Foth H, Hayes Aw
Institute of Environmental Toxicology, Medical Faculty, Martin Luther University, Franzosenweg 1a, Halle, Germany.
Hum Exp Toxicol. 2008 Jun;27(6):443-61. doi: 10.1177/0960327108092296.
Industrial chemicals are needed for chemical synthesis or technical purposes. These beneficial effects are counterbalanced by the potential health risks for all who come into contact with them. The new chemical legislation of the EU, Registration, Evaluation and Authorization of Chemicals (REACH) will force the responsibility of manufacturers and importers of chemical substances to gather the right information needed to decide on the right circumstances of use and control of chemical substances and products. In order to understand the roots of REACH, experiences gained with regard to existing chemicals legislation, particularly in Germany, will be reviewed. Since Council Directive 67/548/EEC all chemicals placed on the market need a set of standard information and provisions for safe transportation. This directive and its amendments (Council Directive(s) 79/831/EEC and 92/32/EEC) have established for new substances a sound information data basis for classification of dangerous properties. Under Council Regulation 793/93/EEC, regulations and administrative provisions have established the requirement to assess the risk to man and the environment of existing substances. So far, only 119 substances have been evaluated under the forces of this regulation. This separation has led to a substantial imbalance between existing substances and new substances with respect to available data needed to recognize hazards for health. The register of produced and imported chemical substances under REACH should eliminate some of this separation and will also be the key for selection of substances of very high concern by the authorization process to restrict the use and distribution accordingly.
工业化学品用于化学合成或技术目的。这些有益影响被所有接触它们的人面临的潜在健康风险所抵消。欧盟新的化学品法规《化学品注册、评估、授权和限制》（REACH）将迫使化学物质的制造商和进口商承担责任，收集所需的正确信息，以确定化学物质和产品的正确使用情况和控制措施。为了理解REACH的根源，将回顾在现有化学品法规方面，特别是在德国所获得的经验。自理事会指令67/548/EEC以来，所有投放市场的化学品都需要一套标准信息和安全运输规定。该指令及其修正案（理事会指令79/831/EEC和92/32/EEC）为新物质建立了一个完善的危险特性分类信息数据基础。根据理事会条例793/93/EEC，法规和行政规定确立了评估现有物质对人类和环境风险的要求。到目前为止，在该条例的推动下，仅对119种物质进行了评估。这种区分导致在识别健康危害所需的现有数据方面，现有物质和新物质之间存在严重失衡。REACH下的生产和进口化学物质登记册应消除部分这种区分，并且也将是通过授权程序选择高度关注物质以相应限制其使用和分销的关键。
