Regulatory challenges of nanomaterials in food and feed

Wrześniewska-Wal, I. and Dominiak, B. and Wal, A. and Gralak, M.A. (2025) Regulatory challenges of nanomaterials in food and feed. ACTA ALIMENTARIA: AN INTERNATIONAL JOURNAL OF FOOD SCIENCE, 54 (4). pp. 576-590. ISSN 0139-3006

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Abstract

Nanomaterials, including engineered particles with dimensions in the nanoscale range (≤100 nm), are increasingly used in the food and feed sectors, particularly in applications such as nanoencapsulation of bioactive compounds, targeted nutrient delivery, texture improvement, and shelf-life extension. This study analyses the European Union's legal framework, including the 2011 and 2022 European Commission recommendations, Regulation (EC) No 178/2002, Regulation (EU) 2015/2283, and European Food Safety Authority (EFSA) guidance documents, and highlights definitional ambiguities and regulatory inconsistencies that hinder effective risk assessment and management. Ongoing debates concerning the 50% particle size threshold used to define a nanomaterial illustrate these challenges. Using a qualitative and comparative legal approach grounded in the precautionary principle and scientific uncertainty, the study identifies major gaps in current risk assessment, including issues related to particle accumulation, long-term exposure, and the lack of validated methods for characterisation and detection. Based on these findings, key regulatory improvements are proposed: clearer and harmonised definitions, updated classification thresholds, stronger requirements for data on physicochemical properties, and enhanced transparency in risk communication. These recommendations aim to inform the ongoing revision of EFSA guidance (2024–2029) and support the development of a coherent and effective regulatory framework for nanomaterials in food and feed.

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