Ortho-phthalates, often referred to as “phthalates,” are chemicals used in plastic products (most commonly in the specific type of plastic named polyvinyl chloride, also known as PVC or vinyl) to make the material soft and less brittle. This function in the manufacturing of plastics is often referred to as a “plasticizer.” Some phthalates may be used in food packaging or other minor food contact uses such as components of adhesives, lubricants, and sealants.
Regulatory Approach for Phthalates in Food Contact Applications
The FDA currently allows nine phthalates in food contact applications (eight for use as plasticizers and one for use as a monomer) in the production of food contact polymers. Phthalates are not authorized to be directly added to food.
The body of available toxicological information on phthalates has expanded since the food contact uses of phthalates were authorized. The FDA is generally aware of updated toxicological and use information on phthalates that is publicly available, but stakeholders may have access to information that is not always made public. On May 19, 2022, we issued a request for information seeking scientific data and information on the specific current food contact uses, use levels, dietary exposure, and safety data for the eight phthalates that are still authorized as plasticizers for use in food contact applications through either a food additive regulation or a prior-sanctioned use. The agency may use this information to update the dietary exposure estimates and safety assessments for the permitted food contact uses of these phthalates. The request for information does not include the phthalate authorized for use as a monomer since any exposure resulting from this use is expected to be negligible.
On September 26, 2022, we reopened the comment period in response to a request to provide stakeholders with more time to fully consider the request for information and submit comments. The extended deadline for submissions was December 27, 2022. The FDA is currently reviewing the more than 23,900 comments submitted in the docket and may use this information to update the dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.
Timeline of Additional Regulatory Actions
This timeline provides chronological information about the FDA’s additional regulatory actions related to phthalates in food contact applications.
- On April 16, 2016, the FDA received a citizen petition by several 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. On May 19, 2022, the FDA denied this citizen petition because the petition did not demonstrate through scientific data or information that these actions are warranted.
- On May 20, 2016, the FDA filed a food additive petition from the same public interest groups that submitted the citizen petition, requesting the FDA amend 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. On May 19, 2022, the FDA denied this petition. The FDA determined that the petition did 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.
- On July 3, 2018, the FDA filed a food additive petition from the Flexible Vinyl Alliance requesting the agency remove food contact uses for 23 phthalates and two other substances used as plasticizers, adhesives, defoaming agents, surface lubricants, resins, and slimicides. The petitioners demonstrated that the uses of the 25 substances have been abandoned by industry. On May 19, 2022, the FDA responded to this petition by issuing a final rule to amend its food additive regulations revoke the authorizations for the food contact use of these 25 substances. This action removed these phthalates from the list of substances authorized by our regulations in 21 CFR parts 175 through 178. This action also resulted 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. Granting this petition resulted in removing food additive authorizations for 23 of the 28 phthalates requested by the public interest groups’ food additive petition that was filed on May 20, 2016. If, in the future, a manufacturer wants to use any of the revoked phthalates for use in food contact applications, we expect the manufacturer to submit either a food additive petition or a food contact substance notification to the agency because these intended uses were previously authorized under our food additive authorities.
- On June 21, 2022, the FDA received a petition for reconsideration requesting that the agency reconsider its denial to a citizen petition originally submitted on April 16, 2016. On July 21, 2023, the FDA denied this petition for reconsideration because we concluded that it does not provide a basis for modifying the FDA’s response to the original citizen petition. Our response explains that we adequately considered relevant information and views contained in the administrative record when responding to the original citizen petition. Additionally, we have considered the information submitted in the reconsideration petition and other relevant information in the administrative record. The FDA’s decision to deny the original citizen petition remains unchanged.
- The FDA is currently reviewing an objection to the agency’s final rule which removed the authorizations for the food contact use of 23 phthalates and two other substances due to abandonment of those uses by industry, and a separate objection to the agency’s denial of the food additive petition filed by several public interest groups to amend its food additive regulations to no longer provide for the food contact use of 28 phthalates due to alleged safety concerns. The FDA will inform the food industry and the public of any updates on our review of these objections.
The original safety assessments that resulted in the authorized uses of phthalates in food contact applications were based on dietary exposure and toxicological information and data provided during the period of 1961 through 1985. However, the food supply and packaging markets have changed over the years, and the use of phthalates in food contact materials has also evolved.
Over the last few years, we have analyzed numerous samples of PVC and non-PVC fast food packaging and food contact articles (for example, gaskets, tubing and conveyer belts) available on the U.S. market for the presence of phthalates. Data from these studies were published in 2018, 2021, and 2022, and suggest that manufacturers have been replacing phthalates as their primary plasticizer with alternative compounds. For example, no phthalates were detected in representative samples of food contact tubing used by industry that were obtained and analyzed in 2021. That evidence suggests that at this time the use of phthalates in food contact applications is limited and consumer exposure to phthalates from food contact uses is decreasing.
We also evaluated the effectiveness of portable devices that industry and the FDA could use to identify plasticizers, including phthalates, in PVC tubing as part of our continued efforts to identify phthalates in food packaging and processing materials. Results from this study demonstrated that some portable devices may be a valuable phthalate screening tool for both the food industry and regulators.
Although FDA has reaffirmed its decision to deny the April 16, 2016 citizen petition from several public interest groups because the petition failed to adequately justify its requests, the agency remains aware of concerns raised about possible health effects of exposure to high levels of phthalates, and its review of information submitted in response to its May 19, 2022 Federal Register notice is ongoing.
We will continue to keep the food industry and the public informed of updates related to our activities on 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