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 regulation of food packaging and the system being adopted in the European Economic Community (EEC). These differences have significant implications for the efficient regulation of packaging materials and for achieving the common goal of regulatory harmonization. The United States effects preclearance of packaging materials by generic regulation, a modified 'positive list' system with certain jurisdictional exclusions. Distinguishing 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 system under which no substance may be used in making a package or packaging material unless it is on the positive list on the basis of a toxicological conclusion as to the general safety of the substance. This paper examines the logical and philosophical underpinnings of both systems and the potential for common sense application of de minimis, or regulatory threshold principles, and worldwide use of the Estimated Dietary Intake concept, to help bring about a measure of harmonization consistent with the safe and efficient regulation of food packaging materials.
J H
JH
Heckman
D005062:European Union; D005503:Food Additives / Q000009:adverse effects; D005511:Food Handling / Q000331:legislation & jurisprudence* / Q000592:standards; D005524:Food Technology; D007391:International Cooperation; D007881:Legislation, Food; D011137:Polystyrenes / Q000009:adverse effects; D012449:Safety; D014481:United States; D014486:United States Food and Drug Administration
D005503:Food Additives; D011137:Polystyrenes