List of Prohibited and Restricted Cosmetic Ingredients
(The Cosmetic Ingredient "Hotlist")

The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Proposed Changes to the Cosmetic Ingredient "Hotlist"
September 5, 2008

Health Canada welcomes comments to this proposal which are to be received no later than 60 calendar days from the above date.

Entries to be Amended:

The entries for the ingredients listed below are to be amended for clarification, to include new information or to include new requirements. Sections in italics have been revised.

Alkali earth metal sulfides (including, but not limited to barium sulfide (21109-95-5), calcium sulfide (20548-54-3), magnesium sulfide (12032-36-9), or strontium sulfide (1314-96-1))

Permitted at concentrations equal to or less than 6% sulfur in hair removal (depilatory) products only.

Alkali sulfides (including, but not limited to lithium sulfide (12136-58-2), potassium sulfide (1312-73-8), or sodium sulfide (1313-82-2))

Permitted at concentrations equal to or less than 2% sulfur in hair removal (depilatory) products only.

Alpha-hydroxy acids (AHAs) (including, but not limited to citric acid (77-92-9), glycolic acid (79-14-1), lactic acid (50-21-5), malic acid (6915-15-7), glycolic acid + ammonium glycolate, alpha-hydroxyethanoic acid + ammonium alpha-hydroxyethanoate, alpha-hydroxyoctanoic acid, alpha-hydroxycaprylic acid, hydroxycaprylic acid, mixed fruit acid, triple fruit acid, tri-alpha hydroxy fruit acids, alpha hydroxy and botanical complex, L-alpha hydroxy acid and glycomer in cross-linked fatty acids alpha nutrium)

Permitted at total concentrations equal to or less than 10%, with a pH equal to or greater than 3.5.

Preparations containing higher concentrations of AHAs may be permitted for professional use if the manufacturer provides Health Canada with evidence of their safety, pH levels, and the directions for use.

The inner and outer labels of all leave-on skin products containing AHAs at concentrations equal to or greater than 3% shall carry cautionary statements to the effect: "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", "Contact of the product with the skin must be of limited frequency and duration."

Preparations intended to be diluted in bath water may contain levels of citric acid exceeding 10%.

Androgenic effects, substances with

Including but not limited to testosterone (58-22-0), prasterone (53-43-0), androstenediol (521-17-5), and androsterone (53-41-8)

Barium salts

Permitted only as barium sulfide (21109-95-5) in hair removal products (see: "Alkali earth metal sulfides"), as barium sulfate (7727-43-7), or as a colouring agent or lake for preparation of other colouring agents.

Benzalkonium chloride (8001-54-5, 61789-71-7, 68391-01-5, 68424-85-1)
Please note the addition of a required cautionary statement due to concerns of eye irritation.

Permitted at concentrations equal to or less than 0.1% as a preservative only (i.e. benzalkonium chloride with chain lengths ≥ 14 C).

Permitted at concentrations equal to or less than 3% in rinse-off hair care products only, as a conditioning agent (i.e. benzalkonium chloride with chain lengths ≥ 16 C). The inner and outer label of all products containing more than 0.1% benzalkonium chloride shall carry a cautionary statement to the effect: "Avoid contact with eyes".

Coal tar dye, coal tar dye base or coal tar dye intermediate (including, but not limited to toluene-2,5-diamine (95-70-5) and toluene-2,5-diamine sulphate (615-50-9)). See also: "p-Phenylenediamine".

All other information associated with this entry remains the same.

Fluoride (16984-48-8) containing substances (including, but not limited to sodium fluoride (1333-83-1,7681-49-4), calcium fluoride (7789-75-5), stannous fluoride (7783-47-3) and sodium monofluorophosphate (10163-15-2))

Not permitted in oral products.

Formaldehyde (50-00-0)

Not permitted in aerosol cosmetics.

Permitted at concentrations equal to or less than 0.1% in oral products.

Permitted at concentrations equal to or less than 0.2% in non-oral products as a preservative only.

Permitted at concentrations equal to or less than 5% in nail hardeners only. Nail hardeners containing formaldehyde must be sold with nail shields, directions for use, and a cautionary statement on the inner and outer labels to the effect: "This product contains formaldehyde which has the potential to cause skin sensitivity".

Gold Salts

Gold Salts (including, but not limited to gold chloride HCl (16903-35-8), gold acetylmethionate (105883-47-4), or gold aspartate/glutamate)

Nail adhesives
(See Cyanoacrylate-based adhesives)

Nitrosamines

Including, but not limited to N-nitrosodiethanolamine (1116-54-7)

Potassium bromate (7758-01-2)

The inner label and the outer label of a cosmetic that contains an amount of potassium bromate equal to or greater than 50 mg shall carry a cautionary statement to the effect: "This product contains potassium bromate, is poisonous, and is to be kept out of the reach of children" and, "In case of accidental ingestion, a Poison Control Centre or physician is to be contacted immediately."

Cosmetics containing an amount of potassium bromate equal to or greater than 50 mg must be packaged in a child-resistant container, according to part II of the Consumer Chemicals and Containers Regulations as they read on September 30th, 2001.

Sodium borate (borax, sodium tetraborate) (1303-96-4)

Permitted at concentrations equal to or less than 5%.

The inner and outer label of the cosmetic shall carry cautionary statements to the effect: "Do not use on broken or abraded skin", "Not to be used by children under three years of age." Warnings are not required where sodium borate is used as a pH adjuster, and the concentration is equal to or less than 0.1%.

Sodium bromate (7789-38-0)

The inner label and the outer label of a cosmetic that contains an amount of sodium bromate equal to or greater than 600 mg shall carry a cautionary statement to the effect: "This product contains sodium bromate, is poisonous, is to be kept out of the reach of children and, in case of accidental ingestion, a Poison Control Centre or physician is to be contacted immediately."

Cosmetics containing an amount of sodium bromate equal to or greater than 600 mg must be packaged in a child-resistant container, according to part II of the Consumer Chemicals and Containers Regulations as they read on September 30th, 2001.

Spironolactone (52-01-7)

Talc

The inner and outer label of preparations in powder form intended for infants and children shall carry cautionary statements to the effect: "Keep out of reach of children, keep powder away from child's face to avoid inhalation which can cause breathing problems."

Triclosan (3380-34-5)

Permitted at concentrations equal to or less than 0.03% in mouthwashes.

Permitted at concentrations equal to or less than 0.3% in other cosmetic products.

All oral products must meet the following conditions:

(a) the labels of oral cosmetics shall carry statements to the effect: "The product is not to be used by children under the age of 12". In the case of mouthwashes, the labels shall also carry a statement to the effect of "Avoid swallowing";

(b) manufacturers must ensure that polychlorinated dibenzo-p-dioxin (PCDD) and polychlorinated dibenzofuran (PCDF) impurities must not be present in quantities that exceed:

1. (i) 0.1 ng/g 2,3,7,8-tetra-chlorodibenzo-p-dioxin and 2,3,7,8-tetra-chlorodibenzofuran
   
   
2. (ii) 10 µg/g total other PCDD/PCDF impurities, with no individual impurity greater than 5 µg/g.

(c) manufacturers must possess the following:

1. (i) raw material specifications for triclosan;
   
   
2. (ii) identification of the method of analysis used to determine the levels of PCDDs and PCDFs in triclosan;
   
   
3. (iii) finished product specifications

Urea (57-13-6)

Permitted at concentrations equal to or less than 10%. Cosmetics intended to be diluted in bath water may contain levels exceeding 10% urea.

Zirconium (7440-67-7) and its compounds

Permitted as aluminum zirconium complexes and as zirconium lakes, salts and pigments of colouring agents only.

Not permitted in aerosol dispensers.

Aluminum zirconium chloride hydroxide complexes Al_xZr(OH)_yCl_z and aluminum zirconium chloride hydroxide glycine complexes are permitted in deodorants only, at concentrations equal to or less than 20%, as anhydrous aluminum zirconium chloride hydroxide and equal to or less than 5.4% as zirconium.

The inner and outer label of cosmetics containing aluminum zirconium chloride hydroxide complexes and aluminum zirconium chloride hydroxide glycine complexes shall carry a cautionary statement to the effect: "Do not apply to irritated or damaged skin".

Note: The ratio of the number of aluminum atoms to that the number of aluminum atoms to that of zirconium atoms must between 2 and 10. The ratio of the number of (Al + Zr) atoms to that of chloride atoms must between 0.9 and 2.1.

Items to be Added:

The entries for the ingredients listed below have been added as restriction or prohibitions.

The following ingredient has been added due to safety concerns with products with quick skin bonding properties.

Cyanoacrylate-based adhesives including, but not limited to ethyl cyanoacrylate (7085-85-0), methyl cyanoacrylate (137-05-3), and isopropyl cyanoacrylate (10586-17-1)

For adhesives used in the area of the eye for the application of false eyelashes:

The following ingredient has been added as a restriction due to toxicity concerns.

Diethylene glycol (DEG) (111-46-6)

Not permitted in oral or leave-on products. (See also: "Glycerin")

The following ingredient has been added as a prohibition in cosmetic products to reflect a declaration of 'toxic' under the Canadian Environmental Protection Act due to health concerns.

Diethylhexyl phthalate (DEHP) (117-81-7)

The following ingredient has been added as a restriction due to possible contamination of diethylene glycol in glycerin.

Glycerin (56-81-5)

Manufacturers of oral and leave-on products containing glycerin must ensure the raw material used is within the specifications of an accepted pharmacopoeia with respect to diethylene glycol (DEG) impurities (e.g. Glycerin Official Monograph in USP30).

The following ingredient has been added as a restriction due to risk of sensitization.

1-Naphthol (90-15-3), and its salts

Permitted at concentrations equal to or less than 2% in hair dyes as an oxidizing colouring agent only.

Permitted at concentrations equal to or less than 1% when used in combination with hydrogen peroxide.

Hotlist Comment Period

A list of the proposed changes to the Hotlist will be posted on the Health Canada Web site for comment. Companies have 60 days to review the proposed changes and respond. Furthermore, companies who have notified products containing proposed Hotlist ingredients will be sent a letter notifying them of the intended changes. Provided there are no comments received initiating further review within this time, the proposed Hotlist decisions will become final.

Submit your comments to:

Cosmetics Program
Health Canada
MacDonald Building
123 Slater Street , 4th Floor A.L. 3504D
Ottawa , Ontario K1A 0K9

Telephone: (613) 946-6452
Facsimile: (613) 952-3039
E-mail: cosmetics@hc-sc.gc.ca

Changes to the Hotlist

Changes to the Hotlist do not undergo an extensive regulatory amendment process. The list is considered to be an elaboration of section 16 of the Food and Drugs Act which states that 'no person shall sell any cosmetic that has in or on it any substance that may cause injury to the health of the user'.

Currently, the list is updated once or twice per year by a Hotlist committee consisting of Cosmetics Division scientists. The group meets on a regular basis to review and discuss ingredients of concern. Conclusions are based on weight of evidence - information is gathered through recognized scientific journals, as well as opinions/decisions on the safety of cosmetic ingredients made by national/international counterparts and expert panel groups.

Hotlist Update Procedure

1. Decision to add ingredient to Hotlist.
2. Proposed changes to the Hotlist are prepared for publication on the Web; comment period opens.
3. Letters to companies are generated advising them of their options and 60-day notice to respond.
4. Company responds or 60-day period expires; comment period closes.
5. Official Hotlist is published.

This process offers greater transparency to all stakeholders and affords companies the opportunity to provide data to Health Canada to support the safety of an ingredient.