2025-05-192025-05-192025-01-22Turck, D., Bohn, T., Cámara, M., Castenmiller, J., Henauw, S., Jos Gallego, Á.M.,...,McArdle, H.J. (2025). Safety of oil from Schizochytrium limacinum (strain ATCC-20889) for use in infant and follow-on formula as a novel food pursuant to Regulation (EU) 2015/2283. Efsa Journal, 23 (1), e9156. https://doi.org/10.2903/j.efsa.2025.9156.1831-4732https://hdl.handle.net/11441/172905Following a request from the European Commission, the EFSA Panel on Nutrition,Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on thesafety of an oil derived from the microalga Schizochytrium sp. (strain ATCC-20889)as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixtureof triglycerides in which docosahexaenoic acid (DHA) represents 40%–43% offatty acids. The available evidence indicates that the source organism (strain ATCC-20889) belongs to the species Schizochytrium limacinum. The applicant intendsto market the NF as an ingredient in infant formulae (IF) and follow-on formulae(FOF). The use levels proposed by the applicant were derived from Regulation (EU)2016/127, which states the mandatory presence of DHA to IF and FOF at the levelsof 20–50 mg/100 kcal. Schizochytrium limacinum was attributed the qualified pre-sumption of safety (QPS) status with the qualification ‘for production purposesonly’. Data provided by the applicant demonstrated the absence of viable cells inthe NF. No toxicological studies were performed with the NF. However, based onthe available toxicological data on oils derived from Schizochytrium sp., the QPSstatus of the source of the NF, the production process, the composition of the NF,the absence of marine biotoxins and viable cells in the NF, the Panel considers thatthere are no concerns with regard to the toxicity of the NF. The Panel concludesthat the NF is safe under the proposed conditions of use.application/pdf16engAttribution-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nd/4.0/AlgaeDocosahexaenoic acid (DHA)Fatty acidinfants and young childrenNovel foodsSafetySchizochytriuminfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccesshttps://doi.org/10.2903/j.efsa.2025.9156