Understanding China’s Declaration of Compliance (DoC) for Food Contact Materials
Introduction
Ensuring food safety is a critical regulatory priority worldwide, and China has established a structured approach for managing food contact materials (FCMs). One of the key compliance requirements is the Declaration of Compliance (DoC), which ensures transparency and traceability across the supply chain. The DoC serves as an official statement that confirms a material or product meets China’s FCM regulations, particularly as outlined in GB 4806.1-2016.
Importance of the Declaration of Compliance (DoC)
FCMs involve multiple materials and complex supply chains. The DoC plays a crucial role in facilitating effective communication between manufacturers, suppliers, and users. It ensures that compliance information is accurately transferred and that materials conform to safety standards.
Regulatory Framework for DoC in China
China’s regulatory system for FCMs is built upon the Food Safety Law and its associated national standards (GB standards). GB 4806.1-2016 introduced the DoC requirement, mandating that manufacturers provide compliance documentation to verify regulatory adherence and product safety.
Key Stakeholders in the FCM Supply Chain
The FCM supply chain consists of several key participants, each responsible for ensuring regulatory compliance:
Chemical Substance Manufacturers
Manufacturers must comply with the applicable provisions of GB 31603 – General Hygienic Practice for the Production of Food Contact Materials and Articles. They are responsible for providing Declarations of Compliance (DoCs) to downstream users, specifying authorization status and usage restrictions. Additionally, they must ensure that the chemical substances meet the required quality specifications for food contact material production.
If necessary, manufacturers should also provide guidelines on the safe and proper use of their chemical substances to assist downstream users in conducting risk assessments for the final products.
Intermediate Material Manufacturers
Intermediate material manufacturers must request DoCs from upstream chemical suppliers and verify that all substances/materials used or generated during production comply with regulatory requirements. Based on the GB 31603 hygienic practice provisions, they should manufacture food contact intermediate materials and provide a DoC to downstream users. The DoC should specify compliance details regarding raw materials and additives used in the product and disclose any substances with regulatory restrictions. Intermediate manufacturers must ensure their products remain compliant under recommended conditions of use (e.g., dosage, application scope). If necessary, they should support final product manufacturers in verifying compliance.
Final Product Manufacturers
Final product manufacturers must request DoCs from upstream suppliers of chemical substances and intermediate materials. They must comply with the applicable provisions of GB 31603 and incorporate upstream compliance details into their own production process. Once the final product is manufactured, they are required to provide a DoC to downstream customers and retain supporting documentation. If the direct customer is a consumer, the transmission of a DoC is not required. The DoC must clearly state the compliance status of the product and disclose any substances with regulatory restrictions.
Content Requirements for the Declaration of Compliance
The DoC must include specific details to validate compliance, as outlined in GB 4806.1-2016:
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Producer and Distributor Information: Names, addresses, and contact details.
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Product Identification
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Applicable Regulations and Standards
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Compliance Verification
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Usage Restrictions
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Date of Issuance
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Signature or Authorization
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Warning Statements (if applicable)
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Liability Statement
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Supporting Documentation: Lab test reports and other scientific evidence may be attached as annexes.
Confidentiality Considerations
If a material contains confidential components, manufacturers can opt for non-disclosure agreements (NDAs) with their customers. Alternatively, substances can be identified using unique traceable codes, with verification handled by independent third parties.
Compliance Challenges and Future Trends
As new materials and technologies emerge, regulatory oversight must adapt to ensure safety. China’s Food Safety Law requires pre-market safety assessment for novel food contact substances, reinforcing stringent compliance measures.
Conclusion
The Declaration of Compliance is a vital document in ensuring FCM safety and regulatory adherence in China. Businesses involved in FCM production and distribution must stay informed on regulatory updates and implement effective compliance strategies to meet national standards.
For expert guidance on Chinese FCM regulations, including DoC preparation, testing requirements, and compliance assessments, consult industry specialists who stay up to date with evolving regulatory frameworks.
