Canada Cosmetic Regulations

Canada Cosmetic Regulations - Comprehensive Guide

Understanding Canada Cosmetic Regulations

All cosmetics sold in Canada must comply with the Food and Drugs Act and Cosmetic Regulations, ensuring they are safe and manufactured under sanitary conditions. Importers must notify Health Canada and provide a list of ingredients. Additionally, products must meet the requirements of the Consumer Packaging and Labelling Act and the Canadian Environmental Protection Act

Cosmetic Regulations Quebec language

Importance of the French language

Cosmetic labels in Quebec must be available in both English and French, with equal prominence to comply with local regulations.

Canada Cosmetic Regulations

Cosmetics and Natural Health Products

  • Cosmetics include substances for cleansing, improving, or altering appearance, and cover professional and handmade products.
  • Natural Health Products (NHPs) are naturally occurring substances used to maintain health, including vitamins, herbal remedies, and traditional medicines.

BIORIUS assists with:

  1. Formula Review: Toxicological assessment and INCI list creation.
  2. Label & Claims Review: Ensuring compliance with labeling requirements.
  3. Notification to Health Canada: Submission of product details to obtain registration numbers.

For Natural Health Products, the process is similar but includes the creation or review of Drug Facts and notification requirements specific to Canada.

Regulatory Process by Biorius

1. Cosmetics

BIORIUS can register cosmetics products in Canada from start to finish. The regulatory process consists of a formula review, a label, and claims review and notification to Health Canada.

Formula Review

A toxicological and regulatory assessment of ingredients and impurities, and establishment of the INCI list and warnings.

A Formula Review report is issued, which highlights the following elements:

  1. Ingredients
  2. Percentages of each ingredient
  3. Restrictions
  4. Margins of Safety
  5. Expert comments – Missing documents, amendments needed
  6. INCI list and warnings/directions for use

Label & Claims Review

Evaluation of the product label (ingredients list, symbols, legal requirements, etc.) and claims substantiation.

Strategic recommendations are provided for updating the label.

The labels and claims review consists in the form of a report with all the information that needs to appear on the labeling material:

  1. Required elements
  2. Presence of required elements (primary packaging, secondary packaging & leaflet)
  3. Conclusion on each claim
  4. Expert comments – amendments needed

Notification to Health Canada

Product notification to Health Canada, the federation that manages the regulation of various types of products, such as food and cosmetics.

This notification is required in order to sell cosmetic products in Canada.

Our experts submit a file containing all ingredients and their percentages to Health Canada. BIORIUS then receives two temporary registration numbers.

These numbers are sufficient for selling products in Canada.

Health Canada then checks the submission and comes back to BIORIUS with any questions. The final registration number is then received between two and six months.

When notifying the products, BIORIUS becomes the contact person for Health Canada. As such, our experts can ensure follow-up on the products and relay any important information to the cosmetics brand.

2. Natural Health Products

Canada distinguishes between cosmetic products and natural health products.

BIORIUS can assess the following categories of NHP’s:

  • Acne Therapy
  • Anti-dandruff Products
  • Antioxidants
  • Corn & Callus Removers
  • Sunscreen Products

The regulatory process consists of a formula review, a label review and the NHP notification.

  1. Formula Review: see above for cosmetics – same process
  2. Label Review: see above for cosmetics + drafting or review of Drug Facts
  3. Notification: BIORIUS is unable to notify natural health products since the notification party must be established within the Canadian territory.

Drug Facts is a labeling format that includes important information for non-prescription drugs and natural health products.

Get in Touch

Need a piece of advice, a quotation or answers to your questions? Contact us…

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As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

  • First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
  • 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
  • A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
  • No hidden costs: Biorius does not charge you for any question, call, or meeting.
  • A best-in-class IT tool, free of charge, and saving a lot of your time.
  • More than 1,500 international clients have already chosen Biorius!
  • We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.

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