Reliability of methods and data for regulatory assessment of nanomaterial risks

Abstract Within the EU funded project Prosafe a review on the regulatory relevance of the results of several EU and US funded nanosafety research projects was conducted. The objective was to identify those methods, data and protocols that are appropriate for regulatory risk assessment of manufactured nanomaterials. A task force with nine experienced experts was established which examined approximately 1000 publications. They looked at reliability and regulatory relevance as the main criteria to identify which research products are most useful to regulators. The results of this review are published in this Special Issue. This article summarizes the main recommendations, identifies the most relevant knowledge gaps and draws some general conclusions. The review demonstrates that a number of new tools to enable regulatory risk assessment of nanomaterials are now available or near completion.

[1]  Dirk Dahmann,et al.  Comparability of portable nanoparticle exposure monitors. , 2012, The Annals of occupational hygiene.

[2]  Klaus Günter Steinhäuser,et al.  Methods and data for regulatory risk assessment of nanomaterials: Questions for an expert consultation , 2017 .

[3]  Gibson Peter,et al.  Towards a review of the EC Recommendation for a definition of the term "nanomaterial"Part 2: Assessment of collected information concerning the experience with the defintion , 2014 .

[4]  Division on Earth Risk Assessment in the Federal Government: Managing the Process , 1983 .

[5]  Fadri Gottschalk,et al.  Meeting the Needs for Released Nanomaterials Required for Further Testing-The SUN Approach. , 2016, Environmental science & technology.

[6]  Monika Herrchen,et al.  Test strategy for assessing the risks of nanomaterials in the environment considering general regulatory procedures , 2015, Environmental Sciences Europe.

[7]  Richard Zepp,et al.  NanoRelease: Pilot interlaboratory comparison of a weathering protocol applied to resilient and labile polymers with and without embedded carbon nanotubes , 2017, Carbon.

[8]  Phil Sayre,et al.  Regulatory relevant and reliable methods and data for determining the environmental fate of manufactured nanomaterials , 2017 .

[9]  Andrea Haase,et al.  Nanomaterial exposures for worker, consumer and the general public , 2018 .

[10]  Phil Sayre,et al.  In vitro approaches to assess the hazard of nanomaterials , 2017 .

[11]  Gregory V. Lowry,et al.  Progress towards standardized and validated characterizations for measuring physicochemical properties of manufactured nanomaterials relevant to nano health and safety risks , 2018 .

[12]  Anders Baun,et al.  Regulatory adequacy of aquatic ecotoxicity testing of nanomaterials , 2017 .

[13]  Dik van de Meent,et al.  Multimedia Modeling of Engineered Nanoparticles with SimpleBox4nano: Model Definition and Evaluation , 2014, Environmental science & technology.

[14]  Reinhard Kreiling,et al.  A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping). , 2015, Regulatory toxicology and pharmacology : RTP.

[15]  Gibson Peter,et al.  Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation , 2015 .

[16]  Enrico Burello,et al.  Review of (Q)SAR models for regulatory assessment of nanomaterials risks , 2017 .

[17]  Richard Handy,et al.  Regulatory ecotoxicity testing of nanomaterials – proposed modifications of OECD test guidelines based on laboratory experience with silver and titanium dioxide nanoparticles , 2016, Nanotoxicology.

[18]  Fadri Gottschalk,et al.  The release of engineered nanomaterials to the environment. , 2011, Journal of environmental monitoring : JEM.

[19]  Wendel Wohlleben,et al.  Quantitative rates of release from weathered nanocomposites are determined across 5 orders of magnitude by the matrix, modulated by the embedded nanomaterial , 2016 .

[20]  Thomas A. J. Kuhlbusch,et al.  Release from nanomaterials during their use phase: combined mechanical and chemical stresses applied to simple and multi-filler nanocomposites mimicking wear of nano-reinforced tires , 2016 .

[21]  Adriele Prina-Mello,et al.  Towards a nanospecific approach for risk assessment. , 2016, Regulatory toxicology and pharmacology : RTP.

[22]  Bernd Nowack,et al.  Evaluation of environmental exposure models for engineered nanomaterials in a regulatory context , 2017 .

[23]  Teresa F. Fernandes,et al.  Practical considerations for conducting ecotoxicity test methods with manufactured nanomaterials: what have we learnt so far? , 2012, Ecotoxicology.

[24]  Harald F Krug,et al.  Nanosafety research--are we on the right track? , 2014, Angewandte Chemie.

[25]  Riego Sintes Juan,et al.  NANoREG framework for the safety assessment of nanomaterials , 2017 .

[26]  Nirupam Aich,et al.  Research strategy to determine when novel nanohybrids pose unique environmental risks , 2015 .

[27]  Albert A Koelmans,et al.  Spatially explicit fate modelling of nanomaterials in natural waters. , 2015, Water research.

[28]  Nanna B. Hartmann,et al.  Adapting OECD Aquatic Toxicity Tests for Use with Manufactured Nanomaterials: Key Issues and Consensus Recommendations. , 2015, Environmental science & technology.

[29]  Frank von der Kammer,et al.  Separation and characterization of nanoparticles in complex food and environmental samples by field-flow fractionation , 2011 .

[30]  Yoram Cohen,et al.  Simulation tool for assessing the release and environmental distribution of nanomaterials , 2015, Beilstein journal of nanotechnology.

[31]  Jérôme Labille,et al.  Heteroaggregation of titanium dioxide nanoparticles with natural clay colloids. , 2015, Environmental science & technology.

[32]  Thomas A. J. Kuhlbusch,et al.  In vivo effects: Methodologies and biokinetics of inhaled nanomaterials , 2018 .

[33]  Steffen Foss Hansen,et al.  NanoRiskCat: a conceptual tool for categorization and communication of exposure potentials and hazards of nanomaterials in consumer products , 2013, Journal of Nanoparticle Research.

[34]  Andrea Cristofolini,et al.  Safety assessment of essential oil from Minthostachys verticillata (Griseb.) Epling (peperina): 90-days oral subchronic toxicity study in rats. , 2015, Regulatory toxicology and pharmacology : RTP.

[35]  Reinhard Kreiling,et al.  Case studies putting the decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping) into practice. , 2016, Regulatory toxicology and pharmacology : RTP.

[36]  Susan Wijnhoven,et al.  Risk assessment frameworks for nanomaterials: Scope, link to regulations, applicability, and outline for future directions in view of needed increase in efficiency , 2018 .