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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:

  • A revision of the current entry "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 concerns 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.

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:

  • Introduce a maximum permitted concentration for hair products due to the risk of skin irritation at high concentrations;
  • Introduce conditions for eyelash and eyebrow products due to the risk of eye irritation at low concentrations;
  • Indicate that these ingredients are not permitted for use in products with intended application in the genital area due to the risk of irritation.

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.

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

Further Reading

 

Reference Links

[1] Notice to Stakeholders Concerning Review of the Cosmetic Ingredient Hotlist

 

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