Cosmetics Compliance – Canada

Regulatory Context

All cosmetics sold in Canada must be safe for use and must not pose any health risks. They must meet the requirements of the Food and Drugs Act and the Cosmetic Regulations. The Food and Drugs Act and the Cosmetic Regulations require that cosmetics sold in Canada be manufactured, prepared, preserved, packaged and stored under sanitary conditions.

The manufacturer and importer must notify Health Canada that it is selling the product and provide a list of the product’s ingredients. Additionally, cosmetics are subject to the requirements of the Consumer Packaging and Labelling Act and Regulations, and any chemicals found in cosmetics may be subject to the Canadian Environmental Protection Act.

Importance of the French language

Canada has two official languages: English and French. With French being spoken mainly in Quebec, this province, recognized as a nation within Canada, requires that cosmetic labels are made available in French and must have the same impact as English (for example, the French text needs to appear in the same size as the English text). This is an important rule which applies to all cosmetic products sold in Quebec.

BIORIUS can cover both cosmetic products and natural health products and helps cosmetics companies with the regulatory process.

Cosmetics and Natural Health Products

Under the Food and Drugs Act, a cosmetic includes “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.”  This includes cosmetics used by professional esthetic services, bulk institutional products (such as hand soap in schools) and “handmade” cosmetics sold at craft sales or home-based businesses.

Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as “naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops.”

E.g.: Vitamins, herbal remedies, homeopathic medicines, probiotics, medicines such as traditional Chinese and Ayurvedic (East Indian) medicines and other products such as amino acids and essential fatty acids.

How does it work?

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.

Contact

Avenue Leonard de Vinci, 14
1300 Wavre, Belgium

+32 2 888 40 10
+44 20 3866 1208

info@biorius.com

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