Proposed updates to the Cosmetic Ingredient Hotlist: Prohibited and Restricted Ingredients
The purpose of this document is to solicit comments on a proposal to update the Cosmetic Ingredient Hotlist. The proposal includes the following:
- additions to the Hotlist
- changes to the conditions for existing entries on the Hotlist
- changes to include new substance identifiers or make minor corrections
Background
The Cosmetic Ingredient Hotlist is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain substances, when present in a cosmetic, may contravene the general prohibition found in section 16 of the Food and Drugs Act (FDA) or a provision of the Cosmetic Regulations. In addition, the Hotlist communicates that the presence, or use under specific conditions, of certain substances may make the product unsuitable for classification as a cosmetic under the FDA. The Hotlist is not exhaustive, and those selling cosmetics must not wait for a regulatory or Hotlist update in order to comply with the general prohibition. The sale of a cosmetic should stop as soon as it is known that the cosmetic may cause injury, in order to comply with section 16 of the FDA.
Proposed updates to the Hotlist are put forward as needed, and conclusions are based on weight of evidence. Information is gathered through a review of recognized scientific journals, as well as opinions or decisions made by national or international counterparts and expert panel groups. The last update to the Hotlist was in December 2019.
The proposed updates to the Hotlist are posted for consultation for a 60-day comment period. Prior to publication of the final revised Hotlist, Health Canada will respond to comments received during the consultation. Following evaluation of information and comments received during the consultation, the revised Hotlist will be posted on the website. Additionally, a notice will be sent to subscribers to the Cosmetics Mailing List as well as all notifiers who have previously submitted a cosmetic notification form.
Proposed Additions to the Hotlist
Restrictions:
Ethylhexyl Ethylhexanoate: Ethylhexyl Ethylhexanoate is being considered for addition to the list of restricted substances due to health concerns, as assessed by the Government of Canada's Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999).
| 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) |
| Ethylhexyl Ethylhexanoate | 7425-14-1 | 2-Ethylhexyl-2-ethylhexanoate | a) Body lotion | 0.1% | - |
| b) Foot lotion | 0.5% | ||||
| c) Face make-up | 0.6% | ||||
Azelaic acid and its salts: Azelaic acid and its salts are being considered for addition to the list of restricted substances due to therapeutic properties at certain concentrations and risk of skin irritation at high concentrations.
| 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) |
| Azelaic acid and its salts | 123-99-9; 52457-54-2; 132499-85-5; 17265-13-3; 27825-99-6 | Nonanedioic acid; Disodium Azelate; Dipotassium Azelate | a) Leave-on products | 0.3% | - |
| b) Rinse-off products | 10% | ||||
Proposed revisions to existing entries on the Hotlist
The entries for the following ingredients are proposed to be revised to reflect changes in requirements.
Prohibitions:
Retinoic acid: The entry will be revised to clarify that derivatives and salts of retinoic acid are captured by the entry. These substances are currently captured under the Prescription Drug List entry for “Tretinoin or its salts or derivatives”. While the Prescription Drug List (PDL) does not pertain to cosmetic products, a Hotlist entry can communicate that the presence, or use under specific conditions, of certain substances (including some PDL substances), may make the product unsuitable for classification as a cosmetic under the FDA. Retinoic acid has known therapeutic action at low concentration, with marketed prescription drugs for topical use containing retinoic acid at a concentration as low as 0.01% listed in Health Canada’s Drug Product Database. The available scientific evidence suggests that derivatives of retinoic acid display an innate retinoic acid activity, as supported by their therapeutic use in topical products at concentrations that overlap with the therapeutic range of retinoic acid.
| Ingredient | CAS (including but not limited to) | Synonyms and Related Compounds (Including but not limited to) |
|---|---|---|
| Retinoic acid or its salts or derivatives | 302-79-4; 4759-48-2; 893412-73-2; 74534-80-8 | Tretinoin; cis-Retinoic Acid; Hydroxypinacolone Retinoate; Ethyl Lactyl Retinoate |
Restrictions:
Alpha-Hydroxy Acids: Polyhydroxy acids (PHAs) and bionic acids do not have their own entry on the Hotlist, however they are captured under the entry for alpha-hydroxy acids (AHAs), since they meet the chemical definition of AHAs. The entry will be revised to clarify that PHAs and bionic acids with alpha-hydroxyl groups, as well as their salts, are captured by the existing entry. At this time, information available to Health Canada is not sufficient to conclude that the dermal effects of PHAs and bionic acids are significantly lower than those of other AHAs at the levels used in cosmetics.
Additional revisions are being considered to further clarify the entry, including updates to the warnings and cautionary statements, and considerations for product-specific directions for safe use.
| 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
|
|
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a) Skin Products intended for consumer use: Manufacturer must provide Health Canada with pH levels. |
a) Between 3% and 10% total mono-AHA equivalents with a pH equal to or greater than 3.5 |
a) and b) "Use only as directed.", Note: 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:
|
b) Between 10% and 30% total mono-AHA equivalents and/or a pH between 3.0 to 3.5 |
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c) Products intended to be diluted in bath water may contain levels of citric acid exceeding 10%. |
- |
- |
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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.", |
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e) Any cosmetics |
3% |
- |
|||
Eucalyptus oil: A revision to the entry is being considered to better mitigate risk of unintentional ingestion, particularly in pediatric populations. Comments received in response to the consultation posted in May 2019 have been reviewed and were significant, requiring further consultation. Changes under consideration include modifications to the cautionary statements, as well as limiting cautionary statements for certain product types only.
| 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) |
| Eucalyptus oil | 8000-48-4; 85203-56-1; 1627700-32-6; 91771-69-6; 90028-48-1 | Eucalyptus Globulus Leaf Oil; Eucalyptus Citriodora Oil; Eucalyptus Radiata Leaf/Stem Oil; Eucalyptus Staigeriana Branch/Leaf Oil; Eucalyptus Dives Leaf/Twig Oil | a) Cosmetics in solid forms | - | - |
| b) Cosmetics in other forms | b) greater than 0.022% | b) "This product contains eucalyptus", "Keep out of reach of children", and "In case of accidental ingestion, call a Poison Control Centre or doctor immediately." | |||
| c) Cosmetics in other forms | c) 0.022% | - | |||
Peroxide and peroxide-generating compounds: For oral cosmetics containing more than 3% hydrogen peroxide (or equivalent), a revision to the entry is being considered to require hydrogen peroxide levels in saliva only, and not within the soft tissue of the oral cavity. Furthermore, a removal of the statement allowing evidence that may include analog studies from recognized sources or independent clinical research, is being considered.
| 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 |
|
|
Oral products containing peroxides or peroxide-generating compounds: Manufacturers should have the following information on hand as it may be requested by Health Canada:
NB: 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." |
p-Hydroxyanisole: A revision to the entry is being considered to expand the permitted nail product categories, including products for consumer use, and increase the maximum concentration permitted for these products.
| 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 | Nail products | 0.1% | "Avoid skin contact", "Read directions carefully before using." |
Other miscellaneous revisions:
In addition to the above changes, several existing entries will be revised to include new synonyms and Chemical Abstract Service Registry (CAS) numbers or make minor corrections.
Comments
The Government of Canada is committed to providing the Canadian public and other stakeholders with the opportunity to participate in the development of regulatory initiatives. Health Canada invites stakeholders to submit comments on the proposed additions to the Hotlist, changes to the conditions for existing entries, changes to include new substance identifiers or make minor corrections to the Cosmetics Ingredient Hotlist, or any other suggestions. As applicable, please supply evidence to support your comments.
Please provide comments no later than December 12, 2020. Comments may be submitted by email or in writing to:
Email: hc.cosmetics.sc@canada.ca
Mail:
Hotlist Coordinator
Cosmetics Program
Consumer and Hazardous Products Safety Directorate
Health Canada
269 Laurier Avenue West
Address Locator: 4908A
Ottawa, ON K1A 0K9
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