EC Adopts Communication on Regulatory Review on Nanomaterials

The Communication underlines nanomaterials' diverse nature and types, ranging from everyday materials that have been used safely for decades (e.g., in tyres or as anticoagulants in food) to highly sophisticated industrial materials and tumour therapies.

4 Oct 2012 --- Nanotechnology is delivering major advances today and also has the potential to allow “game changing” technological breakthroughs and rekindle economic growth. In recognition of this fact, the European Commission has adopted a Communication on the Second Regulatory Review on Nanomaterials, which also includes the Commission’s plans to improve EU law to ensure the safe use of nanomaterials.

The Communication underlines nanomaterials' diverse nature and types, ranging from everyday materials that have been used safely for decades (e.g., in tyres or as anticoagulants in food) to highly sophisticated industrial materials and tumour therapies. There is an increasing body of information on the hazard properties of nanomaterials, which are difficult to generalize and justify specific risk assessments.

Therefore, rather than putting all nanomaterials in one basket, a case-by-case approach to risk assessment should be applied, using strategies based on indications of potential risks, either in terms of exposure or hazard. Today's communication was jointly presented by European Commissioners Antonio Tajani, Janez Potocnik, John Dalli, and Máire Geoghegan-Quinn.

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.

Important challenges relate primarily to establishing validated methods and instrumentation for detection, characterization, analysis, completing information on hazards of nanomaterials and developing methods to assess exposure to nanomaterials.

The recent definition of nanomaterials will be integrated in EU legislation, where appropriate. The Commission is currently working on detection, measurement and monitoring methods for nanomaterials and their validation to ensure the proper implementation of the definition.

Overall the Commission remains convinced 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.

In order to improve availability of information on nanomaterials, the Commission will create a web platform with references to all relevant information sources, including registries on a national or sector level, where they exist. In parallel, the Commission will launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight, including an in-depth analysis of the data gathering needs for such purpose. This analysis will include those nanomaterials currently falling outside existing notification, registration or authorisation schemes.

Nanomaterials 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.

Benefits of nanomaterials range from lifesaving applications in medicine to innovation generators to simple improvements of consumer products. Equally, hazard properties and exposure to workers, consumers and the environment differ largely from no concern at all to potential risks that need to be addressed. The European Union has the tools to address those in a focused way.