U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
October 15, 2002


FDA Workshop on the Notification Process for Food Contact Substances

Food Contact Notifications Stakeholders Meeting Toxicology Workshop.

October 15, 2002


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Author: Mary E. Shackelford, Ph.D.


Table of Contents

  1. Food Contact Notifications.Stakeholders Meeting Toxicology Workshop
  2. Organization of the Safety Information
  3. Safety Narrative
  4. Safety Narrative (cont.)
  5. Comprehensive Toxicological Profile (CTP)
  6. Comprehensive Toxicology Profile (cont.)
  7. FDA Form 3480 Part III Toxicology Information
  8. FDA Form 3480 Part III Section A Safety Narrative
  9. Form 3480 Part III Section B Relevant Safety Studies on the FCS or Food Additive
  10. Form 3480 Part III Section B Genetic Toxicity Studies on the FCS or Food Additive
  11. Form 3480 Part III Section B Other Relevant Safety Studies on the FCS or Food Additive
  12. Form 3480 Part III Section B Carcinogenicity Studies on the FCS or Food Additive
  13. Genetic Toxicity Studies on the FCS or Food Additive
  1. Form 3480 Part III Section B Other Relevant Safety Studies on the FCS or Food Additive
  2. Form 3480 Part III Section B Carcinogenicity Studies on the FCS or Food Additive
  3. FDA Form 3480 Part III Section C Information About the Potential Carcinogenicity and Toxicity of the Constituents
  4. Form 3480 Part III Section C Genetic Toxicity Studies on the Constituents
  5. Form 3480 Part III Section C Carcinogenicity Studies on the Constituents
  6. Section C Genetic Toxicity Studies on the Constituents
  7. Section C Carcinogenicity Studies on the Constituents
  8. Form 3480 Part III Section C Constituent Known to be a Potent Toxicant
  9. Form 3480 Part III Section D Other Relevant Toxicology Data or Information
  10. Form 3480 Part VI List of Attachments
  11. Toxicology Information for a Complete Notification
FCN Workshop Agenda & Presentations

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