Your Monthly Regulations Radar: MoCRA and Prop65 - March 2025

On this page

• MoCRA Update
• Allergens disclosure
• California Proposition 65 Labeling Updates
• California Proposition 65 - Updated Carcinogen List
• Christine's takeaways
• Navigating Global Cosmetics Regulations

MoCRA Update

In December 2024, the Food and Drug Administration (FDA) proposed to require testing of talc-containing cosmetic products for the presence of asbestos that may be present as a contaminant in talc using standardized testing methods. The proposed rule also contains corresponding adulteration provisions and failure of a manufacturer to operate in compliance with both the testing and the record keeping requirements would render the product adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act) and thus, subject to recall.

Asbestos, a known human carcinogen, is a potential contaminant in talc, which is an ingredient used in certain cosmetic products. If finalized, this proposed rule would contribute to consumer protection by potentially reducing exposure to asbestos, thereby decreasing the incidence of asbestos-related illnesses. The test method proposed by the FDA makes use of both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Sepctroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to test talc-containing cosmetic products for potential asbestos contamination. The ruling is expected to be finalized in March 2025.

Allergens Disclosure

There is no new update from the FDA regarding the disclosure of allergens on labels and the final ruling should not be expected any time soon. Since the FDA does not discourage over-declaring, ToxEssential recommends to declare allergens on the labels according to the Commission Regulation (EU) 2023/1545 issue on July 26th, 2023. By being proactive and declaring allergens, your company will be ready for when the FDA issues the new ruling. The FDA is likely to align with the EU Commission with regards to the allergens labeling requirement for the existing 26 allergens.

California Proposition 65 Labeling Updates

California has updated and expanded their short-form warning for the Safe Harbor labeling requirements. This regulatory action will make the Proposition 65 short-form warning more informative to consumers by adding at least one chemical name and providing additional warning options for businesses to select from. The regulations provide businesses that currently rely on the existing short-form warnings, three years to transition to the new short-form content.

For example, companies can select from the word "WARNING:" or the words "CA WARNING:" or "CALIFORNIA WARNING" in all capital letters and bold print, and for exposures to listed carcinogens, the words, "This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov."

For exposures to listed reproductive toxicants, the words "This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov."

California Proposition 65 - Updated Carcinogen List

Vinyl acetate was added to the Prop65 list of carcinogens on January 3rd, 2025, which now requires labeling. Vinyl acetate is a monomer used in the making of polyvinyl acetate polymer, used, for example, as a binder holding ingredients in a compressed table. It is also used as a stabilizer and fixative in the formulation of eye makeup preparations, eyeliners, and mascara. 

💡 Christine's Takeaways: When using talc in your formulations, make sure to obtain a certificate of analysis or specification from your supplier that verifies testing for asbestos in talc. I also recommend to disclose on cosmetic labels the presence of allergens. If you are selling in California, remember to update your labeling to include the name of chemicals recognized by the State of California as a carcinogen or reproductive toxicant. In addition, if your product contains vinyl acetate polymer, you may very well have residual vinyl acetate monomer and therefore you may have to label your product as a carcinogen.

👉 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

Navigating Global Cosmetics Regulations

Navigating regulatory differences across Europe, China, Korea, the UK, India, and the Middle East can be a significant challenge. Join us at in-cosmetic Global's Testing & Regulation Forum on Day 3 at 15:25 CET, where industry experts will share valuable insights on ingredient compliance, sustainable packaging, and marketing regulations. Discover actionable strategies to enhance transparency, ensure compliance, and confidently navigate evolving regulations. Don't miss out—register now!