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Grant Analysis

Purpose & Target

This grant, 'Advancing knowledge on the impacts of micro- and nanoplastics on human health,' aims to deepen our understanding of how micro- and nanoplastics (MNPs) affect human health. The core objective is to support research that provides robust scientific evidence to inform environmental and health policies, prevent adverse health impacts, and protect citizens' well-being from MNP exposure. This is a SECTOR-SPECIFIC grant primarily targeting the healthcare and environment research sectors. Target Recipients This funding opportunity is designed for research organizations, universities, public bodies, and potentially industry players (SMEs, enterprises) engaged in health and environmental research. It emphasizes collaborative efforts, requiring applicants to form a consortium. Geographic Scope The grant is open to entities established in EU Member States, Associated Countries (under Horizon Europe rules), and explicitly, the United States of America. Key Filtering Criteria To be a good fit, your project should: * Focus directly on the human health impacts of micro- and nanoplastics. * Propose Research and Innovation Actions (RIA), meaning a strong research component. * Be prepared to apply as part of a consortium. * Understand and comply with the two-stage application process and the blind evaluation pilot for the first stage. Grant Program Context This topic is part of the Horizon Europe, Health Cluster (Cluster 1) for 2025, specifically under the destination 'Living and working in a health-promoting environment'. While this specific topic is for the 2025 Work Programme, Horizon Europe is a multi-annual framework, suggesting that similar environmental health topics may recur in future years.

Financial Structure

Total Budget and Individual Grant Amounts

The total available budget for this specific topic is EUR 40,000,000 for 2025.
Individual projects are expected to receive between EUR 7,000,000 (minimum) and EUR 8,000,000 (maximum) in Union funding.

Funding Mechanism: Lump Sum This grant uses a lump sum contribution funding model. This means: * Payments are based on the proper implementation and completion of defined work packages, as outlined in your grant agreement's Annex 1. Payments are not dependent on the actual costs incurred. * Your proposal must detail the estimated costs per work package and per beneficiary, which will then form the basis for the fixed lump sum amount. * There is generally no obligation to report actual costs or undergo financial ex-post audits focused on costs. Checks will primarily focus on the technical implementation of the project and fulfillment of work package conditions. Eligible Costs for Lump Sum Calculation When proposing your lump sum amount, you can include costs that would typically be eligible under an actual costs grant. These may cover: * Personnel costs: Employees, natural persons under direct contract, seconded persons, SME owners, natural person beneficiaries. * Subcontracting costs. * Purchase costs: Travel and subsistence, equipment (depreciation or full capitalised costs, depending on call conditions), other goods, works, and services. * Other cost categories: Financial support to third parties (if applicable), internally invoiced goods and services, transnational/virtual access to research infrastructure (if applicable), PCP/PPI procurement costs (if applicable). Indirect Costs Indirect costs are calculated by applying a 25% flat rate to the direct cost categories that qualify, and this is included in the lump sum calculation. Co-financing The methodology for lump sums complies with co-financing principles. If the EU contribution partially covers the total project costs, the relevant Horizon Europe reimbursement rates will be factored into the lump sum calculation to ensure adherence to this principle. Payment Schedule

Lump sum contributions for completed work packages are paid to the coordinator after each reporting period, assuming conditions are met.
If conditions for a work package are not met in a reporting period, payment is deferred but can be made in a subsequent period if conditions are then met.
If work package conditions are never met, that portion of the grant will not be paid, and the overall grant amount may be reduced.

Financial Guarantees

Pre-financing will follow standard Horizon Europe rules.
A contribution of 5% to 8% of the total lump sum is retained for the Mutual Insurance Mechanism.

Eligibility Requirements

Eligible Organization Types Any legal entity is eligible to apply for this grant. Specifically, the following can participate: * Universities * Research Organizations * Public Bodies * Companies/Industry (SMEs, enterprises, etc. are implied as possible beneficiaries within the broader 'legal entity' definition and Horizon Europe's general scope) * Legal entities established in the United States of America are explicitly eligible to receive Union funding. * The Joint Research Centre (JRC), European Chemicals Agency (ECHA), or other relevant decentralized EU agencies (e.g., European Environment Agency - EEA) may participate as members of a selected consortium but without direct funding. Consortium Requirements A consortium is required for this grant. All proposals selected for funding will also be required to form a 'cluster' and participate in common networking and joint activities. Geographic Location Requirements Applicants must be established in: * EU Member States (full list not provided, but standard for Horizon Europe) * Associated Countries (as per Horizon Europe general rules) * The United States of America Financial and Operational Capacity Applicants must demonstrate sufficient financial and operational capacity, as described in Annex C of the Work Programme General Annexes (not provided in detail, but a standard requirement for Horizon Europe). Specific Application Rules If submitting a proposal under the blind evaluation pilot (applicable to the first stage), applicants must not disclose their organization names, acronyms, logos, or names of personnel in the proposal abstract and Part B of their first-stage application. This ensures impartiality in the initial review.

Application Process

Application Process: Two-Stage Submission This grant utilizes a two-stage submission process. You'll first submit a shorter proposal, and if successful, you'll be invited to submit a more detailed full proposal. Application Deadlines

First Stage Deadline: September 16, 2025, 00:00:00 UTC+00:00
Second Stage Deadline: April 16, 2026, 00:00:00 UTC+00:00

Submission Format and Platform Applications must be submitted electronically through the Electronic Submission Service available on the Funding & Tenders Portal. Required Documentation

First Stage: Use the 'Standard application form (HE RIA IA Stage 1)' template, available in the Submission System.
Second Stage: Use the 'Standard application form (HE RIA, IA)' template. Additionally, if your proposal includes clinical studies (a broad definition, so review carefully), you must provide details in a dedicated annex using the template provided in the submission system.

Project Implementation and Collaboration

Clustering Requirement: All projects selected for funding under this topic will automatically form a cluster. This means you'll be required to participate in common networking and joint activities with other funded projects.
Joint Activities: These activities are part of a dedicated work package within your project and must have sufficient budget allocated (approximately 2% of your total requested budget). They may include:
- Regular joint meetings (e.g., kick-off, annual meetings).
- Periodic reports on joint activities.
- Common dissemination and communication activities (strategy, web portal, brochures, newsletters).
- Common Data Management Strategy and Policy Strategy (including joint policy briefs).
- Thematic workshops/trainings.
- Working groups on common interests (data management, communication, science-policy link, scientific synergies).

Application Assistance and Resources The following resources are available to support applicants: * Online Manual: Provides guidance on procedures from submission to grant management. * Horizon Europe Programme Guide: Detailed guidance on the structure, budget, and political priorities of Horizon Europe. * Funding & Tenders Portal FAQ: Answers to frequently asked questions on submission, evaluation, and grant management. * Research Enquiry Service: For general questions about European research and EU Research Framework Programmes. * National Contact Points (NCPs): Guidance and assistance on participating in Horizon Europe, available in EU, Associated, and many non-EU/non-associated countries. * Enterprise Europe Network (EEN): Business advice with a focus on SMEs, including EU research funding guidance. * IT Helpdesk: For technical issues with the Funding & Tenders Portal (e.g., login, access rights, submission technicalities). * European IPR Helpdesk: Assistance on intellectual property issues. * Standardization Organizations: CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk for advice on standardization in proposals. * European Charter for Researchers and Code of Conduct: General principles for researchers, employers, and funders. * Partner Search: A tool to help find partner organizations for your consortium.

Evaluation Criteria

The grant evaluation follows a two-stage process, with specific criteria and thresholds for each stage: First Stage (Blind Evaluation Pilot) This stage operates under a 'blind evaluation pilot' for impartiality. * Criteria: Proposals are evaluated based on 'Excellence' and 'Impact'. * Thresholds: * 'Excellence': 4 * 'Impact': 4 * Overall Threshold: The cumulative score for 'Excellence' and 'Impact' must meet a level that ensures the total requested budget of proposals invited to Stage 2 is between 3.5 to 4 times the available budget. This indicates a highly competitive environment where only the strongest proposals will proceed. Second Stage

Criteria: Proposals are evaluated based on 'Excellence', 'Impact', and 'Implementation'.
Thresholds:
- 'Excellence': 4
- 'Impact': 4
- 'Implementation': 4
Cumulative Threshold: The total cumulative score across all three criteria must be 12.

Expert Assessment Focus External independent experts will assess the quality of proposals across these criteria, focusing on: * Excellence: The scientific and technical quality, novelty, and soundness of the research approach. * Impact: The potential societal, economic, and environmental benefits, and how well the project contributes to the expected outcomes, especially in supporting policies and reducing MNP impacts on health. * Implementation: The quality and efficiency of the proposed work plan, resource allocation, and management structure. Key Research Aspects for Evaluation Proposals are expected to include several of the following activities, which will likely weigh heavily in the evaluation: * Comparability and Standardization: Improving and standardizing analytical methods and protocols for MNP collection, detection, and quantification in humans and the environment. * Causal Mechanisms: Studying the molecular, cellular, and organism-level effects and pathways of MNP exposure. * Toxicity Drivers: Improving understanding of MNP toxicity and adverse health effects, using realistic samples and considering varying properties (size, shape, concentration, chemical composition). * Reference Materials: Developing suitable and environmentally relevant reference materials. * Models and Methods: Developing better in-vivo, in-silico, and in-vitro models, instruments, and methods for harmonized risk and hazard assessment, including long-term exposure and observational human studies. * Human Biomonitoring: Strengthening knowledge on human exposure through biomonitoring studies and specific biomarkers. * Long-term Impacts: Generating robust evidence on long-term health impacts, MNP fate, and systemic effects. * Occupational Exposure: Providing evidence on MNP exposure at work, identifying high-concentration environments, and improving assessment/mitigation approaches. * Exposure Routes and Mitigation: Increasing understanding of environmental exposure routes and proposing mitigation measures, including health impacts of alternative materials. * Interactions: Gaining insights into MNP interactions with other pollutants/biological agents and their combined health impacts. * Delivery and Elimination: Better understanding of MNP delivery mechanisms and elimination processes in the human body, including the role of the microbiome. Cross-Cutting Themes and Considerations

Social Sciences and Humanities (SSH): Effective contribution of SSH disciplines and experts is required to enhance societal impact.
Gender and Sex Differences: These should be addressed where appropriate in the research.
FAIR Data Principles: Adherence to FAIR (Findable, Accessible, Interoperable, Reusable) data principles, data standards, and good data sharing practices is crucial.
Non-Animal Methods: Applicants are encouraged to use experimental methods not involving live animals if relevant and providing comparable data validity.

Compliance & Special Requirements

Regulatory and Policy Compliance

Projects must comply with all regulatory requirements of the Horizon Europe Work Programme General Annexes, including:
- Admissibility Conditions (Annex A and E).
- Eligible Countries (Annex B).
- Financial and Operational Capacity and Exclusion criteria (Annex C).
- Evaluation and Award processes (Annex D and F).
- Legal and Financial Set-up of the grants (Annex G).
Proposals should align with relevant policy developments and support policy gaps/needs, contributing to EU’s environment and health policies like the European Green Deal, Chemical Strategy for Sustainability, Zero Pollution Action Plan, and the EU Strategic Framework on Health and Safety at Work.

Data Management and Sharing

Adherence to FAIR (Findable, Accessible, Interoperable, Reusable) data principles is mandatory.
Applicants should adopt relevant data standards and data sharing/access good practices.
Chemical monitoring and human biomonitoring data generated by the project must be shared in the Information Platform for Chemical Monitoring (IPCHEM) and/or the future Common Data Platform for Chemicals (via involvement with the European Commission's Joint Research Centre - JRC, European Chemicals Agency - ECHA, or European Environment Agency - EEA).

Intellectual Property (IP) Policies While not detailed in the provided information, the grant explicitly states that checks will cover 'management of intellectual property', indicating that standard Horizon Europe IP rules will apply. Technology Specifications

If your project uses satellite-based earth observation, positioning, navigation, and/or related timing data/services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data/services may be used additionally).

Risk Management and Security

Checks will focus on the technical implementation of the action, ensuring work package conditions are met. This includes verifying ethics and research integrity compliance.

Unique Aspects and Strategic Opportunities

Blind Evaluation Pilot: The first stage of evaluation is conducted blindly, meaning organizational identifying information is removed to ensure impartiality.
Lump Sum Funding Model: The financial setup simplifies administration by basing payments on the completion of work packages rather than detailed cost reporting. This shifts focus to technical outputs.
Clustering Requirement: Successful proposals will form a cluster, fostering mandatory joint activities, networking, knowledge exchange, and common dissemination efforts, thereby maximizing synergies and impact.
Social Sciences and Humanities (SSH) Integration: Effective contribution of SSH disciplines and involvement of SSH experts are crucial to ensure meaningful societal impact.
Gender and Sex-Related Differences: These aspects should be explicitly addressed in the research where appropriate.
Non-Animal Experimental Methods: Applicants are encouraged to prioritize experimental methods that do not use live animals, provided they yield comparable data validity.
Collaboration with EU Agencies: Opportunities for collaboration with the JRC, ECHA, or EEA exist, particularly regarding regulatory interface, harmonized test methods, and data sharing. Such collaborations would be established after a proposal's approval.
Clinical Studies: Projects expected to include clinical studies (broadly defined) require specific annexes at the second stage of application.

Environmental and Ethical Standards

Projects must adhere to ethical standards, and 'ethics and research integrity' are areas subject to checks.
The broader goal is to support 'the green transition' and address environmental health risks, reflecting strong environmental considerations throughout the grant's scope.

Grant Details