Turck Dominique, Bohn Torsten, Cámara Montaña, Castenmiller Jacqueline, De Henauw Stefaan, Hirsch-Ernst Karen Ildico, Jos Ángeles, Maciuk Alexandre, Mangelsdorf Inge, McNulty Breige, Naska Androniki, Pentieva Kristina, Siani Alfonso, Thies Frank, Aguilera-Gómez Margarita, Cubadda Francesco, Frenzel Thomas, Heinonen Marina, Knutsen Helle Katrine, Neuhäuser-Berthold Monika, Poulsen Morten, Prieto Maradona Miguel, Schlatter Josef Rudolf, Siskos Alexandros, van Loveren Henk, Nuin Garciarena Irene, Turla Emanuela, McArdle Harry J
EFSA J. 2025 Jan 22;23(1):e9156. doi: 10.2903/j.efsa.2025.9156. eCollection 2025 Jan.
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 oil derived from the microalga sp. (strain ATCC-20889) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a mixture of triglycerides in which docosahexaenoic acid (DHA) represents 40%-43% of fatty acids. The available evidence indicates that the source organism (strain ATCC-20889) belongs to the species . The applicant intends to 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 levels of 20-50 mg/100 kcal. was attributed the qualified presumption of safety (QPS) status with the qualification 'for production purposes only'. Data provided by the applicant demonstrated the absence of viable cells in the NF. No toxicological studies were performed with the NF. However, based on the available toxicological data on oils derived from sp., the QPS status 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 that there are no concerns with regard to the toxicity of the NF. The Panel concludes that the NF is safe under the proposed conditions of use.
应欧盟委员会的要求，欧洲食品安全局营养、新型食品和食品过敏原专家小组（NDA）被要求根据欧盟法规（EU）2015/2283，就源自微藻 sp.（菌株ATCC - 20889）的一种油作为新型食品（NF）的安全性发表意见。该新型食品是甘油三酯的混合物，其中二十二碳六烯酸（DHA）占脂肪酸的40%-43%。现有证据表明，来源生物（菌株ATCC - 20889）属于 物种。申请人打算将该新型食品作为婴儿配方奶粉（IF）和后续配方奶粉（FOF）中的一种成分进行销售。申请人提议的使用水平源自欧盟法规（EU）2016/127，该法规规定婴儿配方奶粉和后续配方奶粉中必须含有20 - 50毫克/100千卡的DHA。 被赋予了“仅用于生产目的”这一限定条件下的安全合格推定（QPS）地位。申请人提供的数据表明新型食品中不存在活细胞。未对该新型食品进行毒理学研究。然而，基于关于源自 sp.的油的现有毒理学数据、新型食品来源的QPS地位、生产工艺、新型食品的成分、新型食品中不存在海洋生物毒素和活细胞，专家小组认为该新型食品的毒性不存在问题。专家小组得出结论，在提议的使用条件下，该新型食品是安全的。
