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

• Main Authors: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Lieve Herman, Magdalena Andryszkiewicz, Ana Gomes, Yi Liu, Andrew Chesson
• Format: Article
• Language: English
• Published: Wiley 2020-05-01
• Series: EFSA Journal
• Subjects: food enzyme; cyclomaltodextrin glucanotransferase; cyclodextrin glycosyltransferase; EC 2.4.1.19; Paenibacillus illinoisenis
• Online Access: https://doi.org/10.2903/j.efsa.2020.6044

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.