Methods and approaches used by FDA to evaluate the safety of food packaging materials

Abstract

In the Federal Register of July 17 1995 (60 FR 36582), the US Food and Drug Administration (FDA) established a ‘threshold of regulation’ process. This process was established for determining when the extent of migration to food is so trivial that safety concerns would be negligible. The process exempts materials in food‐contact articles whose use results in dietary concentrations at or below 0.5ppb (μg/kg) from the food additive listing regulation requirement. Carcinogens or substances that may be carcinogens are excluded from this regulation. This paper explores some of the ramifications of the threshold of regulation policy with respect to traditional migration testing. It examines the use of the threshold approach and migration modelling to estimate food additive exposures. These results indicate that modelling may be a reasonable alternative to traditional migration testing.