Test strategy for assessing the risks of nanomaterials in the environment considering general regulatory procedures

Abstract

Background: 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. Results: 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. Conclusion: 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.