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California Bans DEHP in Certain Medical Devices

SafeGuardSHardgoodsOctober 08, 2024

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.


SubstanceScopeRequirementEffective date
DEHPIntravenous solution containers (IV bags)
Prohibited if intentionally added1,2

< 0.1%, if unintentionally added
January 1, 20303
DEHP
Intravenous tubing
Prohibited if intentionally added1,2

< 0.1%, if unintentionally added
January 1, 2035

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.


Entry
Abbreviation
Ortho-phthalate
CAS
1BBPBenzyl-butyl phthalate
85-68-7
2DBPDibutyl phthalate
84-74-2
3DCHPDicyclohexyl phthalate
84-61-7
4DEHPDi-(2-ethylhexyl) phthalate
117-81-7
5DEPDiethyl phthalate
84-66-2
6DIBPDi-isobutyl phthalate
84-69-5
7DIDPDi-isodecyl phthalate
26761-40-0
8DINPDi-isononyl phthalate
28553-12-0
9DnHPDi-n-hexyl phthalate
84-75-3
10DNOPDi-n-octyl phthalate
117-84-0
11DnPPDi-n-pentyl phthalate
131-18-0
12DIHPDiisoheptyl phthalate
71888-89-6

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.

© SGS Société Générale de Surveillance SA. This publication or website is a property of SGS Société Générale de Surveillance SA. All contents including website designs, text, and graphics contained herein are owned by or licensed to SGS Société Générale de Surveillance SA. The information provided is for technical and general information purposes only and offers no legal advice. The information is no substitute for professional legal advice to ensure compliance with the applicable laws and regulations. All information is provided in good faith “as is”, and SGS Société Générale de Surveillance SA makes no representation or warranty of any kind, express or implied, and does not warrant that the information will be error-free or meet any particular criteria of performance or quality.

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