WHO/Codex General Standards for Soy Protein Products
WHO/Codex Standard 175-1989
6.3 (c) When tested by appropriate methods of sampling and
examination the product shall not contain other poisonous substances
which may represent a hazard to health.
WHO/Codex General Guidelines for the Utlization of Vegetable
Protein Products (VPP) in Foods
CAC/GL 4-1989
4.1 VPP intended for human consumption should not represent a hazard
to health.
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:
- Subacute toxicity
- Chronic toxicity
- Reproductive toxicity
- Teratogenic effects
- Mutagenic effects
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.
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