ECHA’s activities on nanomaterials under REACH and CLP
Since REACH and CLP cover nanomaterials, industry and authorities need to fulfil their obligations and carry out their tasks within the various REACH (e.g. registration, evaluation, authorisation and restrictions) and CLP processes (e.g. classification and labelling) for nanoforms as for any other form of a substance.
To enable this, ECHA has been working in a strong partnership with key EU and international regulatory bodies to build sufficient scientific and regulatory capacity.
The European Commission concluded in its second Regulatory Review of Nanomaterials that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures, but more specific requirements for nanomaterials within the framework have proven necessary.
However, ECHA’s experience has shown that to be fully effective, REACH will need to have nano-specific provisions. The current situation where REACH is implicitly covering nanomaterials without explicitly stating so in the legal text, has left room for intrepretation among stakeholders.
ECHA’s main activities:
- Implementing REACH, CLP and the BPR for nanomaterials including e.g. verifying compliance of registration dossiers.
- Sharing experience with and generating consensus among Member State competent authorities and scientific committees.
- Providing feedback and advice to registrants who wish to register substances with nanoforms under REACH or to notify under the CLP Regulation.
- Participating and contributing to ongoing international regulatory activities.
- Publishing webinars on the latest nanomaterial developments under REACH and CLP processes.
- Hosting ECHA’s Nanomaterials Expert Group which is an informal advisory group consisting of experts from the EU Member States, the European Commission, ECHA and accredited stakeholder organisations. The mandate of the group is to ’provide informal advice on any scientific and technical issues regarding the implementation of BPR, REACH and CLP legislation in relation to nanomaterials’.
- Establishing the EU Observatory for Nanomaterials.
Verifying compliance under REACH
Together with EU Member States, ECHA facilitates two different evaluation processes under REACH: dossier and substance evaluation.
Under dossier evaluation, ECHA can carry out a compliance check for any registration dossier. The aim of the compliance check is to verify that all information requirements are fulfilled. If they are not, ECHA can request further information or testing.
The aim of the substance evaluation is to clarify whether a substance poses a risk to human health or the environment. ECHA can request further information or testing to verify the concern. The substances subject to this process are indicated on the Community rolling action plan.
Currently, the following substances with nanoforms are indicated to be assessed.