California legislators propose to ban ortho-phthalate DEHP in Medical Devices

California legislators have sent to the governor a pioneering bill to prohibit intravenous (IV) bags and tubing containing the ortho-phthalate DEHP.

If signed into law, the legislation would make California the first US State to forbid phthalate use in medical devices.

From 2030, California’s measure would block the in-state manufacture, sale or distribution of IV solution containers with intentionally added di-(2-ethylhexyl) phthalate (DEHP) – which is often utilised as a polyvinyl chloride (PVC) plasticiser.

DEHP is listed under Proposition 65 product warning scheme due to its carcinogenicity and reproductive effects. The phthalate will be prohibited in cosmetics from January pursuant to a 2020 state statute.

Companies waiting for the US Food and Drug Administration (FDA) to greenlight their DEHP-free alternatives would get an extra two years for the phase-out, as would entities that lack the equipment to produce them. In both cases, businesses would need to let customers know by 1 July 2025 that they have begun developing substitutes, then provide a notification and online declaration by 2028.

From 2035, the bill would ban DEHP-containing IV tubing used to administer fluids, medication or nutrients.

Moreover, it would limit DEHP not intended for a functional or technical purpose to 0.1% weight per weight (w/w) in IV bags and tubing.

Beyond the US, the EU last year postponed to mid-2030 its cutoff for the medical devices sector to stop using DEHP without REACH authorisation. The delay gives businesses more time to analyse alternatives.

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