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The month of July 2024 has passed and the US FDA still has not published the draft for fragrance allergens regulation as required by MoCRA.
The Office of Information and Regulatory Affairs (OIRA) published the Spring 2024 edition of its Unified Agenda of Federal Regulatory and Deregulatory Actions. The FDA Agenda includes three proposed rules specific to cosmetic products, including two proposed rules that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) directed the FDA to issue, such as the disclosure of fragrance allergens in cosmetic labelling, testing methods for detecting and identifying asbestos in talc-containing cosmetic products, and the use of formaldehyde and formaldehyde-releasing chemicals as an ingredient in hair smoothing products or hair straightening products.
Officially, they are targeting October 2024 for the allergens labelling; however, the FDA doesn’t have a timing for this regulation. They cannot confirm that the regulations will be ready by the end of the year as required by MoCRA.
Other rules for fragrance allergens in the US: California
While waiting for MoCRA, California has determined that any EU fragrance allergen will need to be reported per The Cosmetic Fragrance and Flavor Ingredient Right to Know Act, beginning on the 1st of January 2024. This regulation is essentially useless to consumers, as the allergens are listed on a website instead of being listed on the products, so the consumers have to consult the California website if the product they are buying contains allergens or not.
Allergens in Canada: New rules
Canada also has published their response to the EU’s expanded list of fragrance allergens. This change affects both existing and new products in the Canadian market. With this update, key definitions in the cosmetics industry have been clarified, such as the meaning of leave-on and rinse-off cosmetics, to align these rules to the EU Regulation.
For products introduced before the 1st of August 2026, the initial 24 fragrance allergens must be displayed in the ingredient list when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.
For products introduced after the 1st of August 2026, all fragrance allergens (old and new ones) must be listed in the ingredient list when their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. The deadline for declaring all the allergens is the 1st of August 2028.
Reminder, EU fragrance allergens & UK regulations
As a reminder, in the EU market, the new fragrance allergens introduced by the Commission Regulation (EU) 2023/1545 must be listed in the ingredient list when the concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Of course, the old ones too.
Cosmetic products containing these substances that do not comply with the restrictions may be placed on the Union market until the 31st of July 2026 and made available on the Union market until the 31st of July 2028.
The timing for the UK has not yet been determined. Cosmetic products marketed in the UK must be listed with the initial 24 allergens, and there is no date of exemption.
Need Help with Cosmetic Regulation?
In light of the changing landscape, please look for specialized regulatory advice. At Cosmeservice, we help in guiding companies through the complex maze of cosmetic regulations. Our expertise ensures that your products comply with current regulatory standards and safety profiles. Contact us to ensure that your cosmetic products meet all requirements.
