Impact assessment on transparency measures for nanomaterials on the market
The Commission has launched a public consultation on transparency measures for nanomaterials on the market.
This consultation is conducted in support of an impact assessment to identify and develop the most adequate means to increase transparency of nanomaterials on the market. The objective of the public consultation is to obtain stakeholder views on the currently available information on nanomaterials on the market, the problem definition that forms the basis of the impact assessment, as well as the potential positive and/or negative impacts of different policy options.
In order to get the broadest and strongest evidence base for the Commission's further work, all relevant stakeholders are encouraged to participate. The consultation closed on 5 August 2014.
In addition to the public consultation, the Commission will organise a validation workshop to discuss the preliminary results of the study supporting the impact assessment on transparency measures for nanomaterials with interested stakeholders. The workshop will take place on 30 June 2014 in Brussels.
Nanomaterials are regulated by REACH because they are covered by the definition of a chemical "substance" in REACH. The general obligations in REACH therefore apply as for any other substance and there are no provisions referring explicitly to nanomaterials.
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 20 bn €. 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 200 bn € in 2009 to 2 trn € 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.
Additional information on nanotechnologies in general can be found on the Europa website on nanotechnologies.
On 30 January 2013, the Commission did organise a workshop to present and discuss the Second Regulatory Review on Nanomaterials.
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) applied to substances manufactured or imported at 1000 tonnes or more per year and the second one (1 June 2013) to volumes higher than 100 tonnes and lower than 1000 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 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. 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: Nanomaterials in REACH [236 KB] provides an overview of how the provisions of REACH apply to nanomaterials and 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.
ECHA has published advice on how to enter nanomaterial information in IUCLID, updated the guidance for nanomaterials on the basis of the final reports from REACH Implementation Projects on Nanomaterials (RIPoN2 Information requirements and RIPoN3 Chemicals safety assessment ) and the Commission Recommendation on the definition of Nanomaterial . ECHA, together with the Member States has also included some substances with nanoforms in the CORAP list of substances to be evaluated in 2012-2014. 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 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 after 2013. 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. If appropriate the Commission will come forward with a draft implementing act by December 2013.
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.