Comprehensive Guide to Canada Cosmetics Regulation

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Canada Cosmetics Regulation

Are You Planning to Sell Your Cosmetics in Canada ?

Canada presents a lucrative opportunity for cosmetic brands, but its strong regulatory framework can make entering the market seem daunting.

Biorius is here to guide you every step of the way. From formula review to official notifications and serving as your Responsible Person, we provide the expertise needed to turn your projects into reality with confidence.

Compliance with Canada's Cosmetics Regulations

To sell cosmetics in Canada, products must adhere to the Food and Drugs Act and Cosmetic Regulations, which mandate that all cosmetics are safe and produced under sanitary conditions. Importers and manufacturers must notify Health Canada with a detailed list of ingredients. Additionally, products must comply with the Consumer Packaging and Labelling Act, as well as the Canadian Environmental Protection Act, ensuring both transparency and environmental responsibility. In Quebec, labels must also comply with the “Charte de la langue française,” requiring both English and French to be equally prominent.

Navigating these regulations is essential for brands looking to succeed in the Canadian market.

Biorius: Experts in Canada Cosmetics Safety Assessment.

With over 15 years of expertise in cosmetic safety assessments and regulatory compliance, Biorius offers a trusted, turnkey solution for navigating Canada’s cosmetic regulations. Our solution leverages a deep understanding of Canadian legislation and is backed by a team of more than 50 scientific consultants, along with advanced IT tools.

This comprehensive approach ensures the fastest and most reliable path to getting your cosmetic products approved and available in the Canadian market.

4 Steps to Achieve Canada Cosmetics Compliance

Formula Review

Labels & Claims Review

Health Canada Notification

Legal Representation

Step 1: Formula Review

The initial step involves a toxicological and regulatory assessment of the ingredients and impurities, along with the creation of the INCI list and any necessary warnings.

A Formula Review report is then generated, highlighting the following elements:

A Formula Review can also be performed on its own, outside of our Canada registration. Discover our Cosmetic Formula review service.

Step 2: Ensuring Accurate Labels & Claims

The evaluation process includes a thorough review of the product label, covering the ingredient list, symbols, legal requirements, and claims substantiation.

Strategic recommendations are provided to update and improve the label.

The labels and claims review is presented in a detailed report, outlining all necessary information for the labeling materials, including:

For products classified as NHPs or non-prescription drugs, Biorius manages the drafting of the required Drug Facts for the label. If the Drug Facts already exist, we perform a comprehensive review to ensure full compliance.

Step 3: Notification to Health Canada

Product notification to Health Canada, the authority responsible for regulating various products, including food and cosmetics, is required before selling cosmetic products in Canada.

Our experts handle the submission process by providing Health Canada with a file that includes a full list of ingredients and their percentages. Upon submission, Biorius receives two temporary registration numbers, which are sufficient to begin selling products in Canada.

Health Canada then reviews the submission and may reach out to Biorius with any questions. The final registration number is typically issued within two to six months.

As part of the notification process, Biorius acts as the designated Contact Person or Responsible Person for Health Canada. This allows our team to monitor the products and communicate any important updates to your cosmetic brand.

For the previously mentioned NHP or non-prescription drug products, Biorius is unable to perform the notification due to specific requirements.

Step 4: Legal Representation in Canada

Appointing a Responsible Person with a Canadian office is a legal necessity. This individual or company acts as the Canadian manufacturer or importer on your behalf, ensuring your brand meets all regulatory and safety standards.

As your designated Responsible Person, we will:

Represent your brand to Canadian regulatory authorities
Provide guidance on legal matters related to Canadian cosmetic laws and regulations
Manage customer concerns and complaints professionally
Conduct ongoing monitoring of regulatory changes to ensure your brand remains compliant
Take responsibility for any potential adverse effects from your products

With our name and address on your product labels, Biorius becomes the point of contact for authorities and consumers, ensuring smooth operations and compliance in the Canadian market.

Differences Between Cosmetic Products, Natural Health Products (NHPs), and Non-prescription Drugs

Cosmetic products encompass any substance or mixture of substances manufactured, sold, or marketed for use in cleansing, enhancing, or altering the appearance of the complexion, skin, hair, or teeth. This category also includes deodorants and perfumes.
Natural Health Products (NHPs) are naturally occurring substances used to restore or maintain good health. While they are often derived from plants, they can also be sourced from animals, microorganisms, and marine sources.
Category IV Drugs, or non-prescription drugs, are products with a well-established safety and efficacy profile when used under specific conditions. They are similar to over-the-counter (OTC) products in the USA.

For products classified as either NHPs or drugs, Biorius is here to assist you with the following categories:

These products require an additional labeling component known as Drug Facts. Biorius can help draft these Drug Facts based on your product’s formula or review existing information.

However, please note that the final step of the notification process to Health Canada for these products must be completed independently.