Safety Assessment of an Extension of Use of the Novel Food Schizochytrium sp. (ATCC PTA-9695) Oil (RP2328)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application, in July 2025 from DSM Nutritional Products Europe Ltd., Switzerland (“the applicant”). The application is seeking to change the conditions of use of an authorised novel food Schizochytrium sp. (ATCC PTA-9695) oil, to increase the daily intake of the novel food in food supplements to 1 g DHA/day for those 3 years of age and above including pregnant and lactating women, whilst maintaining 250 mg DHA/day in food supplements for the general population below 3 years of age. The purpose of the proposed change is to align with similar authorisations for high-DHA Schizochytrium sp. oils. 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 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 in the conditions of use of Schizochytrium sp. (ATCC PTA-9695) oil did not raise any safety concerns for the target populations. The anticipated intake levels and the intended use was not considered to be nutritionally disadvantageous. The assessment represents the opinion of the FSA and FSS.