HORIZON EUROPE
Europeo
Specific Challenge:There are a variety of natural and anthropogenic chemicals that can produce adverse effects via a disruption of the body's endocrine (hormone) system, referred to as endocrine disruptors (EDs)[1]. EDs are of increasing importance in chemical regulations in the European Union, and criteria to identify EDs have recently been presented for two pieces of EU legislation (Biocidal Product Regulation and Plant Protection Products Regulation)[2].
In the EU, the legislation regulating chemical substances often includes their screening and testing according to the EU test methods regulation[3], which predominantly contains test methods developed under the OECD[4]. The current testing tools, including regulatory in vivo tests and novel in vitro assays, do not appropriately identify effects related to certain less studied endocrine-mediated pathways or health outcomes, in which EDs may be implicated. Moreover, the new ED criteria require information about both the adverse effects and the endocrine mode of action.
Scope:New and improved approaches are needed to increase the quality, the efficiency and the effectiveness of existing methods...
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Specific Challenge:There are a variety of natural and anthropogenic chemicals that can produce adverse effects via a disruption of the body's endocrine (hormone) system, referred to as endocrine disruptors (EDs)[1]. EDs are of increasing importance in chemical regulations in the European Union, and criteria to identify EDs have recently been presented for two pieces of EU legislation (Biocidal Product Regulation and Plant Protection Products Regulation)[2].
In the EU, the legislation regulating chemical substances often includes their screening and testing according to the EU test methods regulation[3], which predominantly contains test methods developed under the OECD[4]. The current testing tools, including regulatory in vivo tests and novel in vitro assays, do not appropriately identify effects related to certain less studied endocrine-mediated pathways or health outcomes, in which EDs may be implicated. Moreover, the new ED criteria require information about both the adverse effects and the endocrine mode of action.
Scope:New and improved approaches are needed to increase the quality, the efficiency and the effectiveness of existing methods to meet demanding and evolving regulatory requirements worldwide. In consultation with relevant regulatory bodies, research should improve and harmonise screening and testing protocols/strategies and hazard/risk assessments by developing better and faster tools, test methods or models, including in vitro and in vivo tests, high-throughput and in silico methods (e.g. QSAR), potentially combined with research on adverse outcomes pathways. For in vitro tests, appropriate coupling of their results to human health effects should be ensured. Information is also needed as regards how epidemiological and field monitoring data, which are also to be considered as data sources in a regulatory context, can be used to gain information about possible associations between levels of exposure to specific chemicals and ED-related effects. Focus should be on the most urgent regulatory needs, e.g., methods addressing the thyroid axis, developmental neurotoxicity, metabolic disorders, female reproduction and non-genotoxic carcinogenicity. Proposals should involve, in addition to academic researchers, regulatory agencies and other actors as appropriate. Proposers should consider sex and gender analysis when relevant. International cooperation is essential. Proposals are required to describe how they will contribute to ongoing international ED related activities (e.g. OECD work, EU level databases), including decision schemes under development. To speed up regulatory uptake of tests, validation is an essential step to be included in the proposals.
The Commission considers that a proposal requesting an EU contribution between EUR 4 to 6 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.
Collaboration between successful proposals will be encouraged.
Proposals could consider the involvement of the European Commission Joint Research Centre (JRC) as an added value in order to provide an effective interface between the research activities and regulatory aspects and/or to translate the research results into validated test methods and strategies fit for regulatory purpose. In that respect, the JRC will collaborate with any successful proposal.
Expected Impact: Improved hazard and risk assessment of EDs, including in the workplace. Novel ED assay candidates for regulatory use. Support for the OECD work on testing and assessing chemicals for ED identification. Enhanced international cooperation. Contribution to the development of an international strategy and guidelines for testing EDs and assessing associated hazard and risk.
Cross-cutting Priorities:GenderInternational cooperation
[1]WHO/UNEP-State of the science of endocrine disrupting chemicals – 2012: http://www.who.int/ceh/publications/endocrine/en
[2]Communication from the Commission to the European Parliament and the Council on endocrine disruptors and the draft Commission acts setting out scientific criteria for their determination in the context of the EU legislation on plant protection products and biocidal products: http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm
[3]eurl-ecvam.jrc.ec.europa.eu/alt-animal-testing-safety-assessment-chemicals/test_method_reg
[4] OECD work on endocrine disrupters: http://www.oecd.org/env/ehs/testing/oecdworkrelatedtoendocrinedisrupters.htm
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Características del consorcio
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La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Características del Proyecto
Los costes de personal subvencionables cubren las horas de trabajo efectivo de las personas directamente dedicadas a la ejecución de la acción. Los propietarios de pequeñas y medianas empresas que no perciban salario y otras personas físicas que no perciban salario podrán imputar los costes de personal sobre la base de una escala de costes unitarios
Los otros costes directos se dividen en los siguientes apartados: Viajes, amortizaciones, equipamiento y otros bienes y servicios. Se financia la amortización de equipos, permitiendo incluir la amortización de equipos adquiridos antes del proyecto si se registra durante su ejecución. En el apartado de otros bienes y servicios se incluyen los diferentes bienes y servicios comprados por los beneficiarios a proveedores externos para poder llevar a cabo sus tareas
La subcontratación en ayudas europeas no debe tratarse del core de actividades de I+D del proyecto. El contratista debe ser seleccionado por el beneficiario de acuerdo con el principio de mejor relación calidad-precio bajo las condiciones de transparencia e igualdad (en ningún caso consistirá en solicitar menos de 3 ofertas). En el caso de entidades públicas, para la subcontratación se deberán de seguir las leyes que rijan en el país al que pertenezca el contratante
Características de la financiación
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. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
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. See the information in the Online Manual.
2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
3. Evaluation:
Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
Submission and evaluation processes are described in the Online Manual.
The thresholds for each criterion in a single stage process will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement
Essential information for clinical studies
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
8. Additional documents:
Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020
Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme
7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
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.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
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