Key takeaway
What This Development Means
FDA's post-market review identifies DEHP, DCHP, DIOP and DINP as related phthalates for future cumulative risk assessment of authorised food contact uses. The review does not impose new restrictions, but it may shape future safety assessments and substitution decisions.
Which phthalates did the FDA group together?
The FDA concluded that DEHP, DCHP, DIOP and DINP should be considered chemically or pharmacologically related substances for a future cumulative risk assessment. The grouping is based on evidence relating to antiandrogenic effects, toxicokinetic similarities and physicochemical characteristics.
Does the FDA review ban any phthalates?
No. The FDA review does not introduce new restrictions or bans. It provides a scientific assessment that will inform future cumulative risk assessments and post-market evaluations of authorised food contact uses.
Source basis: FDA, FDA Advances Post-Market Review Of Phthalates Used In Food Contact Materials (27 May 2026)
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.
Summary
The FDA has identified DEHP, DCHP, DIOP and DINP as related phthalates that should be assessed together in future cumulative risk evaluations. No immediate regulatory changes have been announced, but the review signals continued attention on phthalate exposure from food contact materials and may influence future substitution strategies.
Related Articles
Great Britain To Introduce BPA Ban In Food Contact Materials
Great Britain is preparing to introduce a ban on BPA and its analogues in food contact materials, following consultation feedback on health concerns, substitution risks, derogations and transition challenges.
FDA Food Chemicals Review Process Expands Transparency And AI Monitoring
The FDA food chemicals review process marks a more transparent and proactive approach to post-market oversight. By combining AI-supported monitoring, annual work plans and public consultation, the agency aims to identify potential risks earlier while giving industry clearer routes to provide data and prepare for regulatory action.
Polish Market Surveillance Finds Chemical Non-Compliance In More Than 7% Of Consumer Products
Poland's 2025 chemical compliance campaign found excessive phthalates, cadmium, lead and chromium(VI) in jewellery, PVC tablecloths and leather goods, reinforcing the need for stronger REACH controls.
