2024 Updates to the Canadian Cosmetic Regulations

By: Teah Jazey, Regulatory Affairs & Product Safety Associate, email

On April 24, 2024 the Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (SOR/2024-63) were published in the Canada Gazette, Part 2, updating the current cosmetic regulations in Canada. In this post we will provide a description of some of the changes that importers and manufacturers of cosmetic products should be aware of.

The Canada Gazette document outlines the changes that impact the current Cosmetic Regulations, such as: updated definitions throughout the regulations; who is considered the “manufacturer”; updates on fragrance allergens; and labelling of small or ornamental containers.

We will discuss some of the changes in detail below.

Definitions

The first section of the Cosmetic Regulations that has been updated is the interpretations. These are the definitions of terms used throughout the regulations. The following definitions have been changed and we recommend you review these changes to ensure your business is in compliance.

The new definitions, taken from the Canada Gazette, Part 2 update, are as follows:

• INCI name: means the International Nomenclature Cosmetic Ingredient name assigned to an ingredient in the International Cosmetic Ingredient Dictionary and Handbook published by the Personal Care Products Council on its website, as amended from time to time. (appellation INCI)
• Inner label: means a label on or affixed to the immediate container of a cosmetic.
• Manufacturer: in respect of a cosmetic, means one of the following persons:
  • (a) a person in Canada who sells the cosmetic under the person’s own name or under a trademark, design, trade name or other name or mark owned or controlled by the 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 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.
• Practitioner: means a person who is registered and licensed under the laws of a province to practice the profession of medicine in that province.
• Prescription: means a direction given by a practitioner.
• Act: means the Food and Drugs Act.
• Botanical: means an ingredient that is directly derived from a plant and that has not been chemically modified before it is used in the preparation of a cosmetic.
• Child resistant container: has the same meaning as in section 2 of the Consumer Chemicals and Containers Regulations, as they read on September 30, 2001.
• Flame projection: means the ability of the pressurized contents of an aerosol container to ignite and the length of that ignition, when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981.
• Flashback: means that part of the flame projection that extends from its point of ignition back to the aerosol container when tested in accordance with official method DO-30, Determination of Flame Projection, dated October 15, 1981.
• Ingredient: means any substance that is one of the components of a cosmetic and includes colouring agents, botanicals, fragrance and flavour, but does not include substances that are used in the preparation of the cosmetic but that are not present in the final product as a result of the chemical process.
• Official method: means a method of analysis or examination designated as such by the Minister for use in the administration of the Act and these Regulations.
• Ornamental container: means a container that, except on the bottom, does not have any promotional or advertising material on it other than a trademark or common name, and that appears to be a decorative ornament because of a design that is on its surface or because of its shape or texture, and is sold as a decorative ornament in addition to being sold as the container of a cosmetic.
• Outer label: means a label on or affixed to the outside package of a cosmetic.
• Principal display panel: has the same meaning as in the Consumer Packaging and Labelling 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.

Amendments to the “Manufacturer” Definition – Who is the Manufacturer?

In addition to the new definition to the term “manufacturer” the amendments have further clarified who is considered the manufacturer. If no person can be identified as the manufacturer, then the reference is as follows: (a) an importer of the cosmetic product; or (b) if no person meets the definition importer, any person that manufactures or processes the cosmetic product in Canada on behalf of another person.

Selling Cosmetics – When is a Notification Required?

A new Section 15.3 has been added to the Food and Drugs Act, specifying when a cosmetic product is prohibited for sale in Canada. If you haven’t submitted a cosmetic notification within 10 days of the first sale, the product cannot be sold. Additionally, if a notified product undergoes changes, you must file a new cosmetic notification, reflecting the product changes, within 10 days of selling the modified product. Lastly, if the Minister requests further information during the notification review and you fail to provide it, the product cannot be sold and must be removed from all sale channels within 10 days of the information request.

Fragrance Allergens – A Hot Topic in Canada

With the fragrance allergens regulation changes drawing nearer to implementation in Canada, it’s crucial to grasp their nature and the timeline for disclosure requirements.

The amendments to the Cosmetic Regulations give a detailed description of what a fragrance allergen is: “a fragrance or flavour that can cause an allergic reaction and that is included in the European Restricted Substances List and for which the restrictions set out in column h of that list provide that its presence must be indicated in a cosmetic’s list of ingredients”.

If there are no fragrance allergens present in the fragrance or flavour of a cosmetic product, then you can list the words “fragrance” or “aroma” in the list of declared ingredients, respectively. In other words, a complete declaration of the ingredients used for these purposes is not required.

On the other hand, a fragrance allergen must be listed on the label in the following cases:

1. In the case of a rinse-off product, the concentration of the fragrance allergen in the cosmetic is greater than 0.01%; or
2. In the case of a leave-on product, the concentration of the fragrance allergen in the cosmetic is greater than 0.001%.

The section on Fragrance Allergens is a new addition to the Canadian Cosmetic Regulations and we highly suggest you familiarize yourself with the requirements for labelling and disclosure of such ingredients in your products. We have provided a resource link at the bottom of this post for additional information.

You can learn more about this important topic here: What are Fragrance Allergens?

Changes to the Online Cosmetic Notification Form

One of the biggest changes to the online notification form will be the replacement of the old concentration rage with new, tighter ranges for declaration of cosmetic ingredients. Below is Table 30 of the existing Cosmetic Regulations, as well as the new table that will come into effect with the new regulations.

Existing

New

Keep in mind that the lowest percentages of cosmetic ingredients added together must equal at least 100% when using these provided ranges in the online cosmetic notification form.

Any updates to the formulation or the product must be notified to Health Canada via a cosmetic amendment within 10 days of the new data/formulation change coming into effect.  Please also note that if you are no longer selling a product in Canada, a Discontinue Notification should be submitted using the online CNF, a process that is similar to submitting a cosmetic product amendment.

Timeline for Regulations Coming Into Force for Cosmetic Products

The amendments to the Cosmetic Regulation will take effect on October 9, 2024, with the exception of the disclosure of fragrance allergens, which will be enforced two years after the registration of the amendments, on April 12, 2026.

It is important that all cosmetic importers, manufacturers and sellers examine these forthcoming changes to Canada’s Cosmetic Regulations. Numerous minor adjustments have been made throughout the Regulations, potentially impacting any personal care product falling within their scope. While this blog highlights some significant changes, it’s important to also remain mindful of the smaller adjustments to the regulations.

Reach out to our team for assistance with your cosmetic products sold in Canada.

Health Canada and Other Resources

The amendments discussed in today’s blog can be found here, or at the bottom of the Cosmetic Regulations under Related Information: Amendments Not In Force. We would encourage you to review these changes to ensure your product remain compliant.

Dell Tech has provided professional, confidential consulting services to the specialty chemical industry in Canada, the USA, Europe, and Asia for the last 40 years.