UNITED-STATES-OF-AMERICA AND EUROPEAN REGULATION OF FOOD-PACKAGING - FINDING COMMON GROUND TO REACH A COMMON GOAL

There are pronounced differences between the USA approach to the regul ation of food packaging and the system being adopted in the European E conomic Community (EEC). These differences have significant implicatio ns for the efficient regulation of packaging materials and for achievi ng the common goal of regulatory harmonization. The United. States eff ects preclearance of packaging materials by generic regulation, a modi fied 'positive list' system with certain jurisdictional exclusions. Di stinguishing characteristics of the USA system include exemptions for materials that are 'prior sanctioned', 'generally-recognized-as-safe' (GRAS) or 'not reasonably expected to become a component of food'. The USA also embraces the application of the concept of Estimated Dietary Intake and use limitations to take into account likely exposure and, thereby, delimit the requirements for toxicological data. The EEC, on the other hand, is moving towards adoption of a strict positive list s ystem under which no substance may be used in making a package or pack aging material unless it is on the positive list on the basis of a tox icological conclusion as to the general safety of the substance. This paper examines the logical and philosophical underpinnings of both sys tems and the potential for common sense application of de minimis, or regulatory threshold principles, and worldwide use of the Estimated Di etary Intake concept, to help bring about a measure of harmonization c onsistent with the safe and efficient regulation of food packaging mat erials.