Cosmetics Alliance has received a communique from the NNHPD that several ingredient entries in the NHPID have been updated given the updates to the Cosmetic Ingredient Hotlist from Août 2022 and Mai 2024 (see list of ingredients below). These changes are to mitigate potential risks to health that products containing these ingredients that may pose to consumers.
These ingredients may be present in some natural health products (NHPs) and non-prescription drugs (NPDs). The conditions for these ingredients in the hotlist are now subject to additional requirements, including additional caution statements, prohibitions and added or amended concentration restrictions.
The NNHPD is taking steps to ensure previously licensed NHPs and NPDs containing these ingredients align with these NHPID updates to support the safety of the impacted products. Post-licence request notices for impacted NHPs or advisement letters requesting changes to impacted NPDs will be issued in the coming months.
There are approximately 114 NHPs licensed to 81 product licence holders and 9 DIN holders that will be contacted and requested to make changes to the licenses and labels depending on the ingredient.
Stakeholders may be asked to confirm the quantity of these ingredients, remove, replace or reduce these ingredients in their products, add cautionary and/or other missing risk statements to their NHP & DIN market authorizations and labelling.
The following ingredients as non-medicinal ingredients are included in scope:
- Benzophenone is now restricted up to 3% in oral products due to concerns regarding potential adverse effects in pregnant people, such as decreased body weight.
- p-Chloro-m-cresol (chlorocresol) is now restricted up to 0.1% for topical use only (products not to be used around mucosal membranes such as eyes, nose or mouth) due to concerns that products may affect the adrenal organs.
- Solvent Violet 13 (D&C Violet No. 2 and Violet 2) is now restricted up to 0.3% (excluding nail products) due to possible health concerns, such the potential carcinogenicity of their analogue anthraquinone in certain uses.
- Eucalyptus oil was amended to better mitigate the risk of unintentional ingestion, particularly in pediatric populations, by introducing cautionary statements for certain products with concentrations greater than 0.022%.
- Dialkanolamines, secondary (diethanolamine; 1-Hexadecanol, Phosphate, compd. with 2,2′-Iminobis(Ethanol); Diisopropylamine; DEA-Oleth-3 Phosphate; 1-(2-Hydroxypropylamino)propan-2-ol)) was revised to include secondary alkyl- and alkanolamines and their salts as prohibited due to concerns that these substances could act as precursors of carcinogenic nitrosamines.
- Talc was revised to help reduce exposure to talc from products that may be inhaled or may result in genital exposure to the population with intact ovary/ovaries.
- Hydroquinone (arbutin and alpha-arbutin) are now restricted up to 0.5% in topical products as certain concentrations have been shown to cause cancer in some studies with laboratory animals. Although exposures to Canadians are low, Health Canada’s objective is to minimize exposure to this ingredient.
As a reminder, changes to the Cosmetic Ingredient Hotlist from Février 2025 are posted here.
