Nanotechnology is the study of phenomena and fine-tuning of materials at atomic, molecular and macromolecular scales, where properties differ significantly from those at a larger scale. 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 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 recent 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 billion in 2009 to €2 trilion 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 Commission has launched a public consultation on the modification of the REACH Annexes on nanomaterials. The consultation will run from 21 June to 13 September 2013 and is open to all interested stakeholders. The objective of this policy initiative is to ensure further clarity on how nanomaterials are addressed and safety demonstrated in registration dossiers. The REACH legislation (Registration, Evaluation, Authorisation and Restriction of Chemical substances) must ensure a high level of health, safety and environmental protection. At the same time it should permit access to innovative products and promote innovation and competitiveness.
DG Enterprise and Industry launched a call for tenders titled ' Study to assess the impact of possible legislation to increase transparency on nanomaterials on the market' with the deadline set for 19 August 2013. The objective of this open call for tenders is to assist the Commission in the preparation of an Impact Assessment to identify and to develop the most adequate means to increase the transparency and to ensure the regulatory oversight for nanomaterials on the market ("nano-registry").
This call responds directly to the announcement made in the communication from the Commission on the Second Regulatory Review on Nanomaterials (adopted on 3 October 2012) about the intention from the Commission to the launch of an Impact Assessment that would 'include those nanomaterials currently falling outside existing notification, registration or authorisation schemes'. This work should consider a register of nanomaterials and/or products containing nanomaterials in parallel to the existing REACH and CLP obligations.