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TA4.HLO1 - To facilitate EU-wide harmonisation and standardisation in the implementation of EU legislation on control of food and consumer products, including the provision of validated analytical methods and tools

TA4.HLO2 - To develop improved frameworks, systems, and tools for the safety assessment of chemicals (including nanomaterials) to scientifically underpin the EU legislative process and contribute to international harmonisation

TA4.HLO3 - To advance and coordinate efforts and activities at the EU-level in preventing and combating Europe's disease-related health burden and foster harmonisation according to best practices

Nanomaterials, and more broadly nanotechnologies in general, promise benefits in a wide spectrum of fields, including environmental protection, affordable and sustainable 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 agriculture and food production/packing. They are therefore considered to provide many opportunities for economic growth.
Properties of nanomaterials, which are linked to their size and surface characteristics, differ appreciably from those of larger sized particles. The same properties which promise the aforementioned benefits may also lead to new hazards for health and environment, and the use of certain products may raise safety concerns, which must be addressed in the regulatory context. The dimensions of nanoparticles are similar to those of large biomolecules or viruses and consequently they may be 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. There is no specific legislation in the EU on nanotechnology or nanomaterials; however, EU legislation, such as on workers protection, environment and chemicals applies in principle also to nanomaterials. Furthermore, nanomaterials are addressed explicitly in recent EU Regulations (for example Reg. 1223/2009 on Cosmetic products, Reg. 528/2012 on Biocidal products, Reg. 10/2011 on Plastic materials and articles intended to come into contact with foodstuffs and Reg. 1169/2011on Provision of food information to Consumers), and some specific provisions have been introduced, including ingredient labelling for consumer products. As any introduction of provisions specific to nanomaterials requires a regulatory definition of nanomaterial, in October 2011 the European Commission adopted a "Recommendation on the definition of a nanomaterial". However, harmonised methods to measure the size distribution of (nano)materials and methods for the implementation of the labelling requirements are still needed. Faced with the need of the EU industry to replace, reduce and refine testing on animals and in particular with the 2013 animal testing ban under the Cosmetics Directive (Council Directive 76/768), specific in-vitro alternatives for nanomaterials hazard identification are also not yet available. Finally, availability and transparency of information on nanomaterials and products containing nanomaterials is going to be extremely important as a basis for sound, knowledge-based policy making.
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, 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 NBS (Nanobiosciences) Action is one of the Actions implementing the work programme of the Institute for Health and Consumer Protection (IHCP), and addresses three of IHCP's strategic objectives. (1) It facilitates EU-wide harmonisation and standardisation through its activities on methods needed for the implementation of EU legislation regarding nanomaterials. (2) It contributes to developing improved frameworks and tools for the safety assessment of nanomaterials. (3) Finally, it contributes to activities in preventing and combating Europe's disease-related health burden by producing radioisotopes for medical diagnostics/therapeutics.
The Nanobiosciences Action will continue its work in developing and harmonising methods related to EU legislation regarding nanomaterials. In 2013, the work will focus on detection and quantification methods for nanomaterials (e.g. Ag, TiO2, ZnO and SiO2) in consumer products (e.g. sunscreens, food and food contact material). In parallel to the practical laboratory work, the Action will participate in the related Commission working groups, standardisation bodies and committees (including ISO and CEN).
Concerning methods for the hazard assessment of nanomaterials, the Action will continue its work on the adaptation and optimisation of in-vitro test methods (in the areas of cytotoxicity, genotoxicity and carcinogenicity), which will be summarised in a JRC Report on in vitro methods for toxicity testing of nanomaterials. The Action will focus on the interactions between cells, cell-barriers and nanoparticles, and it will adapt and develop innovative methods and protocols for the elucidation of the mechanisms and intracellular pathways involved in nanoparticle-induced toxicity using specially synthesised and well-characterised nanoparticles, as well as innovative sensing techniques. For these studies and to enable tracing experiments for nanoparticle dosimetry, (radio-)labelled nanoparticles will be developed at the IHCP cyclotron facility. This facility, for which 2013 is the last full year of operation, will also be used to support Nuclear Medicine research carried out by JRC and EU research groups. The knowledge from the research activities will also be used to support the implementation of EU legislation such as the current REACH Regulation (Reg. 1907/2006) and any follow-up of its review, as well as the Cosmetic Products Regulation (Reg. 1223/2009).
The Action will continue to direct the activities of the EU National Coordinators on testing methods and integrated testing strategies for characterisation and safety assessment of nanomaterials and other chemicals (i.e. industrial chemicals, biocides and pesticides) for the Test Method Regulation (Reg. 440/2008). It will further participate in and chair, where requested, OECD committees and working parties in relation to manufactured nanomaterials and the test guidelines programmes. The Action will maintain the JRC repository of nanomaterials for testing purposes used by the OECD and within EU funded research projects. It will maintain and further develop the JRC NANOhub to collect information on nanomaterials, and to provide input to the development of IUCLID towards the reporting of nanomaterials' properties. Furthermore, the Action will carry out preparatory work towards a web platform on nanomaterials with references to all relevant information sources in close collaboration with Commission services.