What Is a Declaration of Compliance (DoC)?
A Declaration of Compliance (DoC) for food contact materials is a self-declared document issued by manufacturers to confirm that their products meet the applicable U.S. Food and Drug Administration (FDA) regulations. It serves as critical evidence of regulatory compliance and acts as a "passport" for products entering the U.S. market.By issuing a DoC, manufacturers demonstrate to regulators, supply chain partners, and consumers that their products are safe and compliant with U.S. requirements for food contact materials.Who Needs a DoC?
Typically, manufacturers of raw materials, intermediate materials, and finished food contact products are required to prepare a DoC. Each party must ensure that their products undergo necessary compliance evaluations and testing in accordance with FDA regulations.Importance of the DoC
While the FDA does not mandate a DoC for food contact materials at the distribution stage, it remains widely adopted across the supply chain to clarify responsibilities and ensure traceability. The DoC allows upstream suppliers to communicate regulatory compliance and usage restrictions to downstream users.A comprehensive DoC should include:- Manufacturer’s identity and contact details
- Applicable FDA regulation(s) and specific citations
- Usage limitations or conditions
- Summary of relevant compliance tests and reports (where applicable)
DoC Issuance Process
Product Evaluation
We conduct a detailed assessment to identify the material type (e.g., plastic, metal, glass) and intended use, and determine applicable FDA regulatory requirements.Data Collection
We gather all necessary product information, including compositional data, migration test results, manufacturing process details, and supplier qualifications.
DoC Drafting
Based on the collected data, we prepare a legally compliant DoC referencing the applicable regulations and outlining compliance testing and conclusions.Internal Review
Our in-house experts carefully review and validate the DoC to ensure technical accuracy and legal sufficiency.Delivery and Support
The final DoC is delivered along with guidance on its use, helping you confidently respond to regulatory reviews or customer inquiries.FAQs About DoC
Q: Is a DoC required during customs clearance?A: The FDA does not currently require a DoC at the border. However, in practice, many companies exchange DoCs within the supply chain based on mutual agreements to ensure accountability.Q: What types of testing are required for a DoC?
A: Testing requirements depend on the product type. Typically, we begin by identifying any specific chemical substance restrictions, followed by general migration or solvent extraction tests as outlined in the relevant FDA regulations. If no testing is mandated, referencing the regulation in the DoC may suffice.Q: Is the DoC valid indefinitely?
A: No. A DoC is not valid permanently. It must be reviewed and updated whenever there are changes to product formulation, suppliers, intended use, or applicable regulations. Our standard recommendation is to reassess every two years.
Our Services
Customized Compliance Solutions
We tailor compliance strategies based on your material type and intended use, ensuring a precise and efficient pathway to issuing a valid DoC.Expert Regulatory Interpretation
Our team closely monitors FDA regulatory developments and interprets specific provisions relevant to your product, ensuring that your documentation reflects the latest legal standards.Ongoing Compliance Support
Compliance is an ongoing process. We provide continuous regulatory updates and assistance to help you maintain product compliance over time.Why Choose Us?
- Professional Team: Our experts include regulatory specialists and technical engineers with deep knowledge of U.S. FDA food contact regulations and years of practical experience.
- Efficient Execution: We streamline the DoC process to help you obtain compliance documentation quickly—minimizing delays and maximizing market access.
- Trusted Network: We maintain strong relationships with accredited labs and certification bodies, ensuring reliable testing and verification services.
- Tailored Solutions: We understand that every company and product is unique. We deliver customized compliance plans that fit your specific needs.
