Safety Assessment on the Change of Specification of the Novel Food Schizochytrium sp. Oil Rich in DHA and EPA (RP2180)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application in March 2024 from DSM Nutritional Products Ltd., Switzerland (“the applicant”) for a change of conditions of use of Schizochytrium sp. oil rich in docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) as a novel food. The specific strain used to produce the novel food is also known as DHA-O and was first authorised for use in 2012. The novel food is Schizochytrium sp. oil rich in DHA and EPA, which is intended to be used as a food ingredient. The novel food is manufactured by self-contained fermentation using the algae Schizochytrium . Subsequently, the algae are subject to various oil recovery phases to produce the refined novel food, which is described as an oil rich in DHA and EPA. Schizochytrium sp. oil rich in DHA and EPA is currently authorised as a novel food in the UK and EU under assimilated Regulation (EU) 2015/2283. This application for a change of conditions of use of the novel food, is seeking to revise the level of DHA in the specification from the currently authorised level of ‘equal to or greater than 22.5%’ to ‘equal to or greater than 15.0%’. The proposed change to the specification is to reflect changes made to the composition as a result of manufacturing process improvements. No other changes have been requested. 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 novel food assessment is to ensure the change of conditions of use to extend 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 that the change of conditions of use for Schizochytrium sp. oil rich in DHA and EPA was safe under the intended conditions of use. The anticipated intake levels and the intended use in foods was not considered to be nutritionally disadvantageous. The safety assessment represents the opinion of the FSA and FSS.