FDA Update on Phthalates in Food Packaging and Food Contact Applications
Constituent Update
October 29, 2024
Today, the U.S. Food and Drug Administration (FDA) responded to objections on the agency’s final rule that removed the authorized food contact uses of most phthalates because industry 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 we have received through our request for information, and phthalates are included on the list of select chemicals under FDA review.
The FDA issued the final rule in 2022 which granted a petition demonstrating that industry has abandoned the food contact use of most phthalates that were previously authorized for food contact uses. An objection from several public interest groups followed. Today’s response to this objection explains that the FDA’s action on the final rule was reasonable.
The FDA also received objections to the agency’s denial of a separate food additive petition requesting that the agency revoke authorized food contact uses of 28 phthalates due to alleged safety concerns. We have concluded that the objectors have not established a basis for modifying or revoking the denial order as requested in the objections.
Today'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. 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of the safety-based petition, we note that the authorization of 23 of the 28 phthalates were no longer in use and have been revoked in the final rule issued at the same time as the denial of the safety-based petition.
We will continue to keep the food industry and the public informed of updates related to our activities on phthalates in food contact applications. Up to date information is available on the FDA’s phthalates page.
Additional Information
- Hearings, Meetings, Proceedings, etc.: Environmental Defense Fund, et al.
- Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
- Phthalates in Food Packaging and Food Contact Applications
- Constituent Update: FDA Responds to Petition on Phthalates in Food Packaging and Food Contact Applications - July 2023
- Constituent Update: FDA Limits the Use of Certain Phthalates in Food Packaging and Issues Request for Information About Current Food Contact Uses and Safety Data - September 2022
- FDA’s list of chemicals in the food supply that are under review