Assessment on the Safety of DHA-rich Algal Oil From Schizochytrium Limacinum Strain ATCC 20889 for Use in Infant Formula and Follow-On Formula (RP2358)

BioPlus Life Sciences (“the applicant”) submitted a novel food application for the authorisation of DHA-rich algal oil produced by Schizochytrium limacinum (strain ATCC 20889) as a novel food to each nation of Great Britain in November 2025. The new application is seeking authorisation for DHA-rich algal oil produced by Schizochytrium limacinum (strain ATCC 20889) for use in infant formula and follow-on formula. The application for authorisation of this novel food was assessed by the European Food Safety Authority (EFSA), and its opinion was published in January 2025. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have reviewed the information available, including the EFSA opinion, and confirmed that DHA-rich algal oil produced by Schizochytrium limacinum strain ATCC 20889 was safe under the proposed conditions of use. The anticipated intake levels and proposed use in infant and follow-on formula was not considered to be nutritionally disadvantageous. This assessment represents the opinion of the FSA and FSS.