On November 26, 2024, the U.S. Food and Drug Administration (FDA) proposes to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This proposed rule, if finalized, would protect consumers by, to the extent it reduces exposure to asbestos, resulting in fewer asbestos-related illnesses.

This article compiles the cosmetic regulation updates that took place in November and December, covering regions and countries including Europe (EU, Austria, Russia), the Americas (USA, Canada), and the Asia-Pacific region (China, Thailand, Indonesia, Vietnam, Malaysia).

On December 11, 2024, the US Food and Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products. The guidance finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, three new FAQs (Q20-22) in Appendix B of the guidance are marked as “for comment purposes only”. These three FAQs are available for comments until January 13, 2025.

In 2024, CIRS Group helped enterprises successfully apply for various types of International Nomenclature of Cosmetic Ingredients (INCI) names, including peptides, chemical synthesis-based ingredients, and more.

This article compiles the cosmetic regulation updates that took place in September and October in Europe (including the UK), America, and the Asia Pacific region.

The International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO), has updated its classification of talc and acrylonitrile, now labeling it as “probably carcinogenic to humans” (Group 2A) for all forms not containing asbestos or asbestiform fibers. This update, published in The Lancet Oncology, may significantly impact the chemical industry, especially under California’s Proposition 65 (Prop 65).

According to the regulations, the FDA was required to accept facility registrations and product listings by December 29, 2023. However, in November 2023, the FDA issued guidelines delaying the implementation of cosmetic facility registrations and product listings under MoCRA until July 1, 2024, to ensure the industry had sufficient time to submit the necessary information. Additionally, the FDA adjusted the requirements for registrations and product listings for facilities that first began manufacturing or processing cosmetic products after December 29, 2022, to be mandatorily enforced by July 1, 2024.

FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.

According to FDA regulations, if a product is intended to be applied to a person’s body to make the person more attractive, it’s a cosmetic under the law, for instance perfumes, colognes and aftershave should all be regulated as cosmetics. However, some products add fragrances for therapeutic purposes, such as aromatherapy products that could relieve muscle pain or headaches, and fragrance products that help sleep. These kind of fragrance products are generally regulated as pharmaceuticals. Other products that may contain fragrance ingredients, but are not applied to the body, including detergent, fabric softener and carpet freshenerare, are under the administration of the Consumer Product Safety Commission.

The US Food and Drug Administration has published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetic product facility registrations and product listings are now included within the SPL framework. The Implementation Guide can be used to develop SPL authoring tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software including Xforms, for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).