Does the EU Allow Stevia? Understanding the Regulations

In 2011, the European Food Safety Authority (EFSA) officially approved the use of high-purity steviol glycosides as a food additive. Since then, consumer interest has grown, leading many to ask, "Does the EU allow stevia?" The approval marked a significant shift, but strict regulations govern which forms of stevia are permitted in the EU and how they can be used.

Quick Summary

The EU authorizes specific, high-purity steviol glycoside extracts (E960) derived from the stevia plant for use as food additives, not the crude leaf. Regulations define purity standards, permitted food categories, and maximum usage levels. The plant's leaves can only be used for herbal infusions.

Key Points

• EU Approval: The EU permits stevia, but only as specific, highly purified steviol glycoside extracts, not the raw leaves or crude extracts.

• EU Food Additive: Approved stevia extracts are regulated as food additives with E-numbers, such as E960a for steviol glycosides from Stevia.

• Strict Safety Assessment: The approval is based on a thorough safety assessment by the European Food Safety Authority (EFSA), which set an Acceptable Daily Intake (ADI).

• Usage Restrictions: Steviol glycosides can only be used in specific food categories and are subject to maximum permitted levels (MPLs).

• Limited Use for Leaves: Raw stevia leaves are not authorized as a food ingredient but can be used for preparing herbal and fruit infusions.

• Clear Labeling: Packaged food containing EU-approved stevia must be clearly labeled with the E-number or the name 'steviol glycosides'.

The Regulatory Framework: What is Permitted?

While the answer to 'Does the EU allow stevia?' is a definitive yes, it is crucial to understand that not all forms of the Stevia rebaudiana plant are treated equally under EU law. The approval applies strictly to highly purified steviol glycoside extracts, which are the sweet compounds found in the stevia leaf, rather than the raw leaves or crude extracts themselves. This distinction is critical and is based on a rigorous safety evaluation process overseen by the European Food Safety Authority (EFSA).

The Role of the European Food Safety Authority (EFSA)

Any new food additive in the EU must undergo a comprehensive safety assessment by the EFSA. Following their evaluation in 2010 and 2011, which established an Acceptable Daily Intake (ADI) of 4 mg/kg of body weight per day, the European Commission authorized the use of steviol glycosides (E 960) in November 2011.

The Steviol Glycosides (E Numbers)

Steviol glycosides, the sweet components of the stevia plant, have specific E-numbers in the EU. Recent updates clarified these numbers, including E 960a for steviol glycosides from Stevia, E 960c for enzymatically produced versions, and E 960d for glucosylated steviol glycosides. These numbers are required on product labels.

Usage Restrictions and Maximum Levels

EU regulations define specific maximum permitted levels (MPLs) for steviol glycosides in various food and beverage categories to ensure the ADI is not exceeded. Examples include limits for flavored fermented milk, edible ices, and food supplements. Product labels must indicate the presence of stevia extracts.

The Status of Raw Stevia Leaves

Raw stevia leaves and crude extracts are classified as 'novel foods' under EU law because they were not widely consumed before May 1997. As novel foods, they are not authorized for general use, except for Stevia rebaudiana Bertoni leaves used in herbal infusions.

The European vs. US Approach to Stevia Regulation

Aspect	EU Regulation	US Regulation (FDA)
Approved Form	Strictly regulated high-purity steviol glycoside extracts (E960a, E960c, E960d).	High-purity steviol glycoside extracts are designated as "Generally Recognized as Safe" (GRAS).
Raw Leaf/Crude Extract	Not approved as a food ingredient, categorized under Novel Food Regulation, with an exception for tea infusions.	Not approved for use as food ingredients and do not have GRAS status.
Regulatory Body	European Food Safety Authority (EFSA) provides safety assessments for the European Commission.	Food and Drug Administration (FDA) reviews GRAS notifications.
Legal Status	Authorized and regulated as a food additive with a specific E-number and conditions of use.	GRAS status allows use as a sweetener, but not as an approved food additive.
Market Timeline	Approved as a food additive in November 2011.	High-purity extracts received GRAS status starting in December 2008.

Conclusion

In conclusion, the EU permits stevia, but only as specified, high-purity steviol glycoside extracts authorized by the EFSA as food additives (e.g., E960a). Use is limited to designated food categories and maximum levels. Raw leaves or crude extracts are not permitted for general food use, except for herbal infusions. This regulatory approach ensures consumer safety and provides clear guidelines.

Frequently Asked Questions

Steviol glycosides are the only part of the stevia plant approved for use as a food additive in the EU. Raw stevia leaves are considered a 'novel food' and are not approved for general use, except for Stevia rebaudiana Bertoni leaves in tea and herbal infusions. The E-number for steviol glycosides from stevia is E960a, and E960c for enzymatically produced versions. The European Food Safety Authority (EFSA) assesses safety, and the European Commission authorizes additives like stevia based on their findings. The Acceptable Daily Intake (ADI) is 4 mg/kg of body weight per day. EU regulations differ from the US, where high-purity steviol glycosides are generally recognized as safe (GRAS) by the FDA. Products containing EU-approved stevia extracts will list 'steviol glycosides from Stevia' or E960a on the label. Enzymatically produced steviol glycosides (E960c) are also authorized as an additive. While mean consumption is within the ADI, EFSA notes some high-level consumers could potentially exceed it. You can find more details about EU regulations on {Link: EUR-Lex https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1156}.

Frequently Asked Questions

What part of the stevia plant is approved for use in the EU?

The sweet-tasting compounds known as steviol glycosides are the only part approved for use as a food additive in the EU, not the entire leaf.

Why are raw stevia leaves not allowed as a food ingredient?

Raw stevia leaves are not approved as a food ingredient because they are considered a 'novel food' under EU regulations and have not undergone the necessary safety assessments for general food use.

Are there any exceptions for using stevia leaves in the EU?

Yes, there is an exemption that allows Stevia rebaudiana Bertoni leaves to be used specifically for the preparation of tea and herbal infusions.

What is the E-number for stevia in the EU?

Steviol glycosides from stevia have been assigned the E-number E960a. Other related, enzymatically produced steviol glycosides are labeled E960c.

Who is responsible for approving food additives like stevia in the EU?

The European Food Safety Authority (EFSA) performs the safety evaluation, and the European Commission then authorizes and regulates the food additive based on EFSA's findings.

What is the Acceptable Daily Intake (ADI) for steviol glycosides?

Based on EFSA's assessment, the ADI for steviol glycosides is 4 mg per kg of body weight per day.

Is the EU regulation for stevia different from the United States?

Yes, the regulations differ. In the US, high-purity steviol glycosides are considered Generally Recognized as Safe (GRAS) by the FDA, a different regulatory category than the EU's food additive system.