Digestibility and metabolic fate
Karaya gum passes through the gut largely intact. It is poorly fermented by intestinal bacteria compared with other plant gums. Because it is not absorbed or broken down into nutritionally significant components, it contributes negligible calories and does not enter the bloodstream.
Karaya gum is practically indigestible and only minimally degraded by intestinal microflora, resulting in negligible systemic absorption.
2016Regulatory reviewEFSA ANS Panel, Re-evaluation of karaya gum (E 416) as a food additive, EFSA Journal
Genotoxicity and long-term toxicity
Standard genotoxicity tests (mutagenicity, clastogenicity) have returned negative results. Animal feeding studies at high doses did not produce toxic effects in the organs examined. No carcinogenicity signal has been identified.
No genotoxic concern was identified. In animal studies, karaya gum did not induce toxic effects at doses up to 1,250 mg per kilogram of body weight per day.
2016AnimalEFSA ANS Panel, Re-evaluation of karaya gum (E 416) as a food additive, EFSA Journal
Allergenicity
Karaya gum is a recognised contact allergen, particularly associated with occupational exposure (nurses and healthcare workers using karaya-based ostomy appliances). Ingested karaya as a food additive appears at much lower levels, but isolated cases of allergic reactions following food consumption have been documented. People with known karaya hypersensitivity should check labels.
Karaya gum is a recognised contact allergen. Occupational exposure (stoma care products) is the primary route of sensitisation; food-intake reactions have been reported in sensitised individuals.
2016Regulatory reviewEFSA ANS Panel, Re-evaluation of karaya gum (E 416) as a food additive, EFSA Journal
Case reports of allergic reactions to karaya gum in stoma care settings have appeared in the literature since the 1970s, with food-triggered reactions documented in already-sensitised individuals.
ObservationalContact Dermatitis literature, multiple authors
Human tolerance at higher intakes
Short-term human studies at doses around 100 mg per kilogram of body weight per day for four weeks reported no adverse effects. Estimated real-world dietary exposure from food use is far below these study doses.
Karaya gum was reported to be tolerated in humans at approximately 100 mg per kilogram of body weight per day over four weeks in short-term studies.
2016RCTEFSA ANS Panel, Re-evaluation of karaya gum (E 416) as a food additive, EFSA Journal