July 19, 2022
The U.S. Food and Drug Administration (FDA) will reopen the comment period for the request for information seeking available use and safety information on the remaining phthalates authorized for use as plasticizers in food contact applications. The request for information appeared in the Federal Register on May 19, 2022, with comments due by July 19, 2022. The new deadline for comments will be published in an upcoming Federal Register notice. The FDA is reopening the comment period in response to a request to provide stakeholders with more time to fully consider the request for information and submit comments. Comments about the request for information should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-0571.
The original Constituent Update describing the request for information is below.
Original Constituent Update
May 19, 2022
Today, the U.S. Food and Drug Administration (FDA) issued responses to two food additive petitions and a citizen petition requesting agency action on phthalates in food contact applications. We also issued a request for information about available safety data and current use information of certain phthalates in food contact applications. While there was some overlap among the phthalates that were addressed by all three petitions, we evaluated and responded to each petition individually after having assessed the distinct requests made in each petition, the information included in each petition, and other available information related to phthalates in food packaging and food contact applications.
Our Responses to Recent Petitions about Phthalates in Food Packaging and Food Contact Applications
The FDA amended its food additive regulations to no longer provide for most phthalates to be used in food contact applications because these uses have been abandoned by industry. The 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 is taking this action in response to a food additive petition from the Flexible Vinyl Alliance, filed on July 3, 2018, requesting the agency remove food contact uses for these 25 substances. The petitioners demonstrated that the uses of the 25 substances have been abandoned by industry. This action removes these phthalates from the list of substances authorized by our regulations in 21 CFR parts 175 through 178.
This action also results in limiting 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 these remaining phthalates, we have 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.
The FDA denied a separate food additive petition filed by several public interest groups that requested the FDA revoke its food additive regulations to no longer provide for the food contact use of 28 phthalates. This food additive petition proposed to group all 28 phthalates as a single class and remove the listings for those phthalates from the FDA’s food additive regulations based on alleged safety concerns for the proposed class. The FDA determined that the petition does not support grouping the 28 phthalates into a single class, and that the petition also did not demonstrate the proposed class of phthalates is no longer safe for the approved food additive uses. The FDA’s Federal Register Notice includes our response to the assertions included in the petition. Granting the Flexible Vinyl Alliance food additive petition based on abandonment resulted in removing food additive authorizations for 23 of the 28 phthalates addressed by the public interest groups’ food additive petition.
The FDA also denied a related citizen petition by the same public interest groups which requested a ban on the food contact use for certain phthalates and revocation of the prior sanctioned authorization of other phthalates based on alleged safety concerns that were described in their food additive petition. The FDA denied this citizen petition because the petition did not demonstrate through scientific data or information that these actions are warranted.
We Seek Current Data About Phthalate Use and Safety in Food Contact Applications
The FDA issued today’s request for information seeking available use and safety information on the remaining phthalates authorized for use as plasticizers in food contact applications. The FDA is generally aware of updated toxicological and use information on phthalates that is publicly available. Nevertheless, stakeholders may have access to information that is not always made public.
The FDA is seeking scientific data and information on the specific current food contact uses, use levels, dietary exposure, and safety data for the remaining eight phthalates that are still authorized for use as plasticizers in food contact applications after today’s action on the food additive petition based on abandonment. We may use this information to update the dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.
Comments about the request for information should be submitted by July 19, 2022, to Regulations.gov and identified with the docket number FDA-2022-N-0571.
For Additional Information:
- Final Rule: Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers (Docket No. FDA-2018-F-3757)
- Federal Register Notice: Natural Resources Defense Council, et al.; Denial of Food Additive Petition; Denial Without Prejudice of Food Additive Petition (Docket No. FDA-2016-F-1253)
- Federal Register Notice: Ortho-phthalates for Food Contact Use; Request for Information (Docket No. FDA-2022-N-0571)
- Response to Citizen Petition (found in Docket No. FDA-2016-P-1171)
- Phthalates in Food Packaging and Food Contact Applications