Background

Regulatory Background
(How the Food Contact Substance Notification program began)

Regulatory Report: FDA's Food Contact Substance Notification Program
(From Food Safety Magazine Oct/Nov 2005)

Regulatory Report: Assessing the Safety of Food Contact Substances
(From Food Safety Magazine Aug/Sep 2007) 

Guidance and Other Information for Industry

• Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (DRAFT)
• Preparation of Food Contact Substance Notifications (Administrative)
  • See also: CFSAN Online Submission Module (COSM)
• Forms for Notifications for Food Contact Substances
  Note: To open field fillable forms they must be downloaded and then opened from your local computer (not from a web browser).
  • Premarket Notification for New Use of a Food Contact Substance (FCN), a Pre-notification Consultation (PNC), and a submission of a Food Master File (FMF).
    • FDA Form 3480 (PDF - 311KB)
    • Instructions for FDA Form 3480 (PDF - 95KB)
  • Amendment to an FCN, PNC, or FMF.
    • FDA Form 3480a (PDF - 64KB)
    • Instructions for FDA Form 3480a (PDF - 153KB)
  • Notification for the Use of a Food Contact Substance Formulation.
    • FDA Form 3479 (PDF - 505KB)
• Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations)
• Preparation of Food Contact Substance Notifications (Toxicology Recommendations)
• Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission
• Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk
• Redbook 2000
• Submitting Requests Under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact Articles
• Use of Recycled Plastics in Food Packaging (Chemistry Considerations)
• Microbiological Considerations for Antimicrobial Agents Used in Food Applications
• Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives

Inventories and Tables

• Inventory of Effective Food Contact Substance (FCS) Notifications
• Food Types and Conditions of Use for Food Contact Substances
• Inventory of Environmental Decisions for Effective FCS Notifications
• Threshold of Regulation Exemptions
• Cumulative Estimated Daily Intake (CEDI) Database for Food Contact Substances
• Recycled Plastics in Food Packaging
• Inventory of Food Contact Substances Listed in 21 CFR