Safety Assessment on AM-1 Glycolipids Used as a New Food Additive (RP1457)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application for the authorisation of a new food additive glycolipids (AM-1) under Regulation (EC) No 1331/2008. The glycolipids compound is produced by the fermentation of the edible mushroom Dacryopinax spathularia, strain MUCL 53181 (internal identifier: FU50088). The views of the Joint Expert Group on Additives, Enzymes, and other Regulated Products (AEJEG), Advisory Committee on the Microbiological Safety of Food (ACMSF) and Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) were considered in this safety assessment which represents the opinion of the FSA and FSS on the authorisation of a new food additive glycolipids (AM-1). The advice of AEJEG can be found in the corresponding Committee Advice Document. The FSA and FSS concluded there were no toxicity, genotoxicity or other safety concerns for glycolipids produced using specifically the strain MUCL 53181 and agreed on a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg bw per day based on the 90-day rat study, and the use of a total uncertainty factor of 300 to give an Acceptable Daily Intake (ADI) of 3.3 mg/kg bw per day.