Regulatory Watch
FDA Advances Post-Market Review of Phthalates Used in Food Contact Materials
This work will inform the agency’s upcoming post-market safety assessment of the food contact uses of phthalates.
The U.S. Food and Drug Administration has released a scientific evaluation of the eight ortho-(o)-phthalates currently 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 will inform the agency’s upcoming post-market safety assessment of the food contact uses of phthalates. The FDA accepted public comment through July 26.
Specifically, the FDA analyzed the 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 eight 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 inclusion and exclusion criteria for CPR grouping of these phthalates. The FDA’s findings support CPR grouping for DEHP, DCHP, DIOP and DINP for a future cumulative risk assessment. The FDA will consider stakeholder input on the use of this grouping for a future cumulative risk assessment.
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.
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