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Wednesday, July 22, 2020Regulation

Canada: amendments to Ingredient Hotlist delayed ... and clarified

Canada : les modifications de la Liste Critique des ingrédients retardées... et précisées

In January 2020, Health Canada issued a “Notice to Stakeholders” regarding several proposed amendments to the Cosmetic Ingredient Hotlist. Due to the Covid-19 pandemic, stakeholder consultation was postponed. This delay allowed the Canadian health authority to clarify the framework for the proposed amendments for two ingredients: Retinoic acid and Alpha-Hydroxy Acids.

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Health Canada’s Notice to Stakeholders regarding the Cosmetic Ingredient Hotlist was first published online on January 13, 2020.
A consultation concerning proposed changes to the Hotlist is generally posted approximately three months after the Notice to Stakeholders. However, due to the COVID-19 pandemic, the consultation planned for publication in April 2020 has been delayed until “later in the year.”
In the meantime, this notice has been updated for two entries, which appeared to be “misunderstood”.

The new entry for “Retinoic acid”
A revision to the entry will be made to clarify that derivatives and salts of retinoic acid are captured by the entry. These substances are currently captured under the Prescription Drug List entry for “Tretinoin or its salts or derivatives”. While the Prescription Drug List (PDL) does not pertain to cosmetic products, a Hotlist entry can communicate that the presence, or use under specific conditions, of certain substances (including some PDL substances), may make the product unsuitable for classification as a cosmetic under the FDA. Retinoic acid has known therapeutic action at low concentration, with marketed prescription drugs for topical use containing retinoic acid at a concentration as low as 0.01% listed in Health Canada’s Drug Product Database. The …

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