Nanotechnology – promoting uses of new assessment methods

NAMs refers to a wide variety of methods for testing and assessing chemicals that do not use experiments on animals or humans. As well as gradually replacing animal testing, these methods can contribute to improved safety assessments by using models that better simulate conditions in humans.

NAMs can be performed in test tubes, culture dishes, or using software. NAM-based approaches offer great potential for assessing the safety of nanotechnology since in many cases traditional methods cannot easily be adapted to address nanoscale hazards. In particular, their use in the first steps of a risk assessment can minimise the need for additional animal studies.

Advances in science and technology are stimulating a flood of these approaches, however few of them have been validated according to international standards for use in regulatory risk assessments.

NAMs4NANO proposal

The proposal details a generic framework for a qualification system. This includes the overall process, evaluation criteria, test method description, and procedures to describe the set-up of the NAM, its application and evaluation phase. It also addresses the scientific validity: how to demonstrate its reliability and relevance for a specific context-of-use.

The current report is intended to stimulate a broader discussion among experts and stakeholders involved in nanotechnology, food safety, and public health. Comments are welcome by the end of December 2024: MESE[at] efsa.europa.eu.

EFSA's partners

The report was developed by experts from EFSA's partners: the German Federal Institute for Risk Assessment (BfR), the European Commission's Joint Research Centre, the French Agency for Food, Environmental and Occupational Health & Safety, the Luxembourg Institute of Science and Technology, the Belgian Institute for Health - Sciensano, the Dutch National Institute for Public Health and the Environment, the University of Amsterdam, the Italian Istituto Superiore di Sanità - National Institute of Health, and Wageningen Food Safety Research, part of Wageningen University and Research.

BfR coordinated the project and provide further information on their website: NAMs - more than just alternatives to animal testing

• Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment
• Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges

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