Abstract
Abstract The food enzyme pectin lyase (1,4‐6‐O‐methyl‐α‐d‐galacturonan lyase, EC 4.2.2.10) is produced with the genetically modified Aspergillus niger strain CCTCC M 2023341 by Suntaq International Limited. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in two food manufacturing processes. The dietary exposure was estimated to be up to 1.926 mg Total Organic Solids (TOS)/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90‐day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1038. A search for the homology of the amino acid sequence of the pectin lyase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is 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.