Methods without animal testing in the assessment of nanomaterials in food and feed: implementation plan for a NAM qualification system — comments and case studies until 31 October 2026
On 24 July 2026 Italy’s Istituto Superiore di Sanità (ISS) reported on an implementation plan for a qualification system for new approach methodologies without animal use (NAMs) in the food and feed sector, prepared by the NAMs4NANO consortium on behalf of EFSA. The first application is nanomaterial risk assessment.
- The problem the system is meant to solve: many alternative methods are available, but without validation and adoption as an OECD Test Guideline their results are treated in regulatory decisions mainly as mechanistic support rather than direct evidence. Qualification is an expert-based process that establishes the scientific validity of a method — its reliability and relevance — in a well-defined context of use: how the method will be applied, what information it provides and what role it plays in the decision.
- The ISS refers to existing qualification systems: the U.S. FDA Drug Development Tools programme and the qualification of novel methodologies at the European Medicines Agency. EFSA’s guidance on risk assessment of nanomaterials in food and feed (2021) recommends using NAMs in the first steps of generating new information.
- The implementation plan, published in July 2026 as a report in EFSA Supporting Publications, consolidates feedback from a public consultation and dialogue with the OECD, ECHA, the Scientific Committee on Consumer Safety (SCCS), EMA and the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM). The proposed readiness criteria were tested on selected NAMs in case studies within the consortium and in other projects; the results led to the first amendments of the criteria.
- The plan remains open for comments until 31 October 2026; by that date external case studies can also be proposed to test the qualification criteria, including outside nanotechnology. The ISS links the qualification system to the European Commission’s roadmap for phasing out animal testing.