The European Commission (EC), in close co-operation with the member states and stakeholder experts of the CARACAL sub-group on nanomaterials (CASG Nano), prepares advice on how to manage nanomaterials under the REACH and CLP Regulation.
REACH is the EU Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into operation on 1st June 2008. REACH lays down provisions on substances, which apply to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. It is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment.
Although there are no provisions in REACH referring specifically to nanomaterials, REACH deals with substances, in whatever size, shape or physical state. As stated in the 2008 EC document "Nanomaterials in REACH" [pdf], substances at the nanoscale are therefore covered by REACH and its provisions apply. It thus follows that under REACH manufacturers, importers and downstream users have to ensure that their nanomaterials do not adversely affect human health or the environment. The European Chemicals Agency (ECHA) receives the REACH registrations and the Agency plays a central role in the collection, evaluation and dissemination of information on substances and preparations, including nanomaterials.
The legislation on classification and labelling (67/548/EEC and 1999/45/EC), as well as the new Classification, Labelling and Packaging(CLP) Regulation (1272/2008/EC), which came into force in 2009 and implements the Globally Harmonised Systems (GHS), also provides the general framework for the classification and labelling of nanomaterials. In 2009, the EC published a document on the "Classification, labelling and packaging of nanomaterials in CLP and REACH" [pdf]. It is stated that nanomaterials that fulfil the criteria for classification as hazardous under the CLP Regulation must be classified and labelled. This applies to nanomaterials as substances in their own right, or nanomaterials as special forms of the substance. Many of the related provisions, including safety data sheets and classification and labelling apply already today, independently of the tonnage in which the substances are manufactured or imported. Substances, including nanomaterials, meeting the classification criteria as hazardous should have been notified to ECHA by 3rd January 2011. Any further update to the classification must also be notified without undue delay. ECHA has established a classification and labelling inventory, containing the information provided in accordance with the regulation.
In February 2013, the European Commission (EC) completed its five-year review of the REACH Regulation. In relation to nanomaterials, the pre-publication version of the EC’s report [pdf] states that the EC "will make an impact assessment of relevant regulatory options, in particular possible amendments of REACH Annexes, to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers. If appropriate the Commission will come forward with a draft implementing act by December 2013." The pre-publication version of the staff working paper [pdf] specifically recommends that, if REACH needs amending "for other reasons," then "consideration should be given to the introduction of the definition of a nanomaterial in line with Recommendation 2011/696/EU." Further details of the REACH review are available on the EC website.
Following publication of this report, the European Commission launched a public consultation on the modification of the REACH Annexes on nanomaterials, which was open for input from 21 June 2013 until 13 September 2013. Further information is available here.
Further information on REACH & CLP in general can be found on the European Chemicals Agency (ECHA) website.
Until recently, ECHA’s REACH Technical Guidance Documents gave no specific guidance concerning nanomaterials. However, over the last couple of years, ECHA has initiated activity to ensure the availability and applicability of guidance for those registering nanomaterials under REACH.
A technical manual providing guidance on how to include information on nanomaterials in registration dossiers prepared in the International Uniform Chemical Information Database (IUCLID) was released in 2010, and subsequently updated in 2013. This manual includes instructions on how registrants can explicitly report when a nanoform has been used in experimental studies and aims to help registrants to prepare or update registration dossiers for substances that are nanomaterials or include nanoforms. A video tutorial is also available.
In 2009, the European Commission launched the REACH Implementation Projects on Nanomaterials (RIP-oNs) to provide advice on key aspects of the implementation of REACH with regard to nanomaterials. Final reports from these projects are available concerning:
It should be noted that, whilst the final report of the RIP-oN 1 project is available, it was not possible to reach consensus amongst the experts on the recommendations of this project and further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.
However, based on the scientific and technical state of the art recommendations made in the RIP-oN 2 & 3 final reports, in April 2012 ECHA published three new appendices, updating Chapters R.7a, R.7b and R.7c of the Guidance on Information Requirements and Chemical Safety Assessment (IR & CSA) with recommendations for registering nanomaterials.
Based on further work by ECHA’s Nanomaterials Working Group (NMWG) and the Group Assessing Already Registered Nanomaterials (GAARN), further appendices to key REACH guidance documents are currently under consultation with a view to providing further advice in relation to nanomaterials. ECHA has indicated a tentative date of May 2017 for publication of the final versions of the appendices.
In 2010, DG Environment initiated a project on "Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information". The project was divided in two separate Tasks: