Is Monk Fruit the Next Approved Natural Sweetener in the EU? Examining the Regulatory Process

Sweeteners play a critical role in modern food production, enabling sugar reduction while maintaining palatability. The European Union (EU) regulates sweetening agents under Regulation (EC) No 1333/2008, ensuring safety through European Food Safety Authority (EFSA) evaluations. However, regulatory inconsistencies persist, particularly concerning novel sweeteners like monk fruit extract (MFE). This study conducts a comprehensive regulatory analysis of sweetening agents approved in the EU, classifying them into intense sweeteners, sugar alcohols (polyols), and sweetness modifiers. A comparative review of MFE’s legal status highlights regulatory disparities in novel food approvals. We systematically reviewed EFSA scientific opinions, EU legislative documents, and international regulatory frameworks. Sweetening agents were assessed based on Acceptable Daily Intake (ADI) values, toxicological profiles, metabolic effects, and gut microbiota influence. The regulatory status of monk fruit extract was analyzed in the context of the EU Novel Foods Regulation (EU 2015/2283). Eighteen sweetening agents were identified and categorized: seven intense sweeteners, eight polyols, and three sweetness modifiers. While all approved agents meet EFSA safety criteria, certain compounds, such as cyclamates (E 952), have undergone re-evaluations due to historical safety concerns. Regulatory discrepancies were evident in MFE’s approval process: while aqueous extracts are permitted as a traditional food ingredient, concentrated extracts containing high mogroside levels remain unapproved due to insufficient safety data. Findings indicate inconsistencies in the EU’s novel food approval process, particularly for botanical-derived sweeteners. Harmonization of regulatory frameworks is needed to ensure fair assessment of novel sweetening agents and balance food innovation, safety, and consumer health concerns. As part of the ongoing research, a systematic review following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines is currently in progress. This review aims to comprehensively evaluate the scientific literature, regulatory documents, and policy frameworks concerning the approval of Monk Fruit extract as a natural sweetener within the European Union. The PRISMA methodology will provide a transparent and reproducible framework for identifying, screening, and analyzing relevant studies, ensuring a rigorous and evidence-based assessment of the regulatory landscape. The findings from this systematic review will be presented in subsequent publications, contributing to a more detailed understanding of the approval process and regulatory challenges. This additional work is expected to enhance the robustness of the study's conclusions, offering valuable insights for policymakers, industry stakeholders, and researchers interested in food technology, nutrition, and regulatory affairs.