Fermented soybean extract: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Food Supplements as defined in Directive 2002/46/EC (capsules, tablets or powder form) intended for the adult population, excluding pregnant and lactating women: 100 mg/day

Additional specific labelling requirements

1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Fermented soybean extract’. 2. The labelling of food supplements containing fermented soybean extract shall bear a statement that persons taking medication should only consume the product under medical supervision.

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

Fermented soybean extract is an odourless milk-white coloured powder. It is comprised of 30 % fermented soybean extract powder and 70 % resistant dextrin (as carrier) from corn-starch, which is added during the processing. Vitamin K2 is removed during the manufacturing process.

Fermented soybean extract contains nattokinase isolated from natto, a foodstuff produced by the fermentation of non-genetically modified soybeans (Glycine max (L.)) with a selected strain of Bacillus subtilis var. natto.

Nattokinase activity: 20 000 -28 000 Fibrin degradation unit/g(1)

Identity: Confirmable

Condition: No offensive taste or smell

Loss on drying: ≤ 10 %

Vitamin K2: ≤ 0,1 mg/kg

Heavy metals:

Lead: ≤ 5,0 mg/kg

Arsenic: ≤ 3,0 mg/kg

Microbiological criteria:

Total viable aerobic count: ≤ 103 CFU(3)/g

Yeast and mould: ≤ 102 CFU/g

Coliforms: ≤ 30 CFU/g

Spore-forming bacteria: ≤ 10 CFU/g

Escherichia coli: Absence/25 g

Salmonella: Absence/25 g

Listeria: Absence/25 g

(1) Assay method as described by Takaoka et al. (2010).

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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