Nanotechnology is a key enabling technology and has great potential for addressing societal challenges including energy supply and health care. Nonetheless, the use of nanomaterials also raises safety concerns, which need to be addressed in a Europe-wide regulatory context.
JRC scientists are contributing to the reduction of uncertainties about the potential impact of nanomaterials on health and the environment and are supporting the development of a sound regulatory framework by providing informed science-based advice. Research focuses on the development of methods for the detection and characterisation of nanomaterials and on in vitro testing methods to analyse the interaction of nanoparticles with cells and proteins.
EU regulations on consumer products such as food, cosmetics and biocides have specific provisions for nanomaterials. Such provisions for nanomaterials, e.g. ingredient labelling, have to be based on a regular definition of the term 'nanomaterial'. The JRC provides scientific and technical advice on the implementation of this definition and is working on methods for the detection and quantification of nanomaterials in consumer products such as cosmetics and food.
Details on how nanomaterials are covered by EU legislation such as the chemicals legislation (REACH Regulation) are described in the Commission's Second Regulatory Review on Nanomaterials. Further information on policy issues is available on the Europa Website on Nanotechnologies.
Safety assessment of nanomaterials
The JRC is at the heart of EU efforts to understand and assess nanomaterials and participates in various collaborative research projects with European and international partners. Furthermore, its work on methods for assessing the safety of nanomaterials is closely connected to the OECD’s Test Guidelines Programme and its Working Party on Manufactured Nanomaterials. The JRC also collaborates with the European Committee for Standardisation (CEN) and the International Organisation for Standardisation (ISO) regarding their activities on the characterisation of nanomaterials.
JRC scientists support the development and implementation of EU policy for nanomaterials safety assessment. They provide advice on the nanomaterial definition, methodologies and guidance for nanomaterials in REACH (e.g. via the REACH Implementation Projects on Nanomaterials and the NanoSupport Project) and other EU legislation (such as cosmetics, food and feed).
The JRC provides scientific and technical advice concerning nanomaterials to other Commission Services (e.g. DG Internal Market, Industry, Entrepreneurship and SMEs, DG Environment and DG Health and Food Safety) and regulatory agencies (European Chemical Agency, European Food Safety Authority and European Medicines Agency). It supports the work of the Competent Authorities for REACH and Classification and Labelling Subgroup on Nanomaterials and the ECHA Nanomaterials Working Group.
The JRC contributes to standardisation and harmonisation of methods for nanomaterials. It closely co-operates with the ISO Technical Committee 229 and the CEN Technical Committee 352 on Nanotechnologies and is a key player in the OECD Working Party on Manufactured Nanomaterials.
JRC scientists participate in about ten FP7 and H2020 research projects concerning nanomaterials, including those of particular strategic importance for policy support such as NanoDefine and MARINA. In the NANoREG project, the JRC leads the key work package which aims to provide scientific answers to regulatory issues. In support of these activities the JRC hosts a repository of representative nanomaterials.
Interaction of nanomaterials with biological systems
Investigation of interactions between nanomaterials and biological systems is of utmost importance in understanding the potential risks arising from the use of nanomaterials. The JRC contributes to the development, adaptation and optimisation of suitable in vitro test methods for studying the interactions between cells and nanomaterials and to understand their potentially toxic effects. The research approach integrates conventional in vitro toxicology assays, appropriately adapted for nanomaterials testing, with mechanistic studies performed using advanced cell sensing, imaging and labelling techniques as well as large-scale screening tools such as transcriptomics, proteomics and metabonomics and high content image analysis.
Nanomaterial properties such as chemical composition, size, shape, surface functionalisation may affect the way the nanomaterials interact with biological systems (proteins, cells, tissues). The increasing number and variety of nanomaterials requires robust, standardised in vitro methods to screen their toxic potential and to assess their safety in consumer products.
The JRC is contributing to the development and optimisation of in vitro methods suitable for the hazard assessment of nanomaterials. Well-established in vitro methods for the testing of chemicals are adapted for nanomaterials by investigating possible interferences of the nanomaterials with the assays. The relation between the physico-chemical properties of the nanomaterials in the in vitro conditions and the observed biological response is studied. Special focus is being placed on the development of methods for nanomaterial dosimetry to quantify the effective cellular dose. This work is performed in collaboration with the OECD Working Party on Nanomaterials.
Studies of the kinetic interactions between cells and nanoparticles are conducted, including uptake, intracellular distribution and translocation of nanomaterials across biological barriers, by using advanced imaging and labelling techniques (fluorescent or radioactive labelling). Mechanistic studies of cell responses to nanomaterials are also performed using a range of techniques including cell sensing, imaging and labelling methods, as well as large-scale screening tools, such as transcriptomics, proteomics and metabonomics and high content image analysis.
All of the above activities are supported by in-house expertise in the synthesis of nanomaterials and their careful physico-chemical characterisation in their pristine form and in the testing systems. This is a multidisciplinary effort between biologists, toxicologists, chemists and physicists. The work is carried out in the JRC's modern, well equipped research laboratories, and in close collaboration with universities and external laboratories.
Physico-chemical characterisation of nanomaterials
The JRC develops methods for the identification and characterisation of nanomaterials for a number of different reasons. Firstly, methods to implement the recommended EC nanomaterial definition are needed, i.e. determining whether a particulate material is a nanomaterial or not. Secondly, for the implementation of legislation on ingredient labelling, e.g. of cosmetics and food, methods for the detection and quantification of nanomaterials in complex matrices are required. Additionally, a thorough knowledge of the physico-chemical characteristics of nanomaterials is of utmost importance in the study of nanomaterial interactions with living systems.
In 2011 the European Commission agreed on a common definition for the term nanomaterial in which materials are characterised in terms of the number size distribution of their constituent particles. The implementation of this definition requires that industry and enforcement laboratories be provided with fit-for purpose analytical methods for particle size measurement for the classification of materials. JRC is participating in the development of procedures for such measurements using, singularly or in combination, a wide variety of advanced particle sizing methods.
Implementation of ingredient labelling for nanomaterials as required by EU legislation (e.g. for cosmetics, food and biocides) requires methods for the detection and quantification of particulate materials in complex matrices such as sunscreens (e.g. titanium dioxide used as UV filter) or alimentary products (e.g. silica dioxide used as anti-caking agent). For such matrices JRC is developing the specialised pre-treatments steps (physical, chemical or enzymatic) necessary make these sample types compatible with the standard measuring methodologies.
The interactions between biological systems and nanomaterials can depend not only on size but other factors such surface charge, chemical functionality and hydrophobicity. These properties, being relevant to possible toxicological mechanisms, are being studied using advanced spectroscopic methods such as X-ray Photoelectron, Tof-SIMS (Time-of-Flight Secondary Ion Mass Spectrometry) and via large scale European synchrotron sources (such as Diamond in UK or Elettra in Italy).
All of the above activities are supported by in-house expertise in the synthesis of tailored nanomaterials with carefully controlled physico-chemical properties. These play a valuable role in developing and testing of new characterisation methods for nanostructured materials as well as being applicable to mechanistic studies of in nanotoxicology. The work is carried out in the state-of-the art equipped laboratories of JRC and in close collaboration with FP7 and H2020 research projects such as NanoDefine, NanoMILE, SMART-NANO, HIPAD, and BiOrigin.
Tools and databases
The JRC provides scientific tools and databases in support of EU policy on nanotechnology and research projects, in particular: