Safety Assessment of Pea Protein Fermented by Shiitake (Lentinula Edodes) Mushroom Mycelia as a Novel Food (RP1759)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application in October 2022 from MycoTechnology, Inc. (“the applicant”) for authorisation of pea protein fermented by Shiitake mycelia as a novel food. The novel food is manufactured by fermentation of pea protein concentrate with Shiitake mycelia. The resulting biomass is concentrated and spray dried to a powder. The novel food is intended for use by the general population in the following food categories: dairy analogues; margarine; nut butters; breakfast cereals; baked goods; meat products; soups; protein products, excluding products covered in category 1.8; iced coffee; ready-to-eat snacks; and foods intended for total diet replacement for weight control, as defined in assimilated Regulation (EU) 609/2013. Potential de novo sensitisation to pea protein and cross-reactivity in legume allergic consumers due to consumption of the novel food, which contains higher levels of pea protein compared to the traditional diet, cannot be disregarded. Consumption of the novel food would likely be a risk to pea-allergic consumers; risk managers may wish to consider labelling as some proposed food categories are not generally recognised as sources of pea protein. The FSA and FSS in their evaluation of the application reviewed the safety dossier and supplementary information provided by the applicant. The FSA and FSS did not consider any potential health benefits or claims arising from consuming the food, as the focus of the assessment is to ensure the food is safe and not putting consumers at a nutritional disadvantage. The FSA and FSS concluded that the applicant had provided sufficient information to assure the novel food was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in food and beverages was not considered to be nutritionally disadvantageous. The safety assessment represents the opinion of the FSA and FSS.