欧盟评估一种食品酶D-阿洛酮糖3-差向异构酶的安全性

 

　　据了解，这种食品酶是由转基因谷氨酸棒杆菌菌株FIS002生产的，旨在用于果糖的加工中。

 

　　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和诱发反应的风险，但这种情况发生的可能性很低。小组得出结论，该食品酶在预期的使用条件下不会引起安全隐患。部分原文报道如下：

 

　　This assessment addresses a food enzyme preparation consisting of the immobilised intact but non-viable cells of the genetically modified Corynebacterium glutamicum strain FIS002 by CJ-Tereos Sweeteners Europe SAS. The production strain produces the food enzyme d-fructose 3-epimerase (d-psicose 3-epimerase; EC 5.1.3.30). The food enzyme preparation is used in processing fructose to produce a speciality carbohydrate d-allulose (synonym d-psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d-allulose, dietary exposure was not calculated. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level (NOAEL) of 1,796 mg TOS/kg body weight (bw) per day, the highest dose tested. A search for similarity of the amino acid sequence of the enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood of such reactions to occur is low. The food enzyme preparation contains multiple copies of an antimicrobial resistance gene, which is considered a hazard. However, under the specific intended conditions of use described by the applicant, and based on the evidence showing the removal of TOS during the production of d-allulose and the absence of recombinant DNA in the d-allulose, the Panel concluded that the identified hazard associated with the food enzyme d-psicose 3-epimerase produced with the genetically modified C. glutamicum strain FIS002 will not result in a risk.

 

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