EFSA Pioneers Animal-Free Nanomaterial Safety Assessment with New Certification System

August 2, 2026

EFSA (European Food Safety Authority) European Union

Overview

The European Food Safety Authority (EFSA) has introduced a groundbreaking ‘New Approach Methodologies (NAMs) Certification System’ to enhance the safety assessment of nanomaterials in food and feed, aiming to replace traditional animal testing. This innovative framework utilizes advanced in vitro tests, computational modeling, and omics technologies to evaluate unique nano-specific interactions and cellular responses, providing a more ethical and efficient pathway for risk assessment. Already integrated into EFSA’s safety assessments for various products and bolstered by the NAMs4NANO project, this initiative sets a new global standard for safe nanotechnology development and regulatory harmonization.

In Depth

Background

Advances in nanotechnology have expanded the potential for nanomaterials to be used in various products, including food, feed, and packaging materials. However, their innovative properties also raise concerns about potential impacts on human health and the environment. The European Union (EU) has a strong commitment to the phasing out of animal testing, and the introduction of NAMs in risk assessment aligns perfectly with this objective. As a food safety authority, EFSA is responsible for making science-based, efficient regulatory decisions while ensuring consumer trust. The adoption of NAMs has the potential to enhance the transparency of safety assessments and enable faster approval processes, thereby also fostering industrial innovation.

Key Findings

The European Food Safety Authority (EFSA) has developed a groundbreaking ‘New Approach Methodologies (NAMs) Certification System’ to significantly improve the safety assessment of nanomaterials in food and feed, serving as an alternative to animal testing. This innovative system is designed to evaluate critical aspects such as the biological uptake of nanomaterials in specific cell models, aiming for a more efficient and ethical risk assessment process.

Technical / Clinical Details

NAMs represent modern risk assessment approaches that are independent of animal testing, combining in vitro tests, computational modeling, and omics technologies. For nanomaterial assessment, conventional chemical substance evaluation methods are often insufficient due to the unique physicochemical properties (size, shape, surface area, chemical composition) of nanomaterials that significantly influence their biological interactions. EFSA’s NAMs certification system is specifically designed to address these nano-specific aspects. It utilizes cell culture models to analyze in detail how nanomaterials are taken up by cells and what cellular responses they induce. This allows for the identification of initial toxicity mechanisms and the assessment of potential extrapolation to human health risks.

EFSA’s Scientific Committee has already integrated guidance from these NAMs into the safety assessments of food additives, novel foods, and food contact materials. This marks a crucial step towards strengthening consumer protection across a wide range of product categories where nanomaterials may be used. Furthermore, the ‘NAMs4NANO’ project is underway until 2027, focusing on understanding and overcoming challenges in applying NAMs to nanomaterial risk assessment (e.g., integrating results from different NAMs, evaluating complex materials, developing standardized protocols). This project aims to promote safe innovation in nanomaterials while ensuring scientific robustness and regulatory harmonization.

Strategic Significance & Outlook

The ongoing development of EFSA’s NAMs certification system and the outcomes of the NAMs4NANO project are expected to further evolve the regulatory framework for nanomaterials in the food and feed sectors. In the future, it is anticipated that more NAMs will be validated and certified, enabling highly accurate risk assessments while significantly reducing the need for animal testing. This approach could influence other regulatory bodies and international standardization organizations, promoting global harmonization in nanomaterial safety assessment. This ensures the safe and responsible development of nanotechnology, allowing its benefits to be widely realized across society.

Source: https://www.efsa.europa.eu/en/topics/topic/nanotechnology

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