REACH and nanomaterials

Nanomaterials

Nanomaterials are chemical substances or materials that are manufactured and used at a very small scale (down to 10,000 times smaller than the diameter of a human hair). Nanomaterials are developed to exhibit novel characteristics (such as increased strength, chemical reactivity or conductivity) compared to the same material without nanoscale features.

Hundreds of products containing nanomaterials are already in use. Examples are batteries, coatings, anti-bacterial clothing etc. Analysts expect markets to grow to hundreds of billions of Euros by 2015. Nano innovation will be seen in many sectors including public health, information society, industry, innovation, environment, energy, transport, security and space.

Nanomaterials have the potential to improve the quality of life and to contribute to industrial competitiveness in Europe. However, the new materials may also pose risks to the environment and raise health and safety concerns. These risks, and to what extent they can be tackled by the existing risk assessment measures in the EU, have been subject to several opinions from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) . The overall conclusion so far is that, even though nanomaterials are not per se dangerous, there still is scientific uncertainty about the safety of nanomaterials in many aspects and therefore the safety assessment of the substances must be done on a case-by-case basis.

Information on nanotechnologies in general can be found on the Europa website on nanotechnologies.

Information on how EU regulation in general applies to nanomaterials can be found in the Commission Communication on Regulatory Aspects of Nanomaterials and in the Commission Staff Working Document .

Nanomaterials in REACH and in CLP

REACH provides an 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.

The first registration deadline under REACH (30 November 2010) applies to substances manufactured or imported at 1000 tonnes or more per year. The registrations of nanomaterials in this tonnage band will help to generate more information useful for the assessment of risks. The European Chemicals Agency (ECHA) receives the 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. 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 must be notified to ECHA by 3 January 2011.

In close co-operation with the CARACAL subgroup on nanomaterials ("CASG Nano", composed of Member States and stakeholder experts) the Commission is preparing advice on how to manage nanomaterials in accordance with REACH and the CLP Regulation. The first paper Nanomaterials in REACH [236 KB] 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 [560 KB] , focuses on the classification of nanomaterials in accordance with REACH and particularly the CLP Regulation. Additional papers are planned on registration, communication in the supply chain, substance identification, information requirements and chemical safety assessment. These papers can be considered as a preliminary advice and will be used by ECHA in their further work on relevant guidance documents.