No major chemical modification of the components is involved during extraction of „fermented black

bean extract‟ with water, despite the extraction is performed at elevated temperature. Although only

the water soluble components will be extracted, the Panel considers that the composition and the

nature of the nutrients remain similar to the traditional fermented black bean products. The

chromatograms obtained from HPLC analysis of „fermented black bean extract‟ and fermented black

bean paste were very similar and exhibit peaks consistent with low molecular weight peptides and

amino acids. 

The Panel acknowledged that the applicant‟s arguments on the similarity between

fermented black bean sauce and „fermented black bean extract‟ are based on the commonly shared

fermentation process and data obtained by SDS-Gel Electrophoresis. The applicant indicates that the

water extraction of 15 g of fermented black beans yields 4.5 g of Touchi extract, which is the

maximum dose per day proposed by the applicant. The Panel considers that the data on the

composition and on the production process do not raise concerns.

The applicant indicated, however, that „fermented black bean extract‟ can be considered as providing

approximately 60 g protein (minimum 55 g), no more than 1 g fat and 25 to 30 g of carbohydrate per

100 g. Furthermore analysis of the composition of a single batch of „fermented black bean extract‟

indicated the presence of 7.8 g ash/100g. If 7.8 g ash/100 g is added to the specifications, about 93-98% of the material is accounted for.

The Panel notes that the specifications as provided by the applicant do not include levels of a variety

of ingredients known to be present in soybean which might be relevant from a safety point of view,

including for example kojic, cyclopiazonic and beta-nitropropionic acid and biogenic amines,

especially histamines and ethyl carbamate, as well as levels of antinutritive substances including

tannic acid, trypsin inhibitor and isoflavones. Isoflavones are flavonoids with structural similarities to

oestrogens. The applicant indicated that the whole soybean contains approximately 200 mg of

isoflavones per 100 g, but actual levels present in the Touchi extract are not provided. Taking into

account that the preparation process does not concentrate isoflavones and the intended maximum

intake of 4.5 g Touchi extract per day, the content of isoflavones is not of concern.

The Panel asked the applicant for detailed compositional information, such as the quality of the

protein/peptide content, qualitative and quantitative data on the carbohydrate fraction (other than

calculating the content of carbohydrates by 100 % minus other constituents), on secondary plant

constituents such as kojic, cyclopiazonic and beta-nitropropionic acid and biogenic amines, especially

histamines and ethyl carbamate, as well as levels of other potential anti-nutritive substances including

tannic acid and trypsin inhibitor. The Panel also asked for data on micronutrients, if available,

because these would be supportive for the overall characterisation of „fermented black bean extract‟.

The HPLC chromatograms of a sample of the „fermented black bean extract‟ and of a fermented

black bean paste were shown to be similar, exhibiting peaks consistent with amino acids and low

molecular weight peptides. However neither amino acids nor peptides were identified. It is noted that

amino acids and peptides are referred as “proteins”. Data obtained by SDS Gel-

Electrophoresis indicate that upon fermentation with A. oryzae the levels of peptides with a molecular

weight smaller than 20 kDa are significantly increased as compared to the starting raw soybeans, with

a concomitant decrease of the larger peptides. Specifically, on fermentation of soybean meal no

peptides greater than 60 kDa in size were detected, compared to ca. 22 % in the starting material.