Safety evaluation of the food enzyme alternansucrase from Leuconostoc citreum strain NRRL B‐30894
Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.
The food enzyme alternansucrase (sucrose:1,6(1,3)‐α‐d‐glucan 6(3)‐α‐d‐glucosyltransferase, EC 18.104.22.168) is produced with a non‐genetically modified Leuconostoc citreum strain NRRL B‐30894 by Cargill Incorporated. As a consequence of the absence of antimicrobial resistance genes identified in its genome, the production strain meets the criteria to qualify for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no other concerns arising from the microbial source or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. The alternansucrase food enzyme is intended to be used for the manufacture of α‐d‐glucan oligosaccharides as a sweetening agent. The purification processes applied to syrups produced from sucrose with alternansucrase are expected to largely remove the food enzyme. Any residual TOS remaining in the final product would consist of non‐hazardous material. This is based on the QPS status of the production organism, the medium components and the identified material used in downstream processing. Consequently, the Panel decided that dietary exposure did not need to be calculated. Similarity of the amino acid sequence to those of known allergens was searched and no match was 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 for this to occur is considered to be low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.