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

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Adopted: 24 March 2021*

* This opinion was first adopted on 27 January 2021, as reflected in the minutes of the 18th plenary meeting of the CEP Panel (available online:…). However, the adopted version was withdrawn prior to publication and the current version was adopted on 24 March 2021.

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 isomaltulose synthase (sucrose glucosylmutase; EC 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.