Earlier this month, Health Canada released a new list of proposed updates to the Cosmetic Ingredient Hotlist, which included new additions, as well as revisions, to both the restricted and prohibited cosmetic ingredient lists.
The proposed new additions to the Cosmetic Ingredient Hotlist, as released by Health Canada, are as follows:
This entry is proposed to be restricted in body lotions to a maximum concentration on 0.1%, in foot lotions to a maximum concentration of 0.5% and in face make-up to a maximum concentration on 0.6%. Health Canada is considering the addition of Ethylhexyl Ethylhexanoate to the Cosmetic Ingredient Hotlist “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
Azelaic acid and its salts are proposed to be restricted in leave-on products to a maximum concentration of 0.3% and in rinse-off products to a maximum concentration of 10%. The addition of this entry is being considered “due to therapeutic properties at certain concentrations and risk of skin irritation at high concentrations”.
The proposed amendments to existing Hotlist entries, as released by Health Canada, are as follows:
Retinoic acid or its salts or derivatives
It is proposed this entry be on the list of ingredients that are prohibited for use in cosmetic products. The purpose of this revision is to “clarify that derivatives and salts of retinoic acid are captured by the entry. These substances are currently captured under the Prescription Drug List entry for “Tretinoin or its salts or derivatives”.”
Alpha-Hydroxy Acids including polyhydroxy acids and bionic acids with alpha hydroxyl groups, and their salts
This entry is proposed to be revised to “clarify that PHAs and bionic acids with alpha-hydroxyl groups, as well as their salts, are captured by the existing entry.”
A modification to this entry is proposed to “better mitigate risk of unintentional ingestion, particularly in pediatric populations” by adding the following warnings and cautionary statements to cosmetics in non-solid forms:
“This product contains eucalyptus”
“Keep out of reach of children”
“In case of accidental ingestion, call a Poison Control Centre or doctor immediately.”
Peroxide and peroxide-generating compounds
The proposed amendment for this entry is states that “If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit a clinical study to demonstrate the salivary peroxide levels do not exceed 3% during the use of the product as per the directions of use.” This is a modification from the current restriction which requires proof of the hydrogen peroxide levels in saliva, as well as within the soft tissue of the oral cavity.”
“A revision to the entry is being considered to expand the permitted nail product categories, including products for consumer use, and increase the maximum concentration permitted for these products” to 0.1%.
There is now a 60 day consultation period, ending December 12, 2020, during which individuals and stakeholders from the Canadian public have the opportunity to submit comments on the proposed updates. A full list of these proposed updates, as well as information on where to submit comments, can be found here.
For more information, please contact Focal Point Research Inc. We are leading North American Regulatory and New Product Consultants for Medical Devices, Natural Health Products, OTC Drugs, Cosmetics, and other consumer products regulated by Health Canada and the U.S. FDA.