Export Certificate Application & Checklist for Food Contact Materials

When a manufacturer or exporter intends to place foodcontact articles (FCAs) on an international market, most jurisdictions require an Export Certificate (sometimes called a Certificate of Conformity or Declaration of Compliance). This document confirms that the product complies with the specific legislation of the destination country and that all relevant testing, documentation, and manufacturing controls are in place.

Why an Export Certificate Is Required

• Legal compliance: Demonstrates adherence to regulations such as EU Regulation1935/2004, US 21CFR117, China GB48061, and others.
• Market access: Many buyers, distributors, and customs authorities will not accept shipments without a valid certificate.
• Consumer safety: Guarantees that materials have been evaluated for migration, toxicity, and overall suitability for contact with food.
• Traceability: Provides a permanent record linking the product batch to the test results and regulatory references.

Key Steps in the Application Process

1. Identify the Applicable Regulations

Determine which legislation applies to the product in the target market. Consider:

• Type of food contact (e.g., packaging, processing equipment, utensils).
• Material composition (plastics, paper, metal, glass, composites).
• Intended use (singleuse, reusable, hightemperature, acidic foods, etc.).

2. Conduct or Obtain the Required Testing

Testing must be performed by an accredited laboratory and typically includes:

• Overall migration limits (OML).
• Specific migration tests for known hazardous substances (e.g., plasticizers, heavy metals, bisphenols).
• Thermal stability, extraction studies, and, where relevant, leaching under simulated use conditions.

3. Compile Technical Documentation (TechFile)

The techfile should contain every piece of evidence supporting compliance:

4. Submit the Application

Most authorities or accredited certification bodies accept electronic submissions. Required elements usually include:

• Completed application form (company details, product identification).
• PDF version of the techfile or a secure link to a document repository.
• Proof of payment for the certification fee.
• Signed declaration from an authorized representative.

5. Review, Audit, and Issuance

The certifying body will:

• Verify the completeness of the submission.
• Assess the technical file against the relevant regulation.
• May conduct a factory audit or request additional information.
• Issue the Export Certificate, typically valid for 13years, after which renewal is required.

Comprehensive Export Certificate Checklist

Company Information

• Legal company name and address.
• VAT/Tax identification number.
• Contact person for the certification process (name, phone, email).
• Authorized signatorys signature and date.

Product Identification

• Trade name and model number.
• Detailed description of the FCA (e.g., polypropylene film for wrapped readymeals).
• Intended food type(s) and conditions of use (temperature, duration).
• Batch or lot numbers covered by the certificate.

Regulatory Reference

• Specific regulation(s) and clause numbers (e.g., EURegulation1935/2004 Art.9).
• Applicable standards (e.g., ISO22000, FDA21CFR117, BfRII 2).
• List of restricted substances and allowed limits for the product.

Technical Documentation

• Material safety data sheets (MSDS) for all components.
• Formulation sheet with percentages of each ingredient.
• Manufacturing process description, including cleaning and qualitycontrol steps.
• Risk assessment report (e.g., HACCPstyle analysis).
• Certificates of analysis (CoA) from rawmaterial suppliers.

Testing Evidence

• Laboratory accreditation details (ISO17025, NABL, etc.).
• Overall migration test report with conditions (temperature, time, solvent).
• Specific migration reports for each regulated substance.
• Stability study results if the product is reusable or intended for longterm storage.
• Any additional tests required by the destination country (e.g., BPAfree verification for the EU).

Labeling & Markings

• Copy of the label that will appear on the product.
• Compliance symbols (e.g., Food Contact Material, recycling code, EUNo.10).
• Instructions for proper use and cleaning, if applicable.

Administrative Items

• Application fee receipt.
• Proof of insurance or liability coverage (often requested by customs).
• Export licence or permits, where required.
• Export declaration (e.g., Incoterms, shipping mode).

Common Pitfalls & How to Avoid Them

• Inadequate test scope: Always match the test conditions to the worstcase use scenario (high temperature, fatty foods, long contact time).
• Outofdate documents: Keep the techfile current; a change in formulation or supplier requires a new test and possibly a renewed certificate.
• Missing signatures: Ensure the authorized signatory is clearly identified and that electronic signatures meet the certifiers requirements.
• Improper lab accreditation: Verify that the testing lab is recognized by the authority you are applying to (e.g., EU Recognised Certification Bodies, FDAapproved labs).
• Neglecting local language requirements: Some countries demand the certificate and labeling in the official language; include translations as annexes.

Renewal and PostMarket Surveillance

Certificates are generally valid for a limited period. Renewal involves resubmission of the latest test results and any changes to the product or manufacturing process. In addition, many markets require postmarket surveillance a record of any consumer complaints, nonconformities, or adverse events. Maintaining these records simplifies future renewals and demonstrates ongoing compliance.

Useful Resources

• EU Food Contact Materials Portal
• U.S. FDA Food Contact Substances
• ISO22000 Food Safety Management Systems
• German Federal Institute for Risk Assessment (BfR)

By following the steps and checklist above, exporters can streamline the certification process, reduce the risk of shipment delays, and ensure that foodcontact materials meet the stringent safety expectations of global markets.