The U.S. Food and Drug Administration is moving closer to a long-anticipated safety reassessment of phthalates used as plasticizers in food packaging and other food-contact materials. On May 27, 2026, FDA released a scientific evaluation grouping four of the eight currently authorized ortho-phthalates for a future cumulative risk assessment, and on June 24 the agency extended the public comment period on that evaluation by 30 days. For importers of food packaging, plastic food-contact articles, and finished food products packaged in phthalate-containing materials, this is the clearest signal yet that FDA’s decades-old authorizations for these plasticizers are heading toward substantive review.
A Decade-Spanning Regulatory Thread
Phthalates have been authorized for use as plasticizers in food-contact polymers since safety determinations made between 1961 and 1985, long before FDA developed its current post-market chemical review framework. That original authorization has been under increasing pressure for several years:
- September 2022 — FDA limited certain authorized uses of phthalates and issued a request for information (RFI) seeking updated data on current uses, exposure levels, and safety. The agency received roughly 24,000 comments.
- July 2023 — FDA responded to a citizen petition asking the agency to revoke food-contact approvals for all 28 ortho-phthalates, declining to act on the full scope of the request.
- October 2024 — FDA denied administrative objections to that decision, prompting Earthjustice to file suit on behalf of environmental and public health groups challenging FDA’s refusal to revoke the remaining approvals.
- May 12, 2026 — FDA finalized its Enhanced Systematic Process for post-market assessment of chemicals in food, expanding the formal review list to include other ingredients such as BHT and ADA.
- May 27, 2026 — FDA released the scientific evaluation now at the center of this article, proposing to group four phthalates for cumulative risk assessment.
What the May 2026 Evaluation Actually Found
FDA’s evaluation assessed all eight phthalates still authorized as food-contact plasticizers:
- DINP — diisononyl phthalate
- DIDP — diisodecyl phthalate
- DEHP — di(2-ethylhexyl) phthalate
- DCHP — dicyclohexyl phthalate
- BPBG — butylphthalyl butyl glycolate
- DEP — diethyl phthalate
- EPEG — ethylphthalyl ethyl glycolate
- DIOP — diisooctyl phthalate
The evaluation asked whether these substances are “chemically or pharmacologically related” (CPR) — a classification that allows FDA to assess combined, rather than individual, dietary exposure risk. Based on shared anti-androgenic, male reproductive toxicity endpoints, FDA’s analysis supports CPR grouping for four of the eight: DEHP, DCHP, DIOP, and DINP.
Grouping these four substances does not itself restrict or revoke any current authorization. It establishes the analytical foundation FDA intends to use in the upcoming post-market safety assessment of food-contact phthalate uses generally — the step that could ultimately lead to use restrictions, additional data requirements, or further rulemaking.
Comment Deadline Now Extended to July 26, 2026
In response to a stakeholder request, FDA announced on June 24, 2026 that it is extending the comment period on the May evaluation by 30 days. Comments may now be submitted through July 26, 2026, to docket FDA-2026-N-5776. This gives industry additional time to weigh in before FDA finalizes the grouping approach it will carry into the cumulative risk assessment.
Why This Matters for Importers
Phthalate plasticizers appear in a wide range of imported goods beyond obvious food-packaging films and flexible plastics — gaskets, seals, tubing, adhesives, and coatings used in food processing and packaging equipment can all contain one or more of the eight authorized phthalates. A future cumulative risk assessment that narrows or restricts authorized uses could affect:
- Sourcing and reformulation timelines for flexible PVC food packaging, films, and closures manufactured abroad
- Supplier documentation requirements, as importers may need to confirm which specific phthalate plasticizers are used in component materials
- Compliance costs tied to reformulation, retesting, or substitution of plasticizers in finished food-contact articles
- HTS classification considerations where reformulated materials change a product’s composition for tariff or origin purposes
What Importers Should Do Now
- Identify whether imported food-contact packaging, components, or equipment contain DEHP, DCHP, DIOP, or DINP, or any of the other four authorized phthalates
- Request supplier documentation on plasticizer formulations for flexible plastics, gaskets, seals, and adhesives used in food-contact applications
- Submit comments to docket FDA-2026-N-5776 by July 26, 2026 if the grouping approach or future risk assessment could affect your supply chain
- Monitor FDA’s Post-Market Chemical Safety Program for the formal post-market safety assessment once it is initiated
- Build flexibility into supplier contracts and sourcing plans in case reformulation becomes necessary down the line
Selection for cumulative risk assessment is not itself a safety determination, and FDA has not proposed banning or restricting any of the eight phthalates at this stage. But the direction of travel — finalized systematic review process, expanded chemical watchlist, ongoing litigation pressure, and now a formal CPR grouping — suggests food-contact phthalates will remain an active compliance issue for the foreseeable future.
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References
FDA, “FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials,” May 27, 2026
FDA Scientific Evaluation — Docket FDA-2026-N-5776 (Regulations.gov)
FDA, “Phthalates in Food Packaging and Food Contact Applications” (constituent update history)
FDA, “List of Select Chemicals in the Food Supply Under FDA Review”
FDA, “HFP Constituent Updates”
DLA Piper, “FDA responds to objections over phthalates in food packaging”
Morrison Foerster, “FDA Expands Post-Market Review of Food Chemical Safety”
