On October 29, 2024, the U.S. Food and Drug Administration (FDA) released a constituent update on the use of phthalates in materials intended for food contact. The update includes the response to two objections issued to the administration.
The first case refers to an objection to a final ruling from May 2022, where 25 specific phthalates in food contact applications were removed from authorization. This was petitioned by the Flexible Vinyl Alliance, stating that the industry has phased out these phthalates and is no longer actively using them in products. Several civil society organizations, including the Environmental Defense Fund (EDF), submitted an objection to this final ruling. They argued that the substance diallyl phthalate (CAS 131-17-9) should also be included in the list of substances. However, the FDA concluded that this objection did not provide sufficient grounds to alter the ruling from 2022.
In a similar case from May 2022, the FDA denied a separate petition from the Natural Resources Defense Council and other organizations requesting the removal of 28 ortho-phthalates from food contact approval.
The FDA received objections to this denial from public interest groups, including the EDF. Again, the Fund requested the FDA to group the 28 phthalates as a class and revoke the authorizations for the 28 phthalates on the basis that they were unsafe as a class. The FDA now denied these objections too and argued that the submitted evidence did not justify the modification of their ruling or the need for a public hearing on the matter. In addition, the FDA noted that 23 of these 28 phthalates were revoked in the initial final rule from 2022.
These petitions have gone through years of back-and-forth between civil society and the FDA, with the FDA now reaffirming its decision not to remove certain phthalates from approval (FPF reported and here)
References
FDA (October 29, 2024) “FDA update on phthalates in food packaging and food contact applications.”
FDA (May 20, 2022) “Indirect food additives: Adhesives and components of coatings; paper and paperboard components; polymers; adjuvants, production aids, and sanitizers.”
FDA (October 30, 2024) “Indirect food additives: Adhesives and components of coatings; paper and paperboard components; polymers; adjuvants, production aids, and sanitizers.”
FDA (May 20, 2024) “Natural Resources Defense Council, et al.: Denial of food additive petition; denial without prejudice of food additive petition.”
FDA (October 30, 2024) “Environmental Defense Fund, et al.: Response to objections and requests for a public hearing.”
Read more
Sharon Mayl, Greg Sperla (November 7, 2024) “FDA responds to objections over phthalates in food packaging.” DLA Piper
Tom Neltner, Maricel Maffini (June 22, 2022) “FDA decisions leave ortho-phthalates in food and our safety in limbo.” Environmental Defense Fund
