Turck Dominique, Bresson Jean-Louis, Burlingame Barbara, Dean Tara, Fairweather-Tait Susan, Heinonen Marina, Hirsch-Ernst Karen Ildico, Mangelsdorf Inge, McArdle Harry J, Naska Androniki, Neuhäuser-Berthold Monika, Nowicka Grażyna, Pentieva Kristina, Sanz Yolanda, Siani Alfonso, Sjödin Anders, Stern Martin, Tomé Daniel, Vinceti Marco, Willatts Peter, Engel Karl-Heinz, Marchelli Rosangela, Pöting Annette, Poulsen Morten, Schlatter Josef Rudolf, Gelbmann Wolfgang, Ververis Ermolaos, van Loveren Henk
EFSA J. 2017 Oct 26;15(10):e05001. doi: 10.2903/j.efsa.2017.5001. eCollection 2017 Oct.
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 1-methylnicotinamide chloride (1-MNA) as a novel food (NF) ingredient submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council, taking into account the comments and objections of a scientific nature raised by Member States. 1-MNA is a substance present naturally in the human body as a normal downstream product of niacin metabolism. The Panel considers that the information provided on the composition, the specification and the batch-to-batch variability of the NF is sufficient. The applicant intends to use 1-MNA in food supplements and proposes a maximum intake of 58 mg/day. 1-MNA is not genotoxic. In a subchronic rat study, epithelium degeneration of the non-glandular stomach was observed at all dose levels with increasing frequency. The Panel notes that the human stomach does not have non-glandular epithelium and considers this finding is toxicologically not relevant for humans. At doses of 500 and 1,000 mg/kg body weight (bw), changes of the urine pH, that did not reverse in the recovery period, were reported. As adversity of this finding cannot be ruled out, the Panel selected 250 mg/kg bw in this rat study as the reference point. The Margin of Exposure to humans weighing 70 kg and consuming 58 mg would be about 300. The Panel notes the upper level for nicotinamide, i.e. 900 mg/day for adults. Taking into account that 1-MNA is a main metabolite from nicotinamide, the Panel considers that it is unlikely that an intake of 58 mg 1-MNA from food supplements would result in adverse health outcomes in humans. The Panel concludes that the NF, 1-MNA, is safe under the proposed uses and use levels.
应欧盟委员会的要求，欧洲食品安全局（EFSA）的营养产品、营养与过敏专家小组（NDA）被要求就按照欧洲议会和理事会第258/97号条例提交的新型食品（NF）成分1-甲基烟酰胺氯化物（1-MNA）发表意见，同时考虑成员国提出的具有科学性质的意见和反对意见。1-MNA是人体中作为烟酸代谢正常下游产物天然存在的一种物质。专家小组认为，所提供的关于该新型食品的成分、规格和批次间变异性的信息是充分的。申请人打算将1-MNA用于食品补充剂，并提议最大摄入量为58毫克/天。1-MNA无遗传毒性。在一项亚慢性大鼠研究中，在所有剂量水平下均观察到非腺胃上皮变性，且频率增加。专家小组指出，人类胃中不存在非腺上皮，并认为这一发现对人类在毒理学上不相关。在体重500和1000毫克/千克体重（bw）的剂量下，报告了尿液pH值的变化，恢复期未恢复。由于不能排除这一发现的不利影响，专家小组在该大鼠研究中选择250毫克/千克bw作为参考点。体重70千克且摄入58毫克的人的暴露边际约为300。专家小组注意到烟酰胺的上限，即成年人900毫克/天。考虑到1-MNA是烟酰胺的主要代谢产物，专家小组认为，从食品补充剂中摄入58毫克1-MNA不太可能对人类健康产生不良影响。专家小组得出结论，新型食品1-MNA在所提议的使用和使用水平下是安全的。
