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欧盟评估非转基因黑曲霉菌株AN-SHGA-100生产的葡聚糖1,4-α-葡萄糖苷酶的安全性

   2026-11-04 食品伙伴网泽夕836
核心提示:2026年11月3日,欧盟食品安全局就一种葡聚糖1,4-α-葡萄糖苷酶(glucan-1,4-α-glucosidase)的安全性评价发布意见。……(世界食品网-www.shijieshipin.com)
     2026年11月3日,欧盟食品安全局就一种葡聚糖1,4-α-葡萄糖苷酶(glucan-1,4-α-glucosidase)的安全性评价发布意见。 
  据了解,这种食品酶是由非转基因黑曲霉菌株AN-SHGA-100生产的,旨在用于7种食品生产过程。
 
  经过评估,专家小组认为,在预期的使用条件下,不能排除饮食暴露引起过敏反应的风险,但这种情况发生的可能性很低。根据所提供的数据,评估小组无法对该食品酶的安全性得出结论。部分原文报道如下:
 
  The food enzyme glucan 1,4-α-glucosidase (4-α-D-glucan α-glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified Aspergillus niger strain AN-SHGA-100 by Suntaq International Limited. The description of the food enzyme manufacturing process provided by the applicant refers to a pectinase and not to the food enzyme under assessment. The food enzyme glucan 1,4-α-glucosidase was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes. Since residual amounts of food enzyme–Total Organic Solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining five processes. It was calculated to be up to 26.829 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats with the food enzyme glucan 1,4-α-glucosidase. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted margins of exposure (MoEs) of 95, 75, 107, 133, 337 and 429 for infants, toddlers, children, adolescents, adults and the elderly, respectively. A search for the homology of the amino acid sequence of the glucan 1,4-α-glucosidase to known allergens was made and a match with one respiratory allergen was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, but that the likelihood is low. The Panel could not conclude on the safety of this food enzyme glucan 1,4-α-glucosidase produced with the non-GM A. niger strain AN-SHGA-100, because the description of the manufacturing process corresponds to a different enzyme. In addition, the MoEs are insufficient to exclude safety concerns for infants, toddlers, children and adolescents.
 
 
地区: 欧盟
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