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TA4.HLO1 - To ensure EU-wide harmonised approaches via the provision of validated analytical methods for identification, characterisation, detection and quantification of substances in food and consumer products falling under EU legislative and consumer concern

TA4.HLO3 - To develop improved systems, frameworks, and tools for assessing human-health risk from factors including manufactured chemicals, chemical emissions, nanomaterials, and environmental noise; and to co-ordinate consensus-reaching processes of EU Member State national risk assessment bodies and to operate the European Union Reference Laboratory for Alternatives to Animal Testing (ECVAM)

NBS (Nanobiosciences) forms one of the Actions implementing the work programme of JRC's Thematic Area 4 (TA4 - Safety of Food and Consumer Products). It addresses two of the Thematic Area's strategic objectives in the area of harmonised approaches for analytical testing and risk assessment, via its activities in relation to: standardisation and testing methods for nanomaterials and test guidelines programmes; development of advanced methods and protocols for in vitro testing; hosting the repository of nanomaterials for testing purposes; and coordination of methods and strategies for the Test Method Regulation.

Nanomaterials, and more broadly nanotechnologies in general, promise benefits in a wide spectrum of fields, including environmental protection, affordable energy, waste treatment, medicine (e.g. in diagnostic and therapeutic technologies), information technology and applications related to security. Moreover, nanotechnologies have the potential to impact on many aspects of food and agricultural systems. They are therefore considered to provide many opportunities for economic growth.

Notwithstanding, nanotechnologies also raise safety concerns and it is therefore necessary to address these in the regulatory context. In particular, the dimensions of nanoparticles are similar to those of large biomolecules or viruses and consequently they are able to move across biological barriers into various organs in the body. Current understanding of physiological responses to engineered nanomaterials is far from comprehensive. There is also a particular lack of reliable data for risk assessment. Whereas the existing EU regulatory framework appears to be sufficiently broad and flexible to handle most of the contemporary issues relating to potential health and environmental risks of nanomaterials, the European Parliament has expressed the need to address nanomaterials explicitly within the scope of specific legislation (for example in chemicals, food, worker protection, air quality, water quality and waste). It has also called for legislation requiring the mandatory labelling of nanomaterials when incorporated into consumer products. It is important therefore that the EU's legislative processes concerning nanotechnology proceed from the basis of sound scientific judgment and knowledge.

As well as supporting the regulatory processes via the development of appropriate risk assessment and management methodologies, the Nanobiosciences Action conducts in-house research into innovative aspects of nanotechnology in areas anticipating future policy support needs such as environment and health safety, biotechnology and security. In addition, the Action intends to reduce gaps in current understanding related to the impact of nanomaterials on human health and the environment. In this rapidly growing scientific discipline, the Action will provide particular added value by linking scientific outcomes to regulatory needs.

The Nanobiosciences Action will continue its work in developing and standardising detection and quantification methods of nanomaterials in complex matrices. In 2012 these methods will focus on sunscreen and food, and in addition (radio)labelling methods will be developed for biological tracing experiments. As a related activity, the Action will aim to improve detection and quantification of OECD priority-list materials in complex matrices. In parallel to the practical laboratory work, the Action will participate in the related standardisation bodies and committees (including ISO and CEN).

The Action will continue to coordinate the activities of the EU National Coordinators on testing methods and integrated testing strategies for characterisation and safety assessment of nanomaterials and other chemicals (industrial, biocides, pesticides) for the Test Method Regulation. It will further participate in and chair where requested OECD committees and working parties in relation to manufactured nanomaterials and the test guidelines programmes. It will also support the 2012 REACH review concerning nanomaterials.

The Action will maintain the JRC repository of nanomaterials for testing purposes to ensure standardised reference samples. It will aim at the development of the NANOhub database into a European inventory on the uses of nanomaterials in close collaboration with Commission services and ECHA.

In terms of research activities, the Nanobiosciences Action will develop innovative methods and protocols for studying dynamic toxicity with single cell resolution for application to short- and long-term hepatotoxicity and metabolism studies and also for three-dimensional cell positioning for improved neurotoxicity testing. In addition, it will adapt existing in vitro methods (in the areas of genotoxicity, carcinogenicity, and cytotoxicity) for the quantitative evaluation of cellular uptake and induced toxicity of specially synthesised and characterised nanoparticles. Radiolabelled nanoparticles will be developed at the IHCP cyclotron facility for these studies and to enable tracing experiments for nanoparticle dosimetry. The facility will also be used to support Nuclear Medicine research carried out by JRC and EU research groups.