July 2008. Application from Glycanova for the approval of lentinan-rich extract obtained from the mycelium of fermented-produced shiitake mushroom (Lentinus edodes). Authorised February 2011.
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 intends to market its lentinan-rich extract as a food supplement and food ingredient.
Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).
One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.
Application Status: Authorised
Before any new food product can be introduced on the European market, it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists appointed by the Food Standards Agency, the Advisory Committee on Novel Foods and Processes (ACNFP). The applicant (formerly known as Medimush) previously submitted an application under the substantial equivalence route, however equivalence could not be demonstrated and a full application was subsequently submitted in February 2008. Following an initial public consultation period and the discussion of this application by the ACNFP at its meetings in 2007 and 2008, the committee has formulated a positive initial opinion on this novel food ingredient. This opinion led to the product being authorised under commision regulation (2011/73/EU).