A review of common non-ortho-phthalate plasticizers for use in food contact materials

Several non-ortho phthalate plasticizers, including ATBC, DEHA, DINCH, DOTP, and ESBO, are currently used in flexible PVC applications for food packaging and processing. The aim of this review is to summarize the available toxicity, migration, and human biomonitoring data. Available assessments from US CPSC, EFSA, other governmental and non-governmental organizations, and published toxicology studies were used to show that these plasticizers are generally well-studied and demonstrate low toxicity with a focus on potential carcinogenicity, reproductive, developmental, and endocrine related adverse effects as well as biodegradation, aquatic toxicity, and bioaccumulation. Seven other plasticizers, 2EHESBO, ASE, COMGHA, DBT, DEHCH, PETV, and TOTM, have at least some recent but limited food contact clearances; assessments from CPSC, EFSA, and robust summaries in the REACH dossiers were reviewed for these products. Data gaps were found for some of these; however, there were no concerns raised by the existing data, and they for now have limited use in food contact applications. Migration of ASE, COMGHA, DINCH, DOTP, DEHCH, and TOTM in simulants for aqueous and low alcohol foods ranged from <0.02 to 0.165 mg/kg, which showed they are below established migration limits and well-suited for these applications. Human biomonitoring data are available for DINCH, DOTP, DEHA, DINA, and TOTM, and are essential for determining exposure from all uses.