Word
Action number 15024 Last updated 26/01/2011 16:45:25 Year 2011
Title Nanobiosciences
Acronym NBS
Type Action
Url
Institute JRC.I Institute for Health and Consumer Protection (Ispra)
Leader SOKULL-KLUETTGEN Birgit JRC.I.4   E-Mail
1 Prosperity in a Knowledge intensive society
1.5 Life Sciences and biotechnology
European Committee for Standardization
European Chemicals Agency (ECHA)
European Food Safety Agency
International Organization for Standardization (ISO)
Organisation for Economic Co-operation and Development (OECD)
Customer DGs ELARG - Enlargement
ENTR - Enterprise and Industry
ENV - Environment
SANCO - Health and Consumers
Nanomaterials, nanotechnology, nanoparticle synthesis and activation, advanced surface characterisation, in-vitro toxicology, test-methods harmonisation and standardisation, integrated testing strategies, safety and risk assessment, bio/non-bio surface interaction, data-management systems, nuclear medicine, radiotracers, cell and molecular imaging
Rationale
Nanomaterials and nanotechnologies (N&N) promise benefits in a wide spectrum of fields, including environmental protection, affordable energy, waste treatment, medicine (especially in diagnostic and therapeutic tools), information technology and applications related to security. Moreover, N&N has the potential to impact on many aspects of food and agricultural systems. As such, N&N are expected to provide many opportunities for economic growth. However, N&N raise as well safety, regulatory, social, and ethical issues, which should be addressed before any associated problems materialise.
The Nanobiosciences (NBS) Action conducts 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 N&N on human health and the environment, and also to develop risk assessment and management methodologies for N&N. Research activities in the Action will address key issues in understanding the interaction of nanomaterials with living organisms in order to obtain a better understanding of potential risks to health and the environment. Future regulatory developments related to N&N depend strongly on further research and reliable scientific data. In this rapidly growing scientific area the action will provide significant added value by linking scientific outcomes to regulatory needs.
Summary of the activity
In 2011 research and policy support activities within the NBS action will address:
• Safety and risk assessment issues related to nanomaterials
• Nanomaterials identification and properties determination
• Advanced applications of nanotechnology on bio/non-bio interaction and effects
• Clustering and networking activities for underpinning capacity building.
The results of the activities will provide principal input to the PSA Nanotechnology. Owing to the horizontal nature of nanotechnology applications, horizontal interactions with the IHCP Operational Actions on 'Systems Toxicology' and 'In Vitro Methods' will continue and further settled with 'Molecular Biology and Genomics'. Horizontal support to Policy Support Actions will address as well 'Alternative methods and ECVAM'.
The work in 2011 will be developed in view of the new JRC strategy and investigate innovative applications of NBS expertise on bio/non-bio interfaces and nanodesign of surfaces and interfaces in the area of Systems Biology. Research on environmental, health and safety aspects of nanotechnology including related policy support will continue to be the focus of principal NBS activities. It will also address research for the identification and characterization of nanomaterials which will be relevant for different areas of legislation, i.e. cosmetics, food, medical devices, etc.. The activities are interconnected by the repository of reference nanomaterials and the corresponding reference database, hosted at the JRC.
Activities concerning the development of globally harmonised approaches to safety assessment of nanomaterials, and activities related to nanomaterials characterisation and testing will be carried out within the OECD Working Party on Manufactured Nanomaterials (WPMN) and in collaboration with CEN and ISO. This will also include work on the development of information requirements; chemicals safety assessment; and management tools for nanomaterials - in liaison with relevant Commission Scientific Committees and Working Groups. Further activities will include the coordination of Commission Services and EU Member State Authorities regarding the Test Method Regulation (TMR) and the OECD Test Guideline Programme, and the provision of test methods for the TMR with emphasis on alternative (non animal) methods.
N.B. It is important to note that JRC'S Institute for Health and Consumer Protection (IHCP) differentiates between two classes of Actions – Policy Support Actions (PSAs) and Operational Actions (OAs). PSAs provide the formal interface to IHCP's customers. The PSAs describe all the main Objectives and associated deliverables agreed beforehand with IHCP's customers. In contrast the OAs describe in more technical detail how IHCP will perform the Objectives formalised in the PSAs. The starting place to understand IHCP's work plan is therefore the PSAs, where each Objective identifies the customer(s) to whom it is relevant. Moreover, in order to allow a transparent and more detailed mapping of the work, each PSA Objective is also cross referenced to the OAs which contribute to the work of the PSA. In similar fashion, each Objective in the OAs is cross referenced to the PSA to which they contribute.
This Action is one of IHCP's OAs and therefore provides a more detailed breakdown of the work defined in the PSAs to which reference has been made in the individual Objectives.
 
  1
To plan and manage the action including maintenance of laboratory infrastructures respecting safety regulations and ISO quality procedures.
Deliverable  1.1
Updated project file.
31/12/2011
Deliverable  1.2
Periodic progress reports and PR material.
31/12/2011
Deliverable  1.3
Work programme 2012 and budget table.
31/12/2011
Deliverable  1.4
Follow up of 2010 safety audit.
31/12/2011
Deliverable  1.5
Follow-up of 2010 quality audits.
31/12/2011
  2
To develop and optimise methods for assessing the environmental, health and safety impact of nanomaterials
  2.1
To provide specific and practical advice on substance identity, information requirements, exposure assessment, hazard identification and risk characterisation for nanomaterials. Contributes to JRC Actions: NT Obj. 2.2
Draft report providing an overview of the parameters relevant for substance identification of nanomaterials with proposals on how these substances can be clearly identified.
31/03/2011
CAT2 - Policy support documents
Gap analysis describing relevant intrinsic properties of nanomaterials which may not be addressed by current test guidelines, including an analysis of possible integrated-testing strategies.
31/08/2011
CAT2 - Policy support documents
Draft report on hazard and risk characterisation, including applicability and efficiency of risk management/mitigation measures.
31/12/2011
CAT2 - Policy support documents
Background document identifying critical aspects of dose descriptors and related parameters, outlining needs for possible different metrics/parameters (such as mass, number, surface area and particle size(s)) in exposure assessment, hazard identification and risk characterisation.
31/12/2011
CAT2 - Policy support documents
3-4 case studies for exposure scenarios for different nanomaterials.
31/08/2011
CAT2 - Policy support documents
Draft terms of reference of a network to facilitate scientific, policy-makers and stakeholders dialogue on Nanosafety issues.
31/12/2011
CAT2 - Policy support documents
Analysis of modifications needed in chemicals legislation in order to address nanomaterials.
31/12/2011
CAT2 - Policy support documents
  2.2
To manage and to contribute to expert groups by coordinating technical work, and by drafting and editing of documents. Contributes to JRC Actions: NT Obj. 2.1
Briefing of the activities and discussions within the expert group 'Testing of a Representative Set of Manufactured. Nanomaterials', the so-called sponsorship programme.
31/12/2011
CAT5 - Other policy support products and services
Briefing of the activities and discussions within the sponsorship programme as lead sponsor (together with France) for the safety testing of synthetic amorphous silicon dioxide.
31/12/2011
CAT5 - Other policy support products and services
Briefing of the activities and discussions within the expert group 'Test Guidelines and Manufactured Nanomaterials'.
31/12/2011
CAT5 - Other policy support products and services
Briefing of the activities and discussions within the expert group 'The Role of Alternative Methods in Nanotoxicology'.
31/12/2011
CAT5 - Other policy support products and services
Briefing of the activities and discussions within the expert groups 'Sharing Risk Assessment Experiences and Approaches', 'Nanomaterials Exposure Assessment and Mitigation' and 'Co-operation on Environmentally Sustainable Use of Nanotechnology'.
31/12/2011
CAT5 - Other policy support products and services
  2.3
To adapt and apply in-vitro methods for the quantitative evaluation of cellular uptake, genotoxicity (comet assay, micronucleus test, gene expression analysis), carcinogenicity (in-vitro cell transformation assay, CTA) and cytotoxicity (Colony Forming Efficiency assay, CFE) for specially synthesised and well characterised nanoparticles. Contributes to JRC Actions: NT Obj. 2.1
Publication on in-vitro protocols including long-term exposure and repeated doses for cytotoxicity (CFE assay,) and carcinogenicity (in-vitro CTA) for nanoparticles (specially synthesised and well characterised Au, SiO2 and CeO2)
31/12/2011
CAT7 - Scientific publications
In-vitro protocols suitable for automated HTS and HCA testing of NM series reference nanoparticles (in collaboration with OA ST).
30/09/2011
CAT3 - Validated and harmonized methods and measurements
Publication on the mechanisms of nanoparticle uptake in-vitro (using also radio tracers) in relation to physico-chemical properties, and its relation to genotoxicity (comet assay, micronucleus test or gene expression analysis), carcinogenic potential (in-vitro CTA) and cytotoxicity (CFE assay) for selected nanomaterials with different physico-chemical properties: Au and SiO2 (specially synthesised) with sizes between 10 and 80 nm and different surface functionalities.
31/12/2011
CAT7 - Scientific publications
Publication on the interaction of nanoparticles with protein systems, in particular adsorption/desorption with human serum proteins, and change of protein structure upon adsorption as measured by Mass Spectrometry (MS), Nuclear Magnetic Resonance (NMR), Fourier Transmission Infrared Spectroscopy (FTIR) and Circular Dichroism (CD) for SiO2 and Au nanoparticles (specially synthesised, different particles sizes and surface functionalities).
30/12/2011
CAT7 - Scientific publications
Gene expression analysis of in vitro models (MDCK and Balb/3T3) exposed to Au nanoparticles of two different sizes (in collaboration with OA MBG 15006)
01/12/2011
CAT4 - Technical systems
Publication on the protein expression analysis (Balb/3T3) to determine the endocytotic pathway during Au nanoparticle uptake
31/12/2011
CAT7 - Scientific publications
  2.4
To develop and apply novel methods for radiolabelling of nanoparticles, including NM series reference nanomaterials, for use in biodistribution and detection measurements. Contributes to JRC Actions: NT Obj. 2.1 and 4.1
Publication on a new method for radiolabelling of nanoparticles based on recoil/dopant incorporation either during irradiation or radiochemical synthesis
31/08/2011
CAT7 - Scientific publications
Publication on irradiation experiments with TiO2 nanoparticles carried out at various beam currents in order to validate theoretical calculations on the temperature profile of NPs under irradiation.
30/09/2010
CAT7 - Scientific publications
Report/publication on radiation damage to Multi-Walled Carbon Nanotubes (MWCNTs) caused by direct proton bombardment at low beam energies, focussing on structural and morphological effects, in order to validate high-energy labelling protocols with Be-7.
30/11/2011
CAT7 - Scientific publications
Activated nanoparticles for in-vitro and (collaborative) in-vivo studies, focusing in particular on Au, TiO2, SiO2, MWCNTs, and CeO2 (including NM series reference materials from the JRC repository).
30/11/2011
CAT4 - Technical systems
  3
To develop and optimise measurement and testing approaches for nanomaterials identification and properties determination.
  3.1
To develop methods for detection, identification and quantification of nanomaterials in complex matrices (cosmetics). Contributes to JRC Actions: NT Obj. 3.2
Publication on the optimisation of a separation process allowing the detection and identification of nanomaterials in cosmetic products.
31/12/2011
CAT7 - Scientific publications
  3.2
To participate actively in technical/scientific committees (from e.g. ISO TC 229, CEN TC 352, SCENIHR) dealing with standardisation of measurement methods for nanomaterials and potential health risks of nanomaterials. Contributes to JRC Actions: NT Obj. 2.3
Briefing of the activities and discussions within technical/scientific committees for the standardisation of measurement methods for nanomaterials.
31/12/2011
CAT5 - Other policy support products and services
Analysis of available data on nanomaterials in databases such as NAPIRAhub and/or IUCLID.
31/12/2011
CAT2 - Policy support documents
Report (or other activities e.g. workshop) on 'Next generation nanomaterials - foresight for risk assessment.
31/12/2011
CAT2 - Policy support documents
  3.3
To host and maintain a specific database on nanomaterials (NapiraHub) as the reference database for nanomaterials compatible with IUCLID. Contributes to JRC Actions: NT Obj. 3.5
System log of updates to NapiraHub database, including registration of new users, validation of new users, uploading datasets, hosting data, and maintenance in collaboration with OA ST.
31/12/2011
CAT4 - Technical systems
Response log of answers to queries of users of the NapiraHub database.
31/12/2011
CAT4 - Technical systems
Provide training to users of the NapiraHub database.
31/12/2011
CAT8 - Training courses
  3.4
To build up and maintain a repository of reference nanomaterials for testing, and to provide nanomaterials for testing. Contributes to JRC Actions: NT Obj. 3.4
A repository of reference nanomaterials for testing which will include silver, titanium dioxide, silicon dioxide, zinc oxide, cerium dioxide, and carbon nanotubes in different specifications (such as different sizes, uncoated and coated nanomaterials).
31/12/2011
CAT1 - Reference materials
  3.5
To characterise the NM series reference nanomaterials of the JRC Nanomaterial Repository such as silver, titanium dioxide, silicon dioxide, zinc oxide, cerium dioxide, and carbon nanotubes. Contributes to JRC Actions: NT Obj. 3.4
Operational plan for homogeneity and stability testing of nanomaterials of repository.
31/03/2011
CAT1 - Reference materials
Study reports on physico-chemical properties of nanomaterials of repository regarding impurities (ICP-MS) and crystalline phase (XRD).
31/12/2011
CAT1 - Reference materials
Study reports on physico-chemical properties of nanomaterials of repository (silver and gold) regarding particle size analysis by electron microscopy and DLS and electro-static charge by zeta potential.
31/12/2011
CAT1 - Reference materials
  4
To develop advanced applications of nanotechnology on bio/non-bio interaction and effects for imaging and molecular detection.
  4.1
To develop and optimise high sensitivity molecular detection methods and probes. Contributes to JRC Actions: NT Obj. 4.1
Publication on high sensitivity detection by surface plasmon resonance on nano-patterned surfaces and plasmonic structures.
30/09/2011
CAT7 - Scientific publications
Publication on the application of synchrotron and advanced nuclear analysis techniques for the high resolution imaging of nanomaterials in complex organic or biological systems (cosmetics, serum).
31/12/2011
CAT7 - Scientific publications
Publication on methods for 3D tomography by Scanning Electron Microscopy (SEM), confocal microscopy and synchrotron radiation for imaging of NP distribution in cellular systems.
31/12/2011
CAT7 - Scientific publications
  4.2
To develop advanced in vitro model systems focusing in particular on protein, DNA and cell-surface interactions. Contributes to JRC Actions: NT Obj. 4.1
Publication on protein deposition on patterned surfaces and their impact on protein conformation change depending on the pattern size, shape and chemical properties.
30/09/2011
CAT7 - Scientific publications
Publication on kinetics studies with amyloid-forming peptides and proteins.
30/09/2011
CAT7 - Scientific publications
Publication on the influence of a 3D protein environment on the maintenance and development of neural-umbilical-cord-blood stem cells (cell differentiation and metabolism, in collaboration with OA IVM).
30/09/2011
CAT7 - Scientific publications
  4.3
To develop nanotechnology based components for Synthetic biology applications. Contributes to JRC Actions: NT Obj. 4.1
Publication on signalling peptides/NP constructs for organelle targeting.
31/12/2011
CAT7 - Scientific publications
Publication on immobilisation of arrays of reporter cells for targeted cell response detection
31/12/2011
CAT7 - Scientific publications
Publication on immobilisation on nanostructures of synthetic peptide receptors for targeted cell response detection.
31/12/2011
CAT7 - Scientific publications
  5
Clustering and networking activities for underpinning capacity building.
  5.1
To coordinate EU activities on Testing Methods and Integrated Testing Strategies via the EU National Coordinators Meeting in order to obtain a coordinated position of the COM and EU Member States regarding the needs and work for the Test Method Regulation (TMR) and the OECD Test Guidelines Programme. Contributes to JRC Actions: AM& ECVAM Obj. 5.1
Report summarising the activities concerning the Test Methods Programme (e.g. 37th EU National Coordinators meeting on test guidelines), communication with the National Coordinators and COM services.
31/12/2011
CAT2 - Policy support documents
Test methods, co-ordinated and discussed with Member States at a technical level in the EU and OECD, provided to leading DG. Ca. 20 methods (2 methods for the determination of physico-chemical properties, 13 methods for the determination of toxicity and other health effects (including 5 alternative methods in the meaning of the 3 Rs), and 6 methods for the determination of ecotoxicity or environmental fate) are foreseen for the 3rd Adaptation to Technical Progress (ATPs) of the TMR organised by the policy DGs.
31/12/2011
CAT3 - Validated and harmonized methods and measurements
  5.2
To coordinate the Commission input to the OECD Test Guidelines Programme (TGP) by acting as the central point for developing and delivering the official Commission position in the OECD TGP, as well as representing the Commission in this forum and related Committees. Act as JRC central contact point for regulatory acceptance of testing methods and strategies within the role of European Commission Coordinator. Contributes to JRC Actions: AM& ECVAM Obj. 5.2
Report summarising the official Commission's input provided to the OECD Test Guidelines Programme within the 23rd WNT Meeting (OECD working group of the National Coordinators of the Test Guidelines Programme).
31/12/2011
CAT2 - Policy support documents
Report summarising the Commission official position in response to the OECD requests for comments (number depends on actual issues).
31/12/2011
CAT2 - Policy support documents
Report summarising the coordination provided to the Commission led Test Guideline projects (at least two) to ensure that the projects are directly suited for the OECD Test Guidelines programme, reach their objective and result in OECD accepted tests.
31/12/2011
CAT2 - Policy support documents
Written or oral briefings on Testing Methods issues and strategies to the Commission representative of the OECD Joint Meeting and other relevant services.
31/12/2011
CAT5 - Other policy support products and services
  5.3
To contribute to research and to develop novel methods in the field of nuclear medicine, focussing on production of novel medical isotopes in direct support to the ITU activities on alpha-immunotherapy, and on development of new cyclotron-based methods for production of established isotopes (2 patent applications of 2010).
Irradiated target material (supplied by ITU) analysed and delivered to ITU according to agreed schedule.
31/12/2011
CAT4 - Technical systems
Publication on cross section and yield data related to the production of Cu-67 and/or Mo-99 using cyclotron irradiation of enriched Zn-70 or Th-232.
31/10/2011
CAT7 - Scientific publications
  5.4
To support the Commission's Enlargement & Integration programme by organising three workshops in Ispra.
Summary of workshop with New Member States and Candidate Countries on cyclotron research and radio-labelling of nanoparticles, as part of the yearly cyclotron networking workshops (with participation of approximately 15-20 relevant research institutions).
15/12/2011
CAT7 - Scientific publications
Summary of workshop with New Member States and Candidate Countries on NanoBiotechnology (with participation of approximately 60-80 researchers of the field).
15/12/2011
CAT7 - Scientific publications
Summary of the 2nd ENPRA Stakeholder Workshop “Challenges of Regulation and Risk Assessment of Nanomaterials” with New Member States and Candidate Countries (with approximately 70 participants).
31/12/2011
CAT7 - Scientific publications
  6
Exploratory and innovation research.
  6.1
To contribute to the exploratory research project "Nanotechnology based 3D structures to facilitate functional differentiation of human stem cells". In collaboration with IVM (In Vitro Method Optimization) and ST (Assay Technologies and HTS)
Progress report summarising the activities and results of the project.
31/12/2011
CAT5 - Other policy support products and services
  6.2
To contribute to the exploratory research project "NanoEcotoxicology: Environmental toxicity and fate of nanoparticles". In collaboration with IES (Rural, Water and Ecosystem Resources Unit and Transport and Air Quality Unit)
Progress report summarising the activities and results of the project.
31/12/2011
CAT5 - Other policy support products and services
  6.3
To contribute to the exploratory research project " Synthetic Biology: development of modified organism-based microarrays for detection of toxicants". In collaboration with MBG (Applied Molecular Biology) and IES (Rural, Water and Ecosystem Resources Unit)
Report summarising the activities and results of the project.
31/12/2011
CAT5 - Other policy support products and services
  6.4
To contribute to the exploratory research project "Understanding nanoparticle mechanisms of toxicity: gene expression study on in vitro models exposed to gold nanoparticles". In collaboration with MBG (Applied Molecular Biology)
Report summarising the activities and results of the project.
31/12/2011
CAT5 - Other policy support products and services
  6.5
To carry out the JRC innovation project "Development of spectrally interrogated multiplexing biochips for label- free analysis of complex biological samples".
Report summarising the activities and results of the project.
31/12/2011
CAT5 - Other policy support products and services
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