KGS KOREA

KGS KOREA

Overseas Certification

Country and regional certification guidance for global market entry.

Details

FCN

Purpose of Certification

Food Contact Notification (FCN) certification aims to verify the safety of food contact substances (FCS) regulated by the U.S. FDA as indirect food additives, including materials that directly contact food such as articles, containers, and packaging. If an unapproved substance is used, safety is assessed against applicable CFR requirements.

Certification Overview

This scheme demonstrates conformity with FDA requirements. Anyone intending to manufacture or distribute food contact substances (FCS) in the U.S. must notify and obtain FDA approval for the safety of the FCS.

Target Products

FCN related marks example
  • Indirect food additives: General (21 CFR 174)
  • Indirect food additives: Adhesives and components of coatings (21 CFR 175)
  • Indirect food additives: Paper and paperboard components (21 CFR 176)
  • Indirect food additives: Polymers (21 CFR 177)
  • Indirect food additives: Adjuvants, production aids, and sanitizers (21 CFR 178)
  • Irradiation in the production, processing, and handling of food (21 CFR 179)

Required Documents

Submission documents

  • FDA Form No. 3479 and 3480, etc.
  • Information on chemical identity (including major impurities and CAS Registry No., etc.)
  • Information on conditions of use (max use temperature, food types, contact duration, reusable vs. single-use, etc.)
  • Technical effect information
  • Estimated dietary intake information
  • Toxicological information (safety tests and toxicology profile based on CEDI, etc.)
  • Environmental information (EA under NEPA or rationale for categorical exclusion, etc.)
  • (If required) Other documents as requested

Exemptions

  • Substances that do not migrate to food
  • No migration due to an effective barrier between the food contact material and food
  • FCS authorized prior to 1958
  • Substances generally recognized as safe
  • Migration does not exceed 0.5 ppb, is not carcinogenic, and is calculated to be less than 1% of the daily recommended intake
  • Household articles (note: items that may release hazardous substances, such as cookware and ceramics, may be separately regulated)

Remarks

Other Matters

* Even if classified as outside FCN scope, products may be subject to seizure and fines if hazardous substances are detected post-market.