Turck Dominique, Bohn Torsten, Cámara Hurtado María de la 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, Cubadda Francesco, Frenzel Thomas, Gundert-Remy Ursula, Marcon Francesca, Prieto Maradona Miguel, Neuhäuser-Berthold Monika, Siskos Alexandros, Wright Matt, Matijević Leonard, McArdle Harry
EFSA J. 2025 Jul 10;23(7):e9528. doi: 10.2903/j.efsa.2025.9528. eCollection 2025 Jul.
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 magnesium orotate dihydrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and to address the bioavailability of magnesium from this source in the context of Directive 2002/46/EC. The NF is produced by chemical synthesis and is proposed to be used in food supplements at a maximum intake level of 6100 mg per day by adults. This intake level corresponds to around 5000 mg/day orotic acid and 400 mg/day magnesium. The Panel notes that this would exceed the established UL for supplemental magnesium of 250 mg/day, therefore the use of the NF could be nutritionally disadvantageous. The Panel also notes the previous safety assessment of magnesium orotate dihydrate, where concerns were raised regarding the exposure to orotic acid, based on several animal studies demonstrating tumour-promoting effects. The ANS Panel derived a no observed adverse effect level (NOAEL) for orotic acid of 50 mg/kg bw per day. The margin between the derived NOAEL for orotic acid and the exposure resulting from the proposed maximum use level of the NF is 0.7 (based on the average bw of an adult person of 70 kg) which is even lower than the margin considered by the ANS Panel of being inadequate. The applicant has not provided any toxicological data on the NF or on orotic acid that could address or mitigate these safety concerns. The Panel concludes that the safety of the NF, magnesium orotate dihydrate, cannot be established under the proposed conditions of use. The assessment of bioavailability of magnesium from the NF in comparison to natural sources was not conducted.
应欧盟委员会的要求，欧洲食品安全局（EFSA）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就二水合乳清酸镁作为新型食品（NF）的安全性发表意见，并根据指令2002/46/EC探讨该来源镁的生物利用度。该新型食品通过化学合成生产，建议用于食品补充剂，成人的最大摄入量为每天6100毫克。该摄入量相当于约5000毫克/天的乳清酸和400毫克/天的镁。专家小组指出，这将超过已确定的补充镁的每日可耐受最高摄入量（UL）250毫克/天，因此使用该新型食品在营养方面可能不利。专家小组还注意到之前对二水合乳清酸镁的安全性评估，基于多项显示促肿瘤作用的动物研究，人们对乳清酸暴露表示担忧。毒理学和营养科学专家小组得出乳清酸的未观察到有害作用水平（NOAEL）为每天50毫克/千克体重。乳清酸的推导NOAEL与该新型食品建议最大使用水平所导致的暴露量之间的差距为0.7（基于70千克成年人体重平均值），甚至低于毒理学和营养科学专家小组认为不足的差距。申请人未提供任何关于该新型食品或乳清酸的毒理学数据来解决或减轻这些安全问题。专家小组得出结论，在提议的使用条件下，无法确定该新型食品二水合乳清酸镁的安全性。未对该新型食品中镁与天然来源相比的生物利用度进行评估。
