To enhance public health and safety, the California State Senate and House of Representatives have passed Bill AB 2300, introduced by Assembly Member Wilson. The bill imposes strict restrictions on the use of Di(2-ethylhexyl) phthalate (DEHP), especially in intravenous fluid containers and tubing in medical devices.
Overview of DEHP and Its Risks
DEHP is a chemical primarily used to increase the flexibility of plastics made from polyvinyl chloride (PVC). It is widely used in the medical industry. Over time, DEHP can leach out of these plastics into the contained liquids, potentially leading to exposure during medical treatments. As an endocrine disruptor, DEHP poses risks including hormonal disruptions, reproductive health issues, and an increased risk of various cancers.
Key Provisions of Bill AB 2300
1. Prohibition on the Use of DEHP in Medical Devices
- From January 1, 2030, the manufacture, sale, or distribution of intravenous fluid containers containing intentionally added DEHP will be prohibited within the state.
- Companies waiting for FDA approval of their DEHP-free alternatives, as well as entities lacking the equipment to produce these alternatives, will receive an additional two-year transition period. In these cases, businesses must notify their customers by July 1, 2025, that they have begun developing alternatives, followed by a notification and online statement by 2028 that they will comply with the extended deadline.
- From 2035, the use of DEHP-containing intravenous tubing will be prohibited.
2. Restrictions on Substitutes
The bill explicitly prohibits the use of the following phthalates as substitutes for DEHP in new or modified products:
- Benzyl-butyl phthalate (BBP) 85-68-7.
- Dibutyl phthalate (DBP) 84-74-2.
- Dicyclohexyl phthalate (DCHP) 84-61-7.
- Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7.
- Diethyl phthalate (DEP) 84-66-2.
- Di-isobutyl phthalate (DIBP) 84-69-5.
- Di-isodecyl phthalate (DIDP) 26761-40-0.
- Di-isononyl phthalate (DINP) 28553-12-0.
- Di-n-hexyl phthalate (DnHP) 84-75-3.
- Di-n-octyl phthalate (DNOP) 117-84-0.
- Di-n-pentyl (DnPP) phthalate 131-18-0.
- Diisoheptyl phthalate (DIHP) 71888-89-6.
3. Exemptions
According to Title 21 of the Code of Federal Regulations, the following items are exempt from these regulations:
- Human blood collection and storage bags.
- Apheresis and cell therapy blood kits and bags, including integral tubing.
California Governor Gavin Newsom will decide whether to sign or veto the bill by September 30. If signed into law, Bill AB 2300 will make California the first region in the United States to ban the use of phthalates in medical devices.
