Safety of fermented soybean extract NSK‐SD® as a novel food pursuant to Regulation (EC) No 258/97

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the fermented soybean extract NSK-SD® as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. The NF is the fermented soybean extract NSK-SD®, which is standardised to a nattokinase enzyme activity of 20,000–28,000 fibrin degradation units/g. The information provided on the composition of the NF, the specifications, batch-to-batch variability and the stability is sufficient and does not raise safety concerns. The proposed maximum intake is 100 mg NSK-SD®/day as a food supplement. The target population proposed by the applicant is healthy men and women over the age of 35 years, excluding pregnant and lactating women. The Panel noted that nattokinase exhibits in vitro fibrinolytic activity and in vivo thrombolytic activity in animals when administered parenterally. However, the information provided with respect to absorption, distribution, metabolism and excretion of the NF does not allow conclusions to be drawn on the absorption of active nattokinase or any functional metabolites therefrom. A bacterial reverse mutation test did not show any indication of mutagenicity, and the NF was not clastogenic in an in vitro chromosome aberration assay. Taking into account the no observed adverse effect level (NOAEL) of 1,000 mg/kg body weight per day in the subchronic toxicity study in rats, and considering the proposed maximum intake level for the NF, the Panel concludes that the margin of exposure is sufficient. The Panel concludes that the NF, the fermented soybean extract NSK-SD®, is safe under the intended conditions of use as specified by the applicant.