Safety evaluation of the food enzyme preparation isomaltulose synthase from Serratia plymuthica strain Z12A

© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority..

The food enzyme isomaltulose synthase (sucrose glucosylmutase; EC 5.4.99.11) is produced with Serratia plymuthica strain Z12A by BENEO-Palatinit GmbH. The food enzyme is used only in the form of an immobilised preparation of non-viable cells for the production of isomaltulose. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of isomaltulose consequently, dietary exposure was not calculated. Genotoxicity tests did not indicate 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 1,011 mg TOS/kg body weight (bw) per day, the highest dose tested. Similarity of the amino acid sequence of the enzyme to those of known allergens was searched and no 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 of such reactions to occur is considered to be low. Based on the data provided, the use of an immobilised food enzyme and the removal of TOS during the production of isomaltulose the Panel concluded that this food enzyme preparation does not give rise to safety concerns under the intended conditions of use.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:19

Enthalten in:

EFSA journal. European Food Safety Authority - 19(2021), 4 vom: 13. Apr., Seite e06432

Sprache:

Englisch

Beteiligte Personen:

EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) [VerfasserIn]
Silano, Vittorio [VerfasserIn]
Barat Baviera, José Manuel [VerfasserIn]
Bolognesi, Claudia [VerfasserIn]
Cocconcelli, Pier Sandro [VerfasserIn]
Crebelli, Riccardo [VerfasserIn]
Gott, David Michael [VerfasserIn]
Grob, Konrad [VerfasserIn]
Lambré, Claude [VerfasserIn]
Lampi, Evgenia [VerfasserIn]
Mengelers, Marcel [VerfasserIn]
Mortensen, Alicja [VerfasserIn]
Rivière, Gilles [VerfasserIn]
Steffensen, Inger-Lise [VerfasserIn]
Tlustos, Christina [VerfasserIn]
Van Loveren, Henk [VerfasserIn]
Vernis, Laurence [VerfasserIn]
Zorn, Holger [VerfasserIn]
Herman, Lieve [VerfasserIn]
Aguilera, Jaime [VerfasserIn]
Andryszkiewicz, Magdalena [VerfasserIn]
Kovalkovicova, Natalia [VerfasserIn]
Liu, Yi [VerfasserIn]
Chesson, Andrew [VerfasserIn]

Links:

Volltext

Themen:

EC 5.4.99.11
Food enzyme
Isomaltulose synthase
Journal Article
Protaminobacter rubrum
Serratia plymuthica
Sucrose glucosylmutase
Z12A

Anmerkungen:

Date Revised 11.11.2023

published: Electronic-eCollection

Citation Status PubMed-not-MEDLINE

doi:

10.2903/j.efsa.2021.6432

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM32414475X