Commission Implementing Decision (EU) 2017/115

law://eu/dec/2017/115@2026-11-13

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients^note, and in particular Article 7(1) thereof,Whereas:

(1)On 8 May 2014, the company Japan Bio Science Laboratory made a request to the competent authorities of Belgium to place fermented soybean extract on the Union market as a novel food ingredient within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97. The application excluded from the use pregnant and lactating women.

(2)On 1 December 2014, the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that fermented soybean extract meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.

(3)On 6 January 2015, the Commission forwarded the initial assessment report to the other Member States.

(4)Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

(5)On 22 April 2015, the Commission consulted the European Food Safety Authority (EFSA) asking it to carry out an additional assessment for fermented soybean extract as novel food ingredient in accordance with Regulation (EC) No 258/97.

(6)On 28 June 2016, EFSA concluded in its opinion on the safety of fermented soybean extract as a novel food^note that fermented soybean extract used in food supplements intended for adults is safe under the conditions of use proposed by the applicant limiting consumption per day to a maximum dose of 100 mg. That opinion gives sufficient grounds to establish that fermented soybean extract as a novel food ingredient complies with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(7)In its opinion, EFSA noted that fermented soybean extract contains nattokinase which exhibits in vitro fibrinolytic activity and in vivo thrombolytic activity in animals when administered parenterally. It is therefore necessary to inform consumers about the need of medical supervision in cases when fermented soybean extract is consumed in combination with medication.

(8)In its opinion, EFSA concludes that the margin of exposure is sufficient considering the maximum intake level for fermented soybean extract proposed by the applicant.

(9)In its opinion, EFSA considers that the risk of allergic reaction to fermented soybean extract is similar to that associated with other soy-derived products which are to be labelled pursuant to Annex II to Regulation (EU) No 1169/2011 of the European Parliament and of the Council^note. Therefore, the novel food ingredient should be labelled in accordance with Article 8 of Regulation (EC) No 258/97 and Regulation (EU) No 1169/2011.

(10)Directive 2002/46/EC of the European Parliament and of the Council^note lays down requirements for food supplements. The use of fermented soybean extract should be authorised without prejudice to the provisions of that Directive.

(11)The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

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.

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 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.

Specification of the fermented soybean extract

Parameters	Specification value
Nattokinase activity	20000-28000 FU^note/g^note
Identity	Confirmable
Condition	No offensive taste or smell
Loss on drying	Not more than 10 %
Vitamin K₂	Not more than 0,1 mg/kg
Heavy metalsLeadArsenic	Not more than 20 mg/kgNot more than 5 mg/kgNot more than 3 mg/kg
Total viable aerobic count	Not more than 1000 CFU^note/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

Commission Implementing Decision (EU) 2017/115

Commission Implementing Decision (EU) 2017/115

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Article 2 #

Article 3 #

Specification of fermented soybean extract

Specification of the fermented soybean extract

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Article 2 #

Article 3 #

Specification of fermented soybean extract

Specification of the fermented soybean extract