1. United States

FDA (Food and Drug Administration): Monk fruit Extract is generally recognized as safe (GRAS) for use in food and beverages, particularly as a sweetener. The GRAS status is based on scientific evidence demonstrating its safety for consumption.

Usage: monk Fruit Extract is used as a sweetener in a variety of food products, including beverages, dairy, baked goods, and dietary supplements.

Labeling: Products containing Monk Fruit Extract must adhere to FDA guidelines for labeling, which may include a declaration that it is a "natural" sweetener. The FDA does not specify an upper limit for its use, but manufacturers must ensure the extract is used in safe amounts.

2. European Union (EU)

EFSA (European Food Safety Authority): Monk Fruit Extract is not yet authorized as a food additive in the EU. However, it is often used in some countries as a food ingredient if it meets the general requirements for novel foods.

Novel Food Regulation: Since Monk Fruit Extract is not traditionally consumed in the EU, it may require approval under the Novel Foods Regulation (EU Regulation 2015/2283), which governs new food ingredients that have not been consumed to a significant degree in the EU before May 1997.

Approval Process: To be authorized for use, Monk Fruit Extract would need to undergo a safety assessment by EFSA and receive approval from the European Commission.

3. Canada

Health Canada: Monk Fruit Extract is considered a natural sweetener in Canada, and its use is regulated under the Food and Drug Act and the Natural Health Products Regulations. It has been approved for use as a sweetener in food and beverages.

Approval for Use: Health Canada has provided approval for Monk Fruit Extract, but manufacturers must follow the allowable limits for usage and meet specific safety standards.

Labeling: As with the U.S., food products containing Monk Fruit Extract must be labeled in accordance with Canadian food labeling regulations.

4. Australia and New Zealand

FSANZ (Food Standards Australia New Zealand): Monk Fruit Extract is allowed for use in Australia and New Zealand as a sweetener. FSANZ has reviewed the safety of Monk Fruit Extract and confirmed that it can be used in food products.

Approval: Monk Fruit Extract is classified as a food additive under the Food Standards Code in these countries. Specific usage levels may be regulated to ensure consumer safety.

5. China

National Food Safety Standards: In China, Monk Fruit Extract is recognized as a food ingredient and can be used in food and beverages. Regulations allow it to be used as a sweetener, but similar to other regions, the extract must comply with safety standards.

Food Additive Regulations: The specific use of Monk Fruit Extract as a food additive may be governed by China’s food safety regulations and standards for sweeteners.

6. Japan

Ministry of Health, Labour and Welfare (MHLW): Japan allows the use of Monk Fruit Extract as a sweetener in food products. The extract has been assessed for safety by Japan's regulatory authorities.

Usage: Monk Fruit Extract can be used in a wide range of food products, similar to other sweeteners such as stevia, without specific limits on its use.

7. Brazil

ANVISA (National Health Surveillance Agency): Monk Fruit Extract is recognized for use as a sweetener in Brazil, but it must meet the requirements set by ANVISA for food ingredients and additives.

Regulatory Approval: ANVISA requires safety assessments for food products containing Monk Fruit Extract, and it must comply with the relevant food safety and labeling regulations.

8. Other Countries

Latin America: Regulations in countries like Mexico, Argentina, and Chile vary. In many cases, the use of Monk Fruit Extract as a sweetener is accepted, but manufacturers must ensure that it adheres to local food safety standards.

Middle East & Africa: The acceptance of Monk Fruit Extract in food products is generally aligned with global trends, but regulatory practices may differ, and in some cases, approvals from local authorities may be required before the extract can be used in food products.

General Considerations

Safety and Toxicology: Across many regions, Monk Fruit Extract is considered safe, but in some countries, it may require approval as a novel food (i.e., a food that hasn't been traditionally consumed in that country). Manufacturers must provide scientific evidence of the product’s safety before approval.

Labeling: Food products containing Monk Fruit Extract must adhere to specific labeling guidelines. This may include disclosing the presence of the sweetener and any necessary claims (e.g., "natural sweetener").

Market Trends: The demand for natural, plant-based sweeteners like Monk Fruit Extract is growing globally, especially as consumers seek healthier, lower-calorie alternatives to sugar and artificial sweeteners.

Conclusion

Monk Fruit Extract is regulated differently in various countries, with some requiring specific approvals or safety assessments before use in food products. It is generally recognized as safe in many regions, but manufacturers should stay updated on local regulations to ensure compliance.