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Health Canada Cosmetic Regulations and Registration Process

Health Canada Cosmetic Regulations in Canada

Cosmetic regulations in Canada are laid out under the Food & Drugs Act and the Cosmetic Regulations by Health Canada. It says all these products sold must be safe and risk-free for human use in the region. There may be other legislation, but a Cosmetic Notification Form (CNF), Health Canada’s Cosmetic Ingredient Hotlist, and label standards are mandatory to follow.

Incorrectly classified products or claims that fail to meet standards may lead to delays in importation, enforcement measures, or product removal from the market. So, if you’re looking to avoid these problems, read this guide outlining the legal conditions and processes.

Regulatory Authority for Cosmetic Regulations in Canada

Cosmetics are regulated by Health Canada under the following:

  • Food and Drugs Act (FDA)
  • Cosmetic Regulations
  • Other legislation, such as the Consumer Packaging and Labeling Act (CPLA), the Canadian Environmental Protection Act, 1999 (CEPA), and the Cannabis Act (if applicable)

It requires that products sold in the country should be manufactured, formulated, preserved, packed, and kept in sanitary conditions. The manufacturers and importers of such products must offer a list of the ingredients and notify Health Canada about selling them

Cosmetics Classification in Canada

The FDA in Canada classifies cosmetics as “Any substance or mixture of substances manufactured, sold, or represented for use in cleansing, improving, or altering the complexion, skin, hair, or teeth, including deodorants and perfumes.”

This includes:

  • Cosmetics for professional services
  • Bulk supplies (hand soap) in school restrooms
  • “Handmade” cosmetics made by people who sell these products from home or at craft sales

Cosmetics vs Drugs: Claims Matter

Canada distinguishes cosmetics from drugs and natural health products by looking at a product’s composition and how it is represented for sale. Claims can therefore change the regulatory pathway. Health Canada explains that words, sentences, pictures, symbols, or implications via labels, package inserts, and ads can be a way of expressing claims.

Products around the cosmetic-drug boundary can include the following:

  • Anti-dandruff shampoos
  • Antiperspirants
  • Skin whiteners
  • Sunburn protectants

So, if a product’s ingredients or regulatory claims move it into another category, cosmetics won’t be the only regulatory body managing it.

Takeaway: So, ensuring such compliance requires establishing the product classification before finalizing claims, labels, and market-entry papers.

Compliance Requirements for Cosmetics in Canada

Checking only Canada’s cosmetic regulations isn’t enough. The below-mentioned information is also a must-check:

1. Cosmetic Notification Form

Canada requires notification, but a Cosmetic Notification Form is not the same thing as pre-market approval. Under section 30 of the Cosmetic Regulations, manufacturers and importers must notify Health Canada within 10 days after the product is first sold in Canada. This form provides Health Canada with the following information:

Information What Health Canada Requires
Product Brand and product name
Product type Leave-on or rinse-off
Use Area of application and function
Format Cream, powder, gel, etc.
Formula Cosmetic ingredients
Concentration Concentration of each ingredient
Business information Manufacturer/importer information
Contact
Label and notifier contact information

2. Ingredient Requirements

Before launching, the complete formulation should be reviewed against Canada’s Cosmetic Ingredient Hotlist. It is Health Canada’s administrative tool for communicating information about substances that may be prohibited or restricted in cosmetics under the Food and Drugs Act and Cosmetic Regulations. It separates substances into the following two groups:

  • Prohibited Ingredients: Should not be there as intentionally added cosmetic ingredients in products sold in Canada.
  • Restricted Ingredients: Only to be used when the particular conditions are satisfied, like concentration, type of the product, use terms, or required cautionary statements.

A critical point for formulators is that the Hotlist is not exhaustive. If an ingredient is absent from the list, does not automatically make it safe or acceptable. The manufacturer or importer has to ensure the finished product meets the set requirements.

Health Canada periodically updates the Hotlist. For example, the current cosmetic ingredient hotlist shows changes made in February 2025. It added retinal as a restricted substance and thioglycolic acid esters as prohibited. August 2025 saw further amendments with changes in cannabis and some hemp derivatives.

That makes regulatory monitoring important even for products that have already entered Canada.

3. New Fragrance Allergen Rules

Brands that sell fragranced skincare, haircare, perfumes, body products, and related formulations should pay close attention to Canada’s newer fragrance-allergen disclosure rules. Starting April 12, 2026, 24 specified fragrance allergens must be individually disclosed in the ingredient list when present above the following:

  • 0.001% in leave-on cosmetics
  • 0.01% in rinse-off cosmetics

When the given threshold is exceeded, put the same information in the Cosmetic Notification Form. Further, the disclosure framework expands to 81 fragrance allergens from August 1, 2026. Existing cosmetics can only comply with the expanded list until August 1, 2028, when those allergens exceed the given limits. This brings Canada’s approach closer to the European Union’s fragrance-allergen disclosure system.

Companies should obtain detailed fragrance composition information from fragrance houses and suppliers rather than assuming that declaring only “parfum” will remain sufficient. For affected products, brands may need to reassess the following:

Supplier Documentation → Allergen Concentrations → Artwork → Ingredient List → CNF Information

4. Labeling Requirements

Packaging that works in the United States or another international market should not automatically be reused for Canada. For applicable prepackaged consumer products, the Consumer Packaging and Labeling Act and Regulations apply.

Core information can include the following:

A. Product Identity

The product should be understandable to the consumer. So, make applicable prepackaged cosmetics appear in English and French.

B. Net Quantity

Net quantity must be declared in metric units and is subject to bilingual requirements.

C. Ingredient List

The International Nomenclature of Cosmetic Ingredients (INCI) system identifies them.

D. Dealer Information

The identity and principal place of business of the dealer must be provided as required by applicable packaging legislation.

E. Warnings and Directions

Where a product presents an avoidable hazard, appropriate directions, warnings, or cautionary information may be necessary. If some restricted ingredients are present, they can also trigger specific label statements. When such labeling requirements apply, copies of labels and inserts may need to accompany the CNF.

F. Consumer Contact Information

Canadian labels also need contact information through which consumers can direct product-related questions, such as a telephone number, email, website, or postal address

5. Cosmetic Safety is the Company’s Responsibility

Canadian cosmetic regulation places significant responsibility on industry. Section 16 of the Food and Drugs Act prohibits the sale of a cosmetic containing a substance that may cause injury when used according to its directions or customary method. Such products must also not consist of filthy or decomposed substances or foreign matter.

Notification does not transfer responsibility for safety to Health Canada. Manufacturers and importers need appropriate evidence and controls to support the safety of their products. Health Canada also operates post-market surveillance. Complaints from consumers and industry can be investigated, and products may be assessed for compliance after reaching the marketplace.

6. Good Manufacturing Practices for Cosmetics

Health Canada encourages cosmetic manufacturers to follow Good Manufacturing Practices (GMPs). It also endorses ISO 22716 guidance with its international regulatory partners.

A practical GMP system should address areas such as the following:

  • Facilities And Hygiene
  • Equipment Maintenance
  • Personnel Training And Cleanliness
  • Raw-Material Handling
  • Written Manufacturing Procedures
  • Laboratory Controls
  • Finished-Product Testing
  • Manufacturing And Distribution Records
  • Compliant Labels
  • Consumer Complaint Handling

Brands using contract manufacturers find this supplier qualification particularly important. Outsourcing manufacturing does not make product quality irrelevant to the company placing the cosmetic on the Canadian market.

7. Heavy Metal Impurities in Beauty Products

Lead, arsenic, cadmium, mercury, and antimony-like heavy metals can enter cosmetics unintentionally through pigments, minerals, raw materials, or environmental contamination. Health Canada offers guidance and provides the following concentrations, as levels above these impurities are considered technically avoidable:

Heavy Metal Health Canada Guideline
Lead 10 ppm
Arsenic 3 ppm
Cadmium 3 ppm
Mercury 1 ppm
Antimony 5 ppm

The manufacturers must ensure that the finished cosmetics contain as few heavy-metal impurities as possible and do not exceed these levels.

Important: The Hotlist principally addresses intentionally added substances. However, unavoidable trace impurities and contaminants are managed through the broader safety framework and relevant guidance.

8. Canada’s Cosmetic Animal-Testing Ban

Canada’s cosmetic regulatory landscape changed significantly on December 22, 2023, when its cosmetic animal-testing prohibitions took effect. The framework covers products manufactured domestically as well as those imported into Canada. Broadly, the law now prohibits:

  • Cosmetic testing on animals in Canada where the specified testing is intended to satisfy such requirements under Canadian law or safety requirements of another country.
  • Selling cosmetics where safety cannot be established without relying on prohibited animal-testing data, subject to statutory exceptions.
  • A business that states that its cosmetic product was not tested on animals should have evidence to back this claim.

9. Documents Required for Cosmetic Compliance in Canada

The following documents and information should be kept by the manufacturer/importer:

  • Cosmetic Notification Form (CNF)
  • Fill in ingredients in full using INCI names
  • Use the proper product and concentration in the product
  • Bilingual product labels/artwork
  • Information about the manufacturer and importer
  • Information about the functions and usage of a product
  • Warning statements required (if applicable)
  • Provide safety or toxicological information
  • Records for compliance with the Cosmetic Ingredient Hotlist for ingredients

Health Canada may ask for more product information, labels, or safety data during compliance review and/or post-market investigation.

Cosmetic Registration Process in Canada

The structured CNF process follows the steps mentioned below:

Step 1: Validate Product Classification

Prior to submitting a CNF to identify if the product is a regulated cosmetic, drug, or natural health product, companies should be aware of the claims, intended use, and formulation of their product.

Step 2: Review Ingredients

All ingredients should be evaluated for prohibited, restricted, or concentration limits and/or warning statements prior to completing the formulation or artwork using the Health Canada Cosmetic Ingredient Hotlist.

Step 3: Make Compliant Product Labels

The FDA and CPLA require bilingual labeling with product name, net contents, dealer information, ingredient statements, and warnings (in English and French).

Step 4: Review & Compile Documents & Product Information

The formulation, ingredient concentrations, manufacturer or importer information, label artwork, and supporting safety information for the CNF submission and compliance verification should be developed by the manufacturer or importer.

Step 5: Submit the Cosmetic Notification Form (CNF)

There are several types of notifications to be submitted within the first 10 days, like the following:

  • New notifications
  • Amendments
  • Discontinued sale notifications

The last two should have the assigned cosmetic number.

Step 6: Ensure Post-Market Compliance

Once commercialized, companies will have to keep updated notifications and ensure continuous compliance with the ingredient, labeling, and safety rules. Non-compliant claims, safety issues, or consumer complaints can be raised after market entry, with the possibility of investigation.

Timeline for Cosmetic Market Entry in Canada

The process and time to get into the market depend on the following:

Activity Estimated Timeline
The classification and evaluation of ingredients in products 1–2 weeks
Cosmetic Ingredient Hotlist review 3–7 business days
Adaptation of labels and artwork (bilingual) 1–3 weeks
Completed and submitted CNF and supporting documents 3–7 business days
Cosmetic Notification Form (CNF) submission Within 10 days after the first sale in Canada
Requests for follow-up and/or clarification by Health Canada 2–6 weeks

If ingredient disclosure is incomplete, claims are non-adhering, or labeling is wrong, it can slow down the process or result in compliance action.

Conclusion

Health Canada’s cosmetic regulations and FDA laws are a must-follow if manufacturers & importers want to sell cosmetics in the country. Avoiding labeling problems, reformulation delays, and import-related compliance actions when entering the market is possible by early initiation of the compliance process.

Artixio provides cosmetic compliance consulting and legal representative services, CNF submission, ingredient review, and bilingual labeling services for cosmetic companies to help them get products to the Canadian market. Contact Artixio for regulatory assistance: info@artixio.com.

FAQs

Can I sell handmade cosmetics in Canada?

Handmade status does not exempt a product from Canada’s cosmetic framework. Health Canada specifically includes handmade products sold through home-based businesses or craft sales within the types of products captured by the cosmetic definition.

Does a cosmetic label have to be bilingual in Canada?

Key mandatory information for applicable prepackaged cosmetics is subject to English/French requirements. For example, the CPLA framework requires product identity and net quantity information in both English and French. Companies should assess the complete label against both the Cosmetic Regulations and applicable packaging legislation rather than simply translating the front panel.

Are fragrance ingredients required to be disclosed individually?

24 specified fragrance allergens require disclosure above prescribed leave-on and rinse-off thresholds. For new cosmetics, the list expands to 81 allergens, with the expanded requirement applying to existing cosmetics.

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