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, van Loveren Henk, Nuin Garciarena Irene, Turla Emanuela, Valtueña Martínez Silvia, Knutsen Helle Katrine
EFSA J. 2024 Oct 24;22(10):e9043. doi: 10.2903/j.efsa.2024.9043. eCollection 2024 Oct.
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 (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. 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 (FCC-3204)) is safe under the new intended use.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品及食品过敏原专家小组（NDA）被要求根据欧盟法规（EU）2015/2283，就将（菌株FCC - 3204）的油作为新型食品（NF）扩大用途的安全性发表意见。该用途扩展涉及将该新型食品作为蛋白质产品中的食品成分使用，最高使用水平为每100克产品中含有1克二十二碳六烯酸（DHA）。专家小组认为，所提供的关于成分和生产工艺的信息已得到充分描述，不存在安全问题。已将（菌株FCC - 3204）赋予“仅用于生产目的”的有条件安全推定（QPS）地位。所提供的数据表明该新型食品中不存在活细胞。在提议的用途扩展下，蛋白质产品中该新型食品的DHA最高摄入量估计值（第95百分位数），青少年为每天6.3毫克DHA/千克体重。专家小组指出，与已获授权的食品类别（不包括食品补充剂）中的DHA暴露量相比，蛋白质产品中该新型食品新预期用途的DHA暴露量非常低。专家小组得出结论，在新的预期用途下，该新型食品（（菌株FCC - 3204）的油）是安全的。
