21 October 2024
Canada Cosmetic Ingredient Hotlist Update
February 2025 - Changes to the Cosmetic Ingredient Hotlist
Health Canada has recently updated its Cosmetic Ingredient Hotlist, a critical reference document that outlines ingredients prohibited or restricted in cosmetic products in Canada. These changes may directly impact the formulation, importation, and marketing of your products.
The main purpose of this update is to strengthen the safety of each cosmetic product available on the market
As industry experts, we are here to help you navigate these new requirements and ensure regulatory compliance. In this article, we will review the key changes made to the Hotlist and their implications for your business.
New entries to the Cosmetic Ingredient Hotlist
Retinal
This ingredient was added to the list of substances described as restricted due to therapeutic properties and risk of skin irritation. The maximum concentrations for this ingredient were calculated based on the recommended tolerable upper intake levels for vitamin A.
| Ingredient | Conditions of Use by product type | Maximum concentration permitted |
|---|---|---|
| Retinal | a) Leave-on products intended for full body application | 0.01% |
| b) Other cosmetics | 0.05% |
Thioglycolic acid esters
This ingredient was added to the list of substances described as prohibited due to risk of skin sensitization. A health protective limit could not be calculated based on available data. Additionally, there was evidence that glyceryl thioglycolate can remain on permed hair for at least 3 months after a procedure. Continuous exposure increases the risk for developing skin sensitization and long-lasting dermatitis for people who are already sensitized.
Amended entries of the Cosmetic Ingredient Hotlist
Mixed cresols and derivatives
The entry for mixed cresols and derivatives was amended to create separate entries for different cresols, as the substances have different risk profiles. p-Cresol and mixtures thereof remains prohibited, while new restrictions were created for m-cresol and o-cresol. Conditions for m- and o-cresol were based on a review of the available data indicating that these ingredients may affect the central nervous system when used on mucous membranes or when used at higher concentrations. Minimal risk is expected when used in lower concentrations on areas other than mucous membranes.
| Ingredient | Conditions of Use by product type | Maximum concentration permitted | Warnings and Cautionary Statements: (to the effect of) |
|---|---|---|---|
| m-Cresol | a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose | ||
| b) Other cosmetics | 0.1% | “Do not use in the area of the eye, mouth or nose” | |
| o-Cresol | a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose | ||
| b) Other cosmetics | 0.1% | “Do not use in the area of the eye, mouth or nose” | |
| p-Cresol and mixtures thereof | This ingredient is not permitted in cosmetics. | ||
Peroxide and peroxide-generating compounds
This entry was amended to:
- Introduce a maximum permitted concentration for hair products due to risk of skin irritation at high concentrations
- Introduce conditions for eyelash and eyebrow products due to risk of eye irritation at low concentrations
- Indicate that these ingredients are not permitted for use in products intended for application to the genital area due to risk of irritation
Conditions of use for oral products were not changed from the previous version.
| Ingredient | Conditions of Use by product type | Maximum concentration permitted | Warnings and Cautionary Statements: (to the effect of) |
|---|---|---|---|
| Peroxide and peroxide-generating compounds | a) Not permitted for use in products intended for application to the genital area | ||
| b) Oral products containing peroxides or peroxide-generating compounds Manufacturers should have the following information on hand as it may be requested by Health Canada: • A laboratory report providing pH of the product as applied to tooth or teeth. Section 13 of the Cosmetic Regulations requires that the pH is greater than or equal to 4.0 • Product labelling indicating the directions of use and cautionary statements. • If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit a clinical study to demonstrate the salivary peroxide levels do not exceed 3% during the use of the product as per the directions of use. Note: Be aware of the conversion factor between hydrogen peroxide and other peroxide-generating compounds. For example, 10% carbamide (urea) peroxide is approximately equivalent to 3% hydrogen peroxide | b) “If irritation (such as redness, swelling, soreness) of the gums or the mouth occurs, discontinue use and consult an oral health professional” “Products containing peroxides are not recommended for use by children under 12 years of age” “Consult your oral health professional before prolonged use of this product” “Avoid swallowing the cosmetic or part thereof” “Avoid contact of the product with the eye” “Avoid direct contact of the active surface of the tooth whitening product with the gums and/or salivary flow” | ||
| c) Products for use on eyelashes or eyebrows must be sold for professional use only | c) 10% | c) “For professional use only” “Avoid contact with eyes and, in the event of contact with eyes, rinse immediately with plenty of water and seek medical attention” | |
| d) Hair products | d) 10% (as applied) | ||
| e) Other cosmetics |
Benzoyl peroxide
This entry was amended to indicate that the ingredient may only be used in nail products for professional use. Warnings and cautionary statements to avoid skin contact have been included due to the strong potential to cause irritation and sensitization.
| Ingredient | Conditions of Use by product type | Maximum concentration permitted | Warnings and Cautionary Statements:(to the effect of) |
|---|---|---|---|
| Benzoyl peroxide | Permitted only in nail products for professional use | 10% | “For professional use only” “Avoid skin contact” “Read directions carefully before using” |
Modification of Annex V – Allowed preservatives:
| INCI name | CAS number | Future restriction | Current situation |
|---|---|---|---|
| TRICLOCARBAN | 101-20-2 | Max. 0.2% in all cosmetic products with the exception of mouthwash. Purity criteria: 3,3′,4,4′- Tetrachloroazobenzene ≤ 1 ppm 3,3′,4,4′- Tetrachloroazoxybenzene ≤ 1 ppm Not to be used in toothpaste intended for children under 6 years of age. Obligatory labelling for toothpaste containing Triclocarban: ‘Not to be used for children under 6 years of age’. For uses other than preservative, see Annex III/100. | Max. 1.5% in rinse-off products. Purity criteria: 3,3′,4,4′-Tetrachloroazobenzene ≤ 1 ppm 3,3′,4,4′-Tetrachloroazoxybenzene ≤ 1 ppm. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product. For uses other than preservative, see Annex III/100 (Annex V/23) |
| TRICLOSAN | 3380-34-5 | Max. 0.3% in toothpastes; hand soaps ; body soaps/shower gels; deodorants (non-spray); face powders and blemish concealers; nail product for cleaning the fingernails and toenails before the application of artificial nail systems. Not to be used in toothpaste intended for children under 3 years of age. Obligatory labelling for toothpaste containing Triclosan: ‘Not to be used for children under 3 years of age’. | Max. 0.3% in toothpastes; hand soaps ; body soaps/shower gels; deodorants (non-spray); face powders and blemish concealers; nail product for cleaning the fingernails and toenails before the application of artificial nail systems. Max. 0.2% in Mouthwashes (Annex V/23) |
Retinol and its esters
This entry was amended to reduce the maximum concentration permitted for certain products such as body lotions. Exposure from these products at the previously permitted concentrations may exceed the tolerable upper intake levels of vitamin A that are recommended by Health Canada.
| Ingredient | Conditions of Use by product type | Maximum concentration permitted |
|---|---|---|
| Retinol and its esters | a) Leave-on products intended for full body application | 0.2% total retinol equivalents |
| b) Other cosmetics | 1.0% total retinol equivalents |
Author
Pierre Verachten
Pierre Verachten is Biorius's Cosmetic International Compliance Lead and has been working in the cosmetic industry for more than 10 years.
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