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Where is monk fruit sweetener banned? A look at global regulations

3 min read

Monk fruit extract is derived from the fruit of the Siraitia grosvenorii vine, which has been used in Traditional Chinese Medicine for centuries. Despite its long history of use in some regions, its regulatory status as a commercial sweetener varies drastically around the world, creating confusion for consumers and manufacturers alike.

Quick Summary

Monk fruit sweetener faces regulatory hurdles in certain markets, most notably the European Union, due to insufficient safety data for its use as a food additive. While the US, Canada, Australia, and UK generally permit its use, specific restrictions and pending reviews for certain forms exist.

Key Points

  • EU Restrictions: Highly purified monk fruit extract is not fully approved as a food additive across the European Union due to insufficient long-term safety data, though specific aqueous decoctions were recently authorized.

  • US Approval: The FDA granted monk fruit extract 'Generally Recognized as Safe' (GRAS) status in 2010, allowing its widespread use as a sweetener in the United States.

  • UK Status Shift: The UK recently reversed its 'novel food' classification for certain monk fruit decoctions, permitting their use based on evidence of pre-1997 consumption.

  • Canada's Limitations: In Canada, monk fruit extract is approved only as a tabletop sweetener, with more restrictive regulations for its inclusion in commercial food products.

  • Australia & New Zealand Approval: The FSANZ permitted monk fruit extract as an intense sweetener in 2018, aligning it with other approved sweeteners.

  • Regulatory Hurdles: Approval for monk fruit in different regions depends on costly studies and navigating complex 'novel food' regulations, which require proving a history of safe consumption.

In This Article

Monk Fruit Sweetener: A Global Regulatory Overview

Monk fruit, or Luo Han Guo, is a natural, zero-calorie sweetener gaining popularity as a sugar substitute in many regions. The sweet compounds, known as mogrosides, are extracted from the fruit and offer an intense sweetness without affecting blood glucose levels. However, its classification and approval status differ significantly across different countries and economic blocs, leading to misconceptions about a widespread ban. The primary reasons for regulatory caution are the 'novel food' classification and the varying requirements for long-term safety data.

The European Union: The Main Region with Restrictions

The European Union (EU) is the most prominent market where monk fruit extract has faced significant regulatory challenges. The EU Novel Food Regulation requires food ingredients not consumed before May 1997 to undergo a safety evaluation by EFSA. Highly purified monk fruit extract previously lacked sufficient data. EFSA had indicated a need for more toxicological data before approval. As of late 2024, a specific aqueous monk fruit extract was authorized for use in some food categories, but highly purified forms still lack approval.

United Kingdom: A Post-Brexit Turnaround

Following Brexit, the UK's approach has diverged from the EU. The UK's Food Standards Agency (FSA) and Food Standards Scotland (FSS) changed their stance on certain monk fruit decoctions in 2024. A court ruling in March 2024 determined certain monk fruit decoctions were not novel foods based on historical consumption evidence. This change allows non-selective aqueous decoctions. For more details on the UK's specific regulations and approval status for purified extract, you can refer to {Link: PMC website https://pmc.ncbi.nlm.nih.gov/articles/PMC12386098/}.

Other International Markets: Widespread Approval

Monk fruit sweetener is widely approved in many other major markets. The FDA granted monk fruit extract GRAS status in 2010 in the US. Health Canada approved it as a tabletop sweetener in 2013, with more restricted use in commercial food products. Australia and New Zealand approved it as a food additive in 2018. China also permits its use due to a long history of consumption.

Comparison of Regulatory Status for Monk Fruit Sweetener

Country/Region Overall Status Specific Approval/Restriction Primary Regulatory Body Key Reason for Approval/Restriction
European Union (EU) Partially Restricted Specific aqueous decoctions authorized; highly purified extract unapproved. EFSA Historically insufficient toxicological data and 'Novel Food' status.
United Kingdom (UK) Partially Approved Non-selective decoctions deemed 'not novel'. Purified extract approval under consideration. FSA Legal challenge based on pre-1997 consumption.
United States (US) Permitted Generally Recognized as Safe (GRAS) for use in food since 2010. FDA Industry data and expert panel consensus.
Canada Restricted Approved as tabletop sweetener only. Limited use in commercial food products without further approval. Health Canada Regulatory process for commercial food products is separate.
Australia & NZ Permitted Approved as a food additive (intense sweetener) since 2018. FSANZ Positive safety assessment.
China Permitted Long history of use, approved as a food additive. National Health Commission Established history of consumption.

What Lies Ahead for Monk Fruit Regulation

The regulatory status of monk fruit is evolving, particularly in the EU and UK. Increased research and demand may lead to more approvals for different forms. The recent EU decision is a step toward broader acceptance. Consumers should be aware of the different forms (decoctions vs. concentrated extracts) and check local regulations. Monk fruit is not universally banned, but its approval varies based on scientific data, regulations, and market interests.

Frequently Asked Questions

Yes, highly purified monk fruit extract has been in a state of regulatory limbo in the European Union and was previously unapproved in the United Kingdom, though recent EU and UK regulatory shifts have allowed for specific, less-concentrated forms (decoctions). Its status as a food additive is not universally approved.

The European Food Safety Authority (EFSA) previously deemed monk fruit extract a 'novel food' without sufficient toxicological data to prove its safety for use as a food additive. A recent authorization in late 2024 allowed for a specific aqueous extract, but other forms remain unapproved.

Yes, as of 2024, certain monk fruit decoctions are no longer classified as 'novel food' in the UK and can be used in food and beverage products. However, the regulatory status for highly purified monk fruit extract as a food additive differs.

Yes, the U.S. Food and Drug Administration (FDA) has classified monk fruit extract as 'Generally Recognized as Safe' (GRAS), meaning it is approved for use as a general-purpose sweetener in foods and beverages.

Monk fruit extract is a highly purified, concentrated sweetener derived from the fruit's mogrosides, while a monk fruit decoction is a less-processed extraction, often made by boiling the fruit in water. The regulatory status varies for these different forms.

While both are natural, zero-calorie sweeteners, stevia (steviol glycosides) has undergone decades of safety studies and has been more widely approved by international bodies like EFSA. This makes its regulatory pathway more established than monk fruit's in many regions.

In some cases, products might contain forms of monk fruit that are approved (e.g., decoctions in the UK) or are imported for personal use in small quantities. Additionally, products might contain blends where the monk fruit is not the primary regulated ingredient, and enforcement can vary.

References

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Medical Disclaimer

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