Your Monthly Regulations Radar: Review of the 2024 Regulatory Landscape - December 2024

Ending 2024 With a Splash!

We have seen a few major changes in the cosmetics and OTC arena in 2024, which are highlighted briefly below, and more are coming in 2025, therefore stay tuned to your Monthly Regulations Radar with Dr Thiffault.

Health Canada Launch Amendment to Regulations SOR/2024-63 Concerning the Disclosure of Cosmetic Ingredient and Safety Information – April 2024

Canada has adopted the EU restricted substance list and EU disclosure of fragrance allergens listed on Annex III (0.01% rinse-off / 0.001% leave-on). The amendment introduces additional flexibility for the disclosure of ingredients sold in small packages. The amendments also modernized the regulation to improve regulatory oversight of cosmetics e.g., safety information and has modified the requirements related to cosmetic notifications. The good part is that the changes are consistent with EU legislation.

All amendments, except those related to fragrance disclosure, "will come into force 180 days following registration" (October 2024 time frame). Fragrance disclosure comes into force "2 years following the date of registration" (or April 12, 2026). Furthermore, Health Canada makes requests to importers for evidence of safety information on a regular basis, and has done so for over a decade. Most importers are responsive; however, if the requested information is not provided, with the recent amendments, Health Canada can exercise section 29 of the Regulations to issue a “stop sale” in the case of insufficient safety data.

FDA Listing of Cosmetic Products and Registration of Facility –July 2024

On December 18, 2023, the FDA launched the Cosmetics Direct portal for the listing of cosmetic products and the registration of the production facilities, pursuant to the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. MoCRA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States to register each facility with the FDA. It also requires the Responsible Person to submit to the FDA a listing for each cosmetic product produced. Both facility registration and cosmetic product listings were required by July 1, 2024. If your manufacturing facility or your products have not been listed yet, you are not compliant with FDA requirements. However, MoCRA exempts certain small businesses from facility registration and product listing requirements. A small business is defined by MoCRA as one with average gross annual sales of less than US $1Million for the previous 3-year period. 

The First Sunscreen UV Filter Submitted to the FDA in Nearly 25 Years! – October 2024

As mentioned in my previous article; in October 2024, DSM-Firmenich announced it had submitted the first Over-the-Counter Monograph Order Request (OMOR) Tier 1 application to the U.S. FDA for its sunscreen active ingredient Bemotrizinol, branded as PARSOL Shield under the Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020. You would be surprised to know that “Parsol Shield” has been safely used worldwide for over 20 years and has yet to be approved in the U.S. This marks a significant milestone, as it officially starts the FDA’s 17.5-months, or by March 2026, review process to determine whether Bemotrizinol will be classified as Generally Recognized as Safe and Effective (GRASE) for inclusion in the OTC Sunscreen Monograph M020.

U.S. FDA Fragrance Allergen Rule – December 2024

MoCRA stipulates that each fragrance allergen included in products must be identified on the label. Substances that are fragrance allergens for the purposes of this requirement will be identified in rulemaking, and the proposed rulemaking for allergen identification is to be issued by the FDA no later than June 29, 2024. The final rulemaking is to be issued 180 days after the proposed rulemaking's public comment period closes. 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 under MoCRA; these include the disclosure of fragrance allergens in cosmetic labelling as discussed above, 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. The FDA doesn’t have a timing for these regulations and the FDA has not yet confirmed that the regulations will be ready by the end of the year 2024 as required by MoCRA.

💡 Christine's Takeaways: 2024 is ending with a splash with regards to changes in the cosmetic regulation in Canada and the U.S. 2025 is expected to see additional updates from MoCRA including Talc-related, allergens and GMP rules which will significantly impact manufacturers and the labeling of cosmetic products.

👉 If you want to know more about how to comply with the cosmetic regulation in the USA, Canada and Europe and your regulatory and safety obligations as a manufacturer don’t hesitate to reach out to Christine Thiffault, PhD DABT ERT at cthiffault@toxessential.com, Toxicology Expert at ToxEssential, or visit the website: toxessential.com

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