Regulatory fragmentation in the EU insect-based food sector and potential implications for the development of an emerging food chain

Insect-based foods (IBFs) are regulated in the European Union (EU) as Novel Foods through a centralized authorization procedure. However, the absence of specific hygiene requirements for establishments operating along the IBF supply chain in Annex III of Regulation (EC) No 853/2004, together with the possibility for Member States (MSs) to require their approval, may result in divergent approaches to their regulatory classification across the EU. Against this background, this study systematically examined national legal databases and the institutional websites of competent authorities (CAs) across the 27 MSs to assess how establishments producing, processing or marketing IBFs are classified and to discuss the potential implications for food business operators (FBOs) and CAs. Relevant national sources were retrieved for 16 MSs, whereas no specific information was identified for 11 MSs. Three models were identified: 1) a registration-based approach (12/16 MSs), 2) a conditional approval approach (3/16 MSs), and 3) a multi-tier hybrid approach including authorization (1/16 MSs). Further heterogeneity was observed in the delimitation between primary production and post-primary stages, as well as in the application of the identification mark in MSs requiring approval. These differences may affect legal certainty and potentially create non-uniform regulatory conditions for FBOs, while also complicating the work of CAs. These findings highlight the need for clarification at EU level regarding the regulatory classification of establishments operating along the IBF supply chain. Such clarification could enhance regulatory predictability, harmonize official controls and reduce internal market disparities.