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[Chemlinked] Canada Proposes to Amend Cosmetic Ingredient Use Requirements
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등록일 2022-12-20
조회수 8127
The main proposed amendments are
1) adding 2 prohibited ingredients;
2) adding 4 restricted ingredients;
3) amending the requirements for 2 prohibited ingredients;
4) amending the requirements for 8 restricted ingredients.
Introduction to Cosmetic Ingredient Hotlist The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate with manufacturers and other stakeholders that certain ingredients may be prohibited or restricted for use in cosmetics. It consists of two distinct tables, one for ingredients identified as prohibited and another for those identified as restricted.
1) Prohibited ingredients, including synonyms, salts and related compounds, should not be present in cosmetic products sold in Canada. 2) Restricted ingredients are permitted only if the conditions of use and/or cautionary statement(s) are met as outlined. If the ingredient has a concentration restriction, the applicant is encouraged to provide the exact concentration used in the product at the time of notification, which will help expedite Health Canada's processing of the Cosmetic Notification Form.
The Hotlist is a science-based document that is reviewed and updated when new scientific data becomes available. Last update to the Hotlist was in August 2022. |
On Nov. 18, 2022, Health Canada released a notice concerning the review of the Cosmetic Ingredient Hotlist. 1 Health Canada is considering the following amendments to the Hotlist. Companies are welcome to contact Health Canada (cosmetics@hc-sc.gc.ca) to provide safety information or other considerations about the proposed ingredients, which may further inform Health Canada's decisions. Information that are recommended to be provided includes:
- Additions to the Hotlist;
- Changes to the requirements for existing ingredients on the Hotlist;
- Changes to include additional ingredient identifiers or make minor corrections.
1. Adding 2 prohibited ingredients
Ingredient Name |
CAS Number |
Reasons for Addition |
Basic Green 4 / Malachite Green |
569-64-2 |
Potential developmental effects, as assessed by the Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). |
Thioglycolic acid esters |
/ |
Risk of skin sensitization. |
2. Adding 4 restricted ingredients
Ingredient Name |
CAS Number |
Reasons for Addition |
Benzophenone |
119-61-9 |
Potential maternal effects for certain cosmetic uses, such as decreased body weight, as assessed by the Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). |
p-Chloro-m-cresol |
59-50-7 |
Potential effects on adrenal organs for certain cosmetic uses, as assessed by the Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). |
Retinal |
/ |
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. |
Solvent Violet 13 |
81-48-1 |
For the protection against possible health concerns for certain cosmetic uses. |
3. Amending the requirements of 2 prohibited ingredients
Ingredient Name |
CAS Number |
Amendments |
Mixed cresols and derivatives |
1319-77-3 |
An amendment is being considered to create separate entries for different cresols due to the different risk profiles of the ingredients captured by the current entry:
|
Dialkanolamines, secondary |
111-42-2 / 110-97-4 |
An amendment is being considered to expand the entry to "Secondary alkyl- and alkanolamines and their salts" due to similar properties in their potential as carcinogenic nitrosamine precursors. |
4. Amending the requirements of 8 restricted ingredients
Ingredient Name |
CAS Number |
Amendments |
Alpha-Hydroxy Acids |
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 |
An amendment to the entry is being considered to clarify that Polyhydroxy acids (PHAs) and bionic acids with alpha-hydroxyl groups, as well as their salts, are captured under the entry for “alpha-hydroxy acids (AHAs)”. Currently, information available to Health Canada is insufficient 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 amendments 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. |
Aluminum chlorohydrate and its associated complexes |
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 |
An amendment to the entry is being considered to indicate that Aluminum chlorohydrate and its associated complexes are not permitted in aerosol products due to the potential risk towards lung from inhalation of small particles produced in aerosols. |
Peroxide and peroxide-generating compounds |
124-43-6 / 1305-79-9 / 7722-84-1 / 1335-26-8 / 7632-04-4 / 1314-22-3 |
An amendment to the entry is being considered to:
|
Benzoyl peroxide |
94-36-0 |
An amendment to the entry is being considered to indicate that the ingredient may only be used in nail products for professional use without skin contact due to its strong irritation and sensitization potential. |
Hydroquinone |
123-31-9 |
An amendment to the entry is being considered to expand the permitted nail product categories to include products for consumer use. An increase in the maximum concentration permitted for these products, and the introduction of a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product, are also being considered. |
p-Hydroxyanisole |
150-76-5 |
An amendment to the entry is being considered to introduce a combined limit when both p-Hydroxyanisole and Hydroquinone are used in a nail product. |
Retinol and its esters |
68-26-8 / 127-47-9 / 79-81-2 |
An amendment 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. |
Talc |
/ |
Amendments 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, as assessed by the Chemicals Management Plan (CMP) under the Canadian Environmental Protection Act, 1999 (CEPA 1999). |
5. Other Amendments
In addition to the above changes, existing ingredient entries may be amended to include new synonyms and CAS numbers, as well as other minor corrections, such as fixing typos.
6. Ingredients under Evaluation
The ingredients listed below are being assessed under the CMP. Preliminary assessments, which indicate potential risks associated with cosmetic usage, may result in future changes to the Hotlist if the final screening assessments confirm the proposed conclusions.
|
Further Reading
- Canada Amends Cosmetic Ingredient Use Requirements
- Webinar | Overview of the Canadian Regulatory Framework for Cosmetics
- Webinar | Overview of Cosmetic Labeling and Claims Regulations in the EU, UK, US and Canada
Reference Links
[1] Notice to Stakeholders Concerning Review of the Cosmetic Ingredient Hotlist
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