How ProtoPRED® Supports the EU Roadmap Towards Animal-Free Chemical Safety Assessment
The European Union is moving towards a safety assessment framework that increasingly relies on human-relevant new approach methodologies (NAMs) rather than conventional animal testing. This transition is guided by the EU roadmap towards phasing out animal testing for chemical safety assessments, which outlines key milestones, research priorities and regulatory adaptations needed to achieve this goal. The roadmap emphasizes the development, validation and regulatory acceptance of alternative methods to ensure a high level of protection for human health and the environment.
The EU Roadmap Towards Phasing Out Animal Testing
On 1 June 2026, the European Commission adopted its “Roadmap towards phasing out animal testing for chemical safety assessments.” It sets out 22 actions and more than 30 endpoint-specific recommendations across 15 legislative domains, including industrial chemicals, pesticides, biocides, chemical pharmaceuticals, food and feed additives, and medical devices.
Its three pillars focus on:
- Accelerating the development, validation, standardisation and regulatory application of non-animal approaches
- Strengthening European research and innovation
- Establishing the governance and international cooperation needed to implement the transition
The Role of QSAR Models and in-silico NAMs
In this transition, QSAR models and other in silico NAMs can play a central role by generating early evidence on chemical hazards, supporting substance prioritization and helping determine when additional testing is genuinely necessary.
How ProtoPRED® Fits Into This Shift
ProtoPRED® contributes to this shift through a broad portfolio of predictive models covering:
- Human toxicity and genotoxicity (ProtoTOX, GenoITS)
- ADME and toxicokinetic properties (ProtoADME)
- Endocrine-disrupting activity (ProtoED)
- Ecotoxicity and environmental fate (ProtoECO)
- Physicochemical properties (ProtoPHYSCHEM)
- ICH-M7 mutagenicity assessment (ProtoICH)
- QSAR for nanomaterials (ProtoNANO)
ProtoPRED®’s predictions are accompanied by elements that are essential for scientific and regulatory interpretation, including applicability-domain assessment, model documentation through QMRFs, prediction-specific QPRFs and transparent reporting of results and limitations.
Their results can be used as a stand-alone result for assessment purposes or integrated with experimental data, read-across, mechanistic information and other NAMs within weight-of-evidence (WoE) approaches and integrated testing strategies.
The Practical Value of ProtoPRED®
ProtoPRED®’s practical value is clear: earlier hazard identification, more efficient substance prioritization, reduced development costs and fewer unnecessary animal studies.
Looking Ahead
The transition towards animal-free safety assessment will require more than individual models. It will also depend on transparent, documented and fit-for-purpose computational evidence that can support real scientific and regulatory decisions.
