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Canada Amends Cosmetic Ingredient Hotlist

The amendments are: 1) Adding 1 prohibited ingredient; 2) Adding 3 restricted ingredients; 3) Revising the requirements of 1 prohibited ingredient; 4) Revising the requirements of 3 restricted ingredients.

Background

The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain ingredients may be prohibited or restricted for use in cosmetics. It consists of two distinct tables, one for ingredients identified as prohibited ingredients and another for those identified as restricted ingredients.

 

1) Prohibited ingredients, including synonyms, salts and related compounds, should not be present in cosmetic products sold in Canada.

2) Restricted ingredients are permitted only if the conditions of use and/or cautionary statement(s) are met as outlined in the Hotlist. If the ingredient has a concentration restriction, notifiers to provide the exact concentration used in the product at the time of notification will help expedite Health Canada’s processing of the Cosmetic Notification Form.

 

The Hotlist is a science-based document reviewed and updated periodically when new scientific data becomes available.

On July 13, 2023, Health Canada issued a notice regarding the review of proposed amendments to the Cosmetic Ingredient Hotlist. 1 In May 2024, Canada implemented revised usage requirements for nine cosmetic ingredients 2, followed by amendments to four entries in February 2025. 3 Please refer to the table below for details on these updates.

Comments on the proposed changes to “Aluminum chlorohydrate and its associated complexes” are still under review.

1. Adding 1 prohibited ingredient

No.

Ingredient name

Synonyms and related compounds (including, but not limited to)

CAS   No. (including, but not limited to)

Reasons for addition

1

Thioglycolic acid esters

Glyceryl thioglycolate; Isooctyl thioglycolate

30618-84-9; 25103-09-7

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.

2) Adding 3 restricted ingredients

No.

Ingredient name

Synonyms and related compounds (including, but not limited to)

CAS No. (including, but not limited to)

Conditions of use by product type

Maximum concentration permitted

Warnings   and cautionary statements (to the effect of)

Reasons for addition

1

Retinal

Retinaldehyde

116-31-4

a) Leave-on products intended for full body application

a) 0.01%

/

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.

b) Other cosmetics

b) 0.05%

2

m-Cresol

/

95-48-7; 108-39-4

a) Not permitted in cosmetics intended to be used on or around mucosal membranes such as eyes, nose or mouth

/

/

Potential effects on the central nervous system when used on mucous membranes or when used at higher concentrations. There is minimal risk when used in lower concentrations on areas other than   mucous membranes.

b) Other cosmetics

0.1%

"Do not use in the area of the eye,   mouth or nose"

3

o-Cresol

/

95-48-7; 108-39-4

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"

3) Revising the requirements of 1 prohibited ingredient

No.

Ingredient   name

Synonyms and related compounds (including, but not limited to)

CAS No. (including, but not limited to)

Revisions

1

p-Cresol and mixtures thereof

Mixed cresols

106-44-5; 1319-77-3

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.

Notes: The text in red indicates changes to the previous lists.

4) Revising the requirements of 3 restricted ingredients

No.

Ingredient name

Synonyms and Related Compounds (including, but not limited to)

CAS   (including, but not limited to)

Conditions of use by product type

Maximum concentration permitted

Warnings and cautionary statements (to the effect of)

Revisions

1

Peroxide and peroxide-generating compounds

124-43-6; 1305-79-9; 7722-84-1;   1335-26-8; 7632-04-4; 1314-22-3

Urea peroxide; calcium peroxide; calcium dioxide; hydrogen peroxide; magnesium peroxide; sodium perborate; zinc   peroxide

a) Not permitted for use in products intended for application to the genital area

/

/

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.

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 be 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.

/

"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

/

/

2

Benzoyl peroxide

94-36-0

/

Permitted only in nail products for professional use

10%

"For professional use only"

 

"Avoid skin   contact"

 

"Read directions carefully   before using"

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.

3

Retinol and its esters

68-26-8; 127-47-9; 79-81-2; 631-89-0; 7069-42-3

Vitamin A; Retinyl acetate; Retinyl   palmitate; Retinyl linoleate; Retinyl propionate

a) Leave-on products intended for full body application

0.2% total retinol equivalents

/

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.

b) Other cosmetics

1.0% total retinol equivalents

Notes: The text in red indicates changes to the previous lists.

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