Essential for Exporting Food Contact Materials: An Explanation of EU 10/2011 Food-Grade Testing and Declaration of Conformity

 Essential for Exporting Food Contact Materials: An Explanation of EU 10/2011 Food-Grade Testing and Declaration of Conformity

Below is a comprehensive practical guide on EU 10/2011 food-grade testing and Declaration of Conformity (DoC):

🧪 I. Core food-grade testing requirements

The core of EU 10/2011 lies in quantifying the risk of substances migrating from materials into food through scientific simulation. The tests are mainly divided into the following three categories:

1. Overall Migration (OM)

This is a comprehensive indicator for evaluating the overall "inertness" of materials, detecting the total amount of all non-volatile substances migrated from the material into food simulants.

Limit standard: Not to exceed 10 mg/dm² (calculated based on the contact area); for products with a capacity of less than 500mL, irregular shapes, or where the contact area cannot be estimated, the limit is 60 mg/kg.

Test method: According to the EN 1186 series of standards.

2. Specific Migration (SML)

Conduct precise detection of specific harmful substances (such as heavy metals, plasticizers, monomers, etc.) with limited quantity requirements in the EU's "positive list".

Primary Aromatic Amines (PAAs): The "top risk substance" in nylons, with potential carcinogenicity. Extremely stringent requirements are imposed, typically mandating non-detection (with a detection limit typically set at 0.01 mg/kg or 0.002 mg/kg).

Heavy metals, such as lead (Pb), cadmium (Cd), mercury (Hg), chromium (Cr), etc., all have extremely low specific migration limits (for example, the detection limit for lead is 0.01 mg/kg).

Other monomers: such as formaldehyde (SML ≤ 15 mg/kg) and melamine (SML ≤ 2.5 mg/kg) in melamine products.

3. Food simulants and testing conditions

The test must simulate the "most stringent foreseeable usage conditions" of the product. You need to select the simulants and conditions based on the type of food contacted, temperature, and duration:

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Note: For materials that are only used at room temperature and have a contact time not exceeding 30 minutes, the simplified test condition of 40°C / 30 minutes (OM0) can be applied.

📝 II. Detailed Explanation of Declaration of Conformity (DoC)

The Declaration of Compliance (DoC) serves as the "legal identity card" for product compliance. It must be signed by the manufacturer or EU importer and passed along with the product in the supply chain.

1. Core information that must be included in the DoC:

Subject information: The identity and address of the operator (manufacturer or importer) who issues the DoC.

Product characteristics: Detailed description of the characteristics of food contact materials, intermediate products, or substances.

Compliance statement: It is hereby declared that the product complies with the requirements of Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011.

Restricted substance information: Compliance information for restricted and regulated substances (such as additives, monomers).

Usage specifications: Clarify the safe usage conditions of the product, such as the types of food it can come into contact with (e.g., "only for non-fat foods").

Contact time and temperature (e.g. "Maximum tolerable temperature 180°C, not suitable for use with open flames").

The area/volume ratio in contact with food.

Issuing information: The declared location, date, and the signature of the authorizer.

2. Dynamic updating and validity period:

DoC is not a one-time process. Once there are changes to the product formula or production process, or updates to relevant EU regulations and standards (such as the periodic revisions to the list of authorized substances in EU 10/2011), a new DoC must be re-evaluated and issued.

📢 III. Latest Regulatory Developments and Compliance Suggestions

EU regulations are constantly evolving. For instance, in February 2026, the EU issued Regulation (EU) 2026/245, updating the list of authorized substances, introducing six new substances, and revising certain restrictions (such as certain substances not being applicable to infant formula). Additionally, for reused plastic products, it is required that their migration values do not increase during continuous testing.

Practical suggestions for export enterprises:

Source control: Strictly screen raw material suppliers and require them to provide DoC and test reports for raw materials that comply with EU regulations.

Scientific testing: Before a product is put into production, it is imperative to entrust a professional laboratory to design the most rigorous migration testing scheme based on the actual intended use of the product (temperature, food type).

Document retention: Establish a complete archive of technical documents, properly keep the DoC and the supporting compliance test reports, in preparation for random inspections by the competent authorities of EU member states at any time.

Clear marking: Clearly label the product with the words "safe for food contact" or relevant symbols, and include instructions and warnings that comply with EU requirements.