EDF Health

Selected tag(s): chemicals in food

How and when will FDA rule on ortho-phthalates in food? It’s anyone’s guess.

Tom Neltner, J.D.is Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

The Food and Drug Administration (FDA) has yet to decide three overlapping petitions requesting the agency take action on uses of ortho-phthalates in contact with food. Two of the petitions—a food additive petition and a citizen petition—were submitted by EDF, Earthjustice and nine other public health allies. In those petitions, we requested the revocation of all uses of this class of chemicals in food because the agency can no longer conclude that such use is safe. The law required FDA to make a decision by no later than September 2018; that deadline has long since come and gone, and the agency hasn’t acted.

The third petition was submitted by the Flexible Vinyl Alliance, an industry group. It requested that the agency revoke the food additive uses of 26 ortho-phthalates because, according to FDA’s notice, they had been abandoned. The agency agreed to review the petition in July 2018 and invited public comment on it in November 2018.  Public comments were due on January 14, 2019.

In a press release about its petition, the industry group announced that only four ortho-phthalates “remain relevant in food contact applications”:  di(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP), dicyclohexyl phthalate (DCHP) and diisodecyl phthalate (DIDP).  It also stated that it confidentially provided the agency with exposure and safety data on these four substances. The agency has made neither the industry’s petition nor the safety data on the four ortho-phthalates publicly available. We submitted a Freedom of Information Act (FOIA) request seeking industry’s “confidential” report and more information on the petition.  We await a response.

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