An inventory of ready-to-use and publicly available tools for the safety assessment of nanomaterials

A Paula K Jantunen,Stefania Gottardo,Kirsten Rasmussen,Hugues P Crutzen

doi:10.1016/j.impact.2018.08.007

A Paula K Jantunen, Stefania Gottardo + Show 2 more

Open Access

https://doi.org/10.1016/j.impact.2018.08.007

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Journal: NanoImpact	Publication Date: Sep 1, 2018
Citations: 37	License type: cc-by

Affiliation: Joint Research Centre

Abstract

Legislation addressing environmental, health and safety aspects of nanomaterials in consumer products and ensuring their safe use is being continuously updated in the European Union and globally. This leads to a growing need for tools to implement this developing legislation. A freely accessible inventory of ready-to-use and publicly available tools that together cover the tasks within a nanomaterial safety assessment process was built in the presented work. This inventory is a unique metadata set in Excel® format: the ‘NANoREG Toolbox’, which assembles information needed for selecting and accessing instruments that meet specific goals. The recorded tools are categorised according to their purpose, type and regulatory status. The Toolbox covers an unprecedented and broad range of over 500 current tools, developed in Europe and beyond. While NANoREG focussed on safety assessment under the EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the instruments in the Toolbox are relevant and useful for nanomaterial safety assessments worldwide.

Highlights

Environmental, Health and Safety (EHS) aspects of nanotechnology applications and nanomaterials (NMs) have been debated in the scientific and regulatory communities since the early 2000s (e.g. Oberdörster et al, 2005; NSTC, 2006; Maynard et al, 2006; Science Policy Group Council, 2007; EC, 2008; Warheit, 2008; Warheit et al, 2008)
This article does not aim to use the content of the Toolbox to identify and discuss research gaps or further needs for tool development or validation in the nanomaterial EHS (nanoEHS) field in any detail, as this has been more extensively done e.g. in the NANoREG Framework (Gottardo et al, 2017) and by Sayre et al (2017)
It should be noted that while the NANoREG Toolbox is organised according to the logic of chemical and NM safety assessment in the European Union (EU) (REACH), this is highly consistent with the international framework of chemical risk assessment (WHO, 2001; OECD, 2012) and with the general understanding of information needs regarding chemicals (OECD, 1982, 1987) and NMs (OECD, 2010; Stefaniak et al, 2013)

Summary

Introduction

Environmental, Health and Safety (EHS) aspects of nanotechnology applications and nanomaterials (NMs) have been debated in the scientific and regulatory communities since the early 2000s (e.g. Oberdörster et al, 2005; NSTC, 2006; Maynard et al, 2006; Science Policy Group Council, 2007; EC, 2008; Warheit, 2008; Warheit et al, 2008). It has been proposed that regulatory risk assessment be combined with flexible, predictive and semi-quantitative strategies, such as safe-by-design, grouping, control banding and decision analysis. This combination would enable early-stage assessment and management of NMs in a context of limited information and uncertainty (e.g. IRGC, 2007; Gottardo et al, 2017; ProSafe, 2017; Linkov et al, 2018; Stone et al, 2018). The resulting increase of knowledge and awareness of scientific and regulatory hurdles has led to the introduction of legal definitions of the term ‘nanomaterial’ and the amendment of consumer protection legislation (concerning the use of NMs in e.g. cosmetics, food, food contact materials, biocides and medical devices) (Rauscher et al, 2017)

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