FDA Evaluates Food Contact Phthalates for Cumulative Risk Assessment

The U.S. Food and Drug Administration (FDA) released a scientific evaluation of the eight ortho-phthalates (phthalates) authorized as plasticizers for food contact use to determine if they should be grouped together for the purpose of a cumulative risk assessment.

This work is intended to inform the agency’s upcoming post-market safety assessment of the food contact uses of phthalates, FDA said.

FDA analyzed scientific literature to understand if phthalates should be considered chemically or pharmacologically related (CPR) substances. Grouping similar chemicals as CPR enables assessment of their combined risk to consumers in a cumulative risk assessment.

The FDA evaluated the following phthalates: 

• diisononyl phthalate (DINP)
• diisodecyl phthalate (DIDP)
• di(2-ethylhexyl) phthalate (DEHP)
• dicyclohexyl phthalate (DCHP)
• butylphthalyl butyl glycolate (BPBG)
• diethyl phthalate (DEP)
• ethylphthalyl ethyl glycolate (EPEG)
• diisooctyl phthalate (DIOP)

The evaluation proposes science-based inclusion and exclusion criteria for CPR grouping of the eight phthalates. FDA’s findings support CPR grouping for DEHP, DCHP, DIOP and DINP for a future cumulative risk assessment. The agency said it will consider stakeholder input on the use of this grouping for a future cumulative risk assessment.

The public can comment through June 26 via docket FDA-2026-N-5776.  

To better understand the eight phthalates still authorized as plasticizers, the FDA previously issued a request for information seeking data on current uses, use levels and safety to support an updated post-market assessment. The FDA received and reviewed approximately 24,000 comments in response to the RFI. This information was considered when conducting the evaluation.