Re-evaluation of soybean hemicellulose (E 426) as a food additive.

Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion on the re-evaluation of soybean hemicellulose (E 426) as a food additive. Soybean hemicellulose is not absorbed intact, but is extensively fermented by the intestinal microflora in animals and humans. No adverse effects were reported in a 90-day dietary toxicity study in rats at the highest doses tested of 2,430 mg/kg body weight (bw) per day for males and 2,910 mg/kg bw per day for females. Furthermore, soybean hemicellulose is not of genotoxic concern. The highest exposure estimates calculated based on the maximum permitted levels were up to 191 mg/kg bw per day for children (95th percentile). Given the limited uses, if any, reported, the Panel considered it probable that the actual dietary exposure to soybean hemicellulose (E 426) would be negligible. Following the conceptual framework for the risk assessment of certain food additives, the Panel concluded that it is very unlikely that there is a safety concern from the current use of soybean hemicellulose (E 426) as a food additive, and that there is no need for a numerical acceptable daily intake (ADI). The Panel recommended that the amount of residual proteins in E 426 should be reduced as much as possible, and that consumers should be informed of the presence of potentially allergenic proteins in the food additive.