California Bans DEHP in Some Medical Devices, Echoing EU Regulatory Trends

California lawmakers have unanimously passed a bill to ban Di-2-ethylhexyl phthalate (DEHP) in intravenous (IV) bags by 2030 and in IV tubing by 2035. This move follows increasing concerns about DEHP, a plasticiser used in polyvinyl chloride (PVC) medical devices, which has been linked to cancer and other health risks.

While the bill does not directly target PVC, it is seen by some as part of broader efforts to phase out PVC in medical products. Pressure is mounting on the Environmental Protection Agency (EPA) to regulate PVC under the Toxic Substances Control Act (TSCA), due to environmental and health concerns.

In the European Union, DEHP is regulated under several frameworks, including the Medical Device Regulation (MDR), REACH, and the RoHS Directive. Under the MDR, all legacy medical devices containing DEHP must be CE marked. The CE marking deadlines are 31 December 2027 for high-risk devices and 31 December 2028 for low-risk devices. Manufacturers must justify the presence of DEHP based on patient exposure, available alternatives, and the benefit-risk balance of the device. Additionally, REACH regulations mandate that by 1 July 2030, medical devices containing DEHP must either obtain authorisation or be withdrawn from the EU market.

Read more about the regulation of DEHP in medical devices.

Despite these regulatory pressures, PVC remains a critical material in healthcare due to its flexibility, affordability, and safety. This is stressed in the recent ECHA investigation report on PVC and PVC additives. PVCMed Alliance highlights that the plasticiser industry has developed safe alternatives to DEHP, ensuring PVC medical devices remain a viable option without compromising patient care.