Choking risk in firm gel confectionery
Unlike gelatine, konjac gel is very firm, smooth and slow to dissolve in the mouth. When set inside small, rigid mini-cup containers it can slide to the back of the throat and create a physical airway blockage. Multiple fatal choking incidents, primarily involving children, were reported in Europe and elsewhere in the late 1990s and early 2000s. These led to an EU emergency suspension in 2002 and a permanent ban in jelly mini-cup confectionery from 2004.
The European Commission issued an emergency suspension in 2002 on konjac-containing jelly mini-cups after several choking deaths, citing the product's firmness, slipperiness and failure to dissolve. A permanent ban on E425 in jelly mini-cups followed in 2004.
2004RegulatoryEuropean Commission Press Release IP/02/435 and Commission Directive 2004/93/EC
EFSA's re-evaluation noted historical cases of oesophageal obstruction from konjac taken in tablet form without adequate liquid, which contributed to the rationale for restricting its use in jelly confectionery.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
Gastrointestinal effects at higher intakes
At doses of around 3g per day (used in clinical weight-management and cholesterol trials), konjac glucomannan causes abdominal discomfort, bloating, diarrhoea or constipation in some people. These effects are well above typical food-additive exposure levels but are relevant for people who take konjac supplements or eat large portions of konjac noodles daily.
In 90-day animal studies, a no-observed-effect level of 1,250mg/kg body weight per day was established for konjac gum. No genotoxicity was found.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
At 3,000mg daily over 12 weeks, several human subjects experienced abdominal discomfort including diarrhoea or constipation.
2017RCTEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal
Missing long-term safety data
EFSA's 2017 re-evaluation found no chronic toxicity or carcinogenicity studies and no reproductive or developmental toxicity studies for either konjac gum or konjac glucomannan. The Panel concluded the current additive use levels appeared acceptable, but noted the toxicological database was limited and that only three out of 67 authorised food categories had submitted usage-level data.
No chronic toxicity, carcinogenicity, reproductive toxicity or developmental toxicity studies were available for konjac gum or konjac glucomannan at the time of re-evaluation.
2017Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal