Canada cosmetics regulation: how to sell skincare legally in Canada

The law and who regulates it

Cosmetics in Canada are governed by four texts, and Health Canada's Consumer Product Safety Program runs the cosmetics side:

• Food and Drugs Act. Defines a cosmetic as any substance or mixture manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, including deodorants and perfumes. Section 16 bans selling a cosmetic that may cause injury to health when used as intended.
• Cosmetic Regulations (C.R.C., c. 869). Labeling, the ingredient list, specific warnings, and notification (sections 30 and 31).
• Consumer Packaging and Labelling Act and Regulations. Bilingual product identity, net quantity in metric units and the dealer's name and place of business. False or misleading claims on cosmetics are offenses under section 7 of the Act.
• Cosmetic Ingredient Hotlist. Health Canada's administrative list of prohibited and restricted ingredients, linked to section 16 of the Act and the Regulations.

Products that make therapeutic claims fall under the Food and Drug Regulations (drugs) or the Natural Health Products Regulations, managed by other parts of Health Canada.

Who is legally responsible

Canada does not use a "Responsible Person" title. The duties sit with the manufacturer and the importer, defined in the Cosmetic Regulations as the person who imports a cosmetic into Canada for the purpose of selling it, and with the dealer named on the label.

A Korean-made serum bought by a Canadian company for resale has that company as importer, and it must make sure the CNF is filed. Health Canada can stop the sale of a cosmetic that has not been notified, has no required revised notification, or whose notifier did not answer an information request (section 15.3).

Cosmetic, drug or natural health product

Health Canada's guidance on the cosmetic-drug interface classifies a product by two factors: how it is represented for sale (claims on the name, label, inserts, ads and websites) and its composition. A drug includes anything represented for treating, mitigating or preventing a disease or abnormal physical state, or for restoring, correcting or modifying organic functions. A natural health product (NHP) is the subset of drugs whose medicinal ingredients are natural substances listed in Schedule 1 of the Natural Health Products Regulations.

Classification decisions apply to all products, whatever their past status. A brand that writes "heals eczema" on its website can have a cosmetic reclassified. When a CNF shows therapeutic claims or ingredients that change the class, Health Canada redirects the notifier to the drug or NHP program. Our cosmetic vs drug claims guide and the sunscreen regulation guide go deeper.

Step by step: from formula to legal sale

The example is a hyaluronic acid and ceramide cream made in Korea, sold online across Canada and through a Toronto spa.

1. Set up the Canadian importer

   A Canadian business with a CRA business number and an import-export account. If you are a foreign brand, you work with a Canadian importer or distributor, who becomes the importer under the Regulations. Setup steps are in our Canada launch guide.

2. Confirm it is a cosmetic

   Read every claim in the name, label, inserts, website and social posts against the cosmetic-drug interface guidance.

3. Screen the formula against the Hotlist

   Check every ingredient against both Hotlist tables and any specific rules in the Cosmetic Regulations. For restricted ingredients, record the exact concentration.

4. Check the fragrance allergens

   Get an allergen declaration from the fragrance supplier and calculate the level of each allergen in the finished product.

5. Write the bilingual label

   Identity, warnings and directions in English and French; INCI list; metric net quantity; dealer name and place of business; a consumer contact. Approve a proof before print.

6. Produce and import

   The importer clears the goods with the CBSA. Keep the commercial invoice and origin documents for the duty rate.

7. File the CNF within 10 days of first sale

   Online through Health Canada's notification service. There is no fee. Save the confirmation and any number Health Canada assigns to the notification.

8. Keep it current

   A new formula, a name change, a new address or a discontinued product means a revised CNF within 10 days.

The Cosmetic Notification Form in depth

Section 30 of the Cosmetic Regulations requires each manufacturer and importer to give the Minister, at the latest 10 days after first selling the cosmetic, a notification stating whether they intend to continue sales in Canada, with:

• the contact information shown on the inner label;
• the name under which the cosmetic is sold;
• its function, including whether it is a leave-on or rinse-off product;
• every ingredient by INCI name (or chemical name if there is none), each with its exact concentration or the concentration range code set by the regulations;
• the name and address of the manufacturer and importer;
• copies of the labels when they must carry the specific warnings of sections 22 to 24.

Health Canada's notification guide adds the form of the product (cream, gel, powder) and the area of application. Its list of common problems is worth reading before you file: an ingredient on the Hotlist, therapeutic claims in the name, label or website, ingredients that affect classification, and wrong concentration math. Concentrations are each ingredient's share of the total formula, in the same units, so a 75 g batch containing 60 g of ingredient X has X at 80.00%.

Kits and multi-component products. A kit whose parts are mixed before use is notified on one CNF with the ingredient list of the mixed product.

Revisions. Section 31 requires a revised notification within 10 days after any information becomes inaccurate, including when the product is no longer sold in Canada. If it is not revised in time, the cosmetic cannot be sold.

The Cosmetic Ingredient Hotlist

The Hotlist is Health Canada's tool for telling industry which substances may be prohibited or restricted in cosmetics. It has two tables:

• Prohibited ingredients, including their synonyms, salts and related compounds, should not be present in cosmetics sold in Canada.
• Restricted ingredients are allowed only when the listed conditions of use, concentration limits or cautionary statements are met. Limits are read to 3 significant figures.

The Hotlist covers intentionally added substances, not trace impurities such as heavy metals. It is updated when new science or international decisions justify it: Health Canada posts a notice to stakeholders about 3 months before it consults on proposed changes. The page we checked was dated March 31, 2026. Because Canada's list differs from the EU annexes, check every Korean ingredient against the Hotlist itself rather than assuming EU compliance carries over.

Bilingual labeling summary

Health Canada lists what a cosmetic label must show:

• an ingredient list using INCI names;
• the product identity in English and French;
• net quantity in metric units;
• contact information for consumer questions;
• the dealer's identity and principal place of business, often "Imported by / Importé par" with the Canadian importer;
• warnings or cautions in English and French;
• directions for safe use in English and French according to provincial requirements.

Quebec's Charter of the French Language adds its own rules for product inscriptions; check the Office québécois de la langue française guidance if you sell there. Full label details and examples are in our label requirements by country. Our label proof check covers English and French text before printing.

The 2024 amendments and fragrance allergens

The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (SOR/2024-63) were registered on April 12, 2024. Most provisions came into force 180 days later, in October 2024; the fragrance allergen section came into force on the second anniversary, April 12, 2026.

• Notification changes. The CNF now asks for leave-on or rinse-off status and the label contact, uses concentration range codes set in the regulations, and must be revised within 10 days of any change.
• Ingredient names. The ICI Dictionary reference was replaced by INCI names, and certain EU technical names (such as "Aqua") are allowed with their INCI name and French equivalent listed in a schedule.
• Fragrance allergens. A fragrance allergen is defined by reference to the EU Annex III entries that must be named in the ingredient list. It must be listed when above 0.01% in rinse-off or 0.001% in leave-on products. The words "parfum" and "aroma" can still cover other fragrance and flavor ingredients.

Allergens present above the thresholds must also be shown on the CNF. Because Canada follows the EU list, a formula and ingredient list built for the EU usually works here too. The EU side is explained in our EU cosmetics regulation guide.

Safety evidence and claims

Section 16 of the Food and Drugs Act bans selling a cosmetic that may cause injury under normal use, and Health Canada can ask for evidence that a cosmetic is safe. Canada has no CPSR-style document in law, but a manufacturer or importer should hold a safety file: formula and INCI list, ingredient safety data, stability, challenge test, microbiology results per batch and any skin tests. Our product testing guide explains each test.

Claims must not be false or misleading (CPLA section 7 and the Competition Act), and claims that stray into treatment change the product's class. "Hydrates for 24 hours" is cosmetic if you can support it; "repairs damaged skin cells" invites a drug review. See our claims guide.

Complaints, incidents and recalls

Unlike the US and EU, Canada has no mandatory incident reporting for cosmetics under the Food and Drugs Act or the Cosmetic Regulations. Health Canada says industry reports are voluntary, but it encourages companies to report incidents, and recommends a report for a cosmetic that has caused harm. The mandatory reporting duties of section 14 of the Canada Consumer Product Safety Act apply to consumer products, not to cosmetics.

In practice, keep a complaint log, investigate every reaction, report harmful incidents to Health Canada through its incident report form, and work with Health Canada on any recall. Health Canada can refuse entry at the border and remove products from sale. Our recalls and adverse events guide has a template plan.

Importing through the CBSA

The CBSA, Canada's border service, releases imported goods. The importer needs a business number with an import-export program account, usually uses a licensed customs broker, and declares the goods under tariff heading 3304 for most skincare. Goods that qualify as Korean origin under the Canada-Korea Free Trade Agreement can use its preferential rate with the right origin documents; GST or HST is charged at import. Duty rates, the business number and costs are covered in our Canada launch guide and guide to importing skincare from Korea. A product without a valid CNF can be denied entry.

What the importer does and what we provide

Frequently asked questions

Do cosmetics need Health Canada approval?

No. Health Canada does not approve cosmetics before sale. Each manufacturer and importer must file a Cosmetic Notification Form at the latest 10 days after first selling the product, and the product must be safe and correctly labeled.

How much does a Cosmetic Notification Form cost?

Health Canada charges no fee for a cosmetic notification. If you want it filed for you, KoreanOEM files the CNF for about USD 450 per product.

Who files the CNF when skincare is made in Korea?

The law puts the duty on every manufacturer and importer that sells the product in Canada, so the Canadian importer must make sure a CNF is filed within 10 days of first sale. The filing needs the full ingredient list with concentrations, which the manufacturer supplies.

What happens if I change the formula after notifying?

You must file a revised notification within 10 days after the information becomes inaccurate, under section 31 of the Cosmetic Regulations. If you do not, the cosmetic cannot be sold.

Do Canadian cosmetic labels have to be in French?

Yes. The product identity, warnings and directions must be in English and French, and the net quantity must be in metric units. The ingredient list uses INCI names, which do not need translation.

What changed for fragrance allergens in Canada in 2026?

Since April 12, 2026, cosmetics must name the 24 historic fragrance allergens above 0.001% in leave-on or 0.01% in rinse-off products. New cosmetics must name the expanded EU list from August 1, 2026, and all cosmetics by August 1, 2028.

Is sunscreen a cosmetic in Canada?

No. A sunscreen is a natural health product with an NPN if its only filters are zinc oxide or titanium dioxide, and a nonprescription drug with a DIN if it contains chemical filters. Either way it needs a product license before sale.

Do I have to report adverse reactions to Health Canada?

Reporting cosmetic incidents is voluntary under the Food and Drugs Act and Cosmetic Regulations, but Health Canada encourages it and recommends a report when a cosmetic has caused harm. Keep a complaint log either way.

Sources

• Justice Laws: Cosmetic Regulations, C.R.C., c. 869 (sections 2, 15.3, 20, 21 to 24, 30, 31)
• Canada Gazette Part II: SOR/2024-63, Disclosure of Cosmetic Ingredients (registered April 12, 2024)
• Health Canada: Notification of cosmetics and Common issues when submitting a notification
• Health Canada: Cosmetic Ingredient Hotlist, prohibited and restricted ingredients
• Health Canada: Labelling of cosmetics and Industry Guide for the labelling of cosmetics (allergen lists and dates)
• Health Canada: Classification of products at the cosmetic-drug interface
• Health Canada: Sunscreens (DIN and NPN)
• Health Canada: Report an incident involving a consumer product or cosmetic, industry
• CBSA: Step-by-step guide to importing commercial goods and OQLF: French on products in Quebec

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.