Significant progresses have been made in assessing nanomaterial hazard. Yet, knowledge gaps remain on long-term effects (low doses, chronic exposure), both for human health and the environment. Questions also arise on the adequacy of the models used in existing in-vitro and in-silico testing and on the relevance of the exposure conditions (e.g. linked to the current understanding of the nanomaterial-biomolecule-cell interface) to correctly assess and predict real-life hazards. It is also necessary to prepare the ground for the next challenge, defining hazard profiles based on in-silico testing alone.

Scope:

With a view to intelligent testing strategies (ITS) for nanomaterials, it is of high priority to develop and adopt realistic and advanced in vitro tests which have the potential to substantially improve the relevance of in-vitro approaches. Current in-vitro experiments mostly rely on established immortalized single cell lines, which often do not reflect the in-vivo situation. Therefore, new or advanced models, such as co-culture models, 3D cultures or primary cell models should be developed for relevant endpoints lacking, or having inadequate, in-vitro models. Transport through biological barriers could also be addressed, for instance with the objective of assessing the true internal dose of the materials to which living organisms are being exposed, as well as disease models or models with impaired barriers.

Low-level chronic exposure is a likely scenario as many ENMs will probably exist at very low concentrations in the environment and potentially be persistent. Thus, assays and models with low chronic exposure, elucidating toxicokinetics, different mechanisms of action and adverse outcome pathways, as well as specific disease models, should be developed and assessed against appropriate animal studies and could include for instance effects on kinetics, growth, reproduction, metabolism, and behaviour. Research could also focus on long-term, ecologically relevant, effects in realistic environmental concentrations of ENMs.

The transformations in biological or environmental matrices have been demonstrated as having potentially significant effect on the ENM tests results. Therefore, dosing with realistic exposure levels and conditions should be an integral part of the developments, taking into consideration the dynamic and complex nature of environmentally induced transformations with realistic external and internal forms and levels of exposure.

For validation purposes and to ensure that the experimental results can form a solid and meaningful basis for grouping, read-across, and modelling purposes, the testing should be performed on sets of well-defined and characterised libraries of nanomaterials and, when possible, on nanomaterials for which high-quality in-vivo data are already existing (to minimize animal testing).

Activities are expected to focus on Technology Readiness Levels 4 to 6.

This topic is part of the open data pilot.

This topic is particularly suitable for international cooperation.

The Commission considers that proposals requesting a contribution from the EU between EUR 10 and 13 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

No more than one action will be funded.

Expected Impact:

• The research approach should be innovative and represent a significant advance beyond the current state-of-the-art. Research should focus on provision of solutions to the long-term challenge of nanosafety and nanoregulation;
• New models and assays for use in in-vitro and in-silico testing improving prediction of chronic effects in a broad array of representative organisms and changes in ecosystem function;
• Improved predictive power of in-vitro and in-silico approaches for in vivo systems to support acceptance in a regulatory framework;
• Developed test guidelines for further standardisation, and ring testing (including guidance on design of the ring testing).

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.
 

LIST OF COUNTRIES and APPLICABLE RULES FOR FUNDING
described in part A of the General Annexes of the General Work Programme.

Note also that a number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects (follow the links to Australia, Brazil, Canada, China, Hong Kong &Macau, India, Japan, Republic of Korea, Mexico, Russia, Taiwan).
 

ELIGIBILITY and ADMISSIBILITY CONDITIONS
described in part B and C of the General Annexes of the General Work Programme.

Proposal page limits and layout: Please refer to Part B of the standard proposal template.

 

EVALUATION

3.1  Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme , with the following exceptions:

For single-stage and second-stage evaluations, the threshold for the criteria Excellence and Impact will be 4.
The overall threshold, applying to the sum of the three individual scores, will be 12.

In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except that proposals will be ranked on the basis of individual scores for the Impact criterion before the Excellence criterion.

In case of equal overall scores in the ranked list, the priority order of proposals will be established in accordance with part H of the General Annexes, except, when comparing ex aequo proposals of different topics, the proposals will be ranked first according to the position in the topic ranked lists

3.2 Submission and evaluation process: Guide to the submission and evaluation process
    

INDICATIVE TIMETABLE for EVALUATION and GRANT AGREEMENT

Information on the outcome of two-stage evaluation:
      For stage 1: maximum 3 months from the deadline for submission.
      For stage 2: maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

 

PROVISIONS, PROPOSAL TEMPLATES and EVALUATION FORMS
for the type of action under this topic

Research and Innovation Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
H2020 General MGA -Multi-Beneficiary
Annotated Grant Agreement
 

ADDITIONAL PROVISIONS

• Horizon 2020 budget flexibility
• Classified information
• Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
• Financial support to Third Parties – where a topic description foresees financial support to Third Parties, these provisions apply.

OPEN ACCESS
must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. 

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
 

ADDITIONAL DOCUMENTS

• Legal basis: Horizon 2020 - Regulation of Establishment
• Legal basis: Horizon 2020 Rules for Participation
• Legal basis: Horizon 2020 Specific Programme
• H2020 Work Programme 2016-17: Introduction
• H2020 Work Programme 2016-17: Introduction to Leadership in enabling and industrial technologies (LEITs)
• H2020 Work Programme 2016-17: Nanotechnologies, advanced materials, advanced manufacturing and processing, biotechnology
• H2020 Work Programme 2016-17: Cross-cutting activities (Focus Areas)
• H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation
• H2020 Work Programme 2016-17: General Annexes

The deadline for the second stage is 4 May 2017.