Assessment on the Safety of an Extension of Use of DHA-rich Oil From Schizochytrium sp. Strain FCC-3204 for Use in All Protein Products (RP2316)

Fermentalg, France (“the applicant”) submitted a novel food application for a change in conditions of use of Schizochytrium sp. strain (FCC‑3204) oil as a novel food to each nation of Great Britain (GB) in June 2025. The novel food is an oil rich in docosahexaenoic acid (DHA) produced by the microalga Schizochytrium sp. strain (FCC‑3204), which is already authorised for use in a range of food categories and supplements in GB. The applicant is seeking authorisation of a change in conditions of use to extend the permitted uses to protein products, at a proposed maximum level of 1 g DHA per 100 g of product. The application for a change in the conditions of use for this novel food was assessed by the European Food Safety Authority (EFSA), which published its scientific opinion in 2024. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have reviewed the information available, including the EFSA opinion, and confirmed that the proposed change in conditions of use for Schizochytrium sp. strain (FCC‑3204) was safe. The anticipated intake levels and proposed uses were not considered to be nutritionally disadvantageous. This assessment represents the opinion of the FSA and FSS.