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• Introduction
• Definition of a nanomaterial
• Nanomaterials in REACH and CLP
• RiPON
• Nano Support Project
• CARACAL Subgroup on Nanomaterials
• Study on inventory for products containing nanomaterials

Introduction

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, employment and occupational safety and 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 the subject of several opinions of 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.

In 2011, as part of the second review of regulatory aspects of nanomaterials (in preparation), DG Environment commissioned a study "Review of Environmental Legislation for the Regulatory Control of Nanomaterials" that was conducted by Milieu.

The objective of the study was to review environmental legislation for waste, water and other relevant acts as regards their legal coverage of nanomaterials and, where possible, implementation on the ground. The second objective was to identify and describe legislative and implementation gaps in environmental legislation, including details on whether gaps relate to a lack of legal coverage, limitations in technical capacities or dependences on other legislation.

There are some further thematic studies that touch on the emerging issue of nanomaterials and the environmental legislation, e.g. "Coherence of Waste legislation".

Definition of a nanomaterial

On 18 October 2011 the Commission adopted the Recommendation on the definition of a nanomaterial. According to this Recommendation a "Nanomaterial" means:

A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.

In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

The definition will be used primarily to identify materials for which special provisions might apply (e.g. for risk assessment or ingredient labelling). Those special provisions are not part of the definition but of specific legislation in which the definition will be used.

Nanomaterials are not intrinsically hazardous per se but there may be a need to take into account specific considerations in their risk assessment. Therefore one purpose of the definition is to provide clear and unambiguous criteria to identify materials for which such considerations apply. It is only the results of the risk assessment that will determine whether the nanomaterial is hazardous and whether or not further action is justified.

Today there are several pieces of EU legislation, and technical guidance supporting implementation of legislation, with specific references to nanomaterials. To ensure conformity across legislative areas, where often the same materials are used in different contexts, the purpose of the Recommendation is to enable a coherent cross-cutting reference. Therefore another basic purpose is to ensure that a material which is a nanomaterial in one sector will also be treated as such when it is used in another sector.

Detailed and technical information about the definition of a nanomaterial is available in the "questions and answers" section.

Nanomaterials in REACH and CLP

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.

The first registration deadline under REACH on 30 November 2010 applied 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 next registration deadline is on 31 May 2013 and applies to substances manufactured or imported at or above 100 tonnes  per year. 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. 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. ECHA has made a classification and labelling inventory.

RIPoN

The European Chemicals Agency's (ECHA) REACH Technical Guidance Documents 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 (RIPoN) in 2009 to provide advice on key aspects of the implementation of REACH with regard to nanomaterials concerning Information Requirements and Chemical Safety Assessment. The two final reports are available here:

RIPON2 : Information Requirements

RIPON3 : Chemical Safety Assessment

Based on the scientific and technical state of the art recommendations in these reports ECHA on 30 April 2012 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). These three new appendices are recommendations for registering nanomaterials.

A third report of the RIPoN project relates to Substance Identity. The final report 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.

Nano Support Project

DG Environment initiated in 2010 a project on "Scientific technical support on assessment of nanomaterials in REACH registration dossiers and adequacy of available information". The project is managed by the Commission's Joint Research Centre (JRC) in close collaboration with ECHA. The project is divided in two separate Tasks. Task I entails identification of REACH registration dossiers that cover nanomaterials, scientific assessment of the information on nanomaterials contained in these dossiers and finally proposing how potential cross-cutting shortcomings can be addressed. Task I was finished in March 2012 and the public version of the final report from this Task is available here. Task II commenced in February 2012 focusing on assessing potential economic and environmental consequences of the technical proposals made in Task I (see Final Report Task II here).

CARACAL Subgroup on Nanomaterials

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. Additional papers are planned on registration, communication in the supply chain and substance identification. These papers can be considered as a preliminary advice and will be used by ECHA in their further work on relevant guidance documents in conjunction with the detailed RIPoN reports.

Examining the development of an inventory for products containing nanomaterials

DG Environment commissioned this study on the 'Development of an inventory for consumer products containing nanomaterials' which was taken forward by the Rijksinstituut voor Volksgezondheid en Milieu (RIVM) throughout the course of 2011. (The report does not necessarily constitute the views of the European Commission)

The report covers technical aspects of developing a methodology to identify such products on the market. It also examines the challenges associated with the development of a database - including both searchability and technical IT issues - and discusses other issues of relevance, such as ongoing maintenance.

Recommendations are presented on how to set up a comprehensive database, and on those relevant organisational and practical issues that would accompany potential implementation.