Health Canada Hotlist Updates - February 2025

Health Canada has made the following changes to the Hotlist that go into effect immediately. For more information visit https://www.iri-sys.com/

Substances Added

Retinal

Retinal/Retinaldehyde (CAS No. 116-31-4) has been added to the List of Ingredients that are Restricted for Use in Cosmetic Products.? Maximum permissible use level in leave-on products intended for full body application is 0.01%.? The maximum permissible use level in other cosmetic products is 0.05%.? Reason for listing: 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

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Thioglycolic Acid esters

Health Canada has added Thioglycolic Acid esters to the List of Ingredients that are Prohibited for Use in Cosmetic Products.? Specifically, Health Canada has banned the use of Glyceryl Thioglycolate (CAS No. 30618-84-9) and Isoocytl Thioglycolate (CAS No. 25103-09-7).? While not explicitly listed on the Hotlist, there are other Thioglycolic Acid esters, that may also be covered by this ban and include:

1. 2-Ethylhexyl Thioglycolate (also known as Octyl Thioglycolate)
2. Methyl Thioglycolate
3. Butyl Thioglycolate
4. Isopropyl Thioglycolate
5. Ethyl Thioglycolate

Reason for listing: Risk of skin sensitization. Safe use levels 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.

Substances Amended

Mixed Cresols and derivatives

Health Canada has modified this category of chemicals.? P-Cresol (CAS No. 106-44-5, 1319-77-3) has not changed and is still on the List of Ingredients that are Prohibited for Use in Cosmetic Products.? m-Cresol (CAS No. 95-48-7, 108-39-4) and o-Cresol (CAS No. 95-48-7, 108-39-4) – Not permitted for use in cosmetics intended to be used on or around mucosal membranes such as eyes, mouth or nose.? The maximum permissible use level in other cosmetic products is 0.1%.? Products containing m-Cresol or o-Cresol must be labeled with the warning, “Do not use in the area of the eye, mouth or nose.”? Reason for changes: To create separate entries for different cresols, as the substances have different risk profiles.?p-Cresol and mixtures thereof?remain 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.

Peroxide and peroxide-generating compounds

Health Canada amended the following ingredients - Urea Peroxide (CAS No. 124-43-6), Calcium Peroxide (CAS No. 1305-79-9), Calcium Dioxide (CAS No. 7722-84-1), Hydrogen Peroxide (CAS No. 1335-26-8), Magnesium Peroxide (CAS No.? 7632-04-4), Sodium Perborate (CAS No. 1314-22-3), Zinc Peroxide (CAS No. 1314-22-3) There are no changes to the use in oral products.?

Not permitted for use in products intended for application to the genital area.? 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 for use and cautionary statements.
• If an oral cosmetic contains more than 3.0% hydrogen peroxide (or equivalent), notifiers must submit a clinical study to demonstrate the salivary peroxide levels do not exceed 3.0% 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, 10.0% carbamide (urea) peroxide is approximately equivalent to 3.0% hydrogen peroxide.? Oral products containing peroxides or peroxide-generating compounds must be labeled with the warning, "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".

Maximum permissible use level in products for use on eyelashes or eyebrows containing peroxide and peroxide-generating compounds is 10.0%.? Products for use on eyelashes or eyebrows containing peroxide and peroxide-generating compounds are for professional use only and must be labeled with the warning, “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”.? Maximum permissible use level in hair products is 10.0% (as applied).?

?Benzoyl Peroxide

Benzyl Peroxide (CAS No. 94-36-0) was amended to maximum permissible use level in professional use nail products only is 10.0%.? Products must be labeled with the warning, "For professional use only.? Avoid skin contact.? Read directions carefully before using."? Reason for changes: This 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.

Retinol and its esters

Health Canada has amended the use level of retinol and its esters – Vitamin A (CAS No. 68-26-8), Retinyl Acetate (CAS No. 127-47-9), Retinyl Palmitate (CAS No. 79-81-2), Retinyl Linoleate (CAS No. 631-89-0), Retinyl Propionate (CAS No. 7069-42-3).? Maximum permissible use level in leave-on products intended for full body application is 0.2% total retinol equivalents.? Maximum permissible use level in other cosmetic products is 1.0% total retinol equivalents.? Reason for changes: 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.