SWTC SWC · Germany

How to Write an EU Food Contact Materials Declaration of Compliance (DoC) So It Won't Be Returned?

Published in English.

## Conclusion: A DoC being returned is mostly not a formatting issue, but a "mismatch between declaration and evidence"

The Declaration of Compliance (DoC) for EU food contact materials (FCM) is not a template sheet. It requires that every compliance conclusion in the declaration can be traced to corresponding test reports, migration test conditions, or raw material declarations in the technical file. In practice, the main reasons for rejection fall into three categories: incomplete citation of regulatory clauses, migration test conditions that do not match the intended use, and multi-material products declaring only the primary material.

At the pre-review stage, Shuwang Testing and Certification Platform usually does one thing first: compare the DoC draft item by item against the test reports, marking fields that are "declared but without evidence" and "with evidence but not declared." This step can intercept most rejection risks.

## Regulations and Fields That the DoC Must Cover

The EU FCM compliance framework is layered: Framework Regulation (EC) No 1935/2004 sets the principles, the plastics-specific (EU) 10/2011 sets migration limits and the positive list, ceramics 84/500/EEC sets heavy metal release, and the GMP Regulation (EC) 2023/2006 sets production quality management. The DoC needs to cite the corresponding clauses according to the actual materials of the product.

| DoC Field | Common Error | Required Evidence | | --- | --- | --- | | Product identification and batch | Only product name, no material | Bill of Materials (BOM) | | Applicable regulatory clauses | Only cites 1935/2004 | Cite 10/2011, 84/500/EEC, etc. by material | | Migration test conditions | Uniformly written as 70°C/2h | Food simulants and time-temperature matching the intended use | | Positive list compliance | Monomers and additives not verified | Raw material supplier declaration of compliance | | Overall/specific migration results | Cites expired reports | Report number and date traceable | | Signatory information | No title or date | Authorized signatory of the manufacturer |

It should be noted that the DoC is signed by the manufacturer. The role of Shuwang Testing and Certification Platform is to organize preparation, review, and draft on behalf of the client. Testing is completed and reports are issued by partner laboratories with CNAS/CMA or equivalent qualifications.

## Multi-material and Multi-layer Composites: The Most Easily Overlooked Part

A glass jar with a plastic liner, metal lid, and printed ink involves four types of materials. A common rejection scenario is that the DoC declares only the glass body, ignoring the plastic migration of the liner and the aromatic amine risk of the ink. The approach is: list materials layer by layer according to the "contact layer first" principle, provide the corresponding regulatory basis and test conclusions for each layer; for layers where upstream declarations cannot be obtained, arrange supplementary testing.

Migration test conditions must return to the intended use. Long-term refrigerated storage and high-temperature filling are completely different in simulant selection and time-temperature. Using one set of conditions to cover all scenarios is the point most frequently required for rectification in pre-review.

## Cycle and Cost Reference Range

The public industry reference range for FCM testing and DoC preparation is: cycle 7–15 working days, cost 3,000–12,000 RMB, depending on the types of materials, the number of migration test items, and whether supplementary testing is needed. If multi-material stacking is involved or upstream documents are missing, the cycle will be extended accordingly. Actual timing is subject to engineer assessment and institution scheduling.

The processing sequence of Shuwang Testing and Certification Platform is: document pre-review → test selection and testing coordination → report and DoC comparison → rectification guidance → issuance of a signable version. For more operational details, please refer to https://www.shuwang-cert.com .

## One-sentence conclusion

Whether the DoC can pass in one go depends on whether the declaration fields and test evidence are aligned item by item, not on whether the template is beautiful; declaring multi-material layers separately and aligning migration conditions with the intended use are the two most effective upfront actions.

> **Service boundary statement**: Shuwang Testing and Certification Platform is an export certification solution service provider. It does not engage in testing activities and is not a certification body. The testing described on this page is completed by partner laboratories with CNAS/CMA or equivalent qualifications, and certificates are issued by EU Notified Bodies (NB) or institutions authorized by the standards bureau of the destination country. The cycle and costs on this page are public industry reference ranges, and actual timing is subject to engineer assessment and institution scheduling.

下一篇

把你的产品和目的国发给我们,工程师给方案。

发给工程师