On May 14, 2026, Hangzhou CIRS Group Co., Ltd. (CIRS Group) achieved another major breakthrough in the food contact materials regulatory field by successfully representing another U.S. Food Contact Notification (FCN), obtaining formal approval from the U.S. Food and Drug Administration (FDA).
Overview of This FCN Submission
The food contact substance (FCS) submitted this time is a 2-methyl compound, which can be used in food contact materials contacting all food types, but is not suitable for use in contact with infant formula and breast milk. The use of this substance must comply with the maximum limit requirements stipulated by the FDA. CIRS Group conducted focused assessments on migration assumptions and impurity toxicology. After detailed and efficient pre-submission communication with the U.S. FDA, the following key points of the submission were confirmed:
- Through migration assumptions, the calculated human exposure assessment exempted migration testing for impurities.
- Impurity Toxicological Assessment: Regarding impurities, based on CIRS's QSAR calculation capabilities, multiple QSAR model methods were used to verify the low toxicity of the impurities, which was successfully recognized by the U.S. FDA.
Introduction to U.S. FCN
The U.S. food contact materials regulations constitute a complex system designed to ensure food safety and consumer health, formulated and enforced by the U.S. Food and Drug Administration (FDA). These regulations cover all materials that directly or indirectly contact food, including packaging materials, containers, tableware, and processing equipment, ensuring that these materials do not pose a threat to food safety. The regulations require companies to provide detailed physicochemical properties, toxicological data, migration test results, etc., to prove that their products are harmless to human health.
Under this framework, the Food Contact Notification (FCN) program is an efficient pathway that allows material manufacturers or suppliers to submit safety data for new food contact substances directly to the FDA to obtain approval. Once an FCN is approved, the substance is considered safe for its intended use.
U.S. FCN submission data requirements are extensive, involving substance physicochemical information, specification data, technical effects, stability data, migration data, dietary exposure, toxicological data, environmental assessment, etc.
Since substances approved through FCN are only valid for the applicant, other manufacturers/suppliers wishing to independently market the same FCS for the same use typically need to submit their own FCN. Companies can also use the Global Food Contact Materials Database independently developed by CIRS Group to confirm whether any company has already completed the relevant submission in the United States.
Successful FCN submission can greatly facilitate the entry of related products into the U.S. market.
ChemRadar Global Food Contact Materials Database
The Global Food Contact Materials Database independently developed by CIRS Group collects food contact materials regulatory standards and substance approval lists from major countries and regions, including China (GB 4806 series, GB 9685, etc.), the European Union (EU 10/2011), the United States (21 CFR/FCN), Japan (Positive List), ASEAN, and Mercosur. It is organized by region, marked with update dates and compliance reminders, enabling enterprises to quickly query raw material compliance and confirm target market access requirements, providing authoritative regulatory references for the production, R&D, and trade of food packaging and contact materials.
https://hgt.cirs-group.com/tools/fcmd/inv/list
Our Services
- U.S. FDA Certification Consulting and Training;
- U.S. FDA Food Contact Materials Compliance Determination;
- U.S. FDA Food Contact Substance Notification (FCN);
- U.S. FDA Food Contact Materials Testing;
- U.S. FDA Food Contact Materials Declaration of Compliance (DoC) Preparation/Review
