Monk fruit (Siraitia grosvenorii), is a melon native to Southern China. Its extract is used as a calorie-free sweetener in North America and Asia because of mogrosides, its sweetening compounds. The European Union (EU) has different regulatory requirements, explaining the varied approval status. The EU's Novel Food Regulation is central to this issue.
The Novel Food Regulation: A key requirement
EU Regulation (EU) 2015/2283, also known as the Novel Food Regulation, requires pre-market authorization for food ingredients not significantly consumed within the EU before May 15, 1997. Because concentrated monk fruit extract doesn't have a documented history of widespread consumption in Europe prior to this date, it is classified as a 'novel food'. This classification demands a thorough application process and submission of comprehensive safety data for evaluation by the European Food Safety Authority (EFSA).
Data Gaps and Safety Concerns
A primary reason for the delayed approval has been insufficient data from manufacturers. The EFSA could not conclude on the safety of an application for monk fruit extract in 2019 due to missing data.
EFSA highlighted the need for more information in several areas:
- Genotoxicity of metabolites.
- Effects observed in animal studies.
- Long-term safety, reproductive toxicity, and metabolic breakdown data.
These requirements reflect the EU's adherence to the precautionary principle, which differs from the US's GRAS system.
Comparison: EU vs. US Regulatory Approaches
The different statuses of monk fruit in the EU and US highlight the contrasting regulatory approaches.
| Feature | European Union (EU) | United States (US) |
|---|---|---|
| Regulatory Body | European Food Safety Authority (EFSA) and European Commission | Food and Drug Administration (FDA) |
| Core Principle | Precautionary Principle; must demonstrate safety | Generally Recognized as Safe (GRAS) or food additive petition |
| Historical Use | Must prove significant consumption in EU before May 1997 | Can claim based on history of safe use before 1958 or scientific evidence |
| Evidence Burden | High, requires comprehensive toxicological dossiers | Lower for GRAS; can be determined by industry experts |
| Approval Speed | Typically takes years, involves a centralized process | Faster pathway available through voluntary GRAS notification |
| Current Status | Concentrated MFE unapproved, gaps remain in safety data | Generally Recognized as Safe (GRAS) since 2010 |
Extracts vs. Decoctions: Understanding the Difference
Recent developments have clarified the status of the ingredient's various forms.
- Monk fruit decoctions: These are less-processed aqueous extracts. The EU recently acknowledged their historical consumption before May 1997, meaning that they are no longer novel and can be used in the EU. This followed a successful appeal based on historical use.
- Highly purified mogroside extracts: These are concentrated extracts. Their selective processing leads to their classification as a novel food. As of late 2024, these remain unapproved due to insufficient toxicological data and incomplete industry applications.
The Path to Future Approval
The reclassification of monk fruit decoctions is a positive step. However, full approval for concentrated extracts still requires manufacturers to provide a complete safety data dossier to EFSA. This process is essential to meet the EU's safety standards, similar to the path taken by steviol glycosides and other sweeteners.
[Link: Food Ingredients First https://www.foodingredientsfirst.com/news/monk-fruit-opportunities-open-up-in-uk-and-eu-after-regulatory-approval-signals-sugar-reduction-boost.html]
Conclusion
The lack of broad approval for monk fruit in Europe stems from the EU's Novel Food Regulation and its safety assessment process. Concentrated extracts require thorough toxicological data, which manufacturers have not fully supplied to EFSA. Although traditional decoctions are now approved based on historical use, concentrated extracts are still considered novel foods that require extensive testing. Future approval depends on companies submitting the necessary scientific evidence to meet EU safety standards.
