FSA News Item, 18 September 2006
A Danish company has asked the Agency to rule on whether its food supplement is substantially equivalent to one already approved for use.
The company, MediMush, wants to sell its lentinan-rich extract from fermented shiitake mushrooms as a food supplement, in the form of a capsule, liquid, powder and gel. The Belgian company Bio-Life Laboratorial Natural Products* has been selling food supplements containing the dried pulverised fruit-bodies of shiitake mushroom in the European Union since the 1990s.
MediMush is requesting a ruling from the Agency on whether its supplement is substantially equivalent to Bio-Life Laboratorial Natural Products's whole-fungal product. The evaluation of these sorts of applications is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP).
BackgroundLentinan is a beta-glucan, a complex carbohydrate, 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 produced widely in Europe and is available in most supermarkets and fresh food stores.
The Novel Foods Regulation includes a simplified procedure where a novel food is considered substantially equivalent to a food that is already on the market. In this case, the applicant can submit a notification to the European commission after obtaining an opinion on equivalence from an EU Member State.
Deadline for comments
Any comments on this application should be sent to the ACNFP Secretariat by 8 October 2006 and will be passed to the Committee before it finalises its opinion.