California lists BPS on Prop 65 – Environmental Law

The Developmental and Reproductive Toxicant Identification Committee voted unanimously to list bisphenol S as a reproductive toxicant under Prop 65

On December 29, the California Office of Environmental Health and Hazard Assessment (OEHHA) formally added bisphenol S (BPS) as a reproductive toxicant under the Safe Drinking Water and Toxic Enforcement Act of 1986, known as Prop 65. BPS under Prop 65 will impact manufacturers across a wide range of industries, as BPS can be found in a range of consumer products, including sportswear, rainwear, baby clothes, blankets, curtains, food can coatings, nonstick cookware and thermally printed receipts that are produced in factories. gas pumps and cash registers.

BPS and other bisphenols are common substitutes for bisphenol A (BPA), which was listed as toxic to reproduction under Prop 65 in 2015 and as toxic to development in 2020. Products that result in significant exposure to BPD require warnings starting one year from the date of listing. , December 29, 2024.

Weighing the Evidence for the Prop 65 Listing of Bisphenol S

The list follows a virtual meeting on December 12 where OEHHA convened the Developmental and Reproductive Toxicant Identification Committee (DARTIC), which “serves as the state’s qualified experts to determine whether a chemical has been clearly shown to cause reproductive toxicity.”

During the December 12 meeting and vote, participants referred to a 137-page hazard identification document, “Evidence on the Female Reproductive Toxicity of Bisphenol S,” published in October 2023 by OEHHA. The paper identifies 23 human epidemiological studies on possible effects of BPD on the female reproductive system. These were cohort, case-control, or cross-sectional studies assessing individual-level exposure to BPD and various female reproductive outcomes, including gestational diabetes, thyroid hormones, sex hormones, and polycystic ovary syndrome (PCOS).

The paper also includes a review of 43 animal studies and the related pharmacokinetics of BPD. According to the pharmacokinetics section of the document, BPS has been found in human blood, cord blood, amniotic fluid, breast milk, semen, skin and urine, but has not been found to accumulate in tissues or blood over time.

At its December 12 meeting, DARTIC voted 9-0 to list BPS as a female reproductive toxicant, stating that BPS “had been clearly demonstrated by scientifically valid testing in accordance with generally accepted principles to cause reproductive toxicity in women.”

Potential future regulatory developments for bisphenol S

DARTIC will meet again in 2024 to investigate the effects of BPD on male reproductive and developmental toxicity. Other countries are also considering legislation on BPD. In January 2023, the European Chemicals Agency (ECHA) added BPS to the candidate list for Substances of Very High Concern (SVHC) designation while investigating BPS for reproductive toxicity and endocrine disruption. ECHA also lists bisphenol A, bisphenol B and 2,2-bis(4′-hydroxyphenyl)-4-methylpentane as SVHCs.

Related substances are also checked for possible limitations, making the search for viable alternatives even more challenging. In 2022, Germany proposed additional restrictions on bisphenol F and bisphenol AF and their salts, as they meet the World Health Organization’s criteria for endocrine disruptors in the environment. Other ECHA Member States have recommended the restriction of more than 30 bisphenols due to their potential hormonal or reproductive toxic effects.

Originally published on January 10, 2024

The contents of this article are intended to provide general guidance on the subject. Specialist advice should be sought regarding your specific circumstances.