Innovative methods for safety and sustainability assessments of chemicals and materials (RIA)

Topic description

ExpectedOutcome:

Proposals are expected to contribute to the following outcomes:

• EU strategies/policies and regulations, such as the (proposed) Ecodesign for Sustainable Products Regulation^[1], the EU Ecolabel^[2], REACH^[3] or CLP^[4] can build on new methods and the associated data for chemicals and materials;
• Methods and data will be made available in a format which will allow existing validation networks or bodies (e.g., the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) or the OECD) or other platforms to launch a validation/standardisation process and to promote wider uptake of the new methods developed;
• Industry and public authorities have access to innovative tools for more comprehensive safety and sustainability assessment covering a wider range of chemicals and advanced materials including composites/mixtures and nanomaterials, supporting the implementation of the Safe and Sustainable by Design framework^[5].

The Commission initiative for Safe and Sustainable by Design^[6] (SSbD) sets a framework for assessing the safety and sustainability of chemicals and materials, which should be considered as a reference for project proposals. This topic aims at developing new methods, or improve existing methods, to support the improvement of safety and sustainability assessment.

In the EU, the legislation regulating chemical substances often includes their safety screening and testing according to the EU test methods regulation^[7], which predominantly contains test methods harmonised under the OECD^[8]. For safety assessment, e.g., human and eco-toxicity, there is a lack of validated in vitro and in silico tools for a variety of substances and materials. An advance in alternative methods for safety assessment (e.g., New Approach Methodologies, NAMs) is needed, preferably without animal models, but also to support modelling and design of new Safe and Sustainable by Design chemicals and materials. Research should improve and harmonise screening and testing protocols/strategies and hazard/risk assessments by developing robust, reliable and faster test methods or models, including high-throughput and in silico models.

Sustainability aspects cover the entire life cycle including the design phase, raw material extraction, production, use and end-of-life. Sustainability assessment across the life cycle is in growing demand and there is the need to further develop methods for a robust assessment. The development of absolute sustainability methods^[9] that consider ecosystems carrying capacities are also needed. The integration of life cycle assessment with risk assessment is likewise a challenge. New and improved approaches are needed to increase the quality, the efficiency and the effectiveness of existing methods to drive innovation and to bridge gaps in the data for sustainability and life cycle assessment.

Proposals should consider all the following activities:

• Address a set of at least three chemicals/groups of chemicals/(advanced) materials for which the project consortium will develop new methods and models for safety and sustainability assessment along their life cycle in accordance with the Safe and Sustainable by Design Framework^[6]. Selected materials can be composed of/contain the selected chemicals. The justification for their selection should include socio-economic aspects and a gap analysis with regards to existing methods and models and their relevance to improve the current safety and sustainability assessments;
• Methods and models developed can be either for the already existing chemicals and materials or to be used during the design phase of future chemicals and materials;
• For each method or model developed an ‘in project interlaboratory’ validation should be done, and the method or model shall be shared via the most appropriate open platform, e.g., the Horizon Europe Partnership on the Assessment of Risks from Chemicals (PARC)^[11], to encourage use and feedback from stakeholders. In addition, an initial standardisation or validation dossier should be prepared and submitted to an appropriate body/initiative, e.g., the OECD, EU Reference Laboratory for alternatives to animal testing (EURL ECVAM);
• Data produced during the development process and in particular for inclusion in the validation/standardisation dossier must be FAIR^[12] and shared through available platforms (e.g., the Information Platform for Chemical Monitoring – IPCHEM^[13]). Data for the validation/standardisation dossier shall be produced according to existing guidelines and stored in standardised data formats.

International collaboration on uptake of new methods and/or models shall be enhanced involving relevant players from academia, public authorities and the private sector.

Proposals should indicate to which chapters of the Strategic Research and Innovation Plan for chemicals and materials^[14] they will contribute.

Proposals submitted under this topic should demonstrate synergies with the EU-funded projects resulting from the topic HORIZON-CL4-2023-RESILIENCE-01-22. In addition, collaboration with the European Partnership on Assessments of Risks from Chemicals (PARC)^[11] is encouraged with regards to their task on delivering the SSbD toolbox. Proposals should allocate the necessary resources for collaboration with the relevant projects mentioned above. Proposals should also build on the extensive experience from European, national or regional clusters/platforms and initiatives such as the Malta Initiative^[16] engaged in validation/standardisation of methods.

Co-operation with the European Commission’s Joint Research Centre (JRC) may be envisaged in areas of mutual interest with regards to new methods development and their wider uptake.

Synergies with Horizon Europe missions as relevant are encouraged.

Activities are expected to start at TRL 3 and achieve TRL 6 by the end of the project – see General Annex B.

[1]https://ec.europa.eu/environment/publications/proposal-ecodesign-sustainable-products-regulation_en

[2]https://ec.europa.eu/environment/ecolabel/the-ecolabel-scheme.html

[3]https://ec.europa.eu/environment/chemicals/reach/reach_en.htm

[4]https://echa.europa.eu/regulations/clp/legislation

[5]See documents defining the SSbD framework on: https://ec.europa.eu/info/research-and-innovation/research-area/industrial-research-and-innovation/key-enabling-technologies/advanced-materials-and-chemicals_en

[6]See documents defining the SSbD framework on: https://ec.europa.eu/info/research-and-innovation/research-area/industrial-research-and-innovation/key-enabling-technologies/advanced-materials-and-chemicals_en

[7]https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX%3A32008R0440

[8]https://www.oecd.org/chemicalsafety/testing/oecd-guidelines-testing-chemicals-related-documents.htm

[9]The term absolute sustainability refers to the possibility of a chemical to comply with safety and to carry limited environmental impacts within the planetary boundaries.

[10]See documents defining the SSbD framework on: https://ec.europa.eu/info/research-and-innovation/research-area/industrial-research-and-innovation/key-enabling-technologies/advanced-materials-and-chemicals_en

[11]https://www.anses.fr/en/content/european-partnership-assessment-risks-chemicals-parc

[12]Findable, Accessible, Interoperable, Reusable

[13]https://ipchem.jrc.ec.europa.eu/

[14]https://ec.europa.eu/info/research-and-innovation/research-area/industrial-research-and-innovation/key-enabling-technologies/advanced-materials-and-chemicals_en

[15]https://www.anses.fr/en/content/european-partnership-assessment-risks-chemicals-parc

[16]https://www.bmuv.de/en/topics/health-chemicals/nanotechnology/the-malta-initiative