The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following the date the Regulations concerning cosmetic ingredients. Six months following the date of registration, all other rules would take effect.
In this article, we discuss the issues that lead to Health Canada’s cosmetic notification proposal and how the changes will improve safety and reduce costs.
What are the issue’s?
The most recent significant changes to the Cosmetic Regulations went into effect in 2006, when ingredient disclosure on cosmetic labels became mandatory. The Cosmetic Regulations (the Regulations) allow the use of the term “parfum” at the end of a cosmetic’s ingredient list to indicate the presence of a fragrance ingredient, or a mixture of fragrance ingredients.
However, using the term “parfum” does not provide consumers with the necessary information if they are allergic or sensitive to certain fragrance ingredients that are known to be contact allergens for a portion of the population (hereafter referred to as “fragrance allergens”). Without the disclosure of these fragrance allergens on labels, consumers have few options for obtaining this information and taking steps to avoid purchasing and using the product that may have these ingredients.
What is Health Canada proposing to address the issues?
Health Canada proposes to address this issue by amending the Cosmetic Regulations to strengthen cosmetic labelling requirements by requiring the disclosure of certain fragrance allergens on cosmetic labels. Health Canada proposes to incorporate fragrance allergens listed in Annex III of the European Commission’s Cosmetic Products Regulation by reference, as well as the transition period set out in that Annex for future updates to substances identified for disclosure, on an ambulatory basis.
Alignment with the EU would be made easier with this strategy. The addition of a flexibility to disclose ingredients, including fragrance allergens, on a website is proposed in recognition of the fact that this proposal requires additional information to be put on cosmetic labels for cosmetics sold in small packages. Additionally, by strengthening the cosmetic notification requirements, clarifying the terminology used in the Cosmetic Regulations, and improving compliance and enforcement tools, this plan would improve the oversight of cosmetics. Administrative adjustments are made in the plan to update entries in the Schedule to the Regulations, correct the publisher for a referenced document, and update French definitions to suit modern drafting practices.
What will the Health Canada regulatory proposal seek to improve?
Consumers could identify ingredients to which they might be allergic, sensitive, or wish to avoid thanks to the regulatory plan. This would enable customers to choose and use products with better knowledge about their health. These well-informed choices would result in lower costs for medical exams and treatments, less need for prescription drugs and over-the-counter remedies, less time off work and income lost due to illness, and avoided quality-of-life losses due to the discomfort and social effects of allergic contact dermatitis.
What will be the cost-benefit savings for companies resulting from the regulations?
33.3% of businesses recommended that they already reveal fragrance allergens on their labels based on the cost-benefit survey results. The estimated cost for the cosmetic business to comply with the proposed new rule requiring disclosure of fragrance allergens on cosmetic labels is $1.44 million annually or $10.14 million in present value (also known as PV) spread over ten years.
The ability to reveal ingredients for cosmetics sold in small packages on a website is expected to save the cosmetics industry $48,064 annually or $337,581 PV over a ten-year period. As a result, it is anticipated that the net cost of the proposal as a whole will be $9.94M PV over ten years, or $1.42M annualized. This proposal would result in administrative costs for industry, namely, the requirement to submit a notification to inform Health Canada if the cosmetic contains one or more of the specified fragrance allergens.