REACH is the over-arching legislation applicable to the manufacture, placing on the market and use of substances on their own, in preparations or in articles. Nanomaterials are covered by the definition of a "substance" in REACH, even though there is no explicit reference to nanomaterials. The general obligations in REACH, such as registration of substances manufactured at 1 tonne or more and providing information in the supply chain apply as for any other substance.
Information on the implementation of REACH for nanomaterials, including guidance and the application of the REACH evaluation processes, can be found on the ECHA website.
The Commission Communication on the Second Regulatory Review on Nanomaterials (October 2012) as well as the REACH Review (February 2013) concluded that REACH and CLP offered the best possible framework for the risk management of nanomaterials when they occur as substances or in mixtures. However, within this framework more specific requirements for nanomaterials have proven necessary.
Therefore the Commission is currently modifying some of the technical provisions in the REACH Annexes.
In the REACH Committee on 26 April Member States voted for the draft Commission Regulation amending several Annexes to REACH. The proposed amendments will significantly clarify REACH registration requirements with regard to nanomaterials. REACH always applied to nanomaterials but did not contain specific provisions for them. Therefore companies often did not know how to register substances in nanoform. The specific requirements will address the current knowledge gap on which substances registered under REACH are placed on the market as nanomaterials and in which quantities. We will also know more about their basic characteristics, how they are being used, how they must be handled safely, what risks they potentially pose to health and the environment and how these risks are adequately controlled.
The draft Commission Regulation will be submitted for scrutiny by Parliament and Council for three months before being adopted by the Commission.
Nanomaterials that fulfill 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 3 January 2011. Any further update to the classification must also be notified without undue delay. Based on the information received under REACH registrations and CLP notifications, ECHA published a classification and labelling inventory.
Applicability of provisions of UNECE Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for nanomaterials is being assessed in the biennium 2015-2016 by the subcommittee of experts (see Program of Work). As appropriate, the outcomes will be reflected under CLP.
In close co-operation with the CARACAL subgroup on nanomaterials ("CASG Nano", composed of Member States and stakeholder experts) the Commission prepares advice on how to manage nanomaterials in accordance with REACH and the CLP Regulation. The first paper "Nanomaterials in REACH" provides an overview of how the provisions of REACH apply to nanomaterials. The second paper, Classification, Labelling and Packaging of Nanomaterials in REACH and CLP, focuses on the classification of nanomaterials in accordance with REACH and particularly the CLP Regulation. CASG Nano also recommended RIPoN reports as a preliminary advice and basis for ECHA in its further work on relevant guidance documents.
CASG Nano is following the development of major initiatives of the Commission on nanomaterials such as the revision of REACH, the assessment of impacts of EU registry of nanomaterials (also known as 'transparency measures') and serves as the expert group and sounding board for the on-going review of Commission Recommendation on the definition of nanomaterial.