Notice to Stakeholders of proposed updates to the Cosmetic Ingredient Hotlist

The purpose of this notice is to inform you of substances that Health Canada is currently reviewing which may be included in future updates to the Cosmetic Ingredient Hotlist (Hotlist). The proposal includes the following:

• Changes to the conditions for existing entries on the Hotlist
• Changes to include additional substance identifiers or make minor corrections

At this time, stakeholders are invited to provide safety information or other considerations about the proposed substances that may further inform the Department’s decisions. This notice is not a formal consultation process, Health Canada will not respond to the information, or comments received at this stage

Background

The 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 certain substances, with no known cosmetic or functional purpose in a cosmetic formulation, make it unlikely for the product to meet the definition of 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.

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 Notice to Stakeholders is issued approximately three months prior to the consultation on proposed updates to the Hotlist. During this time, Health Canada expects that those selling cosmetics in Canada will start to determine which of their products could be impacted by the possible updates, and begin to think about the necessary changes to product formulations, distribution and sale. Following this time period, the proposed updates to the Hotlist will be posted for consultation for a 60-day comment period. After the consultation period, but prior to publication of the final revised Hotlist, Health Canada will respond to the comments received.  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 existing entries on the Hotlist (5)

Prohibitions:

1. 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.
2. 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 skin sensitization 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 at higher concentrations but can be used at low levels without significant risk.

Restrictions:

1. Eucalyptus Oil: A revision to the entry is being considered to better mitigate risk of accidental ingestion, particularly in pediatric populations.
2. 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.
3. 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.

Other Miscellaneous Revisions

In addition to the above changes, existing ingredient entries may be revised to include new synonyms, Chemical Abstract Service Registry (CAS) numbers as well as other minor corrections, such as fixing typos.

Chemicals Management Plan (CMP) - Ingredients under Evaluation

The ingredients listed below are being assessed under the CMP. Preliminary assessments indicate potential risks associated with cosmetic usage, which may result in future changes to the Hotlist if the proposed conclusions are confirmed in the final screening assessments. These ingredients may not appear in the upcoming consultation but sellers are advised to stay informed of the CMP process, and determine which of their products could be impacted. Stakeholders may subscribe to receive updates on publications, including public comment periods and consultations under the CMP.

• 2-ethylhexyl 2-ethylhexanoate
• Boric Acid
• Benzophenone
• Solvent Violet 13 (Anthraquinone Group)
• Malachite Green (Triarylmethane Group)

Please note, if at any time Health Canada receives information that indicates the potential for a serious risk concerning a product in this process, the Program will bypass the usual Hotlist update approach and take any immediate action necessary.

Talc

Please note that the review and consultation of the Talc entry on the Hotlist will be carried out alongside the CMP assessment on Talc. Pending the conclusion of the final Talc screening assessment, the targeted timing for posting of the final Hotlist entry could be at the same time, or shortly after the publication of the final Talc screening assessment. Stakeholders may review documents associated with CMP assessment for Talc and submit comments.

All comments must cite the Canada Gazette, Part I, and the date of publication of this notice. They must be directed to Environment and Climate Change Canada.

Mail: Executive Director
Program Development and Engagement Division, Department of the Environment
Gatineau, Quebec K1A 0H3

Fax:  819-938-5212

Email:  eccc.substances.eccc@canada.ca.

Comments can also be submitted to the Minister of the Environment, using the online reporting system available through Environment and Climate Change Canada’s Single Window.

Comments About the Proposed Revisions

The Government of Canada is committed to providing the Canadian public and stakeholders with the opportunity to participate in the development of regulatory initiatives. At this time, stakeholders are invited to provide any safety information or other considerations about the proposed substances that may further inform the Department’s decisions. Health Canada will not provide a detailed response to the information, or any comments, received at this stage.

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

Stay Informed

Please refer to Consumer Product Safety for up-to-date information.

You may also subscribe to the cosmetics mailing list to receive the latest news and information about Health Canada's efforts in the area of cosmetics.