PARCroute

As part of its mission to strengthen the uptake of innovation into chemical risk assessment policy and practice, PARC is developing strategic roadmaps that support the integration of the innovative — especially New Approach Methodologies (NAMs) and Next-Generation Risk Assessment (NGRA) — into regulatory chemical risk assessment (CRA) practice. The first major initiative under this effort is NGRAroute, a dedicated roadmap to support the transition to NGRA within major EU chemical regulation programmes.

NGRAroute: Paving the way towards Next-Generation Risk Assessment in the EU

Across Europe, the U.S., and internationally, there is growing momentum to modernise how we assess the safety of chemicals — shifting away from traditional animal testing and towards animal-free, NAM-based NGRA approaches. While scientific progress has been substantial, implementation into EU regulation remains limited, mostly in areas like skin sensitisation or irritation. To drive meaningful change, stronger connections between science, regulation and policy are essential.

NGRAroute in action

NGRAroute is a strategic activity under PARC. Originally launched to align scientific innovation with EU chemical safety legislation, it was re-aligned in 2023 to support and be an active contributor of the European Commission’s Roadmap for phasing out animal testing in chemical safety assessments.

Key activities to date:

December 2023: co-organised the 1^st roadmap workshop ↗ together with the European Commission, EU agencies, and the European Partnership for Alternative Approaches to Animal Testing (EPAA). A dedicated session introduced a vision for a future NGRA framework. The recordings from the workshop, including the NGRAroute-related presentations can be found here ↗.
Developed 10 guiding principles to support the transition to NGRA — addressing areas such as level of protection, confidence and transparency, scientific excellence and coverage of biology, chemistry, and regulatory needs and requirements. These principles underpin four main work streams: scientific development, regulatory acceptance, policy Implementation and change management.
Collected over 1,000 stakeholder comments on the draft principles and work streams from stakeholders within and beyond PARC, leading to a revised version ↗ submitted to the European Commission in October 2024 (final approval pending).
2024-2025: NGRAroute representatives joined two EC-led Roadmap Working Groups on Human Health and Environmental Safety Assessment. They initiated projects focused on replacing acute toxicity testing and developing probabilistic approaches to better express protection levels and uncertainty. They also proposed activities to support a next-generation environmental risk assessment framework, including considerations for the impact of chemicals on biodiversity.
Participated in key events:
- June 2024: NGO-led multi-stakeholder roundtable ↗.
- October 2024: EC’s 2^nd Roadmap Conference ↗ — contributed to the organisation and actively participated (presentations available here ↗)
- March 2025: AF-CSA conference ↗ by EPAA — provided presentations and co-chaired a session on replacing acute toxicity testing

More on NGRAroute’s vision and its integration with wider PARC efforts can be found in this article ↗.

What’s Next?

The 3^rd and last roadmap conference ↗ will take place at the European Chemicals Agency (ECHA ↗) in June 2025, where the first full outline of the Commission's roadmap will be presented. Finalisation and internal approval are expected by the end of 2025, with official publication planned for Q1 2026.

After finalisation of the roadmap, NGRAroute will continue working closely with policymakers, scientists, regulators, and stakeholders to ensure the roadmap’s effective, inclusive, and long-lasting implementation — paving the way for a future where chemical safety assessments are more ethical, efficient, and scientifically robust.

Supporting the Transition: PARCopedia

To help overcome persistent barriers to the uptake of NAMs and NGRA, PARC has also launched PARCopedia ↗ — a new open-access platform for knowledge-sharing and community building. Designed for anyone working towards safer chemicals for human health and the environment, PARCopedia connects professionals across sectors and disciplines, both inside and outside the PARC network.

All thematic areas

Risk assessments

Find out how we monitor chemicals guided by regulatory challenges both in humans and in the environment, observing different sources, chemical fates and exposure pathways.

Learn new approaches and methods of health assessment and provide data to fill gaps in knowledge on poorly characterised contaminants or new emerging hazards while promoting the use of innovative methods.

Tools & resources

Come to know how we are catalysing the shift towards safe and sustainable chemicals, materials and products to to minimize negative impacts on human health and the environment.

PARC is developing the PARC FAIR Data Hub that will be a service to provide FAIR data (Findable, Accessible, Interoperable, and Reusable) to the different stakeholders.

Building infrastructure and human capacities

Get to know the European laboratories that belong to our existing network as well as the new recruitments in order to maintain and to strengthen monitoring capacities.

Check our mapping and cataloguing environmental (air, water/sediment, soil, biota, drinking water, food & feed) monitoring networks as well as the gaps and opportunities for future alignment.

Stay up to date on the latest trainings in the field of environmental monitoring and biomonitoring of chemicals to improve the overall quality of chemical risk assessment and management globally.

PARC has the ambition to make 70-80% of PARC-generated data Findable, Accessible, Interoperable, and Reusable (FAIR). This requires extensive technical development to provide the infrastructure needed, as well as training of FAIR implementers to support PARC partners and projects to implement the FAIR workflows being developed. Discover our progress in building FAIR skills and capacity here.

Check out how we work towards increased harmonisation of quality assurance (QA) and quality control (QC) in chemical analysis and toxicity testing to ensure that monitoring and hazard data generated in PARC are reliable, consistent, and comparable.

Science to policy

We are connecting PARC partners and external stakeholders, from both the research and the regulatory domains, to apply the long-term visions of the European policies related to chemical safety.

PARC is inviting the whole community of professionals in chemical risk assessment in Europe and worldwide to share their knowledge and ideas on the PARCopedia platform launched in November 2023. PARCopedia is a not-for-profit, ad-free knowledge management and social media environment.

PARC will develop a series of strategic roadmaps guiding step-by-step to the uptake of innovative science into the regulatory practice of chemical risk assessment in the EU. The first one will be NGRAroute, an activity to implement Next Generation Risk Assessment (NGRA) in all major legislations on chemicals in the EU.

See the Next Generation Risk Assessment in action for the benefit of human and the environment.

Explore how PARC’s Rapid Response Mechanism tackles urgent health and environmental challenges.