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Safety evaluation of the food enzyme d‐psicose 3‐epimerase from the genetically modified Escherichia coli strain K‐12 W3110 (pWKLP)

on the Wiley Online Library


Panel members at the time of adoption

José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Vittorio Silano (until 21 December 2020†), Inger‐Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis and Holger Zorn.

Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once decision on confidentiality will be received from the European Commission.


The food enzyme d‐psicose 3‐epimerase (EC is produced with the genetically modified Escherichia coli strain K‐12 W3110 (pWKLP) by Matsutani Chemical Industry Co., Ltd. The production strain of the food enzyme contains multiple copies of an antimicrobial resistance gene. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is used as an immobilised preparation in processing fructose for the production of a speciality carbohydrate d‐allulose (syn. d‐psicose). Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of d‐allulose, dietary exposure was not calculated and toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the enzyme to known allergens was made and no match was found. The Panel notes that the food enzyme may contain traces of protein, including a known allergen, after processing of the food enzyme. Therefore, allergenicity cannot be excluded, but the Panel considers that the likelihood of allergic reactions to occur is low. Based on the data provided, the immobilisation process and the removal of TOS during the production of d‐allulose products, the Panel concluded that this food enzyme does not give rise to safety concerns when used in the immobilised form.