Cardboard products EU EC) NO 1935/2004 international certification process
Date：2025-09-04 10:16:29 Classification
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The EU framework regulation for food contact systems is (EC) No 1935/2004. It has evolved to cover materials such as plastics (EU) No 10/2011, regenerated cellulose films (2007/42/EC), ceramics (84/500/EEC), rubber (93/11/EEC), and active and smart materials (EC) No 450/2009. The complete process and key points for testing and international certification of paperboard products under EU EC No 1935/2004 are summarized based on the latest regulatory requirements (as of 2025):
I. Pre-certification Preparation
1. Confirming the Scope of Application
- Compulsory Items: All paperboard products intended for direct food contact (e.g., food packaging boxes, paper cups, cake trays, hamburger wrappers, etc.).
- Exempt Products: Decorative paperboard and industrial paperboard for non-food contact purposes (e.g., appliance linings).
2. Select a Certification Body
- EU-accredited laboratories (such as Dezewei) are required, with preference given to those with CNAS/CMA accreditation.
3. Document Preparation Checklist
| Document Type | Specific Requirements
| Product Technical Documents | Product drawings, ingredient list (including coating/ink ingredients), usage scenario description
| Supply Chain Information | List of raw material suppliers, Material Safety Data Sheets (MSDS) for each component
| Sample Specifications | Provide 3-5 production-ready samples (including printed surfaces)
II. Core Testing Process and Standards
Chemical Safety Testing (Mandatory Items)
According to ResAP (2002)1:
1. Heavy Metal Migration Test
- Items: Lead (Pb), Cadmium (Cd), Mercury (Hg)
- Limits: Pb ≤ 0.3 mg/kg, Cd ≤ 0.1 mg/kg, Hg ≤ 0.01 mg/kg
2. Organic Pollutant Testing
- Pentachlorophenol (PCP): Limit ≤ 0.05 mg/kg (GC-MS).
- Formaldehyde Migration: Limit ≤ 15 mg/kg (Immersion in water/alcohol simulant).
- Optical Brighteners (OPTs): Completely Prohibited (Mandatory from July 2023).
3. Polycyclic Aromatic Hydrocarbons (PAHs)
- New requirement (June 2024): Benzo[a]pyrene ≤ 0.002 mg/kg.
▶ Physical and Microbiological Testing
- Sensory Testing: No discoloration or odor (Olive oil immersion verification).
- Microbiological Limit: No detectable Escherichia coli/Salmonella (EN 12905 standard).
III. Certification Process and Timeline
A [Submit Application + Sample] --> B [Laboratory Split Testing]
B --> C [Chemical Migration Test]
C --> D {{Compliant? }}
D --> | Yes | E [Issue Declaration of Conformity]
D --> | No | F [Retest after rectification]
E --> G [Obtain EC 1935/2004 Certificate]
G --> H [Annual Surveillance Audit]
- Turnaround: 5-7 working days (routine), extended to 15 days for complex samples.
- Fees:
- Basic testing fee: ¥1,000-3,000 (depending on the number of test items)
- Expedited fee: +30% of the total cost.
IV. Technical Documentation and Labeling Requirements
1. List of Compliance Documents
- Declaration of Conformity (DoC): Includes product model, test standards, and declaration of compliance with limits.
- Test Report: Issued by an accredited laboratory (specify EN standard methods).
- Traceability Records: Proof of raw material origin, production batch number.
2. Product Labeling Specifications
- Must be labeled with the "Food Contact Suitable" mark and operating conditions (e.g., temperature range).
- Printed information must include: manufacturer's address, production date, and ingredient code (e.g., "PP>5" indicates polypropylene).
V. Subsequent Compliance Management
1. Annual Audit
- The certification body will conduct annual spot checks on the factory's production processes.
2. Change Management
- Changes in ink/coating suppliers require resubmission for inspection.
Key Timelines and Updates (Applicable from 2025)
- New Regulations Effective:
- Mandatory cobalt/arsenic testing (starting from January 2024).
- Paper packaging requires an electronic DoC (Document of Conformity Assessment) (starting from 2025).
- Report Validity Period: No fixed period, but updates are required for material changes.
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