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FDA updates phthalates regulation

The US Food and Drug Administration (FDA) has amended the law on chemicals commonly found in plastic food packaging and food contact applications.

Phthalates are common chemicals that are found in plastic-based products such as food packaging and food contact applications. A type of plasticisers, phthalates are often added to plastics to improve their flexibility, durability and longevity. Therefore, they can support the overall appeal of brands and manufacturers’ food products, however there are health concerns with phthalates known to be endocrine disruptors.

On the 29 October 2024, the US Food and Drug Administration (FDA) confirmed it had reached a decision on a petition to remove authorised food contact uses of most phthalates. The statement came in response to objections on the FDA’s final rule, which rejected the application to remove phthalates.

In its statement, the FDA said it evaluated the objections to its final rule on phthalates and concluded there was no basis to modify its decision.

The presence of phthalates in food

The FDA has confirmed it is developing an updated safety assessment relating to the remaining authorised uses of phthalates. These safety considerations extend to information the agency has received through its request for information and the phthalates included on the list of select chemicals under FDA review.

“The FDA has taken eight years to respond to the 2016 petition by the Center for Food Safety and a half dozen other US environmental and health groups,” Jaydee Hanson,

policy director of the Center for Food Safety, told Ingredients Network. The Center for Food Safety was one of the organisations that had requested the FDA ban all phthalates as food contact substances.

A collection of organisations made the request including the Environmental Defense Fund, Learning Disabilities Association of America, Center for Environmental Health, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Defend our Health, Alaska Community Action on Toxics and Center for Food Safety.

“The groups filing the 2016 petition opposed the FDA decision, accusing the FDA of responding to just the plastics industry and not doing their own comprehensive risk assessments of all phthalates rather than removing just the phthalates already abandoned by the plastics industry,” Hanson said.

FDA timeline

The FDA reopened the comment period for the notice titled “Ortho-phthalates for Food Contact Use; Request for Information,” in September 2022, after first launching a request for information in May 2022. The agency granted the extension following a request from stakeholders to give interested parties additional time to produce and send data, other information and comments.

In 2022 following an industry petition, the FDA deauthorised the inclusion of 23 phthalates in food. The agency also issued a request for information for safety and use information on the nine remaining authorised phthalates. “In 2022, the FDA responded to the 2018 petition from the Vinyl Alliance that noted 23 orthophthalates had been discontinued,” Hanson said. The response left nine orthophthalates on the market with FDA approval.

On 21 July, 2023, the FDA responded to a petition in response to the actions the agency agreed to take. As of 24 September 2024, phthalates were included in the FDA’s list of under-review select chemicals. The position of chemicals on this list indicates the FDA’s intention to reassess the safety of exposure to chemicals in the food supply chain. If new, relevant data becomes available, the FDA may choose to reassess the safety of food ingredients, food contact substances and contaminants.

“FDA, in late October 2024, reaffirmed its 2022 decision instead of doing a comprehensive review as called for by our coalition,” said Hanson. The agency’s most recent announcement on 29th October 2024 says its action on the final rule was reasonable. Currently, the FDA still allows food companies to include nine phthalates in the production of food contact polymers.

Potential next steps

Concerns remained regarding the presence of phthalates and the impact of US consumers’ exposure to them. “Our groups said that the FDA was continuing to expose consumers to the remaining phthalates on the US market,” Hanson added.

“We are considering whether to take additional legal action to push the FDA to ban all phthalates as food contact substances,” said Hanson. “The FDA’s approach is to reject the class-based approach used by European regulators and force groups to challenge each separate chemical’s health effects,” Hanson added.