Threshold of regulation

Abstract

This chapter discusses the scientific and legal basis for establishment of a threshold of regulation for substances used in food contact material. The so-called threshold of regulation is set at a level below which exposure to a given chemical substance can be reasonably expected to result in negligible risk in the absence of specific information on the toxicity of the substance. The utility of the threshold of regulation concept in enabling regulatory decision-making has been frequently discussed in the literature (Frawley, 1967; Flamm et al., 1987; Rulis, 1989; Munro, 1990; Machuga et al., 1992). In August 1995, the United States Food and Drug Administration (FDA) established a process for applying a threshold of regulation to uses of substances in food contact materials (Food and Drug Administration, 1995). Other regulatory bodies worldwide are also currently considering the application of the concept to the regulation of food packaging and other regulatory areas. We use the FDA’s process as an established example, but the general principles of the threshold process are applicable to any regulatory process for food packaging and may have application in broader regulatory areas.