Nanomaterials are chemical substances or materials that are manufactured and used on a very small scale. Their structures range from approximately 1 to 100 nm in at least one dimension.
Nanomaterials have unique and more pronounced characteristics compared to the same material without nanoscale features. Therefore, the physico-chemical properties of nanomaterials may differ from those of the bulk substance or particles of a larger size.
Nanotechnology is rapidly expanding. A large number of products containing nanomaterials are already on the European market (e.g. batteries, coatings, anti-bacterial clothing, cosmetics, food products). Nanomaterials offer technical and commercial opportunities, but may pose risks to the environment and raise health and safety concerns for humans and animals.
Although there are no explicit requirements for nanomaterials under REACH or CLP, they meet the regulations' substance definition and therefore the provisions apply. In 2011, the European Commission released a specific recommendation on the definition of a nanomaterial. The recommendation should be used in different European regulations, including REACH and CLP.
While there are clear practical and commercial prospects in the use of nanomaterials, the rapid increase in their use raises questions about their potential effects on health and the environment. There is a need to adequately assess and manage the potential risks of these new forms of materials. Even though manufacturers, importers and downstream users must ensure the safe use of each substance (whatever its form) under REACH, this introduces new challenges for regulators, such as the Commission and ECHA, as well as all other stakeholders.
ECHA works in close collaboration with Member State competent authorities, the European Commission, stakeholders and international organisations such as the Organisation for Economic Cooperation and Development (OECD).
ECHA's activities on nanomaterials under REACH
Since REACH and CLP cover nanomaterials, ECHA needs to be able to carry out its tasks within the various REACH processes (e.g. registration, evaluation, authorisation and restrictions) and CLP processes (e.g. classification and labelling) for nanoforms 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 gradually increased its activities in this area since 2011 focusing on:
- Internal and external capacity building
- Sharing experience with and generating consensus among MSCAs, MSC and RAC members on safety information for nanomaterials in REACH registration dossiers
- Providing feedback and advice to registrants who wish to register nanomaterials for the next registration deadline
- Participating and contributing to ongoing international regulatory activities (such as the OECD Working Party on Manufactured Nanomaterials)
- Nanomaterials webinars to inform and discuss about the latest developments regarding REACH and CLP processes related to nanomaterials, and also to help registrants prepare and submit dossiers that involve nanomaterials.
Visit the webinars page to register for upcoming webinars and consult previous presentations.
In October 2012, ECHA established a nanomaterials working group (ECHA-NMWG) to discuss scientific and technical questions relevant to REACH and CLP processes and to give recommendations on strategic issues.
It is an informal advisory group consisting of experts from Member States, the European Commission, ECHA and accredited stakeholders organisations, with the mandate to "provide informal advice on any scientific and technical issues regarding the implementation of REACH and CLP legislation in relation to nanomaterials."
ECHA-NMWG also aims to have discussions with industry regarding the experience it gained in documenting the intrinsic properties of nanoforms using recent methods and its obligations towards fulfilling REACH requirements.
This last objective is closely related to the work carried out by ECHA through the group assessing already registered nanomaterials (GAARN). Established in January 2012 by DG Environment from the European Commission and chaired by ECHA, the purpose of GAARN is to build a consensus in an informal setting on best practices for assessing and managing the safety of nanomaterials under the REACH Regulation and thereby increase confidence and mutual understanding among stakeholders so that nanomaterials can be sustainably developed. Conclusions and best practices from GAARN are reported to ECHA-NMWG and shared with stakeholders.
- About nanotechnology
- ECHA Workplan on nano-materials [PDF] [EN]
- Workshop – Regulatory Challenges in Risk Assessment of Nanomaterials 2014
- Nanomaterials working group mandate [PDF] [EN]
- ECHA Guidance on Information Requirements and Chemical Safety Assessment - recommendations for nanomaterials
- Group assessing already registered nanomaterials (GAARN) - meeting reports
- Nanomaterials in IUCLID 5
- Video tutorial: Nanomaterials in IUCLID 5
- OECD Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme: First Revision [PDF] [EN]
- OECD Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials [PDF] [EN]