European Chemicals Agency, Annankatu, Helsinki, Finland.
Integr Environ Assess Manag. 2013 Jul;9(3):e85-91. doi: 10.1002/ieam.1445. Epub 2013 Jun 25.
Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking predictions and measured data in an integral "-omic type" approach, considering collectively data from different sources and offering a complete assessment of the chemical risk of individuals and ecosystems, with new conceptual approaches that could be defined as "risk-omics based" paradigms and models.
自 20 世纪 90 年代以来，基于科学的生态风险评估已成为支持监管决策的重要工具。本文以欧洲 REACH 法规为例，介绍了化学控制和环境保护领域新科学发展所面临的挑战和机遇。这些挑战可以分为 3 个主要相关主题（集）。短期内，这些挑战直接与监管要求相关，需要为促进工业界和管理部门履行不同义务提供科学合理的实施奠定基础。需要指出的是，尽管由于监管要求，实际工具因不同而有所不同，但基本需求与 20 世纪 90 年代初所涉及的需求仍然相同：理解预测影响的生态相关性，包括不确定性，并促进与社会经济评估的联系。第二组挑战涵盖了从监管工作中获得附加值的机会。通过 REACH 注册和通知程序汇编的信息被分析为在区域层面评估化学风险的综合风险的新综合发展的来源。最后，文章讨论了将过程颠倒并开发以受体（个人或生态系统）为重点而不是以应激源或源为重点的风险评估方法的挑战。由于信息缺乏，这些方法在过去受到限制，但标准信息的识别和传播，包括用途、制造地点、物理化学、环境、生态毒理学和毒理学特性以及数千种化学物质的操作条件和风险管理措施，再加上通过大规模监测计划和空间信息系统收集的知识，正在创造新的机会。挑战是在整体“组学型”方法中结合预测和测量数据，综合来自不同来源的数据，并对个人和生态系统的化学风险进行全面评估，采用新的概念方法，这些方法可以被定义为“基于风险组学”的范式和模型。
