Risk assessment of food-contact materials: past experience and future challenges.

The tiered approaches used in the European Union and the USA for the risk assessment of substances in food-contact materials are based on the principle that the amounts of data required to establish safety-in-use depend on the extent of dietary exposure. Tiered approaches are increasingly recognized as sound approaches for chemical risk assessment, which not only offer consumers reasonable certainty of no harm, but also avoid unnecessary toxicological testing and focus scarce risk-assessment resources on substances of potential concern. Although the European Union and United States approaches were developed separately, their tiered testing recommendations are similar. This paper indicates the savings they have brought in the use of animals and suggests areas where testing recommendations for higher dietary exposures might be further refined. It also discusses some of the future challenges in risk assessment of food-contact materials.