TY - JOUR
T1 - Safety evaluation of the food enzyme α-amylase from the genetically modified Bacillus amyloliquefaciens strain DP-Czb53
AU - EFSA CEF Panel
AU - Herman, Lieve
N1 - © 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
PY - 2020/10/1
Y1 - 2020/10/1
N2 - The food enzyme α-amylase (4-α-d-glucan glucohydrolase; EC 3.2.1.1) is produced with the genetically modified B. amyloliquefaciens strain DP-Czb53 by Danisco US Inc. The genetic modifications do not raise safety concerns, except for the presence of a multicopy plasmid carrying known antimicrobial resistance genes. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in starch processing for the production of glucose syrups. Toxicological studies and dietary exposure estimation were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and one 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 for this to occur is considered to be 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.
AB - The food enzyme α-amylase (4-α-d-glucan glucohydrolase; EC 3.2.1.1) is produced with the genetically modified B. amyloliquefaciens strain DP-Czb53 by Danisco US Inc. The genetic modifications do not raise safety concerns, except for the presence of a multicopy plasmid carrying known antimicrobial resistance genes. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in starch processing for the production of glucose syrups. Toxicological studies and dietary exposure estimation were not considered necessary. Similarity of the amino acid sequence to those of known allergens was searched and one 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 for this to occur is considered to be 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.
KW - 1,4-α-d-glucan glucanohydrolase
KW - 4-α-d-glucan glucanohydrolase
KW - Bacillus amyloliquefaciens
KW - EC 3.2.1.1
KW - Food enzyme
KW - genetically modified microorganism
KW - α-amylase
UR - https://www.mendeley.com/catalogue/1e2b86d9-d0f1-3949-9f83-54d08e6a7dff/
U2 - 10.2903/j.efsa.2020.6185
DO - 10.2903/j.efsa.2020.6185
M3 - A1: Web of Science-article
C2 - 33144885
SN - 1831-4732
VL - 18
SP - e06185
JO - EFSA Journal
JF - EFSA Journal
IS - 10
ER -