FDA Extends Comment Period for Evaluation of Phthalates in Food Contact Materials

In response to a stakeholder request, the U.S. Food and Drug Administration (FDA) has extended the public comment period by 30 days forits scientific evaluation of phthalates authorized as plasticizers for food contact use. Comments may now be submitted through July 26 to docket FDA-2026-N-5776.

The evaluation aims to help inform the agency's upcoming post-market safety assessment of food contact uses of phthalates, said FDA.

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.

For more information, see FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials.