Regulatory guidance

Acceptable daily intake

Stevia’s current acceptable daily intake (ADI) value of 0 to 4 mg/kg body weight (expressed as steviol) is established and well-studied. 

There is recent evidence that also supports significantly higher ADI for stevia.

What is ADI ?

Acceptable daily intake or ADI is a measure of the amount of a specific substance (originally applied for a food additive, later also for a residue of a veterinary drug or pesticide) in food or drinking water that can be ingested (orally) daily over a lifetime without an appreciable health risk. ADIs are expressed usually in milligrams (of the substance) per kilograms of body weight per day.

The ADI is determined by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), a committee maintained by two United Nations bodies: the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).  JECFA is an international scientific expert committee that sets the ADI value based on current research, with long-term studies on animals and observations of humans.

First, a no-observed-adverse-effect level (NOAEL), the amount of a substance that shows no toxic effects, is determined. The NOAEL of stevia has been robustly studied in many populations and across numerous outcomes.  All of the studies have shown no adverse effects from stevia use.

Evidence to establish ADI

The JECFA studied the safety of steviol glycosides at five separate meetings, from 1998-2016, over the course of which they established specifications and an acceptable daily intake for stevia extract as a food additive. The ADI began as a generic value which was subsequently specified through studies.  Significant milestones in this process included:

While today’s ADI is safe and well-established, current research suggests that it could be safe at even higher levels.

The current ADI is based on application of a 100-fold safety factor to a no-observed-adverse-effect-level (NOAEL) value from a chronic rat study (Toyoda et al., 1997). In 2016, a new study focused on identifying potential pharmacokinetic differences between rats and humans in regards to the generation of plasma steviol/steviol glucuronide. This study was able to generate a chemical-specific, interspecies toxicokinetic adjustment factor (CSAF). By using these CSAF values in place of the default toxicokinetics safety factor of 4, research shows a justification for an ADI of 6 to 16 mg/kg body weight/day.

The evidence base for ADI of stevia has continue to grow over more than 2 decades continuing to verify safe use of increasing amounts of stevia.  PureCircle invests deeply in this knowledge and research in order to provide customers confidence that the use of stevia is safe and healthy for their consumers.

Project Name

FAO (2016). Steviol glycosides

In: 82nd JECFA - Chemical and Technical Assessment (CTA)

[82nd meeting held June 7-16, 2016]. Rome, Italy: Food and Agriculture Organization of the United Nations (FAO) / Geneva, Switz.: Joint FAO/WHO Expert Committee on Food Additives Meeting (JECFA). Available at: http://www.fao.org/3/a-br566e.pdf.

Project Name

JECFA (1999). Stevioside

In: Safety Evaluation of Certain Food Additives

 51st Meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), June 9-18, 1998. (WHO Food Additives Series, no 42). Geneva, Switz.: World Health Organization (WHO) / International Programme on Chemical Safety (IPCS), pp. 119-143. Available at: http://www.inchem.org/documents/jecfa/jecmono/v042je07.htm.

Project Name

JECFA (2006b). Steviol glycosides

In: Safety Evaluation of Certain Food Additives

Sixty-third Meeting of the Joint FAO/WHO Expert Committee on Food Additives, June 8-17, 2004, Geneva, Switz. (WHO Food Additives Series, no 54). Geneva, Switz.: World Health Organization (WHO) / International Programme on Chemical Safety (IPCS), pp. 117-144, 638. Available at: http://whqlibdoc.who.int/publications/2006/9241660546_eng.pdf.

Project Name

JECFA (2007b). 3.1.9 Steviol glycosides

Evaluation of Certain Food Additives and Contaminants.

 Sixty-eighth Report of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), June 19-28, 2007, Geneva, Switz. (WHO Technical Report Series, no 947). Geneva, Switz.: World Health Organization (WHO), pp. 50-54, 78, 206, 215. Available at: http://whqlibdoc.who.int/publications/2007/9789241209472_eng.pdf.

Project Name

JECFA (2009). Steviol glycosides (addendum).

In: Safety Evaluation of Certain Food Additives.

Sixty-ninth Meeting of the Joint FAO/WHO Expert Committee on Food Additives, June 17-26, 2008, Geneva, Switz. (WHO Food Additives Series, no 60). Geneva, Switz.: World Health Organization (WHO) / International Programme on Chemical Safety (IPCS), pp. 183-219, 618-619. Available at: http://whqlibdoc.who.int/publications/2009/9789241660600_eng.pdf.

Project Name

JECFA (2017b). 3.2.4 Steviol glycosides

In: Evaluation of Certain Food Additives.

Eighty-fourth Report of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), June. 6-15, 2017, Rome. (WHO Technical Report Series, no 1007). Geneva, Switz. Rome, Italy: Food and Agriculture Organization of the United Nations (FAO) / Geneva, Switz.: World Health Organization (WHO), pp. 66-68, 90. Available at: http://apps.who.int/iris/bitstream/handle/10665/259483/9789241210164-eng.pdf;jsessionid=5BA6B0D19E0C76C6F84FC8C911F51FD2?sequence=1.

Project Name

References

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