Insights from Health Canada on Cosmetic/NHP Regulation and Ingredient Use

Over the years, ChemLinked has consulted Health Canada on a range of issues concerning cosmetic supervision, ingredient usage, etc. Health Canada provided the following responses.

Health Canada

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.

Cosmetic Supervision

Q1. What role does Health Canada play in regulating cosmetics?

A1: All cosmetics sold in Canada must be safe to use and must meet the requirements of the Food and Drugs Act (FDA), and its Cosmetic Regulations (CR). In Canada, no person shall sell any cosmetic that has in or on it any substance that may cause injury to the health of the user (section 16 of the FDA).

In Canada, cosmetics are regulated in a post-market system. This includes:

Notification: the manufacturer and importer must notify Health Canada within 10 days after they first sell a cosmetic and provide information about the product’s formulation;
Labelling: the manufacturer or importer is required to disclose all ingredients on the product label.

In addition, the Cosmetic Ingredient Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances may be prohibited or restricted for use in cosmetics.

Departmental officials review the information provided by manufacturers or importers to make sure that the cosmetic product does not contain prohibited ingredients, or ingredients in quantities above the acceptable concentration limits as indicated on the Hotlist. If a health or safety problem is identified after a cosmetic product is on the market, Health Canada investigates and takes appropriate enforcement actions.

For more information on how cosmetics are regulated in Canada, please visit: Regulatory information for cosmetics.

Q2. How does Canada define “cosmetics,” and how does this definition differ from that of other jurisdictions such as the EU or US?

A2: Section 2 of the FDA defines a "cosmetic" 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." Specific examples can be found here: Notification of Cosmetics: Examples of cosmetics and products not considered to be cosmetics.

In the European Union (EU), the definition of a cosmetic product is broader than what is considered a cosmetic in Canada. For example, in the EU, fluoride toothpastes, sunscreens and anti-dandruff shampoos are cosmetics; however, under Canadian legislation, those products are considered to be drugs or natural health products.

The definition of “cosmetic” in the United States is aligned with the Canadian definition of a cosmetic.

Q3. Are cosmetic products subject to market surveillance or spot checks in Canada?

A3: Each year, Health Canada plans compliance verification project(s) where a targeted set of cosmetics are reviewed to verify compliance with the applicable laws. Follow-up compliance and enforcement activities are also performed as required.

Compliance verification projects may involve laboratory testing of products for a particular chemical or microbial contamination, or inspecting products to verify that they are notified and/or labelled correctly. Any non-compliances identified are brought to resolution following Health Canada’s risk-based enforcement model for cosmetics and may involve compliance and enforcement actions such as: product corrections, stop distributions, stop sales, or recalls.

More information on compliance verification projects can be found here: Guide to Compliance Verification Projects - Summary - Canada.ca.

Details of recently completed projects, as well as annual statistics, can be found on the Health Canada website: Consumer Product Enforcement Report.

Q4. Are there any upcoming updates to existing Canadian cosmetic regulations?

A4: On April 24, 2024, the Regulations Amending Certain Regulations Concerning the disclosure of Cosmetic Ingredients (amended regulations) were published in the Canada Gazette, Part II.

These regulatory amendments introduced, among other things, a requirement for the disclosure of certain fragrance allergens — which currently can be listed as “parfum” or “fragrance” — on cosmetic labels. Under the amended regulations, Health Canada will require cosmetics sold in Canada to disclose, on their label, certain fragrance allergens, when present at a concentration greater than 0.01% in rinse-off products and 0.001% in leave-on products. This will help people in Canada make informed decisions regarding the products they use, and avoid products that contain certain fragrance ingredients to which they may be sensitive. Amendments related to the disclosure of fragrance allergens will come into force on April 12, 2026.

Health Canada publishes its Forward Regulatory Plan, which is a public list of planned federal regulatory changes that are intended to be made over a 24-month period. Any anticipated updates to the Canadian Cosmetic Regulations would be described in this document.

Ingredient Use

Q5. DEHP is prohibited in cosmetics, and its intentional addition is strictly banned. However, is the presence of DEHP due to unintentional addition or technically unavoidable trace residues allowed? In such cases, is it necessary to submit a safety assessment report as part of the cosmetic notification to demonstrate the safety of DEHP residues?

A5: 1. The Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene the general prohibition found in section 16 of the FDA or a provision of the CR. In addition, the Hotlist communicates that certain substances, with no known cosmetic or functional purpose in a cosmetic formulation, make it unlikely for the product to meet the definition of a cosmetic under the FDA.

The Cosmetic Ingredient Hotlist applies to substances that are intentionally added to cosmetics. It is not meant to cover common and pervasive impurities and/or contaminants (e.g. heavy metals) that may be present at trace levels in a finished product.

It is the responsibility of the manufacturer or Canadian distributor to ensure that a cosmetic meets the requirements of the FDA and the CR. For instance, Section 16 of the FDA states that no person shall sell a cosmetic that has in it any substance that may injure the health of the user when the cosmetic is used according to its customary method. Included in this requirement is the notion that a finished cosmetic product contains as few impurities as possible. If DEHP is present at a concentration that may cause injury, regardless of whether it is present intentionally, the product may not be sold.

2. While a safety assessment report is not a regulatory requirement for submission of a cosmetic notification, it is the responsibility of the manufacturer or importer to ensure that a cosmetic meets the requirements of the FDA and the CR. For instance, Section 16 of the FDA states that no person shall sell a cosmetic that has in it any substance that may injure the health of the user when the cosmetic is used according to its customary method. Completion of the cosmetic notification and submission to Health Canada does not constitute approval for sale by Health Canada, or agreement that the product is in compliance with all regulatory requirements.

Q6. What are the microbiological limits in cosmetics in Canada?

A6: Section 16 of the FDA prohibits the sale of cosmetics that are manufactured, prepared, preserved, packaged or stored under unsanitary conditions, that may cause injury to the health of the user, or that consist of any filthy or decomposed substance or any foreign matter. Section 18 of the FDA prohibits the acts of manufacturing, preparing, preserving, packaging and storing a cosmetic under unsanitary conditions with the intention of sale. Under the FDA, "unsanitary" means: "such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food, drug or cosmetic."

Regarding microbiological limits, Health Canada encourages all cosmetic manufacturers to follow the limits and methods outlined in the International Standards Organization (ISO) Standard on Cosmetics – Microbiology – Microbiological limits, ISO 17516:2014. Health Canada, along with its regulatory partners of the International Cooperation on Cosmetics Regulation (ICCR), endorsed ISO 17516:2014 in Summer 2016. More information is available at the following links:

ICCR report: https://www.iccr-cosmetics.org/topics-documents/7-microbiology
ISO 17516:2014 - Cosmetic Microbiological Limits: https://www.iso.org/standard/59938.html

Q7. What are the classification of a toothpaste containing olaflur?

A7: NNHPD has considered the product information provided with the request; however, there isn’t sufficient information provided to confirm the product classification.

In order to be classified as a natural health product (NHP), a product must meet the substance and function aspects of the definition of an NHP as outlined in Section 1(1) of the Natural Health Products Regulations (NHPR), which means it needs to contain ingredients set out in Schedule 1 of the NHPR and be represented for therapeutic use.

Products at the cosmetic interface but marketed for therapeutic use may be considered NHPs or drugs. The ASC Guidelines list claims that are considered to be therapeutic/health claims and non-therapeutic claims. In order to be considered an NHP, the medicinal ingredients in the product must be set out in Schedule 1 to the NHPR.

As per the Natural Health Products Ingredient Database, olaflur is an acceptable medicinal ingredient in accordance with the NHPR, and therefore meets the substance aspect of the NHP definition as outlined in the NHPR. The full ingredient list would be required to confirm the product meets the substance aspect of the NHP definition.

Furthermore, the recommended use(s) or purpose(s) associated with the product were not provided in order to determine if the product is represented for therapeutic use and meets the function aspect of the definition of an NHP as per the NHPR.

If the product is represented for therapeutic use and all of the ingredients are in accordance with the NHPR, the product maybe an NHP.

If the product is not represented for therapeutic use, you may refer to the Cosmetics Program website for more information on the process and requirements for cosmetics (https://www.canada.ca/en/health-canada/services/cosmetics.html). Questions may be directed to [email protected]. Please note that the Cosmetic Ingredients Hotlist mentioned above includes restrictions and prohibitions for certain cosmetic ingredients.

Products at the cosmetic-NHP/drug interface

The following documents provide information on distinguishing a cosmetic product from a therapeutic product:

Q8. What are the requirements for natural health products (NHP)?

A8: If the product is represented for therapeutic use and meets the definition of an NHP (in both substance and function), please refer to the following information:

To be sold in Canada, natural health products (NHPs) must under-go pre-market review to ensure that they meet the requirements of the Natural Health Products Regulations (NHPR) pertaining to the safety, efficacy and quality of products.

Ensure all the medicinal and non-medicinal ingredients in the product are present and acceptable in the Natural Health Products Ingredient Database (NHPID).

If an ingredient is not in the NHPID, please submit an NHPID Issue Form, which captures the details necessary to make a timely and accurate decision regarding requests for changes to the database. Please refer to the NHPID Issues Form Guide for any further assistance in completing the form.

Site Licence

A site licence is required to manufacture, package, label or import natural health products for sale in Canada. If the site for the manufacturing, labelling, packaging and importing is already known has an NHP site licence, include it in the PLA form. Note that a separate submission is required to obtain a site licence; a site licence is required before commencing activities. The Site Licensing guidance document outlines the way in which SLAs for NHPs are submitted in accordance with the NHPR and performance targets for all types of site licence applications.

Links to supporting documents can be found at:

Product Licence

The Natural Health Products Management of Applications Policy (NHP MAP) outlines the way in which PLAs for NHPs are submitted in accordance with the NHPR; responsibilities and expectations for NHP applicants before and throughout the application review process; and performance targets for all types of product licence applications.

Links to supporting documents can be found at:

Following a review of all relevant regulations, guidance and tools, if you are unsure if a product is an NHP, please contact Health Canada including a rationale for why the product would be considered an NHP. Please also clearly indicate the area of confusion related to the classification of the product.

A product classification request should include your assessment of the product classification. If not provided earlier, the following information for each product is required:

name of the product, route of administration, and subpopulation(s);
complete lists of medicinal and non-medicinal ingredients, with their quantity per dosage unit or concentration;
the recommended use(s) or purpose(s) associated with the product;
any other relevant conditions of use (if available), such as duration of use, directions of use, and risk information;
dosage form or product format (e.g. beverage, powder, bar, cream, capsule, etc.);
the product label (if available) or proposed label text;
information on the product placement of sale (if available); and
product website (if available)