ensure that cosmetic products are produced in sanitary conditions to prevent contamination and potential harm to consumers. Health Canada plays an active role in monitoring product safety, conducting inspections, and taking enforcement actions, such as seizing unsafe products or issuing recalls, when necessary.
Regulatory Requirements for Sanitary Production
Under Section 16 of the Food and Drugs Act, it is illegal to sell cosmetics that:
- Have been manufactured, prepared, preserved, packaged, or stored under unsanitary conditions, which could pose a risk to consumer health.
- Contain any filthy, decomposed, or contaminated substances.
- Include foreign matter that could compromise product safety.
Furthermore, Section 18 of the Act makes it an offense to manufacture, prepare, preserve, package, or store cosmetics in unsanitary conditions with the intent to sell them. In this context, “unsanitary” refers to any conditions or circumstances that might contaminate a product with dirt, filth, or other harmful substances, rendering it unsafe for use.
To comply with these safety and quality requirements, Health Canada strongly recommends that all cosmetic manufacturers adhere to Good Manufacturing Practices (GMPs). While GMP compliance is not a legal requirement for cosmetics in Canada, following these guidelines helps ensure that products meet quality and safety standards, reducing the risk of contamination, formulation errors, or product instability.
International GMP Standards for Cosmetics
Health Canada, in collaboration with international regulatory bodies such as the United States, the European Union, and Japan, supports the adoption of the International Organization for Standardization (ISO) Guidelines on Good Manufacturing Practices for Cosmetics, ISO Standard 22716. This globally recognized standard provides a comprehensive framework for the safe and hygienic production of cosmetics, covering key areas such as:
- Manufacturing processes – Ensuring that all production steps are conducted under sanitary and controlled conditions.
- Quality control and testing – Implementing procedures to verify ingredient quality and product safety before release.
- Storage and handling – Establishing conditions that prevent contamination or degradation of raw materials and finished products.
- Packaging and labeling – Using appropriate materials and methods to maintain product integrity and provide accurate consumer information.
- Personnel training and hygiene – Ensuring that employees involved in production follow strict hygiene protocols to prevent contamination.
- Complaint handling and recalls – Establishing procedures for managing customer complaints, investigating safety concerns, and conducting recalls when necessary.
Oversight of Sanitary Production
Although GMP adherence is voluntary, Health Canada maintains the authority to take corrective action if a cosmetic product is found to be manufactured in conditions that violate Section 16 or Section 18 of the Food and Drugs Act. This can include:
- Conducting facility inspections to assess compliance with sanitary requirements.
- Issuing product recalls for cosmetics found to be contaminated or otherwise unsafe.
- Seizing non-compliant products that pose a health risk to consumers.
- Issuing warnings, fines, or legal actions against manufacturers that repeatedly violate safety regulations.
Cosmetic Regulation Safety obligations
The Cosmetic Regulations in Canada ensure the safety, quality, and transparency of cosmetic products by setting rules for ingredient disclosure, labeling, manufacturing standards, and prohibited substances. Enforced by Health Canada, these regulations help prevent harmful chemicals, misleading claims, and unsafe manufacturing practices, protecting consumers from potential health risks.
Cosmetic Notification
Under Section 30 of the Cosmetic Regulations, all manufacturers and importers of cosmetic products in Canada are required to submit a Cosmetic Notification Form (CNF) to Health Canada within 10 days of first sale. This regulation ensures that Health Canada can monitor, assess, and track cosmetic products available on the Canadian market, helping to identify potential safety concerns and ensure compliance with regulatory standards.
The primary objective of Section 30 is to provide Health Canada with key product information, allowing regulatory authorities to:
- Assess the safety of cosmetic formulations by reviewing declared ingredients.
- Ensure compliance with the Food and Drugs Act and Cosmetic Regulations, particularly in relation to prohibited and restricted ingredients.
- Track products available on the Canadian market, helping to identify and respond to safety concerns.
- Monitor trends in the cosmetic industry, including the use of potentially hazardous ingredients.
Unlike drugs or natural health products, cosmetics do not require pre-market approval in Canada. However, the CNF serves as an essential post-market surveillance tool, enabling Health Canada to take action if a product is found to be unsafe or non-compliant.
Cosmetic Notification Data
The Cosmetic Notification Form requires the following details:
Product Identity & Brand Information
- The brand name and product name as it will appear on packaging.
- The intended function of the cosmetic (e.g., moisturizer, shampoo, lipstick).
Manufacturer & Importer Details
- The name and address of the manufacturer or importer.
- Contact information for regulatory correspondence.
Product Form & Intended Use
- The physical form of the cosmetic (e.g., cream, liquid, powder).
- Whether it is intended for professional or consumer use.
List of Ingredients
- A full list of ingredients in the product, expressed in International Nomenclature of Cosmetic Ingredients (INCI) format.
- The concentration of certain restricted substances, if applicable.
- Confirmation that the product does not contain any prohibited substances from Health Canada’s Cosmetic Ingredient Hotlist.
Compliance Statement
- A declaration that the product meets all applicable regulations and is safe for consumer use.
On-Pack Ingredient Disclosure
The Cosmetic Regulations stipulate how ingredients should be disclosed on pack, but general labelling requirements for products are listed in the Consumer Packaging & Labelling Act.
Use of the INCI System
- All ingredients must be listed using their International Nomenclature of Cosmetic Ingredients (INCI) names, rather than common or brand-specific names.
- This standardization allows consumers, healthcare professionals, and regulators to easily identify ingredients regardless of brand or product type.
Order of Ingredients
- Ingredients must be listed in descending order of concentration, meaning the ingredient present in the highest amount appears first.
- However, if an ingredient is present at 1% or less, it may be listed in any order after the ingredients present in greater amounts.
Fragrance and Flavor Ingredients
- The terms “parfum” (for fragrances) and “aroma” (for flavors) can be used instead of listing every individual fragrance or flavor ingredient.
- However, if a specific fragrance compound is a known allergen, it may need to be declared separately in accordance with international safety recommendations.
Colour Additives
- For colourants, manufacturers may use the Colour Index (CI) number (e.g., CI 77491 for iron oxides) or the INCI name.
- If a product may contain certain colourants depending on the shade, the label may use the phrase “may contain” or “±” followed by the list of potential colourants.
Exemptions for Small Packages
- If a cosmetic product is too small to display a full ingredient list (e.g., lipsticks, small compacts), the ingredients must be made available upon consumer request (e.g., on a leaflet, website, or point-of-sale display).
Regulatory requirements for special cosmetics
There are particular requirements for specific types of cosmetics in the Canadian Cosmetic Regulations. These product types include:
- Hair dyes
- Deodorants for use in the genital area
- Cosmetics in pressurized containers
- Cosmetics requiring security packaging
The regulations lists additional warnings, labelling requirements and safety considerations for these products.
Evidence of Safety
The Minister may request in writing that a manufacturer or importer submit to the Minister, on or before a specified day, evidence to establish the safety of a cosmetic under the recommended or the normal conditions of use.
A manufacturer or importer who does not submit the evidence requested must cease to sell the cosmetic on the day after the day specified in the request.
If the Minister determines that the evidence submitted by a manufacturer or importer is not sufficient, the Minister must notify the manufacturer or importer in writing to that effect, and the manufacturer or importer must cease to sell the cosmetic until the manufacturer or importer:
(a) has submitted further evidence to the Minister; and
(b) has been notified in writing by the Minister that the further evidence is sufficient.
There are no set requirements as to how the evidence of safety must be substantiated (unlike in the EU with a CPSR). But it is generally accepted that a cosmetic product safety report conducted by a qualified toxicologist is sufficient to meet this requirement.
CEPA Safety Obligations
Canadian Environmental Protection Act (CEPA) regulates chemical substances found in cosmetics through a comprehensive assessment process, which includes:
- Toxic Substance Classification and Regulation
- Environmental Risk Assessments for Cosmetic Ingredients
DSL & NDSL
CEPA maintains two key lists to regulate chemicals:
- Domestic Substances List (DSL) – Contains approved substances that have been assessed for safety.
- Non-Domestic Substances List (NDSL) – Includes chemicals not commonly used in Canada, which require additional safety review before being introduced.
Cosmetic companies must check these lists before formulating or importing products, ensuring that ingredients comply with CEPA regulations.
CEPA's influence on Cosmetics
Health Canada maintains the Cosmetic Ingredient Hotlist, which identifies prohibited and restricted substances in cosmetics. CEPA assessments directly influence which ingredients are added or removed from the Hotlist.
Examples of substances regulated or banned under CEPA in cosmetics include:
- Microbeads (banned in 2018 due to their environmental impact).
- Certain phthalates (restricted due to concerns about endocrine disruption).
- Heavy metals like lead and mercury (prohibited because of toxicity concerns).
CEPA encourages companies to develop safer alternatives to toxic cosmetic ingredients. Manufacturers are urged to use biodegradable, non-toxic, and eco-friendly substances to minimize environmental harm. Sustainable ingredient choices help reduce chemical pollution in waterways and ecosystems.
CMP Safety Obligations
The Chemical Management Plan (CMP) is Canada’s comprehensive strategy for assessing, monitoring, and managing chemicals that may pose risks to human health or the environment. Launched in 2006, the CMP is a collaborative effort between Health Canada and Environment and Climate Change Canada (ECCC) to ensure that chemicals used in various consumer products, including cosmetics, meet strict safety standards.
CMP Enhancement of Consumer Safety
Cosmetics often contain a wide range of chemical ingredients, including preservatives, fragrances, colorants, and active compounds. While many of these substances are safe in regulated amounts, some chemicals may pose long-term health risks or have environmental consequences. The Chemical Management Plan (CMP) plays a critical role in identifying and regulating such substances by:
Evaluating the Safety of Chemicals in Cosmetics
- The CMP conducts scientific risk assessments of chemicals found in cosmetics to determine their potential health effects (e.g., skin irritation, endocrine disruption, carcinogenicity).
- It prioritizes chemicals for assessment based on factors such as potential exposure levels, previous safety concerns, and international research findings.
- Evaluations focus on long-term health risks, ensuring that repeated or prolonged exposure to a substance does not lead to adverse effects.
Regulating and Restricting Harmful Ingredients
- If a chemical is found to pose a health or environmental risk, the CMP may introduce new regulations, restrictions, or prohibitions on its use in cosmetics.
- These regulatory changes are implemented through updates to the Cosmetic Ingredient Hotlist, which is a list of substances that are prohibited or restricted in cosmetics in Canada.
- Ingredients commonly assessed under the CMP include:
- Formaldehyde (used as a preservative, but restricted due to potential carcinogenic effects).
- Parabens (some forms have been restricted due to links to endocrine disruption).
- Phthalates (used in fragrances and plastics, with concerns about reproductive toxicity).
- Lead and heavy metals (prohibited due to toxicity concerns).
Monitoring Emerging Chemical Risks
- The CMP continuously monitors new scientific research and international regulatory developments to identify emerging risks related to cosmetic ingredients.
- It collaborates with global organizations, such as the European Union (EU) Scientific Committee on Consumer Safety (SCCS) and the U.S. Food and Drug Administration (FDA), to align Canadian regulations with global best practices.
Ensuring Compliance with CEPA
- The Canadian Environmental Protection Act (CEPA) is the primary legislation governing the assessment and regulation of chemicals in Canada.
- The CMP is the way in which the legislation is enforced.
