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Safety evaluation of curdlan as a food additive

机译:可得然胶作为食品添加剂的安全性评价

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摘要

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of curdlan as a new food additive used as firming and gelling agent, stabiliser, thickener. Curdlan is a high molecular weight polysaccharide consisting of β‐1,3‐linked glucose units, produced by fermentation from Rhizobium radiobacter biovar 1 strain NTK‐u. The toxicological dataset consisted of sub‐chronic, chronic and carcinogenicity, reproductive and developmental toxicity studies as well as genotoxicity. In vivo data showed that curdlan is not absorbed as such but is extensively metabolised by the gut microbiota into CO2 and other innocuous compounds. Curdlan was not genotoxic and was well‐tolerated with no overt organ‐specific toxicity. Effects observed at very high doses of curdlan, such as decreased growth and increased cecum weight, are common for indigestible bulking compounds and therefore considered physiological responses. In a combined three‐generation reproductive and developmental toxicity study, decreased pup weight was observed during lactation at 7500 mg curdlan/kg body weight (bw) per day, the highest dose tested. The Panel considered the observed effects as treatment‐related and adverse, although likely secondary to nutritional imbalance and identified a conservative no observed adverse effect level (NOAEL) of 2500 mg/kg bw per day. Despite the limitations noted in the dataset, the Panel was able to conclude applying the margin of exposure (MOE) approach. Given that curdlan and its break‐down products are not absorbed and that the identified adverse effect is neither systemic nor local, no adjustment factor was deemed necessary. Thus, an MOE of at least 1 was considered sufficient. The highest exposure estimate was 1441 mg/kg bw per day in toddlers at the 95th percentile of the proposed maximum use level exposure assessment scenario. The Panel concluded that there is no safety concern for the use of curdlan as a food additive at the proposed uses and use levels.
机译:欧洲食品安全局食品添加剂和调味剂专家组 (FAF) 就可得然胶作为一种新型食品添加剂的安全性提供了科学意见,用作固化剂和胶凝剂、稳定剂、增稠剂。可得然胶是一种高分子量多糖,由 β-1,3-连接的葡萄糖单元组成,由根瘤菌放射性杆菌生物型 1 菌株 NTK-u 发酵产生。毒理学数据集包括亚慢性、慢性和致癌性、生殖和发育毒性研究以及遗传毒性。体内数据表明,可得然多糖不会被吸收,而是被肠道微生物群广泛代谢成 CO2 和其他无害化合物。可得然胶 没有遗传毒性,耐受性良好,没有明显的器官特异性毒性。在非常高剂量的凝固多糖下观察到的效果,例如生长减慢和盲肠重量增加,对于难以消化的膨胀化合物来说很常见,因此被认为是生理反应。在一项三代联合生殖和发育毒性研究中,在哺乳期间观察到幼犬体重减轻,每天 7500 毫克凝乳胶/公斤体重 (bw),这是测试的最高剂量。专家组认为观察到的效果与治疗相关且有害,但可能继发于营养失衡,并确定了每天每公斤体重2500毫克的保守无观察到不良反应水平(NOAEL)。尽管数据集中指出了局限性,但小组还是得出了应用暴露幅度 (MOE) 方法的结论。鉴于可得然胶及其分解产物未被吸收,并且已确定的不良反应既不是全身性的也不是局部的,因此认为不需要调整因子。因此,至少 1 的 MOE 被认为就足够了。在拟议的最大使用水平暴露评估情景的第 95 个百分位数,幼儿的最高暴露估计值为 1441 毫克/千克体重。小组的结论是,在建议的用途和用途水平上,使用可得然胶作为食物添加剂不存在安全问题。
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