Timing, hosts and locations of (grouped) events of NanoImpactNet

NanoSafetyCluster - Compendium 2012
2 Background
The volume of information on hazard characterisation of ENM is
increasing fast. In parallel with the scientific development in
toxicology and eco-toxicology, regulation orientated initiatives are
also taking place at the international as well as European and
nation state levels. The main initiatives are the OECD Sponsorship
Programme for the testing of Nanomaterials, the ISO classification
of nanomaterials, and the REACH guidance on regulatory safety
testing for chemicals, which is to be updated for ENM. Together,
all these sources of information form the state-of-the-art
landscape of the safety testing of ENM. The ITS-NANO concept is
to gather scientific evidence and assemble representative
stakeholders for the consent on a research strategy for rational
grouping of ENM and a risk assessment approach for ENM.
Moreover, the framework for future research aiming at grouping
ENM according to (i) their physico-characteristics and (ii) specific
endpoints will be based on the nanosafety landscape above and
specifically on the knowledge gaps that need to be bridged in
order for such rational grouping to be made. However, as
expected, there will be a considerable knowledge gap. Therefore it
is essential to narrow this gap. Of course, with all the time and
funding available, this could be eventually be achieved. However,
time is critical and funding is restricted, so a rationale is needed for
future research. This rationale will reflect the need for different
types of evidence by industry, regulators (e.g. OECD WPMN,
REACH) and scientists to prioritise the process for information
generation (i.e. (eco)-toxicology tests) accordingly. This is why it is
an ‘Intelligent Testing Strategy’. Our approach is also ‘intelligent’ at
the testing level because we will identify:
− a battery of in vitro (eco)-toxicology tests with predictive
power
− in vivo tests only where it is essential (in respect of the 3R
principle).
− A risk assessment strategy is only effective if the key
stakeholders (e.g. food industry, nano-material
manufacturers, pharma- and health-related industry)
approve and adopt it. This will be achieved by
integrating, engaging them in the very shaping and
development of the strategy.
3 What is ITS-NANO
The ITS-NANO consortium consists of 11 partners from 4 European
Countries (Italy, United Kingdom, Denmark and Germany) and the
Joint Research Centre of the European Commission; it includes
industries, renowned universities, research centres of excellence,
and a consultancy firm to provide a management structure in line
with the needs of the European Commission.
The ITS-NANO consortium consists of experts in nanotechnology,
nanotoxicology, nanoecotoxicology, and risk assessment, from
academia and industries with considerable experiences in
collaborative research in FP6 and 7 NMP programme. Some of the
collaborators are also members of the OECD Working Party on
Manufactured Nanomaterials (WPMN), ISO-TC229, and are
contributors to the review and extension of REACH for
nanomaterials as well as other National initiatives. Project partners
has a direct access to state-of-the-art knowledge, being involved in
several initiatives already ongoing and about to start, including the
two large NMP research projects MARINA and NanoValid. Finally,
sustainable industrial implementation themes are also
represented, due to the presence of industry, technology transfer
experts but also occupational health research institutes.
ITS-NANO will receive further inputs from the integration of the
most relevant stakeholders, regulatory bodies, policy makers, and
industries, being the latter both the most significant actors of
nanotechnology R&D at the moment, but also the end-users.
Integrating such competences in the project, and also networking
and interacting with the wide scientific community represented by
the NanoSafetyCluster and by selected experts in the United
States, will provide the consortium with a clear understanding of
which are the priorities to be addressed in the future, according
both to stakeholders’ needs, but also identifying the direction in
which nanotechnology development and transfer is moving
towards.
ITS-NANO first objective is to create a scientific basis for ensuring
the safe and responsible development of manufactured
nanoparticles and nanotechnology-based materials and products,
and to support the determination of regulatory measures and
implementation of legislation in Europe. Current (eco)toxicological
approaches to assessing nano-material hazard are
based either on classical toxicology approaches or on novel
multiplexed assays. These approaches do not provide a
comprehensive assessment due to the many unique aspects of
nanomaterials, such as the transport mechanisms (in the body and
within cells) and, in particular, the relationship between the
physico-chemical properties of the nanoparticles with:
1. the biological identity in situ (i.e. in various culture
media);
2. the fate and behaviour (uptake, translocation,
localisation);
3. the functional impacts at system and cellular level
Thus, new (eco)-toxicology approaches, which consider and
exploit these unique aspects of engineered nanoparticles, are
urgently needed. Specifically, an Intelligent Testing Strategy for
Engineered Nano-Materials is required. This strategy is ‘intelligent’
both at the strategic level by identifying and setting a priority
research agenda to reduce the research gaps according to the
need of the stakeholders (industry, regulators) and at the tactical
level, to be economical and ethical. This is the aim of the ITS-NANO
proposal.
Specifically, our objectives are to develop:
• A framework for future research aiming at rational
grouping, through well standardized methods, of
engineered nanomaterials (ENM) according to their i)
physical, ii) chemical, iii) biological characteristics.
• A framework for future research aiming at specific
grouping of ENM according to the specific health risk
they present towards the immunological, respiratory,
reproductive, circulatory, etc... systems.
• A strategy to increase the integration among
stakeholders (food industry, nano-material
manufacturers, pharma- and health-related industry) for
a shared, agreed-upon risk assessment strategy and
60 Compendium of Projects in the European NanoSafety Cluster