New approach methodologies (NAMs)

The ways scientists assess chemical hazards and risks have been steadily evolving over recent decades because of advances in technology and scientific knowledge. 

New approach methodologies (NAMs) refer to any non-animal approach, methodology, technology or combination of these, used in hazard and risk assessments.

They encompass computational models (in silico), in vitro and in chemico laboratory-based assays, and integrated approaches that combine different sources of scientific knowledge. They also include new tools such as high-throughput screening and high-content methods (e.g. “Omics” - see below).
These approaches can provide more targeted and biologically relevant information that help to improve scientists’ understanding of how harmful effects occur through understanding mechanisms, i.e. how substances behave and interact with humans and animals. 

There is growing evidence to show that use of NAMs can improve the scientific robustness and relevance of risk assessments while supporting the EU’s commitment to replace, reduce and refine animal testing (the 3Rs principles).
 

Latest

On 1 June 2026, the European Commission adopted a Roadmap towards phasing out animal testing for chemical safety assessments. 

The comprehensive approach encompasses a wide range of legislative domains, including industrial chemicals, pharmaceuticals, and food additives, and outlines over 30 key recommendations to facilitate the transition to alternative testing methods.

EFSA is working closely with the Commission, European Chemicals Agency, European Medicines Agency, and a broad coalition of stakeholder organisations to implement the roadmap towards a future without animal testing.

NAMs at EFSA

At EFSA, we typically use NAMs and other sources of evidence together, within a structured weight of evidence approach, to support scientific conclusions. These include:

• Non-testing approaches, such as read-across, threshold of toxicological concern, use of existing toxicological information and artificial intelligence.
• Computational (in silico) models such as (quantitative) structure-activity relationship models (referred to as (Q)SARs), PBK models for characterising the ADME[AS2.1] of chemicals, quantitative in vitro to in vivo extrapolation models (QIVIVE) to link effects observed in lab work to effects that can happen in humans or animals, and benchmark dose[AS3.1] modelling (BMD) to assess dose response relationships. 
• In vitro and in chemico assays are used to assess specific endpoints including metabolism, developmental neurotoxicity, endocrine disruption, genotoxicityprotein and allergenicity testing, whole genome sequencing and omics. 
• NAM data can also be combined using, for example, integrated approaches to testing and assessment (IATA) and/or adverse outcome pathways (AOP) to depict the mode of action of chemicals and translate lab results into real-world biological outcomes.

Growing areas of interest include high-throughput screening and high-content methods, e.g. transcriptomics (the study of gene activity), proteomics (the study of proteins), and metabolomics (the study of small molecules produced by cells), which are referred to collectively as ‘omics’. These approaches are also laboratory-based and generate big data that provide deeper insight into biological responses at a molecular level.

NAMs in practice

NAM-based approaches are used across EFSA’s risk assessment and scientific advice activities, including contaminants in food and feed, pesticides, food and feed additives, flavourings, novel foods, and food contact materials.  

• Guidance to applicants – provide sectorial guidance (for example on food additives, food enzymes, novel foods, pesticides, and feed additives) on how NAMs can be used to complement or, where appropriate, reduce reliance on animal testing.
• Cross-cutting guidance – these frameworks address the use of non-animal approaches in multiple scientific areas. 
• Tools and resources – our scientists and partners have developed tools that allow integration of NAMs in our risk assessments. They include TKPlate, an open-access platform for toxicokinetic and toxicodynamic modelling of chemicals, the OpenFoodTox chemical hazards database, and the compendium of botanicals. 
• Development projects – there is support for NAMs development of tools, databases, modelling and data integration, and for investigating and optimising emerging methods and approaches such as in vitro batteries and omics. Several of these projects fall under our Innovative Risk Assessment Methodologies programme. 
• Qualification – a qualification system for the risk assessment of nanomaterials in the food and feed sector has been developed. It aims to demonstrate the reliability and relevance of a given method and can be done to varying degrees depending on the specific context-of-use. It can also support the further improvement of promising NAMs still in development.

EFSA’s role

Supporting the development and use of NAMs is part of EFSA’s strategic objective to prepare for future risk assessment needs.

EFSA contributes by developing scientific frameworks, guidance and tools to support the integration of NAMs into regulatory risk assessment. EFSA has published key concept papers and roadmaps setting out how NAMs can be applied in practice .

• Implementation of NAMs in risk assessment: concept paper (2020), roadmap (2022)

• Application of omics and bioinformatics approaches towards next generation risk assessment: concept paper (2022), roadmap (2024)

Throughout these developments EFSA has worked closely with the scientific community worldwide to explore and standardise promising NAMs and regulatory opportunities for their application.

Expertise and cooperation

Several working groups of experts support EFSA’s Scientific Committee and scientific panels, respectively, on cross-cutting and specific activities related to NAMs. They include for example endocrine disruptors, genotoxicity, neurotoxicity,NAMs (e.g. on nanotechnologies), and read-across.

In 2026, EFSA established an internal Advisory Group on the integration of NAMs in risk assessment to accelerate the transition towards next-generation, non-animal approaches. The Advisory Group supports coordination across scientific domains, provides guidance to staff and experts on the regulatory uptake of NAMs, and promotes harmonisation of approaches within EFSA and with external partners. By strengthening links with ongoing initiatives and aligning with the European Commission’s roadmap on phasing out animal testing, the Advisory Group aims to ensure that emerging methods and knowledge are efficiently translated into robust, science-based risk assessment practices.

EFSA collaborates, exchanges data, expertise and methodologies, and develops case studies with other EU agencies, EU Member States and relevant international and third country organisations such as the World Health Organization, Organisation for Economic Co-operation and Development, US Food and Drug Administration, and US Environmental Protection Agency, including through the European Partnership for Alternative Approaches to Animal Testing and the International Liaison Group on Methods for Risk Assessment of Chemicals in Food.

The aim of these ties and cooperation is to harmonise approaches and help ensure that NAMs are applied in a scientifically robust and consistent way.

EFSA collaborates with key European research projects such as the Partnership for the Assessment of Risks from Chemicals (PARC). Our scientists are also part of Accelerating the pace of chemical risk assessment (APCRA), an international consortium set up to reach a broader global consensus on the applicable criteria and standards for NAMs-based data and their integration in food and feed risk assessment.

EU Framework

The use of NAMs at EFSA is embedded in the broader EU policy and regulatory framework promoting the 3Rs principles in animal testing, scientific innovation and the use of advanced data and modelling approaches.

This framework has progressively evolved to support the development, validation and regulatory acceptance of non‑animal methods across sectors, including chemicals and food safety.

At EU level, key elements shaping this framework include:

• EU roadmap on phasing out animal testing, which sets a strategic direction towards the transition to non‑animal methods in regulatory safety assessments
• Animals in science in the EU, providing an overview of EU actions to protect animals used for scientific purposes and promote alternatives
• Directive 2010/63/EU on the protection of animals used for scientific purposes, which establishes the legal basis for applying the 3Rs principles and encourages the development and uptake of alternatives to animal testing
• The Chemicals Strategy for Sustainability, which promotes innovation for safe and sustainable chemicals, including the development and use of NAMs for hazard and risk assessment
• The ‘one substance, one assessment’ (OSOA) approach, which aims to streamline and harmonise chemical risk assessments across EU legislation, facilitating the integration of NAMs
• The EU’s approach to artificial intelligence, supporting the responsible use of AI for data integration, modelling and decision‑making in regulatory science
• The European Virtual Human Twins Initiative, which advances the use of computational and mechanistic models to better predict human responses and reduce reliance on animal data
• The Food and Feed Simplification Package (Omnibus), which seeks to modernise and simplify regulatory requirements, including through greater use of innovative assessment approaches
• The EU Biotech Act, supporting innovation in biotechnology and enabling the uptake of advanced methods relevant to risk assessment.

Together, these legal and policy initiatives provide the strategic and regulatory context within which EFSA develops guidance, tools and scientific practice to support the use of NAMs in food and feed risk assessment.