根据法规(EC) No 1925/2006第8(4)条提交的关于红曲米中monacolins安全性的额外科学数据的科学意见

IF 3.3 3区 农林科学 Q2 FOOD SCIENCE & TECHNOLOGY
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Ángeles Jos, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Leonard Matijević, Silvia Valtueña Martinez, Alexandre Maciuk
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引用次数: 0

摘要

根据欧盟法规(EC) No 1925/2006第8(4)条,欧盟要求营养、新型食品和食品过敏原小组(NDA)就红曲米(RYR)中的单抗霉素的安全性发表科学意见。NDA小组审查了审查期间提交的其他科学数据,包括RYR补充剂成分的分析数据,莫那可林从其他膳食来源的摄入量,莫那可林与其他他汀类药物的体外生物可及性和细胞毒性数据,营养警戒/上市后数据,病例报告和临床研究。根据提供的新的营养警戒数据,NDA小组重申了ANS小组(EFSA ANS小组,2018年)的担忧,即从RYR中摄入低至3毫克/天的莫纳可林K可能导致对肌肉骨骼系统(包括横纹肌溶解)和肝脏的严重不良影响。NDA小组得出结论,利益相关方在欧盟审查期间提交的数据不允许确定RYR补充剂中莫那可林的安全性低于3毫克/天,也不允许确定食品补充剂中每日从RYR中摄入的莫那可林不会引起一般人群或弱势亚群体的安全担忧。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Scientific Opinion on additional scientific data related to the safety of monacolins from red yeast rice submitted pursuant to Article 8(4) of Regulation (EC) No 1925/2006

The Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on the safety of monacolins from red yeast rice (RYR), which have been placed under Union scrutiny in Part C of Annex III in accordance with Article 8(4) of Regulation (EC) No 1925/2006. The NDA Panel reviewed the additional scientific data submitted during the period of scrutiny, which included analytical data on the composition of RYR supplements, the intake of monacolins from other dietary sources, in vitro bioaccessibility and cytotoxicity data of monacolins vs. other statins, nutrivigilance/post-marketing data, case reports and clinical studies. Based on the new nutrivigilance data provided, the NDA Panel reiterates the concerns of the ANS Panel (EFSA ANS Panel, 2018) that exposure to monacolin K from RYR at intake levels as low as 3 mg/day could lead to severe adverse effects on the musculoskeletal system, including rhabdomyolysis, and on the liver. The NDA Panel concludes that the data submitted by interested parties during the Union scrutiny period do not allow establishing the safety of monacolins in RYR supplements below 3 mg/day or to identify a daily intake of monacolins from RYR in food supplements that does not raise safety concerns for the general population or vulnerable subgroups thereof.

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来源期刊
EFSA Journal
EFSA Journal Veterinary-Veterinary (miscellaneous)
CiteScore
5.20
自引率
21.20%
发文量
422
审稿时长
5 weeks
期刊介绍: The EFSA Journal covers methods of risk assessment, reports on data collected, and risk assessments in the individual areas of plant health, plant protection products and their residues, genetically modified organisms, additives and products or substances used in animal feed, animal health and welfare, biological hazards including BSE/TSE, contaminants in the food chain, food contact materials, enzymes, flavourings and processing aids, food additives and nutrient sources added to food, dietetic products, nutrition and allergies.
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