22 Aug 2024

The Prop 65 grace period for bisphenol S (BPS) ends in December 2024

Background

Proposition 65 (Prop 65) is a California right-to-know regulation that mandates businesses to inform consumers if their products contain chemicals listed as known to cause cancer or reproductive toxicity by the state. Failure to comply with the regulation may result in a Notice of Violation (NOV) and, possibly, legal action against the violator.

In December of 2023, following a meeting of the Developmental and Reproductive Toxicant Identification Committee, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) added bisphenol S (BPS) to the Prop 65 list as a chemical known to cause female reproductive toxicity. The committee concluded, “BPS was clearly shown through scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.”

As a result of this listing, any product that contains BPS may be subject to an NOV. Products may need to be reformulated or may require the appropriate warning if exposures to BPS exceed the Safe Harbor Level. Companies have a one-year grace period before the change takes effect; hence, the grace period for BPS expires in December 2024.

How Does this Affect You?

The addition of BPS to the Prop 65 list may be a concern for manufacturers and distributors of bisphenol A (BPA)-free consumer products: BPS is a common substitute for BPA.

Used for decades in the manufacture of many polymers, BPA was phased out after being linked to several adverse health effects and has been listed on Prop 65 since 2015 as a chemical known to cause female reproductive toxicity. In 2020, the listing was updated to include developmental toxicity.

Unfortunately, finding a substitute for BPA in consumer products has not been easy. BPA enhances the physical properties of polymers which makes it highly useful in a wide range of products, and BPS, being an analogue of BPA, shares similar physical and chemical properties. Recent studies report that BPS has become ubiquitous in common consumer products made by companies striving to replace BPA, such that resultant exposures to BPS are reported to be comparable to those of BPA when it was commonly used in the United States. For example, an investigation of thermal receipt paper demonstrated that levels of BPS are similar to historical levels of BPA.

How Can Intertek Help?

If your product is considered BPA-free, it may be prudent to verify with your suppliers that it is also BPS-free to avoid a Prop 65 warning label requirement. If you suspect your product contains BPS, Intertek can assist with providing comprehensive Prop 65 services, including analytical testing, testing guidance, exposure assessments, Safe Harbor Level derivation, and labeling guidance. 
Our experts can help determine the best path-to-market for your product.

For more information on California Proposition 65 Services, visit: https://www.intertek.com/assuris/consumer-goods/safety/prop65/ or contact us at: prop65.assuris@intertek.com

A picture of Spencer West
Spencer West

Manager, Consumer Products Risk Assessment, Intertek Assuris

Spencer offers scientific support on food sciences and consumer product-related projects. He is involved in consumer product work, including toxicological risk assessments, ASTM D4236 assessments, California Proposition 65 screening and exposure assessments, and safe harbor level development. He is involved in the project management and preparation of submissions and notifications for review by global regulatory agencies and organizations including the U.S. Food and Drug Administration (FDA), Health Canada, the European Food Safety Agency (EFSA), and Flavor Extract Manufacturers Association (FEMA).

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