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Re-evaluation of tragacanth (E 413) as a food additive. 2017
, and
Alicja Mortensen, and
Fernando Aguilar, and
Riccardo Crebelli, and
Alessandro Di Domenico, and
Maria Jose Frutos, and
Pierre Galtier, and
David Gott, and
Ursula Gundert-Remy, and
Claude Lambré, and
Jean-Charles Leblanc, and
Oliver Lindtner, and
Peter Moldeus, and
Pasquale Mosesso, and
Agneta Oskarsson, and
Dominique Parent-Massin, and
Ivan Stankovic, and
Ine Waalkens-Berendsen, and
Rudolf Antonius Woutersen, and
Matthew Wright, and
Maged Younes, and
Leon Brimer, and
Anna Christodoulidou, and
Federica Lodi, and
Petra Gelgelova, and
Birgit Dusemund
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of tragacanth (E 413) as a food additive. In the EU, tragacanth (E 413) has been evaluated by the Scientific Committee for Food (SCF, 1989) and by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, 1987), who both allocated an acceptable daily intake (ADI) 'not specified' for this gum. 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. Tragacanth (E 413) is unlikely to be absorbed intact and is partially fermented by intestinal microbiota. No adverse effects were reported in carcinogenicity studies at the highest dose tested and there is no concern with respect to the genotoxicity. Oral daily intake of a large amount of tragacanth up to 9,900 mg tragacanth/person per day (approximately equivalent 141 mg tragacanth/kg body weight (bw) per day) for up to 21 days was well tolerated in humans. The Panel concluded that there is no need for a numerical ADI for tragacanth (E 413) and that there is no safety concern for the general population at the refined exposure assessment of tragacanth (E 413) as a food additive at the reported uses and use levels.
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