Heckman J H
Food Addit Contam. 1994 Mar-Apr;11(2):271-83. doi: 10.1080/02652039409374225.
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.
美国对食品包装的监管方式与欧洲经济共同体（EEC）所采用的体系之间存在显著差异。这些差异对包装材料的有效监管以及实现监管协调的共同目标具有重大影响。美国通过通用法规对包装材料进行预先批准，这是一种经过修改的“肯定列表”制度，存在某些管辖权上的排除情况。美国体系的显著特点包括对“先前已获批准”、“一般认为安全”（GRAS）或“不太可能成为食品成分”的材料给予豁免。美国还采用了估计膳食摄入量的概念并设置使用限制，以考虑可能的接触情况，从而界定毒理学数据的要求。另一方面，EEC正朝着采用严格的肯定列表制度迈进，根据该制度，除非某种物质基于其一般安全性的毒理学结论被列入肯定列表，否则不得用于制造包装或包装材料。本文探讨了这两种体系的逻辑和哲学基础，以及采用微量豁免或监管阈值原则以及在全球范围内使用估计膳食摄入量概念的常识性应用潜力，以帮助实现一定程度的协调，符合对食品包装材料进行安全有效监管的要求。
