Nano or Not Nano? A Structured Approach for Identifying Nanomaterials According to the European Commission’s Definition

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.

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

“…So far, there are no generic methods for the characterisation of nanomaterials, but there is a large variety of individual characterisation methods available, with different capabilities and fields of application. A thorough knowledge of the measurement techniques' capabilities and detailed information of the materials’ physicochemical properties allow selecting the method(s), which is/are best suited to measure the attributes of a material with specific physico-chemical properties ( Mech et al, 2020a , 2020b ; Rauscher et al, 2019b ).…”

“…A hands-on training prior to the summit (September 24) on determining size distributions of nanomaterials was provided to 28 participants from 12 countries. Participants had the opportunity to deepen their knowledge on nanoparticle size distributions, to apply specific measurement techniques and to discover the capabilities of the NanoDefiner e-tool, a decision support framework for the characterisation of potential nanomaterials developed in the European Union NanoDefine project ( Mech et al, 2020a ; Brüngel et al, 2019 ). Furthermore, 29 participants of the 2019 GSRS attended a short course on the use of reference materials including the estimation of measurement uncertainty organised by the JRC and another 40 attendees of 2019 GSRS visited several laboratories at the JRC-Ispra site on September 27.…”

Considerations for and Guidance to Testing and Evaluating Migration/Release of Nanoparticles from Polymer Based Nanocomposites

“…The objective of this project was to develop an integrated approach based on validated and standardized methods to support the implementation of the EC recommendation for a definition of nanomaterial. Comprehensive information, technical reports and analytical methods [22][23][24] can be found on the project's website (http://www.nanodefine.eu/). The question as to how reliably can a material be classified as a nanomaterial, via application of particle-sizing techniques as an outcome of this project was tackled by Babick et al [25].…”

Aerogels are not regulated as nanomaterials, but can be assessed by tiered testing and grouping strategies for nanomaterials

“…Hence, aerogels might be in the scope of the labelling provisions for nanomaterials provided by the EU Novel Foods Directive. On the other hand, internally structured porous materials such as aerogels are explicitly excluded 15,16 from the need to register a "nanoform" under the revised REACH Annexes. Aerogels are also exempted from the need to report to national nanomaterials product inventories such as those in France, Belgium, the USA or Canada.…”