PO15 | FRAGMENTED RULES FOR THE EU INSECT-BASED FOOD SECTOR: IMPLICATIONS FOR THE DEVELOPMENT OF AN EMERGING FOOD CHAIN

Andrea Gori¹, Valentina Garretto¹, Gabriele Spatola¹, Clara Girardi^1|2, Giovanni Nardone², Luca Cianti³, Andrea Armani¹ | ¹Dip. di Scienze Veterinarie, Università di Pisa, Italy; ²U. F. di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Azienda Unità Sanitaria Locale Toscana Centro, Pistoia, Italy; ³U. F. di Sanità Pubblica Veterinaria e Sicurezza Alimentare, Azienda Unità Sanitaria Locale Toscana Centro, Firenze 2, Firenze, Italy.

Aim. Insect-based foods (IBFs) are increasingly considered an emerging alternative protein source and are regulated in the European Union (EU) as Novel Foods through a centralized authorization procedure. However, while product authorization is harmonized at EU level, the regulatory classification of establishments operating along the IBF supply chain remains less clearly defined. In particular, the absence of specific hygiene requirements for IBFs in Annex III of Regulation (EC) No 853/2004, together with the possibility to require establishment approval under national law, may result in divergent approaches across Member States (MSs). This study analyzed institutional sources from the 27 MSs to assess how establishments producing, processing or marketing IBFs are classified (registration, authorization or approval, the delimitation between primary and post-primary stages, and the use of the identification mark). In addition, the implications for food business operators (FBOs) and competent authorities (CAs) were assessed.

Methods. National legislation, official guidance, technical notes, ministerial circulars and information published by CAs or relevant ministries were collected and analyzed. For MSs requiring approval, the analysis was complemented, where possible, by the verification of official lists of establishments and publicly available labelling or packaging materials.

Results. Relevant institutional sources were retrieved for 16 MSs, whereas no specific information was identified for 11 MSs. Three regulatory models were identified: a registration-based approach in 12 of 16 MSs, a conditional approval approach in 3 of 16 MSs, and a multi-tier hybrid approach including authorization in 1 of 16 MSs. Differences were also reflected in the uneven availability and legal nature of national sources, ranging from binding legislation to soft-law instruments. Further heterogeneity concerned the criteria used to distinguish primary from post-primary production, including approaches based on the supply-chain stage, sales modality and insect killing method, as well as the application and format of the identification mark in MSs requiring approval.

Conclusions. These findings show that, despite the centralized authorization of IBFs as Novel Foods, the regulatory treatment of establishments in this emerging food chain remains fragmented across the EU. Such fragmentation may affect legal certainty, create non-uniform market access conditions and administrative burdens for FBOs, and complicate the harmonization of official controls by CAs. Greater clarification at EU level would improve regulatory predictability, support proportionate risk-based controls and reduce disparities within the internal market, thereby facilitating the development of the IBF sector.