Italy
The food enzyme has four declared activities (endo‐polygalacturonase ((1→4)‐α‐d‐galacturonan glycanohydrolase (endo‐cleaving); 3.2.1.15), pectinesterase (pectin pectylhydrolase; 3.1.1.11), pectin lyase ((1→4)‐6‐O‐methyl‐α‐d‐galacturonan lyase; 4.2.2.10) and non‐reducing end α‐l‐arabinofuranosidase (α‐l‐arabinofuranoside non‐reducing end α‐l‐arabinofuranosidase; 3.2.1.55) and is produced with the non‐genetically modified Aspergillus niger strain PEC by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in the manufacture of alcoholic beverages from fruits other than grapes, fruit and vegetable processing for juice production, and wine and wine vinegar production. Dietary exposure was estimated to be up to 0.25 mg TOS/kg bodyweight (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 204 mg TOS/kg bw per day, the highest dose tested which, when compared with the estimated dietary exposure, results in a margin of exposure of at least 800. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and several matches were 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, particularly for individuals sensitised to several pollen allergens or papaya allergens. Based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns, under the intended conditions of use.
