Risk assessment for migration of styrene oligomers into food from polystyrene food containers.

Regulation EU 10/2011 requires a risk assessment of Non Intentionally Added Substances (NIAS) migrating into food for food contact plastics within the EU. Styrene oligomers are important potential components of NIAS in polystyrene used for food packaging and so far only dimers and trimers have been identified. They are not genotoxic in vitro, and there is good evidence that they are not endocrine disruptors. Hazard characterization to establish "safe" exposure levels is based on 1. The No Adverse Effect Level (NOAEL) of 1 mg/kg bw/d in an oral rat study during pregnancy and lactation and 2. The concept of Threshold of Toxicological Concern (TTC). Likely human exposure is derived from 1. the concentrations of dimers and trimers in food simulants or 2. in food and 3. the probabilistic FACET exposure estimation based on dimer and trimer concentrations in polystyrene and their potential for migration. The Margin of Safety as the relation of potential consumer exposure and the "safe" exposure level was always above 1 (apart from migration with 95% ethanol which is no longer recommended as an official food simulant for overall migration into fatty food) demonstrating that dimers and trimers in PS food packaging present a low risk for consumers.