Declaration of Conformity (DoC) for FCMs

Declaration of Conformity (DoC) for FCMs - WESSLING

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Declaration of Conformity (DoC) for FCMs

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Declaration of Conformity (DoC) for Food Contact Materials

WESSLING offers a one-stop service for declarations of conformity—from raw material screening to declaration drafting, and from documentation preparation to supply chain audits.

When the “Declaration of Compliance” (DoC) was first introduced into China’s food contact materials regulatory framework through GB 4806.1-2016 “General Safety Requirements for Food Contact Materials and Articles,” it became more than just a statement on a label; it evolved into a systematic process with legal standing that tests the collaborative capabilities of the supply chain.

If the content of a statement is found to be false, illogical, or inconsistent with supporting documentation, the company will face administrative penalties, product recalls, and even systemic risks to its brand reputation.

About the “Declaration of Conformity (DoC)”

Under China’s national regulatory framework for food contact materials, a Declaration of Conformity (DoC) is a mandatory piece of product information. A DoC is not simply a statement that “this product complies with national standards”—it requires companies to clearly list which substances in the product are subject to restrictions, their respective limit values, and whether the product’s total migration test results are compliant. It is a legal document that must be supported by precise technical data.

The Legal Status of the DoC
The Importance of the DoC
DoC's Regulatory Framework

According to Chapter 8 of GB 4806.1-2016: “The label shall include the product name, material composition, a declaration of conformity with relevant regulations and standards, the name, address, and contact information of the manufacturer and/or distributor, the date of manufacture, and the shelf life (where applicable).”
The declaration of conformity itself must include the following core elements: the regulations and standards followed; a list of substances subject to restrictive requirements along with those requirements; and compliance with total migration limits (for finished products only), among other details.

Market regulation authorities have continued to strengthen enforcement regarding declarations of conformity. Administrative review cases and consumer complaints in recent years have repeatedly confirmed that products lacking a declaration of conformity or containing an incomplete declaration may be directly deemed non-compliant with mandatory national standards.
At the same time, end consumers are becoming increasingly aware of their rights regarding product labeling.

Primary Legal Source 1: Food Safety Law
Primary Legal Source 2: Product Quality Law
Core Standard: GB 4806.1 “General Safety Requirements for Food Contact Materials and Articles”
Supporting Standard System: GB 9685 and Material-Specific Standards(GB4806 series)

Declaration of Conformity (DoC) Services

WESSLING’s DoC services are not simply a matter of drafting boilerplate documents. We help you establish the “evidence chain framework” for your declaration—ensuring that every compliance claim is verifiable, traceable, and supported by documentation. Our core services include:

Raw Material Compliance Screening and Positive List Verification

Prior to drafting the declaration, we assist in verifying whether the resins, additives, and colorants used in the product are included in the positive list set forth in Appendix A of GB 9685 and relevant announcements issued by the National Health Commission, and provide a detailed analysis of the restricted usage conditions for each substance. For substances not included in the list, we assess whether they fall under exceptions such as “permitted passive migration,” ensuring the accuracy of the declaration from the source and identifying potential risks of residues or exceedances of substances of high concern.

Evaluation and Supporting Documents

By leveraging the testing capabilities of WESSLING Laboratories, we conduct tests in accordance with the GB 31604 series of method standards, including total migration testing, specific migration testing (for heavy metals, bisphenol A, phthalate plasticizers, etc.), and sensory analysis. We generate test reports that can be directly used as annexes to the Declaration of Conformity (DoC), establishing a one-to-one chain of evidence between each set of limit values stated in the declaration and the actual test results.

Compliance Breakdown for Multi-Material Products

For composite materials, multi-component materials, and coated products, analyze the applicable standards for each material layer (GB 4806.7 for plastics, GB 4806.8 for paper, GB 4806.10 for coatings, etc.), verify the authorized substance lists, migration limit requirements, and testing methods for each layer, develop a comprehensive assessment plan, and systematically present the findings in the declaration.

Content Planning and Template Customization for Declearation

Based on your product materials, intended conditions of use, and role in the supply chain (chemical supplier, intermediate material manufacturer, or finished product manufacturer), we will customize a tailored Declaration of Compliance framework in accordance with the latest industry guidelines and templates to ensure that all regulatory requirements are covered, including: issuer information, product information, applicable regulations and standards, a list of restricted requirements in labels or instructions, compliance with total migration limits, conditions for product use, the date of the declaration and the issuer, warning information, and liability disclaimers.

Supply Chain Compliance Assessment

Conduct compliance reviews and risk classification assessments of the declarations of conformity provided by material suppliers; guide upstream suppliers to provide standardized chemical substance declarations (specifying authorized uses and usage restrictions) and intermediate material declarations (disclosing substances subject to usage restrictions and compliance details); and ensure that the final product declaration is traceable at every stage and logically consistent.

Regulatory Change Tracking and Declaration Maintenance

In the event of changes to regulations or standards, or alterations to the composition or purity of substances, we promptly initiate a review to update the declaration, ensuring that issued declarations of conformity remain valid at all times. We offer ongoing regulatory monitoring services, providing regular updates and alerts, and assisting with the revision and reissuance of declaration documents as needed.

Retrospective Review and Rectification of Non-Compliant declearation

If compliance issues arise during on-site inspections—such as incomplete DoC documentation or questionable limit data—WESSLING experts step in immediately to identify the root cause: Is it a lack of upstream information? Are the test results inaccurate? Is there a misunderstanding of the standards? They then propose a phased corrective action plan and validation strategy to help companies complete declaration revisions, retesting, and document reconstruction in the shortest possible timeframe.

At its core, the Declaration of Conformity serves as a pivotal hub for information exchange within the food contact materials compliance system. It not only provides technical evidence of product safety but also reflects a company’s commitment to consumer responsibility and respect for the law. With the intensification of regulatory oversight and the implementation of new standards, the quality of the DoC has become a key indicator of a company’s food safety management capabilities.

Why WESSLING?

Originating in Germany and specializing in Chinese standards: With a deep understanding of international compliance principles and a thorough grasp of China’s GB 4806 series of standards and regulatory framework, our declarations combine an international perspective with local effectiveness.
Seamless Integration of Consulting and Testing: Regulatory experts and laboratory analysis teams work in close collaboration, ensuring that all recommendations can be efficiently validated through subsequent testing, thereby creating a highly efficient closed-loop process of “risk assessment—solution design—test verification.”
A Deep Dive into Supply Chain Compliance: We are not only a DoC service provider for end products; we also help companies map out information flow paths from raw materials to distribution, enabling true traceability across the entire supply chain.
Stay Ahead of Regulatory Changes: By choosing WESSLING, you gain access to an external think tank that stays abreast of the latest developments in food contact material standards, helping you stay one step ahead as standards evolve.