Canada Amends Cosmetic Ingredient Use Requirements

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%.

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%.

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.