Mushroom extract seeks Novel Foods approval (again)
The application has been made to the UK Food Standards Agency for a lentinan extract marketed by Danish firm, GlycaNova. It is seeking "substantial equivalence" for its ingredient as it argues it is similar to existing offerings on-market, and therefore should be deemed safe.GlycaNova originally submitted an application under the Novel Foods regulation's simplified procedures in 2006 but the evidence was not deemed substantial enough and so it resubmitted in February this year with additional safety data. Novel Food regulations, which many view as constraining trade and innovation because of the time consuming process involved for ingredient and food approvals, state that foods that cannot demonstrate a history of safe use within the European Union before May, 1997, must provide supporting data via the European Union Novel Foods regulations. These applications typically take years to process. GlycaNova's Lentinex ingredient, a beta-glucan, is produced by fermenting the shiitake mushroom. The company noted that its production technology was similar to processes used in the production of a range of food products such as baker's yeast, food acids and beer. It is a clear, light brown liquid containing glucose, other sugars, protein and polysaccharides, all of which have GRAS (generally regarded as safe) status in the US. In its 97-page application to the FSA's Advisory Committee on Novel Foods and Processes (ACNFP), GlycaNova noted that the fruiting body of the mushroom has been marketed extensively in the EU along with aqueous extracts marketed either as capsules or liquid extracts. GlycaNova said it intended to market Lentinex for use as a food supplement to companies within the EU as an alternative form of the lentinan from Lentinus edodes (the shiitake mushroom). "This will present a standardised lentinan product that is free from fungal cellular debris, has a long shelf life and offers consumers an increased choice when selecting lentinan containing products," it wrote. The application included reference to many in vitro and in vivo studies and the FSA has set a deadline of July 23 to receive feedback. Lentinan is found in various foods including legumes, cereals, tubers, fruits and mushrooms such as shiitake (Lentinus edodes). It is indigenous to Asia climates and is usually found growing on fallen deciduous trees and is known to boost the immune system. Whole shiitake mushrooms have become popular in Europe and are widely available in retail outlets such as supermarkets and health food stores. The full application can be found here.