On May 19, 2022, the US Food and Drug Administration rejected two citizen petitions asking the agency to remove 28 phthalates allowed for food contact use that were listed in the national food additives regulation. The FDA stated that the citizen petitions “did not demonstrate the proposed class of phthalates is no longer safe for the approved food additive uses” and did not demonstrate that actions were warranted. It did grant a 2018 petition from the Flexible Vinyl Alliance to remove 23 phthalates because “they have been abandoned by industry.”
Civil society organizations had put forward the petitions in 2016 based on concerns about the human health effects from phthalates that migrate into food from packaging and processing equipment (FPF reported). The FDA is legally supposed to respond to a petition within 180 days. The organizations called for a response from FDA in 2019 (FPF reported) and finally sued the agency in 2021 (FPF reported). After the legal suit, members of congress also demanded the FDA formally respond (FPF reported).
In the same press release, the FDA announced it was issuing a request for information on eight phthalates that remain on the food additives list. Stating, “the FDA is generally aware of updated toxicological and use information on phthalates that is publicly available.” Comments must be submitted by July 19, 2022. The eight phthalates are:
- 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)
- Butylphthalyl butyl glycolate (BPBG, CAS 85-70-1)
- Diethyl phthalate (DEP, CAS 84-66-2)
- Ethylphthalyl ethyl glycolate (EPEG, 84-72-0)
- Diisooctyl phthalate (DIOP, CAS 27554-26-3)
The Food Packaging Forum’s new database on migrating and extractable food contact chemicals (FCCmigex) lists 142 scientific publications that detected phthalates migrating into food or food simulants including six of those still approved. Sixty-two scientific articles were published in the years between the citizen petitions and FDA’s ruling.
Other research published in 2021 found the current regulatory safe limits for phthalates may not be safe (FPF reported) and could lead to a diverse array of health impacts (FPF reported), phthalate exposure from fast food packaging in the US is significant (FPF reported), and that the estimated economic cost of phthalate exposure to society in the US is $39-47 billion annually (FPF reported).
Reference
FDA (May 19, 2022). “FDA limits the use of certain phthalates in food packaging and issues request for information about current food contact uses and safety data.”
Read more
Scott Medintz (May 20, 2022). “FDA denies petition to ban all phthalates in food packaging.” Consumer Reports
Sharon Udasin (May 19, 2022). “FDA sparks anger with decision on ‘phthalates’ — a chemical in fast-food packaging.” The Hill
Erin Fitzgerald (May 19, 2022). “FDA allows hormone-disrupting phthalates in food packaging.” Earthjustice
Food Packaging Forum (2022). “Database on migrating and extractable food contact chemicals (FCCmigex).” Interactive tool
