RE-EVALUATION OF KONJAC GUM (E 425 I) AND KONJACGLUCOMANNAN (E 425 II) AS FOOD ADDITIVES 03/07/17
The present opinion deals with the re-evaluation of konjac (E 425), comprising konjac gum (E 425 i)and konjac glucomannan (E 425 ii) when used as food additives. Following the conceptual frameworkfor the risk assessment of certain food additives re-evaluated under Commi ssion Regulation (EU)No 257/2010, the Panel considered that current use of konjac (E 425) was limited in all food categoriesto maximum permitted level (MPL) of 10 g/kg, and that the calculated indicative reﬁned exposureassessment for all population groups was below 0.1 mg/kg body weight (bw) per day for the generalpopulation (mean and high level). Konjac gum and konjac glucomannan were unlikely to be absorbedintact and were signiﬁcantly fermented by intestinal microbiota. The available database on toxicologicalstudies was considered limited, however, no relevant adverse effects were seen in rats and dogs in90-day feeding studies according to the SCF, the no-observed-effec t level (NOEL ) in rats being 1,250 mgkonjac glucomann an/kg bw per day. Konjac gum and konjac glucomannan were of no concern withrespect to the genotoxicity. After a daily dosage of 3,000 mg in adults for 12 weeks, several individualsexperienced abdominal discomfort includi ng diarrhoea or constipation. The Panel concluded that therewas no need for a numerical acceptable daily intake (ADI) and that there was no safety concern for thegeneral population at the reﬁned exposure assessment for the reported uses of konjac gum (E 425 i) andkonjac glucomannan (E 425 ii) as food additives under the current conditions of use of 10 g/kg. ThePanel agreed with the conclusions of the SCF (1997) that the uses of konjac (E 425) as an additive at thelevels up to 10 g/kg in food are acceptable, provided that the total intake from all sources stays below3 g/day.
Re-evaluation of konjac gum (E 425 i) and konjacglucomannan (E 425 ii) as food additives