Safety evaluation of certain food additives
Assessment of dietary exposure
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Assessment of dietary exposure Branching glycosyltransferase can be used in a wide range of foodstuffs, but it is not expected to be present in the final product. However, the following estimation is based on the worst-case assumption that the enzyme is used in all processed food and beverages and remains in the products consumed. The maximum amount of TOS added to food is 48 mg/kg. Assuming a daily consumption of 750 g of food (50%) and 1500 g of beverages (25%), according to the budget method, the amount of TOS ingested would be about 2 mg/kg bw per day for an adult weighing 60 kg. 5. EVALUATION The Committee allocated an acceptable daily intake (ADI) “not specified” for branching glycosyltransferase from this recombinant strain of B. subtilis (JA1343) used in the specified applications and in accordance with Good Manufacturing Practice. 8 BRANCHING GLYCOSYLTRANSFERASE FROM RHODOTHERMUS OBAMENSIS 6. REFERENCES Appel, M.J. & Van den Hoven, M.J. (2008) Repeated-dose (13-week) oral (gavage) toxicity study with branching enzyme, PPY 27209 in rats. Unpublished report No. 7510/02 from TNO, Zeist, the Netherlands. Submitted to WHO by Novozymes, Bagsvaerd, Denmark. Baur, X. & Czuppon, A.B. (1995) Allergic reaction after eating alpha-amylase (Asp o 2)- containing bread. A case report. Allergy, 50, 85–87. Bindslev-Jensen, C., Skov, P.S., Roggen, E.L., Hvass, P. & Brinch, D.S. (2006) Investigation on possible allergenicity of 19 different commercial enzymes used in the food industry. Food Chem. Toxicol., 44, 1909–1915. European Food Safety Authority (2008) The maintenance of the list of QPS microorganisms intentionally added to food and feed. Scientific opinion of the Panel on Biological Hazards adopted on 10 December 2008. EFSA J., 923, 1–48. FAO/WHO (2001) Evaluation of allergenicity of genetically modified foods. Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, 22–25 January 2001. Rome, Italy, Food and Agriculture Organization of the United Nations ( ftp://ftp.fao.org/es/esn/food/allergygm.pdf ). FAO/WHO (2006) General specifications and considerations for enzyme preparations used in food processing. Prepared at the sixty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives, Rome, 20–29 June 2006. Rome, Italy, Food and Agriculture Organization of the United Nations (FAO JECFA Monographs, No. 3; http:// www.fao.org/ag/agn/jecfa-additives/docs/enzymes_en.htm ). FAO/WHO (2008) Report of the fortieth session of the Codex Committee on Food Additives, Beijing, China, 21–25 April. Rome, Italy, Food and Agriculture Organization of the United Nations, Codex Alimentarius Commission (ALINORM 08/31/12 Rev.; http:// www.codexalimentarius.net/web/archives.jsp?year=08 ). Kanny, G. & Moneret-Vautrin, D.-A. (1995) Į-Amylase contained in bread can induce food allergy. J. Allergy Clin. Immunol., 95, 132–133. Losada, E., Hinojosa, M., Quirce, S., Sànchez-Cano, M. & Moneo, I. (1992) Occupational asthma caused by alpha-amylase inhalation: clinical and immunologic findings and bronchial response patterns. J. Allergy Clin. Immunol., 89, 118–125. Moreno-Ancillo, Á., Dominguez-Noche, C., Gil-Adrados, A.C. & Cosmes, P.M. (2004) Bread eating induced oral angioedema due to Į-amylase allergy. J. Investig. Allergol. Clin. Immunol., 14, 346–347. Pariza, M.W. & Johnson, E.A. (2001) Evaluating the safety of microbial enzyme preparations used in food processing: update for a new century. Regul. Toxicol. Pharmacol., 33, 173–186. Pedersen, P.B. (2008) Branching enzyme, PPY 27209: test for mutagenic activity with strains of Salmonella typhimurium and Escherichia coli. Unpublished study no. 20078073 from Novozymes, Bagsvaerd, Denmark. Submitted to WHO by Novozymes, Bagsvaerd, Denmark. Skamstrup Hansen, K., Vestergaard, H., Petersen, L.N., Bindslev-Jensen, C. & Poulsen, L.K. (1999) Food allergy to fungal alpha-amylase in occupationally sensitized individuals. Allergy, 54(Suppl. 52), 64–65. Whitwell, J. (2008) Induction of micronuclei in cultured human peripheral lymphocytes. Unpublished report No. 1974/71 from Covance Laboratories, Harrogate, England. Submitted to WHO by Novozymes, Bagsvaerd, Denmark. tải về 1.44 Mb. Chia sẻ với bạn bè của bạn:
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