EFSA (European Food Safety Authority), 2009a.Opinion of the Scientific Committee related to uncertainties in dietary exposure assessment. EFSA (European Food Safety Authority), 2006.Clinical responses to ingested fungal α-amylase and hemicellulase in persons sensitized to Aspergillus fumigatus? Allergy, 52, 346– 349. Cullinan P, Cook A, Jones M, Cannon J, Fitzgerald B and Newman Taylor AJ, 1997.Occupational and Environmental Medicine, 59, 498– 502. Why can patients with baker's asthma tolerate wheat flour ingestion? Is wheat pollen allergy relevant? Allergologia et Immunopathologia, 37, 203– 204. Armentia A, Dias-Perales A, Castrodeza J, Dueñas-Laita A, Palacin A and Fernándes S, 2009.Based on the data provided, the Panel considered the margin of exposure as insufficient to exclude safety concerns under the intended conditions of use. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel identified a no observed adverse effect level of 56 mg TOS/kg bw per day, the mid-dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of 16. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. Genotoxicity tests did not indicate a safety concern. In addition, it is used in the production of acacia gum with the highest dietary exposure at the 95th percentile of 0.018 mg TOS/kg bw per day in infants, when acacia gum is used as a food additive. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 3.61 mg TOS/kg body weight (bw) per day in European populations. ![]() The food enzyme is intended to be used in eight food manufacturing processes: baking processes, cereal-based processes, coffee processing, egg processing, vegetable processing for juice production, processing of tea, herbal and fruit infusions, herring roe processing and milk processing for cheese production. It is considered free from viable cells of the production organism. The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase EC 1.11.1.6) is produced with the non-genetically modified Aspergillus niger strain CTS 2093 by Shin Nihon Chemical Co., Ltd.
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