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Is Monkfruit Sweetener Banned in Europe? The Surprising EU Regulations Explained

4 min read

In October 2024, the EU officially declared aqueous monk fruit decoctions “not novel”. This created significant confusion, leading many to ask: is monkfruit sweetener banned in Europe? The truth is more complex, as the regulatory status depends heavily on the specific form of the monk fruit product.

Quick Summary

European regulations on monk fruit vary significantly by product type. While some water-based monk fruit decoctions are now permitted, concentrated mogroside extracts lack full EU approval due to insufficient safety data submitted to the European Food Safety Authority (EFSA).

Key Points

  • Partial Approval: Only aqueous decoctions of monk fruit are considered non-novel and approved for use as ingredients in the EU based on historical consumption.

  • Purified Extracts Unapproved: High-purity mogroside extracts used as intense sweeteners are still not approved in the EU due to insufficient toxicological data submitted to EFSA.

  • UK vs. EU Rules: The UK has a different regulatory stance post-Brexit, and its approval of monk fruit decoctions does not extend to the EU concerning purified extracts.

  • Regulatory Hurdles: The lack of a comprehensive, industry-backed safety dossier for purified extracts has left them in a prolonged regulatory review state in the EU.

  • Approved Alternatives: Consumers in the EU seeking low-calorie sweeteners can choose from a range of approved alternatives, including stevia (steviol glycosides) and erythritol.

  • Not a 'Ban' Based on Danger: The primary reason for non-approval of concentrated extracts is regulatory caution and incomplete data, not definitive proof of harm.

In This Article

The question, "is monkfruit sweetener banned in Europe?" requires a detailed look at recent regulatory changes. The blanket answer of a few years ago—yes—is no longer entirely accurate, but the picture remains complicated. The key lies in distinguishing between different forms of monk fruit products and understanding the EU's "Novel Food" regulation framework. While a specific type of monk fruit preparation is now authorized, the highly concentrated, purified sweetener remains off-limits for general sale in the EU.

The EU's Novel Food Regulation and Monkfruit

The European Union's food safety is governed by strict regulations, notably Regulation (EU) 2015/2283 on Novel Foods. This rule states that any food ingredient not significantly consumed in the EU before May 15, 1997, must undergo a rigorous pre-market authorization process by the European Food Safety Authority (EFSA).

The Change for Monk Fruit Decoctions

For years, all forms of monk fruit were considered novel under this regulation. However, in late 2024, a significant shift occurred. Following a successful application process led by an industry player, the Food Safety Authority of Ireland (FSAI) on behalf of the EU concluded that non-selective aqueous monk fruit decoctions were not novel.

This decision, based on historical evidence of consumption prior to 1997, means that manufacturers can now use these water-based decoctions as ingredients in food and beverage products across the EU.

Why Purified Extract is Still Not Approved

Crucially, this approval only applies to the specific decoction form—a simple, water-based extract. The decision does not cover highly purified monk fruit extracts, which contain concentrated mogrosides (the intensely sweet components) and are typically sold as zero-calorie sweeteners. These purified extracts are still classified as novel foods and have not received full authorization. The EFSA has cited concerns over insufficient toxicological data, including studies on genotoxicity and long-term safety, as the reason for the delay. An industry-led application with comprehensive safety data is still pending for these high-purity forms.

The Divergent Path of the UK

Since leaving the European Union, the United Kingdom has developed its own regulatory framework, leading to a different outcome for monk fruit products.

UK Allows Monkfruit Decoctions

In March 2024, a UK High Court ruling sided with a monk fruit supplier, concluding that the Food Standards Agency (FSA) had unlawfully classified monk fruit decoctions as novel foods. Based on evidence of consumption before 1997, the FSA reversed its decision, and monk fruit decoctions are now allowed in England and Wales.

What this means for consumers

The UK's independent decision, while mirroring the EU's later decision for decoctions, did not rely on EFSA's safety conclusions. This means that while some monk fruit products are available in the UK, they are still not automatically permissible in the EU. This regulatory divergence affects availability for consumers and formulation freedom for food manufacturers across the two markets.

Approved Alternatives to Monkfruit in Europe

For consumers looking to reduce sugar intake in the EU, several approved alternatives are widely available. Many of these are often blended together to improve the flavour profile and reduce potential aftertastes.

Stevia (Steviol Glycosides)

  • Approval: Approved by EFSA since 2011 after extensive safety assessments.
  • Origin: A natural sweetener derived from the Stevia rebaudiana plant.
  • Properties: Zero-calorie, heat-stable, but can have a mild, licorice-like aftertaste.

Erythritol

  • Approval: Approved for use in the EU.
  • Origin: A sugar alcohol produced by fermentation.
  • Properties: Zero-calorie, well-tolerated, and minimal impact on blood sugar. Absorbed in the small intestine, leading to fewer digestive issues than other polyols.

Xylitol

  • Approval: Approved in the EU.
  • Origin: A sugar alcohol found in fruits and vegetables.
  • Properties: Low-calorie, helps prevent dental caries. Excessive consumption can have a laxative effect.

Aspartame and Sucralose

  • Approval: Widely approved artificial sweeteners.
  • Properties: Zero-calorie, intense sweetness, but are not natural extracts.

Comparing Monkfruit (Purified Extract) to Approved Sweeteners

Feature Purified Monkfruit Extract Stevia (Steviol Glycosides) Erythritol Xylitol
EU Approval Status No (Still considered Novel Food) Yes (Approved since 2011) Yes (Generally Recognized as Safe) Yes (Approved)
Origin Natural (Luo Han Guo fruit) Natural (Stevia plant) Natural (fermented) Natural (plant sources)
Approval Basis in EU Insufficient toxicological data Completed extensive EFSA safety review Well-established safety record Well-established safety record
Primary Sweetening Agent Mogrosides Steviol Glycosides Erythritol Xylitol
Key EU Regulatory Issue Pending comprehensive safety evaluation Fully authorized and regulated Fully authorized and regulated Fully authorized and regulated

Conclusion

So, is monkfruit sweetener banned in Europe? The answer is both no and yes, depending on the form. The EU recently permitted the use of non-selective aqueous monk fruit decoctions in food and drinks, a major change that aligns its rules with the UK in that specific regard. However, the highly purified mogroside extracts commonly sold as stand-alone zero-calorie sweeteners are still considered novel and remain unapproved in the EU due to a lack of sufficient safety data provided to regulators. For now, consumers in the EU can explore a variety of approved natural and artificial sweeteners, including stevia and erythritol, while the regulatory journey for concentrated monk fruit continues. The ultimate approval of purified monkfruit will likely depend on a manufacturer completing and submitting a robust, industry-backed safety dossier to the EFSA.

Further Reading

For a deeper dive into the regulatory landscape, an academic review on the subject can be found here: Why Does Monk Fruit Extract Remain Only Partially Approved in the EU? Regulatory Barriers and Policy Implications for Food Innovation.

Frequently Asked Questions

You can find products containing aqueous monk fruit decoctions, which were recently declared 'not novel' and are authorized as ingredients in the EU. However, highly purified mogroside extracts sold as stand-alone sweeteners are not yet approved for sale in the EU.

The purified extract is classified as a 'novel food,' which requires a full safety evaluation by the European Food Safety Authority (EFSA). As of now, regulators state that insufficient toxicological data and a lack of a completed, industry-backed application have delayed approval.

A monk fruit decoction is a simple water-based extract made from the whole fruit, which is now considered a non-novel food ingredient in the EU. The 'extract' sweetener, however, is a highly purified and concentrated form of the fruit's sweet mogrosides and is still awaiting full EU approval.

Yes. The UK has a different regulatory framework post-Brexit. Following a High Court ruling, non-selective aqueous monk fruit decoctions were deemed not novel, and a specific aqueous extract has been authorised as a novel food, allowing certain monk fruit products to be legally sold in the UK market.

Yes. Several zero and low-calorie sweeteners are approved for use in the EU. These include natural options like stevia (steviol glycosides) and erythritol, as well as artificial sweeteners like aspartame and sucralose.

The EU's hesitation is based on regulatory caution and a lack of complete data for purified extracts, not a definitive conclusion that monk fruit is unsafe. The EFSA simply requires more scientific evidence to authorize it as a food additive.

For highly purified mogroside extracts to be approved, a company or industry group would need to submit a comprehensive dossier of scientific and toxicological data to the EFSA. This lengthy and expensive process is required under the Novel Foods Regulation.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.