The U.S. Food and Drug Administration responded to objections to the agency’s final rule that removed the authorized food contact uses of most phthalates because the industry has abandoned these uses.
The FDA evaluated the objections and concluded that they did not provide a basis for modifying the final rule. However, the FDA is working on an updated safety assessment of the remaining authorized uses, including considering information the agency has received through our request for information.
Phthalates are included on the list of select chemicals under FDA review.
Since the 1930s, a family of chemicals called phthalates have been used in a variety of products including food containers. Phthalates are used for many purposes including to soften and strengthen plastic.
The FDA issued the final rule in 2022, which granted a petition demonstrating that the industry has abandoned the previously authorized food-contact use of most phthalates. Several public interest groups objected. The latest response to this objection explains that the FDA’s action on the final rule was reasonable.
The FDA also received objections to its denial of a separate food additive petition requesting that it revoke the authorized food contact uses of 28 phthalates because of alleged safety concerns.
The agency has concluded that the objectors have not established a basis for modifying or revoking the denial order as requested in the objections.
The 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.”
Fundamental to the petition was the claim that all 28 phthalates could be reviewed together as a class, applying data from one chemical to the entire set of 28. The FDA assessment found that available information does not support grouping all 28 phthalate chemicals into a single class assessment.
For the 28 phthalates that were the subject of the safety-based petition, the FDA notes that the authorization of 23 of the 28 phthalates was no longer in use and was revoked in the final rule issued at the same time as the denial of the safety-based petition.
The FDA promises to continue informing the food industry and the public of updates related to these activities on phthalates in food-contact applications. Up-to-date information is available on the FDA’s phthalates page.
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