Younes Maged, Aggett Peter, Aguilar Fernando, Crebelli Riccardo, Dusemund Birgit, Filipič Metka, Frutos Maria Jose, Galtier Pierre, Gundert-Remy Ursula, Kuhnle Gunter Georg, Lambré Claude, Leblanc Jean-Charles, Lillegaard Inger Therese, Moldeus Peter, Mortensen Alicja, Oskarsson Agneta, Stankovic Ivan, Waalkens-Berendsen Ine, Woutersen Rudolf Antonius, Wright Matthew, Tobback Paul, Smeraldi Camilla, Gott David
EFSA J. 2018 Jan 5;16(1):e05086. doi: 10.2903/j.efsa.2018.5086. eCollection 2018 Jan.
The present scientific opinion deals with the safety of orthosilicic acid-vanillin complex (OSA-VC) as a novel food ingredient for use as a source of silicon (Si) in food supplements and with the bioavailability of Si from this source. OSA-VC is stable in liquid solution at low pH values. OSA from OSA-VC was available as revealed by the increase in plasma Si concentrations after oral ingestion in human volunteers. The toxicological data provided in support of the current application were not in accordance with the Tier 1 requirement of the 'Guidance for submission for food additive evaluations'; however, this was considered justified by the Panel given that OSA-VC at pH 6.8 dissociates into orthosilicic acid and vanillin. The daily consumption of OSA-VC at the dose recommended by the applicant would provide a supplemental intake of Si of approximately 10-18 mg Si/day which would result in an estimated total intake of roughly 30-70 mg Si/day. The maximum vanillin intake resulting from the consumption of OSA-VC would be less than 5% of the acceptable daily intake (ADI) value for vanillin of 10 mg/kg body weight (bw) per day established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2002. The Panel concluded that there would be no safety concern with the proposed use and use level of OSA-VC as a novel food ingredient intended to be used as a source of Si in food supplements for the adult population. The Panel concluded that OSA, measured as Si, is bioavailable following ingestion of OSA-VC and appears similar to values reported in the literature for other established sources of OSA.
本科学意见涉及原硅酸 - 香草醛复合物(OSA - VC)作为一种新型食品成分在食品补充剂中用作硅(Si)来源的安全性以及该来源中Si的生物利用度。OSA - VC在低pH值的液体溶液中稳定。口服摄入后人体志愿者血浆Si浓度升高表明,OSA - VC中的OSA是可利用的。支持当前申请提供的毒理学数据不符合“食品添加剂评估提交指南”的一级要求;然而,鉴于OSA - VC在pH 6.8时会分解为原硅酸和香草醛,专家小组认为这是合理的。按照申请人推荐的剂量每日食用OSA - VC将提供约10 - 18mg Si/天的Si补充摄入量,这将导致估计的总摄入量约为30 - 70mg Si/天。食用OSA - VC产生的最大香草醛摄入量将低于联合国粮食及农业组织/世界卫生组织食品添加剂联合专家委员会(JECFA)2002年确定的香草醛每日可接受摄入量(ADI)值(10mg/kg体重(bw)/天)的5%。专家小组得出结论,对于拟用作成人食品补充剂中Si来源的新型食品成分OSA - VC的提议用途和使用水平,不存在安全问题。专家小组得出结论,摄入OSA - VC后,以Si衡量的OSA具有生物利用度,且似乎与文献中报道的其他已确定的OSA来源的值相似。