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. 2014 May 2;12(5):3639. doi: 10.2903/j.efsa.2014.3639

Scientific Opinion on the revised exposure assessment of steviol glycosides (E 960) for the proposed uses as a food additive

European Food Safety Authority
PMCID: PMC13159869  PMID: 42125368

Abstract

Following a request from the European Commission, the European Food Safety Authority (EFSA) carried out an exposure assessment of steviol glycosides (E 960) from its use as a food additive, taking into account the proposed extension of uses. In 2010, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the safety of steviol glycosides (E 960) and established an Acceptable Daily Intake (ADI) of 4 mg/kg body weight (bw) per day. Conservative estimates of exposure, both in adults and children, suggested that it is likely that the ADI would be exceeded at the maximum proposed use level. In 2011, EFSA carried out a revised exposure assessment for steviol glycosides based on revised proposed uses and concluded that high level dietary exposure in children may still exceed the ADI. The current refined exposure estimates are based on the currently authorised uses, the proposed extension, and the EFSA Comprehensive Food Consumption Database. The mean dietary exposure to steviol glycosides ranges from 0.1 mg/kg bw/day in adults and the elderly, to 2.4 mg/kg bw/day in toddlers. Estimates at the 95th percentile of exposure range from 0.3 to 4.3 mg/kg bw/day in the elderly and toddlers, respectively. The Panel concluded that dietary exposure to steviol glycosides is considerably lower than that in the previous exposure assessment. Overall, the revised exposure estimates for all age groups remain below the ADI, except for toddlers at the upper range of the high level (95th percentile) estimates, in one country. Moreover, the Panel noted that table top sweeteners may represent an important source of exposure and therefore a MPL with a numerical value, rather than quantum satis, would be preferable, to allow for a more precise estimation of the potential maximum level of exposure from table top sweeteners.

Keywords: steviol glycosides, E 960, refined exposure, EFSA Comprehensive European Food Consumption Database

EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food) , 2014. Scientific Opinion on the revised exposure assessment of steviol glycosides (E 960) for the proposed uses as a food additive. EFSA Journal 2014;12(5):3639, 23 pp. doi: 10.2903/j.efsa.2014.3639

Panel members: Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Pierre Galtier, David Gott, Ursula Gundert‐Remy, Jürgen König, Claude Lambré, Jean‐Charles Leblanc, Pasquale Mosesso, Alicja Mortensen, Agneta Oskarsson, Dominique Parent‐Massin, Martin Rose, Ivan Stankovic, Paul Tobback, Ine Waalkens‐Berendsen, Ruud Woutersen and Matthew Wright.

Correspondence: ans@efsa.europa.eu

Acknowledgement: The Panel wishes to thank the members of the Working Group on Exposure Assessment: Polly Boon, Jürgen König, Jean‐Charles Leblanc, Christina Tlustos, Christophe Matthys for the preparatory work on this scientific opinion and EFSA staff: Davide Arcella, Petra Gergelova, Alexandra Tard and Stavroula Tasiopoulou for the support provided to this scientific opinion.

Adoption date: 2 April 2014

Published date: 2 May 2014

Question number: EFSA‐Q‐2013‐00433

On request from: European Commission

References

  1. EFSA Panel on Food Additives and Nutrient Sources (ANS) , 2010. Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA Journal 2010;8(4):1537, 85 pp. doi:10.2903/j.efsa.2010.1537. [Google Scholar]
  2. EFSA (European Food Safety Authority) , 2011a. Revised exposure assessment for steviol glycosides for the proposed uses as a food additive. EFSA Journal 2011;9(1):1972, 19 pp. doi:10.2903/j.efsa.2011.1972. [Google Scholar]
  3. EFSA (European Food Safety Authority) , 2011b. Use of the EFSA Comprehensive European Food Consumption Database in Exposure Assessment. EFSA Journal 2011;9(3):2097, 34 pp. doi:10.2903/j.efsa.2011.2097. [Google Scholar]
  4. EFSA (European Food Safety Authority) , 2011c. Evaluation of the FoodEx, the food classification system applied to the development of the EFSA Comprehensive European Food Consumption Database. EFSA Journal 2011;9(3):1970, 27 pp. doi:10.2903/j.efsa.2011.1970. [Google Scholar]
  5. JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2000. Evaluation of certain food additives. Fifty‐first Report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Geneva, Switzerland. WHO Technical Report Series No 891, 35–37. [PubMed] [Google Scholar]
  6. JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2005. Evaluation of certain food additives. Sixty‐third Report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Geneva, Switzerland. WHO Technical Report Series, No 928, 34–39 and 138.
  7. JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2006. Safety evaluation of certain food additives. Prepared by the 63rd meeting of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Geneva, Switzerland. WHO Food Additives Series, No 54, 117–144. [Google Scholar]
  8. JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2007. Evaluation of certain food additives and contaminants. Sixty‐eighth Report of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Geneva, Switzerland. WHO Technical Report Series No 947, 50–54.
  9. JECFA (Joint FAO/WHO Expert Committee on Food Additives) , 2009. Safety evaluation of certain food additives. Prepared by the 69th meeting of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Geneva, Switzerland. WHO Food Additives Series, No. 66, 183–220.
  10. SCF (Scientific Committee on Food) , 1984. Reports of the Scientific Committee for Food concerning Sweeteners (Opinion Expressed by the SCF on 14 September 1984). In: Food Science and Techniques. Brussels, Belgium: Commission of the European Communities (EEC), Health & Consumer Protection Directorate‐General, Scientific Committee on Food, 1985. (Reports of the Scientific Committee for Food (16th series). [Google Scholar]
  11. SCF (Scientific Committee on Food) , 1989. Reports of the Scientific Committee for Food on Sweeteners. 21st series. Opinion expressed 11 December 1987 and 10 November 1988, and adopted 10 November 1988. SCF (Scientific Committee on Food), 1999.
  12. SCF (Scientific Committee on Food) , 1999. Opinion on Stevioside as a Sweetener (Adopted on 17/6/99). Belgium: European Commission, Health & Consumer Protection Directorate‐General, Scientific Committee on Food. [CS/ADD/EDUL/167 Final]. [Google Scholar]
  13. Tennant D, 2006. Screening of Colour Intakes from Non‐Alcoholic Beverages. Report prepared for the Union of European Beverages Associations (UNESDA), December 2006.
  14. Tennant D, 2007. Screening potential intakes of natural food colours. Report provided for the Natural Food Colours Association (NATCOL), July 2007.
  15. Tennant D, 2010. Potential intakes of steviol glycosides from use as a sweetener. Report prepared for the Union of European Beverages Associations (UNESDA), September 2010.

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