Hansson Sven Ove, Rudén Christina
Royal Institute of Technology, Department of Philosophy, Stockholm, Sweden.
Toxicol Sci. 2006 Apr;90(2):304-8. doi: 10.1093/toxsci/kfj071. Epub 2005 Dec 9.
Due to the large number of chemicals for which toxicological and ecotoxicological information is lacking, priority setting for data acquisition is a major concern in chemicals regulation. In the current European system, two administrative priority-setting criteria are used, namely novelty (i.e., time of market introduction) and production volume. In the proposed Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) system, the novelty criterion is no longer used, and production volume will be the main priority-setting criterion for testing requirements, supplemented in some cases with hazard indications obtained from QSAR modelling. This system for priority setting has severe weaknesses. In this paper we propose that a multicriteria system should be developed that includes at least three additional criteria: chemical properties, results from initial testing in a tiered system, and voluntary testing for which efficient incentives can be created. Toxicological and decision-theoretical research is needed to design testing systems with validated priority-setting mechanisms.
由于大量化学品缺乏毒理学和生态毒理学信息,确定数据获取的优先顺序是化学品监管中的一个主要问题。在当前的欧洲体系中,使用了两个行政上确定优先顺序的标准,即新颖性(即上市时间)和产量。在拟议的化学品注册、评估、授权和限制(REACH)体系中,不再使用新颖性标准,产量将成为确定测试要求的主要优先顺序标准,在某些情况下辅以从定量构效关系(QSAR)建模获得的危害指示。这种确定优先顺序的体系存在严重缺陷。在本文中,我们建议应开发一种多标准体系,该体系应至少包括另外三个标准:化学性质、分层体系中初始测试的结果以及可为其创造有效激励措施的自愿测试。需要进行毒理学和决策理论研究,以设计具有经过验证的优先顺序确定机制的测试体系。