Nano or Not Nano? A Structured Approach for Identifying Nanomaterials According to the European Commission’s Definition
Open Access
- 2 August 2020
- Vol. 16 (36), e2002228
- https://doi.org/10.1002/smll.202002228
Abstract
Identifying nanomaterials (NMs) according to European Union legislation is challenging, as there is an enormous variety of materials, with different physico‐chemical properties. The NanoDefiner Framework and its Decision Support Flow Scheme (DSFS) allow choosing the optimal method to measure the particle size distribution by matching the material properties and the performance of the particular measurement techniques. The DSFS leads to a reliable and economic decision whether a material is an NM or not based on scientific criteria and respecting regulatory requirements. The DSFS starts beyond regulatory requirements by identifying non‐NMs by a proxy approach based on their volume‐specific surface area. In a second step, it identifies NMs. The DSFS is tested on real‐world materials and is implemented in an e‐tool. The DSFS is compared with a decision flowchart of the European Commission’s (EC) Joint Research Centre (JRC), which rigorously follows the explicit criteria of the EC NM definition with the focus on identifying NMs, and non‐NMs are identified by exclusion. The two approaches build on the same scientific basis and measurement methods, but start from opposite ends: the JRC Flowchart starts by identifying NMs, whereas the NanoDefiner Framework first identifies non‐NMs.Keywords
Funding Information
- FP7 Nanosciences, Nanotechnologies, Materials and new Production Technologies
This publication has 10 references indexed in Scilit:
- Volume-specific surface area by gas adsorption analysis with the BET methodPublished by Elsevier BV ,2019
- NanoDefiner e-Tool: An Implemented Decision Support Framework for Nanomaterial IdentificationMaterials, 2019
- A technique-driven materials categorisation scheme to support regulatory identification of nanomaterialsNanoscale Advances, 2018
- Advanced tools for the safety assessment of nanomaterialsNature Nanotechnology, 2018
- Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal healthEFSA Journal, 2018
- Implementation of Safe-by-Design for Nanomaterial Development and Safe Innovation: Why We Need a Comprehensive ApproachNanomaterials, 2018
- Reliable nanomaterial classification of powders using the volume-specific surface area methodJournal of Nanoparticle Research, 2017
- Challenges in the size analysis of a silica nanoparticle mixture as candidate certified reference materialJournal of Nanoparticle Research, 2016
- How reliably can a material be classified as a nanomaterial? Available particle-sizing techniques at workJournal of Nanoparticle Research, 2016
- Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelinesRegulatory Toxicology and Pharmacology, 2016