ILSI Europe Report Series
Since the beginning of the harmonisation of legislation on food contact materials, a conservative approach with substantial built-in safety margins has been applied by the European Commission and the Scientific Committee for Food (SCF) for approval of the use of substances in plastic packaging. This approach assumes that every European Union citizen consumes 1 kg of foodstuffs each day over a lifetime that are entirely packaged in the same plastic material. This potential “exposure” sets the maximum concentration permitted to migrate and is related to the toxicological tolerable daily intake (TDI) for the substance in question. In this way, substances are authorised for use subject to migration restrictions stipulated as specific migration limits (e.g. smells) or, in some cases, residual amounts of the substance in the material itself.
In 1993, ILSI Europe, together with the EC and scientific experts, initiated studies to support a more advanced exposure evaluation process. These new evaluation concepts are not limited to food consumption factors, packaging usage factors, or thresholds of toxicological (regulatory) concern as shown during the workshop. Until the discovery of high levels of bisphenol-A-diglycidyl-ether (BADGE) in canned fish products in Switzerland in 1995, the focus had been on migration into foods and migration limits in foods. Since then, studies of food consumption data have accelerated, in part to determine whether observed high levels are of concern from a health point of view (for BADGE) and in part to put migration into a wider perspective. Because daily ingestion of a specific food item containing a packaging substance over a lifetime may be decisive for adverse health effects, focus should be on long-time exposure. Scientists in the field were brought together with the purpose of capturing the latest scientific developments, drafting a refined exposure evaluation concept, developing guidelines, proposing tools, and defining possible areas for further research. Presentations covered areas such as risk assessment, food consumption data, food packaging usage, migration aspects, probabilistic modelling and biomarkers.
These presentations were discussed at a two-day workshop held by the EC Joint Research Centre and ILSI Europe in Ispra, Italy (15–16 October 2001). During the workshop, a number of key themes were highlighted and formed the basis for further discussion. Among these themes were the need to define uncertainties in dietary exposure assessments (and risk assessment) and to propose means to address them, including transparent risk communication, consumer protection, probabilistic modelling in exposure assessments, and the necessity for toxicity testing at threshold levels. This new ILSI Europe report summarises the presentations, key points from the discussions, and conclusions from the workshop.
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