EC: Nanomaterials: Case by case safety approach for breakthrough technology

09 October 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.
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 (Press Release European Commission, 3 October 2012).