Nanomaterials are chemical substances or materials with particle sizes between 1 to 100 nanometres in at least one dimension.
Due to an increased specific surface area by volume, nanomaterials may have different characteristics compared to the same material without nanoscale features. As a result, the physicochemical properties of nanomaterials may differ from those of bulk substances or particles of a larger size.
Many everyday products containing nanomaterials are already on the European market such as batteries, coatings, anti-bacterial clothing and cosmetics. While nanomaterials may offer technical and commercial opportunities, they may also pose risks to our health and the environment. Just like any other substance on the EU market, it is important to ensure that their uses are properly assessed and that any risks are adequately controlled.
ECHA works in close collaboration with Member State competent authorities, the European Commission, NGOs and industry associations as well as international organisations such as the Organisation for Economic Cooperation and Development (OECD), to help implement EU chemicals legislation for nanomaterials.
Nanomaterials fall under the existing REACH and CLP definition of a substance, and provisions set by both regulations apply. In 2011, the European Commission released a recommendation for a definition of a nanomaterial. It is used in different European regulations, including REACH and CLP, to harmonise how nanomaterials are defined across legal frameworks.
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 to the REACH regulation:
- characterisation of nanoforms or sets of nanoforms covered by the registration (Annex VI);
- chemical safety assessment (Annex I);
- registration information requirements (Annexes III and VII-XI); and
- downstream user obligations (Annex XII).
The amendments apply to all new and existing registrations covering nanoforms.
ECHA's activities on nanomaterials under REACH and CLP
Since REACH and CLP cover nanomaterials, ECHA needs to be able to carry out its tasks for nanoforms within the various REACH (e.g. registration, evaluation, authorisation and restrictions) and CLP processes (e.g. classification and labelling) as it would for any other form of a substance, and needs to have sufficient scientific and technical capacity to do so.
With this aim, ECHA has increased its activities in this area since 2011 focusing on:
- Preparing new and updated guidance documents
- Internal and external capacity building
- Sharing experience with, and generating consensus among, Member State Competent Authorities and members of the risk assessment and Member State committees concerning safety information for nanomaterials in REACH registration dossiers
- Providing feedback and advice to companies that register nanomaterials
- Participating and contributing to ongoing international regulatory activities (such as the OECD Working Party on Manufactured Nanomaterials or the Malta Initiative for developing test guidelines)
- Webinars to inform and discuss the latest developments regarding REACH and CLP processes related to nanomaterials, and to help registrants prepare and submit dossiers that involve nanomaterials
- The Nanomaterials Expert Group (NMEG) was established in October 2012 with the support of the competent authorities for REACH and CLP (CARACAL) and for Biocides. This informal advisory group supports the implementation of ECHA’s workplans for nanomaterials and provides information and advice on scientific and technical issues regarding the implementation of REACH, CLP and BPR legislation in relation to nanomaterials
- Hosting the European Union Observatory for Nanomaterials to increase transparency of information on nanomaterials
- How to report nanomaterial parameters in IUCLID 6 (Annex 8) [PDF] [EN]
- Guidance for identification and naming of substances under REACH and CLP [PDF] [EN]
- ECHA Guidance on Information Requirements and Chemical Safety Assessment for nanomaterials:
- Appendix to Chapter R.6: Guidance on QSARs and Grouping of Chemicals [PDF] [EN]
- Appendix to Chapter R.7a: Endpoint specific guidance [PDF] [EN]
- Appendix to Chapter R.7b: Endpoint specific guidance [PDF] [EN]
- Appendix to Chapter R.7c: Endpoint specific guidance [PDF] [EN]
- Appendix to Chapter R.8: Characterisation of dose [concentration] - response for human health [PDF] [EN]
- Appendix to Chapter R.10: Characterisation of dose [concentration] - response for environment [PDF] [EN]
- Appendix to Chapter R.14: Occupational exposure assessment [PDF] [EN]
- Template to document practical constraints for fulfilling REACH Annex VII and VIII information requirements [PDF] [EN]
- Registering nanoforms: practical advice – 2020 | Webinar Q&A
- Getting ready for revised REACH information requirements for nanoforms – 2019 | Webinar Q&A
- Updated REACH Guidance for nanomaterials - what you need to know – 2017
- How to ensure the safe use of nanomaterials under REACH - Part III: current best practices for human health and environmental exposure assessment and risk characterisation for nanomaterials – 2014
- How to ensure the safe use of nanomaterials under REACH - Part II: Current best practices for human health and environmental hazard assessment for nanomaterials – 2013
- How to ensure the safe use of nanomaterials under REACH Part I – 2012
- New OECD guidance documents for the risk assessment of nanomaterials, News release 27 July 2020
- Companies need to provide more data on nanoforms, News release 24 February 2020
- Updated guidance for registering substances in nanoform, News release 3 December 2019
- Get ready for new REACH requirements for nanomaterials, News release 8 October 2019
- Companies to provide more information on nanomaterials, Press release 3 December 2018