據(jù)了解，這種食品酶是由轉(zhuǎn)基因黑曲霉菌株P(guān)ME生產(chǎn)的，旨在用于果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工。

 

　　經(jīng)過評(píng)估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險(xiǎn)，尤其是對(duì)花粉過敏的個(gè)體。根據(jù)所提供的數(shù)據(jù)，評(píng)估小組得出結(jié)論，這種食品酶在預(yù)期使用條件下不會(huì)引起安全問題。部分原文報(bào)道如下：

 

　　The food enzyme pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) is produced with the genetically modified Aspergillus niger strain PME by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. It is intended to be used in fruit and vegetable processing, for juice production and fruit and vegetable processing for products other than juices. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.095 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with a xylanase obtained from A. niger strain XEA. The Panel considered this food enzyme as a suitable substitute for the pectinesterase to be used in the toxicological studies, because both production strains are derived from the same recipient strain, the location of the inserts is comparable, no partial inserts were present and the production methods are essentially the same. 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. The Panel identified a no observed adverse effect level (NOAEL) of 1,852 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 19,495. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

 

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