Why did Europe ban monk fruit? Understanding the Regulatory Status in the EU and UK

October 26, 2025 •

3 min read

Despite its growing popularity in the U.S. and Asia, Europe has long maintained a cautious stance on monk fruit extracts as a food additive. Contrary to popular belief, Europe did not outright ban monk fruit, but rather withheld broad approval for highly purified versions due to insufficient safety data, a classification that has recently seen minor changes for specific forms.

Quick Summary

This article explores the European Union's complex regulatory landscape for monk fruit extract, revealing it was never explicitly banned but faced approval delays under 'novel food' rules. We explain the European Food Safety Authority's (EFSA) concerns over safety data gaps and outline the recent, limited authorisations for specific aqueous extracts.

Key Points

Not banned, but unapproved: Europe did not explicitly ban monk fruit but rather withheld approval for highly purified extracts, categorizing them as 'novel foods' requiring extensive safety testing.
Insufficient safety data: The EFSA review found the toxicological database for highly purified mogroside extracts to be insufficient, citing concerns over reproductive effects observed in animal studies and a lack of long-term safety data.
UK and EU differ: A recent High Court ruling determined that monk fruit decoctions (water extracts) were not novel in the UK or EU, allowing their use as ingredients. However, this does not apply to the concentrated sweetener extracts.
Highly purified mogrosides are still restricted: The most common form of monk fruit sweetener found in products internationally (concentrated mogrosides) remains largely unapproved in the EU due to data gaps and lack of industry-led applications.
Precautionary regulatory approach: The EU's cautious, pre-market approval system differs significantly from the U.S. FDA's GRAS (Generally Recognized as Safe) process, leading to a much slower integration of new ingredients.
Industry action is needed: Broader approval of monk fruit sweeteners in the EU hinges on industry players funding and submitting a complete safety dossier to address EFSA's data requirements.
Consumers can import for personal use: Although commercial sales of the restricted extracts are prohibited, individuals can often import small quantities for personal use from countries where it is approved.

Monk fruit, or Siraitia grosvenorii, is a fruit traditionally used in China for centuries as a natural sweetener and remedy. Its sweetness comes from mogrosides, which provide a zero-calorie sweetening option. Its introduction to Western markets brought it under the scrutiny of European regulators. The question of why did Europe ban monk fruit? isn't about a ban, but rather its status under the EU's Novel Food Regulation.

The EU Novel Food Regulation and Monk Fruit's Status

The EU's Novel Food Regulation (EU 2015/2283) requires pre-market safety evaluation for any food ingredient not significantly consumed in the EU before May 1997. Highly purified monk fruit extracts and mogrosides fell under this 'novel' category because they were not widely used in Europe before the cutoff date, necessitating authorization from the European Food Safety Authority (EFSA). This authorization process requires extensive safety data from the industry.

What the EFSA Said About Monk Fruit Extract

In a 2019 opinion, the EFSA Panel on Food Additives concluded that the safety data for highly purified monk fruit extract was insufficient for approval as a food additive. The panel identified several areas needing more data, including toxicity and reproductive safety, noting potential effects observed in a 90-day animal study that could not be fully dismissed without further testing.

The Shift for Monk Fruit Decoctions in the EU and UK

A distinction has emerged between highly concentrated monk fruit extracts and simpler water extracts (decoctions). In 2024, both the UK's Food Standards Agency (FSA) and the EU determined that monk fruit decoctions were not novel, based on evidence of consumption before May 1997. This allows their use as ingredients in the UK and EU. However, this classification does not apply to highly purified mogroside extracts, which remain subject to the Novel Food Regulation due to data gaps.

A Comparative Look at Regulatory Pathways

The EU's approach to monk fruit highlights differences compared to other regions like the U.S. and China.


Feature	European Union (EU)	United States (U.S.)	China
Regulatory Approach	Precautionary principle. Requires pre-market authorization for all 'novel foods'.	Generally Recognized as Safe (GRAS) process. Relies on a history of safe use or scientific evidence.	Historical use and established food safety standards.
Monk Fruit Status	Limited approval for aqueous decoctions. Highly purified mogroside extracts unapproved due to insufficient safety data.	Classified as GRAS, allowing widespread use in food products.	Approved as a food additive based on traditional use.
Regulatory Timeline	Can be lengthy and complex, as seen with the multi-year delay for purified extracts.	Typically faster than the EU for ingredients with an existing safety profile.	Approval is often expedited for ingredients with a long history of traditional use.
Safety Evidence Needed	Rigorous toxicological data, including long-term and reproductive studies, with EU-centric data often preferred.	Relies on a broad base of historical use and scientific evidence.	Utilizes traditional use and existing national standards.

Future Prospects for Monk Fruit in the EU

While the approval of monk fruit decoctions is a step, broader use of highly purified mogroside sweeteners requires more data and industry effort. A company would need to fund and submit a complete safety study to EFSA addressing the previously identified concerns to gain full authorization. This process is costly and time-consuming, making the timeline for widespread availability of these specific sweeteners in the EU uncertain.

Conclusion

The idea that Europe banned monk fruit is a misunderstanding of the EU's regulatory process. The issue centered on the lack of comprehensive safety data for highly processed extracts under the Novel Food Regulation, not a finding of definitive harm. While recent decisions allow less-processed monk fruit decoctions, highly concentrated mogroside sweeteners remain largely unapproved, a situation driven by strict EU safety rules and the pace of industry research. Growing consumer interest in natural, low-calorie sweeteners may motivate companies to conduct the necessary research for broader EU market access.

A Note on Personal Consumption vs. Commercial Sales

Although highly purified monk fruit sweeteners are not approved for commercial sale in most of the EU, individuals may import small quantities for personal use. Consumers should be aware that these products have not undergone the full EU safety assessment required for commercial food additives.

What This Means for Consumers

For European consumers, this means that while products with less-processed monk fruit (decoctions) might be available, pure monk fruit sweeteners are generally not found in stores. This regulatory environment leads consumers to use other approved sweeteners like stevia or erythritol for zero-calorie options. This situation demonstrates how international food regulations impact consumer choices and product availability.

Frequently Asked Questions

No, it's not completely banned. The misconception comes from the EU's Novel Food Regulation, which delayed approval for highly purified monk fruit extracts. Simpler monk fruit decoctions were recently deemed not novel in the EU and UK and are now permitted as food ingredients.

The EFSA delayed approval because it found the industry-submitted safety data on highly purified mogroside extracts to be insufficient. Specific concerns included potential effects on the testes observed in animal studies and a general lack of long-term and metabolic safety data.

In a recent ruling, monk fruit decoctions were reclassified as 'not novel' in the UK, making them legal to use as food ingredients. However, this does not extend to the concentrated extracts containing high mogroside levels, which would still require separate authorization.

You generally cannot find pure monk fruit sweeteners (highly concentrated mogroside extracts) in EU stores because they lack full regulatory approval. However, products containing less-processed monk fruit decoctions may be available following recent rulings.

Monk fruit extract, particularly the highly concentrated powder, contains high levels of mogrosides that act as an intense sweetener. A decoction is a less-processed water extract of the fruit, which was recently reclassified as a traditional, non-novel food ingredient.

The U.S. Food and Drug Administration (FDA) operates under a different system called GRAS (Generally Recognized as Safe), which allowed for the approval of monk fruit extract based on existing scientific evidence and a history of use. The EU requires more specific and extensive testing for 'novel foods'.

Yes, many other natural and alternative sweeteners are approved in the EU. These include steviol glycosides (stevia), erythritol, and xylitol, which have all undergone the necessary safety assessments.