Stevia, scientifically known as Stevia rebaudiana, is a plant native to South America. Its leaves have been used for centuries to sweeten foods and beverages. The intense sweetness comes from steviol glycosides, which are natural, zero-calorie alternatives to sugar. While many consumers believe Stevia was outright banned in the European Union (EU), its specific components were subject to a long period of regulatory restriction. High-purity steviol glycosides are now fully approved for use across the EU, following a detailed scientific safety review.
The Initial Regulatory Restriction
The restriction on Stevia’s use was rooted in the EU’s “Novel Food” regulation (Regulation (EC) No 258/97). This regulation requires pre-market authorization for any food or ingredient not consumed to a significant degree in the EU before May 1997. Since Stevia extracts fell into this category, they could not be legally sold as a food ingredient or sweetener without explicit approval.
Early attempts to authorize the Stevia rebaudiana plant and its dried leaves failed because applicants could not provide sufficient toxicological data to satisfy EU regulators. The EU’s Scientific Committee on Food (SCF) raised concerns about the lack of precise specifications for the extracts, the substance’s metabolism, and questionable results from chronic toxicity studies. Consequently, the Commission refused to place the plant and dried leaves on the market in 2000, maintaining the restriction due to the incomplete safety profile.
Scientific Safety Assessment and Approval
The regulatory status changed when manufacturers sought approval for purified steviol glycosides as a food additive, rather than the whole leaf as a novel food. This shift triggered a comprehensive review by the European Food Safety Authority (EFSA), which provides independent scientific advice on food risks. EFSA’s assessment focused on the safety of high-purity steviol glycosides, specifically those containing at least 95% of sweetening compounds like stevioside and rebaudioside A.
In 2010, the EFSA Panel on Food Additives and Nutrient Sources (ANS) concluded that purified steviol glycosides were not genotoxic, carcinogenic, or associated with adverse reproductive or developmental effects. This toxicological evaluation paved the way for the compounds to be recognized as safe for human consumption within defined limits. Official approval was granted in November 2011, adding steviol glycosides to the list of approved food additives under Regulation (EC) No 1333/2008 and formally ending the restriction.
Current Legal Status and Usage Limits
Stevia’s current legal standing in the EU is as an authorized food additive, identified by the E-number E 960. This authorization applies only to highly purified steviol glycosides, not to the whole leaf, crude extracts, or dried Stevia rebaudiana plant, which remain unapproved for food use. The use of this additive is strictly controlled to ensure consumer safety, primarily through the establishment of an Acceptable Daily Intake (ADI).
The EFSA set the ADI for steviol glycosides at 4 milligrams per kilogram of body weight per day, expressed as steviol equivalents. This ADI dictates the Maximum Permitted Levels (MPLs) of E 960 in various food and beverage categories, such as soft drinks, yogurts, and confectionery. A revised exposure assessment in 2011 ensured that consumption, even by high-level consumers and children, remains within these scientifically determined safe limits across all EU member states.