California Bans DEHP in Certain Medical Devices

SG 152/24

Californian prohibition will phase out DEHP and other plasticizers in intravenous solution containers by 2030 and in intravenous tubing by 2035.

On September 25, 2024, the governor of California signed AB 2300 (Chapter 562) into law, prohibiting Di-(2-ethylhexyl) phthalate (DEHP) in intravenous solution containers (IV bags) and IV tubing. The law makes California the first US jurisdiction to restrict ortho-phthalates in medical devices. 

DEHP is an ortho-phthalate, which is commonly added to plastic materials, particularly polyvinyl chloride (PVC), as a plasticizer to increase the material’s flexibility. Exposure to DEHP has been associated with various adverse health effects, such as endocrine disruption, harm to the reproductive system and cancer.

The law provides several terms and their definitions, including but not limited to the following:

• ‘Intravenous solution containers’ means a container used to house medicine, fluid or nutrition therapy that is intravenously administered to patients in a hospital, outpatient or other health care facility
• ‘Intravenous tubing‘ means any tubing used to intravenously administer fluids, medication or nutrients directly to an adult, child or infant
• ‘Ortho-phthalates’ means a class of chemicals that are esters of ortho-phthalic acid, including all of the substances listed in Table 2

Highlights of AB 2300 are summarized in Table 1.

Table 1

¹ DEHP shall not be replaced with other ortho-phthalates

² Exempts human blood collection and storage bags as well as apheresis and cell therapy blood kits and bags, including integral tubing

³ Effective date of January 1, 2032 applies to manufacturers awaiting US Food and Drug Administration (FDA) approval of DEHP-free IV bags or lacking equipment to manufacture DEHP-free IV bags if manufacturer meets the following requirements (1) manufacturer to inform California customers by July 1, 2025, about its development of DEHP-free IV bags meeting requirements of this law, and (2) manufacturer to provide notice to customers and post to its website by January 1, 2028, that original deadline of January 1, 2030, cannot be met

Ortho-phthalates as listed under CA AB 2300 are specified in Table 2.

Table 2

From the simplicity of a syringe to the complexity of a pacemaker, medical devices are heavily regulated and must meet market-specific quality, safety, and performance standards. At SGS, we help you bring medical devices to market safely and efficiently. Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies. Contact us for more information or visit our website. In the end, it’s only trusted because it’s tested.