Notice to Stakeholders concerning review of 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:

• Additions to the Hotlist
• 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 December 2019.

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 Additions to the Hotlist (3)

Restrictions:

1. 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).
2. Azelaic acid: Azelaic acid is being considered for addition to the list of restricted substances due to therapeutic properties and risk of skin irritation at high concentrations.
3. Retinal: Retinal is being considered for addition to the list of restricted substances due to therapeutic properties and risk of skin irritation. The ingredient is currently listed in Health Canada's Natural Health Products Ingredients Database with an upper limit of 0.05% for use as a non-medicinal ingredient in creams.

Proposed revisions to existing entries on the Hotlist (6)

Prohibitions:

1. Retinoic acid: A revision to the entry will be made 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.

Restrictions:

1. 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. A revision to the entry will be made to clarify that PHAs and bionic acids with alpha-hydroxyl groups, as well as their salts, are captured by the 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.
2. 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.
3. 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.
4. 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.
5. Retinol and its esters: A revision to the entry is being considered to reduce the concentration permitted for certain products such as body lotions as exposure from such products at current permitted concentrations may exceed Tolerable Upper Intake levels of Vitamin A recommended by Health Canada.

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.

• Talc
• Boric Acid
• Benzophenone
• Solvent Violet 13 (Anthraquinone Group)
• Malachite Green (Triarylmethane Group)
• Chlorocresol

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.

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 and Hazardous Products 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.