FDA Defends Revoking Authorizations for Most Phthalates; Remaining Uses Under Review
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In 2022, the U.S. Food and Drug Administration (FDA) revoked the authorized food contact uses of most phthalates due to the widespread abandonment of these uses by industry. After receiving objections on the final rule amending the authorizations for phthalates, FDA has decided that the objections do not justify any amendment to the agency’s rulemaking.
Phthalates are used in plastics and can be found in food packaging and other food contact materials, such as surfaces in food processing plants and food handling gloves. Their use has become an issue of concern due to increasing evidence of the associated negative health consequences.
Phthalates can migrate from food contact materials into foods, and independent testing has shown the pervasive presence of the chemicals in foods, often at high levels.
FDA’s 2022 final rule revoking authorizations for many phthalates was issued to grant a petition demonstrating that industry has abandoned the food contact use of most phthalates that were previously authorized for food contact uses.
At the same time, FDA has received objections on its denial of a separate additive requesting that the agency revoke authorized food contact uses of 28 phthalates due to food safety concerns. FDA concluded that the objectors did not establish a basis for modifying or revoking the denial order as requested in the objections. The petition was denied because it did not provide sufficient evidence to support 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. FDA found that available information does not support grouping all 28 phthalate chemicals into a single class assessment, which was the basis of the petition.
However, FDA notes that 23 of the 28 phthalates named in the petition were no longer in use and have been revoked in 2022 the final rule, which was issued at the same time as the denial of the safety-based petition. Regardless, in October 2024, U.S. Senators wrote a letter to FDA urging the agency to revoke its remaining authorizations for phthalates in food contact materials, arguing that the chemicals are proven to be toxic.
As part of its efforts to enhance its post-market review of food chemicals, the agency is currently conducting an updated safety assessment of the remaining authorized uses of phthalates, which are included in FDA’s list of select chemicals under FDA review.
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