REACH is the E.U. Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which entered into operation on 1st June 2008. The purpose of REACH is to ensure a high level of protection of human health and the environment, including the promotion of alternative methods for assessment of hazards of substances, as well as the free circulation of substances on internal market while enhancing competitiveness and innovation. 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. REACH 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. Its provisions are underpinned by the precautionary principle.
Although there are no provisions in REACH referring specifically to nanomaterials, REACH deals with substances, in whatever size, shape or physical state. 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.
Nanomaterials that fulfil the criteria for classification as hazardous under Regulation 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures 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 made a classification and labelling inventory
ECHA’s REACH Technical Guidance Documents
implementation until recently gave no specific guidance concerning nanomaterials. There was a technical manual
on how to include information on nanomaterial in a IUCLID dossier which is an integral part of every REACH registration. This manual describes possibilities and best practices to include nanomaterials and to structure the available nanomaterial information. The latter is particularly important when nanomaterials are additional forms of a substance rather than substances in their own right. Further guidance on the clarification and elaboration of the REACH information requirements and the Chemical Safety Assessment in case of nanomaterials is needed as registration dossiers for nanomaterials must be prepared or updated by companies and reviewed by ECHA.
Work in the scientific community as well as in international organisations has been ongoing for almost a decade on methodologies for assessing risks associated with nanomaterials. On this basis the Commission launched a comprehensive REACH Implementation Project on Nanomaterials (RIP-oN) in 2009 to provide advice on key aspects of the implementation of REACH with regard to nanomaterials concerning Information Requirements
[pdf] and Chemical Safety Assessment
Based on the scientific and technical state of the art recommendations in these reports, on the 30th 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), providing recommendations for registering nanomaterials.
A third report of the RIP-oN project relates to Substance Identity. The final report
[pdf] is available but as it was not possible to reach consensus amongst the experts on the recommendations, further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA.