Commission Implementing Decision (EU) 2017/115 of 20 January 2017 authorising the placing on the market of fermented soybean extract as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document C(2017) 165)

• CELEX: Implementing Decision (EU) 2017/115
• Articles: 4

Article 1

Without prejudice to Directive 2002/46/EC, fermented soybean extract as specified in the Annex to this Decision may be placed on the market in the Union as a novel food ingredient to be used in food supplements in capsule, tablet or powder form intended for the adult population, excluding pregnant and lactating women with a maximum dose of 100 mg fermented soybean extract per day.

Article 2

1.   The designation of fermented soybean extract authorised by this Decision on the labelling of the foodstuffs containing it shall be ‘fermented soybean extract’.

2.   Without prejudice to further labelling requirements under Article 8 of Regulation (EC) No 258/97 and Regulation (EU) No 1169/2011, the labelling of food supplements containing fermented soybean extract shall also bear a statement that persons taking medication should only consume the product under medical supervision.

Article 3

This Decision is addressed to Japan Bio Science Laboratory Osaka Head Office 1-4-40 Fukushima-ku, Osaka-city Osaka 5533-0003 Japan.

Schedules & Appendices

ANNEX

ANNEX

SPECIFICATION OF FERMENTED SOYBEAN EXTRACT

Description: 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 K 2 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 .

Specification of the fermented soybean extract

Parameters

Specification value

Nattokinase activity

20 000 -28 000 FU  ( 1 ) /g  ( 2 )

Identity

Confirmable

Condition

No offensive taste or smell

Loss on drying

Not more than 10 %

Vitamin K 2

Not more than 0,1 mg/kg

Heavy metals

Lead

Arsenic

Not more than 20 mg/kg

Not more than 5 mg/kg

Not more than 3 mg/kg

Total viable aerobic count

Not more than 1 000 CFU  ( 3 ) /g

Yeast and mould

Not more than 100 CFU/g

Coliforms

Not more than 30 CFU/g

Spore-forming bacteria

Not more than 10 CFU/g

Escherichia coli

Absence/25 g

Salmonella sp.

Absence/25 g

Listeria

Absence/25 g

( 1 )

FU : Fibrin degradation unit.

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

( 3 )

CFU : Colony forming unit.