Nanomaterials as defined in a 2011 Commission Recommendation, are materials which often have specific properties due to their small particle size.
The global market for nanomaterials is estimated at 11 million tonnes at a market value of EUR 20 billion. The current direct employment in the nanomaterial sector is estimated at 300 000 to 400 000 in Europe. It is still dominated by materials which have been in use for decades, such as carbon black (mainly used in tyres) or synthetic amorphous silica (used in a wide variety of applications including tyres, as polymer filler but also in toothpaste or as anticoagulant in food powders).
In the past years, many new nanomaterial-related applications have been developed. Those include a number of consumer products such as UV-filters in sun creams and anti-odour textiles. However, many medical and technical applications such as tumour therapies, lithium-ion batteries which can drive electrical cars, or solar panels also exist. Those applications have the potential to create major technological breakthroughs, and therefore nanomaterials have been identified as a key enabling technology. Products underpinned by nanotechnology are forecast to grow from a global volume of EUR 200 billion in 2009 to EUR 2 trillion by 2015.
In the light of current knowledge and opinions of the EU Scientific and Advisory Committees and independent risk assessors, nanomaterials are similar to normal chemicals/substances in that some may be toxic and some may not. Possible risks are related to specific nanomaterials and specific uses. Therefore, nanomaterials require a risk assessment, which should be performed on a case-by-case basis, using pertinent information. Current risk assessment methods are applicable, even if work on particular aspects of risk assessment is still required.
The 2012 Communication on the Second Regulatory Review on Nanomaterials describes the Commission’s plans to improve EU law and its application to ensure their safe use. It is accompanied by a Staff Working Paper on nanomaterial types and uses, including safety aspects, which gives a detailed overview of available information on nanomaterials on the market, including their benefits and risks. The Communication was presented at a workshop on 30 January 2013, for which the presentations are available.
Additional information on nanotechnologies in general can be found on the Europa website on nanotechnologies.
Nanomaterials are regulated by REACH and CLP because they are covered by the definition of a chemical "substance" in both Regulations. The general obligations in REACH and CLP therefore apply as for any other substance, although there are no provisions referring explicitly to nanomaterials.
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. 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) applied to substances manufactured or imported at ≥1000 t/y, carcinogenic, mutagenic and reproductive (CMR) substances at ≥1 t/y and persistent, bioaccumulative and toxic (PBT) of very persistent and very bioaccumulative (vPvB) substances ≥100 t/y. The second registration (1 June 2013) applied to volumes higher than 100 tonnes and lower than 1000 tonnes per year, while the remaining substances manufactured or imported at 1-100 t/y have to be registered by 1 June 2018. 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 fulfill the criteria for classification as hazardous under Regulation (EC) No 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 and put on the market must be notified to ECHA.
In close co-operation with the CARACAL subgroup on nanomaterials ("CASG Nano", composed of Member States Competent Authorities and stakeholder experts) the Commission advises on how to manage nanomaterials safely in accordance with REACH and the CLP Regulation and assess possible further legislative modifications. ECHA has published advice on how to enter nanomaterial information in IUCLID and on best practices with nanomaterials’ registration, updated the guidance for nanomaterials and has created a Nanomaterial Working Group supporting the implementation of REACH, CLP and Biocides Regulation ECHA, together with the Member States has also included some substances with nanoforms in the CORAP list of substances to be evaluated in 2014-2016. Furthermore, the Classification and Labelling Inventory and the web portal on Registered substances of ECHA also contain information on substances with nanoforms.
A study contracted by DG Enterprise and Industry on the development of emerging technologies indicates that REACH and CLP may cause administrative burden, affect time to market, marginal cost structure and allocation of resources, especially for SMEs. However, a few companies also foresee them to create new business opportunities and contribute to consumer and investor confidence in the technology.
The Commission concludes on the basis of the Communication of second Regulatory review on Nanomaterials that REACH sets the best possible framework for the risk management of nanomaterials when they occur as substances or mixtures but more specific requirements for nanomaterials within the framework have proven necessary. The Commission envisages modifications in some of the REACH Annexes and encourages ECHA to further develop guidance for registrations. The Commission 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.
This study has been undertaken to support the drafting of the forthcoming Impact Assessment for an amendment of relevant Annexes to the REACH Regulation with regard to Nanomaterials (NM), which pursues the objective “to ensure further clarity on how NM are addressed and safety demonstrated in registration dossiers”.
The study includes an assessment of future options to address NM under REACH while taking into account, on the one hand, the competitiveness of the European chemicals and NM sector, innovation and employment, including SME-specific impacts, and on the other hand, human health and the environment and impacts from the use of NM.
As a follow-up to the Second Regulatory Review on Nanomaterials, the Commission undertook an 'impact assessment' to identify and develop the best-suited means to increase transparency and ensure regulatory oversight [on nanomaterials].”
The starting point of the impact assessment was evaluating whether an EU nanomaterials registry (i.e. a database to which economic operators would notify the presence of nanomaterials in their products) was necessary to address concerns that market information on nanomaterials is insufficient for risk assessment, consumer choice and worker protection. In analysing those concerns, it became clear that more detailed information on markets alone would be of limited additional value for risk assessment, and that registries in practice are neither accessible to nor understandable for the general public. Therefore, the impact assessment came to the conclusion that an Observatory for Nanomaterials is not only much cheaper and less burdensome to implement than the registry options, but also more flexible to focus on relevant information, including information on hazards and risks.
The Observatory aims at giving objective and reliable information on markets and safety aspects of nanomaterials in the EU market. It will collect, analyse and review available information from a wide range of sources, and complete this information by external studies to fill specific data gaps (e.g. new market studies and surveys) on nanomaterials on the market. A major part of the Observatory shall be devoted to presenting information on nanomaterials, their uses and their safety in a clear and user-friendly way to business, workers, consumers and authorities.
The Observatory for Nanomaterials is being set up by the European Chemicals Agency, on the basis of a Delegation Agreement signed on 6 December 2016. The Observatory will be implemented in a stepwise approach and will integrate and expand the existing Commission information sources on nanomaterials.
As part of the impact assessment on transparency measures, a study evaluated existing notification systems for nanomaterials and to collect data. The study consists of 3 reports:
The European Commission conducted a public consultation between 13 May and 5 August 2014 and received 202 responses. 14 respondents requested that their contributions would not be published. All other contributions can be viewed by following the links in the table below. Please note that some contributions are published in anonymous form upon request.
|Questionnaire for industry||Questionnaire for other stakeholders|
|Non-registered organisations and citizens|
|Responses not to be published|
* Registered organisations are included in the Transparency Register and subscribe to its code of conduct. The Transparency Register ID numbers are listed in the questionnaires.
A technical workshop with stakeholder representatives was organised in Brussels on 30 June 2014.
The following documents from the French, Belgian, Danish and German authorities are of particular relevance to the topic of nanomaterial registries: