Nanomaterials under REACH and CLP
Nanotechnology is rapidly expanding and is being used in various areas, such as health care, consumer products like cosmetics, electronics, energy technologies, food, and agriculture. It is therefore not surprising that many products containing engineered nanoparticles are already available on the European market. Nanotechnology deals with structures ranging from approximately 1-100 nm in at least one dimension. This nano size results in specific physico-chemical properties that may differ from those of the bulk substance or particles of a larger size.
Although there are no explicit requirements for nanomaterials under REACH or CLP, they meet the regulations' substance definition and therefore their provisions apply. In 2011, the European Commission has released a specific recommendation on a Nanomaterials definition. The recommendation is to be used in different European regulations, including REACH and CLP.
While nanomaterials clearly provide unique technical and commercial opportunities, the rapid increase in their use raises questions regarding their potential effects on health and environment. There is a need to adequately assess and manage the potential risks of these new forms of materials, and even if manufacturers, importers and downstream users have to ensure the safe use of each substance (whatever its form) under REACH, this introduces new challenges for regulators (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).
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 and Labelling) for nanoforms as 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 on nanomaterials in REACH registration dossiers
- Providing feedback and advice to registrants that wish to register nanomaterials at the next registration deadline (2013)
- Participating and contributing to ongoing international regulatory activities (such as OECD Working Party on Manufactured Nanomaterials)
In October 2012, ECHA has established a nanomaterials working group (ECHA-NMWG) to discuss scientific and technical questions relevant to REACH and CLP processes and to provide 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 implementation of REACH and CLP legislation in relation to nanomaterials."
ECHA-NMWG also aims to facilitate discussions with industry regarding its experience gained in documenting intrinsic properties of the nano-forms of substances using recent methodologies and its obligations towards fulfilling REACH requirements.
This last objective is closely related with 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.
ECHA will regularly organise webinars to inform and discuss about the latest developments regarding REACH and CLP processes related to nanomaterials, and also to help registrants to prepare and submit dossiers that involve nanomaterials.
Visit the webinars page to register for upcoming webinars and consult previous presentations.
- News Alert: The IUCLID User Manual for nanomaterials has been updated
- Workshop on Nanomaterials 30-31 May 2012
- Frequently Asked Questions about Nanotechnology (by European Commission)
- European Policy on nanomaterials
- Communication on the Second Regulatory Review on Nanomaterials [PDF] [EN]
- Commission Staff Working Paper on nanomaterial types and uses [PDF] [EN]
- European Commission recommendation on Nanomaterials definition [PDF] [EN]
- Scientific technical support on assessment of NM in REACH registration dossiers and adequacy of available information [PDF] [EN]
- JRC report on Requirements on measurements for the implementation of the European Commission definition of the term 'nanomaterial'
- Best Practices on physicochemical and substance identity information for Nanomaterials - Report from 1st GAARN meeting [PDF] [EN]
- Assessing human health and environmental hazards of nanomaterials - Best practice for REACH Registrants - Report from 2nd GAARN meeting [PDF] [EN]
- ECHA-NMWG Mandate [PDF] [EN]
- Nanomaterials in IUCLID 5
- ECHA Guidance on Information Requirements and Chemical Safety Assessment - recommendations for nanomaterials
- 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]