Canada updates Cosmetic Ingredient Hotlist: Bans Basic Green 4 and restricts three ingredients

Canada updates Cosmetic Ingredient Hotlist: Bans Basic Green 4 and restricts three ingredients 

On May 17, 2024, Health Canada released its latest update to the Cosmetic Ingredient Hotlist, adding Basic Green 4 (also known as malachite green) to the list of prohibited substances due to possible developmental consequences. In addition, the following 3 ingredients were added to list of restricted substances in the update:  

• Benzophenone, maximum concentration up to 3% 

• p-chloro-m-cresol, not allowed in products intended to be applied on or near mucous membranes, such as those in the mouth, nose or eyes; maximum concentration up to 0.1% in other cosmetics. 

• Solvent violet 13, maximum concentration up to 0.3% in cosmetic products other than nail products. 

The previous update to the Hotlist was in August 2022.  

Review and Feedback on Proposed Changes Ongoing 

The current update does not include retinal and thioglycolic acid esters as proposed in July 2023. Health Canada is still reviewing feedback on these substances and is accepting comments on the proposed ban on thioglycolic acid esters and the intention to amend the entries for an additional four compounds until June 7. 

Cosmetic Ingredient Hotlist 

The Food and Drugs Act (FDA) and the Cosmetics Regulations (CR) must be followed in order for a cosmetic product to be sold in Canada. Under Section 16 of the FDA, cosmetics that are produced, imported, or offered for sale in Canada must be safe to use. Health Canada notifies producers and other stakeholders of potential bans or restrictions on certain ingredients used in cosmetics through the Cosmetic Ingredient Hotlist, an administrative mechanism. Hundreds of cosmetic ingredients are currently listed on the hotlist, which consists of two parts, one for ingredients that are prohibited and another for those that are restricted. 

Further Amendments to Cosmetic Ingredient Hotlist Entries  

Health Canada has also modified the Hotlist for 5 additional substances with new restrictions:  

1. The Alpha-hydroxy acids (AHAs) entry was amended to clarify that polyhydroxy acids (PHAs) and bionic acids with alpha-hydroxyl groups and their salts satisfy the chemical definition of AHAs. 

2. The entry for secondary dialkanolamines was amended to encompass secondary alkyl- and alkanolamines and their salts  

3. For hydroquinone the entry was amended to include both compounds p-hydroxyanisole and hydroquinone used in nail products with increased maximum concentration limits and a concentration limit of 0.1% 

4. The entry for p-hydroxyanisole was amended to introduce a concentration limit of 0.1% in nail products that contain both p-hydroxyanisole and hydroquinone. 

5. The talc entry was amended to reduce both genital and chronic inhalation exposure, as well as to broaden warnings about the risks of acute inhalation to all loose powder products.