FDA: There is insufficient data to assess the safety of PFAS in cosmetic products

The US Food and Drug Administration (FDA) has published a report, required by Congress under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products marketed in the United States.

After reviewing the available scientific evidence, the FDA concludes that current data are insufficient to draw clear conclusions about the safety of most PFAS used in cosmetics, primarily due to significant gaps in available toxicological information.

Table of contents

• Use of PFAS in cosmetics: key findings from the report

• Scope of the report

• Conclusion

FDA: There is insufficient data to assess the safety of PFAS in cosmetic products

PFAS in cosmetics: Key findings from the report

According to the mandatory cosmetic product listing data submitted to the FDA under MoCRA:

• 51 PFAS are being used in 1,744 cosmetic formulations.

• The assessment focused on the 25 most commonly used PFAS, which represent approximately 96% of the PFAS intentionally added to cosmetic products.

• For most of these substances, the FDA identified that toxicological data are incomplete or nonexistent, limiting the agency's ability to conduct a robust risk assessment.

Although five PFAS appeared to present a low level of concern under their intended conditions of use, the FDA was unable to draw definitive conclusions for most of the substances evaluated. Furthermore, one of the PFAS analyzed was identified as potentially concerning, although significant uncertainties remain due to a lack of data.

PFAS in Cosmetics: Scope of the report

The report focuses exclusively on PFAS intentionally added as ingredients in cosmetic products. It does not address the potential presence of PFAS as unintentional contaminants.

PFAS are synthetic substances used for properties such as water resistance, durability, or texture modification, but their persistence in the environment and their potential toxicity have generated growing health and environmental concerns, prompting greater regulatory attention at the state, federal, and international levels.

Conclusion

The FDA report highlights significant scientific uncertainty regarding the safety of PFAS in cosmetic products. While it does not introduce any immediate bans, it reinforces the regulatory focus on these substances and anticipates increased regulatory scrutiny in the short and medium term.

At Belab Services, we closely monitor regulatory and scientific developments regarding PFAS and support our clients in regulatory assessment, formulation review, and compliance planning in markets such as the United States and the European Union.

Get in touch with our team of experts today.