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Annex The raw materials from which VPP are produced may contain naturally occurring toxic or anti-nutritional factors. Some of these factors may still be present in VPP after processing. In the light of the above observations it becomes important that prior to the use as human food, VPP be subjected to adequate testing to demonstrate safety and appropriate nutritional quality. A distinct VPP needs to be tested pursuant to this guideline only once, that is, to obtain a toxicological and nutritional profile for VPP. Prior history of safe use may be taken into account in the evaluation of a novel VPP proposed for general consumption, but this alone is not necessarily sufficient to preclude adequate pre-clinical testing by currently available, more objective, laboratory animal feeding studies, and, where applicable, studies using human volunteers. 1.4 Toxicological Safety: The safety of the VPP should be predicted from information concerning methods of production, chemical and physical properties. This should be supported, where necessary, by safety data using laboratory animals. 2.4.1 Subacute Toxicity Studies: The purpose of these studies is to delineate the toxic potential of VPP and to elucidate such problems as species sensitivity, the nature of gross and micro-pathological changes and the approximate dose level at which these effects occur. They also provide guidelines for the selection of dosage for chronic toxicity tests and any functional or biochemical studies that may be necessary. 2.4.1.3 Length of Study: Subacute toxicity feeding trials should be at least three months duration. 2.4.2 Other Studies: Following an appraisal of the source and the method of manufacture of the VPP together with the results of nutritional and subacute toxicity studies, the need for further studies including chronic, reproduction, teratogenic and mutagenic studies will be evaluated.
SOS comment: There is clear evidence that Soy Protein does not meet WHO/Codex Guidelines. The isoflavones present in soy protein induce: The potential oral hazard of phytoestrogens has long been known by food regulator such as the FDA. During his presentation at the 3rd International Phytoestrogen Conference in 1995, FDA regulator Dr Michael Bolger made direct reference to the soy isoflavones causing infertility, uterine hypertrophy and testicular atrophy in rodents, liver disease and reproductive failure in cheetah and menstrual cycle effects on women. |