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.
On May 19, 2022, the FDA issued a rule to amend its food additive regulations to no longer provide for most previously-authorized phthalates to be used as food additives 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, lubricants, resins, and slimicides. We issued a request for information about the current specific food contact uses, use levels, dietary exposure, and safety data for the remaining phthalates still authorized as plasticizers for use in food contact applications. 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.
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.
Early Research and Possible Health Effects of Phthalates in Food Contact Applications
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.
The FDA is aware of concerns raised about possible health effects of exposure to high levels of phthalates. However, at present the FDA is not aware of evidence that the dietary exposure to phthalates resulting from their use as food contact substances poses a safety risk.
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 eight representative samples of food contact tubing 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 exposures 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.
In addition to the evolving use of phthalates in food contact applications, 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. Nevertheless, stakeholders may have access to information that is not always made public.
As such, on May 19, 2022, we issued a request for information with a comment period that closed on July 19, 2022, 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 as plasticizers for use in food contact applications through either a food additive regulation or a prior-sanctioned use. On July 19, 2022, we announced that we would reopen the comment period in response to a request to provide stakeholders with more time to fully consider the request for information and submit comments. On September 26, 2022, we announced in a Federal Register notice that we were reopening the comment period; the new deadline for comments is December 27, 2022. We may use this information to update the dietary exposure estimates and safety assessments for the permitted food contact uses of phthalates.