Health Canada proposes updates to the Cosmetic Ingredient Hotlist

On October 14, 2020, Health Canada published Proposed Updates to the Cosmetic Ingredient Hotlist: ‎Prohibited and Restricted Ingredients.‎ Proposed additions to the Hotlist include Ethylhexyl Ethylhexanoate and Azelaic acid and its salts. Proposed revisions to the Hotlist include Retinoic acid, Alpha-Hydroxy Acids (AHAs), Eucalyptus oil, Peroxide and peroxide-generating compounds, and p-Hydroxyanisole.

Health Canada uses the Cosmetic Ingredient Hotlist (the “Hotlist”) to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene the general prohibition found in section 16 of the Food and Drugs Act or a provision of the Cosmetic Regulations.

Proposed additions to the Hotlist:

• Ethylhexyl Ethylhexanoate: Ethylhexyl Ethylhexanoate is being considered for addition to the list of restricted substances due to health concerns. The addition would restrict permitted concentrations of this ingredient in body lotion, foot lotion, and face make-up.
• Azelaic acid and its salts: Azelaic acid and its salts are being considered for addition to the list of restricted substances due to the therapeutic properties of this ingredient at certain concentrations and the risk of skin irritation at high concentrations. The addition would restrict permitted concentrations of this ingredient in leave-on and rinse-off products.

Proposed revisions to the Hotlist:

• Retinoic acid: A revision to the entry is being considered to clarify that derivatives and salts of retinoic acid are captured by the entry.
• Alpha-Hydroxy Acids (AHAs): A revision to the entry is being considered to clarify that Polyhydroxy acids (PHAs) and bionic acids with alpha-hydroxyl groups, as well as their salts, are captured by the existing entry. Additional revisions being considered include updates to the warnings and cautionary statements and considerations for product-specific directions for use for skin products and other cosmetics.
• Eucalyptus oil: A revision to the entry is being considered to better mitigate risk of unintentional ingestion, particularly in pediatric populations. Changes under consideration include modifications to cautionary statements, as well as limiting the requirement for cautionary statements to cosmetics in forms other than solid forms, where the concentration of the ingredient is greater than 0.022%.
• Peroxide and peroxide-generating compounds: For oral cosmetics containing more than 3% hydrogen peroxide (or equivalent), a revision to the entry is being considered to require evidence of hydrogen peroxide levels in saliva only, and not within the soft tissue of the oral cavity. Furthermore, a removal of the statement allowing evidence that may include analog studies from recognized sources or independent clinical research, is being considered.
• p-Hydroxyanisole: Use of p-Hydroxyanisole is currently restricted to nail products only. A revision to the entry is being considered to expand the permitted nail product categories, including products for consumer use, and to increase the maximum concentration permitted for these products.

Other proposed revisions to the Hotlist:

• Several existing entries will be revised to include new synonyms and Chemical Abstract Service Registry (CAS) numbers.

Health Canada invites stakeholders to submit comments on the proposed changes by no later than December 12, 2020.

This article provides only general information about legal issues and developments, and is not intended to provide specific legal advice. Please see our disclaimer for more details.