Japanese firm CBC Co applied for novel foods approval for its ingredient derived from black bean (glycine max), a form of soy also known as touchi, in 2008. The bean has been widely consumed in the Sichuan province of China for centuries as a basic foodstuff and as a seasoning.
Moreover, the fermentation process for obtaining the extract using Aspergillus oryzae is exactly the same as that used for making miso soup and soy sauce.
In its draft opinion, which is open for comment until January 21, the FSA said that, given that black bean products are available widely on the market, and the same process is used for popular oriental sauces, no adverse effects are expect from consuming the extract.
Its Advisory Committee on Novel Foods and Processes noted that foods containing the novel ingredient would need to be labelled appropriately, however, and no claims should be made that are likely to mislead customers.
According to the applicant the extract, when consumed with a meal, could delay digestion of carbohydrates in the small intestine, whereby the alpha-glucosidase enzyme breaks them down into glucose and fructose. The undigested carbohydrates are then said to be excreted.
However the draft opinion does not constitute a health claim for the ingredient; any such claim would have to be approved under the entirely separate health claim regulation.
CBC Co anticipates that, subject to approval, the extract would be sold as a powder or used in dietary supplement formulations.
The weight loss market
Some industry experts have noted a drop off in the market for weight loss supplements in Europe in recent times, which may be due to the strict new health claim rules.
Data from Mintel’s Global New Product Database indicates a 50 per cent drop off in new supplements launched in the EU claiming to have some impact on weight control.
Conversely, products with a sound scientific base that do overcome the health claim regulatory hurdle are likely to have a privileged place in the market.
In the United States, Pharmachem markets a carbohydrate-blocker derived from white bean (Phaseolus vulgaris). This ingredient was initially used as a dietary supplement, but in 2006 Pharmachem it was declared GRAS, meaning it could also be used in food and beverage products in that market.
The FSA’s draft opinion is available here