EFSA Journal (Nov 2024)

Scientific opinion on the extension of the authorisation of use of the food additive steviol glycosides (E 960a–d) and the modification of the acceptable daily intake (ADI) for steviol

  • EFSA Panel on Food Additives and Flavourings (FAF),
  • Laurence Castle,
  • Monica Andreassen,
  • Gabriele Aquilina,
  • Maria Lourdes Bastos,
  • Polly Boon,
  • Biagio Fallico,
  • Reginald FitzGerald,
  • Maria Jose Frutos Fernandez,
  • Bettina Grasl‐Kraupp,
  • Ursula Gundert‐Remy,
  • Rainer Gürtler,
  • Eric Houdeau,
  • Marcin Kurek,
  • Henriqueta Louro,
  • Patricia Morales,
  • Sabina Passamonti,
  • José Manuel Barat Baviera,
  • Gisela Degen,
  • David Gott,
  • Lieve Herman,
  • Jean‐Charles Leblanc,
  • Peter Moldeus,
  • Ine Waalkens‐Berendsen,
  • Detlef Wölfle,
  • Consuelo Civitella,
  • Laura Ruggeri,
  • Alexandra Tard,
  • Borana Dino,
  • Sam Vermeiren

DOI
https://doi.org/10.2903/j.efsa.2024.9045
Journal volume & issue
Vol. 22, no. 11
pp. n/a – n/a

Abstract

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Abstract The EFSA Panel on Food Additive and Flavourings (FAF Panel) evaluated the safety of proposed changes to the currently permitted uses of the food additive steviol glycosides (E 960a–d) and of a proposed modification of the current acceptable daily intake (ADI) from 4 mg/kg body weight (bw) per day to 6 or 16 mg/kg bw per day, expressed as steviol equivalents. Currently, steviol glycosides (E 960a–d) are authorised in the EU in 32 different food categories (FCs). An extension of use was proposed for four new uses within FC 7.2 ‘Fine bakery wares’. In addition, an increase of the maximum permitted levels (MPLs) for FC 14.1.3 ‘Fruit nectars’ and for three uses within FC 14.1.4 ‘Flavoured drinks’ was requested. Consequently, the Panel updated the exposure estimates using the protocol for assessing exposure to sweeteners, developed to consider the specificities related to consumers' exposure to this functional class of food additives. Considering the proposed extension of use and increase of the MPLs, together with the currently authorised uses (at the MPLs) of E 960a–d, the highest 95th percentiles of exposure are 4.1 and 6.9 mg/kg bw per day for infants and toddlers, respectively. Based on the currently available absorption, distribution, metabolism and excretion (ADME) dataset for steviol glycosides (E 960a–d), the Panel concluded that that there is insufficient justification to increase the current ADI of 4 mg/kg bw per day, expressed as steviol equivalents. With respect to the proposed extension of use and increase of the MPLs, the Panel concluded that the calculated, conservative, dietary exposure would result in an increased exceedance of the ADI for toddlers at the 95th percentile.

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