How do I prepare a petition that contains the appropriate chemistry information?
• Consult the Chemistry Guidance Documents. If for a color additive, consult the chemistry guidelines for color additives and Color Additives for Medical Devices (if applicable). • Guidelines are NOT requirements: • The design of any study and assessment of the results should be based on sound scientific principles, not rote adherence to guidelines. • Significant deviations from appropriate guidelines should be justified and possible effects on the study discussed. • Consult with the Office of Food Additive Safety (OFAS) for protocol review BEFORE initiating any studies to ensure: • that the proper test data will be submitted, • that the analytical methodology will be adequate, and • that the validation methodology will be adequate • Submit all supporting raw data, including that for: • samples, • standards, • construction of calibration curves, and • determination of limits of detection (LOD) and limits of quantitation (LOQ). • Submit a complete description of the analytical methods,
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- How do I prepare a petition that contains the appropriate chemistry information?
