应欧盟委员会的要求,欧盟食品安全局食品添加剂和营养源专家组(ANS)重新评估了氯化亚锡和二水氯化亚锡(stannous chloride)作为食品添加剂的安全性。
从监管最高水平暴露评估方案来看,氯化亚锡作为食品添加剂时,所有年龄组的平均每日暴露使用量均低于1.3微克/千克体重,氯化亚锡暴露的第95百分位范围为每天0.0微克/千克体重至成人每天11.2微克/千克体重。通过动物实验发现,胃肠道吸收氯化亚锡的量很低,欧盟专家小组得出结论认为,氯化亚锡在目前的授权使用水平中不存在安全问题。
部分原文如下:
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of stannous chloride and stannous chloride dihydrate (E 512) as food additives. The Panel considered that adequate exposure and toxicity data were available. Stannous chloride is only permitted as food additives in one food category and no reply on the actual use level of stannous chloride (E 512) as a food additive and on its concentration in food was provided by any interested party. According to the Mintel's Global New Products Database (GNPD), stannous chloride was not labelled on any products in the EU nor in Norway. The regulatory maximum level exposure assessment scenario is based on the maximum permitted levels (MPLs) for stannous chloride (E 512), which is 25 mg Sn/kg. The mean exposure to stannous chloride (E 512) from its use as a food additive was below 1.3 μg Sn/kg body weight (bw) per day for all age groups. The 95th percentile of exposure to stannous chloride (E 512) ranged from 0.0 μg Sn/kg bw per day in all groups to 11.2 μg Sn/kg bw per day in adults. Absorption of stannous chloride from the gastrointestinal tract is low there is no concern with respect to carcinogenicity and genotoxicity. Gastrointestinal irritation was reported in humans after ingestion of a bolus dose of 40 mg Sn. The Panel concluded that stannous chloride (E 512) is of no safety concern in this current authorised use and use levels.