Safety evaluation of the food enzyme with 4-α-d-{(1->4)-α-d-glucano}trehalose trehalohydrolase and (1->4)-α-d-glucan 1-α-d-glucosylmutase activities from the strain S34.

The food enzyme with 4-α-d-{(1->4)-α-d-glucano}trehalose trehalohydrolase ((4-α-d-[(1,4-α-d-glucano]trehalose glucanohydrolase (trehalose-producing)), EC 3.2.1.141) and (1->4)-α-d-glucan 1-α-d-glucosylmutase ((1,4)-α-d-glucan 1-α-d-glucosylmutase, EC 5.4.99.15) activities is produced with a non-genetically modified microorganism (formally ) by Hayashibara Co., Ltd. The applicant states that the food enzyme will not be placed on the open market, but will only be used in-house in starch processing for trehalose production. Since residual amounts of total organic solids are removed by the purification steps applied during the production of trehalose, toxicological studies were considered not necessary and no dietary exposure was calculated. Similarities of the amino acid sequences to those of known allergens were searched and no matches were 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 to occur is considered to be low. Based on the data provided, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.