The Inventory of Food Contact Substances in USA refers to the list of substances permitted for food contact under Title 21 of the U.S. Code of Federal Regulations (21 CFR). It includes details on substance characteristics, FDA-specified intended uses, and authorized usage conditions.
Scope of Application
Covers substances listed in:
- 21 CFR Part 175 (Adhesives and Coatings).
- 21 CFR Part 176 (Paper and Paperboard Components).
- 21 CFR Part 177 (Polymers).
- 21 CFR Part 178 (Adjuvants, Production Aids, and Sanitizers).
- 21 CFR Part 179.45 (Packaging Materials for Pre-Packaged Food Irradiation).
- 21 CFR Part 180.22 (Acrylonitrile Copolymers).
- Secondary direct additives listed in 21 CFR Part 173.
- Previously approved substances in 21 CFR Part 181.
- Substances Generally Recognized as Safe (GRAS) under 21 CFR Part 186.
Core Compliance Requirements
1. Food Contact Notification (FCN)
- Applicability: If a substance is not listed in 21 CFR, an FCN must be submitted to the FDA for authorization prior to U.S. market entry. Required documentation includes chemical composition, migration data, and toxicological assessments.
2. Compliance Verification for Existing Substances
- If a substance is already listed in 21 CFR (e.g., certain plastics, adhesives) and its use aligns with specified conditions (e.g., temperature, contact time), no additional authorization is needed. Suppliers must provide a Declaration of Compliance (DOC) to downstream clients to ensure final product safety and compliance.
Ongoing Compliance Updates
- Re-submission: A new FCN or supplemental data is required if there are significant changes to material formulas, production processes, or intended use.
- DOC Updates: Compliance declarations must be revised to reflect regulatory updates, material composition/purity changes, or other relevant factors.
How to obtain the list?
- Click here for the latest Positive List.
- Contact us for specific inquiries.
Our Services
- FDA Food Contact Material Compliance Assessment.
- FDA Food Contact Substance Notification (FCN) Submission.
- U.S. Food Contact Material Testing.
- FDA Food Contact Material Declaration of Compliance Drafting/Review.
