TY - JOUR
T1 - Safety evaluation of the food enzyme mannan endo-1,4-β-mannosidase from the genetically modified Trichoderma reesei strain RF6232
AU - EFSA CEF Panel
AU - Herman, Lieve
N1 - © 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
PY - 2022/8
Y1 - 2022/8
N2 - The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-d-mannan mannanohydrolase; EC 3.2.1.78) is produced with the genetically modified Trichoderma reesei strain RF6232 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and recombinant DNA. It is intended to be used in coffee processing, fruit and vegetable processing for juice production and for edible oil production. Since residual amounts of total organic solids (TOS) are removed during refined edible oil production by repeated washing, dietary exposure was calculated only for the remaining two food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.09 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 100 mg TOS/kg bw per day, the lowest dose tested. This results in a margin of exposure above 1,100. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made 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, in particular for individuals allergic to avocado, 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 mannan endo-1,4-β-mannosidase (1,4-β-d-mannan mannanohydrolase; EC 3.2.1.78) is produced with the genetically modified Trichoderma reesei strain RF6232 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and recombinant DNA. It is intended to be used in coffee processing, fruit and vegetable processing for juice production and for edible oil production. Since residual amounts of total organic solids (TOS) are removed during refined edible oil production by repeated washing, dietary exposure was calculated only for the remaining two food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.09 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 100 mg TOS/kg bw per day, the lowest dose tested. This results in a margin of exposure above 1,100. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made 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, in particular for individuals allergic to avocado, 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-beta-D-mannan mannanohydrolase
KW - EC 3.2.1.78
KW - Trichoderma reesei
KW - b-mannanase
KW - food enzyme
KW - genetically modified microorganism
KW - mannan endo-1,4-beta-mannosidase
UR - https://www.mendeley.com/catalogue/8fb9e575-dbcf-358b-babd-cb539c63fc1c/
U2 - 10.2903/j.efsa.2022.7478
DO - 10.2903/j.efsa.2022.7478
M3 - A2: International peer reviewed article (not A1-type)
C2 - 36016870
SN - 1831-4732
VL - 20
SP - e07478
JO - EFSA Journal
JF - EFSA Journal
IS - 8
ER -