FDA Groups Four Phthalates For Future Cumulative Risk Assessment Of Food Contact Uses

The US Food and Drug Administration (FDA) has concluded that four ortho-phthalates used in authorised food contact applications should be treated as chemically or pharmacologically related substances for a future cumulative risk assessment. The decision could affect food packaging manufacturers, chemical suppliers, food processors and compliance professionals monitoring restrictions on plasticisers in food contact materials.

The FDA's May 2026 review examined eight ortho-phthalates that remain authorised for specific food contact uses in the United States. After assessing toxicological, chemical and toxicokinetic data, the agency concluded that di(2-ethylhexyl) phthalate (DEHP), dicyclohexyl phthalate (DCHP), diisooctyl phthalate (DIOP) and diisononyl phthalate (DINP) should be grouped together.

Antiandrogenic Effects Drive The Grouping

Phthalates are commonly used as plasticisers to improve flexibility in polymers and have historically been used in food packaging, processing equipment and other food contact materials. The FDA review found that male reproductive toxicity, specifically antiandrogenic effects, is the most sensitive and relevant endpoint for assessing cumulative risks from certain phthalates.

The agency determined that DEHP, DCHP and DINP have robust evidence supporting a common antiandrogenic mode of action. DIOP was conservatively included based on similarities in toxicokinetic profiles, physicochemical properties and available animal data.

Post-Market Review Signals Ongoing Scrutiny

The review highlights how industry use of phthalates in food contact materials has already declined. FDA notes that authorisations for 23 phthalates were revoked in 2022 because the uses had been abandoned by industry, leaving a smaller number of authorised substances.

The agency also cites evidence showing declining DEHP exposure and increasing use of alternative plasticisers such as adipates and epoxidised soybean oil. For manufacturers, the findings reinforce the ongoing shift towards alternative plasticisers and may increase scrutiny of products that still rely on authorised phthalates.