Younes Maged, Aggett Peter, Aguilar Fernando, Crebelli Riccardo, Filipic Metka, Frutos Maria Jose, Galtier Pierre, Gott David, 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, Brimer Leon, Mosesso Pasquale, Christodoulidou Anna, Cascio Claudia, Tard Alexandra, Lodi Federica, Dusemund Birgit
EFSA J. 2018 Jun 20;16(6):e05296. doi: 10.2903/j.efsa.2018.5296. eCollection 2018 Jun.
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of gellan gum (E 418) as a food additive. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/2010, the Panel considered that adequate exposure and toxicity data were available. Based on the reported use levels, a refined exposure of up to 72.4 mg/kg body weight (bw) per day in toddlers at the 95th percentile was estimated. Gellan gum is unlikely to be absorbed intact and would not be fermented by human intestinal microbiota. There is no concern with respect to carcinogenicity and genotoxicity. No adverse effects were reported in chronic studies at the highest doses tested in mice and rats (3,627 and 1,460 mg gellan gum/kg bw per day, respectively). Repeated oral intake up to 200 mg/kg bw per day for 3 weeks had no adverse effects in humans. The Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for gellan gum (E 418), and that there is no safety concern at the refined exposure assessment for the reported uses and use levels of gellan gum (E 418) as a food additive. The Panel recommended to better define the specifications of gellan gum including the absence of viable cells of the microbial source and the presence of polyhydroxybutyrate (PHB), protein and residual bacterial enzymatic activities.
食品添加剂及营养源添加到食品（ANS）小组提供了一项科学意见，重新评估结冷胶（E 418）作为食品添加剂的安全性。按照欧盟委员会条例（EU）No 257/2010重新评估的某些食品添加剂风险评估概念框架，小组认为已有足够的暴露量和毒性数据。根据报告的使用水平，估计95百分位数的幼儿每天精炼暴露量高达72.4毫克/千克体重（bw）。结冷胶不太可能完整吸收，也不会被人类肠道微生物群发酵。不存在致癌性和遗传毒性方面的担忧。在小鼠和大鼠中测试的最高剂量（分别为每天3627和1460毫克结冷胶/千克bw）的慢性研究中未报告不良反应。每天重复口服高达200毫克/千克bw，持续3周，对人类没有不良反应。小组得出结论，结冷胶（E 418）无需设定数值可接受每日摄入量（ADI），并且对于结冷胶（E 418）作为食品添加剂的报告用途和使用水平，在精炼暴露评估中不存在安全问题。小组建议更好地定义结冷胶的规格，包括不存在微生物来源的活细胞以及存在聚羟基丁酸酯（PHB）、蛋白质和残留细菌酶活性。
