On Feb. 11, 2023, Health Canada (HC) published the Canada Gazette, Part I, Volume 157, Number 6. [1] According to the Gazette, the Government of Canada plans to amend Cosmetic Regulations, requiring cosmetics to be labeled with fragrance allergens, allowing the disclosure of the full ingredient list of cosmetics sold in small packages on the website, and modifying cosmetic supervision requirements. Stakeholders can mail any suggestions to cosmetics@hc-sc.gc.ca before Apr. 22, 2023.

The detailed amendments are as follows.

Requiring cosmetics to be labeled with fragrance allergens

HC is proposing amendments to require the identified fragrance allergens to be labeled in the ingredient list on the package of cosmetics when their concentration exceeds 0.001% in leave-on products or 0.01% in rinse-off products. The fragrance allergens proposed to be labeled are exactly consistent with the 24 fragrance allergens listed in Annex III (annex of restricted ingredients) of the European Commission’s Cosmetic Products Regulation. This list is also subject to change by the EU.

24 Fragrance Allergens

As a result of this amendment, it is proposed to submit information on the presence and concentration of fragrance allergens when applying for cosmetic notification.

Allowing the disclosure of the full ingredient list of cosmetics sold in small packages on the website

Currently, cosmetics sold in small packages (e.g. eyeliner pencils, hotel or travel-sized amenities, lipsticks and nail enamels) are allowed to be attached with the full ingredient list on a tag, tape or card affixed to the container or package. HC proposes to allow the disclosure of the full ingredient list (including fragrance allergens) of cosmetics sold in small packages on the website.

In addition, the Gazette proposes to require a bilingual statement on the cosmetic label to inform and direct consumers to the website for the full ingredient list. This proposed amendment would not preclude the presence of digital mechanism to access the list of ingredients, such as a QR code following the required statement.

Modifying cosmetic supervision requirements

HC proposes to amend the Cosmetic Regulations in the following manner to improve the oversight of cosmetics, and to support compliance and enforcement actions.

1. For cosmetic notification application, HC

• Clarifies that if HC requests the manufacturer or importer to supplement the information, the manufacturer or importer has 10 days to respond;
• Adds a provision to clarify that the discontinuation of sale requires the submission of a notification;
• Specifies whether the cosmetic is a “rinse-off” or “leave-on” product should be indicated in the cosmetic notification information;
• Requires ingredients disclosed in the cosmetic notification information to be identified by their INCI names. If the INCI name does not exist, the chemical name would be required;
• Clarifies that the distributor’s name and address information are no longer required for cosmetic notification;
• Amends the table of concentration ranges for cosmetic notification, in which the range increases from the current 7 to 13 as indicated in the table below.

The exact concentration or concentration range of ingredients shall be submitted at the time of notification. The concentration range can be indicated by either the applicable concentration range set out in column 1 or the number in column 2.

2. Modernizing the contact information presented on the label

HC proposes to require the inner label to include a telephone number, an email address, a website address or any other information that would enable consumer to direct any product-related questions to a contact person.

As a result of this amendment, it is proposed to submit the corresponding contact information indicated on the label when applying for cosmetic notification.

3. Giving HC authority

• to stop the sale of a product if the notification requirements are not met, or the information requested is not provided;
• to request evidence of safety from the importer. To protect proprietary information, a foreign manufacturer or a third party would be able to provide evidence of safety information to HC on an importer’s behalf.

In addition, HC also proposes administrative changes to Cosmetic Regulations, such as revising the definitions of manufacturers and importers, and the expressions and wordings in regulations.

Further Reading

• EU to Extend the Individual Labelling Requirement for 56 Newly Identified Fragrance Allergens in Cosmetics
• Canada Proposes to Require Cosmetics to Label Certain Toxic Substances
• Canada Proposes to Amend Cosmetic Ingredient Use Requirements

Reference Links

[1] Canada Gazette, Part I, Volume 157, Number 6: Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients

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