Following a request from the European Commission to the European Food Safety Authority (EFSA), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to provide a scientific opinion on the safety in use of glucosylated steviol glycosides as a food additive in different food categories, in accordance with Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
According to the applicant, glucosylated steviol glycosides preparations consist of not less than 95% (on anhydrous basis) total steviol glycosides, made up of glucosylated steviol glycosides of different molecular weights as well as any remaining steviol glycosides. The Panel noted that within the typical components of the glucosylated steviol glycosides and parent steviol glycosides some steviol glycosides – e.g. rebaudioside N, rebaudioside O – are not included within the current steviol glycosides listed for the food additive E 960.
The applicant proposed that glucosylated steviol glycosides and parent steviol glycosides undergo a common metabolic process in pathway following ingestion. Thus, the applicant suggested that data from steviol glycosides can be used for read-across to glucosylated steviol glycosides.
The limited evidence provided in the application dossier did not demonstrate the complete hydrolysis of the glucosylated steviol glycosides under what the Panel considered extreme hydrolysis conditions. No further information on hydrolysis under realistic conditions was provided.
The applicant provided the information on the GRAS Notice No 375 for ‘glycosylated enzyme treated stevia’. Since the applicant was not able to provide the full data from the studies described in the GRAS Notice No 375, the Panel could not consider the information for the current assessment.
No toxicological studies on glucosylated steviol glycoside preparations under evaluation have been provided for its assessment.
Considering that the complete hydrolysis of the glucosylated steviol glycosides was not demonstrated, toxicological data on steviol glycosides cannot be used in a read-across approach to fully evaluate the safety of the glucosylated steviol glycoside preparations under evaluation. The Panel noted that in such circumstances a Tier 1 evaluation according to the Guidance on food additives is required with the material under evaluation.
The Panel further noted that the proposed glucosylated steviol glycosides preparations may contain up to 20 glucose moieties per molecule of steviol glycoside. The proposed permitted level for this new food additive is expressed on a steviol equivalent basis (as for the already authorised food additive steviol glycosides (E 960)). The Panel therefore considered that this could lead to an additional exposure to glucose from a sweetener which is proposed to have a technological function of replacing sugars in food.
Therefore, the Panel concluded that the submitted data are insufficient to assess the safety of the glucosylated steviol glycoside preparations to be used as a new food additive.