Scientific opinion on the safety of the extension of use of steviol glycosides (E 960) as a food additive


Panel on Food Additives and Nutrient Sources Added to Food
EFSA Journal
EFSA Journal 2015;13(6):4146 [20 pp.].
Panel Members
Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, David Gott, Ursula Gundert-Remy, Claude Lambré, Jean-Charles Leblanc, Oliver Lindtner, Peter Moldeus, Alicja Mortensen, Pasquale Mosesso, Dominique Parent-Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright and Maged Younes.

The Panel wishes to thank the members of the Working Group on Applications: Maria Jose Frutos, David Gott, Lieve Herman, Claude Lambré, Jean-Charles Leblanc, Peter Moldeus, Alicja Mortensen, Ivan Stankovic, Paul Tobback, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen and Matthew Wright for the preparatory work on this scientific output and EFSA staff members: Paolo Colombo, Camilla Smeraldi and Alexandra Tard for the support provided to this scientific output.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
9 June 2015
Published in the EFSA Journal
30 June 2015
European Food Safety Authority (EFSA), Parma, Italy

Following a request from the European Commission, EFSA carried out an exposure assessment of steviol glycosides (E 960) arising from their 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, in both 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 of steviol glycosides based on revised proposed uses and concluded that, even if the estimates were reduced, the high-level dietary exposure in children may still exceed the ADI. A request for extension of use in hot beverages has already been evaluated by EFSA in 2014. The current revised exposure estimates are based on the currently authorised uses, the EFSA Comprehensive European Food Consumption Database and the proposed extension of use for tea beverages and instant coffee and instant cappuccino products up to 29 mg/L of steviol equivalents, rather than 10 mg/L, as assessed in the previous 2014 EFSA opinion. The Panel noted that, overall, the mean exposure estimates remain below the ADI of 4 mg/kg bw per day for all population groups, with the exception of toddlers (in one country) at the upper range of the high-level exposure estimates (95th percentile: 4.3 mg/kg bw per day), which remains above the ADI. The Panel concluded that dietary exposure to steviol glycosides (E 960) is similar to the exposure estimated in 2014 and therefore does not change the outcome of the safety assessment.

food additive, steviol glycosides, E 960, sweetener, extension of use
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