Earlier this week, the FDA affirmed that there is insufficient evidence to group phthalates as a single class and concluded that these materials exceed safe levels. The agency announced that it is working on updated safety assessments of the remaining authorized phthalates and their uses.
Phthalates are chemical compounds used in plastic food packaging making them flexible, durable and transparent.
In 2016, a citizen petition raised concerns about the health risks associated with phthalates requesting that FDA ban the entire class of phthalates in food-contact materials. In 2018, Flexible Vinyl Alliance (FVA) submitted an industry petition to the FDA to remove 26 phthalates from food contact applications citing that these materials were obsolete in the industry. By 2022, the FDA granted the petition, removing 23 of 28 phthalates from the list of authorized substances and limiting the remaining phthalates for food contact use to nine specific compounds.
FDA’s “response to these objections explains that we denied the food additive petition because it did not establish, through data and information, sufficient support to take the requested action of grouping the 28 phthalates as a class and revoking the authorizations for the 28 phthalates on the basis that they were unsafe as a class. The FDA assessment found that available information does not support grouping all 28 phthalate chemicals into a single class assessment,” according to the agency.
The nine remaining authorized phthalates include:
- Di(2-ethylhexyl) phthalate, CAS No. 117-81-7 (DEHP),
- Dicyclohexyl phthalate, CAS No. 84-61-7 (DCHP),
- Diisononyl phthalate, CAS No. 28553-12-0 (DINP),
- Diisodecyl phthalate, CAS No. 26761-40-0 (DIDP),
- Diallyl phthalate, CAS No. 131-17-9 (DAP),
- Diethyl phthalate, CAS No. 84-66-2 (DEP),
- Butyl phthalyl butyl glycolate, CAS No. 85-70-1 (BPBG),
- Diisooctyl phthalate, CAS No. 27554-26-3 (DIOP) and
- Ethyl phthalyl ethyl glycolate, CAS No. 84-72-0 (EPEG)
Objections to FDA's ruling advocate for more comprehensive safety assessments
Health and environmental advocacy groups, including the Environmental Defense Fund, Center for Food Safety and Center for Science in the Public Interest, among many others objected to FDA’s 2022 decision. They argue that the FDA should have conducted a comprehensive safety assessment of all phthalates, rather than removing only those abandoned by the industry. These groups expressed concerns about the health risks from the remaining permitted phthalates used in food-contact materials.
Trade groups support individualized safety assessments of phthalates
In addition to the Flexible Vinyl Alliance, the American Chemical Council (ACC), representing the interests of the American chemical industry, advocates against a “class-based” approach to regulating all phthalates collectively. Instead the ACC supports individualized assessments for each compound based on its unique properties and potential risks, the organization told FoodNavigator-USA.
“This [individualized assessment] ... also unnecessarily jeopardizes access to critical products that rely on these chemistries without having a meaningful impact on public health,” the organization said.
The ACC emphasizes that treating all phthalates as a single class overlooks critical differences in toxicity, functionality and exposure potential among individual phthalates.
"Chemical should be evaluated based on specific characteristics rather than broad, class-based regulations," the ACC noted, citing reviews by independent bodies like the National Academies. Certain phthalates like DINP and DIDP have been rigorously studied and determined safe to use for food contact by multiple regulatory agencies, the ACC highlighted.
“Furthermore, in May 2022, after years of analysis, FDA said that it did ‘not have a basis to conclude that dietary levels from approved ortho-phthalates exceed a safe level,'” it said.
What does FDA’s decision mean for the food packaging industry?
The FDA’s reaffirmation of its decision to unauthorize the list of phthalates is expected to have minimal industry impact since these chemicals were already unused by 2018, Claire Sand, food packaging division member of the Institute of Food Technologists, told FoodNavigator-USA.
By opting not to group phthalates under a single class, the FDA allows each approved phthalate to be used up to its allowed amounts regardless of similar effects on the body or structural similarities, Sand said.
“The FDA’s decision not to combine phthalates in one class means that the amount of phthalates allowed in the packaging will not decrease,” Sand explained.
This differs from the European Food Safety Authority (EFSA) regulations, where packaging companies exporting to the EU must adhere to stricter class-based limits, Sand said. This includes four ortho-phthalates (DBP, BBP, DEHP, DINP) that are classified together under a unified tolerable intake, she added.
“Scientists can help ensure compliance by understanding that regulations differ and that consumers are increasingly concerned and aware of migration from packaging,” Sand advised.
Sand continued, “This is done via a package stewardship process, which ensures that packaging does not contain substances of interest, such as specific phthalates, chlorinated hydrocarbons, bisphenols (BPAs), benzophenone, and per- and polyfluoroalkyl substances (PFAS)," citing more information on stewardship can be found on the Food Packaging Stewardship Certification website.
