Detailed Explanation of the EU EN71 Certification Process for Plush Toys
Date：2025-12-18 09:42:44 Classification
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Plush/fabric toys exported to the EU must undergo EN71 series testing and bear the CE mark. Below, we'll explain the key steps, testing details, and common pitfalls in chronological order:
I. Regulations and Applicable Standards
1.1 Core Regulations: 2009/48/EC Toy Safety Directive – This applies to all plush products intended for children aged 14 and under.
1.2 Harmonized Standards:
- EN71-1 Physical and Mechanical Properties (cleanliness of small parts, filler, cord entanglement, etc.)
- EN71-2 Flame Retardancy (plush fabrics must undergo "horizontal burning" test, velocity ≤30 mm/s, with no dripping)
- EN71-3 Chemical Migration (19 heavy metals, lead ≤10 mg/kg, cadmium ≤1 mg/kg; total of 6 phthalates ≤0.1%)
- If containing electronic sound/lighting components, EN IEC 62115 (Electrical Safety) and EMC testing are also required.
1.3 REACH Supplement: Any SVHC ≥0.1% of the 251 SVHCs must be declared on the label; otherwise, the goods will be detained upon arrival at port.
II. Preparing a Technical Documentation Package (TDF)
The document must be readily available to address EU 10-year traceability audits. Key points specific to plush/fabric toys:
Material List: Detailed down to "100% polyester fabric, new PP cotton filling, TPR soft glue for eyes," accompanied by supplier certification; recycled cotton is prohibited; total bacterial count ≤200 CFU/g.
Design Drawings: Indicate the fixing method of decorative parts (e.g., buttons "stitched + hot melt adhesive reinforcement") to facilitate the laboratory's determination of tensile testing points.
Risk Assessment: Write response measures for the three major hazards: "small parts falling off, filling leakage, and cords entanglement."
EU Authorized Representative Information (required for non-EU companies): Address, email, and contact information are all essential.
III. Selecting a Laboratory/Notified Body
3.1 Low-risk plush toys can use the "Self-Declaration (DoC)" model, but still require supporting documentation from a qualified third-party report.
3.2 Check the EU NANDO database to confirm that the organization's notified body number includes the scope of "2009/48/EC"; inquire whether they have conducted tests on plush flame retardancy and filling cleanliness in the last 3 months to avoid selecting an organization that only tests plastics.
3.3 Discuss after-sales service: Ask if they can assist with RAPEX inquiries and provide technical document storage services, which will help ensure you are prepared if selected for testing later.
IV. Sample Submission and On-site Testing
4.1 Sample Quantity: Usually 2-3 complete toy sets. If multiple colors/fabrics are used, each type should be covered.
4.2 High-Risk Items Specific to Plush Toys:
- EN71-1: Laboratory-produced "slapping test video"—10 N force 10 times, no foreign matter exposed; "neck wrapping" is mandatory for ropes >22 cm.
- EN71-2: Horizontal and vertical burning tests, with a focus on "molten droplets" (a veto factor); request a burning rate curve.
- EN71-3: Produce separate samples of the fabric, filling, soft rubber nose, and printing ink to avoid batch returns due to "missed material testing."
4.3 Rectification: If small parts detach under tensile strength of 50 N/10 s, flame retardancy exceeds limits, or lead migration >10 mg/kg, the structure must be modified or materials changed before retesting. The laboratory will issue a report of non-conformities; the company only needs to rectify the issues accordingly.
V. Technical Documentation Preparation + DoC Signing
After the report is approved, compile the "Test Report (with Notification Number Stamp) + Bill of Materials + Drawings + Risk Assessment + European Representative Information" into a TDF (Test Document Form). The manufacturer or European representative must sign the Declaration of Conformity, declaring compliance with 2009/48/EC and the EN71 series.
VI. Affixing the CE Mark and Market Launch
6.1 The mark size should be ≥5 mm. It is recommended to place it on the care label or woven label to ensure "permanent clarity."
6.2 Even the smallest sales unit must include CE markings, manufacturer's name and address, EU representative information, and production batch number.
6.3 Documents must be archived for 10 years. EU market surveillance agencies can conduct random checks at any time; missing any item may result in a recall and a fine of up to 10 times the product's value.
VII. Time and Cost Reference
Cycle: 5–7 working days for routine EN71-1 to 3 items only;
Cost: Generally 1000–2000 RMB per toy, depending on size, material, and whether it contains electronic components; adding approximately 1000 RMB for REACH 251 screening.
Common Pitfalls Overview
1. Using recycled cotton → excessive bacterial colonies, failing EN71-1 cleanliness test.
2. Cheap flame retardants → although the flame retardant passes the test, exceeding REACH phthalate limits or the flame retardant itself will still result in a recall.
3. SVHC not listed on the label → Content ≥0.1% not disclosed, customs inspection results in direct seizure of goods.
4. Institution without a notification number or offering "10-day pass guarantee" → Certificate invalid, goods still returned upon arrival at port.
Following the above 6 steps and keeping a complete record will ensure plush/fabric toys successfully obtain EN71 reports and CE compliance, allowing them to safely enter the EU 27-nation market.
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