Is Advanced Nutrivigilance a Missing Piece in the EU’s Botanical Supplement Safety Puzzle?

Abstract Despite sophisticated pre-market scientific assessment frameworks, the EU lacks systematic post-market surveillance for botanical food supplements, creating a critical regulatory imbalance. This analysis examines real-world safety incidents that demonstrate how fragmented national responses and inadequate monitoring systems fail to protect consumers effectively. Several Member States have developed nutrivigilance initiatives yet remain uncoordinated and insufficient for union-wide risk detection. The existing framework exhibits a fundamental contradiction: Article 8 procedures under Regulation (EC) no 1925/2006 require scientific evidence of harm to justify restrictions, but no harmonised mechanism exists to systematically collect such evidence. Current tools like RASFF capture acute compositional violations but cannot monitor chronic health effects or supplement–medicine interactions that characterise modern botanical supplement risks. This paper argues that mandatory EU-wide nutrivigilance represents the missing institutional link needed to transform reactive crisis management into proactive risk prevention. A harmonised system built on centralised reporting, standardised causality assessment, and formal regulatory follow-through mechanisms would provide the evidence base necessary to develop Union-wide restrictive lists and support coherent enforcement under existing legal frameworks. Such reform would address the most glaring gap in EU food safety architecture and provide legal certainty for industry operators across the internal market.