Kephalopoulos Stylianos, Bruinen de Bruin Yuri, Arvanitis Athanasios, Hakkinen Pertti, Jantunen Matti
Physical and Chemical Exposure Unit, Institute for Health and Consumer Protection, Joint Research Centre, Commission of the European Communities, Via E. Fermi 1, T.P. 281, I-21027Ispra(VA), Italy.
J Expo Sci Environ Epidemiol. 2007 Dec;17 Suppl 1:S90-100. doi: 10.1038/sj.jes.7500605. Epub 2007 Aug 1.
Understanding where and how chemicals are used throughout their life cycle is becoming increasingly important. In 2003, within the context of REACH and GPSD legislation, the European Commission started developing a European and global infrastructure of exposure methods and tools. The infrastructure aims (1) to link modeling tools and exposure-related data and scenarios in a single framework so that harmonized exposure assessment procedures can be developed for consumer products in the EU and (2) to make this framework flexible enough to allow global application. A number of issues are raised by a global infrastructure of consumer exposure modeling that answers to multi-legislative mandates. These include transparency, consistency, usability, and defensibility of the models, including the relevant degree of complexity for priority setting versus assessment. As part of the initiative to set up a harmonized global infrastructure on consumer exposure assessment, these issues were presented, discussed, and further developed in a series of European Commission-sponsored workshops organized in October 2004 and June 2005 as part of the "Harmonization of Consumer Exposure Models on a Global Scale" project. The project focused on development, harmonization, and validation of consumer exposure modeling approaches. The workshops included experts from the EU, USA, Japan, and Canada. The conclusions and recommendations made on the basis of this work are described. To help achieve harmonization of approaches, the European Commission's Joint Research Centre is proposing a framework (1) to compare information on elements of chemical risk assessment to understand exposure regulations in different countries, (2) to save time and expense by sharing information and models, and (3) to promote credible science through better communication among organizations and by peer review of assessments and assessment procedures.
了解化学品在其整个生命周期中的使用地点和方式变得越来越重要。2003年,在《化学品注册、评估、授权和限制法规》(REACH)及《全球产品安全指令》(GPSD)立法背景下,欧盟委员会开始构建一个欧洲及全球范围的接触评估方法和工具基础设施。该基础设施旨在:(1)将建模工具与接触相关数据及情景整合在一个单一框架内,以便为欧盟的消费品制定统一的接触评估程序;(2)使该框架具有足够的灵活性,以实现全球应用。一个应对多项立法要求的全球消费品接触建模基础设施引发了诸多问题。这些问题包括模型的透明度、一致性、可用性和可辩护性,包括在确定优先事项与评估时的相关复杂程度。作为建立统一的全球消费品接触评估基础设施倡议的一部分,这些问题在2004年10月和2005年6月由欧盟委员会主办的一系列研讨会上进行了介绍、讨论和进一步完善,这些研讨会是“全球范围内消费品接触模型的协调统一”项目的一部分。该项目聚焦于消费品接触建模方法的开发、协调统一和验证。研讨会邀请了来自欧盟、美国、日本和加拿大的专家。文中描述了基于这项工作得出的结论和建议。为助力实现方法的协调统一,欧盟委员会联合研究中心提出了一个框架:(1)比较化学风险评估要素的信息,以了解不同国家的接触法规;(2)通过共享信息和模型节省时间和费用;(3)通过组织间更好的沟通以及对评估和评估程序的同行评审来促进可靠的科学发展。