Proposed amendments to Health Canada’s Cosmetic Ingredient Hotlist (the Hotlist) were introduced on September 30, 2008. They include additional updates on certain ingredients already contained on the list as well as the addition of new ingredients. The proposed amendments are undergoing a 60-day consultation period set to expire on November 5, 2008. To review the proposed changes, visit Health Canada’s website.
Pursuant to the Food and Drugs Act, cosmetics containing substances that may cause injury to the health of the user are prohibited from sale in Canada. The Hotlist contains a list of ingredients that are either prohibited or restricted for use in cosmetic products. The Hotlist assists industry in ensuring compliance with the legislation and, more importantly, the safety of cosmetic products.
If a cosmetic contains an ingredient which appears on the Hotlist, the manufacturer may be required to: remove the substance from the formulation or reduce its concentration; provide safety evidence; or ensure that the product is labelled and/or packaged appropriately (i.e., with the required warning statements or in child-resistant packaging). In some cases, the manufacturer must obtain approval for a cosmetic containing a Hotlist ingredient in a concentration above that deemed acceptable for a cosmetic under the Hotlist and market the cosmetic as a drug product.
Last updated in March 2007, the Hotlist proposes to add ingredients due to various safety concerns, including toxicity and possible sensitivities. For example, cyanoacrylate-based adhesives (used in nail and false eyelash adhesives) have been added due to their quick skin bonding properties. Similarly, diethylene glycol will not be permitted in oral or leave-on products because of toxicity concerns. Due to an identified risk of sensitization, 1-Naphthol and its salts will only be permitted in cosmetic hair dyes at concentrations of less than 2% and only for use as an oxidizing colouring agent. It will be permitted at concentrations of less than 1% when used in combination with hydrogen peroxide.