Word
Action number 15024 Last updated 09/12/2011 09:55:49 Year 2012
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
Thematic Area TA4 - Safety of Food and Consumer Products
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)
1 Prosperity in a Knowledge intensive society
1.5 Life Sciences and biotechnology

ENTR - Enterprise and Industry
ENV - Environment
JRC KB - JRC Knowledge Base
SANCO - Health and Consumers


CC EU - Candidate Countries EU
CEN - European Committee for Standardization
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
ECHA - European Chemicals Agency (ECHA)
ISO - International Organization for Standardization (ISO)
OECD - Organisation for Economic Co-operation and Development (OECD)
Reg Aut R&D - Candidate Countries / Members States regulatory authorities on Research



CEFIC - European Chemical Industry Council (CEFIC)
CIAA - Confederation of the food and drink industries of the EU
Cosmetics Europe - European Cosmetics Association
Nanomaterials, nanotechnology, nanoparticle synthesis and labelling, 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
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.
Summary of the activity
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.
 
  1
To develop and standardise detection and quantification methods including separation techniques, size characterisation and chemical composition analysis for nanomaterials in complex matrices such as cosmetic products and food (TA4 Str. Obj. 1, Gen. Obj. 1.2)
Deliverable  1.1
Validated methods in form of standard operation procedures for: titanium dioxide and zinc oxide nanomaterials in sunscreen.
31/12/2012
Scientific Publications
The single market
TypeYearNumberTitle
REG 20091223 Cosmetic Products Regulation
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
JRC KB - JRC Knowledge Base
SANCO - Health and Consumers
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
Deliverable  1.2
In-house validated method in the form of a standard operation procedure for measurement of size and concentration of silver nanoparticles in water and one simple food matrix.
31/12/2012
Scientific Publications
The single market
TypeYearNumberTitle
REG 20061924 Provision of food information to consumers
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
JRC KB - JRC Knowledge Base
SANCO - Health and Consumers
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
  2
To increase detection and quantification resolution of OECD priority-list nanomaterials (in particular, silicon oxide, silver, and zinc oxide) in consumer products and of their subsequent presence in the environment, e.g. water, soil and biota (TA4 Str. Obj. 1, Gen. Obj. 1.2)
Deliverable  2.1
Improved detection methods based on surface plasmon resonance and Raman spectrometry techniques
31/12/2012
Scientific Publications
The single market
TypeYearNumberTitle
COM 2011696 COMMISSION RECOMMENDATION of 18 October 2011 on the definition of nanomaterial
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
JRC KB - JRC Knowledge Base
  3
To participate in ISO TC 229, ISO TC 194, CEN TC 352 addressing standardisation of measurement and testing methods for nanomaterials (TA4 Str. Obj. 1, Gen. Obj. 1.2)
Deliverable  3.1
Policy support documents for scientific committees
31/12/2012
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
SectionTopic
1: Forthcoming initiatives 2012Review of REACH
ENTR - Enterprise and Industry
ENV - Environment
CEN - European Committee for Standardization
ISO - International Organization for Standardization (ISO)
  4
To adapt in vitro methods for the evaluation of the toxicological profile of specially synthesised and characterised nanoparticles including radiolabelled nanoparticles (TA4 Str. Obj. 3, Gen Obj, 3.2)
Deliverable  4.1
Adapted micronucleus and comet assay (in vitro methods for genotoxicity)
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  4.2
Adapted uptake test (in vitro method for nanoparticle/cell interaction)
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  4.3
Adapted gene expression analysis in vitro method for genotoxicity
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  4.4
Adapted cell transformation assay (CTA) in vitro method for carcinogenicity
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  4.5
Adapted Colony Forming Efficiency (CFE) assay (in vitro method for long term cytotoxicity
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  4.6
Report on the mechanisms and intracellular pathways involved in nanoparticle-induced toxicity, focusing in particular on the induction of oxidative stress and inflammation
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
  5
To develop reliable methods for radiolabelling of OECD priority-list nanomaterials to facilitate in vitro tracing experiments and nanoparticle dosimetry in biological systems (TA4 Str. Obj. 3, Gen Obj, 3.2)
Deliverable  5.1
Novel direct and indirect cyclotron-based nanoparticle radiolabelling methods
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  5.2
Workshop on applied cyclotron research and radio-labelled nanoparticles, as part of the yearly cyclotron networking workshops with participation of approximately 15-20 relevant research institutions.
31/12/2012
JRC Scientific Support - Training
JRC KB - JRC Knowledge Base
Reg Aut R&D - Candidate Countries / Members States regulatory authorities on Research
  6
To adapt and develop innovative methods and protocols using advanced plasmonic and electrode-based systems for studying toxicity with single cell resolution (TA4 Str. Obj. 3, Gen Obj, 3.2)
Deliverable  6.1
Assessment of potential of analytical cytotoxicity methods with advanced plasmonic and electrode-based systems
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
  7
To adapt and develop an in-vitro method for testing the interaction (toxicity and passage) of nanoparticles with physiological barriers (TA Str. Obj. 3, Gen. Obj. 3.3)
Deliverable  7.1
Publication on interaction of SiO2 nanoparticles with in-vitro intestinal barrier (Caco2 Cells)
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
Deliverable  7.2
Report on the development of a Blood Brain Barrier model to study nanoparticles toxicity.
31/12/2012
Scientific Publications
The single market
JRC KB - JRC Knowledge Base
  8
To support the current implementation of the REACH Regulation as well as its review in 2012 with focus on nanomaterials (TA4 Str. Obj. 3, Gen Obj, 3.2)
Deliverable  8.1
Report on ad-hoc support and advice provided to the leading DGs and ECHA regarding the implementation of the advice produced within the RIP-oN projects
31/12/2012
JRC contributions to policy documents
The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
SectionTopic
1: Forthcoming initiatives 2012Review of REACH
ENTR - Enterprise and Industry
ENV - Environment
ECHA - European Chemicals Agency (ECHA)
Deliverable  8.2
Report on evaluation of nanomaterial information provided in REACH dossiers, and recommendations for possible modifications of related requirements of REACH
31/12/2012
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
SectionTopic
1: Forthcoming initiatives 2012Review of REACH
ENTR - Enterprise and Industry
ENV - Environment
ECHA - European Chemicals Agency (ECHA)
Deliverable  8.3
Report summarizing the scientific/technical support with respect to the REACH Regulation
31/10/2012
JRC Scientific Support - Scientific and policy reports
The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
SectionTopic
1: Forthcoming initiatives 2012Review of REACH
ENV - Environment
  9
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 (TMR) (TA4 Str. Obj. 3, Gen Obj, 3.2)
Deliverable  9.1
Prioritised draft test methods as input to Adaptation(s) to Technical Progress (ATP) of the TMR
31/12/2012
JRC Scientific Support - Validated methods, Reference methods and measurements
The single market
TypeYearNumberTitle
REG 2008440 Test Method Regulation
ENV - Environment
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
ECHA - European Chemicals Agency (ECHA)
Deliverable  9.2
Standard Project Submission Forms (SPSFs) and OECD test guidelines on alternative methods issuing from the ECVAM validation process - implemented by Action 15015 In-Vitro Methods
31/12/2012
JRC Scientific Support - Validated methods, Reference methods and measurements
The single market
TypeYearNumberTitle
REG 2008440 Test Method Regulation
ENV - Environment
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
OECD - Organisation for Economic Co-operation and Development (OECD)
  10
To participate in and chair where requested OECD committees and working parties in relation to manufactured nanomaterials and the test guidelines programmes (TA4 Str. Obj. 3, Gen Obj, 3.2)
Deliverable  10.1
Policy support documents for the OECD WPMN and the OECD (WNT)
31/12/2012
JRC contributions to policy documents
The single market
TypeYearNumberTitle
REG 20061907 Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Reg. 1907/2006
REG 2008440 Test Method Regulation
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
SectionTopic
1: Forthcoming initiatives 2012Review of REACH
ENV - Environment
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
OECD - Organisation for Economic Co-operation and Development (OECD)
  11
To maintain and further develop the JRC repository of nanomaterials for testing, i.e. adding additional nanomaterials to the repository (TA4 Str. Obj. 3, Gen Obj. 3.5)
Deliverable  11.1
Repository, with updated information sheets on the characteristics of the JRC nanomaterials (NM series)
31/12/2012
JRC Scientific Support - Reference materials
The single market
ENV - Environment
RTD - Research
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
OECD - Organisation for Economic Co-operation and Development (OECD)
Deliverable  11.2
Samples supplied to strategic partners (e.g. OECD, FP-7 projects) and research community
31/12/2012
JRC Scientific Support - Scientific and policy reports
The single market
RTD - Research
  12
To maintain and promote the NANOhub database as the central tool for the collection and exchange of nanomaterial information and data within the regulatory and research communities and to develop web portal on nanomaterials and their use in close collaboration with Commission services and ECHA (TA4 Str. Obj. 3, Gen Obj. 3.5)
Deliverable  12.1
Updated NANOHub including system for user management and strategy for further development.
31/12/2012
JRC Scientific Support - Scientific information systems and databases
The single market
TypeYearNumberTitle
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
RTD - Research
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
ECHA - European Chemicals Agency (ECHA)
OECD - Organisation for Economic Co-operation and Development (OECD)
Deliverable  12.2
Draft structure of European web portal on nanomaterials and their use
31/12/2012
JRC Scientific Support - Scientific information systems and databases
The single market
TypeYearNumberTitle
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
ENTR - Enterprise and Industry
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
Deliverable  12.3
Proposal for OECD Harmonised Templates (OHTs) for nanospecific physico-chemical endpoints
31/12/2012
JRC Scientific Support - Scientific information systems and databases
The single market
TypeYearNumberTitle
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
ENTR - Enterprise and Industry
ENV - Environment
Chem Cos Pharm Food Agri EU - Competent Authorities of EU Member States Chemicals, Cosmetics, Pharmaceuticals, Food, and Agrochemicals Industry
ECHA - European Chemicals Agency (ECHA)
OECD - Organisation for Economic Co-operation and Development (OECD)
  13
To apply the IHCP cyclotron (large facility) for research into the production of radioisotopes for medical diagnostics/therapeutics in support of EU research groups (TA4 Str. Obj. 4, Gen Obj. 4.3)
Deliverable  13.1
Novel radioisotope production methods and activated materials
31/12/2012
Scientific Publications
Security and citizenship
JRC KB - JRC Knowledge Base
  14
To support the Commission's Enlargement & Integration programme by organising two workshops on scientific and regulatory challenges of nanomaterials/technology
Deliverable  14.1
Three-days workshop on the application of NanoBiotechnologies
30/11/2012
JRC Scientific Support - Training
JRC KB - JRC Knowledge Base
CC EU - Candidate Countries EU
Deliverable  14.2
Workshop on addressing the safety issues and regulatory challenges of nanomaterials
30/06/2012
JRC Scientific Support - Training
The single market
TypeYearNumberTitle
SEC 20082036 REGULATORY ASPECTS OF NANOMATERIALS
ENTR - Enterprise and Industry
ENV - Environment
SANCO - Health and Consumers
CC EU - Candidate Countries EU
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