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

Is Monk Fruit the Next Approved Natural Sweetener in the EU? Examining the Regulatory Process | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Systematic Review Is Monk Fruit the Next Approved Natural Sweetener in the EU? Examining the Regulatory Process Urszula Kaim, Urszula Gawlik This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6218498/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract 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. Food Science & Technology Food additives sweeteners European Union regulation EFSA food policy sugar alternatives novel foods 1. Introduction The global rise in metabolic disorders, including obesity, type 2 diabetes, and cardiovascular diseases, has intensified efforts to reduce added sugar consumption. The World Health Organization (WHO) recommends limiting free sugar intake to less than 10% of total daily energy consumption, with additional health benefits observed when reduced below 5% (WHO, 2022). As a result, the food industry has focused on natural, calorie-free sweeteners to satisfy consumers' desire for healthier options. However, regulatory challenges impact the accessibility and adoption of these options, shaping food markets and public health outcomes. Monk fruit ( Siraitia grosvenorii ) has been used in traditional medicine in China for centuries. Its extract contains mogrosides, a class of triterpene glycosides, primarily mogroside V, which is approximately 250 times sweeter than sucrose (Huang et al., 2024). Unlike caloric sweeteners, mogrosides do not elevate blood glucose levels, making monk fruit extract (MFE) a promising alternative for diabetes management and weight control (Arshad et al., 2022). Despite its entrenched safety and regulatory approval in the United States (US), the United Kingdom (UK), and China, MFE remains unapproved in the European Union (EU), highlighting policy inconsistencies in new food legislation and its food policy implications. The US Food and Drug Administration (FDA) has classified MFE as Generally Recognised as Safe (GRAS), allowing its widespread use in food products. Similarly, China's National Health Commission (NHC) has approved MFE as a food additive under GB 2760 − 2014, permitting its use across various food categories (NHC, 2023). However, under the EU Novel Food Regulation (EU 2015/2283), any food ingredient not significantly consumed in the EU before May 1997 must undergo rigorous safety evaluations before market authorisation (EFSA, 2019). The European Food Safety Authority (EFSA) has yet to approve MFE due to concerns over the absence of long-term toxicological data, particularly regarding genotoxicity (EFSA, 2023). The lack of an industry-led new food submission further delays regulatory authorisation, limiting European consumer access to this natural sweetener. Unlike the US, which permits market access based on historical consumption and industry-led safety evaluations, the EU requires extensive pre-market safety data, even for substances with well-established international acceptance (EFSA, 2024; FDA, 2010). The precautionary approach intended to protect public health may hinder food innovation and delay the implementation of plant-based sweeteners such as MFE. These legislative inconsistencies create economic barriers for food producers and affect the competitiveness of the European food industry in global markets. Recent debates on EU food policy reform suggest that a risk-benefit approach—similar to the UK's post-market surveillance model—could provide a sustainable regulatory framework (FSA, 2024; European Commission, 2020). Conditional approvals based on safety evaluations from other markets and continuous surveillance could help close the gap between regulatory efficacy and public health concerns. Steviol glycosides underwent similar pre-approval checks in 2011 following a comprehensive safety review by EFSA. Other functional ingredients, such as oat beta-glucans and algae-derived omega-3 fatty acids, transitioned from novel ingredients to recognised functional food components based on emerging scientific evidence and regulatory adaptability (EFSA, 2011; EFSA, 2020). Despite the growing demands for natural-based and clean-label alternatives to sugar, MFE remains in regulatory limbo. The EU's approach contrasts with international markets and raises concerns about food system innovation, sugar reduction, and consumer health protection as part of the European Green Deal. Addressing these regulatory barriers requires increased industry engagement, streamlined approval processes, and greater alignment with international safety frameworks. This review examines the regulatory barriers preventing MFE's approval in the EU and compares its regulatory trajectory to previously approved sweeteners, such as steviol glycosides and erythritol. Analysing data from EU regulatory sources, this study provides insight into how MFE can be integrated into the European food market while balancing safety, sustainability, and public health objectives. 2. Materials and Methods This study employs a structured regulatory analysis to examine the approval status of non-caloric intense sweetening agents in the EU and identify the regulatory barriers preventing MFE market authorisation. The study follows a three-stage analytical framework involving (i) classification of authorised non-caloric sweeteners by chemical composition and regulatory status, (ii) comparative assessment of regulatory frameworks in the EU, US, and UK, and (iii) systematic extraction of regulatory data from official sources, including EU legislation, EFSA scientific opinions, FDA and FSA reports, and international food safety guidelines from Codex Alimentarius. 2.1. Study Design This review shows a comparative legal and policy analysis methodology to identify key determinants influencing regulatory outcomes for MFE in the EU according to substances used and approved in the EU to enhance sweetness. Legal instruments and scientific evaluations were reviewed to assess regulatory differences in global jurisdictions. 2.2. Data Collection and Sources Data were extracted from: EU legislation ( Regulation (EU) 2015/2283 on Novel Foods , Regulation (EC) No 1333/2008 on food additives ) EFSA scientific opinions on non-caloric sweeteners and novel foods FDA and FSA regulatory reports, including Generally Recognised as Safe (GRAS) determinations and novel food dossiers Codex Alimentarius international food safety guidelines Appropriate policy documentation was examined to evaluate the risk assessment framework approach, precautionary rules, and the function of industry propositions in structuring and validating approval processes. 2.3. Data Analysis Data were synthesised into regulatory comparison tables outlining: Approval status of non-caloric sweeteners in the EU, US, and UK Acceptable Daily Intake (ADI) values and toxicological evaluation criteria Differences in pre-market safety assessment frameworks and post-market monitoring mechanisms 3. Results This regulatory analysis identified 18 authorized sweetening substances in the EU, classified into three main categories: intense sweeteners, sugar alcohols (polyols), and sweetness modifiers. These compounds fall under Regulation (EC) No 1333/2008, which establishes permissible additives, their maximum usage levels, and safety evaluations conducted by the EFSA (European Commission, 2008). The EFSA assesses their toxicological profiles, Acceptable Daily Intake (ADI) values, and potential metabolic effects before approval (EFSA, 2011, 2016, 2017). A comparative regulatory review of MFE revealed inconsistencies in its approval across different jurisdictions. The EU recognizes monk fruit aqueous extract as a traditional food under the Novel Foods Regulation (EU 2015/2283), allowing its use in herbal beverages. However, powdered or concentrated MFE formulations—which contain high mogrosides—remain unapproved due to insufficient industry-submitted safety data (EFSA, 2024). This regulatory discrepancy highlights the challenges of approving novel sweeteners, especially in cases where natural extracts undergo different processing methods (FSA, 2024). 3.1. Intense Sweetening Agents in the European Union Intense sweeteners are high-potency compounds that impart sweetness without contributing significant caloric value and are widely used in beverages, sugar-free products, and low-calorie formulations. Their approval in the EU is regulated under Regulation (EC) No 1333/2008, with periodic EFSA safety evaluations assessing their toxicology, metabolism, and long-term health risks (EFSA, 2010, 2016, 2017). 3.1.1. Acesulfame K Acesulfame K (E950)is a heat-stable, high-intensity sweetener commonly used in soft drinks, dairy products, and confectionery. It was approved under Regulation (EC) No 1333/2008 and reassessed by EFSA in 2017, which confirmed its safety within the established ADI. However, some research has suggested potential effects on gut microbiota and reports of a bitter aftertaste at high concentrations (EFSA, 2017). 3.1.2. Sucralose Sucralose (E 955) is widely used in baking, beverages, and dairy applications due to its high solubility and thermal stability. It was first approved under Regulation (EC) No 1333/2008, with a safety re-evaluation by EFSA in 2016. While EFSA maintained the ADI of 5 mg/kg body weight, concerns have emerged regarding its potential to alter gut microbiota at high doses. However, no significant public health risks have been identified when used within approved intake levels (EFSA, 2016). 3.1.3. Steviol Glycosides Derived from the Stevia rebaudiana plant, steviol glycosides (E 960a) are considered natural sugar substitutes with widespread use in beverages and food products. While they are thermally stable, they may impart a mild liquorice-like aftertaste. EFSA's 2010 safety evaluation established an ADI of 4 mg/kg body weight, affirming their safety within regulatory limits (EFSA, 2010). 3.1.4. Neotame Neotame (E 961) is a strong sweetener, used mainly in diet beverages and chewing gum, often combined with additional sweeteners to improve the profile of sweetness. It was authorized under Regulation (EU) No 231/2012, with safety evaluations conducted by EFSA (2010) and JECFA (2003) confirming that no adverse health effects occur at the approved ADI of 2 mg/kg body weight (EFSA, 2010; JECFA, 2003). Table 1 Table 1 . Regulatory Status and Safety Evaluation of Intense Sweetening Agents in the European Union. Number Name Common Applications Textural & Technological Aspects ADI [kg bw/day] Potential Health Risks Gut Microbiota Influence References 1 Acesulfame K Soft drinks, dairy products, confectionery High stability, synergistic with other sweeteners 15 mg Possible effect on gut microbiota, bitter aftertaste Minimal effect at approved intake levels EFSA (2017) 3 Sucralose Baking, soft drinks, dairy Highly soluble, thermally stable, no bulk contribution 5 mg Potential gut microbiota disruption, debated long-term safety Potential microbiota alterations at high doses EFSA (2016) 4 Steviol Glycosides Natural sugar substitute, beverages Stable at high temperatures, slight licorice-like aftertaste 4 mg Mild gastrointestinal discomfort in high doses No adverse impact at approved doses EFSA (2010) 5 Neotame Diet beverages, chewing gum Synergistic with other 6sweeteners, m7inimal bulk 8impact 2 mg - No known impact at approved levels EFSA (2010), JECFA (2003) 6 Advantame Baked goods, chewing gum, dairy, sugar-free beverages Ul9tra-high potency, heat-stable, minimal textural impact 5 mg Insufficient data on metabolic effects No adverse effects at approved ADI EFSA (2013), JECFA (2013), FDA (2014) 7 Cyclamates Soft drinks, bakery products Enhances volume, retains moisture, re-evaluated by EFSA 7 mg Previously linked to bladder cancer, EFSA re-evaluated (2017) Limited data, but no confirmed adverse effects EFSA (2017) . ADI - Acceptable Daily Intake, 3.1.5. Cyclamates Cyclamates (E 952), commonly used in soft drinks and baked goods, have undergone multiple safety reassessments due to historical concerns regarding potential carcinogenic effects. Although they were previously linked to bladder cancer, EFSA's 2017 review reaffirmed their safety, maintaining an ADI of 7 mg/kg body weight with no confirmed adverse effects within approved intake levels (EFSA, 2017). 3.2. Sugar Alcohols (Polyols) in the EU Sugar alcohols (polyols) are sweeteners that promote texture, consistency and retention of moisture in foods. Unlike intensive sweeteners, polyols ensure a certain caloric value, but provide a reduced glycaemic response. Their regulatory approval falls under Regulation (EC) No 1333/2008, with EFSA routinely assessing their safety, metabolic impact, and gastrointestinal tolerance (EFSA, 2011, 2017). ADI is not specified for polyols as they are generally recognized as safe, but excessive consumption may cause gastrointestinal effects (EFSA, 2011; EFSA, 2015; EFSA, 2021). Table 2 Classification, Applications, and Safety Profiles of Sugar Alcohols (Polyols) in the European Union. Number Name Common Applications Textural & Technological Aspects Caloric [kcal/g) Potential Health Risks References 1 Sorbitol Sugar-free candies, chewing gums, baked goods Humectant, texturizer, stabilizer 2.6 Gastrointestinal discomfort at high doses EFSA (2011) 2 Mannitol Sugar-free candies, pharmaceuticals Anti-caking agent, stabilizer 1.6 Laxative effect at high doses EFSA (2011) 3 Isomalt Confectionery, baked goods Bulking agent, stabilizer 2.0 Laxative effect at high doses EFSA (2017) 4 Maltitol Sugar-free chocolates, desserts Sweetener, texturizer 2.1 Laxative effect at high doses EFSA (2017) 5 Lactitol Sugar-free candies, baked goods Sweetener, bulking agent 2.0 Laxative effect at high doses EFSA (2017) 6 Xylitol Chewing gums, oral care products Sweetener, moisture retention 2.4 Laxative effect at high doses EFSA (2017) 7 Erythritol Beverages, confectionery Sweetener, bulking agent 0.2 Gastrointestinal discomfort at high doses EFSA (2015) 8 Polydextrose Baked goods, desserts Bulking agent, texturizer 1.0 Gastrointestinal discomfort at high doses EFSA (2021) 3.2.1. Sorbitol Sorbitol (E 420), a polyol derived from glucose, is widely used in sugar-free confectionery, pharmaceuticals, and personal care products due to its humectant and stabilizing properties. It retains moisture, improving the texture and shelf-life of food products. EFSA’s 2011 re-evaluation confirmed its safety but warned that excessive consumption (above 20g per day) may cause gastrointestinal discomfort, including bloating and diarrhoea (EFSA, 2011). 3.2.2. Mannitol Mannitol (E 421) is a naturally occurring sugar alcohol derived from fructose hydrogenation. It is commonly used in sugar-free products, pharmaceutical coatings, and as a stabilizer in medical applications. Approved under Regulation (EC) No 1333/2008, EFSA reaffirmed its safety in 2011, noting its low hygroscopicity, making it suitable for products requiring moisture resistance. However, excessive consumption (above 20g per day) can cause osmotic diarrhoea (EFSA, 2011). 3.2.3. Isomalt Isomalt (E 953) is a hydrogenated disaccharide alcohol derived from sucrose. It is frequently used as a bulking agent and stabilizer in sugar-free confectionery and baked goods. Isomalt is non-cariogenic and provides a suitable alternative to sucrose. While generally well tolerated, EFSA’s 2017 evaluation confirmed that excessive consumption (above 30g per day) can lead to laxative effects such as bloating and flatulence (EFSA, 2017). 3.2.4. Maltitol Maltitol (E 965), derived from maltose hydrogenation, is widely used in sugar-free chocolates, ice creams, and baked goods. It provides a sweetness similar to sucrose while reducing the risk of tooth decay. It has been approved under Regulation (EC) No 1333/2008, and EFSA’s 2017 review confirmed its safety. However, excessive consumption can lead to gastrointestinal discomfort, particularly in sensitive individuals (EFSA, 2017). 3.2.5. Lactitol Lactitol (E 966), derived from lactose hydrogenation, is used as a sweetener and bulking agent in sugar-free candies, ice cream, and baked goods. Its mild sweetness makes it a suitable alternative for people with diabetes. It retains moisture, improving texture. EFSA’s 2017 review reaffirmed its safety but noted that overconsumption can cause bloating and diarrhoea (EFSA, 2017). 3.2.6. Xylitol Xylitol (E 967), a natural sugar alcohol found in fruits and vegetables, is a widely used sweetener in chewing gum, oral care products, and confectionery. It has a cooling effect and retains moisture, preventing food from drying. While it is non-cariogenic and beneficial for dental health, overconsumption (above 40g per day) can cause laxative effects and impact gut microbiota (EFSA, 2017). 3.2.7. Erythritol Erythritol (E 968) is a fermentation-derived polyol found naturally in fruits. It is a low-calorie bulk sweetener in beverages, sugar-free confectionery, and functional foods. Approved in the EU in 2006 under Regulation (EC) No 1333/2008, EFSA’s 2015 assessment confirmed its safety profile, stating that it does not cause major gastrointestinal issues at standard consumption levels. Unlike other polyols, erythritol is absorbed in the small intestine and excreted unchanged, reducing digestive discomfort (EFSA, 2015). 3.2.8. Polydextrose Polydextrose (E 1200), a randomly bonded glucose polymer, is primarily used as a bulking agent and texturizer in baked goods, dairy products, and dietary fibre-enriched foods. Approved under Regulation (EC) No 1333/2008, EFSA’s 2021 re-evaluation confirmed its safety, noting that it has fibre-like properties. However, due to incomplete digestion, high doses can cause gastrointestinal discomfort and mild laxative effects (EFSA, 2021). 3.3. Sweetness Modifiers in the European Union While not always classified as direct sweeteners, sweetness modifiers enhance taste perception by masking bitterness or intensifying sweetness. Their regulatory approval falls under Regulation (EC) No 1333/2008, with EFSA ensuring compliance with ADI limits and public health safety standards (EFSA, 2021, 2022). 3.3.1. Aspartame Aspartame (E 951) is a dipeptide-based sweetener in sodas and sugar-free desserts. Due to historical concerns regarding neurotoxicity and carcinogenicity, EFSA's 2013 re-evaluation reaffirmed its safety within the established ADI of 40 mg/kg body weight (EFSA, 2013). However, aspartame products must display mandatory phenylalanine warnings for individuals with phenylketonuria (PKU) (European Commission, 2013). Table 3 Sweetness Modifiers: Functional and Regulatory Characteristics in the European Union E Number Substance Name Common Applications Textural & Technological Aspects ADI [kg body weight] Potential Health Risks Legislative Authorization References 1 Aspartame Diet sodas, sugar-free gum, desserts High-intensity sweetener 40 mg/kg body weight Individuals with phenylketonuria must avoid Regulation (EC) No 1333/2008; EFSA 2013 (EFSA, 2013; European Commission, 2008 2 Thaumatin Chewing gum, dairy products, desserts Natural sweetener and flavor modifier Not specified No safety concerns at current exposure levels Regulation (EC) No 1333/2008; EFSA 2021 EFSA, 2021; European Commission, 2008 3 Neohesperidine DC Beverages, desserts, chewing gum High-intensity sweetener with bitter aftertaste 20 mg/kg body weight No safety concerns at established ADI Regulation (EC) No 1333/2008; EFSA 2022 EFSA, 2022; European Commission, 2008 3.3.2. Thaumatin Thaumatin (E 957), a protein-derived sweetener and flavour modifier, is widely used in chewing gum, dairy products, and sugar-free confectionery. EFSA's 2021 evaluation confirmed that no ADI is required, as its metabolic breakdown poses no toxicological risk (EFSA, 2021). 3.3.3. Neohesperidine Dihydrochalcone Neohesperidine DC (E 959) is a citrus-derived sweetness enhancer with a bitter aftertaste. EFSA's 2022 assessment reaffirmed its safety within the ADI of 20 mg/kg body weight, confirming no significant health risks at approved consumption levels (EFSA, 2022). 4. Regulatory Landscape of Monk Fruit Extract: Global Perspectives 4.1. European Union The European Union (EU) regulates monk fruit extract (MFE) under the Novel Foods Regulation (EU) 2015/2283, requiring pre-market authorization for any food not widely consumed within the EU before May 1997 (EFSA, 2019). Despite its recognition as a natural sweetener in other global markets, monk fruit extract remains unapproved as a high-intensity sweetener in the EU, primarily due to insufficient long-term toxicological data (EFSA, 2024). The European Food Safety Authority (EFSA) has acknowledged the traditional use of monk fruit in herbal teas and aqueous extracts. Still, it has delayed approval for powdered or concentrated extracts due to concerns over metabolic effects and safety uncertainties (EFSA, 2024). While ensuring consumer safety, the EU’s precautionary approach creates significant barriers to food innovation, delaying industry adoption of monk fruit extract as a sugar alternative. 4.1.1. Traditional Aqueous Extract Monk fruit aqueous extract, derived from non-selective water decoctions, is permitted under traditional food use provisions (EFSA, 2024). This allows its use in herbal beverages and functional teas, provided consumption aligns with historical usage levels. 4.1.2. Powdered/Concentrated Extract (Sweetener) In contrast, powdered and concentrated monk fruit extract—which contains high-intensity mogrosides—is not approved as a food additive under Regulation (EC) No 1333/2008 (EFSA, 2019). Unlike steviol glycosides (Stevia), which were agreed upon following comprehensive industry-led safety assessments (EFSA, 2011), monk fruit extract has not yet undergone formal EFSA evaluation due to the absence of industry applications. The lack of an Acceptable Daily Intake (ADI) determination further restricts its use in sugar-free beverages, confectionery, and dairy products. Policy Challenge: EFSA’s stringent pre-market toxicological requirements have created a regulatory deadlock, preventing manufacturers from introducing monk fruit-based sweeteners into the EU market. While these measures prioritize consumer protection, they also stifle innovation and limit consumer choice compared to jurisdictions with more flexible approval pathways. 4.2. United Kingdom Following Brexit, the UK Food Standards Agency (FSA) now oversees novel food regulations, adopting a similar but more flexible approach than the EU (FSA, 2024). This has allowed for some regulatory divergence, though monk fruit extract remains unapproved as a sweetener pending further safety evaluations. 4.2.1. Traditional Aqueous Extract In June 2024, the FSA determined that aqueous monk fruit extract qualifies as a traditional food ingredient and does not require novel food authorization (FSA, 2024). This permits its use in herbal teas and functional food products, similar to EU regulations. 4.2.2. Powdered/Concentrated Extract (Sweetener) Due to insufficient toxicological data, the high-intensity powdered extract remains unapproved in the UK (FSA, 2024). However, the UK’s independent regulatory framework provides more significant potential for industry-led submissions, allowing for a faster approval process than the EU. The post-Brexit policy challenge is accelerating the approval of novel sweeteners; however, without industry engagement, MFE continues to face regulatory inertia, mirroring the situation in the EU. 4.3. United States Unlike the EU and UK, the United States Food and Drug Administration (FDA) has fully approved monk fruit extract under the Generally Recognized as Safe (GRAS) designation (FDA, 2010, 2022). This regulatory classification allows food manufacturers to use aqueous and powdered monk fruit extracts in various food and beverage products without additional pre-market approval. The aqueous extract is widely used in herbal teas and natural beverages without restrictions (FDA, 2010, 2022). Due to its established safety profile, the powdered and concentrated extract is approved as a high-intensity sweetener with no specific ADI set (FDA, 2022). The GRAS system expedites approvals based on historical consumption and industry-led safety assessments, reducing barriers to innovation. This has positioned the US as a leader in natural sweetener market adoption, allowing monk fruit extract to compete with artificial and caloric sweeteners. 4.4. China China has a long history of monk fruit in traditional medicine and functional foods. The National Health Commission (NHC) classifies monk fruit extract as a permitted food additive, approving its use in beverages, dairy, confectionery, and health supplements under GB 2760 − 2014 (NHC, 2023). Unlike the EU’s risk-averse approach, China’s regulatory framework prioritizes historical usage in food safety assessments (NHC, 2023). No specific ADI restrictions are enforced, reflecting the country’s broader policy of encouraging plant-based sugar alternatives to combat rising health concerns over excessive sugar consumption (WHO, 2022). China’s regulatory flexibility supports rapid market adoption of monk fruit extract, reinforcing its position as a global leader in natural sweetener production. 4.5. Comparative Analysis: Monk Fruit vs. Approved Natural Sweeteners The EU’s regulatory delays contrast with the rapid approval of other natural sweeteners such as Stevia and erythritol. Their approval histories provide insights into the barriers preventing monk fruit extract authorization. Sweetener EU Regulatory Status Approval Timeline Key Industry Factors Steviol Glycosides (Stevia) Approved (2011) 10 + years Strong industry support, comprehensive EFSA safety review (EFSA, 2011) Erythritol Approved (2008) 8 + years Established toxicological data, market familiarity (EFSA, 2008) Monk Fruit Extract Not approved No EFSA review Lack of industry application, regulatory inertia (EFSA, 2024) Key policy insights: Industry support has played a decisive role in obtaining approvals for stevia and erythritol. EFSA pre-marketing requirements are a significant barrier to new natural sweeteners. The lack of notifications from industry is the main reason why monk fruit extract remains unexplored by EFSA. 4.6. Policy Recommendations for the EU The EU's cautious regulatory approach to new sweeteners, while ensuring consumer safety, hinders innovation and sustainability need reforms to align with public health objectives and policies to reduce sugar consumption. Proposed Policy Adjustments: Incorporate international safety assessments (e.g., FDA GRAS evaluations) into EFSA’s review process. Adopt post-market surveillance models rather than pre-market restrictions, similar to US policy. Encourage industry-led applications for monk fruit extract approval. Enhance regulatory harmonization between EU, UK, and global food policies. Without regulatory adjustments, the EU risks falling behind in natural sweetener innovation, forcing manufacturers to rely on synthetic or caloric alternatives that may contradict public health and sustainability objectives (FAO, 2023). Conclusion The EU’s conservative approach to novel sweetener approvals creates a significant regulatory barrier for MFE, despite its global recognition as a safe and effective sugar alternative. While the EU prioritizes consumer protection, adopting a more adaptive regulatory framework—such as recognizing international safety evaluations—could enhance market access for innovative sweeteners while maintaining high safety standards. The implementation of regulatory challenges of MFE validation in the EU highlight considerable barriers to the deployment of functional food ingredients, despite their widespread recognition and acceptability in other global markets. The contrast between the strict EU regulation of novel foods and the more flexible US and Chinese frameworks highlights the need for a more risk-adaptive, evidence-based assessment approach. The current legislative inertia goes against EU policy on sugar reduction, and restricts access to natural, calorie-free sweeteners that have the potential to play a key role in the fight against obesity and metabolic disorders. In order to modernize regulatory avenues and support sustainable food innovation, the following steps should be considered: Integration of International Safety Assessments: Incorporating pre-existing safety evaluations from international agencies, such as the FDA’s Generally Recognized as Safe (GRAS) designation, into EFSA’s risk assessment processes. Industry Engagement and Incentivization: Encouraging food manufacturers to submit safety dossiers and regulatory applications for MFE to ensure comprehensive scientific evaluations. Implementation of Post-Market Monitoring Strategies: Adopting conditional approvals with ongoing safety evaluations, as practised in the United Kingdom and the United States, to accelerate market access while ensuring consumer protection. Regulatory Harmonization: Aligning EU novel food approval processes with international standards to improve efficiency, transparency, and consistency in food safety regulations. A more flexible, science-driven regulatory approach in the EU would facilitate the introduction of innovative, natural sugar alternatives such as MFE. This shift would support public health objectives, enhance consumer choice, and promote sustainability while ensuring the European food industry remains competitive globally. Strengths of the Study This study provides a complex, policy-oriented analysis of the legislative obstacles preventing the validation of MFEs in the European Union, by offering a critical side-by-side comparison with the International Regulatory Framework. Key advantages of this study include: Comparative regulatory analysis: By systematic comparison of EU food safety regulations with those in the United States, the United Kingdom and China, this study highlights regulatory inconsistencies that affect MFE adoption. This jurisdictional cross-sectional view provides useful insights for policymakers aiming to globally harmonize food laws. Policy-relevant insights: The study is aligned with current EU food policy objectives, such as the farm-to-table strategy and sugar reduction initiatives, highlighting the need to reforms the processes for approving novel foods. The policy suggestions provided are evidence-based, actionable and directly relevant to ongoing policy regulatory discussions. Focus on sustainable and health-promoting innovations: Following the rising demand for natural, calorie-free sweeteners, this study highlights the role of the regulatory flexibility in supporting healthier dietary choices. The results support a shift to more adaptive food safety frameworks that strike a balance between protecting consumers and food innovation. Emphasis on Industry Engagement: The study highlights the key role of industry application in the approval of new food ingredients. The identification of key barriers to industry contribution provides a roadmap for enhanced cooperation between regulatory agencies and food producers. Scientific Rigor and Evidence-Based Approach: The analysis is based on the authoritative regulatory documentation and scientific safety evaluations conducted by institutions such as EFSA, FDA and FSA. Consideration of the agreed risk assessment framework enhances the reliability and applicability of the study's findings and recommendations. This study is contributing to the broader discussion of food safety, regulatory efficiency and sustainable innovation in the European food system by relating to those aspects. Its results provide a valuable benchmark for policymakers, industry and public health stakeholders working for a sustainable and science-based regulation landscape. References European Commission. Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. Official Journal of the European Union. (2008) ; L 354:16–33. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008R1333 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2010) Scientific opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA J 8(5):1537. 10.2903/j.efsa.2010.1537 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2013) Scientific opinion on the re-evaluation of aspartame (E 951) as a food additive. EFSA J 11(12):3496. 10.2903/j.efsa.2013.3496 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2016) Scientific opinion on the re-evaluation of sucralose (E 955) as a food additive. EFSA J 14(12):4361. 10.2903/j.efsa.2016.4361 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2017) Scientific opinion on the re-evaluation of cyclamates (E 952) as a food additive. EFSA J 15(11):5113. 10.2903/j.efsa.2017.5113 [Accessed 18 February 2025] European Food Safety Authority (EFSA). Scientific opinion on the safety of sorbitol (E 420) and mannitol (E 421) as food additives. EFSA Journal. (2011) ; 9(4):2180, 2178. 10.2903/j.efsa.2011.2180 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2015) Scientific opinion on the safety of erythritol (E 968) as a food additive. EFSA J 13(7):4144. 10.2903/j.efsa.2015.4144 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2021) Re-evaluation of polydextrose (E 1200) as a food additive. EFSA J 19(3):6363. 10.2903/j.efsa.2021.6363 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2021) Scientific opinion on the re-evaluation of thaumatin (E 957) as a food additive. EFSA J 19(11):6884. 10.2903/j.efsa.2021.6884 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2022) Scientific opinion on the re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive. EFSA J 20(1):7595. 10.2903/j.efsa.2022.7595 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2024) Scientific opinion on the novel food status of monk fruit extract. EFSA J 22(1):7812. 10.2903/j.efsa.2024.7812 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2020) Risk assessment of novel foods: framework and methodologies. EFSA J 18(5):6112. 10.2903/j.efsa.2020.6112 [Accessed 18 February 2025] European Food Safety Authority (EFSA) (2023) Scientific opinion on the post-market reassessment of erythritol (E 968) and potential cardiovascular risks. EFSA J 21(2):7231. 10.2903/j.efsa.2023.7231 [Accessed 18 February 2025] Food Standards Agency (FSA). Novel Food Classification: Monk Fruit Extract. UK Government. (2024) Available from: https://www.food.gov.uk/ [Accessed 18 February 2025] U.S. Food and Drug Administration (FDA). GRAS Notification for monk fruit extract as a sweetener. FDA. (2010) Available from: https://www.fda.gov/food/gras-notice-inventory [Accessed 18 February 2025] U.S. Food and Drug Administration (FDA). Agency response letter GRN 999: Monk fruit extract. FDA. (2022) Available from: https://www.fda.gov/food/gras-notice-inventory [Accessed 18 February 2025] National Health Commission (NHC) of China Food Safety Standards GB 2760 – 2014. NHC. Available from: https://www.nhc.gov.cn/ [Accessed 18 February 2025] European Commission. Farm to Fork Strategy: Sustainable food system in the EU. European Commission. (2020) Available from: https://ec.europa.eu/food/farm2fork_en [Accessed 18 February 2025] FAO/WHO Joint Expert Committee on Food Additives (JECFA). Summary Report on Food Additive Evaluations. FAO/WHO. (2023) Available from: https://www.fao.org/food-safety/en/ [Accessed 18 February 2025] Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6218498","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Systematic Review","associatedPublications":[],"authors":[{"id":428253519,"identity":"68c5f053-0c88-432c-a389-ec87993b6b09","order_by":0,"name":"Urszula Kaim","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIiWNgGAWjYNCCAgYGCQbGBoYPCCELAloMIFoYZyCEJIjRwsDAzEOMFoPbxx9/5jGwY5BsP9y62bbNBihy+OAHxh14tJzLMTDmMUhmkOZJbLud25YGFElLlmA8g0fLGR6GZB4DZgY5BrCWwwxmZ3jMGBjb8Glhf3CYx6CeQY7/Ydtty7b/xGhhMGzmMTjMIC0BtIWx7QBhLZJneIwZ5xgc55Gc8bDtZs+5ZB77M2zJEol4/MJ3hv3xhzcV1XIS59Of3fhRZicn2cN88MPHHTY4tcAADyojsYGgDnTASLqWUTAKRsEoGL4AAG76Sokkk3bzAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0003-4757-4581","institution":"Wrocław University of Economics and Business,","correspondingAuthor":true,"prefix":"","firstName":"Urszula","middleName":"","lastName":"Kaim","suffix":""},{"id":428253520,"identity":"babb6ea0-84b5-40e9-ae07-7368f73a3d24","order_by":1,"name":"Urszula Gawlik","email":"","orcid":"https://orcid.org/0000-0002-7308-4335","institution":"University of Life Sciences in Lublin","correspondingAuthor":false,"prefix":"","firstName":"Urszula","middleName":"","lastName":"Gawlik","suffix":""}],"badges":[],"createdAt":"2025-03-13 09:23:58","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":true,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":true},"doi":"10.21203/rs.3.rs-6218498/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6218498/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":78819615,"identity":"ca864da3-c1b7-48c7-8068-9659fbbd12af","added_by":"auto","created_at":"2025-03-19 11:18:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":985184,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6218498/v1/9a622015-c860-449c-a95d-168a448551ca.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eIs Monk Fruit the Next Approved Natural Sweetener in the EU? Examining the Regulatory Process\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eThe global rise in metabolic disorders, including obesity, type 2 diabetes, and cardiovascular diseases, has intensified efforts to reduce added sugar consumption. The World Health Organization (WHO) recommends limiting free sugar intake to less than 10% of total daily energy consumption, with additional health benefits observed when reduced below 5% (WHO, 2022). As a result, the food industry has focused on natural, calorie-free sweeteners to satisfy consumers' desire for healthier options. However, regulatory challenges impact the accessibility and adoption of these options, shaping food markets and public health outcomes.\u003c/p\u003e \u003cp\u003eMonk fruit (\u003cem\u003eSiraitia grosvenorii\u003c/em\u003e) has been used in traditional medicine in China for centuries. Its extract contains mogrosides, a class of triterpene glycosides, primarily mogroside V, which is approximately 250 times sweeter than sucrose (Huang et al., 2024). Unlike caloric sweeteners, mogrosides do not elevate blood glucose levels, making monk fruit extract (MFE) a promising alternative for diabetes management and weight control (Arshad et al., 2022). Despite its entrenched safety and regulatory approval in the United States (US), the United Kingdom (UK), and China, MFE remains unapproved in the European Union (EU), highlighting policy inconsistencies in new food legislation and its food policy implications.\u003c/p\u003e \u003cp\u003eThe US Food and Drug Administration (FDA) has classified MFE as Generally Recognised as Safe (GRAS), allowing its widespread use in food products. Similarly, China's National Health Commission (NHC) has approved MFE as a food additive under GB 2760\u0026thinsp;\u0026minus;\u0026thinsp;2014, permitting its use across various food categories (NHC, 2023). However, under the EU Novel Food Regulation (EU 2015/2283), any food ingredient not significantly consumed in the EU before May 1997 must undergo rigorous safety evaluations before market authorisation (EFSA, 2019). The European Food Safety Authority (EFSA) has yet to approve MFE due to concerns over the absence of long-term toxicological data, particularly regarding genotoxicity (EFSA, 2023). The lack of an industry-led new food submission further delays regulatory authorisation, limiting European consumer access to this natural sweetener.\u003c/p\u003e \u003cp\u003eUnlike the US, which permits market access based on historical consumption and industry-led safety evaluations, the EU requires extensive pre-market safety data, even for substances with well-established international acceptance (EFSA, 2024; FDA, 2010). The precautionary approach intended to protect public health may hinder food innovation and delay the implementation of plant-based sweeteners such as MFE. These legislative inconsistencies create economic barriers for food producers and affect the competitiveness of the European food industry in global markets.\u003c/p\u003e \u003cp\u003eRecent debates on EU food policy reform suggest that a risk-benefit approach\u0026mdash;similar to the UK's post-market surveillance model\u0026mdash;could provide a sustainable regulatory framework (FSA, 2024; European Commission, 2020). Conditional approvals based on safety evaluations from other markets and continuous surveillance could help close the gap between regulatory efficacy and public health concerns. Steviol glycosides underwent similar pre-approval checks in 2011 following a comprehensive safety review by EFSA. Other functional ingredients, such as oat beta-glucans and algae-derived omega-3 fatty acids, transitioned from novel ingredients to recognised functional food components based on emerging scientific evidence and regulatory adaptability (EFSA, 2011; EFSA, 2020).\u003c/p\u003e \u003cp\u003eDespite the growing demands for natural-based and clean-label alternatives to sugar, MFE remains in regulatory limbo. The EU's approach contrasts with international markets and raises concerns about food system innovation, sugar reduction, and consumer health protection as part of the European Green Deal. Addressing these regulatory barriers requires increased industry engagement, streamlined approval processes, and greater alignment with international safety frameworks.\u003c/p\u003e \u003cp\u003eThis review examines the regulatory barriers preventing MFE's approval in the EU and compares its regulatory trajectory to previously approved sweeteners, such as steviol glycosides and erythritol. Analysing data from EU regulatory sources, this study provides insight into how MFE can be integrated into the European food market while balancing safety, sustainability, and public health objectives.\u003c/p\u003e"},{"header":"2. Materials and Methods","content":"\u003cp\u003eThis study employs a structured regulatory analysis to examine the approval status of non-caloric intense sweetening agents in the EU and identify the regulatory barriers preventing MFE market authorisation. The study follows a three-stage analytical framework involving (i) classification of authorised non-caloric sweeteners by chemical composition and regulatory status, (ii) comparative assessment of regulatory frameworks in the EU, US, and UK, and (iii) systematic extraction of regulatory data from official sources, including EU legislation, EFSA scientific opinions, FDA and FSA reports, and international food safety guidelines from Codex Alimentarius.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1. Study Design\u003c/h2\u003e \u003cp\u003eThis review shows a comparative legal and policy analysis methodology to identify key determinants influencing regulatory outcomes for MFE in the EU according to substances used and approved in the EU to enhance sweetness. Legal instruments and scientific evaluations were reviewed to assess regulatory differences in global jurisdictions.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003e2.2. Data Collection and Sources\u003c/h2\u003e \u003cp\u003eData were extracted from:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eEU legislation (\u003cem\u003eRegulation (EU) 2015/2283 on Novel Foods\u003c/em\u003e, \u003cem\u003eRegulation (EC) No 1333/2008 on food additives\u003c/em\u003e)\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eEFSA scientific opinions on non-caloric sweeteners and novel foods\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eFDA and FSA regulatory reports, including Generally Recognised as Safe (GRAS) determinations and novel food dossiers\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eCodex Alimentarius international food safety guidelines\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eAppropriate policy documentation was examined to evaluate the risk assessment framework approach, precautionary rules, and the function of industry propositions in structuring and validating approval processes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003e2.3. Data Analysis\u003c/h2\u003e \u003cp\u003eData were synthesised into regulatory comparison tables outlining:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eApproval status of non-caloric sweeteners in the EU, US, and UK\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eAcceptable Daily Intake (ADI) values and toxicological evaluation criteria\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eDifferences in pre-market safety assessment frameworks and post-market monitoring mechanisms\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eThis regulatory analysis identified 18 authorized sweetening substances in the EU, classified into three main categories: intense sweeteners, sugar alcohols (polyols), and sweetness modifiers. These compounds fall under Regulation (EC) No 1333/2008, which establishes permissible additives, their maximum usage levels, and safety evaluations conducted by the EFSA (European Commission, 2008). The EFSA assesses their toxicological profiles, Acceptable Daily Intake (ADI) values, and potential metabolic effects before approval (EFSA, 2011, 2016, 2017).\u003c/p\u003e \u003cp\u003eA comparative regulatory review of MFE revealed inconsistencies in its approval across different jurisdictions. The EU recognizes monk fruit aqueous extract as a traditional food under the Novel Foods Regulation (EU 2015/2283), allowing its use in herbal beverages. However, powdered or concentrated MFE formulations\u0026mdash;which contain high mogrosides\u0026mdash;remain unapproved due to insufficient industry-submitted safety data (EFSA, 2024). This regulatory discrepancy highlights the challenges of approving novel sweeteners, especially in cases where natural extracts undergo different processing methods (FSA, 2024).\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003e3.1. Intense Sweetening Agents in the European Union\u003c/h2\u003e \u003cp\u003eIntense sweeteners are high-potency compounds that impart sweetness without contributing significant caloric value and are widely used in beverages, sugar-free products, and low-calorie formulations. Their approval in the EU is regulated under Regulation (EC) No 1333/2008, with periodic EFSA safety evaluations assessing their toxicology, metabolism, and long-term health risks (EFSA, 2010, 2016, 2017).\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003e3.1.1. Acesulfame K\u003c/h2\u003e \u003cp\u003eAcesulfame K (E950)is a heat-stable, high-intensity sweetener commonly used in soft drinks, dairy products, and confectionery. It was approved under Regulation (EC) No 1333/2008 and reassessed by EFSA in 2017, which confirmed its safety within the established ADI. However, some research has suggested potential effects on gut microbiota and reports of a bitter aftertaste at high concentrations (EFSA, 2017).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003e3.1.2. Sucralose\u003c/h2\u003e \u003cp\u003eSucralose (E 955) is widely used in baking, beverages, and dairy applications due to its high solubility and thermal stability. It was first approved under Regulation (EC) No 1333/2008, with a safety re-evaluation by EFSA in 2016. While EFSA maintained the ADI of 5 mg/kg body weight, concerns have emerged regarding its potential to alter gut microbiota at high doses. However, no significant public health risks have been identified when used within approved intake levels (EFSA, 2016).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003e3.1.3. Steviol Glycosides\u003c/h2\u003e \u003cp\u003eDerived from the Stevia rebaudiana plant, steviol glycosides (E 960a) are considered natural sugar substitutes with widespread use in beverages and food products. While they are thermally stable, they may impart a mild liquorice-like aftertaste. EFSA's 2010 safety evaluation established an ADI of 4 mg/kg body weight, affirming their safety within regulatory limits (EFSA, 2010).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003e3.1.4. Neotame\u003c/h2\u003e \u003cp\u003eNeotame (E 961) is a strong sweetener, used mainly in diet beverages and chewing gum, often combined with additional sweeteners to improve the profile of sweetness. It was authorized under Regulation (EU) No 231/2012, with safety evaluations conducted by EFSA (2010) and JECFA (2003) confirming that no adverse health effects occur at the approved ADI of 2 mg/kg body weight (EFSA, 2010; JECFA, 2003).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Regulatory Status and Safety Evaluation of Intense Sweetening Agents in the European Union.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eName\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCommon Applications\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTextural \u0026amp; Technological Aspects\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eADI\u003c/p\u003e \u003cp\u003e[kg bw/day]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePotential Health Risks\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eGut Microbiota Influence\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eReferences\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAcesulfame K\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSoft drinks, dairy products, confectionery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eHigh stability, synergistic with other sweeteners\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15 mg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePossible effect on gut microbiota, bitter aftertaste\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eMinimal effect at approved intake levels\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2017)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSucralose\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaking, soft drinks, dairy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eHighly soluble, thermally stable, no bulk contribution\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 mg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePotential gut microbiota disruption, debated long-term safety\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003ePotential microbiota alterations at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2016)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSteviol Glycosides\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNatural sugar substitute, beverages\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStable at high temperatures, slight licorice-like aftertaste\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 mg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMild gastrointestinal discomfort in high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eNo adverse impact at approved doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2010)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNeotame\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDiet beverages, chewing gum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSynergistic with other 6sweeteners, m7inimal bulk 8impact\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 mg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eNo known impact at approved levels\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2010), JECFA (2003)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAdvantame\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaked goods, chewing gum, dairy, sugar-free beverages\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eUl9tra-high potency, heat-stable, minimal textural impact\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 mg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eInsufficient data on metabolic effects\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eNo adverse effects at approved ADI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2013), JECFA (2013), FDA (2014)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCyclamates\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSoft drinks, bakery products\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEnhances volume, retains moisture, re-evaluated by EFSA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 mg\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePreviously linked to bladder cancer, EFSA re-evaluated (2017)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eLimited data, but no confirmed adverse effects\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2017)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"8\"\u003e. ADI - Acceptable Daily Intake,\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003e3.1.5. Cyclamates\u003c/h2\u003e \u003cp\u003eCyclamates (E 952), commonly used in soft drinks and baked goods, have undergone multiple safety reassessments due to historical concerns regarding potential carcinogenic effects. Although they were previously linked to bladder cancer, EFSA's 2017 review reaffirmed their safety, maintaining an ADI of 7 mg/kg body weight with no confirmed adverse effects within approved intake levels (EFSA, 2017).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e3.2. Sugar Alcohols (Polyols) in the EU\u003c/h2\u003e \u003cp\u003eSugar alcohols (polyols) are sweeteners that promote texture, consistency and retention of moisture in foods. Unlike intensive sweeteners, polyols ensure a certain caloric value, but provide a reduced glycaemic response. Their regulatory approval falls under Regulation (EC) No 1333/2008, with EFSA routinely assessing their safety, metabolic impact, and gastrointestinal tolerance (EFSA, 2011, 2017). ADI is not specified for polyols as they are generally recognized as safe, but excessive consumption may cause gastrointestinal effects (EFSA, 2011; EFSA, 2015; EFSA, 2021).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eClassification, Applications, and Safety Profiles of Sugar Alcohols (Polyols) in the European Union.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNumber\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eName\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCommon Applications\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTextural \u0026amp; Technological Aspects\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCaloric [kcal/g)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePotential Health Risks\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eReferences\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSorbitol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSugar-free candies, chewing gums, baked goods\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eHumectant, texturizer, stabilizer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eGastrointestinal discomfort at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2011)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMannitol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSugar-free candies, pharmaceuticals\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAnti-caking agent, stabilizer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eLaxative effect at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2011)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIsomalt\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eConfectionery, baked goods\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBulking agent, stabilizer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eLaxative effect at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2017)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMaltitol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSugar-free chocolates, desserts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSweetener, texturizer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eLaxative effect at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2017)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLactitol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSugar-free candies, baked goods\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSweetener, bulking agent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eLaxative effect at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2017)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eXylitol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eChewing gums, oral care products\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSweetener, moisture retention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e2.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eLaxative effect at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2017)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eErythritol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBeverages, confectionery\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eSweetener, bulking agent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e0.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eGastrointestinal discomfort at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2015)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePolydextrose\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBaked goods, desserts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eBulking agent, texturizer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eGastrointestinal discomfort at high doses\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA (2021)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec14\" class=\"Section3\"\u003e \u003ch2\u003e3.2.1. Sorbitol\u003c/h2\u003e \u003cp\u003eSorbitol (E 420), a polyol derived from glucose, is widely used in sugar-free confectionery, pharmaceuticals, and personal care products due to its humectant and stabilizing properties. It retains moisture, improving the texture and shelf-life of food products. EFSA\u0026rsquo;s 2011 re-evaluation confirmed its safety but warned that excessive consumption (above 20g per day) may cause gastrointestinal discomfort, including bloating and diarrhoea (EFSA, 2011).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section3\"\u003e \u003ch2\u003e3.2.2. Mannitol\u003c/h2\u003e \u003cp\u003eMannitol (E 421) is a naturally occurring sugar alcohol derived from fructose hydrogenation. It is commonly used in sugar-free products, pharmaceutical coatings, and as a stabilizer in medical applications. Approved under Regulation (EC) No 1333/2008, EFSA reaffirmed its safety in 2011, noting its low hygroscopicity, making it suitable for products requiring moisture resistance. However, excessive consumption (above 20g per day) can cause osmotic diarrhoea (EFSA, 2011).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003e3.2.3. Isomalt\u003c/h2\u003e \u003cp\u003eIsomalt (E 953) is a hydrogenated disaccharide alcohol derived from sucrose. It is frequently used as a bulking agent and stabilizer in sugar-free confectionery and baked goods. Isomalt is non-cariogenic and provides a suitable alternative to sucrose. While generally well tolerated, EFSA\u0026rsquo;s 2017 evaluation confirmed that excessive consumption (above 30g per day) can lead to laxative effects such as bloating and flatulence (EFSA, 2017).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003e3.2.4. Maltitol\u003c/h2\u003e \u003cp\u003eMaltitol (E 965), derived from maltose hydrogenation, is widely used in sugar-free chocolates, ice creams, and baked goods. It provides a sweetness similar to sucrose while reducing the risk of tooth decay. It has been approved under Regulation (EC) No 1333/2008, and EFSA\u0026rsquo;s 2017 review confirmed its safety. However, excessive consumption can lead to gastrointestinal discomfort, particularly in sensitive individuals (EFSA, 2017).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003e3.2.5. Lactitol\u003c/h2\u003e \u003cp\u003eLactitol (E 966), derived from lactose hydrogenation, is used as a sweetener and bulking agent in sugar-free candies, ice cream, and baked goods. Its mild sweetness makes it a suitable alternative for people with diabetes. It retains moisture, improving texture. EFSA\u0026rsquo;s 2017 review reaffirmed its safety but noted that overconsumption can cause bloating and diarrhoea (EFSA, 2017).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section3\"\u003e \u003ch2\u003e3.2.6. Xylitol\u003c/h2\u003e \u003cp\u003eXylitol (E 967), a natural sugar alcohol found in fruits and vegetables, is a widely used sweetener in chewing gum, oral care products, and confectionery. It has a cooling effect and retains moisture, preventing food from drying. While it is non-cariogenic and beneficial for dental health, overconsumption (above 40g per day) can cause laxative effects and impact gut microbiota (EFSA, 2017).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section3\"\u003e \u003ch2\u003e3.2.7. Erythritol\u003c/h2\u003e \u003cp\u003eErythritol (E 968) is a fermentation-derived polyol found naturally in fruits. It is a low-calorie bulk sweetener in beverages, sugar-free confectionery, and functional foods. Approved in the EU in 2006 under Regulation (EC) No 1333/2008, EFSA\u0026rsquo;s 2015 assessment confirmed its safety profile, stating that it does not cause major gastrointestinal issues at standard consumption levels. Unlike other polyols, erythritol is absorbed in the small intestine and excreted unchanged, reducing digestive discomfort (EFSA, 2015).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section3\"\u003e \u003ch2\u003e3.2.8. Polydextrose\u003c/h2\u003e \u003cp\u003ePolydextrose (E 1200), a randomly bonded glucose polymer, is primarily used as a bulking agent and texturizer in baked goods, dairy products, and dietary fibre-enriched foods. Approved under Regulation (EC) No 1333/2008, EFSA\u0026rsquo;s 2021 re-evaluation confirmed its safety, noting that it has fibre-like properties. However, due to incomplete digestion, high doses can cause gastrointestinal discomfort and mild laxative effects (EFSA, 2021).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003e3.3. Sweetness Modifiers in the European Union\u003c/h2\u003e \u003cp\u003eWhile not always classified as direct sweeteners, sweetness modifiers enhance taste perception by masking bitterness or intensifying sweetness. Their regulatory approval falls under Regulation (EC) No 1333/2008, with EFSA ensuring compliance with ADI limits and public health safety standards (EFSA, 2021, 2022).\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003e3.3.1. Aspartame\u003c/h2\u003e \u003cp\u003eAspartame (E 951) is a dipeptide-based sweetener in sodas and sugar-free desserts. Due to historical concerns regarding neurotoxicity and carcinogenicity, EFSA's 2013 re-evaluation reaffirmed its safety within the established ADI of 40 mg/kg body weight (EFSA, 2013). However, aspartame products must display mandatory phenylalanine warnings for individuals with phenylketonuria (PKU) (European Commission, 2013).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSweetness Modifiers: Functional and Regulatory Characteristics in the European Union\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"8\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eE Number\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSubstance Name\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eCommon Applications\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eTextural \u0026amp; Technological Aspects\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eADI\u003c/p\u003e \u003cp\u003e[kg body weight]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ePotential Health Risks\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e \u003cp\u003eLegislative Authorization\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c8\"\u003e \u003cp\u003eReferences\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAspartame\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDiet sodas, sugar-free gum, desserts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eHigh-intensity sweetener\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e40 mg/kg body weight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eIndividuals with phenylketonuria must avoid\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRegulation (EC) No 1333/2008; EFSA 2013\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003e(EFSA, 2013; European Commission, 2008\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThaumatin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eChewing gum, dairy products, desserts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNatural sweetener and flavor modifier\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNot specified\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNo safety concerns at current exposure levels\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRegulation (EC) No 1333/2008; EFSA 2021\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA, 2021; European Commission, 2008\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNeohesperidine DC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eBeverages, desserts, chewing gum\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eHigh-intensity sweetener with bitter aftertaste\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e20 mg/kg body weight\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNo safety concerns at established ADI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eRegulation (EC) No 1333/2008; EFSA 2022\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c8\"\u003e \u003cp\u003eEFSA, 2022; European Commission, 2008\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section3\"\u003e \u003ch2\u003e3.3.2. Thaumatin\u003c/h2\u003e \u003cp\u003eThaumatin (E 957), a protein-derived sweetener and flavour modifier, is widely used in chewing gum, dairy products, and sugar-free confectionery. EFSA's 2021 evaluation confirmed that no ADI is required, as its metabolic breakdown poses no toxicological risk (EFSA, 2021).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003e3.3.3. Neohesperidine Dihydrochalcone\u003c/h2\u003e \u003cp\u003eNeohesperidine DC (E 959) is a citrus-derived sweetness enhancer with a bitter aftertaste. EFSA's 2022 assessment reaffirmed its safety within the ADI of 20 mg/kg body weight, confirming no significant health risks at approved consumption levels (EFSA, 2022).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"4. Regulatory Landscape of Monk Fruit Extract: Global Perspectives","content":"\u003cdiv id=\"Sec27\" class=\"Section2\"\u003e \u003ch2\u003e4.1. European Union\u003c/h2\u003e \u003cp\u003eThe European Union (EU) regulates monk fruit extract (MFE) under the Novel Foods Regulation (EU) 2015/2283, requiring pre-market authorization for any food not widely consumed within the EU before May 1997 (EFSA, 2019). Despite its recognition as a natural sweetener in other global markets, monk fruit extract remains unapproved as a high-intensity sweetener in the EU, primarily due to insufficient long-term toxicological data (EFSA, 2024).\u003c/p\u003e \u003cp\u003eThe European Food Safety Authority (EFSA) has acknowledged the traditional use of monk fruit in herbal teas and aqueous extracts. Still, it has delayed approval for powdered or concentrated extracts due to concerns over metabolic effects and safety uncertainties (EFSA, 2024). While ensuring consumer safety, the EU\u0026rsquo;s precautionary approach creates significant barriers to food innovation, delaying industry adoption of monk fruit extract as a sugar alternative.\u003c/p\u003e \u003cdiv id=\"Sec28\" class=\"Section3\"\u003e \u003ch2\u003e4.1.1. Traditional Aqueous Extract\u003c/h2\u003e \u003cp\u003eMonk fruit aqueous extract, derived from non-selective water decoctions, is permitted under traditional food use provisions (EFSA, 2024). This allows its use in herbal beverages and functional teas, provided consumption aligns with historical usage levels.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section3\"\u003e \u003ch2\u003e4.1.2. Powdered/Concentrated Extract (Sweetener)\u003c/h2\u003e \u003cp\u003eIn contrast, powdered and concentrated monk fruit extract\u0026mdash;which contains high-intensity mogrosides\u0026mdash;is not approved as a food additive under Regulation (EC) No 1333/2008 (EFSA, 2019). Unlike steviol glycosides (Stevia), which were agreed upon following comprehensive industry-led safety assessments (EFSA, 2011), monk fruit extract has not yet undergone formal EFSA evaluation due to the absence of industry applications. The lack of an Acceptable Daily Intake (ADI) determination further restricts its use in sugar-free beverages, confectionery, and dairy products.\u003c/p\u003e \u003cp\u003ePolicy Challenge:\u003c/p\u003e \u003cp\u003eEFSA\u0026rsquo;s stringent pre-market toxicological requirements have created a regulatory deadlock, preventing manufacturers from introducing monk fruit-based sweeteners into the EU market. While these measures prioritize consumer protection, they also stifle innovation and limit consumer choice compared to jurisdictions with more flexible approval pathways.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec30\" class=\"Section2\"\u003e \u003ch2\u003e4.2. United Kingdom\u003c/h2\u003e \u003cp\u003eFollowing Brexit, the UK Food Standards Agency (FSA) now oversees novel food regulations, adopting a similar but more flexible approach than the EU (FSA, 2024). This has allowed for some regulatory divergence, though monk fruit extract remains unapproved as a sweetener pending further safety evaluations.\u003c/p\u003e \u003cdiv id=\"Sec31\" class=\"Section3\"\u003e \u003ch2\u003e4.2.1. Traditional Aqueous Extract\u003c/h2\u003e \u003cp\u003eIn June 2024, the FSA determined that aqueous monk fruit extract qualifies as a traditional food ingredient and does not require novel food authorization (FSA, 2024). This permits its use in herbal teas and functional food products, similar to EU regulations.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec32\" class=\"Section3\"\u003e \u003ch2\u003e4.2.2. Powdered/Concentrated Extract (Sweetener)\u003c/h2\u003e \u003cp\u003eDue to insufficient toxicological data, the high-intensity powdered extract remains unapproved in the UK (FSA, 2024). However, the UK\u0026rsquo;s independent regulatory framework provides more significant potential for industry-led submissions, allowing for a faster approval process than the EU.\u003c/p\u003e \u003cp\u003eThe post-Brexit policy challenge is accelerating the approval of novel sweeteners; however, without industry engagement, MFE continues to face regulatory inertia, mirroring the situation in the EU.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec33\" class=\"Section2\"\u003e \u003ch2\u003e4.3. United States\u003c/h2\u003e \u003cp\u003eUnlike the EU and UK, the United States Food and Drug Administration (FDA) has fully approved monk fruit extract under the Generally Recognized as Safe (GRAS) designation (FDA, 2010, 2022). This regulatory classification allows food manufacturers to use aqueous and powdered monk fruit extracts in various food and beverage products without additional pre-market approval.\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe aqueous extract is widely used in herbal teas and natural beverages without restrictions (FDA, 2010, 2022).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eDue to its established safety profile, the powdered and concentrated extract is approved as a high-intensity sweetener with no specific ADI set (FDA, 2022).\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eThe GRAS system expedites approvals based on historical consumption and industry-led safety assessments, reducing barriers to innovation. This has positioned the US as a leader in natural sweetener market adoption, allowing monk fruit extract to compete with artificial and caloric sweeteners.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec34\" class=\"Section2\"\u003e \u003ch2\u003e4.4. China\u003c/h2\u003e \u003cp\u003eChina has a long history of monk fruit in traditional medicine and functional foods. The National Health Commission (NHC) classifies monk fruit extract as a permitted food additive, approving its use in beverages, dairy, confectionery, and health supplements under GB 2760\u0026thinsp;\u0026minus;\u0026thinsp;2014 (NHC, 2023).\u003c/p\u003e \u003cp\u003eUnlike the EU\u0026rsquo;s risk-averse approach, China\u0026rsquo;s regulatory framework prioritizes historical usage in food safety assessments (NHC, 2023). No specific ADI restrictions are enforced, reflecting the country\u0026rsquo;s broader policy of encouraging plant-based sugar alternatives to combat rising health concerns over excessive sugar consumption (WHO, 2022).\u003c/p\u003e \u003cp\u003eChina\u0026rsquo;s regulatory flexibility supports rapid market adoption of monk fruit extract, reinforcing its position as a global leader in natural sweetener production.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec35\" class=\"Section2\"\u003e \u003ch2\u003e4.5. Comparative Analysis: Monk Fruit vs. Approved Natural Sweeteners\u003c/h2\u003e \u003cp\u003eThe EU\u0026rsquo;s regulatory delays contrast with the rapid approval of other natural sweeteners such as Stevia and erythritol. Their approval histories provide insights into the barriers preventing monk fruit extract authorization.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSweetener\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEU Regulatory Status\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eApproval Timeline\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eKey Industry Factors\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSteviol Glycosides (Stevia)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eApproved (2011)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10\u0026thinsp;+\u0026thinsp;years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStrong industry support, comprehensive EFSA safety review (EFSA, 2011)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eErythritol\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eApproved (2008)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u0026thinsp;+\u0026thinsp;years\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eEstablished toxicological data, market familiarity (EFSA, 2008)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMonk Fruit Extract\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNot approved\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNo EFSA review\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eLack of industry application, regulatory inertia (EFSA, 2024)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \n\u003cp\u003eKey policy insights:\u003c/p\u003e\n\u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eIndustry support has played a decisive role in obtaining approvals for stevia and erythritol.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eEFSA pre-marketing requirements are a significant barrier to new natural sweeteners.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eThe lack of notifications from industry is the main reason why monk fruit extract remains unexplored by EFSA.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec36\" class=\"Section2\"\u003e \u003ch2\u003e4.6. Policy Recommendations for the EU\u003c/h2\u003e \u003cp\u003eThe EU's cautious regulatory approach to new sweeteners, while ensuring consumer safety, hinders innovation and sustainability need reforms to align with public health objectives and policies to reduce sugar consumption.\u003c/p\u003e \u003cp\u003eProposed Policy Adjustments:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eIncorporate international safety assessments (e.g., FDA GRAS evaluations) into EFSA\u0026rsquo;s review process.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eAdopt post-market surveillance models rather than pre-market restrictions, similar to US policy.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eEncourage industry-led applications for monk fruit extract approval.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eEnhance regulatory harmonization between EU, UK, and global food policies.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eWithout regulatory adjustments, the EU risks falling behind in natural sweetener innovation, forcing manufacturers to rely on synthetic or caloric alternatives that may contradict public health and sustainability objectives (FAO, 2023).\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe EU\u0026rsquo;s conservative approach to novel sweetener approvals creates a significant regulatory barrier for MFE, despite its global recognition as a safe and effective sugar alternative. While the EU prioritizes consumer protection, adopting a more adaptive regulatory framework\u0026mdash;such as recognizing international safety evaluations\u0026mdash;could enhance market access for innovative sweeteners while maintaining high safety standards.\u003c/p\u003e \u003cp\u003eThe implementation of regulatory challenges of MFE validation in the EU highlight considerable barriers to the deployment of functional food ingredients, despite their widespread recognition and acceptability in other global markets. The contrast between the strict EU regulation of novel foods and the more flexible US and Chinese frameworks highlights the need for a more risk-adaptive, evidence-based assessment approach. The current legislative inertia goes against EU policy on sugar reduction, and restricts access to natural, calorie-free sweeteners that have the potential to play a key role in the fight against obesity and metabolic disorders.\u003c/p\u003e \u003cp\u003eIn order to modernize regulatory avenues and support sustainable food innovation, the following steps should be considered:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eIntegration of International Safety Assessments: Incorporating pre-existing safety evaluations from international agencies, such as the FDA\u0026rsquo;s \u003cem\u003eGenerally Recognized as Safe (GRAS)\u003c/em\u003e designation, into EFSA\u0026rsquo;s risk assessment processes.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eIndustry Engagement and Incentivization: Encouraging food manufacturers to submit safety dossiers and regulatory applications for MFE to ensure comprehensive scientific evaluations.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eImplementation of Post-Market Monitoring Strategies: Adopting conditional approvals with ongoing safety evaluations, as practised in the United Kingdom and the United States, to accelerate market access while ensuring consumer protection.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eRegulatory Harmonization: Aligning EU novel food approval processes with international standards to improve efficiency, transparency, and consistency in food safety regulations.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eA more flexible, science-driven regulatory approach in the EU would facilitate the introduction of innovative, natural sugar alternatives such as MFE. This shift would support public health objectives, enhance consumer choice, and promote sustainability while ensuring the European food industry remains competitive globally.\u003c/p\u003e \u003cp\u003e \u003cb\u003eStrengths of the Study\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThis study provides a complex, policy-oriented analysis of the legislative obstacles preventing the validation of MFEs in the European Union, by offering a critical side-by-side comparison with the International Regulatory Framework. Key advantages of this study include:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eComparative regulatory analysis: By systematic comparison of EU food safety regulations with those in the United States, the United Kingdom and China, this study highlights regulatory inconsistencies that affect MFE adoption. This jurisdictional cross-sectional view provides useful insights for policymakers aiming to globally harmonize food laws.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003ePolicy-relevant insights: The study is aligned with current EU food policy objectives, such as the farm-to-table strategy and sugar reduction initiatives, highlighting the need to reforms the processes for approving novel foods. The policy suggestions provided are evidence-based, actionable and directly relevant to ongoing policy regulatory discussions.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eFocus on sustainable and health-promoting innovations: Following the rising demand for natural, calorie-free sweeteners, this study highlights the role of the regulatory flexibility in supporting healthier dietary choices. The results support a shift to more adaptive food safety frameworks that strike a balance between protecting consumers and food innovation.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eEmphasis on Industry Engagement: The study highlights the key role of industry application in the approval of new food ingredients. The identification of key barriers to industry contribution provides a roadmap for enhanced cooperation between regulatory agencies and food producers.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003eScientific Rigor and Evidence-Based Approach: The analysis is based on the authoritative regulatory documentation and scientific safety evaluations conducted by institutions such as EFSA, FDA and FSA. Consideration of the agreed risk assessment framework enhances the reliability and applicability of the study's findings and recommendations.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003cp\u003eThis study is contributing to the broader discussion of food safety, regulatory efficiency and sustainable innovation in the European food system by relating to those aspects. Its results provide a valuable benchmark for policymakers, industry and public health stakeholders working for a sustainable and science-based regulation landscape.\u003c/p\u003e "},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eEuropean Commission. Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives. Official Journal of the European Union. (2008) ; L 354:16\u0026ndash;33. Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008R1333\u003c/span\u003e\u003cspan address=\"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32008R1333\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2010) Scientific opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA J 8(5):1537. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2010.1537\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2010.1537\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2013) Scientific opinion on the re-evaluation of aspartame (E 951) as a food additive. EFSA J 11(12):3496. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2013.3496\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2013.3496\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2016) Scientific opinion on the re-evaluation of sucralose (E 955) as a food additive. EFSA J 14(12):4361. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2016.4361\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2016.4361\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2017) Scientific opinion on the re-evaluation of cyclamates (E 952) as a food additive. EFSA J 15(11):5113. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2017.5113\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2017.5113\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA). Scientific opinion on the safety of sorbitol (E 420) and mannitol (E 421) as food additives. EFSA Journal. (2011) ; 9(4):2180, 2178. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2011.2180\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2011.2180\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2015) Scientific opinion on the safety of erythritol (E 968) as a food additive. EFSA J 13(7):4144. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2015.4144\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2015.4144\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2021) Re-evaluation of polydextrose (E 1200) as a food additive. EFSA J 19(3):6363. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2021.6363\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2021.6363\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2021) Scientific opinion on the re-evaluation of thaumatin (E 957) as a food additive. EFSA J 19(11):6884. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2021.6884\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2021.6884\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2022) Scientific opinion on the re-evaluation of neohesperidine dihydrochalcone (E 959) as a food additive. EFSA J 20(1):7595. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2022.7595\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2022.7595\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2024) Scientific opinion on the novel food status of monk fruit extract. EFSA J 22(1):7812. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2024.7812\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2024.7812\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2020) Risk assessment of novel foods: framework and methodologies. EFSA J 18(5):6112. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2020.6112\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2020.6112\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Food Safety Authority (EFSA) (2023) Scientific opinion on the post-market reassessment of erythritol (E 968) and potential cardiovascular risks. EFSA J 21(2):7231. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2903/j.efsa.2023.7231\u003c/span\u003e\u003cspan address=\"10.2903/j.efsa.2023.7231\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e[Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFood Standards Agency (FSA). Novel Food Classification: Monk Fruit Extract. UK Government. (2024) Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.food.gov.uk/\u003c/span\u003e\u003cspan address=\"https://www.food.gov.uk/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eU.S. Food and Drug Administration (FDA). GRAS Notification for monk fruit extract as a sweetener. FDA. (2010) Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.fda.gov/food/gras-notice-inventory\u003c/span\u003e\u003cspan address=\"https://www.fda.gov/food/gras-notice-inventory\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eU.S. Food and Drug Administration (FDA). Agency response letter GRN 999: Monk fruit extract. FDA. (2022) Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.fda.gov/food/gras-notice-inventory\u003c/span\u003e\u003cspan address=\"https://www.fda.gov/food/gras-notice-inventory\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNational Health Commission (NHC) of China Food Safety Standards GB 2760\u0026thinsp;\u0026ndash;\u0026thinsp;2014. \u003cem\u003eNHC.\u003c/em\u003e Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.nhc.gov.cn/\u003c/span\u003e\u003cspan address=\"https://www.nhc.gov.cn/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEuropean Commission. Farm to Fork Strategy: Sustainable food system in the EU. European Commission. (2020) Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://ec.europa.eu/food/farm2fork_en\u003c/span\u003e\u003cspan address=\"https://ec.europa.eu/food/farm2fork_en\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFAO/WHO Joint Expert Committee on Food Additives (JECFA). Summary Report on Food Additive Evaluations. FAO/WHO. (2023) Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.fao.org/food-safety/en/\u003c/span\u003e\u003cspan address=\"https://www.fao.org/food-safety/en/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e [Accessed 18 February 2025]\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Wroclaw University of Economics and Business","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Food additives, sweeteners, European Union regulation, EFSA, food policy, sugar alternatives, novel foods","lastPublishedDoi":"10.21203/rs.3.rs-6218498/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6218498/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eSweeteners 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).\u003c/p\u003e \u003cp\u003eThis 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\u0026rsquo;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).\u003c/p\u003e \u003cp\u003eEighteen 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\u0026rsquo;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\u0026rsquo;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.\u003c/p\u003e \u003cp\u003eAs 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.\u003c/p\u003e \u003cp\u003eThe 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.\u003c/p\u003e \u003cp\u003eThis 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.\u003c/p\u003e","manuscriptTitle":"Is Monk Fruit the Next Approved Natural Sweetener in the EU? Examining the Regulatory Process","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-03-19 11:10:09","doi":"10.21203/rs.3.rs-6218498/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d04009b7-2a7f-4157-95c7-f65c5b2b6531","owner":[],"postedDate":"March 19th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":45625475,"name":"Food Science \u0026 Technology"}],"tags":[],"updatedAt":"2025-03-19T11:10:09+00:00","versionOfRecord":[],"versionCreatedAt":"2025-03-19 11:10:09","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6218498","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6218498","identity":"rs-6218498","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}