Safety Assessment RP1084 Outcome of Assessment of the Modification of use of Steviol Glycosides (E 960) from Stevia Leaf Extract Produced by Enzymatic Bioconversion

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in April 2021 from Purecircle/Ingredion (“the Applicant”) for changes of the existing production method of steviol glycosides (E 960) to include an enzymatic conversion process to yield high purity steviol glycosides. The production method uses the enzymatic conversion of highly purified steviol glycosides rebaudioside A (reb A) and/or stevioside extracted from Stevia leaves (S. rebaudiana ) to rebaudioside M (reb M) and rebaudioside D (reb D) and/or to rebaudioside AM (reb AM; an isomer of reb D), respectively, using UDPglucosyltransferases (EC 2.4.1.17) and sucrose synthase (EC 2.4.1.13) enzymes, derived from genetically modified strains of Escherichia coli. To support the FSA and FSS in evaluating the dossier the Joint Expert Group on Additives, Enzymes and other regulated products (AEJEG) were asked to review the dossier and the supplementary information from the applicant. The AEJEG concluded that the new method for the production of steviol glycosides (E960) using enzymatic bioconversion was safe under the proposed conditions of use. The proposed uses and use levels for rebaudioside AM, D and M, produced via enzymatic bioconversion of purified stevia leaf extract remain the same as the already authorised food additive steviol glycosides (E 960). The views of the AEJEG have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on the modification of the production for steviol glycosides using enzymatic bioconversion. The Committee on Toxicity (COT) also reviewed the AEJEG safety assessment agreeing with the conclusions of the AEJEG.