What documents are required for EU EN71 certification of comfort dolls?
Date：2025-12-31 09:22:56 Classification
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EN71 certification, as the EU's "gatekeeper" standard for children's toy safety, requires meticulous attention to detail in preparing documentation, covering every aspect from materials to manufacturing processes. This is especially true for comfort toys, which may be chewed on by infants and toddlers; the completeness of the documentation directly impacts the pass rate.
I. Core Documents Required for EN71 Certification of Comfort Toys
**Basic Product Information**
| Document Name | Specific Requirements
| Product Instruction Manual/User Manual | Must include: Applicable age (e.g., "0-36 months"), usage scenario (e.g., "comfort and companionship"), and safety warnings (e.g., "Do not disassemble small parts")
| Product Photos/Design Drawings | Must clearly show: Overall structure (e.g., whether there are buttons, eyes, ribbons, etc.), and dimensions (length × width × height)
| Brand and Company Information | Manufacturer's name, address, and contact information (in Chinese and English, must match the exporter's information)
II. Material and Composition Certificates
**Bill of Materials (BOM)**
Must be listed in detail. All accessible materials, including:
Main fabric (e.g., "100% polyester," "65% cotton + 35% polyester")
Filling (e.g., "PP cotton," "down cotton," specifying whether it has undergone sterilization)
Accessories (e.g., plastic eyes, zippers, embroidery thread, material must be individually labeled)
Fashions of different colors/batches must be described separately (e.g., "Red fabric contains azo dye test report")
Supplier material certification
Provide raw material safety test reports, such as:
EN71-3 heavy metal migration test report for the fabric (lead, cadmium, and 19 other elements)
REACH SVHC compliance declaration for adhesives/dyes (ensuring they do not contain substances of very high concern)
III. Sample Requirements
Quantity: Submit 3-5 complete finished products (including all accessories, such as labels and hangtags)
Special Circumstances:
If the doll contains... Detachable parts (such as pacifiers, rattles) require separate accessory samples.
Different color/material versions require separate samples (e.g., "blue" and "pink" versions require separate testing).
Packaging: Must be consistent with export packaging (including CE marking, age label, etc.).
IV. Supplementary Testing Information
Applicable EN71 Test Item Confirmation (Institutions can assist in the determination, but advance preparation is more efficient):
| Test Items | Key Concerns for Pacifiers
| EN71-1 (Physical and Mechanical) | Small Parts Tensile Strength Test (e.g., buttons and eyes must withstand ≥90N of tensile force without detaching)
| EN71-2 (Flammability) | Fabric Burning Speed (Pluff materials must self-extinguish in ≤7 seconds)
| EN71-3 (Chemical Migration) | Heavy Metal Leaching (Lead <90mg/kg, Cadmium <75mg/kg)
Special Process Description: Whether it has undergone... Flame retardant treatment, whether it contains fluorescent whitening agents, etc.
V. Other Compliance Documents
Declaration of Conformity (DoC): Requires signature and seal of the company's responsible person, declaring that the product complies with EN71 and the EU Toy Directive 2009/48/EC.
Brief Description of Production Process: Includes cutting, sewing, stuffing, and assembly processes (to facilitate the assessment of potential risks by the agency).
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