Hund-Rinke Kerstin, Herrchen Monika, Schlich Karsten, Schwirn Kathrin, Völker Doris
Fraunhofer Institute for Molecular Biology and Applied Ecology IME, Auf dem Aberg 1, 57392 Schmallenberg, Germany.
German Federal Environment Agency (UBA), Wörlitzer Platz 1, 06844 Dessau, Germany.
Environ Sci Eur. 2015;27(1):24. doi: 10.1186/s12302-015-0053-6. Epub 2015 Oct 6.
Engineered nanomaterials (ENMs) are marketed as a substance or mixtures and are additionally used due to their active agent properties in products such as pesticides or biocides, for which specific regulations apply. Currently, there are no specific testing strategies for environmental fate and effects of ENMs within the different regulations. An environmental test and risk assessment strategy for ENMs have been developed considering the general principles of chemical assessment.
The test strategy has been developed based on the knowledge of national and international discussions. It also takes into account the conclusions made by the OECD WPMN which held an expert meeting in January 2013. For the test strategy development, both conventional and alternative endpoints were discussed and environmental fate and effects were addressed separately.
A tiered scheme as commonly used in the context of precautionary environmental risk assessment was suggested including the use of mathematical models and trigger values to either stop the procedure or proceed to the next tier. There are still several gaps which have to be filled, especially with respect to fate, to develop the test strategy further. The test strategy features a general approach. It is not specified to fulfil the information requirements of certain legislation (e.g. plant protection act, biocide regulation, REACH). However, the adaption of single elements of the strategy to the specific needs of certain legislation will provide a valuable contribution in relation to the testing of nanomaterials.
工程纳米材料（ENMs）作为一种物质或混合物进入市场，并且由于其活性剂特性，还被用于农药或生物杀灭剂等产品中，而这些产品适用特定法规。目前，在不同法规中，对于ENMs的环境归宿和影响尚无具体的测试策略。基于化学评估的一般原则，已制定了ENMs的环境测试和风险评估策略。
该测试策略是在了解国内和国际讨论情况的基础上制定的。它还考虑了经合组织新兴政策问题工作小组（OECD WPMN）在2013年1月举行的专家会议得出的结论。在制定测试策略时，对传统和替代终点进行了讨论，并分别探讨了环境归宿和影响。
建议采用预防性环境风险评估中常用的分层方案，包括使用数学模型和触发值来决定是停止该程序还是进入下一层级。仍有几个差距需要填补，特别是在归宿方面，以便进一步完善测试策略。该测试策略具有通用方法。它并非专门为满足某些法规（如植物保护法、生物杀灭剂法规、《化学品注册、评估、授权和限制法规》（REACH））的信息要求而制定。然而，将该策略的单个要素根据某些法规的特定需求进行调整，将为纳米材料的测试做出有价值的贡献。
