Green S
Division of Toxicology, Food and Drug Administration, Washington, D.C. 20204.
Biomed Environ Sci. 1988 Dec;1(4):424-30.
The Center for Food Safety and Applied Nutrition of the Food and Drug Administration has published guidelines for the safety assessment of direct food and color additives. These guidelines are to be updated beginning in 1988. The safety of a food and color additive must be established prior to marketing by an evaluation of probable exposure of consumers and appropriate toxicological information. "Safe" and "safety" are defined as a reasonable certainty that a substance is not harmful under the intended conditions of use. A number of tests are used in determining the safety of food additives. Some of these are: subchronic toxicity studies, chronic toxicity studies, carcinogenicity, reproduction, teratogenicity, and occasionally short-term tests for carcinogenicity. The Center also has a research program in toxicology which in part focuses on diet/toxicity interaction and risk assessment. Examples of such activities are investigation of the teratogenicity of textured vegetable protein and of the potential of zinc to prevent or ameliorate such effects, the development of whole rat embryo cultures as a model to investigate the mechanisms by which teratogens may act, and a program in pharmacokinetics and molecular toxicology to aid in studying assumptions underlying risk assessment.
美国食品药品监督管理局的食品安全与应用营养中心发布了直接食品和色素添加剂安全性评估指南。这些指南从1988年开始更新。食品和色素添加剂的安全性必须在上市前通过评估消费者可能的接触情况以及适当的毒理学信息来确定。“安全”和“安全性”被定义为有合理的把握确定一种物质在预期使用条件下不会有害。在确定食品添加剂安全性时会使用多种测试。其中一些测试包括：亚慢性毒性研究、慢性毒性研究、致癌性、生殖毒性、致畸性，偶尔还会进行短期致癌性测试。该中心还有一个毒理学研究项目，部分重点在于饮食/毒性相互作用和风险评估。此类活动的例子包括对组织化植物蛋白致畸性以及锌预防或改善此类影响的潜力的研究，开发全大鼠胚胎培养物作为研究致畸剂作用机制的模型，以及开展一个药代动力学和分子毒理学项目以协助研究风险评估背后的假设。
