Scientific Opinion on the safety of "Lentinus edodes extract" (Lentinex®) as a Novel Food ingredient

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies was asked to carry out the additional safety assessment for Lentinex®, an aqueous mycelial extract of Lentinula edodes (Shiitake mushroom), as a novel food ingredient in the context of Regulation (EC) No 258/97. Lentinex® consists of approximately 98 % water and 2 % dry matter (β-glucan lentinan, free glucose and N-containing constituents). The mushroom Lentinula edodes has an established history of consumption throughout the world. The applicant intends to market the ingredient in a wide range of products: dietary supplements, yoghurts, soft drinks, cooked and processed foods, and baked goods. The proposed intake of 2.5 mL Lentinex® containing 1 mg lentinan (β-glucan)/mL corresponds to 41.7 µg/kg body weight for a 60 kg person. The intake of β-glucan resulting from the proposed use is low compared to the intake estimated from the consumption of the mushroom Lentinula edodes and of other β-glucan sources. The animal and the human studies provided were primarily carried out to determine the efficacy of the novel food ingredient; they are supporting but of limited value regarding a safety assessment. Owing to the fermentative production of the novel food ingredient from the mycelium and the final application of a heat-induced sterilisation step, adverse effects reported after the consumption of the fruiting body of the Shiitake mushroom are not considered relevant. Although an allergenic risk cannot be excluded for sensitive subjects, this risk is expected not to be higher than that resulting from the normal consumption of the fruiting body of Lentinula edodes. The Panel notes the presence of soy peptides in the culture medium. The safety of Lentinex® as a novel food ingredient has been established at the proposed conditions of use and the proposed levels of intake.