Health Canada proposes updates to the Cosmetic Ingredient Hotlist

On 13 July 2023, Health Canada opened a consultation on proposed updates to the Cosmetic Ingredients Hotlist concerning prohibited and restricted ingredients. The consultation is open for new inputs until 11 October 2023. 

Health Canada's Cosmetic Ingredient Hotlist serves as a valuable resource for manufacturers and other stakeholders, offering information on specific substances that may contravene the general prohibition outlined in section 16 of the Food and Drugs Act (FDA) or provisions of the Cosmetic Regulations when present in cosmetic products. Additionally, the Hotlist may identify substances that, when present or used under certain conditions, render the product unsuitable for classification as a cosmetic under the FDA. 

To ensure the safety and compliance of cosmetic products, Health Canada periodically updates the Hotlist, with the most recent revision dating back to August 2022. This list plays a crucial role in informing manufacturers and distributors about the restricted or prohibited status of certain substances under Canada's Food and Drug Act (FDA) and Cosmetic Regulations (CR). 

The proposed update includes specific concentration limits for several substances, as follows: 

1. Benzophenone: Health Canada proposes to add benzophenone (CAS 119-61-9) to the list of restricted substances. Some cosmetic uses of benzophenone have been associated with adverse maternal effects, such as decreased body weight. 

2. p-Chloro-m-cresol: Health Canada proposes to include p-Chloro-m-cresol (CAS 59-50-7) in the list of restricted substances due to potential effects on the adrenal organs from certain cosmetic applications. 

3. Retinal: The proposed maximum concentration for Retinal in leave-in products is 0.01% and 0.05% for use in other products. 

4. Solvent Violet 13: Health Canada suggests adding Solvent Violet 13 (CAS 81-48-1) to the list of restricted substances due to potential health concerns associated with specific cosmetic applications. 

5. Basic Green 4: Health Canada aims to prohibit Basic Green 4 (also known as Malachite Green, CAS 569-64-2) due to potential developmental effects. 

6. Thioglycolic acid esters: Health Canada is considering the addition of Thioglycolic acid esters to the list of prohibited substances due to an increased risk of skin sensitization. 

Furthermore, Health Canada proposes changes to existing substance entries, including: 

1. Mixed cresols and derivatives: The entry will be revised to create separate Hotlist entries for different cresols due to their different risk profiles. 

2. Dialkanolamines, secondary: The entry will be revised to include "secondary alkyl- and alkanolamines and their salts" due to their similar potential to act as precursors of carcinogenic nitrosamines. 

3. Alpha-hydroxy acids: Clarifications will be made to include polyhydroxy acids (PHAs) and bionic acids with alpha hydroxyl groups under the definition of alpha-hydroxy acids. Product-specific directions for safe use will also be added. 

4. Aluminum chlorohydrate and its associated complexes: The entry will be revised to indicate that these substances are not permitted in aerosol products, as inhaling small particles from aerosols may affect the lungs. 

5. Peroxide and peroxide-generating compounds: The entry will be revised to introduce a maximum permitted concentration for hair products to mitigate the risk of skin irritation. Additionally, specific conditions for eyelash and eyebrow products will be outlined to address the risk of eye irritation. Furthermore, these ingredients will not be permitted for use in products intended for application to the genital area due to the risk of irritation. 

6. Benzoyl peroxide: The entry will be revised to specify that the ingredient may only be used in nail products for professional use. 

7. Hydroquinone: The entry will be revised to include products for consumer use within the permitted nail product categories. Health Canada also proposes an increase in the maximum permitted concentration for these products and the introduction of a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product. 

8. p-Hydroxyanisole: The entry will be revised to introduce a combined limit when both p-Hydroxyanisole and hydroquinone are used in a nail product. 

9. Retinol and its esters: The entry will be revised to reduce the permitted concentration for certain products, such as body lotions, to prevent exposure levels that exceed the tolerable upper intake levels of vitamin A recommended by Health Canada. 

10. Talc: The entry will be revised to minimize exposure to talc from cosmetics that may be inhaled or result in genital exposure for individuals with intact ovary/ovaries. 

Health Canada invites stakeholders to submit comments on these proposed changes during a 90-day consultation period. All comments received will be carefully considered, and Health Canada will respond before publishing the revised Hotlist. Stakeholders are encouraged to submit their comments by 11 October.