Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283

• Published in: EFSA journal 2024-10, Vol.22 (10), p.e9043-n/a
• Main Authors: Turck, Dominique, Bohn, Torsten, Cámara, Montaña, Castenmiller, Jacqueline, De Henauw, Stefaan, Hirsch‐Ernst, Karen Ildico, Jos, Ángeles, Maciuk, Alexandre, Mangelsdorf, Inge, McNulty, Breige, McArdle, Harry J., Naska, Androniki, Pentieva, Kristina, Siani, Alfonso, Thies, Frank, Aguilera‐Gómez, Margarita, Cubadda, Francesco, Frenzel, Thomas, Heinonen, Marina, Neuhäuser‐Berthold, Monika, Poulsen, Morten, Prieto Maradona, Miguel, Schlatter, Josef Rudolf, Siskos, Alexandros, Loveren, Henk, Nuin Garciarena, Irene, Turla, Emanuela, Valtueña Martínez, Silvia, Knutsen, Helle Katrine
• Format: Article
• Language: English
• Subjects: alga; Algae; Crude oil; DHA; Dietary supplements; Docosahexaenoic acid; extension of use; Fatty acids; Food; Food allergies; Information processing; novel food; Novel foods; Oils & fats; Proteins; Safety; Schizochytrium; Schizochytrium limacinum; Scientific Opinion; Triglycerides
• ISSN: 1831-4732; 1831-4732; 2314-9396
• DOI: 10.2903/j.efsa.2024.9043

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The extension of use pertains to the use of the NF as a food ingredient in protein products at a maximum use level of 1 g of docosahexaenoic acid (DHA) in 100 g of product. The Panel considers that the information provided on the composition and the production process is sufficiently described and does not raise safety concerns. S. limacinum was attributed the qualified presumption of safety (QPS) status with the qualification ‘for production purposes only’. Data provided demonstrated the absence of viable cells in the NF. Under the proposed extension of use, the highest intake estimate (at the 95th percentile) of DHA from the NF in protein products is 6.3 mg DHA/kg bw per day for adolescents. The Panel notes that the exposure to DHA from the new intended use of the NF in protein products is very low compared to the exposure to DHA from the already authorised food categories (excluding food supplements). The Panel concludes that the NF (oil from S. limacinum (FCC‐3204)) is safe under the new intended use.