Cosmetic Ingredient Hotlist and Proposed Updates

By: Teah Jazey, REGULATORY AFFAIRS & PRODUCT SAFETY ASSOCIATE, email

What is the Canadian Cosmetic Ingredient Hotlist?

The Cosmetic Ingredient Hotlist is a tool that Health Canada uses to inform companies and consumers in Canada of the prohibitions and restrictions that exist for some substances. It is an important component of Canada’s cosmetic regulations. Careful inspection of the Hotlist is important as those present may impact a products compliance with the Food and Drugs Act or the Cosmetics Regulations. The Hotlist is also a useful tool in distinguishing between cosmetic products and registered product, such a Drug or Natural Health Product. Dell Tech’s team provides professional, confidential consulting services to assist companies with Canada’s cosmetic regulations. Our services include product classification, formula assessment against the cosmetic ingredient hotlist, label development and submission of a Cosmetic Notification Form.

Background on These Updates

Occasionally Health Canada will put forward proposed updates or additions to the Hotlist. Examples of changes include new restricted ingredients or a new maximum concentration allowance. This is typically done when new scientific data on a substance becomes available. This information can be sourced through a science based document like a peer-reviewed journal and can come from national and international experts.  Recently, Health Canada issued a proposal for new changes. Please see the below lists of changes that are proposed:

What Changes are Being Proposed by Health Canada?

Proposed Changes to the Prohibited List

Additions:

1. Basic Green 4 (CAS #’s 569-64-2, 18015-76-4): Information from the Chemicals Management Plan assessment describes this substance and its salts a having potential developmental effects.
2. Thioglycolic acid esters (CAS #’s 30618-84-9, 25103-09-7): This substance is being considered due to its high risk of skin sensitization.

Revisions to Existing Entries:

1. p-Cresol and mixtures thereof (CAS #’s 106-44-5, 1319-77-3): Suggestion to differentiate between different cresols in the Hotlist. See also proposed entries for m-Cresol and o-Cresol.
2. Secondary alkyl- and alkanolamines and their salts (CAS #’s 111-42-2, 110-97-4, 69331-39-1, 61693-41-2, 58855-63-3, 124-20-9, 334-50-9, 108-18-9): Proposed addition of Secondary alkyl- and alkanolamines and their salts to existing Dialkanolamines, secondary

Proposed Changes to the Restricted List:

Additions:

1. Benzophenone (CAS # 119-61-9): Information from the Chemicals Management Plan assessment describes this substance as potentially causing adverse maternal effects. The proposed restriction is a maximum of 3%.
2. p-Chloro-m-cresol or Chlorocresol (CAS # 59-50-7): Information from the Chemicals Management Plan assessment describes this substance as restricted due to its effect on adrenal organs. Proposal to restrict use to 0.1% in cosmetics that are not used near mucosal membranes.
3. Retinal (CAS # 116-31-4): Proposed to be added to restricted list die to potential skin irritation and its therapeutic properties.
4. Solvent Violet 13 (CAS #81-48-1): Information from the Chemicals Management Plan assessment suggested additional to restricted list due to potential health concerns when used in cosmetics.

Revisions to Existing Entries:

1. Alpha-hydroxy acids (CAS #’s 77-92-9, 79-14-1, 50-21-5, 133-37-9, 6915-15-7, 79-33-4, 5949-29-1, 617-73-2, 90-64-2, 35249-89-9): Proposal intends to revise the current entry to include PHAs, bionic acids and their salts. Warnings and required statements are also being proposed.
2. Aluminum chlorohydrate and its associated complexes (CAS #’s 12042-91-0, 1327-41-9, 173762-81-7, 173762-82-8, 10284-64-7, 173720-80-4, 180324-83-8, 11097-68-0, 173763-15-0, 242812-86-8, 173763-16-1, 245090-60-2): Proposal to clarify that aluminum chlorohydrate and its associated complexes are not permitted in aerosols.
3. Peroxide and peroxide-generating compounds (CAS #’s 124-43-6, 1305-79-9, 7722-84-1, 1335-26-8, 7632-04-4, 1314-22-3): This entry is proposed to introduce maximum concentrations, and prohibitions for certain product types.
4. Benzoyl Peroxide (CAS# 94-36-0): Propose to update current entry to include the use in only nail products.
5. Hydroquinone (CAS # 123-31-9): Propose to update the existing entry to include categories for consumer use as well as to increase the maximum concentrations for in nail products.
6. p-Hydroxyanisole (CAS # 150-76-5): Health Canada proposes to update the limit when both p-Hydroxyanisole and hydroquinone are used in a nail product.
7. Retinol and its esters (CAS #’s 68-26-8, 127-47-9, 79-81-2, 631-89-0, 7069-42-3): This entry is proposed to reduce the maximum allowable concentration used in body lotions. Health Canada is concerned that current concentrations are above the tolerable intake for Vitamin A.
8. Talc (CAS # 14807-96-6): Information from the Chemicals Management Plan assessment describes this substance to have potential negative effects on the ovaries when the substance is inhaled or exposed to the genitals.

For detailed descriptions of these proposed updates and additions to the Hotlist please review the Consultation posted here.

How to Engage in This Consultation Period

If you are interested in participating in the consultation period for this please forward you comments by email at cosmetics@hc-sc.gc.ca or in writing to:

Hotlist Coordinator

Cosmetics Program

Consumer and Hazardous Products Safety Directorate

Health Canada

269 Laurier Ave West

Address Locator: 4908A

Ottawa ON K1A 0K9

The consultation period for this notice is open from July 13 2023 to October 22 2023.

Resources:

• https://www.canada.ca/en/health-canada/programs/consultation-proposed-updates-cosmetic-ingredients-hotlist.html
• https://www.canada.ca/en/health-canada/programs/consultation-proposed-updates-cosmetic-ingredients-hotlist/document.html

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