Consultation on 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:

  • 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 or a provision of the Cosmetic Regulations. In addition, the Hotlist communicates that certain substances, with no known function in a cosmetic formulation, make it unlikely for the product to meet the definition of a cosmetic under the Food and Drugs Act. 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 September 2018.

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 revisions to the Hotlist

The entries for the following ingredients are proposed to be revised to reflect changes in requirements.

Prohibitions:

Dihydrocoumarin

A revision is being considered to change this entry from a prohibition to a restriction. The ingredient is naturally occurring in some plant derivatives at low levels. A review of the available scientific data indicates that the ingredient may cause sensitization at higher concentrations but can be used at low levels without significant risk.

Table 1. Proposed Hotlist Conditions for Dihydrocoumarin

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)
Dihydrocoumarin 119-84-6   a) Leave-on products 0.035%  
b) Rinse-off products 3.5%

Disulfiram, Thiuram, Thiuram disulfides, and Thiuram monosulfides

A revision is being considered to combine these entries under a single entry for "Thiurams". This entry will also encompass thiuram tetrasulfides which are not presently captured under the Hotlist entry. These substances have all been identified to pose similar skinsensitization risks. Revising the Hotlist entry from a prohibition to a restriction is also being considered because a review of the available scientific data indicates that the ingredients may cause skin sensitization under certain usage conditions but can be used in latex theatrical makeup without significant risk.

Table 2. Proposed Hotlist Conditions for Thiurams

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)
Thiurams 97-77-8; 137-26-8 Disulfiram; Thiram Latex products 14%  

Restrictions:

Eucalyptus Oil

A revision to the entry is being considered to better mitigate risk of accidental ingestion, particularly in pediatric populations.

Table 3. Proposed Hotlist Conditions for Eucalyptus Oil

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       "This product contains eucalyptus oil which is poisonous.", "Keep out of reach of children", and "If swallowed, call a Poison Control Centre or doctor immediately."

Sodium bromate

A revision of the current restriction to a prohibition is being considered. Sodium bromate is toxicologically equivalent to potassium bromate, which has been prohibited since March 2011 due to its carcinogenic potential, as assessed by the Government of Canada's Chemicals Management Plan under the Canadian Environmental Protection Act, 1999. The two entrieswill be combined into one entry for Bromates.

Table 4. Proposed Hotlist Conditions for Bromates

Ingredient CAS (including but not limited to) Synonyms and Related Compounds (Including but not limited to)
Bromates 7789-38-0; 7758-01-2 Sodium bromate; Potassium bromate

Thioglycolic acid and its salts

A revision to the entry is being considered due to changes in ingredient usage. New conditions regarding hair products and products for use in the area of the eye will be considered.

Table 5. Proposed Hotlist Conditions for Thioglycolic acid and its salts

Ingredient Information Restriction
Chemical CAS 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)
Thioglycolic acid and its salts 68-11-1   a) Eyelash curling products a) 11% with a pH of 7 to 9.5 a) "For professional use only.", "Avoid direct skin contact, wear suitable gloves.", "Avoid contact with eyes and, in the event of contact with eyes, rinse immediately with plenty of water and seek medical attention."
b) Hair dyes, waving or straightening products b) 8% with a pH of 7 to 9.5 b) "Avoid direct skin contact, wear suitable gloves.", "Not for use in the area of the eye."
c) Hair dyes, waving and straightening products for professional use c) 11% with a pH of 7 to 9.5 c) "For professional use only.", "Avoid direct skin contact, wear suitable gloves.", "Not for use in the area of the eye."
d) Depilatory products d) 5% with a pH of 7 to 12.7 d) "Avoid contact with eyes and, in the event of contact with eyes, rinse immediately with plenty of water and seek medical attention."

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 updates to the Cosmetics Ingredient Hotlist, or any other suggestions. As applicable, please supply evidence to support your comments.

Please provide comments no later than July 1, 2019. Comments may be submitted by email or in writing to:

Email: hc.cosmetics.sc@canada.ca

Mail:
Hotlist Coordinator
Cosmetics Program
Consumer Product Safety Directorate
Health Canada
269 Laurier Avenue West
Address Locator: 4908A
Ottawa, ON K1A 0K9

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