欧盟评估D-核糖作为新资源食品的安全性

 

    欧盟专家组认为，关于D-核糖的组分、规格、批次差异性与稳定性信息充足，无安全风险。欧盟专家组经过风险评估后认为，按照每天36 mg/kg体重的摄入量，不会产生安全风险。然而，尚不能确定申请人提交的使用条件下D-核糖的安全性。

 

    部分原文报道如下：

 

    Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies （NDA） was asked to deliver an opinion on D‐ribose as a novel food （NF） pursuant to Regulation （EU） 2015/2283. The applicant intends to market the NF as ingredient in a variety of foods, food supplements and in certain foods for specific groups. The NF is produced by fermentation using a transketolase‐deficient strain of Bacillus subtilis and marketed as Bioenergy Ribose?. The information provided on the batch‐to‐batch variability, specifications, stability, production process and history of the organism used as a source of the NF is sufficient and does not raise safety concerns. The Panel considers that the effects observed in a subchronic toxicity study in rats could be the consequence of nutritional imbalances, but toxicological effects could not be ruled out; from this study, the Panel derived a No observed adverse effect level （NOAEL） of 3.6 g/kg body weight （bw） per day. From the human studies indicating a potential decrease in glucose levels and/or the occurrence of transient symptomatic hypoglycaemia at intakes of 10 g of d‐ribose, the Panel defined 70 mg/kg bw per day as the NOAEL with respect to hypoglycaemia that can be considered applicable for adults. For children, the Panel acknowledges the lack of human data directly relevant for this population group. based on the NOAEL derived from the subchronic toxicity study in rats, an acceptable level of intake of 36 mg/kg bw per day was defined that would also take into account the potentially increased sensitivity of certain population groups to hypoglycaemia. The Panel concludes that the NF is safe for the general population at intake levels up to 36 mg/kg bw per day and considers that the safety of the NF at the intended uses and use levels as proposed by the applicant has not been established.