The US Food and Drug Administration’s (FDA) ongoing review of phthalates used in food packaging and other food-contact materials is entering an important scientific phase, but it has yet to result in new regulatory restrictions.
Phthalates (pronounced THAL-ates) are a family of chemicals mainly used to make some plastics softer, more flexible and longer-lasting. They have been widely used in products ranging from flooring and medical devices to food packaging and food-processing equipment.
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Although they are not added directly to food, small amounts can migrate from certain food-contact materials into food, which is why regulators assess their safety.
The FDA is reviewing whether some of the remaining authorised phthalates used in food-contact applications should continue to be considered safe in light of newer scientific evidence.
As part of that process, the agency has concluded that four phthalates share sufficiently similar chemical and biological properties that they should be evaluated together during future cumulative safety assessments.
For packaging manufacturers, converters and material suppliers, the review does not currently change compliance requirements.
However, it signals the FDA’s continued effort to reassess long-standing chemical approvals using modern scientific methods and reflects the growing regulatory focus on substances used in food-contact materials.
Why the FDA is reviewing phthalates
Many of the FDA’s original safety assessments for phthalates were completed between 1961 and 1985, when scientific knowledge of chemical exposure and toxicology was far more limited than it is today.
According to the agency, both the evidence base and the food packaging market have changed significantly over the past several decades.
Advances in toxicology, alongside changes in packaging materials and food manufacturing practices, have prompted the FDA to re-evaluate older authorisations using current scientific standards.
As part of that work, the agency assessed whether eight authorised phthalates should be grouped during future cumulative risk assessments. Its scientific evaluation concluded that four substances—DEHP, DCHP, DIOP and DINP—should be considered together because they exhibit similar chemical structures, biological activity and toxicological characteristics.
The grouping itself does not alter the regulatory status of these substances. Instead, it provides the scientific framework that will inform the FDA’s broader post-market safety assessment of authorised food-contact uses.
The market has already moved away from many phthalates
One of the clearest findings emerging from the FDA’s review is that much of the packaging industry has already reduced its reliance on phthalates.
Testing carried out by the agency on PVC and non-PVC food packaging and food-contact equipment has found widespread adoption of alternative plasticisers. In some food-contact tubing analysed during the review, no phthalates were detected.
This reflects broader changes already seen across the industry. In 2022, the FDA revoked the authorisations for 23 phthalates used in food-contact applications after determining that manufacturers had largely abandoned those uses.
Today, nine phthalates remain authorised for specific food-contact applications in the US. Those uses continue to be evaluated as part of the agency’s ongoing post-market review.
For many packaging businesses, this means the transition away from legacy phthalates has already occurred across significant parts of the supply chain, although certain authorised uses remain in place.
What it means for packaging companies
At present, the FDA has not introduced new bans or restrictions on the remaining authorised phthalates. Instead, it is strengthening the scientific evidence that will underpin any future regulatory decisions.
The agency has indicated that its scientific evaluations, together with information submitted by industry and other stakeholders, will guide future post-market safety assessments of authorised food-contact uses.
For packaging companies supplying the US market, the review highlights the importance of maintaining robust chemical compliance programmes and detailed material documentation.
It also reinforces the need to monitor evolving regulatory requirements, particularly as authorities around the world continue reassessing legacy food-contact chemicals using updated scientific evidence.
Although the FDA’s review has not yet changed the regulatory landscape, it demonstrates that chemicals used in food packaging remain under active scrutiny.
Companies involved in food-contact materials are therefore likely to continue tracking the agency’s assessment as it moves towards future safety decisions.
