EU assesses the safety of an isomaltose synthase
By: Date: 2021-04-12 Categories: newsguide Tags: ,
  Food Partner Network News On April 9, 2021, the European Food Safety Agency issued opinions on the safety evaluation of a food enzyme preparation isomaltulose synthase.

   It is understood that this food enzyme preparation is produced by Serratia plymuthica strain Z12A. After evaluation, the expert team concluded that the food enzyme preparation will not cause safety problems under the expected use conditions. Part of the original report is as follows:
  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 reaction s 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.