Proposed updates to the Cosmetic Ingredient Hotlist: Prohibited and restricted ingredients

Health Canada is proposing to update the Cosmetic Ingredient Hotlist. Updates include additions, changes to the conditions for existing entries and changes to include new substance identifiers or make minor corrections.

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Background

The Cosmetic Ingredient Hotlist is used to inform manufacturers and others that certain substances, when present in a cosmetic, may contravene either:

The Hotlist may also communicate that the presence, or use under specific conditions, of certain substances may also make the product unsuitable for classification as a cosmetic under the FDA.

Health Canada updates the Hotlist periodically, as needed. The last update to the Hotlist was in August 2022.

The Hotlist is not exhaustive. Those selling cosmetics must not wait for a regulatory or Hotlist update to comply with the general prohibition. To comply with section 16 of the FDA, the sale of a cosmetic should stop as soon as it's known that the cosmetic may cause injury.

Proposed updates to the Hotlist are put forward as needed and conclusions are based on weight of evidence. This evidence includes recognized scientific journals and the opinions or decisions of national or international counterparts and expert panel groups.

We are proposing updates to the Hotlist for consultation for a 90-day comment period. We will respond to comments received during the consultation period before publishing the revised Hotlist.

When the final updated Hotlist is published, we will also send a notice to subscribers to the cosmetics mailing list and those who have previously submitted a cosmetic notification form.

Proposed additions

Prohibitions

Table 1. Proposed Hotlist conditions for Basic Green 4
Ingredient CAS (including, but not limited to) Synonyms and related compounds (including, but not limited to)
Basic Green 4 (malachite green and its salts) 569-64-2, 18015-76-4 Malachite green; CI 42000; malachite green hydrochloride; malachite green oxalate

For more information, please refer to the Basic Green 4 information sheet.

Basic Green 4 information sheet

CAS registry number: 569-64-2

Synonyms (including): malachite green; Methanaminium, N-[4-[[4-(Dimethylamino)Phenyl]Phenylmethylene]-2,5-Cyclohexadien-1-ylidene]-N-Methyl-, Chloride

Background

Under the Chemicals Management Plan, the Government of Canada screened a group of chemicals called the Triarylmethanes Group. The final screening assessment was published on October 17, 2020. In the assessment, health concerns were found concerning Basic Green 4, which is used in some cosmetics. To protect those who live in Canada who may use cosmetics with this ingredient, we propose to add it to the Hotlist.

Populations that are disproportionately impacted

Some people in Canada, including infants, children or people of reproductive age, may be more likely to experience adverse health effects after coming into contact with Basic Green 4. These individuals may be more susceptible to its health effects or may be exposed to greater amounts of the ingredient. We considered all data that were available for these groups in our review.

Current status

At this time, Basic Green 4 is not listed on the Hotlist.

Cosmetic uses

Basic Green 4 is used to colour hair. In the last 5 years, we were notified of its use in a small number of temporary hair colouring products at concentrations between 0.1% and 1%.

Human exposures

When using cosmetics, consumers may be exposed to Basic Green 4 through their skin.

Key health effects

Since there were no studies available on Basic Green 4, we used data on malachite green oxalate, a salt of Basic Green 4 (also called malachite green). This substance has similar physical-chemical and structural properties to Basic Green 4.

As there were no health studies where malachite green oxalate was applied to skin, we reviewed studies where malachite green oxalate was taken by mouth. When taken orally, malachite green oxalate caused adverse effects to the developing fetus, including:

  • decreased fetal survival
  • decreased fetal body weight
  • increased pre-implantation loss
  • increased early fetal resorptions
  • increased skeletal deviations

Risk assessment outcomes

We reviewed the scientific studies and known uses of Basic Green 4 in cosmetics. Levels that people in Canada may be exposed to were determined based on the types of products notified and the levels of Basic Green 4 in those products. We compared these exposure levels to the amounts associated with adverse health effects. We found that current uses of Basic Green 4 (0.1% to 1.0% in a small number of temporary hair colouring products) may pose a risk to human health, even at the lowest amount of 0.1%.

Proposed risk management actions

We propose to:

  • describe Basic Green 4 as prohibited on the Hotlist because the calculated health protective limit is significantly below the lowest notified concentration of 0.1%

These information sheets are part of a pilot project to provide additional information on proposed Hotlist changes. Comments provided on format, language, location and types of information included will be used to inform our future Hotlist consultations.

Table 2. Proposed Hotlist conditions for thioglycolic acid esters
Ingredient CAS (including, but not limited to) Synonyms and related compounds (including, but not limited to)
Thioglycolic acid esters 30618-84-9; 25103-09-7 Glyceryl thioglycolate; Isooctyl thioglycolate

Restrictions

Table 3. Proposed Hotlist conditions for benzophenone
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
Benzophenone 119-61-9 - - 3% -
Table 4. Proposed Hotlist conditions for p-Chloro-m-cresol
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
p-Chloro-m-cresol 59-50-7 Chlorocresol 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
Table 5. Proposed Hotlist conditions for retinal
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
Retinal 116-31-4 Retinaldehyde a) Leave-on products intended for full body application a) 0.01% -
b) Other cosmetics b) 0.05% -
Table 6. Proposed Hotlist conditions for Solvent Violet 13
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
Solvent Violet 13 81-48-1 CI 60725; Violet 2 a) Nail products - -
b) Other cosmetics 0.3% -

Proposed revisions to existing entries

Prohibitions

Table 7. Proposed Hotlist conditions for p-Cresol and mixtures thereof
Ingredient CAS (including, but not limited to) Synonyms and related compounds (including, but not limited to)
p-Cresol and mixtures thereof 106-44-5; 1319-77-3 Mixed cresols
Table 8. Proposed Hotlist conditions for m-cresol
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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 - -
b) Other cosmetics 0.1% "Do not use in the area of the eye, mouth or nose"
Table 9. Proposed Hotlist conditions for o-Cresol
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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"
Table 10. Proposed Hotlist conditions for secondary alkyl- and alkanolamines and their salts
Ingredient CAS (including, but not limited to) Synonyms and related compounds (including, but not limited to)
Secondary alkyl- and alkanolamines and their salts 111-42-2; 110-97-4; 69331-39-1; 61693-41-2; 58855-63-3; 124-20-9; 334-50-9; 108-18-9 Diethanolamine (DEA); Diisopropanolamine (DIPA); DEA-Cetyl Phosphate; DEA-Oleth-3 Phosphate; DEA-Oleth-10 Phosphate; Spermidine; Spermidine HCl; Diisopropylamine

Restrictions

Table 11. Proposed Hotlist conditions for alpha-hydroxy acids, including polyhydroxy acids and bionic acids with alpha hydroxyl groups, and their salts
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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"

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%  
Table 12. Proposed Hotlist conditions for polyhydroxy acids and bionic acids with alpha hydroxyl groups
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
Polyhydroxy acids and bionic acids with alpha hydroxyl groups - Gluconolactone; Ammonium gluconate; Lactobionic acid; Calcium lactobionate Refer to Alpha-hydroxy acids - -
Table 13. Proposed Hotlist conditions for aluminum chlorohydrate and its associated complexes
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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

- -
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"

Table 14. Proposed Hotlist conditions for peroxide and peroxide-generating compounds
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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 - -

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 - -
Table 15. Proposed Hotlist conditions for benzoyl peroxide
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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"
Table 16. Proposed Hotlist conditions for hydroquinone
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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"
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"

For more information, please refer to the hydroquinone information sheet.

Hydroquinone information sheet

CAS registry number: 123-31-9

Synonyms (including): 1,4-Benzenediol, 4-Hydroxyphenol, p-Hydroxyphenol, 1,4-Dihydroxybenzene, p-Dioxybenzene

Background

The current limit of 0.02% for 2-component artificial nail systems was implemented following a 2008 Chemicals Management Plan assessment. The assessment concluded that hydroquinone met the Canadian Environmental Protection Act (CEPA), Section 64(c) criteria because of a possible direct DNA-damaging (genotoxic) effect causing kidney cancer (nephrocarcinogenicity).

Since the 2008 assessment, the European Union's Scientific Committee on Consumer Safety (SCCS) and the Cosmetic Ingredient Review (CIR) reviewed scientific studies showing that the kidney cancer observed in the earlier study was caused by a different (non-genotoxic) effect. In light of new safety data and the fact that newer nail products do not require pre-mixing, Health Canada's Consumer Product Safety Program re-examined the existing conditions for the ingredient, particularly for nail products. As a result, on November 18, 2022, we proposed to make changes to the Hotlist conditions for hydroquinone.

Populations that are disproportionately impacted

Some people in Canada, including infants, children and people of reproductive age, may be more likely to experience adverse health effects after coming into contact with hydroquinone. These individuals may be more susceptible to its adverse health effects or may be exposed to greater amounts of hydroquinone. We considered all data that were available for these groups in our review.

Current status

Hydroquinone is listed as restricted on the Hotlist. It may only be used in some products under the following conditions:

  • in 2-component (acrylic) artificial nail systems at a maximum permitted concentration of 0.02% (after mixing for use)
  • in cyanoacrylate adhesive products at a maximum permitted concentration of 0.1%
  • as an oxidizing colouring agent for hair dyes at a maximum permitted concentration of 0.3%

Cautionary statements are also required on the labels of these products.

Other types of products sold in Canada have limits on hydroquinone, which is on the Prescription Drug List and in the Natural Health Products Ingredients Database. Products for use on the skin (topical) with up to 2% hydroquinone may be sold as natural health products. Products with more than 2% hydroquinone may be considered prescription drugs.

Cosmetic uses

Hydroquinone is used in cosmetics as a reducing agent, antioxidant, hair colourant and fragrance ingredient. In the last 5 years in Canada, it was notified in about 700 products, mostly nail polishes and adhesives, at concentrations ranging from less than 0.1% up to 0.3%.

Human exposures

When using cosmetics, consumers may be exposed to hydroquinone through their skin when they apply products containing this ingredient to their nails, hair or eyelashes.

Key health effects (hazards)

Hydroquinone causes the following 3 critical health effects in people:

  • loss of skin colour (depigmentation)
  • skin darkening (exogenous ochronosis)
  • kidney cancer (renal carcinogenesis)

Skin irritation and allergy (sensitization) effects were also considered.

Risk assessment outcomes

We concluded that for artificial nail systems, a concentration of 0.1% hydroquinone when ready/prepared for application is scientifically supported. This amount of hydroquinone is below the level that:

  • can cause changes in skin colour (depigmentation and exogenous ochronosis) and
  • is of concern for kidney cancer (calculated lifetime cancer risk)

The existing maximum permitted concentrations of 0.3% for oxidizing hair dyes and 0.1% for cyanoacrylate adhesives (not for use on skin) are still supported in the scientific literature. They are below the level of concern for potential cancer and skin colour changes.

Another ingredient on the Hotlist, p-hydroxyanisole, functions the same way as hydroquinone in nail products. It poses similar risks for skin colour changes. For products with both ingredients, the combined amounts should not exceed 0.1%.

Proposed risk management actions

We propose the following:

  • the maximum permitted concentration of hydroquinone in artificial nail systems be increased from 0.02% (after mixing for use) to 0.1% (as applied) in all nail products
  • for nail products with both hydroquinone and p-hydroxyanisole, the total amount of hydroquinone and p-hydroxyanisole should not exceed 0.1% (as applied)

We are not considering changes to the conditions of use as an oxidizing colouring agent for hair dyes and in cyanoacrylate adhesive products. We propose to make the product category descriptions clearer.

These information sheets are part of a pilot project to provide additional information on proposed Hotlist changes. Comments provided on format, language, location and types of information included will be used to inform our future Hotlist consultations.

Table 17. Proposed Hotlist conditions for p-Hydroxyanisole
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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"
Table 18. Proposed Hotlist conditions for retinol and its esters
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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 -
b) Other cosmetics 1.0% total retinol equivalents -
Table 19. Proposed Hotlist conditions for talc
Ingredient information Restriction
Chemical CAS (including, but not limited to) Synonyms and Related Compounds (including, but not limited to) Conditions of use by product type Maximum concentration permitted Warnings and cautionary statements (to the effect of)
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) 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 - -

Other miscellaneous revisions

Several existing entries will be revised to include new synonyms and Chemical Abstract Service Registry (CAS) numbers or make minor corrections.

Provide feedback

The Government of Canada is committed to providing people in Canada and other stakeholders with the opportunity to participate in the development of regulatory initiatives.

Health Canada invites stakeholders to submit comments on the changes we're proposing. Changes to the Hotlist include:

Please supply evidence to support your comments, if possible.

Please provide comments no later than October 11, 2023, by email or in writing to:

Hotlist Coordinator
Cosmetics Program
Consumer and Hazardous Products Safety Directorate
Health Canada
269 Laurier Ave West
Address Locator: 4908A
Ottawa ON K1A 0K9

Email: cosmetics@hc-sc.gc.ca

We invite you to:

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