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Re-evaluation of gellan gum (E 418) as food additive. 2018
, and
Maged Younes, and
Peter Aggett, and
Fernando Aguilar, and
Riccardo Crebelli, and
Metka Filipic, and
Maria Jose Frutos, and
Pierre Galtier, and
David Gott, and
Ursula Gundert-Remy, and
Gunter Georg Kuhnle, and
Claude Lambré, and
Jean-Charles Leblanc, and
Inger Therese Lillegaard, and
Peter Moldeus, and
Alicja Mortensen, and
Agneta Oskarsson, and
Ivan Stankovic, and
Ine Waalkens-Berendsen, and
Rudolf Antonius Woutersen, and
Matthew Wright, and
Leon Brimer, and
Pasquale Mosesso, and
Anna Christodoulidou, and
Claudia Cascio, and
Alexandra Tard, and
Federica Lodi, and
Birgit Dusemund
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of gellan gum (E 418) as a food additive. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Based on the reported use levels, a refined exposure of up to 72.4 mg/kg body weight (bw) per day in toddlers at the 95th percentile was estimated. Gellan gum is unlikely to be absorbed intact and would not be fermented by human intestinal microbiota. There is no concern with respect to carcinogenicity and genotoxicity. No adverse effects were reported in chronic studies at the highest doses tested in mice and rats (3,627 and 1,460 mg gellan gum/kg bw per day, respectively). Repeated oral intake up to 200 mg/kg bw per day for 3 weeks had no adverse effects in humans. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for gellan gum (E 418), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of gellan gum (E 418) as a food additive. The Panel recommended to better define the specifications of gellan gum including the absence of viable cells of the microbial source and the presence of polyhydroxybutyrate (PHB), protein and residual bacterial enzymatic activities.
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