2024 Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients
On April 12, 2024, Health Canada released an update to the labelling requirements for cosmetic products regarding the disclosure of certain cosmetic ingredients. Learn about these changes in our post below.
Before the recent regulatory change published in the Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients: SOR/2024-63, manufacturers were allowed to group fragrance ingredients under the name "parfum," exempting them from detailed disclosure unless voluntarily declared. However, this exemption posed a significant health risk to consumers, particularly those with allergies to specific fragrance ingredients. Since most manufacturers listed "parfum" instead of voluntarily declaring the fragrance ingredients, a better approach to product labelling and ingredient declaration is necessary. Transparency in product labelling is crucial for informed decision-making and the safety of Canadian consumers.
What are Fragrance Ingredients?
A fragrance ingredient or fragrances mixture is an ingredient added to a product to produce a specific scent. These ingredients are commonly found not only in perfumes but also in everyday products such as lotions, soaps, hair styling products, and wipes, among others. Often, multiple fragrance ingredients are used in a product to achieve the desired scent. Some common fragrance ingredients that can trigger allergic reactions include limonene, linalool, eugenol, citral, and cinnamon. These oils are frequently used in fragrance mixes and have the potential to cause a range of allergic reactions, as users of these products may be unaware of the presence of allergens.
What are the implications of not declaring the fragrance allergens?
Repeated exposure to fragrance allergens can cause various allergic reactions, including allergic contact dermatitis, irritant contact dermatitis, respiratory reactions, headaches, and migraines. The severity of these reactions varies between individuals.
What are the new fragrance allergen regulations?
Health Canada has updated its cosmetic regulations, mandating that manufacturers disclose certain fragrance allergens on cosmetic labels if they are present at concentrations exceeding 0.01% in rinse-off products and 0.001% in leave-on products. Manufacturers must disclose fragrance allergens the list of ingredients, and their concentrations must be declared on the Cosmetic Notification form. The new regulatory changes are aligned with the European Union cosmetic standards. As with European regulations, the new regulations pertain to the fragrance allergens identified in Annex III of the European Commission’s (EC) Cosmetic Products Regulation. Declaration of the fragrance allergens appearing on this list above the indicated thresholds is mandatory.
What other key changes are introduced?
Health Canada has introduced increased flexibility for ingredient disclosure in cosmetics sold in small packages, in addition to mandating the disclosure of fragrance allergens. Under these new provisions, cosmetics in small packages can opt to list their full ingredient and allergen information on a designated website. Products utilizing this option must display a statement in both official languages directing consumers to the webpage for further details.
Health Canada has also updated the definition of the “manufacturer” to the following:
“Manufacturer, in respect of a cosmetic, means, one of the following persons:(a) a person in Canada who sells a cosmetic under the person’s own name or under a trademark, design, trade name or other name or mark owned or controlled by that person;
or
(b) 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 its own name or under a trademark, design, trade name or other name or marked owned or controlled by the other person.”
As per the manufacturer definition provided above, if there is no manufacturer, the responsibility for the product and its compliance with applicable regulations falls on the product’s importer. In the absence of an importer, this responsibility shifts to the individual responsible for processing or fabricating the cosmetic in Canada.
The definition of an “importer” has also been updated to the following:
“Importer means a person that imports a cosmetic into Canada for the purpose of selling it.”Health Canada has also amendment the concentration ranges and corresponding numbers that must be used on the cosmetic notifications. The new concentration ranges are as follows:
Other changes include strengthening cosmetic notification requirements, removing distributor information from the cosmetic notifications, adding a requirement to identify “rinse-off” or “leave-on” on the cosmetic notification and to identify ingredients by their International Cosmetic Ingredient Dictionary (INCI) name, ability to request evidence of safety from the importer, and modernizing the contact information present on the label. For an in-depth overview of these changes and how they apply to your products, please contact our team.
When do the new cosmetic regulations come into effect?
The new regulations have been implemented and published in Canada Gazette II, with a transition period of three years. New cosmetic products must comply with these regulations by July 31, 2026, while existing products on the market have until July 31, 2028, to meet the new requirements.
What other regulatory requirements apply to cosmetics sold in Canada?
Please explore our Cosmetic Notifications service page to discover more about cosmetic requirements. NPC provides extensive support and is ready to advise you on the best market routes. Our services encompass Cosmetic Notification preparations, submissions, label reviews, and verification of Volatile Organic Compounds (VOCs) calculations for compliance.
