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Monday, March 9, 2026Regulation

Health Canada announces “flexibility” regarding allergen requirements

Santé Canada annonce une "flexibilité" concernant les exigences relatives aux allergènes

Health Canada has just announced that it has “heard concerns from industry” and adopted a “revised approach” to fragrance allergen requirements. The plan is to make no amendments to the Cosmetic Regulations but to allow flexibility in their interpretation…

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As a reminder, the amendments made to the Cosmetics Regulation in April 2024 introduced the requirement to disclose 24 fragrance allergens (the “historical” European allergens) on cosmetics labels when they are present in concentrations greater than 0.01% in rinse-off products and 0.001% in leave-on products.
Another new requirement is that the presence and concentration of these allergens must be indicated in the cosmetic declaration form.

Concerns and ongoing instability

Health Canada says today that it has “heard concerns from industry such as, challenges with suppliers and concerns among industry stakeholders to share confidential business information about the concentration information of fragrance allergens present in cosmetic formulations, and thus this is viewed as an increased regulatory burden.”
The Agency adds that, given the ongoing instability in the current economic and trade environment, the Consumer Product Safety Program has explored options to increase flexibility while maintaining consumer safety.

Updated expectations

As a result, Health Canada will not amend the Cosmetic Regulations, but will rather provide flexibility in interpreting the requirement to disclose information on the concentration of certain fragrance allergens in the Cosmetic Notification Form, which will become optional.
However, allergens must still be listed as separate ingredients …

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