March 31, 2023
By Fatemeh Bamdad, senior regulatory specialist, Supply Chain Team, UL Solutions
On February 10, 2023, proposed regulations amending the Cosmetic Regulations to strengthen the regulatory oversight of the cosmetics in Canada were published in the Canada Gazette Part I.
Currently, the ingredient list on the cosmetic label can include the term “parfum” to represent all the fragrance ingredients of the formulation. However, consumers allergic or sensitive to certain fragrances need to know more details to avoid contact allergens. Therefore, Health Canada proposed the regulations to introduce a new requirement to disclose 24 listed fragrances on the label if present at a concentration greater than 0.01% in rinse-off products and 0.001% in leave-on products. These are fragrances identified in Annex III of the European Commission (EC) Cosmetic Products Regulation and will be expanded if Annex III gets updated.
Disclosure of fragrance allergens has been a requirement in the European Union since 2005 and the proposed amendments would increase alignment with EU requirements and further support the trade between Canada and the EU.
The proposed regulations also amend notification requirements and some administrative provisions. Discontinuation of sale will be considered a change that requires notification. Furthermore, manufacturers and importers must identify all the ingredients, including fragrance allergens, with an exact or a range concentration in the notification. In addition, they must specify whether the cosmetic is a “leave-on” or “rinse-off” product as it impacts the risk profile of the cosmetic product.
Since many cosmetic products have small containers or packages, the proposed regulations add a greater flexibility by incorporating the option of using a website to disclose a complete list of ingredients. The proposal requires that a bilingual statement appear on the label to direct the consumers to the website where a list of fragrance allergens can be found. Other innovative mechanisms such as QR codes to get access to the ingredients list are also acceptable.
A two-year transition period has been proposed for the provisions related to disclosure of fragrance allergens. Other provisions would come into force six months after the registration date.
During the transition, the former Regulations are still applicable while Health Canada will update the notification forms to accommodate the amendments. The proposed changes would not impact, retroactively, on notifications received prior to the implementation date.
The proposal is open for comments until April 22, 2023. Interested parties are encouraged to share their comments on the proposed regulations through the online commenting feature, email, or mail.
*Note: The reader is strongly encouraged to read the full text of the proposed amendments for complete details. Additional information about Cosmetic Regulations can be found on the Government of Canada’s website.
Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients, Canada Gazette, Part I, Vol. 157, No. 6, February 11, 2023.
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