On May 19, the U.S. Food and Drug Administration (FDA) responded to two food additive petitions and a citizen petition asking the agencies to take action on phthalates in food contact applications. In addition, FDA issued a request for available safety data and current use information for some phthalates in food contact applications. Although there is partial overlap among the phthalates addressed in the three petitions, FDA evaluated and responded to each petition separately after assessing the information in each petition, the requests made, and the available information related to phthalates in other food packaging contact applications.

▌FDA's Response to Recent Petitions on Phthalates in Food Packaging Contact Applications

The FDA amended its food additive regulations to no longer specify that most phthalates are allowed in food packaging contact materials because these uses have been abandoned by industry. the FDA revoked the food contact use authorization for 23 phthalates and two other substances used as plasticizers, adhesives, defoamers, surface lubricants, resins, and demulcent agents. the FDA took this action in response to Flexible Vinyl Alliance (FVA), filed on July 3, 2018, requesting revocation of the authorization for 25 substances as food contact materials. Petitioners certify that industry has abandoned the use of these 25 substances. This action removes these phthalates from Parts 175 through 178 of the list of authorized substances under 21 CFR.

This measure also resulted in limiting the available authorizations for phthalates in food contact applications to nine, with eight authorized as plasticizers and one authorized as a monomer. To better understand the current use of these remaining phthalates, FDA requested information on the current food contact uses, use levels, food exposure, and safety data for the eight phthalates authorized for use as plasticizers.

The information request did not address phthalates authorized for use as monomers because any exposure resulting from this substance use is expected to be negligible. the FDA denied a separate food additive petition submitted by multiple public interest groups requesting that the FDA revoke the food contact use of 28 phthalates. This food additive petition proposed to group all 28 phthalates into one category and remove them from FDA's food additive regulations based on the safety concerns of the proposed category.

FDA determined that the petition did not support the grouping of the 28 phthalates into one category and that the petition did not demonstrate that the proposed phthalate category was no longer safe for approved food additive uses.FDA's Federal Register notice included a response to the statements in the petition. The approval of the Flexible Vinyl Alliance food additive petition resulted in the revocation of food additive authorization for 23 of the 28 phthalates involved in the public interest group's food additive petition.

FDA also denied a related citizen petition filed by the same public interest group seeking to prohibit the use of some phthalates in food contact and to revoke prior approval authorizations for other phthalates based on the safety concerns described in the food additive petition.FDA denied this citizen petition because the petition did not demonstrate through scientific data or information that these actions were justified.

▌FDA Seeks Updated Data on the Use and Safety of Phthalates in Food Contact Applications

FDA issued a notice requesting available use and safety information for the remaining eight phthalates authorized for use as plasticizers in food contact applications.FDA generally uses publicly available, up-to-date toxicological information and use information for phthalates. However, stakeholders may provide non-public information.

FDA is seeking scientific data and information on specific current food contact uses, use levels, food exposures, and current safety data for the eight remaining phthalates that remain authorized for use as plasticizers in food contact applications after the action. This information can be used to update the food exposure assessment and safety assessment for phthalates authorized for food contact use.

The eight phthalates authorized for use as plasticizers are as follows

◆ Diisononyl phthalate (DINP, CAS# 28553-12-0)

Diisodecyl phthalate (DIDP, CAS# 26761-40-0)

◆ Di(2-ethylhexyl) phthalate (DEHP, CAS# 117-81-7)

◆ Dicyclohexyl phthalate (DCHP, CAS# 84-61-7)

◆ Butyl phthalate hydroxyethyl ester (BPBG, CAS# 85-70-1)

◆ Diethyl phthalate (DEP, CAS# 84-66-2)

◆ Monoethyleneglycol phthalate (EPEG, CAS# 84-72-0)

◆ Diisooctyl phthalate (DIOP, CAS# 27554-26-3)