U.S. Food Contact Materials Compliance

Background of Food Contact Materials Compliance in the United States

Food contact materials (FCMs) are regulated in the US to ensure that they do not pose a risk to human health. The regulations for food contact materials in the US are primarily enforced by the Food and Drug Administration (FDA) and are based on the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Code of Federal Regulations (CFR). These regulations establish the types of materials that are acceptable for use with food and the maximum levels of certain substances that are allowed to migrate from these materials into food.

There are three main steps to be FDA compliant. The first step involves the established FCMs that follow existing FDA regulations. The second step involves applying FDA authorization for new food contact substances by submitting a Food Contact Notification (FCN) and/or Threshold of Regulation (ToR). The final step involves using the No Migration Exemption, which allows a company to argue that there is no need to notify the substance.

About Us

Our team of experts with food contact regulatory expertise and analytical services provides a holistic approach to ensuring that your FCMs are FDA-compliant and safe for consumers.

As a company that provides compliance solutions and regulatory consulting services to a variety of industries, including food safety, we have many years of experience researching U.S. regulations in the area of FCMs and can support companies engaged in related businesses to deal with these regulations. We offer a range of consulting, testing, verification, inspection, and certification services to ensure your FCMs are compliant with U.S. regulations. Our expertise in FCM compliance allows us to provide customized solutions tailored to your unique requirements.

Our U.S. Food Contact Materials Compliance Services

• FCM regulatory consulting
• Product compliance analysis/new species determination
• Preparation and review of Declarations of Conformity (DoC)
• U.S. FCN preparation and submission
• Self-determination of safe use per FDA TOR
• Preparation and submission of FDA No-Objection Letter for recalled food contact substances
• Analytical testing design to support assessments and compliance strategies
• End-use/final product compliance testing
• Test commissioning and supervision
• Compliance training
• Regulatory translation
• Consult with government authorities (FDA, EFSA, CFSA, etc.)
• US FDA official inquiry communication
• Supply chain management (ensuring supply chain compliance from raw material manufacturers to final product manufacturers)
• Risk assessment to determine safe FCM uses
• Post-market incident management

Our Advantages

Our expertise in FCM compliance allows us to offer our clients the following advantages:

• Regulatory expertise: We have a thorough understanding of FCM regulations and requirements in the United States.
• Customized solutions: We offer customized solutions to meet the specific needs of our clients, including testing, verification, and certification services tailored to your unique requirements.
• Efficiency: We use state-of-the-art technology and streamlined processes to ensure efficient and cost-effective services.
• Excellent resources: We cooperate with many excellent laboratories around the world and maintain good relationships with FDA authorities and authoritative experts in the field.

If you need help or have a question, please feel free to contact us for more details.