(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 (2) 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 (3). 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 (4) 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,