GlycaNova seeks novel foods approval for Lentinex – round three

Lentinan is a form of beta-glucan produced by fermenting the mushrooms in glucose, malt extract, soy peptone and yeast extract, a process similar to the production of a number of food products, including baker’s yeast.

The company wants to market its proposed Lentinex product as a novel food supplement and novel food ingredient in a number of different food categories, including dietary supplements, yoghurts, soft drinks, cooked and processed foods, and baked goods.

Substantial equivalence​

The FSA states that 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​”​.

According to EU legislation, before any new food product can be released on to the European market it must undergo a series of rigorous safety tests by the Advisory Committee on Novel Foods and Processes (ACNFP), an independent committee of scientists appointed by the FSA.

GlycaNova had previously submitted an application in September 2006 under the “simplified procedure”, whereby a company applies to have its novel food recognized as “substantially equivalent” to an item already on the market. The company argued that shiitake mushrooms themselves have an established history of consumption throughout the EU and the rest of the world, and that lentinan is also found in legumes, cereals, tubers and fruits. Moreover, it claimed that beta-glucans extracted from mushrooms, including shiitake mushrooms, are also consumed in concentrated form in a range of commercially available dietary supplements.

However, the ACNFP “concluded that the data provided by the applicant were insufficient to enable an opinion on substantial equivalence to be issued”​.

The company therefore had to submit a full application to have the product approved as a novel food. The ACNFP has now formulated a draft opinion on which it is currently inviting comments before it finalises its decision.

Perceived health benefits​

Tests have suggested that lentinan may be effective in the treatment of cancer, as well as having cholesterol-lowering and immune-regulatory properties. However, the draft opinion states that “any health claims that are attributed to the consumption of lentinan are not considered as part of this application”​. Were GlycaNova to make any health claims for Lentinex, these would have to be examined separately under regulation (EC) 1924/2006.

The company is proposing that its product be marketed without restriction with a recommended daily intake of 1-2.5mg/day. The application does not include any dietary survey data showing that these levels would not be exceeded but notes that daily consumption of four or five shiitake mushrooms would provide an intake of around 1.8mg.

Toxicology studies carried out on animals and humans by GlycaNova have not indicated that consumption of the product would give cause for concern. However, the ACNFP has suggested that the primary purpose of the preliminary tests was to establish the efficacy of the product and that further toxicology reports would be required.

Lentinus edodes​ is native to Asian countries with warm climates such as Japan and China and is usually found growing on fallen deciduous trees.

Fresh shiitake mushrooms are widely available at supermarkets and health food stores across Europe.

The draft opinion can be viewed here​.