Safety evaluation of the food enzyme cyclomaltodextrin glucanotransferase from Paenibacillus illinoisenis strain 107

food enzyme, cyclomaltodextrin glucanotransferase, cyclodextrin glycosyltransferase, EC 2.4.1.19, Paenibacillus illinoisenis
First published in the EFSA Journal
15 mai 2020
Adopted
29 avril 2020
Type
Scientific Opinion

Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.

Abstract

The food enzyme cyclomaltodextrin glucanotransferase ((1→4)‐α‐d‐glucan:(1→4)‐α‐d‐glucan 4‐α‐d‐[(1→4)‐α‐d‐glucano]‐transferase; EC 2.4.1.19) is produced with the non‐genetically modified Paenibacillus illinoisenis strain 107 by Hayashibara Co., Ltd. The cyclomaltodextrin glucanotransferase food enzyme is intended to be used solely by the applicant in‐house in starch processing for trehalose production. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of trehalose, dietary exposure was not calculated. Genotoxicity tests did not raise 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 (NOAEL) of 39 mg TOS/kg body weight per day, the highest dose tested. 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 condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure cannot be excluded, but the likelihood for such reactions 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.

Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Vittorio Silano, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.
Panel on Food Contact Materials, Enzymes and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6044
EFSA Journal 2020;18(5):6044
Question Number
On request from
European Commission