Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)
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 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 18.104.22.168) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–Total Organic Solids (TOS) was estimated to be up to 0.050 mg TOS/kg body weight (bw) per day. Exposure assessment for the modified dextrins was not considered necessary. Genotoxicity tests did not raise a safety concern. Systemic toxicity was assessed by a repeated dose 90‐day oral toxicity study in rats. From this study, the Panel identified a no observed adverse effect level (NOAEL) of at least 900 mg TOS/kg bw per day, the highest dose tested. When the NOAEL value is compared to the estimated dietary exposure to the food enzyme used in baking, this results in a Margin of Exposure (MOE) of at least 18,000. The Panel considers that any additional exposure to the food enzyme from the use of modified dextrins will be covered by the above MOE. A search was made for similarity of the amino acid sequence of the food enzyme with those of known allergens. One match was found with a known respiratory allergen, an α‐amylase. The Panel considered that an allergic reaction upon oral ingestion of 4‐α‐glucanotransferase produced by A. pallidusAE‐SAS in individuals respiratory sensitised to α‐amylase cannot be excluded, but the likelihood is considered to be low. Overall, the Panel concluded that, under the intended conditions of use and based on the data provided, this food enzyme does not give rise to safety concerns.