The U.S. Food and Drug Administration (FDA) has amended its food additive regulations and issued a request for information regarding phthalates. The agency has taken these actions in response to two food additive petitions and one citizen petition requesting that FDA address phthalates in food contact surfaces and food packaging.
FDA revoked authorizations for the food contact use of 23 phthalates and two other substances used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. The agency revoked authorization for these 25 substances after the Flexible Vinyl Alliance filed a petition in 2018 that demonstrated that the use of these substances have been abandoned by industry. The action removes the phthalates from the list of substances authorized by FDA in the Code of Federal Regulations Title 21, Parts 175–178.
The action also limits the use of phthalates in food contact applications to nine phthalates—eight authorized for use as plasticizers and one authorized for use as a monomer. To better understand the current use of the remaining phthalates, FDA has requested information on the current specific food contact uses, use levels, dietary exposure, and safety data for the eight phthalates authorized for use as plasticizers. The request for information does not address the phthalate authorized for use as a monomer since any exposure resulting from this use is expected to be negligible. FDA may use the information gathered to update the dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.
FDA also denied two petitions filed by the same public interest groups that requested 1) FDA revoke its food additive regulations to no longer provide for the food contact use of 28 phthalates, and 2) a ban on the food contact use for certain phthalates and revocation of the prior sanctioned authorization of other phthalates based on the groups’ safety concerns. The petitions were denied because they did not adequately demonstrate that the requested actions are warranted.