California Proposition 65 (also known as Safe Drinking Water and Toxic Enforcement Act) was enacted as a ballot initiative in November 1986. Prop 65 businesses are required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical “Known to the State” to cause cancer or reproductive harm.

Recently, under the Toxic Substances Control Act (TSCA) and related regulations, the U.S. Environmental Protection Agency (EPA) announced the listing of five chemical substances as high-priority substances for risk assessment. This decision took effect on December 18, 2024.

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.

In December 11, 2024, the U.S. Food and Drug Administration (FDA) issued updated guidance for industry on 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 In addition, three new FAQs (Q20-22) in Appendix B of the guidance are marked as “for comment purposes only”.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 before 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).

6PPD, N-(1,3-dimethylbutyl)-N'-phenyl-p-phenylenediamine, with CAS number 793-24-8, serves as an antioxidant and antiozonant in tires, playing a crucial safety role by protecting tire components from erosion by ozone, oxygen, and other harmful factors. However, as tires wear against the road surface during driving, particles containing 6PPD are released, which can transform into the highly toxic 6PPD-quinone upon reaction with ozone, posing risks to aquatic life.

EPA announced that it has finished the risk management rule under the updated existing chemical review process in Toxic Substances Control Act (TSCA), banning the manufacture, import, processing, distribution and use of chrysotile asbestos.

On February 22, 2024, the US Environmental Protection Agency (EPA) updated its Toxic Substances Control Act (TSCA) Inventory for the first half of 2024. The updated TSCA Inventory contains a total of 86,741 chemical substances, of which 42,293 are active. The latest update adds 23 new chemicals compared to the August 2023 Inventory. The TSCA Inventory is updated biannually to keep chemical information current and accurate.