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 considering for inclusion in future updates to the Cosmetic Ingredient Hotlist (Hotlist). At this time, stakeholders are invited to provide safety information or other considerations about the proposed substances that may further inform Health Canada's decisions. 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

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 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 August 2022.

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, proposed updates to the Hotlist will be posted for consultation for a 60-day comment period. After this consultation period, but prior to the 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 that have previously submitted a cosmetic notification form.

Proposed Additions to the Hotlist (6)

Prohibitions

1. Basic Green 4: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Basic Green 4 (also known as Malachite Green, CAS 569-64-2) will be proposed for addition to the list of substances described as prohibited due to potential developmental effects.
2. Thioglycolic acid esters: Thioglycolic acid esters are being considered for addition to the list of substances described as prohibited due to risk of skin sensitization.

Restrictions:

1. Benzophenone: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Benzophenone (CAS 119-61-9) will be proposed for addition to the list of substances described as restricted due to potential maternal effects, such as decreased body weight, for certain cosmetic uses.
2. p-Chloro-m-cresol: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), p-Chloro-m-cresol (CAS 59-50-7) will be proposed for addition to the list of substances described as restricted due to potential effects on adrenal organs for certain cosmetic uses.
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.
4. Solvent Violet 13: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), Solvent Violet 13 (CAS 81-48-1) will be proposed for addition to the list of substances described as restricted to protect against possible health concerns for certain cosmetic uses.

Proposed revisions to existing entries on the Hotlist (10)

Prohibitions:

1. Mixed cresols and derivatives: A revision to the entry is being considered to create separate Hotlist entries for different cresols due to different risk profiles of the substances captured by the current entry.
• A revision of the current entry of "Mixed cresols and derivatives" to "p-Cresol and mixtures thereof" on the prohibited list is being considered, as there is insufficient data to support safe use of p-cresol and mixed cresols containing p-cresol.
• A new entry for o-cresol and m-cresol on the restricted list is being considered. A review of the available scientific data indicates that the ingredients may have health effects when used at higher concentrations or in the area of mucous membranes but can be used at low concentrations in cosmetics applied to other areas without significant risk.
2. Dialkanolamines, secondary: A revision to the entry is being considered to expand the entry to "Secondary alkyl- and alkanolamines and their salts" due to similar properties with respect to their potential as carcinogenic nitrosamine precursors.

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 is being considered 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. Aluminum chlorohydrate and its associated complexes: A revision to the entry is being considered to indicate Aluminum chlorohydrate and its associated complexes are not permitted in aerosol products due to potential risk of lung effects from inhalation of small particles produced in aerosols.
3. Peroxide and peroxide-generating compounds: A revision to the entry is being considered to:
   • Introduce a maximum permitted concentration for hair products due to risk of skin irritation at high concentrations;
   • Introduce conditions for eyelash and eyebrow products due to risk of eye irritation at low concentrations;
   • Indicate these ingredients are not permitted for use in products with intended application in the genital area due to risk of irritation
4. Benzoyl peroxide: A revision to the entry is being considered to indicate the ingredient may only be used in nail products for professional use, with skin contact avoided, due to its strong irritation and sensitization potential.
5. Hydroquinone: A revision to the entry is being considered to expand the permitted nail product categories to include products for consumer use. An increase to the maximum concentration permitted for these products, and introduction of a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product, is also being considered.
6. p-Hydroxyanisole: A revision to the entry is being considered to introduce a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product.
7. 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.
8. Talc: Further to the Chemicals Management Plan (CMP) assessment under the Canadian Environmental Protection Act, 1999 (CEPA 1999), revisions to the entry are being considered to help reduce exposures to talc from certain cosmetics which may be inhaled, or which may result in perineal exposure to the population with intact ovary / ovaries.

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.

• Acyclic, Monocyclic, and Bicyclic Monoterpenes Group
• Alcohols Group
• Coumarin 1
• Monocyclic and Bicyclic Sesquiterpenes Group
• Other Polymers Group
• Parabens Group
• Salicylates 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.

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. 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: cosmetics@hc-sc.gc.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.