Steviol Glycosides in Food

Introduction

1. Steviol glycosides (a mixture of compounds in which steviol is bound to different types of sugar) are natural constituents of plant Stevia rebaudiana Bertoni. Leaves of this plant contain at least ten different steviol glycosides with major ones being stevioside and rebaudioside A.
   
   
2. The stevia plant is native to South America, but it is now also grown in several Asian countries. Leaves of the stevia plant have been used for a long time in Brazil and Paraguay to sweeten food and beverages.
   
   
3. Steviol glycosides have been used as a high intensity low calorie sweetener in places including China and Japan. Stevioside and rebaudioside A have been rated as having about 300 times and 250-450 times the relative sweetness intensity of sucrose.

Safety of Steviol Glycosides

1. The Joint Food and Agriculture Organization / World Health Organization Expert Committee on Food Additives (JECFA) had evaluated the safety of stevioside in 1998. Owing to shortcomings and incompleteness of the research findings, JECFA did not make any conclusion regarding its safety at that time.
   
   
2. JECFA in 2004 re-evaluated the safety of stevioside and other steviol glycosides and concluded that steviol glycosides did not demonstrate any genotoxic and carcinogenic potential from available evidence.
   
   
3. JECFA in 2004 allocated a temporary acceptable daily intake (ADI) of 2 mg/kg bw for steviol glycosides, expressed as steviol. Dietary intake of steviol glycosides at level below this safety reference value is unlikely to cause adverse effects in humans in general.
   
   
4. However, JECFA noted the potential pharmacological effects of stevioside in patients with hypertension or with type-2 diabetes (or noninsulin-dependent diabetes) and raised concern whether these pharmacological effects could lead to adverse effects in some individuals (e.g. those with hypotension or diabetes). JECFA therefore considered that more scientific data is required for further evaluation in 2007.
   
   
5. In June 2007, JECFA considered some newly available data and opined that they did not raise additional concerns regarding the safety of steviol glycosides, but the results of ongoing clinical studies would be essential for further evaluation of the substances. The temporary ADI was therefore extended until 2008, pending submission of the results of the ongoing studies.
   
   

Regulatory Control

1. The Codex Alimentarius Commission has not established any standard for steviol glycosides in foods.
   
   
2. Steviol glycosides, or stevioside, are permitted to be used as sweeteners in food in the Mainland, Japan and Korea. However, they are not permitted to be used in Australia, Canada, member countries of the European Union, Singapore and the USA as a sweetener.
   
   
3. In Hong Kong, according to the Sweeteners in Food Regulations (Cap. 132U), the use of steviol glycosides in food is not permitted. Upon conviction, offenders shall be liable to a fine of $50,000 and imprisonment for six months.
   
   
4. The Centre for Food Safety will keep in view and follow up the future development on the safety assessment of steviol glycosides by JECFA.

Advice to the Public

1. To take a balanced diet so as to avoid excessive exposure to food additives from a small range of food items.
   
   
2. For personal concern and medical reasons over the use of sweeteners, seek advice from medical professionals.
   

Advice to the Trade

1. Do not use steviol glycosides in food.
   
   
2. Ensure that the products comply with local regulations, including food additives and labelling requirements.
   

Risk Assessment Section
Centre for Food Safety
July 2007