Health Canada Updates Hotlist Ingredients: Colorants, Benzophenone, Talc and More

On May 17, 2024, Health Canada announced changes to the Cosmetic Ingredient Hotlist including four additions and five amendments. According to Focal Point Research, this follows a 60-day comment period opened on March 13, 2024. Health concerns including adverse developmental and maternal effects were cited for the additions, in particular. 

See related: FDA Recalls: 24 Benzene Reports + 1 Off-taste Toothpaste

Health Canada also shared its position on alpha hydroxy acids (AHAs) and polyhydroxy acids (PHAs) and their salts. The final May 2024 changes are as follows.

Additions

Basic Green 4

This ingredient was added to the list of prohibited substances due to potential developmental effects, as assessed by the Government of Canada's Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Per the Personal Care Products Council (PCPC) INCI Dictionary, the additive has a reported function of coloring hair. Additional technical names include: CI 42000; and Methanaminium, N-[4-[[4-(Dimethylamino)Phenyl]Phenylmethylene]-2,5-Cyclohexadien-1-ylidene]-N-Methyl-, Chloride.

Benzophenone

This ingredient was reportedly added to the list of restricted substances due to potential adverse maternal effects such as decreased body weight, as assessed by the Government of Canada's Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). The ingredient functions as a fragrance ingredient and light stabilizer, per the INCI Dictionary.

p-Chloro-m-cresol

This ingredient was added to the list of restricted substances due to health concerns regarding possible effects on the adrenal organs, as assessed by the Government of Canada's Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). This material is used as a cosmetic biocide and preservative, also per the INCI Dictionary.

Solvent Violet 13

This ingredient was added to the list of restricted substances due to potential health concerns in general, as assessed by the Government of Canada's Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Its main reported function is as a colorant, per the PCPC dictionary.

Amendments

Dialkanolamines, Secondary

This entry was amended to include secondary alkyl- and alkanolamines and their salts for clarity. These substances reportedly have similar potential to act as precursors of carcinogenic nitrosamines.

Alpha-hydroxy Acids

This entry was amended to clarify that polyhydroxy acids (PHAs) and bionic acids with alpha-hydroxyl groups, as well as their salts, are included. They meet the chemical definition of AHAs and there is insufficient information to support that PHAs are less likely to cause irritation or sun sensitivity than other AHAs. Additionally, the maximum permitted concentration for the consumer use category was increased from 10% to 18%.

The expansion of the consumer use category was a result of a retrospective analysis of Evidence of Safety data submitted to Health Canada for professional-use cosmetic products. Other amendments include updated warnings and cautionary statements and additional product-specific directions for safe use.

Hydroquinone

This entry was amended to expand the permitted nail product categories to include products for consumer use, increase the maximum concentration permitted for these products, and introduce a combined limit when both p-hydroxyanisole and hydroquinone are used in a nail product.

p-Hydroxyanisole

This entry was amended to introduce a combined limit when both p-hydroxyanisole and hydroquinone are used in a nail product.

Talc

This entry was amended to help reduce chronic inhalation exposure to talc in cosmetics that may result in non-cancer lung effects (such as inflammation or fibrosis), as well as genital exposure to the population with intact ovary/ovaries which may result in ovarian cancer, as assessed by the Government of Canada's Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). Cautionary statements related to acute inhalation risks were also adjusted to include all loose powder products.

2022 Hotlist Updates and Henna Product Recall

The above-listed hotlist additions and updates are the first made since 2022. At that time, changes included the additions of ethylhexyl ethylhexanoate and azelaic acid and its salts as restricted ingredients. The former was cited for general health concerns, while the latter was added "due to known therapeutic properties and risk of skin irritation at concentrations above the maximum permitted concentration of 14%." 

Related to skin irritation, the announcement of these hotlist changes follows an April 24, 2024, recall in Canada for several henna products containing the skin sensitizer phenol — another ingredient on the hotlist. Per Health Canada, phenolic compounds are known skin sensitizers and can produce chemical burns (corrosive action) to the skin. The specific products included Shakeel Bhai Mehndi Waley Almas Henna Cones, Original Special Zeenat Henna Cones and Special Bridal Henna Cones. As of March 20, 2024, Health Canada received four incident reports related to the use of the Special Bridal Henna Cone product and no incidents related to the use of the other products.

Growing consumer concerns over ingredient safety and skin sensitivity are well-known, putting regulators on alert and inspiring the tightening of cosmetic restrictions. It's no wonder why ingredient innovation is not just focused on safety, but also skin comfort, as exemplified by skin comfort's prominent presence at in-cosmetics Global this year.