EFSA Journal (Oct 2024)

Re‐evaluation of silicon dioxide (E 551) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as a food additive for uses in foods for all population groups

  • EFSA Panel on Food Additives and Flavourings (FAF),
  • Maged Younes,
  • Gabriele Aquilina,
  • Laurence Castle,
  • Gisela Degen,
  • Karl‐Heinz Engel,
  • Paul Fowler,
  • Maria Jose Frutos Fernandez,
  • Peter Fürst,
  • Rainer Gürtler,
  • Trine Husøy,
  • Melania Manco,
  • Wim Mennes,
  • Peter Moldeus,
  • Sabina Passamonti,
  • Romina Shah,
  • Ine Waalkens‐Berendsen,
  • Matthew Wright,
  • Cristina Andreoli,
  • Maria Bastos,
  • Diane Benford,
  • Margherita Bignami,
  • Claudia Bolognesi,
  • Karlien Cheyns,
  • Emanuela Corsini,
  • Riccardo Crebelli,
  • Birgit Dusemund,
  • Rex Fitzgerald,
  • Eric Gaffet,
  • Katrin Loeschner,
  • Francesca Marcon,
  • Jan Mast,
  • Manuela Mirat,
  • Alicja Mortensen,
  • Agnes Oomen,
  • Josef Schlatter,
  • Dominique Turck,
  • Beate Ulbrich,
  • Anna Undas,
  • Christiane Vleminckx,
  • Detlef Woelfle,
  • Ruud Woutersen,
  • Stefania Barmaz,
  • Borana Dino,
  • Gabriele Gagliardi,
  • Sara Levorato,
  • Elena Mazzoli,
  • Alexis Nathanail,
  • Ana Maria Rincon,
  • Laura Ruggeri,
  • Camilla Smeraldi,
  • Alexandra Tard,
  • Sam Vermeiren,
  • Ursula Gundert‐Remy

DOI
https://doi.org/10.2903/j.efsa.2024.8880
Journal volume & issue
Vol. 22, no. 10
pp. n/a – n/a

Abstract

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Abstract The present opinion is the follow‐up of the conclusions and recommendations of the Scientific Opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is performed. Based on the newly available information on the characterisation of the SAS used as E 551 and following the principles of the 2021 EFSA Guidance on Particle‐TR, the conventional safety assessment has been complemented with nano‐specific considerations. Given the uncertainties resulting from the limitations of the database and in the absence of genotoxicity concern, the Panel considered that it is not appropriate to derive an acceptable daily intake (ADI) but applied the margin of exposure (MOE) approach for the risk assessment. The Panel concluded that the MOE should be at least 36 for not raising a safety concern. The calculated MOEs considering the dietary exposure estimates for all population groups using the refined non‐brand loyal scenario, estimated at the time of the 2018 re‐evaluation, were all above 36. The Panel concluded that E 551 does not raise a safety concern in all population groups at the reported uses and use levels. The use of E 551 in food for infants below 16 weeks of age in FC 13.1.1 and FC 13.1.5.1 does not raise a safety concern at the current exposure levels. The Panel also concluded that the technical data provided support an amendment of the specifications for E 551 laid down in Commission Regulation (EU) No 231/2012. The paucity of toxicological studies with proper dispersion protocol (with the exception of the genotoxicity studies) creates uncertainty in the present assessment of the potential toxicological effects related to the exposure to E 551 nanosize aggregates.

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