European standardisation activities on nanomaterials: work in progress
Nanotechnologies and standardisation at EU level
Standardisation issues around nanotechnologies and nanomaterials are addressed by Technical Committee 352 – Nanotechnologies within CEN (European Committee for Standardization) (https://standards.cen.eu/dyn/www/f?p=204:7:0::::FSP_ORG_ID:508478&cs=1A6FDA13EC1F6859FD3F63B18B98492ED). This TC is organised in 4 working groups on the following topics:
- CEN/TC 352/WG1: Measurement, characterization and performance evaluation
- CEN/TC 352/WG2: Commercial and other stakeholder aspects
- CEN/TC 352/WG3: Health, safety and environmental aspects
- CEN/TC 352/WG4: Manufactured nano-objects in food additives
CEN/TC 352 is linked to its international counterpart, ISO/TC 229 – Nanotechnologies, and to the Committees in charge of nanotechnologies within EU Member States National Standardisation Bodies. Different European Standard (EN) and Technical Specification (TS) have been published over the last years by CEN/TC 352 thanks to the work of European experts. These documents are mainly focused on general guidance regarding nanomaterials characterisation, risk assessment at different steps of the life cycle and guidance to support the deployment of sustainability and responsible approaches:
- CEN/TS 17010:2016
Nanotechnologies – Guidance on measurands for characterising nano-objects and materials that contain them
- CEN/TS 17273:2018
Nanotechnologies – Guidance on detection and identification of nano-objects in complex matrices
- CEN/TS 17274:2018
Nanotechnologies – Guidelines for determining protocols for the explosivity and flammability of powders containing nano-objects (for transport, handling and storage)
- CEN/TS 17275:2018
Nanotechnologies – Guidelines for the management and disposal of waste from the manufacturing and processing of manufactured nano-objects
- CEN/TS 16937:2016
Nanotechnologies – Guidance for the responsible development of nanotechnologies
- CEN/TS 17276:2018
Nanotechnologies – Guidelines for Life Cycle Assessment – Application of EN ISO 14044:2006 to Manufactured Nanomaterials
Mandate M/461 & Specific Agreement CEN/2018-10 NOAA in the workplace
CEN/TC 352 also has a role in coordinating European standardisation work in the field of nanomaterials within CEN Technical Sector through the Mandate M/461 given by the European Commission (https://www.cen.eu/work/areas/nanotech/pages/default.aspx). Standards have been developed in this context within CEN/TC 137 – Assessment of workplace exposure to chemical and biological agents and CEN/TC 195 – Air filters for general air cleaning. Some examples are reported hereafter:
- EN 17199-1:2019Workplace exposure – Measurement of dustiness of bulk materials that contain or release respirable NOAA and other respirable particles – Part 1: Requirements and choice of test methods
- EN 17058:2018Workplace exposure – Assessment of exposure by inhalation of nano-objects and their aggregates and agglomerates
- EN 16966:2018Workplace exposure – Measurement of exposure by inhalation of nano-objects and their aggregates and agglomerates – Metrics to be used such as number concentration, surface area concentration and mass concentration
This mandate was renewed on 1 November 2020 for 4,5 years and should enable the development within CEN/TC 352 of two high impact documents related to the regulatory aspect of nanomaterials:
- CEN/TS (WI 00352043) Nanotechnologies – Guidance on the determination of aggregation and agglomeration state of nano-objects
- CEN/TS (WI 00352044) Nanotechnologies – Guidelines for the characterization of nanomaterials and/or materials that may contain of particles at the nanoscale in food products
Calls for tenders were launched at the end of 2020 to identify project leaders and experts to contribute to this work. A response from the European Commission on the selection of proposals is awaited before work can begin.
At the same time CEN/TC 137 – Assessment of workplace exposure to chemical and biological agents is also developping 3 standards for nano-objects and their aggregates and agglomerates (NOAA) in the workplace within ist WG 3 ‘Particulate matter’:
- CEN/TS (WI=00137085) – Workplace exposure – Sampling of nano-objects and their agglomerates and aggregates in the workplace for electron microscopy
- EN (WI=00137086) – Workplace exposure – Counting rules for the characterization of airborne nano-objects and their agglomerates and aggregates for scanning electron microscopy (SEM) and transmission electron microscopy (TEM)
- CEN/TS (WI=00137087) – Workplace exposure – Application of direct-reading low-cost sensors for measuring NOAA in the workplace
These documents will provide concrete methodologies and tools with validated performance to make risk assessment in the field more reliable.
Short summary of the last CEN/TC 352 meeting
CEN/TC 352 spring WGs and plenary meetings were organised the 24 and 25 March 2021. This was the occasion for experts of CEN/TC 352 to review the progress of ongoing projects and to initiate new works.
CEN/TC 352/WG1: Measurement, characterization and performance evaluation
The CEN/TS “Nanotechnologies -Nano- and micro-scratch testing” will be soon released. The test procedure is intended to complement other standards which are concerned with the scratch resistance of materials. This procedure extends the use of the nano- and micro- single pass scratch test to bulk and coated materials, additionally covering the use of multiple pass nano- and micro- scratch tests.
A study group (SG) was also set up to prepare the basis for a quick start guide to help companies identify the relevant analytical strategy to classify their particulate chemicals as nanomaterials or not according to the European definition recommendation. This guide would aim to be an easy-to-use entry point to more detailed expert documents, such as the reports produced on the subject by the JRC in 2019 on the basis of the NanoDefine project.
Some information was shared about the call for tenders to select the group of experts in charge of developing the TS on the determination of aggregation and agglomeration state of nano-objects. The document aims to provide flow charts and a measurement matrix that guides users in the correct selection of commercially available techniques to use for the measurements of aggregation and agglomeration state of nano-objects in air and liquid suspensions. It will provide guidance on measurands and measurement methods to use along with guidance on sample preparation including sonication.
CEN/TC 352/WG2: Commercial and other stakeholder aspects
The conclusions of the first meeting of the Project Group working on the development of a TS on Safe-by-Design concept dedicated for nano scale materials (MNM) and products containing nanomaterials have been reported. In this first meeting, the main focus was on the discussion, how this TS would be differentiated and/or aligned with relevant published standards (e.g. CEN/TS 16937) and other documents (e.g. OECD-guidance document[1], publications on chemicals safety[2],[3], recent publication on SbD-relevant EU-funded projects[4], etc.). In the next meeting the starting point for this TS will be defined, taking into account developments around safety-, sustainability-by-design and innovation.
The convenor of the Study Group Labelling reported the discussion held within the group since the beginning of the year. The aim would be to develop a document to provide guidance on how improve the traceability of nanomaterials all along the different value chains. B2C-labelling and B2B-labelling are discussed by the group, which pointed out that more transparency in the supply chain in B2B is needed to produce reliable information to eventually support B2C labelling which is a regulatory requirement for some sectors. Therefore it was suggested to start working on the B2B information by paying attention to the key role of measurements.
CEN/TC 352/WG3: Health, safety and environmental aspects
The convenor of the WG3 reported the discussion held over the last months regarding the development of the TS – Quick start guide for deploying a relevant nano health and safety risk management.
The work on this document started in 2021 on the basis of a French standard (AFNOR XP T16-402 / Conducting risk management by of nano-objects, their aggregates and agglomerates (NOAA) and nanoparticulate substances for safety officers) published in 2020 whose objectives is to provide safety officers the main information in the form of a flow chart to help them in their approach. Details can then be found in documents for experts.
CEN/TC 352/WG4: Manufactured nano-objects in food additives
A liaison with CEN/TC 275 – Food analysis – Horizontal methods has been created to allow CEN/TC 275 experts to contribute to the development of the future TS regarding the characterization of nanomaterials and/or materials that may contain particles at the nanoscale in food products. This TS will give an harmonised approach combining Electron Microscopy (EM-EDX) and ICP-MS in Single Particle mode (sp ICP-MS) to determine in a reliable and comparable way the number-based size distribution of the constituent (nano)particles contained in different substances already incorporated in a selection of market-representative food matrices. As the sample preparation is key for both techniques (EM-EDX & sp ICP-MS) in such kind of characterization issue, a major effort will be made at this step of the measurement process. Interlaboratory comparisons will be organised to validate the different SOPs on representative samples of the substances of interest and various food matrices (among which powder, fatty sample, jellified product, acidic sample…). The inter- and intra-laboratory precision will be assessed together with the inter-technical discrepancy in order to give the user all the useful information to choose the best analytical approach depending on the substances features (particles’ shape, chemical composition, agglomeration/aggregation state…) and the type of information required (presence of nanoparticles or number-based percentage of nanoparticles).
Written by: Georges Favre, Laboratoire national de métrologie et d’essais (LNE), France.
Contributed by: Andreas Falk, BioNanoNet (BNN), Austria.
[1] http://www.oecd.org/env/ehs/nanosafety/publications-series-safety-manufactured-nanomaterials.htm
[2] http://doi.org/10.5281/zenodo.3254382
[3] https://www.eea.europa.eu/themes/human/chemicals/delivering-products-that-are-safe
