
Safety evaluation of the food enzyme α ‐amylase from Cellulosimicrobium funkei strain AE‐AMT
Author(s) -
Lambré Claude,
Barat Baviera José Manuel,
Bolognesi Claudia,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lampi Evgenia,
Mengelers Marcel,
Mortensen Alicja,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Andryszkiewicz Magdalena,
Gomes Ana,
Liu Yi,
Rainieri Sandra,
Chesson Andrew
Publication year - 2022
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2022.7463
Subject(s) - food science , starch , amylase , enzyme , genotoxicity , maltotriose , chemistry , food safety , animal feed , toxicity , microbiology and biotechnology , toxicology , biology , biochemistry , organic chemistry
The food enzyme α‐amylase (4‐α‐ d ‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in starch processing for maltotriose production. Since residual amounts of total organic solids (TOS) are removed by purification steps applied during starch processing, the estimation of a dietary exposure is considered unnecessary. 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 at the highest dose of 230 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and nine matches were 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 is considered 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.