Administrative Guidance and Regulations

Table of Contents

1. FDA's Food Contact Notification Program
   Administrative Guidance and Regulations
2. Outline
3. OFAS on the Web
4. What is a Food Additive?
5. Protecting Consumers, Promoting Public Health
6. Food Drug & Cosmetic Act
7. What is a Food Contact Substance?
8. Types of Food Packaging and.Food Contact Substances
9. More Examples of FCS
10. Key Events in the FCN Program
11. Key Events in the FCN Program-cont.
12. Current Inventory of FCN Program
13. FCN Submissions
14. A Notification Must Contain:
15. Mechanism of Submission. FORM 3480
16. General Information (Part I)
17. Chemistry (Part II) FORM 3480
18. Toxicology (Part III) FORM 3480
19. Essential Component
20. Environmental Section (Part IV) FORM 3480
21. Certification (Part V) FORM 3480
22. Attachments (Part VI) FORM 3480
23. FCN Program
24. When should a notification be submitted?
25. Food Additive Petitions
26. Who Should Notify?
27. Who May Rely on an Effective Notification?
28. FCN Vocabulary

29. FCN Vocabulary2
30. FCN Vocabulary2-cont.
31. FCN Vocabulary2-cont.
32. FCN Vocabulary2-cont.
33. FCN Vocabulary2-cont.
34. FCN Key Players
35. FCN Key Players-cont.
36. FCN Review SOP
37. Case A
38. Case B
39. Common Administrative Deficiencies
40. Pre-notification Consultations
41. Pre-notification Consultations-cont.
42. Electronic Submissions
43. Disclosability of Information (FCNs)
44. FCN WEB TOUR
45. FCN WEB TOUR-cont.
46. FCN WEB TOUR-cont.
47. FORM 3480
48. FCN Format
49. FCN Format-cont.
50. FCN Format-cont.
51. TAKE HOME POINTS
52. Questions
53. ACKNOWLEDGEMENTS
54. FCN Key Players
55. Chemistry Guidance
56. Kirk Arvidson