Health Canada Adds Two New Substances to the Cosmetic Ingredient Hotlist

Health Canada’s August 2022 update to the Cosmetic Ingredient Hotlist adds two substances to the restricted list and makes four amendments.

Cosmetic products sold in Canada must comply with both the Cosmetic Regulations (CR) and the Food and Drugs Act (FDA), which specifies in Section 16 that cosmetic products manufactured, imported or offered for sale in Canada must be safe for use.

The Cosmetic Ingredient Hotlist is a tool that Health Canada has put in place to help the industry meet these requirements. It consists of two parts, a prohibited list of ingredients and a restricted list of ingredients.

Health Canada’s August 2022 Hotlist update included two additions to the restricted substances list and amended four of the ingredient listings.

1. Additions to the restricted list:
   
    
   • Ethylhexyl ethylhexanoate (2-ethylhexyl-2-ethylhexanoate) – added due to health concerns.
     Maximum permitted concentrations:
     • • Body Lotion: 0.1%
       • Foot Lotion: 0.5%
       • Face Make-up: 0.6%
        
   • Azelaic acid and its salts (Nonanedioic acid, Disodium azelate, Dipotassium azelate) – added due to known therapeutic properties and the risk of skin irritation at concentrations above the maximum limit
     Maximum permitted concentration: 14%
    
2. Amendments:
   
   
   • Prohibited list:
     • Retinoic acid and its salts (Tretinoin; cis-retinoic acid; all-trans-retinoic acid) – entry amended to add salts for clarity
       
       
   • Restricted list:
     
     
     • Eucalyptus (Eucalyptus globulus leaf oil; Eucalyptus citriodora oil; Eucalyptus radiata leaf/stem oil; Eucalyptus staigeriana branch/leaf oil; Eucalyptus dives leaf/twig oil) – warnings and cautionary statements are now required for cosmetics that are not in solid form and contain greater than 0.022% eucalyptus:
       • • "Keep out of reach of children"; and
         • "In case of accidental ingestion, call a Poison Control Centre or doctor immediately and advise them this product contains eucalyptus oil."
           
           
     • Peroxide and peroxide-generating compounds (urea peroxide; calcium peroxide; calcium dioxide; hydrogen peroxide; magnesium peroxide; sodium perborate; zinc peroxide)
       
       • Entry amended to clarify that for oral cosmetics containing more than 3% hydrogen peroxide (or equivalent) hydrogen peroxide concentrations in saliva will continue to be requested but, concentrations within the soft tissue of the oral cavity will not be routinely requested. Furthermore, the statement allowing evidence that may include analog studies from recognized sources or independent clinical research was removed.
         
         
     • p-Hydroxyanisole (4-methoxyphenol) – entry amended to expand to consumer nail products and increase the maximum permitted concentration to 0.1%

Next step

For the latest updates to Canada's cosmetic ingredient hotlist, check their website:
https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosmetic-ingredient-hotlist-prohibited-restricted-ingredients/changes.html#aug2022

Author
Karen Rauen, Ph.D
Cosmetics & Hygiene - Senior Technical Manager