Safety evaluation of the food enzyme cyclomaltodextrin glucanotransferase from Paenibacillus illinoisenis strain 107
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.
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 18.104.22.168) 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.