Collins T F, Sprando R L, Shackelford M E, Hansen D K, Welsh J J
Center for Food Safety and Applied Nutrition, Food and Drug Administration, Laurel, MD 20708, USA.
Regul Toxicol Pharmacol. 1999 Aug;30(1):39-44. doi: 10.1006/rtph.1999.1307.
The Food and Drug Administration (FDA) is the agency responsible for ensuring that the direct food additives and color additives used in food in the United States are safe for all consumers. In 1982, in an effort to provide guidance concerning appropriate tests, the FDA issued Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food, commonly known as the Redbook. The Redbook included detailed guidelines for testing the effects of direct and indirect food and color additives on mothers and their developing fetuses. Based on refinements in safety assessment and risk evaluation as well as expansion of knowledge concerning the metabolism and pharmacokinetics of food and color additives, the need to revise and update the 1982 document became apparent. In 1993, Redbook II in draft form was made available for public comment. Since then, test end points and developmental landmarks have been refined. The latest proposed guidelines for developmental toxicity studies are provided here.
美国食品药品监督管理局（FDA）负责确保美国食品中使用的直接食品添加剂和色素添加剂对所有消费者都是安全的。1982年，为了提供有关适当测试的指导，FDA发布了《食品中使用的直接食品添加剂和色素添加剂安全性评估的毒理学原则》，通常称为《红宝书》。《红宝书》包含了测试直接和间接食品及色素添加剂对母亲及其发育中的胎儿影响的详细指南。基于安全性评估和风险评估的改进，以及有关食品和色素添加剂代谢及药代动力学知识的扩展，修订和更新1982年文件的必要性变得显而易见。1993年，草稿形式的《红宝书II》可供公众评论。从那时起，测试终点和发育里程碑得到了完善。本文提供了发育毒性研究的最新拟议指南。
