Department of Philosophy and the History of Technology, Royal Institute of Technology/Kungliga Tekniska Högskolan, Stockholm, Sweden.
Environ Health Perspect. 2010 Jan;118(1):6-10. doi: 10.1289/ehp.0901157.
In this commentary we analyze how much data will in fact be generated within REACH.
We conclude that the data requirements for many end points still have not been determined but depend on prioritization criteria and waiving practices that will be decided in the years to come. We propose six important steps toward an improved REACH: a) Clarify prioritization and waiving criteria. Implement decisions to ensure that sufficient data are obtained to make first hazard assessments of as many substances and end points as possible. b) Increase data requirements. Introduce data requirements similar to those currently required for substances produced or imported in quantities of >or= 10 metric tons/year for substances produced or imported in quantities of >or= 1 metric tons/year. c) Develop the tests and approaches needed to satisfy the information requirements taking into account resource limitations and the aim to reduce animal testing. d) Promote substitution of high risk chemicals. Create an effective process for identifying substances of very high concern and for making the appropriate risk management decisions for these substances. e) Address the control of substances incorporated in articles. And f) acknowledge uncertainties. Systematically report lack of data and include this as a basis for risk management.
在这篇评论中，我们分析了实际上将在 REACH 中生成多少数据。
我们的结论是，许多终点的数据要求仍未确定，但取决于未来几年将决定的优先排序标准和豁免实践。我们提出了六个改进 REACH 的重要步骤：a）澄清优先排序和豁免标准。实施决策，以确保获得足够的数据，对尽可能多的物质和终点进行首次危害评估。b）增加数据要求。对于每年生产或进口量大于或等于 10 公吨的物质，引入类似于目前对每年生产或进口量大于或等于 1 公吨的物质所要求的数据要求。c）开发满足信息要求的测试和方法，同时考虑资源限制和减少动物测试的目标。d）促进高风险化学品的替代。为识别非常高关注物质创建一个有效的过程，并为这些物质做出适当的风险管理决策。e）解决物品中所含物质的控制问题。f）承认不确定性。系统地报告数据不足，并将其作为风险管理的基础。
