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

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 thesafety 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 usepertains to the use of the NF as a food ingredient in protein products at a maxi-mum use level of 1 g of docosahexaenoic acid (DHA) in 100 g of product. The Panelconsiders that the information provided on the composition and the productionprocess is sufficiently described and does not raise safety concerns. S. limacinumwas attributed the qualified presumption of safety (QPS) status with the qualifi-cation ‘for production purposes only’. Data provided demonstrated the absenceof viable cells in the NF. Under the proposed extension of use, the highest intakeestimate (at the 95th percentile) of DHA from the NF in protein products is 6.3 mgDHA/kg bw per day for adolescents. The Panel notes that the exposure to DHAfrom the new intended use of the NF in protein products is very low compared tothe exposure to DHA from the already authorised food categories (excluding foodsupplements). The Panel concludes that the NF (oil from S. limacinum (FCC-3204))is safe under the new intended use.