Safety Assessment on a Modification of Specifications of Rebaudioside D (E960c) to Include Manufacture by Enzymatic Conversion (RP1245)

The FSA (Food Standards Agency) and FSS (Food Standards Scotland) received an application for the modification of specifications of rebaudioside D (E960c) to include manufacture via enzymatic conversion of a genetically modified production strain of Komagataella phaffi, using the enzymes sucrose synthase and uridine 5’-diphospho(UDP)-glucosyltransferase. This request for authorisation was assessed by the European Food Safety Authority (EFSA) in the European Union (EU) which was published in 2022; however, concern was raised over the possible presence of residual DNA within the final product. Upon receipt of additional information provided by the Applicant, the FSA/FSS reviewed the information available, including the EFSA Opinion. The FSA and FSS confirmed that RP1245, as described in the application, was unlikely to have any adverse effect on human health with its intended uses in GB, on the condition that the Applicant could show that the residual DNA did not remain. Concerns were initially raised over the possibility of residual kanamycin DNA encoding for the resistance gene being present within the final product; however, PCR data supplied by the Applicant demonstrated the lack of this DNA. FSA and FSS reviewers were satisfied that the updated PCR analysis demonstrated a lack of residual DNA. The views of the AEJEG and Committee on Toxicity (COT) were considered 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 FSA and FSS concluded that the Applicant had satisfactorily demonstrated that the manufacture of rebaudioside D via enzymatic conversion would not pose any toxicological concern under the proposed uses.