Safety evaluation of a second extension of use of the food enzyme α‐amylase from the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT
-
Published:2024-07
Issue:7
Volume:22
Page:
-
ISSN:1831-4732
-
Container-title:EFSA Journal
-
language:
-
Short-container-title:EFS2
Author:
,Zorn Holger,Barat Baviera José Manuel,Bolognesi Claudia,Catania Francesco,Gadermaier Gabriele,Greiner Ralf,Mayo Baltasar,Mortensen Alicja,Roos Yrjö Henrik,Solano Marize L. M.,Sramkova Monika,Van Loveren Henk,Vernis Laurence,Cavanna Daniele,Liu Yi,de Nijs Roos Anna,di Piazza Giulio
Abstract
Abstract
The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase i.e. EC 3.2.1.1) is produced with the non‐genetically modified Cellulosimicrobium funkei strain AE‐AMT by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that the food enzyme did not give rise to safety concerns when used in seven food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of ten food manufacturing processes. As the food enzyme‐total organic solids (TOS) are removed from the final foods in one food manufacturing process, the dietary exposure to the food enzyme‐TOS was estimated only for the remaining nine processes. The dietary exposure was calculated to be up to 0.049 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (230 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 4694. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
Reference7 articles.
1. EFSA (European Food Safety Authority) . (2006). Opinion of the Scientific Committee related to uncertainties in dietary exposure assessment. EFSA Journal, 5(1), 438, 54 pp. https://doi.org/10.2903/j.efsa.2007.438 2. EFSA (European Food Safety Authority) . (2009). Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessments carried out by EFSA. Part 2: General principles. EFSA Journal, 7(5), 1051. https://doi.org/10.2903/j.efsa.2009.1051 3. EFSA (European Food Safety Authority) . (2011). Use of the EFSA Comprehensive European food consumption database in exposure assessment. EFSA Journal, 9(3), 2097, 34 pp. https://doi.org/10.2903/j.efsa.2011.2097 4. EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) , Lambré, C., Barat Baviera, J. M., Bolognesi, C., Cocconcelli, P. S., Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Rivière, G., Steffensen, I.‐L., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Glandorf, B., Herman, L., … Chesson, A. (2021). Scientific guidance for the submission of dossiers on food enzymes. EFSA Journal, 19(10), 6851. https://doi.org/10.2903/j.efsa.2021.6851 5. EFSA CEP Panel (EFSA Panel on Food Contact Materials, Enzymes and Processing Aids) , Lambré, C., Barat Baviera, J. M., Bolognesi, C., Cocconcelli, P. S., Crebelli, R., Gott, D. M., Grob, K., Lampi, E., Mengelers, M., Mortensen, A., Riviere, G., Steffensen, I.‐L., Tlustos, C., Van Loveren, H., Vernis, L., Zorn, H., Andryszkiewicz, M., Gomes, A., … Chesson, A. (2022). Scientific Opinion on the safety evaluation of the food enzyme α‐amylase from Cellulosimicrobium funkei strain AE‐AMT. EFSA Journal, 20(8), 7463. https://doi.org/10.2903/j.efsa.2022.7463
|
|