Open AccessRe‐evaluation of tragacanth (E 413) as a food additive
Author(s) -
Mortensen Alicja,
Aguilar Fernando,
Crebelli Riccardo,
Di Domenico Alessandro,
Frutos Maria Jose,
Galtier Pierre,
Gott David,
GundertRemy Ursula,
Lambré Claude,
Leblanc JeanCharles,
Lindtner Oliver,
Moldeus Peter,
Mosesso Pasquale,
Oskarsson Agneta,
ParentMassin Dominique,
Stankovic Ivan,
WaalkensBerendsen Ine,
Woutersen Rudolf Antonius,
Wright Matthew,
Younes Maged,
Brimer Leon,
Christodoulidou Anna,
Lodi Federica,
Gelgelova Petra,
Dusemund Birgit
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4789
Subject(s) - tragacanth , food additive , population , acceptable daily intake , food science , toxicology , microbiology and biotechnology , medicine , chemistry , environmental health , biology , agronomy , pesticide
Abstract 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.