The potential benefits of nanotechnology and nanomaterials for society are well known. However, the large scale use of particulate nanomaterials raises several issues regarding possible detrimental effects on human health and the environment. This applies to particulate nanomaterials already produced and used in large quantities, as well as the huge range of novel nanomaterials presently under development for different applications. These safety issues need to be addressed before any significant problems arise. For this reason a clear regulatory framework is needed to address them, without stifling innovative research, and without discouraging industry from developing and introducing new processes and consumer products based on nanomaterials. Such a framework should also reassure consumers about nanotechnology developments and foster the acceptance of nanotechnology-based products. EU legislation applies in principle to nanotechnology and nanomaterials, and in recent years some specific provisions for nanomaterials have additionally been introduced into legislation, e.g., for cosmetic products, biocides, food labelling, and also for materials in contact with foods. Any nano-specific provisions must take into account that our current understanding of physiological responses to engineered nanomaterials is far from comprehensive. Improved nano-specific risk assessment and management methods have to be developed and incorporated into a good regulatory framework, based on validated testing methods. Further research and reliable scientific data is urgently needed in this respect. Regarding labelling requirements, analytical methods for their implementation, based on the Commission recommendation for a regulatory definition of nanomaterials, also need to be developed and validated. This presentation provides a brief overview of recent developments as summarized in the Communication from the Commission in its Second Regulatory Review on Nanomaterials[1]. It addresses the major scientific challenges regarding implementation of nano-specific regulations, especially with respect to determining whether a material falls into the category of 'nanomaterial' or not. It also touches on the challenging problem of detection, quantification and characterisation of nanomaterials in complex matrices, for which methods may be required in both industrial and official control laboratories. The presentation also discusses quality assurance tools such as reference materials and methods, including related databases, and emphasizes the role of the OECD Working Party on Manufactured Nanomaterials (WPMN), and the standardization activities of ISO and CEN, which help to foster a globally harmonised approach to the assessment of nanomaterials.

[1] EU Commission Communication COM (2012) 572 final

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1. Bacteriostatic textile-polymeric coat materials modified with nanoparticles