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[Chemlinked] Canada Amends Cosmetic Ingredient Use Requirements
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등록일 2022-09-05
조회수 7486
The main amendments are
1) adding two restricted ingredients;
2) revising the name of one prohibited ingredient;
3) revising the use requirements of three restricted ingredients.
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Background The Cosmetic Ingredient Hotlist (Hotlist) is an administrative tool that Health Canada uses to communicate to manufacturers and others that certain ingredients may be prohibited or restricted for use in cosmetics. It consists of two distinct tables, one for ingredients identified as being prohibited and another for those identified as being 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, to provide the exact concentration used in the product at the time of notification will help expedite Health Canada’s processing of the Cosmetic Notification Form.
The Hotlist is a science-based document that is reviewed and updated periodically when new scientific data becomes available. |
On August 26, 2022, Canada released and implemented the updated Cosmetic Ingredient Hotlist, adding two restricted ingredients, as well as revising the name of one prohibited ingredient and the use requirements of three restricted ingredients. 1
1. Adding two restricted ingredients
| Ingredients Added | CAS Number | Maximum Concentration | Reasons for Amendments |
| Ethylhexyl Ethylhexanoate | 7425-14-1 |
a) Body lotion: 0.1% b) Foot lotion: 0.5% c) Face make-up: 0.6% |
This ingredient was added to the restricted ingredients list 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). |
| Azelaic acid and its salts | 123-99-9; 52457-54-2; 132499-85-5; 17265-13-3; 27825-99-6 | 14% | These ingredients were added to the restricted ingredients list due to known therapeutic properties and skin irritation risk at concentrations above the maximum permitted concentration of 14%. |
2. Amending the ingredient name of one prohibited ingredient
| Ingredients Amended | CAS Number | Amendments |
| Retinoic acid and its salts | 302-79-4; 4759-48-2 | This entry was amended to add salts for clarity. Salts are expected to convert to retinoic acid when mixed in solution. Retinoic acid has known therapeutic action at low concentration. In Health Canada’s Drug Product Database, there are marketed prescription drugs for topical use containing retinoic acid at a concentration as low as 0.01%. |
3. Amending the use requirements of three restricted ingredients
| Ingredients Amended | CAS Number | Applicable Scope/Maximum Concentration | Warnings and Cautionary Statements | Amendments |
| Eucalyptus oil | 8000-48-4; 85203-56-1; 1627700-32-6; 91771-69-6; 90028-48-1 |
a) Cosmetics in solid forms b) Cosmetics in other forms with concentration greater than 0.022% c) Cosmetics in other forms with concentration less than or equal to 0.022% |
For product b: "The product should be kept out of the reach of children," and "In case of accidental ingestion, call a Poison Control Centre or doctor immediately and advise them that this product contains eucalyptus oil." | This entry was amended to better mitigate the risk of unintentional ingestion, particularly in pediatric populations, by introducing cautionary label statements for certain products with concentration greater than 0.022%. |
| Peroxide and peroxide-generating compounds | 124-43-6; 1305-79-9; 7722-84-1; 1335-26-8; 7632-04-4; 1314-22-3 |
Oral products containing peroxides or peroxide-generating compounds:
Manufacturers should have the following information on hand as Health Canada may request it:
1. A laboratory report providing the pH of the product as applied to tooth or teeth. Section 13 of the Cosmetic Regulations requires that the pH should be greater than or equal to 4.0;
2. Product labeling indicating the directions of use and cautionary statements;
3. If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit a clinical study report to demonstrate that the salivary peroxide levels do not exceed 3% during the use of the product as per the directions of use.
Note: Be aware of the conversion factor between hydrogen peroxide and other peroxide-generating compounds. For example, 10% carbamide (urea) peroxide is approximately equivalent to 3% hydrogen peroxide. |
"If irritation (such as redness, swelling, soreness) of the gums or the mouth occurs, discontinue use and consult an oral health professional."
"Products containing peroxides are not recommended for use by children under 12 years of age."
"Consult your oral health professional before prolonged use of this product."
"Avoid swallowing the cosmetic or part thereof."
"Avoid contact of the product with the eye."
"Avoid direct contact of the active surface of the tooth whitening product with the gums and/or salivary flow." |
This entry was amended to clarify that for oral cosmetics containing more than 3% hydrogen peroxide (or equivalent), hydrogen peroxide concentrations in saliva will continue to be requested. However, concentration within the soft tissue of the oral cavity will not be routinely requested.
Furthermore, the statement “allowing evidence that may include analog studies from recognized sources or independent clinical research” was removed. |
| p-Hydroxyanisole | 150-76-5 | Permitted only in nail products: 0.1% | "Avoid skin contact," "Read directions carefully before using." | This entry was amended to expand the permitted nail product categories to include products for consumer use, and increase the maximum concentration permitted for these products. |
Reference Links
[1] Changes to the Cosmetic Ingredient Hotlist
출처 : Chemlinked
