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LC-GD-8-2-2020
LC-GD-8-2-2020: Fostering regulatory science to address combined exposures to industrial chemicals and pharmaceuticals: from science to evidence-based policies
Specific Challenge:Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment[1].
Sólo fondo perdido 0 €
Europeo
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Specific Challenge:Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment[1].

Humans, wildlife and domestic animals are exposed to combinations of different chemicals via air, water (including the marine environment), food and feed, consumer products, materials and goods. The scientific understanding of combination effects has progressed in recent years and approaches for risk assessment and management of unintentional mixtures and combined exposures to chemicals are available.

In parallel with the development and implementation of regulatory approaches, there is a need to improve the scientific knowledge base. Current knowledge shows that exposures to combinations of chemicals pose risks to ecosystems and human health that may not be sufficiently managed under existing regulations. There is a need to advance regulatory science to provide policy-makers and risk assessors wi... ver más

Specific Challenge:Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment[1].

Humans, wildlife and domestic animals are exposed to combinations of different chemicals via air, water (including the marine environment), food and feed, consumer products, materials and goods. The scientific understanding of combination effects has progressed in recent years and approaches for risk assessment and management of unintentional mixtures and combined exposures to chemicals are available.

In parallel with the development and implementation of regulatory approaches, there is a need to improve the scientific knowledge base. Current knowledge shows that exposures to combinations of chemicals pose risks to ecosystems and human health that may not be sufficiently managed under existing regulations. There is a need to advance regulatory science to provide policy-makers and risk assessors with validated and practically applicable approaches, methods and tools and to study the effectiveness and efficiency of different policy approaches. The effects of exposure of humans and the environment to combinations of chemicals should also be further explored.


Scope:This topic calls for applied research studies, demonstrating how new tools and methodological approaches from regulatory science that are workable in a regulatory context and are based on the latest scientific evidence, can be applied to identify, quantify and prevent harmful co-exposures to industrial[2] chemicals and pharmaceuticals.

The applicants can address some or all of the following:

Development of innovative tools and analytical methods to detect and measure complex mixtures in the various environmental compartments[3];Comparisons of different possible regulatory approaches to manage unintentional chemical mixtures and co-exposures, regarding effectiveness (improved protection of health and the environment), workability, cost-effectiveness and benefits to society and business;Estimations of the degree to which current and possible future regulatory practices/approaches underestimate (or possibly occasionally overestimate) risks related to chemicals exposure (based on particular case studies, modelling and overall estimations);Develop and apply modelling, statistical approaches and other relevant methods to identify and study the health impacts on human populations and the environment of exposures to combinations of different chemicals, e.g. through linking results from exposure monitoring with observed health effects;Scientific case studies to identify safety margins for specific unintentional exposures to combination of chemicals to protect human and ecosystems health, while taking into account chronic exposures over longer time scales; The possible effects on humans, in particular on vulnerable sub-populations, from combined (chronic) exposure to low levels of pharmaceuticals via the environment, taking account the inherent pharmacological properties and the potential for combined effects from co-exposures with other chemicals; Combining and analysing EU data sources to generate insights on real-life and potential exposure combinations, typical exposure routes and uses;Development, improvement and validation of models for predicting (chronic) exposure to combinations of chemicals, which can be applied in a premarket stage (risk assessment, risk management measures, including, e.g. authorisation and restriction of chemicals) and possibly already at the design phase of chemicals and materials as well as retrospectively (e.g. in the setting of environmental quality objectives).
Expected Impact:Scientific evidence to enable prevention and/or mitigation of co-exposure to pharmaceuticals and industrial1 chemicals in the environment and the technosphere. Support the implementation of existing risk assessment and risk management approaches to reduce the most critical exposures, including the setting of limit values for exposures taking into account co-exposures..Support the assessment of new regulatory approaches such as, e.g. Mixture Assessment FactorsSupport activities on combined exposures as relevant for the Strategic Approach to Pharmaceuticals in the Environment2 and as to be defined in the forthcoming Chemical Strategy for Sustainability[4] Selected projects under this topic are strongly encouraged to continuously share information and participate to joint activities to optimise synergies to address policy-relevant knowledge gaps.

The Commission considers that proposals requesting a contribution from the EU of between EUR 4 to 6 million would allow the specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.


Cross-cutting Priorities:Open ScienceGender


[1]Commission Communication on the EU strategic approach to pharmaceuticals in the environment COM(2019) 128 final.

[2]In this context the term ‘industrial chemicals is used to identify chemicals of anthropogenic origin, e.g. including pesticides, biocides, cosmetics etc.

[3]Chemical exposure data resulting from the projects data shall be shared via Information Platform for Chemical Monitoring IPCHEM (https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html). Procedures and the network of reference laboratories established by HBM4EU (https://www.hbm4eu.eu) should be used.

[4]https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12264-Chemicals-strategy-for-sustainability-

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Temáticas Obligatorias del proyecto: Temática principal:

Características del consorcio

Ámbito Europeo : La ayuda es de ámbito europeo, puede aplicar a esta linea cualquier empresa que forme parte de la Comunidad Europea.
Tipo y tamaño de organizaciones: El diseño de consorcio necesario para la tramitación de esta ayuda necesita de:

Características del Proyecto

Requisitos de diseño: Duración:
Requisitos técnicos: Specific Challenge:Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment[1]. Specific Challenge:Under ‘Towards a zero-pollution ambition for a toxic free environment’, the European Green Deal will propose a new Chemicals Strategy for Sustainability, aiming at better protection of both humans and the environment against hazardous chemicals. In addition, there is growing concern about the occurrence of pharmaceuticals in the environment[1].
¿Quieres ejemplos? Puedes consultar aquí los últimos proyectos conocidos financiados por esta línea, sus tecnologías, sus presupuestos y sus compañías.
Capítulos financiables: Los capítulos de gastos financiables para esta línea son:
Personnel costs.
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
Purchase costs.
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
Subcontracting costs.
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
Amortizaciones.
Activos.
Otros Gastos.
Madurez tecnológica: La tramitación de esta ayuda requiere de un nivel tecnológico mínimo en el proyecto de TRL 5:. Los elementos básicos de la innovación son integrados de manera que la configuración final es similar a su aplicación final, es decir que está listo para ser usado en la simulación de un entorno real. Se mejoran los modelos tanto técnicos como económicos del diseño inicial, se ha identificado adicionalmente aspectos de seguridad, limitaciones ambiéntales y/o regulatorios entre otros. + info.
TRL esperado:

Características de la financiación

Intensidad de la ayuda: Sólo fondo perdido + info
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1. Eligible countries: described in Annex A of the Work Programme.
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.
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.
Information on the outcome of evaluation (two-stage call):
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.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
Research and Innovation Action:
Specific provisions an...
1. Eligible countries: described in Annex A of the Work Programme.
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.
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.
Information on the outcome of evaluation (two-stage call):
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.
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
6. Additional provisions:
Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply
All chemical monitoring data resulting from the projects must be shared via Information Platform for Chemical Monitoring IPCHEM (https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html). For human biomonitoring activities procedures and the network of reference laboratories established by HBM4EU (https://www.hbm4eu.eu) should be used when relevant and possible.
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
Grants awarded under these topics will be subject to the following additional dissemination obligations:
The European Commission intends to establish network activities for the funded projects in the areas of the European Green Deal Call (see ‘other actions’). Supported projects are requested to contribute to the networking and experience sharing activities.
Applicants must acknowledge and integrate these obligations in their proposal. The respective option of Article 29.1 of the Model Grant Agreement will be applied.
Applicants are reminded that the purchase or lease of land with the purpose of later buying does not constitute eligible costs for the project. Cost for renting of land (for example for provision of a particular ecosystem service to the public benefit) can be eligible during the project’s duration provided they fulfil the eligibility conditions of Article 6.1(a) MGA and the specific eligibility conditions of Article 10.
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.
 
8. Additional documents:
1. Introduction WP 2018-20
12. Climate action, environment, resource efficiency and raw materials WP 2018-20
20. Cross-cutting activities 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
Garantías:
No exige Garantías
No existen condiciones financieras para el beneficiario.

Información adicional de la convocatoria

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