On September 20, 2024, CIRS made a major breakthrough in the field of food contact materials regulations by successfully obtaining the formal approval of the US Food and Drug Administration (FDA) for a US Food Contact Substance Notification (FCN). This achievement not only demonstrates CIRS's professional strength in the field of food contact materials but also paves the way for the company to explore the international market.
Analysis of technical difficulties in FCN
The data requirements for FCN in the United States are cumbersome, involving physical and chemical information, specification data, technical effects, stability data, migration data, dietary exposure, toxicology data, and environmental assessments, to name a few. This time, CIRS focused on impurity analysis, toxicology, and migration, and after careful and efficient communication with the FDA in the early stage, confirmed the key points in the declaration, and achieved a technical breakthrough:
1. Optimization of principal component migration experiment: Through communication with the FDA, the migration test conditions were optimized (according to FDA guidelines, the migration test should take several days, but we optimized it to a very short time).
2. Exemption of migration test of impurities: Through the migration hypothesis, the calculated human exposure assessment exempts the migration test of impurities.
3. Toxicological assessment of impurities: For impurities, multiple QSAR model methods were used to predict the toxicity of impurities, and it was successfully approved by the FDA.
Introduction to the United States Food Contact Materials Bulletin
The US Food Contact Materials Code is a complex system designed to ensure food safety and consumer health, developed and enforced by the FDA. These regulations cover all materials that come into direct or indirect contact with food, including packaging materials, containers, tableware, and processing equipment, to ensure that these materials do not pose a threat to food safety. Regulations require companies to provide detailed physicochemical properties, toxicology data, and migration test results, to prove that their products are not harmful to human health.
Under this framework, the FCN process is an efficient pathway that allows material manufacturers or suppliers to submit safety data for new food contact substances directly to the FDA for approval. Once FCN is approved, the substance is considered safe for a specific use.
Since the substance approved by FCN is only valid for the applicant, other companies must submit a food contact material declaration to the FDA if they want to use the substance in food contact materials, and enterprises can also confirm whether any company has completed the relevant declaration in the United States through the Global Food Contact Materials Regulatory Database independently developed by the CIRS Group.
Once the FCN declaration is successful, it can greatly help the relevant products of the enterprise to enter the US market.
About CIRS’ Food contact materials regulatory team
CIRS’ Food contact materials regulatory team is committed to the research of food contact materials regulations and the declaration of food contact substances in major countries around the world, and has gathered food contact materials regulatory databases including China GB9685, EU 10/2011, Japan, US FDA, and MERCOSUR.
CIRS's successful application for the FDA food contact notification not only shows its professional strength and technological innovation ability in the field of food contact regulations, but also provides a solid foundation for enterprises to enter the international market. CIRS will continue to be committed to the regulatory research and development of food contact materials to contribute to global food safety.
You can access the Global Food Contact Materials Regulatory Database here.
