Safety evaluation of the food enzyme a-amylase from the non-genetically modified Aspergillus niger strain AS 29-286

被引:0
作者
Lambre, Claude
Baviera, Jose Manuel Barat
Bolognesi, Claudia
Cocconcelli, Pier Sandro
Crebelli, Riccardo
Gott, David Michael
Grob, Konrad
Lampi, Evgenia
Mengelers, Marcel
Mortensen, Alicja
Riviere, Gilles
Steffensen, Inger-Lise
Tlustos, Christina
Van Loveren, Henk
Vernis, Laurence
Zorn, Holger
Aguilera, Jaime
Andryszkiewicz, Magdalena
Criado, Ana
Fernandez-Fraguas, Cristina
Liu, Yi
Nielsen, Elsa
Norby, Karin
di Piazza, Giulio
Chesson, Andrew
机构
关键词
food enzyme; a-amylase; 4-a-D-glucan glucanohydrolase; EC; 3.2.1.1; glycogenase; Aspergillus niger; ALPHA-AMYLASE; BREAD;
D O I
10.2903/j.efsa.2023.8090
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
The food enzyme a-amylase (4-a-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Aspergillus niger strain AS 29-286 by Shin Nihon Chemical Co., Ltd. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production, starch processing for the production of maltodextrins, brewing processes and non-wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and starch processing for the production of maltodextrins, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 2.158 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. The Panel identified a no observed adverse effect level of 1,774 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 822. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure cannot be excluded, but the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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