All cosmetics sold in Canada must be safe for use and must not pose any health risk to humans. They shall comply with the Cosmetic Regulations under the Food and Drugs Act. Furthermore, Canada dictates that cosmetics must be produced, preserved, packaged, and stored under hygienic conditions.

To ensure compliance, manufacturers and importers are required to notify Health Canada about their intention to sell the product and provide a list of ingredients used. Moreover, cosmetics must meet the requirements outlined in the Consumer Packaging and Labeling Act, ensuring proper packaging and labeling practices.

Part 1 Regulatory Framework and Competent Authority

1.1 Existing Main Cosmetic Regulations in Canada

Canada's legal and regulatory system operates on three primary levels: Act, Regulation, and Guidance. The Act serves as the foundational framework for governing various aspects of society. The second level is Regulation, which is derived from the Act and provides more specific and detailed instructions on how to enforce Act. At the third level, the Guidance, which is not a legally binding act and regulation in Canada, serves as an interpretive document that consolidates the requirements outlined in relevant acts and regulations. Nonetheless, enterprises are recommended to follow the Guidance to ensure compliance. Together, these three levels form a comprehensive structure that ensures legal compliance and provides guidance within Canada's regulatory framework.

The table below lists Canada's existing main cosmetics regulations.

1.2 Competent Authority

Health Canada, as an agency of the Canadian government, plays a vital role in safeguarding and enhancing the health of Canadians. It contributes to minimizing health risk factors for Canadians through regulations on drugs, food, medical devices, health supplements, cosmetics, etc.

Regarding cosmetic regulation, Health Canada has specific responsibilities, which include accepting cosmetic notifications, establishing ingredient usage requirements, and conducting post-market surveillance, etc.

Part 2 Cosmetic Products

2.1 Cosmetic Definition

Under the Food and Drugs Act, cosmetic is defined as "any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes." This also includes:

• cosmetics used by professional esthetic services

• bulk institutional products such as hand soap in school rest rooms

• "handmade" cosmetics sold through home-based businesses or craft sales

Some products that share characteristics of both "cosmetic" and "drug" are harder to be classified. Health Canada evaluates and determines whether they should be classified as a cosmetic on a case-by-case basis. In making this determination, Health Canada takes into consideration the following factors:

1. Representation: The product is represented for sale to serve a or more cosmetic function(s) such as cleansing, moisturizing, lubricating, perfuming or altering the hair, skin or teeth of humans.

2. Composition: While the product's classification cannot be solely decided according to its composition, the presence or concentration of certain ingredients may render the product unsuitable for classification as a cosmetic.

3. Level of Action: Typically, cosmetics are intended for external application and are not designed to penetrate below the skin to achieve their desired cosmetic effect.

Furthermore, in making the determination, the below points need attention:

• Cosmetics can be applied to the skin surrounding the eyes, but products specifically intended for direct application into the eyes do not fall under the cosmetic classification.

• Products administered through ingestion, inhalation, or injection (such as intramuscular, subcutaneous, or intravenous routes, with the exception of tattoo ink) are not classified as cosmetics.

2.2 General Safety Requirements

Health Canada sets safety rules through the Food and Drugs Act and the Cosmetic Regulations. All cosmetics sold in Canada must ensure:

1) Compliant Ingredient Use

Cosmetics must be free from contaminants and substances that could potentially harm consumers when used as directed. Health Canada maintains the Cosmetic Ingredient Hotlist, which outlines prohibited and restricted ingredients in cosmetics.

Enterprises must notify Health Canada of the composition of their cosmetics, allowing for monitoring and verification against the Cosmetic Ingredient Hotlist. If any safety concerns arise, the cosmetic product may be prohibited from the market.

2) Hygienic Production and Storage Conditions

Cosmetics must be manufactured, prepared, preserved, packed, and stored under hygienic conditions to ensure consumer safety. While specific methods for proving product safety are not prescribed by legislation, it is the responsibility of manufacturers to determine and demonstrate the safety of their products.

While Canada does not mandate the obtain of a production license or strictly enforce Good Manufacturing Practices (GMP), companies are encouraged to adhere to ISO Cosmetics GMP Standard: 22716. It is essential to establish quality control systems for impurities and microorganisms, as well as maintain appropriate packaging and storage conditions.

3) Compliant Label

Cosmetic product labels must comply with specific requirements outlined in various acts and regulations, including the Food and Drugs Act, Cosmetic Regulations, and Consumer Packaging and Labeling Act.

2.3 Cosmetic Notification

Section 30 of the Cosmetic Regulations stipulates that manufacturers or importers are obligated to submit a Cosmetic Notification Form (CNF) to Health Canada within 10 days from the first sale of a cosmetic in Canada. In the case of imported products, it is advisable to notify Health Canada before the importation takes place. Failure to notify may result in the denied entry into Canada or removed from sale.

The notifier can be the manufacturer, importer, distributor, or an authorized third party. While it is not mandatory for the notifier to be a Canadian company, the notification information must include the contact information of a Canadian manufacturer, importer, or distributor.

There are no fees associated with submitting the notification. After the CNF has been completed, no publicly available platform will disclose information on the corresponding products. For comprehensive instructions on completing the CNF, please refer to the How to Complete a Cosmetic Notification Form.

1. Notification Information

2. Notification Review

The CNF can be submitted online to Health Canada. Once submitted, the company can proceed with placing the product on the market. However, it is important to note that submitting the CNF does not imply that the product has been approved for sale, classified as a cosmetic, or complied with all legal requirements. The CNF will undergo subsequent review by Health Canada.

During the review process, Health Canada may have inquiries regarding the product notification information or encounter issues with the product itself, such as unknown ingredients, missing information, safety concerns, and improper classification, etc. In such cases, Health Canada will contact the notifier for additional information to ensure the product's safety. The table below provides an overview of common reasons for non-compliance and possible outcomes of the notification review.

Once the identified issues have been addressed and resolved, Health Canada will issue a Cosmetic Number (CN), a unique 7-digit identifier, to the notifier via email. While the review process may take several months, companies are permitted to place the product on the market upon completing the CNF submission without waiting for the CN to be issued. The CN primarily serves as a reference for future amendments of the CNF or discontinuation of sale, allowing enterprises to expedite processing by entering the CN in the online system.

3. Notification Amendments and Discontinuations

It is important to keep the most accurate and up-to-date information in the CNF. Manufacturers and importers must amend and resubmit the CNF to Health Canada within 10 days when there are changes on the product that affect the information provided. Examples of such changes include

• modifications to the cosmetic formulation;

• changes in the product name;

• discontinuation of sale;

• new company name, address, or contact information.

2.4 Cosmetic Labeling

Cosmetic labeling is regulated by two Acts and their associated Regulations:

1. Food and Drugs Act and its subordinate Cosmetic Regulations:

• The Act and Regulations specify the necessary information that must be included on the label, as well as the specific requirements

2. Consumer Packaging and Labelling Act and its subordinate Consumer Packaging and Labelling Regulations:

• The Act and Regulations specify the labeling requirements for net quantity. Additionally, they emphasize that the label must not contain any false or misleading claims.

The following table outlines the five essential pieces of information that must be included on the label. It is crucial that they are clear and easily identifiable under normal purchase and use conditions.

2.5 Cosmetic Claims

A claim can be a word, a sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisements, including company websites. Together, these claims are used to create a net impression of what the product is and does.

Regarding cosmetic claims, enterprises shall pay attention to the following points:

1. Claims must be true and verifiable

It must accurately convey the attributes, features and benefits of the product. Companies must be able to substantiate claims made on labels and advertisements and keep the substantiation data and evidence. This may include ingredient properties, research data, test results, etc.

2. Claims shall not contain false or misleading statements

False or misleading statements include situations such as:

• The labeled net quantity is inconsistent with the actual quantity;

• The claim indicates that a product contains a specific ingredient that is not actually present.

3. No manufacturer shall make the below claim on a label of or in an advertisement for a cosmetic, unless the manufacturer has evidence that validates the claim:

• the ability of the cosmetic or any of its ingredients can influence the chemistry of the skin, hair or teeth; or

• the formulation, manufacture or performance of the cosmetic implies that the user of the cosmetic will not suffer injury to their health.

4. Any terms of therapeutic effects are prohibited

Health Canada authorized Advertising Standards Canada (ASC) to develop Guidelines for the Nonprescription and Cosmetic Industry Regarding Non-therapeutic Advertising and Labelling Claims. This Guidelines provides examples of prohibited therapeutic claims for six cosmetic product categories: antiperspirants, hair care products, nail care products, intimate products, oral care products, and skin care/color cosmetics.

Please refer to Cosmelist for detailed information.

2.6 Animal Testing Ban

The Budget Implementation Act, Bill C-47 was passed by the Senate on June 22, 2023, and officially came into effect on December 22, 2023. This significant legislation marks the legal prohibition of cosmetic testing on animals in Canada. The following amendments have been implemented as part of this crucial legislation:

1) testing cosmetics on animals in Canada;

2) selling cosmetics that rely on animal testing data to prove the product's safety, with some exceptions; and;

3) false or misleading labeling related to the testing of cosmetics on animals.

The amendments allow the sale of cosmetics that rely on data derived from animal testing, provided that the data satisfies any of the following four conditions:

• the animal testing was conducted before the prohibition on sale came into force;

• the animal testing data has been published by the Government of Canada on its website or in a scientific journal (e.g., referenced in a published Chemicals Management Plan assessment);

• the animal testing data is publicly available and not conducted or sponsored by the manufacturer, importer, or seller; or

• the animal testing was required to meet either a legislative requirement in Canada other than the cosmetic requirements under the Food and Drugs Act, or a requirement unrelated to cosmetics (e.g., pharmaceutical drugs) under another country's legislation, and the ingredient has a valid non-cosmetic use.

2.7 Advance Notice of Importation (ANI)

Upon arrival at the Canadian border, the Canada Border Services Agency (CBSA) refers cosmetics to Health Canada, which assesses them to see if they are compliant with Canadian cosmetics regulations. If the labeling of a specific batch of imported cosmetics fails to meet regulatory requirements, the following actions should be taken by importers:

• Advance Notice of Importation (ANI) Submission: Importers must submit an ANI form to Health Canada before importing the cosmetics.

• Changes or Relabeling: Importers are required to make necessary changes or relabel the products within three months after importation.

However, submitting an ANI form does not guarantee cosmetics and drugs entry into Canada. Health Canada will recommend entry refusal of cosmetics that cannot achieve compliance through modification or relabeling.

2.8 Post-market Surveillance

1. Compliance & Enforcement (C&E) Activities: Working with Product Safety Inspectors

C&E activities encompass the measures undertaken by regulatory authorities to ensure that manufacturers, importers, distributors, and other stakeholders comply with the established rules, regulations, and requirements governing the cosmetic industry.

Product safety inspectors play a key role in performing C&E activities. According to the Food and Drugs Act and its subordinate Cosmetic Regulations, product safety inspectors are empowered to:

• Conduct inspections at premises where cosmetics are sold, manufactured, or stored, including collecting samples for testing or take photographs as evidence;

• Make recommendations regarding the refusal of imports and provide an opportunity for non-compliant products to be rectified to achieve compliance under their supervision;

• Seize non-compliant cosmetic products.

2. Other C&E Activities

In addition to the responsibilities of product safety inspectors, there are various other C&E activities that contribute to the enforcement of cosmetic regulations. These activities include:

Part 3. Cosmetic Ingredient Use

3.1 Cosmetic Ingredient Hotlist

Health Canada maintains an extensive Cosmetic Ingredient Hotlist that outlines specific requirements for cosmetic products regarding ingredient usage, maximum concentration limits, and necessary warnings. However, it's important to note that the Hotlist primarily focuses on intentionally used ingredients and does not encompass common impurities or contaminants present at trace levels in finished products, such as heavy metals.

The Hotlist comprises two distinct tables:

1. Prohibited Ingredients

• These ingredients are strictly forbidden in cosmetic products sold in Canada.

2. Restricted Ingredients

• These ingredients are permitted under specific conditions or with the inclusion of cautionary statements. For example:

               Camphor: The maximum concentration is 3%.

               Ethyl methacrylate: Cautionary statement: "Avoid skin contact."

The Hotlist undergoes regular review and revisions through the review of the following items:

While the Hotlist serves as an administrative tool for communicating substances that may pose risks when used in cosmetics, it should be noted that it is not an exhaustive list. The general prohibition applies as soon as the potential for injury is identified.

3.2 Other Ingredient Prohibitions

Besides the Hotlist, the Canadian government has issued other regulatory documents that prohibit the use of certain ingredients in general products, including cosmetics.