ucm524570.pdf [Natriy sulfat]


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(b) (6)

(b) (6)

(b) (6)

(b) (6)


(b) (6)

Document Outline

  • GRAS Notice (GRN) No. 666 for Chondroitin sodium sulfate 
  • GRAS NOTIFICATION 
    • I. .Claim of GRAS Status 
    • II. Detailed Information About the Identify of the Notified Substance
    • III.Summary of the Basis for the Notifier's Determination that Chondroitin Sulfate Sodium is GRAS
    • IV. Basis for a Conclusion that Chondroitin Surfate Sodium is GRAS for its Intended Use
  • EXPERT PANEL STATEMENT 
  • TABLE OF CONTENTS
  • DETERMINATION OF THE GENERALLY RECOGNIZED AS SAFE (GRAS) STATUS OF CHONDROITIN SULFATE SODIUM AS A NUTRIENT
    • 1. INTRODUCTION 
      • 1.1. Background 
      • 1.2. Description, Manufacturing Process 
        • 1.2.1. Identity and Specifications 
      • 1.3. Manufacturing Process 
        • 1.3.1. Microorganism Characteristics 
          • 1.3.1.1. Strain Characterization 
          • 1.3.1.2. Toxigenic Potential 
          • 1.3.1.3. Endotoxiris 
        • 1.3.2. Cell Banks 
        • 1.3.3. Fermentation Process 
        • 1.3.4. Downstream Process 
        • 1.3.5. Chemical Synthesis 
      • 1.4. Chemistry and Biological Activity 
      • 1.5. Current Uses 
      • 1.6. Intended Use Levels and Foo d Categories
    • 2. DATA PERTAINING TO SAFETY 
      • 2.1. Specific Safety Studies 
        • 2.1.1. Specific Subchronic Toxicity Study
        • 2.1.2. Specific Allerginicity Study 
        • 2.1.3. Specific Genotoxicity Studies 
          • 2.1.3.1. Ames Assay 
          • 2.1.3.2. Chromosomal Aberration Assay 
          • 2.1.3.3. Mutation on Mouse Lymphoma Cells
        • 2.1.4. Specific Human Bioavailability Study
      • 2.2. Endotoxin Levels 
      • 2.3. Studies from Literature 
        • 2.3.1. Absorption, Distribution, Metabolism and Elimination (ASME)
        • 2.3.2. Human Observations 
        • 2.3.3. Animal Toxicity Studies 
        • 2.3.4. Other Genotoxicity Studies 
    • 3. Common Knowledge Elements for a GRAS Determination
    • 4.SUMMARY 
    • 5. CONCLUSION 
    • 6. REFERENCES 
    • 7. APPENDIX I 
    • 8. APPENDIX II 
    • Appendix III 
    • Appendix III Morphological, biochemical (API test) and denotypic characterization of strain GN2284



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