Revising REACH guidance on information requirements and chemical safety assessment for engineered nanomaterials for aquatic ecotoxicity endpoints: recommendations from the EnvNano project.

The European Chemical Agency (ECHA) is in the process of revising its guidance documents on how to address the challenges of ecotoxicological testing of nanomaterials. In these revisions, outset is taken in the hypothesis that ecotoxicological test methods, developed for soluble chemicals, can be made applicable to nanomaterials. European Research Council project EnvNano-Environmental Effects and Risk Evaluation of Engineered, which ran from 2011 to 2016, took another outset by assuming that: ". The aim of this paper is to present the findings of the EnvNano project and through these provide the scientific background for specific recommendations on how ECHA guidance could be further improved. Key EnvNano findings such as the need to characterize dispersion and dissolution rates in stock and test media have partially been addressed in the updated guidance. However, it has to be made clear that multiple characterization methods have to be applied to describe state of dispersion and dissolution over time and for various test concentration. More detailed information is called for on the specific characterization methods and techniques available and their pros and cons. Based on findings in EnvNano, we recommend that existing algal tests are with tests where suspensions of nanomaterials are aged for 1-3 days for nanomaterials that dissolve in testing media. Likewise, for daphnia tests we suggest to supplement with tests where (a) exposure is shortened to a 3 h pulse exposure in daphnia toxicity tests with environmentally hazardous metal and metal oxide nanomaterials prone to dissolution; and (b) food abundance is three to five times higher than normal, respectively. We further suggest that the importance of considering the impact of shading in algal tests is made more detailed in the guidance and that it is specified that determination of uptake, depuration and trophic transfer of nanomaterials for each commercialized functionalization of the nanomaterials is required. Finally, as an outcome of the project a method for assessing the regulatory adequacy of ecotoxicological studies of nanomaterials is proposed.