Nanomaterials and nanotechnology have received growing attention in the past few decades and gave rise to a new field in research and development since 1980s. Thanks to attractive properties and characteristics, nanomaterials are increasingly integrated into many products. In the EU, nanomaterials fall under the existing REACH and CLP definition of a substance, and provisions set by both regulations apply.
What are nanomaterials?
Nanomaterials are materials that have at least one dimension measuring between 1 to 100 nanometres (nm), 1 nm is 10-9 metres. Due to their very small size, nanomaterials have substantially larger specific surface area by volume. As a result, nanomaterials may have different or enhanced characteristics compared to the corresponding coarser bulk material.
On 18 October 2011, the European Commission adopted the following definition of a nanomaterial:
"‘Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %."
The definition is a recommendation to be used as a reference to decide whether a material should be considered as a ‘nanomaterial’ for legislative and policy purposes in the EU.
Annex VI REACH (amended by Commission Regulation (EU) 2018/1881) contains a definition for a nanoform and that must be applied to determine the requirements applicable under REACH:
“A nanoform is a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.”
The Annex VI further defines particles, agglomerates and “sets of similar nanoforms”
Regulatory measures in the EU: REACH and CLP
In the EU, nanomaterials are addressed under the REACH and CLP regulations and thus industry and authorities need to fulfil their obligations and carry out their tasks within the various REACH and CLP processes for nanoforms as for any other form of a substance.
According to the Commission Regulation (EU) 2018/1881 – amending REACH Annexes to address nanoforms of substances – as of 1 January 2020, explicit legal requirements under REACH apply for companies that manufacture or import nanoforms. These reporting obligations address specific information requirements, outlined in revised Annexes I, III, and VI-XII REACH as below:
- chemical safety assessment (Annex I);
- characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
- registration information requirements (Annexe III and annexes VII-XI); and
- downstream user obligations (Annex XII).
Communication in the supply chain via safety data sheets
In June 2020, an amendment of the Annex II REACH (Regulation (EU) 2020/878) on requirements related to the content of the safety data sheet (SDS), has been published to the Official Journal.
This update takes into account in particular the specific requirements related to nanoforms introduced by the Regulation (EU) 2018/1881. As a result of this amendment, the safety data sheet shall mention in each relevant section whether and which different nanoforms it covers and link the relevant safety information to each of those nanoforms.
- EU nanomaterials observatory (EUON): Overview of REACH Annex modifications and available methods
- ECHA’s webpage on nanomaterials under REACH and CLP
- ECHA’s Q&A page on Nanomaterials under REACH
Useful guidance documents by ECHA
- ECHA Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification
- ECHA Guidance on Information Requirements and Chemical Safety Assessment for nanomaterials
- ECHA Guidance on grouping and read-across between nanoforms
Useful resources by OECD
- OECD Nanomet: towards tailored safety testing methods for nanomaterials
- OECD Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme – First Revision
- OECD’s database on research into the safety of manufactured nanomaterials
Other useful resources
- UNITAR’s guidance document on Developing a National Nanotechnology Policy and Programme
- WHO guidelines on protecting workers from potential risk of manufactured nanomaterials: recommendations
- UNEP Strategic Approach to International Chemical Management webpage on Nanomaterials and Nanotechnologies
- FAO and WHO “State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors"
- FAO and WHO’s Expert Meeting on the “Application of nanotechnologies in the food and agriculture sectors: potential food safety implications” – June 2009