**5. The Case of Fermented Soybean Extracts in Europe**

Japanese cuisine, one of the healthiest foods in the world, reflected in the high life expectancy (83 years), is known to use fermented foods such as "Natto" which is sticky, smelly and slimy but still the most popular of Japan's traditional health foods.

Japan Bio Science Laboratory (JBSL) submitted in Europe a request on May 2014, under Article 4 of the Novel Food Regulation (EC No. 258/97) [32], to place on the market a fermented soybean extract (Nattokinase NSK-SD®), obtained by adding beneficial bacteria *Bacillus natto* to soybeans, as a novel food (NF). On December 2014, the competent authority of Belgium forwarded to the European Commission its initial assessment report, which came to the conclusion that the fermented soybean extract met the criteria for acceptance of a NF defined in Article 3 (1) of Regulation (EC) No. 258/79. On 6 January 2015, the Commission forwarded the initial assessment report to the other Member States (MS).

However, several of the MS submitted comments or raised objections. The concerns of a scientific nature raised by the MS on this fermented food can be summarized on their effects on hematological parameters, in particular on blood coagulation. One case report [33] was identified, in which a patient on antihypertensive agents and low-dose aspirin for secondary stroke prevention experienced an acute cerebellar hemorrhage and cerebral micro bleeds after concomitant consumption of this fermented soybean extract.

In accordance with Article 29 (1) (a) of Regulation (EC) No. 178/20024, the European Food Safety Authority (EFSA) was asked to carry out an additional assessment for the fermented soybean extract as an NF in the context of Regulation (EC) No. 258/97. The EFSA considered the elements of a scientific nature in the comments raised by MS and a Scientific Opinion was produced [34] concluding that the fermented soybean extract was safe under the intended conditions of use as specified by the applicant.
