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Canada: Fragrance Allergen Notification in Cosmetic Products
- Daniel Jiménez
- Mar 17
- 4 min read
The regulation of fragrance allergens in cosmetic products has evolved in recent years in multiple jurisdictions. Following updates introduced in the European Union and the growing interest in improving the information available to consumers, Canada has also incorporated new regulatory requirements regarding transparency on fragrance allergens.
However, following the publication of these modifications, Health Canada has decided to introduce greater flexibility in how certain requirements will be applied, especially regarding the declaration of allergen concentration on the cosmetic notification form.
Below we analyze what Canadian regulations require, what aspects have been made more flexible, and what companies that market cosmetics in Canada should take into account.
Table of contents
New requirements for fragrance allergens in Canada
Recent amendments to the Cosmetic Regulations under the Food and Drugs Act introduce the obligation to declare certain fragrance allergens on cosmetic labels when they exceed certain concentration limits.
Specifically, allergens must be indicated in the product's ingredient list when they are present above:
0.01% in rinse-off products (products that are rinsed off, such as shampoos or gels)
0.001% in leave-on products (products that remain on the skin, such as creams or perfumes)
The aim of this measure is to protect consumers who are sensitive or allergic to certain fragrance components, allowing them to easily identify their presence in cosmetic products.
In addition to labeling, the regulations also initially introduced the requirement that the presence and concentration of these allergens be declared in the Cosmetic Notification Form (CNF) submitted to Health Canada.
Concerns of the cosmetics industry
Following the publication of the regulatory changes, Health Canada received comments and concerns from the cosmetics industry, especially related to the obligation to report the exact concentration of fragrance allergens in the CNF.
Among the main problems identified by manufacturers and importers were:
Difficulties in obtaining accurate concentration data from fragrance suppliers
Protection of confidential business information
Supply chain complexity
Increased administrative burden for businesses
In many cases, fragrances are complex mixtures protected as trade secrets, and suppliers do not always share the exact concentrations of each allergen present in the formulation.
This created a situation where manufacturers could know the presence of certain allergens but not necessarily their exact concentration, which complicated compliance with the initial requirement.
Health Canada's response: greater regulatory flexibility
Taking into account these concerns and the current economic and commercial context, Health Canada has decided to adopt a more flexible approach in interpreting the concentration notification requirement.
It is important to note that:
Health Canada will not formally modify the text of the regulation, but will make the interpretation of the requirement to declare the concentration of fragrance allergens in the Cosmetic Notification Form more flexible.
In practice, this means that:
The declaration of the concentration of most fragrance allergens in the CNF will be optional.
However, this flexibility does not eliminate the obligation to declare allergens as individual ingredients.
Therefore, companies must continue to comply with two fundamental obligations:
Fragrance allergens must continue to be listed as individual ingredients on the Cosmetic Notification Form.
Allergens must appear in the list of ingredients on the label when they exceed the established limits.
Cases in which concentration will still be mandatory
Although Health Canada is introducing flexibility for most cases, there are situations where concentration will still be mandatory at the CNF.
This occurs when the fragrance allergen also appears as a restricted ingredient on the Cosmetic Ingredient Hotlist.
In these cases, compliance with the restriction depends on specific concentration limits, so Health Canada continues to require the relevant information.
Some examples mentioned by the authority include:
Eucalyptus
Camphor
Methyl salicylate
When an ingredient is subject to conditions linked to a specific concentration in the Hotlist, the concentration range code or the exact concentration must still be indicated in the CNF.
Planned changes to the Cosmetic Notification Form (CNF)
Currently, the Cosmetic Notification Form requires entering a concentration (exact or by range) for all ingredients, including fragrance allergens.
However, Health Canada has indicated that the next revision of the form will allow certain fragrance allergens to be entered without the need to indicate their concentration.
While this update is being implemented, Health Canada recommends that:
If the concentration is known, it should be provided in the CNF.
If this is unknown, companies may submit an amended notification when the form is updated.
In addition, the form currently allows you to select a "Fragrance Allergen" option, which identifies the ingredient as a fragrance allergen and prevents its concentration from being counted within the total minimum concentration of the product.
Implementation schedule
The new requirements will officially come into effect on:
April 11, 2026
However, Health Canada will apply a phased, risk-based approach to regulatory compliance and enforcement.
The schedule will be as follows:
April 12, 2026 – April 11, 2027
During this period, Health Canada will prioritize promoting compliance, helping regulated businesses adapt to the new requirements.
As of April 12, 2027
Inspection, compliance, and enforcement activities will follow the department's standard risk-based approach.
What should cosmetic companies do now?
For companies that market cosmetics in Canada, these changes involve several key actions.
Among the most important are:
Review formulations to identify fragrance allergens present above regulatory limits
Verify that allergens are correctly included in the product labeling
Confirm that allergens are listed as separate ingredients in the CNF
Evaluate whether any of these ingredients are also subject to restrictions on the Cosmetic Ingredient Hotlist
Prepare for the Cosmetic Notification Form update
Although Health Canada has introduced some flexibility, transparency obligations to the consumer remain a central element of the Canadian regulatory framework.
Conclusion
Health Canada's decision to relax the reporting of fragrance allergen concentrations reflects an attempt to balance two key objectives:
to protect the health of consumers
reduce unnecessary regulatory burdens for the industry
Cosmetic companies must understand that, although the concentration in the Cosmetic Notification Form will be optional in many cases, the obligation to declare these allergens in the labeling and notification remains fully in force.
For international manufacturers and importers, this change represents a partial simplification of the notification process, but still requires careful management of information on fragrances and allergens.
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