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News > Articles > California to ban plasticizers in IV bags and tubing

California to ban plasticizers in IV bags and tubing

2025-07-07

California to Ban Phthalates in IV Bags and Tubing

Plasticizers in Medical Devices to Face Regulations

A measure (California AB 2300), signed and promulgated by the California Governor on September 25, 2024, will ban the production, sale, and distribution of IV bags and tubing containing 12 phthalates, including DEHP, effective January 1, 2030. Unintentional additions of phthalates to a maximum of 0.1% are prohibited. Because these medical devices are supplied by only a limited number of manufacturers, and approximately 70% of hospitals still use IV devices made from PVC containing di(2-ethylhexyl) phthalate (DEHP), this ban is expected to have a significant impact on the market.

How to Ensure Product Compliance

Due to their reproductive toxicity and endocrine disrupting properties, phthalate plasticizers can cause adverse health effects such as decreased fertility, developmental abnormalities in children, and even cancer. They are therefore regulated by various regulations such as RoHS, REACH, MDR, and California Proposition 65. To ensure product compliance and market competitiveness, SGS has comprehensive testing capabilities and solutions for phthalate plasticizers, ensuring smooth entry into both European and US markets. Please refer to the 12 phthalate plasticizers listed in this announcement and their CAS Nos. below:

(1) Benzyl-butyl phthalate (BBP) 85-68-7.
(2) Dibutyl phthalate (DBP) 84-74-2.
(3) Dicyclohexyl phthalate (DCHP) 84-61-7.
(4) Di-(2-ethylhexyl) phthalate (DEHP) 117-81-7.
(5) Diethyl phthalate (DEP) 84-66-2.
(6) Di-isobutyl phthalate (DIBP) 84-69-5.
(7) Di-isodecyl phthalate (DIDP) 26761-40-0.
(8) Di-isononyl phthalate (DINP) 28553-12-0.
(9) Di-n-hexyl phthalate (DnHP) 84-75-3.
(10) Di-n-octyl phthalate (DNOP) 117-84-0.
(11) Di-n-pentyl (DnPP) phthalate 131-18-0.
(12) Diisoheptyl phthalate (DIHP) 71888-89-6.

References:Bill Text – AB-2300 Medical devices: Di-(2-ethylhexyl) phthalate (DEHP).

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