About
Monk fruit extract is a natural, non-caloric high-intensity sweetener derived from the fruit of Siraitia grosvenorii Swingle, a plant native to southern China traditionally known as Luo Han Guo. Its sweetness arises from cucurbitane glycosides called mogrosides (primarily mogroside V), which render the extract 100–400 times sweeter than sugar depending on mogroside V concentration.
Safety summary
The FDA has granted GRAS status to multiple monk fruit extract formulations and has not specified an ADI, noting safety is well-established at levels well above those needed for sweetening. EFSA's 2019 opinion found the toxicological database insufficient for high-purity food additive authorization, citing unresolved testicular effects in a 90-day rat study and missing chronic/carcinogenicity data; however, EFSA issued a positive safety opinion for a specific aqueous extract in 2024, leading to EU authorization under Regulation (EU) 2024/2345 for that form only. Systematic review of human RCTs confirms no severe adverse effects and potential reductions in postprandial glucose (10–18%) and insulin response (12–22%).
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | As of October 2024, only one specific aqueous extract has been authorised as a novel food under Commission Implementing Regulation (EU) 2024/2345. Highly purified mogrosides and non-aqueous extracts remain unapproved due to gaps in toxicological data and absence of industry-led applications. No E-number assigned. Authorization pathway for use as a conventional food additive (high-purity forms) remains paused at EFSA scientific risk assessment stage due to missing chronic/carcinogenicity data.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Restricted | Non-selective aqueous decoctions of monk fruit (fresh/dried fruit of Siraitia grosvenorii) recognised as non-novel foods in England and Wales (FSA, June 2024) based on evidence of significant pre-1997 consumption. Food Standards Scotland will issue a separate determination. Concentrated monk fruit extracts intended as high-intensity sweeteners remain unapproved and require novel food authorisation.source |
| National Health Commission (NHC) (China) | Approved | Listed under GB 2760-2014 as a permitted food additive in beverages, confectionery, and health supplements. China's regulatory framework relies on the long history of monk fruit as both a traditional medicine and food ingredient, allowing use without the extensive toxicological testing required in other regions.source |
Who should approach with care
Research citations
- 1FDA. High-Intensity Sweeteners – FDA. fda.gov
- 2PubMed. Why Does Monk Fruit Extract Remain Only Partially Approved in the EU? Regulatory Barriers and Policy Implications for Food Innovation, 2025. pmc.ncbi.nlm.nih.gov
- 3PubMed. Monk Fruit Extract and Sustainable Health: A PRISMA-Guided Systematic Review of Randomized Controlled Trials, 2025. pubmed.ncbi.nlm.nih.gov
- 4PubMed. Bibliometric analysis on the literature of monk fruit extract and mogrosides as sweeteners, 2023. pmc.ncbi.nlm.nih.gov
- 5EFSA. Safety of use of Monk fruit extract as a food additive in different food categories – EFSA Journal 2019, 2019. efsa.europa.eu
- 6FSSAI. List of product(s)/ingredient(s) applications Approved under FSS (NSF & FI) Regulations, 2017 – Status as on 02 May 2025, 2019. fssai.gov.in
