Key messages

• As chemical safety testing moves away from traditional animal experiments and towards more human-relevant methods, called New Approach Methodologies (NAMs ↗), the use of machine learning (ML) and other artificial intelligence (AI) tools are becoming more important.
• To use these AI/ML tools in real-world regulatory chemical safety decisions, regulators need to be confident that they are reliable and trustworthy.
• Formerly, in vitro NAMs were questioned with their trustworthiness/readiness for regulatory application. A readiness check and scoring system were developed to help assess NAMs readiness by a questionnaire.
• Inspired by the readiness checklist of the in vitro NAMs, READYAI project will develop a readiness check and scoring system for AI/ML-based tools used in.
• The goal is to give regulators a practical way to check how ready and reliable these AI tools are before using them in chemical safety assessment.

Overview

The rapid development of ML and other types of AI tools presents both opportunities and challenges for their integration into chemical risk assessment and regulation. While these computational tools offer promising applications in evidence management, toxicity prediction, and exposure assessment, their reliability for regulatory use remains unclear. READYAI project aims to fill this gap by establishing clear readiness criteria and a practical scoring system to evaluate the regulatory applicability of AI/ML tools.regulatory applicability of AI/ML tools.

The proposed system will be comparable to existing readiness frameworks for NAMs and will serve to guide regulatory scientists in determining the robustness and relevance of AI/ML-based tools.

A key component of the project is the development of a readiness check questionnaire designed specifically for AI/ML tools. This resource will be built in collaboration with AI developers, end-users, and relevant authorities to ensure its applicability across sectors and regulatory domains.

By supporting transparent and structured evaluation of AI/ML tools, the READYAI project contributes to more consistent and confident use of AI in chemical regulatory contexts. It aligns with PARC’s objectives of modernising risk assessment, reducing reliance on animal testing, and harmonising scientific approaches across the EU.

Achievements & Results

• The READYAI project officially kicked off in May 2025.
• Initial implementation steps are already underway.
• A steering committee is currently being assembled, including representatives from international and national agencies such as ECHA ↗, EFSA ↗, OECD ↗ and Swissmedic.
• The team has also started working on a concrete project plan to guide next steps.

Policy relevance

Chemical Risk Assessment is legally binding. So far, respective OECD-guided animal studies have been the basis of setting human health-based guidance values. With the paradigm change towards next generation risk assessment using NAMs, AI/ML-based tools move into the focus of regulatory agencies. Understanding these tools’ readiness and applicability will introduce a large change into policy.