Lentinan-rich extract: MediMush

September 2006. Application from MediMush for an opinion on the equivalence of lentinan-rich extract obtained from the mycelium of fermented-produced shiitake mushroom (<em>Lentinus edodes</em>). Rejected 2007.

Lentinan is a beta-glucan, which is found in various foods including legumes, cereals, tubers, fruits and mushrooms such as shiitake. This fungus is indigenous to Japan, China and other Asian countries with warm climates and is usually found growing on fallen deciduous trees.

Fresh shiitake mushroom is now produced widely in Europe and is available in most supermarkets and fresh food stores. The applicant wrongly indicated in its original dossier published on this website between 18 September and 9 October 2006 that the Malaysian company Bio-Life Marketing Sdn Bhd had been selling food supplements containing the dried pulverised fruit-bodies of shiitake mushroom in the EU since the 1990s. This is in fact the Belgian company Bio-Life Laboratorial Natural Products which is doing this and the applicant has now corrected his application accordingly.

The applicant intends to market its lentinan-rich extract as a food supplement in the form of a capsule, liquid, powder and gel.

Regulation (EC) 258/97 makes provision for novel foods or ingredients that are substantially equivalent to an existing product to be placed on the market once the applicant has informed the European Commission.

In all cases to date, the Commission has required that the applicant first obtains an opinion on substantial equivalence from a Member State. MediMush is requesting such an opinion from the UK Competent Authority on the equivalence of their extract to the whole-fungal product currently on the market.

Any comments received on this application will be passed to the Committee for consideration during its assessment of this novel food ingredient.

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