Business

Canada Updates Cosmetic Regulations

May. 10 2024

The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients: SOR/2024-63 were recently published in the Canada Gazette, Part II. The amended Regulations include many changes to the Cosmetic Regulations including updated and new definitions, fragrance allergen disclosure requirements, updated cosmetic notification requirements, and changes to many EU Trivial Names and their French and English equivalents found in the Schedule.

Definitions

The following definitions were added to the Cosmetic Regulations:

  • Importer: Means a person who imports a cosmetic into Canada for the purpose of selling it.
  • Leave-on product: Means any cosmetic that is intended to stay in prolonged contact with the skin, hair or mucous membranes.
  • Rinse-off product: Means any cosmetic that is intended to be removed after application to the skin, hair or mucous membranes.

The definition of “manufacturer” was amended to also include, “a person in Canada who is authorized to act in Canada on behalf of another person who is not in Canada, if the other person sells the cosmetic under the other person’s own name or under a trademark, design, trade name or other name or mark owned or controlled by the other person.”

Additionally, the following point of clarification was added to Section 2.1:
If, in respect of a cosmetic, no person meets the definition manufacturer, a reference in these Regulations to “manufacturer” is to be read as a reference to:
(a) an importer of the cosmetic; or
(b) if no person meets the definition importer, any person that manufactures or processes the cosmetic in Canada on behalf of another person.

Fragrance Allergen Labeling

Canada has adopted the EU fragrance allergen list, as amended from time to time. Cosmetic products will need to specify fragrance allergens in the ingredient list when:

  • The concentration of the fragrance allergen is greater than 0.01% for rinse-off products
  • The concentration of the fragrance allergen is greater than 0.001% for leave-on products

Small Packaging Requirements

As previously permitted, if a product comes in a small package where the immediate container or outside package is so small that the label can’t comply with the labeling requirements, the product may use a tag, tape, or card affixed to the container or package. The amended Regulations provide a new labeling alternative for small packages where instead of an ingredient list, the package may list a web address with a statement specifying that the ingredients are listed on the website. The statement must be in English and French. Further guidance issued with the amended Regulations also stated that, “this amendment does not preclude the presence of a digital mechanism to access the list of ingredients, such as the use of a QR code following the required statement.”


Inner Labeling Requirements 

The inner labeling requirements have been updated to permit “a telephone number, email address, website address, postal address or any other information that enables communication with a contact person to whom consumers may direct questions about the cosmetic” instead of listing the name and address of the manufacturer.

Cosmetic Notification Requirements

The Cosmetic Notification requirements have been updated for clarity, codify practices that were already in place, specify the importer’s responsibilities, and more.

The amended Regulations modify the following Cosmetic Notification submission requirements:

  • The name and address now needs to be the contact information that appears on the inner
  • You need to identify if the product is a leave-on or rinse-off cosmetic
  • Ingredients need to be identified using the INCI name, or if an INCI name does not exist, the chemical name
  • The concentration ranges are narrower (e.g. there are more concentration ranges) for when the exact concentration of ingredients is not provided
     

Additionally, Canada may now request cosmetic safety information from the manufacturer or the importer. If an importer does not provide the requested safety documentation or if the documentation provided is insufficient, Health Canada may issue a stop sale for the importer.

Lastly, the Regulations were amended to clarify that if you stop selling a cosmetic product, you must submit a notification.

EU Trivial Name Updates
In addition to changing the title and headings of the table in the Cosmetic Regulations Schedule, the following updates were made:

  • Three names were added
  • Eleven names removed
  • “Oil” or “Extract” was added to many of the EU Trivial Names (now EU Technical Names)

Enforcement Dates

Fragrance allergen labeling requirements have the following compliance dates:
 

  • If the product contains any of the 24 fragrance allergens identified by the EU prior to the July 2023 update above the specified concentrations, the label shall be updated by April 12, 2026
  • If the product contains any of the new EU fragrance allergens above the specified concentrations you have until:
    • July 31, 2028 to sell through and update the labeling for existing products
    • July 31, 2026 to update the labeling for new products

All other requirements come into force October 9, 2024.

Link to the Canada Gazette, Part II Posting: https://canadagazette.gc.ca/rp-pr/p2/2024/2024-04-24/html/sor-dors63-eng.html

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