Food Contact Substance Program

Overview

• About the Food Contact Substances Review Program
  (Explanation of the law, Food contact substance category terms)
• 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)
• Determining the Regulatory Status of the Individual Components of a Food Contact Material
  • Tabular Model
  • Decision Tree Model
• How to Submit a Food Contact Substance Notification (Administrative, Scientific, and Environmental requirements)
• Workshop on the Notification Process for Food Contact Substances (October 2002)
  (includes slide presentations detailing administrative, chemistry, toxicology, and environments)

Guidance

• Administrative
• Forms for Notifications for Food Contact Substances
  • Notification for New Use of a Food Contact Substance under Premarket Notification
    • FDA Form No. 3480: PDF format   |   Word Template
      (Word Template includes additional continuation pages)
  • Notification for the Use of a Food Contact Substance Formulation
    •   FDA Form No. 3479:   PDF Format   |   Word Template
• Chemistry
• Toxicology
• Environmental
• Redbook 2000
• E-Submissions
• 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 Food Additive Submissions June 2008

Inventories and Tables

• Inventory of Effective Food Contact Substances (FCS)
• 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/Acceptable Daily Intake Database for Food Contact Substances
• Recycled Plastics in Food Packaging
• List of "Indirect" Additives Used in Food Contact Substances

Contact Information