Anadón A, Martínez-Larrañaga M R, Martínez M A
Department of Toxicology and Pharmacology, Faculty of Veterinary Medicine, Universidad Complutense de Madrid, Spain.
Vet Hum Toxicol. 2001 Oct;43(5):297-301.
Authorization of plant protection products/agrochemicals/pesticides in the European Union is done on the basis of their toxicological properties. This paper reviews the current legislation for placing an agrochemical on the market (ie a new substance or a existing active substance), and the toxicology studies needed for inclusion of a substance in any of the annexes of the Council Directive of the European Economic Community 91/414/ EEC. Risk analysis and its steps is discussed. The "threshold toxicity" employed to allow risk characterisation of plant protection products is described, such as acceptable daily intake, acceptable operator exposure level, acute reference dose, and maximum admissible concentration in water.
欧盟植物保护产品/农用化学品/农药的授权是基于其毒理学特性进行的。本文回顾了农用化学品上市(即新物质或现有活性物质)的现行法规,以及将一种物质纳入欧洲经济共同体理事会指令91/414/EEC任何附件所需的毒理学研究。讨论了风险分析及其步骤。描述了用于对植物保护产品进行风险特征描述的“阈值毒性”,如每日允许摄入量、操作人员可接受接触水平、急性参考剂量和水中最大允许浓度。