罗汉参的食用安全性评估

Edible safety evaluation of Apios fortunei Maxim.

中文关键词:  罗汉参  新食品原料  食用安全性  风险评估

英文关键词:Apios fortunei Maxim.  new food raw material  edible safety  risk assessment

中文摘要:

      系统评估新食品原料罗汉参的食用安全性。方法 根据2017年修正版《新食品原料安全性审查管理办法》中相关规定对罗汉参开展成分分析、卫生学检验、毒理学试验，结合国内外人群食用情况和不良反应报道，综合判定罗汉参作为新食品原料的食用安全性。结果 罗汉参熟制干品富含蛋白质(14.50 g/100 g)，粗多糖含量为14.90 mg/100 g，西瑞香素含量为2.62 μg/g；重金属、农药残留及致病微生物均符合我国食品安全国家标准的相关规定；大鼠急性经口毒性试验表明罗汉参属实际无毒级，3项遗传毒性试验结果均为阴性，90 d经口毒性试验的未观察到有害作用剂量(no observed adverse effect level, NOAEL)为6.0 g/(kg·bw)，致畸试验结果显示试验剂量下母鼠和胎鼠未见明显致畸作用，NOAEL为6.0 g/(kg·bw)；同属植物美洲土圞儿作为传统作物在北美和日本已有多年食用历史；人群食用调查未见不良反应报道；根据民间食用习惯推算罗汉参食用量约为60~150 g/(人·d)。结论 罗汉参作为食品原料熟制后食用是安全的。婴幼儿作为特殊人群在没有经过进一步的论证下，暂不建议食用。

英文摘要:

      ABSTRACT: Objective To systematically evaluate the food safety of Apios fortunei Maxim. as a new food raw material. Methods In accordance with the 2017 revised version of Administrative measures for safety review of new food materials, a series of studies on the Apios fortunei Maxim. were carried out, including the composition analysis, hygienic tests and toxicology tests. Also, combined with survey on eating condition of people at home and abroad and adverse-effect reports, the edible safety of Apios fortunei Maxim. as a new food raw material was evaluted comprehensively. Results The cooked and dried Apios fortunei Maxim. was rich in protein (14.50 g/100 g). And the contents of crude polysaccharides and daphnoretin were 14.90 mg/100 g and 2.62 μg/g, respectively. The detection values of heavy metals, pesticides and microorganisms conformed to the provisions of China national food safety standards. The results of acute oral toxicity tests indicated that cooked and dried Apios fortunei Maxim. was actually nontoxic. The results of 3 genotoxicity tests were all negative. The 90 d oral toxicity tests showed that the no observed adverse effect level (NOAEL) of dried Apios fortunei Maxim. was 6.0 g/(kg·bw) and the results of teratogenicity test showed that there was no teratogenicity on female and fetal rats at the test dose, which was according to the NOAEL of 6.0 g/(kg·bw). The same genus of plants, Apios americana Medikus as a traditional crop in North America and Japan had been consumed for many years, population surveys had not reported adverse effects. According to the folk eating habits, it was estimated that the consumption of Apios fortunei Maxim. was about 60-150 g/(person·d). Conclusion Apios fortunei Maxim. is edible-safety as a new food raw material after cooking. However, as special populations, it is not recommended for infants and toddlers without further demonstration.