Draft Positive Opinion Formulated on Touchi Extract

The ingredient contains an alpha-glucosidase inhibitor and the company, CBC Co Ltd, intends for it to be consumed by anyone who wants to slow the breakdown of carbohydrates.

13/01/09 Japanese company CBC Co Ltd applied to the UK Food Standard’s Agency in July 2008 for approval to market its Touchi extract from fermented black beans as a novel food ingredient. The Advisory Committee on Novel Foods and Processes (ACNFP), an independent committee, has formulated a draft positive opinion on this ingredient.

A novel food is a food or food ingredient that does not have a significant history of consumption within the European Union before 15 May 1997.

Touchi extract is a protein-rich powder extracted from the fermentation of small soybeans with the fungus Aspergillus oryzae. The ingredient contains an alpha-glucosidase inhibitor and the company, CBC Co Ltd, intends for it to be consumed by anyone who wants to slow the breakdown of carbohydrates.

The extract is similar to black bean sauce, which has been on the market in the European Union for many years. One portion of black bean sauce contains 15g of fermented black beans, which corresponds to 4.5g of the novel food ingredient on extraction. The company plans to market the ingredient as a food supplement and a tea/soup style formulation at levels that would not exceed 4.5g per daily serving/dose.

Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, novel foods are assessed by the ACNFP, an independent committee of scientists appointed by the Food Standards Agency.

Following an initial public consultation on the application and the discussion of this application by the ACNFP at its meetings between July and November 2008, the committee has formulated a draft positive opinion on this Touchi extract ingredient.

Any comments on this draft opinion should be emailed to the ACNFP Secretariat at acnfp@foodstandards.gsi.gov.uk by Wednesday 21 January.

BC Co., Ltd. wishes to market Touchi Extract (TE), a protein-rich product in powder form obtained by aqueous extraction of small soybeans that have been fermented using the fungus Aspergillus Oryzae (also known as “salted black beans”) for use in food supplement products in the European Union. Fermented black beans have been widely used in China for the past 1000 years as a traditional seasoning and people are familiar with black beans as a protein source that can be preserved by drying without damage to the nutrient content. In Europe, fermented black beans have also been consumed for many years in Chinese dishes containing “black bean sauce” or involving “black bean paste” as an ingredient, and extensive discussions with the UK Novel Foods Competent Authority have indicated that the use of Touchi extract would not be considered novel for flavouring or seasoning. However, CBC Co., Ltd. also intend to market this product for use in food supplements in the European Union and for these purposes Touchi extract would be considered “novel” and fall under category (e) of Article 1(2) of Regulation (EC) No 258/97 (European Parliament and the Council of the European Union, 1997) (foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practises.

The application for placing Touchi extract on the market as a novel food or novel food ingredient is required to follow the European Commission’s Scientific Committee on Food (SCF) Recommendation 97/618/EC (Commission of the European Communities, 1997). Under Section 4 of this Recommendation, pertaining to the scientific classification of novel foods for the assessment of wholesomeness, Touchi extract would be considered as “Class 2 Complex Novel Food from non-GM sources: 2.1 the source of the novel food has a history of use in the Community”. Unlike the well-known large soybean, the small soybean has not been genetically modified and therefore, Touchi extract is derived from a non-GM source.

The tradename Touchi Extract (TE) will be used for marketing the food ingredient to the manufacturers. The proposed name for labelling purposes is “fermented black (soya) bean extract”, “Touchi extract” or “fermented black bean extract” (where *made from soya may be used as a footnote for the latter 2). Analytical data has been provided to show that Touchi extract does not contain toxic inherent constituents or external contaminants that might be associated with soybean or oilseed type products. Specifically the results of analysis for pesticides, heavy metals, dioxins, dioxin-like PCBs, PAHs, mycotoxins and 3-MCPD have been presented. The nutrient profile of Touchi extract is well understood and the protein composition comparable to that of fermented black beans from which it is obtained. In addition, the results of analysis concerning soy isoflavones and alpha-glucosidase inhibitory activity are presented. The specification has been well defined and analysis for three non consecutive production batches provided to show that the product can be manufactured consistently in accordance will clearly defined chemical and physical parameters.

The production process involves the water extraction of fermented black beans followed by spray drying to yield Touchi extract in the powder form. No chemical modification of the fermented black beans occurs and conventional extraction procedures are employed. As an indication of scale, one tablespoon (15 g) of fermented black beans corresponds to 4.5 g of Touchi extract. The process is performed in accordance with the principles of Hazards Analysis and Critical Control Points (HACCP) and Good Manufacturing Practice (GMP). The inclusion of a pasteurisation stage and the maximum 7% limit on water content in the product specification both ensure that microbial growth is minimised.

The raw material used to prepare Touchi extract is the small soybean (Glycine max.) which has been extensively used in the Sichuan province of China for centuries where it is known as the small yellow bean. Fermentation is performed using the fungus Aspergillus oryzae which has been used for hundreds of years in the production of soy sauce, miso, and sake.

Touchi extract is intended to be consumed as a nutritional support by people who wish to slow the breakdown of carbohydrate following a meal. Such a “carbohydrate blocking” property may help people dieting to feel less hungry for longer after a meal. In order to provide reassurance in relation to the use of such products by at risk groups, Touchi extract will only be marketed in food supplement form either as capsules or in sachet form (e.g., tea formulation) at levels that would not exceed 4.5 g per daily serving/dose. It is anticipated that such products would always be consumed with a meal. Touchi extract will only be added to products as a single dose supplement formulation where presentation to the consumer is controlled by Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements and will not be added to general food products. Furthermore, risk management measures will be applied under the conditions of the Corrigendum to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 (European Parliament and the Council of the European Union, 2007) on nutrition and health claims made on foods.

As stated above, the results of microbiological testing confirm the absence of pathogens. The safety of Touchi extract is based principally on its equivalence to fermented black beans, which have been consumed since ancient times and are widely available in culinary dishes throughout the European Union. At the maximum consumption level of 4.5 g per day, Touchi extract is equivalent to approximately a 1 tablespoon (15 g) serving of fermented black beans. The solvent used is water and no selective extraction occurs with the result that no chemical modification is involved and the composition is comparable its traditional counterpart (fermented black beans). Touchi extract has an inhibitory effect on the enzyme alpha-glucosidase so delaying the digestion of carbohydrate in the small intestinal tract after a meal. Undigested carbohydrates or disaccharides are then excreted rather than being absorbed by the body thus providing possible assistance in weight control regimes. The approval of Touchi extract is requested only for specific food supplement products (in tablet or sachet form) that would be taken with meals at levels not exceeding 4.5 g/day and as such would have specific risk management and labelling clauses that would prevent the consumption by at risk groups such as diabetics. The safety of Touchi extract at these levels is supported by a range of toxicological safety studies, including a 28-day sub-chronic study in the rat, which established a no-observed-adverse-effect level (NOAEL) of 2500 mg/kg body weight/day (Fujita and Yamagami, 2007), equivalent to 150 g/day for a 60 kg adult, or equivalent to approximately a 33-fold safety factor compared to maximum daily consumption of 4.5 g. Numerous human clinical studies have been conducted in both healthy and diabetic subjects with Touchi extract at levels up to 10 g per daily serving and durations of up to 6 months. The absence of major adverse effects in subjects offers additional evidence for the safety of Touchi extract.