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. Last update to the Hotlist was in August 2022.

No.

Ingredient name

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

CAS No. (including, but not limited to)

Reasons for addition

1

Basic Green 4 (malachite green and its salts)

Malachite green; CI 42000; malachite green hydrochloride; malachite green oxalate

569-64-2, 18015-76-4

Potential developmental effects, as assessed by the Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999).

2

Thioglycolic acid esters

Glyceryl thioglycolate; Isooctyl thioglycolate

30618-84-9; 25103-09-7

Risk of skin sensitization. Glyceryl thioglycolate can remain on permed hair for at least 3 months after use. Continuous exposure increases the risk for skin sensitization and long-lasting dermatitis for people who are already sensitized.

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

Benzophenone

/

119-61-9

/

3%

/

Potential adverse maternal effects, such as decreased body weight, as assessed by CMP under CEPA 1999.

2

p-Chloro-m-cresol

Chlorocresol

59-50-7

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

/

/

Potential effects on adrenal organs of certain cosmetic uses, as assessed by CMP under CEPA 1999.

b) Other cosmetics

0.1%

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

3

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 ingredient is currently listed in Health Canada's Natural Health Products Ingredients Database whose concentration has an upper limit of 0.05% for use as a non-medicinal ingredient in creams.

b) Other cosmetics

b) 0.05%

4

Solvent Violet 13

CI 60725; Violet 2

81-48-1

a) Nail products

/

/

Possible health concerns for certain cosmetic uses, as assessed by CMP under CEPA 1999.

b) Other cosmetics

0.3%

5

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"

6

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, nose or mouth

/

/

b) Other cosmetics

0.1%

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

No.

Ingredient name

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

CAS (including, but not limited to)

Proposed revisions

1

p-Cresol and mixtures thereof

Mixed cresols

106-44-5; 1319-77-3

Due to the different risk profiles of the ingredients in the current entry, a revision to create separate entries for different cresols is being considered:

• A revision of the current entry "Mixed cresols and derivatives" to "p-Cresol and mixtures thereof" on the prohibited list is being considered, as there is insufficient data to support the safe use of p-cresol and mixed cresols containing p-cresol;
• A new entry for o-cresol and m-cresol on the restricted list is being considered. A review of the available scientific data indicates that the ingredients may have health concerns when used at higher concentrations or on mucous membranes but can be used at low concentrations in cosmetics without significant risk that are applied to other areas.

2

Secondary alkyl- and alkanolamines and their salts

Diethanolamine (DEA); Diisopropanolamine (DIPA); DEA-Cetyl Phosphate; DEA-Oleth-3 Phosphate; DEA-Oleth-10 Phosphate; Spermidine; Spermidine HCl; Diisopropylamine

111-42-2; 110-97-4; 69331-39-1; 61693-41-2; 58855-63-3; 124-20-9; 334-50-9; 108-18-9

A revision is being considered to expand the current entry “Dialkanolamines, secondary” to "Secondary alkyl- and alkanolamines and their salts" due to similar properties in their potential as carcinogenic nitrosamine precursors.

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

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)

Proposed revisions

1

Alpha-hydroxy acids, including polyhydroxy acids and bionic acids with alpha hydroxyl groups, and their salts

77-92-9; 79-14-1; 50-21-5; 133-37-9; 6915-15-7; 79-33-4; 5949-29-1; 617-73-2; 90-64-2; 35249-89-9

Citric acid; Glycolic acid; Lactic acid; Malic acid; Mandelic acid; Tartaric acid; Ammonium glycolate; Sodium citrate; Hydroxycaprylic acid; Mixed fruit acids; Gluconolactone; Ammonium gluconate; Lactobionic acid; Calcium lactobionate

a) Skin products for consumer use

Manufacturer to provide pH levels

a) Between 3% and 18% total mono-AHA equivalents with a pH equal to or greater than 3.5

a) and b) "Use only as directed"

"Avoid contact with the eyes"

"If irritation persists, discontinue use and consult a physician"

"It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied with sunscreen"

Product labels should contain appropriate directions regarding frequency and/or duration of use

b only) "For professional use only"

• Polyhydroxy acids (PHAs) and bionic acids do not have their own entry on the Hotlist. They're grouped under the entry for alpha-hydroxy acids (AHAs), as they meet the chemical definition of AHAs. A revision is being considered to clarify that Polyhydroxy acids (PHAs) and bionic acids with alpha-hydroxyl groups, as well as their salts, are included in this entry;
• A revision is being considered to update the warnings and cautionary statements, as well as add product-specific directions for the safe use.

b) Skin products for professional use

Manufacturer to provide evidence of safety, including:

• pH levels
• AHA concentrations
• directions for use
• clinical studies demonstrating minimal skin irritation

b) Between 18% and 30% total mono-AHA equivalents and/or a pH between 3.0 to 3.5

c) Products intended to be diluted in bath water may contain levels of citric acid exceeding 10%

/

/

d) Other cosmetics

d) Between 3% and 30% total mono-AHA equivalents with a pH equal to or greater than 3.0

d) "Use only as directed"

"Avoid contact with the eyes"

"Discontinue use if rash or irritation occurs"

e) Any cosmetics

3%

/

2

Polyhydroxy acids and bionic acids with alpha hydroxyl groups

/

Gluconolactone; Ammonium gluconate; Lactobionic acid; Calcium lactobionate

Refer to Alpha-hydroxy acids

/

/

3

Aluminum chlorohydrate and its associated complexes

12042-91-0; 1327-41-9; 173762-81-7; 173762-82-8; 10284-64-7; 173720-80-4; 180324-83-8; 11097-68-0; 173763-15-0; 242812-86-8; 173763-16-1; 245090-60-2

Aluminum chlorohydrate; Ammonium gluconate; Aluminum chlorohydrex PEG; Aluminum chlorohydrex PG; Aluminum dichlorohydrate; Aluminum dichlorohydrex PEG; Aluminum dichlorohydrex PG; Aluminum sesquichlorohydrate; Aluminum sesquichlorohydrex PEG; Aluminum sesquichlorohydrex PG

a) Not permitted in combination with aluminum chloride, other aluminum chlorohydrate complexes or aluminum zirconium complexes

b) Not permitted in deodorants and antiperspirants in aerosol dispensers

/

/

A revision is being considered to indicate that aluminum chlorohydrate and its associated complexes are not permitted in aerosol products. Inhaling small particles produced from aerosols may affect lungs.

c) Deodorants and antiperspirants

c) 25% (calculated as the anhydrous form)

c) "Discontinue use if rash or irritation occurs"

"Do not use on broken skin"

4

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

/

/

The following revisions are being considered:

• introducing a maximum permitted concentration for hair products due to risk of skin irritation at high concentrations;
• introducing permitted use conditions for eyelash and eyebrow products due to risk of eye irritation at low concentrations;
• indicating peroxide and peroxide-generating compounds are not permitted for use in products intended for application to the genital area due to risk of irritation.

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

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 cosmetic products

/

/

5

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"

A revision is being considered to indicate the ingredient may only be used in nail products for professional use. Skin contact is to be avoided, due to the strong potential to cause irritation and sensitization.

6

Hydroquinone

123-31-9

1,4-dihydroxybenzene

a) Oxidizing colouring agent for hair dyes

a) 0.3%

a) "Contains hydroquinone"

"Do not use to dye eyelashes or eyebrows"

"Rinse eyes immediately if the product comes into contact with eyes"

A revision is being considered for permitted nail product categories to include products for consumer use, increase the maximum concentration permitted for these products, and introduce a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product.

b) Nail products

b) 0.1%

If Hydroquinone and p-Hydroxyanisole are used in the same product, the total concentration of the 2 ingredients may not exceed 0.1%

b) "Avoid skin contact"

"Read directions carefully before using"

c) Cyanoacrylate adhesive products for eyelash and eyebrow extensions

c) 0.1%

c) "Avoid skin contact"

"Read directions carefully before using"

7

p-Hydroxyanisole

150-76-5

4-methoxyphenol

Permitted only in nail products

0.1%

If Hydroquinone and p-Hydroxyanisole are used in the same product, the total concentration of the 2 ingredients may not exceed 0.1%

"Avoid skin contact"

"Read directions carefully before using"

A revision is being considered to introduce a combined limit when both p-Hydroxyanisole and hydroquinone are used in a single nail product.

8

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

/

A revision is being considered to reduce the concentration permitted for certain products such as body lotions. Exposure from such products at current permitted concentrations may exceed the tolerable upper intake levels of vitamin A recommended by Health Canada.

b) Other cosmetics

1.0% total retinol equivalents

9

Talc

14807-96-6

/

Note: Certain products may fall under more than 1 product category and may have multiple applicable conditions

Read entire entry to determine all applicable conditions

/

/

A revision is being considered to reduce exposure to talc from cosmetics that may be inhaled or may result in genital exposure to the population with intact ovary/ovaries.

a) Not permitted in products intended for use in the vaginal area

/

/

b) Products that could come in contact with the genital area (for example, diapering products, body powder, bath products)

/

b) "Do not use in the genital area of those who have ovaries"

c) Diapering products in loose powder form

c) 51%

c), d) and e) "Keep out of reach of children"

"Keep powder away from child's face to avoid inhalation, which can cause breathing problems"

d) Other products in loose powder form intended for use on the face or body

d) 77%

e) Other products in loose powder form (for example, dry shampoo, foot powder)

/

f) Other cosmetics

/

/

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