Safety evaluation of certain food additives
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EVALUATION Comparing the conservative exposure estimate of 6 mg/kg bw per day with the lowest reported NOAEL of 1000 mg/kg bw per day (the highest dose tested) derived from the developmental toxicity studies in rats and rabbits, the margin of exposure is at least 160. The Committee noted that in a 28-day study in rats, in 90- day studies in dogs and cats and in a two-generation study in rats, no adverse effects were observed at doses up to, respectively, 4590, 3290, 2410 and 5280 mg/ kg bw per day, the highest doses tested in these studies. Considering the low toxicity and the negative genotoxicity results, the Committee allocated an ADI “not specified” for cassia gum that complies with the tentative specifications established at the current meeting, when used in the applications specified and in accordance with Good Manufacturing Practice. As the method for determination of anthraquinones at a level of 0.5 mg/kg and below was not considered to be suitable for inclusion in the specifications, the Committee decided to make the specifications tentative pending submission of data on a suitable and validated method by the end of 2010. 6. REFERENCES Bertens, A.M.C. (1998) Evaluation of the ability of Diagum CS to induce chromosome aberrations in cultured peripheral human lymphocytes. Unpublished report No. 233088 from NOTOX, ’s-Hertogenbosch, the Netherlands. Submitted to WHO by Lubrizol Advanced Materials Europe BVBA, Brussels, Belgium. European Food Safety Authority (2006) Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from the Commission related to an application on the use of cassia gum as a food additive. Question No EFSA-Q-2003-134. Adopted on 26 September 2006. EFSA J., 389, 1–16. FAO/WHO (2008) Report of the fortieth session of the Codex Committee on Food Additives, Beijing, China, 21–25 April 2008. Rome, Italy, Food and Agriculture Organization of the United Nations, Codex Alimentarius Commission (ALINORM 08/31/12; http:// www.codexalimentarius.net/web/archives.jsp?year=08 ). tải về 1.44 Mb. Chia sẻ với bạn bè của bạn:
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