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GPSR risk assessment example: Crochet amigurumi bunny for babies

This is a real preview that GPSR Kit generated for a sample product. It shows what the free preview finds. The full pack adds the measures, residual risk, every warning, listing text, translations and the signed-off technical file. Your own pack is written for your product, materials and markets.

Sample product
Crochet bunny amigurumi

A hand-crocheted soft-filled toy bunny, approximately 20 cm tall and 80 g, made from cotton yarn and stuffed with polyester fibre. The eyes are plastic safety eyes held by locking washers on the inside of the crocheted body. Ears, limbs and head are crocheted separately and sewn on, or crocheted as one piece with the body. It is sold as a cuddly toy for babies and young children.

Materials

Cotton yarn (dyed), Polyester fibre stuffing, Plastic safety eyes (shank) with plastic locking washers, Cotton or polyester sewing/yarn thread, Polyester or cotton satin label

Intended users

Children from birth to 3 years (babies and toddlers), handled under adult supervision. Older children and adults may also handle it.

⚠ Red flags found for this product

  • THIS PRODUCT IS A TOY under the Toy Safety Directive 2009/48/EC. Before it is sold to DE, FR or IE it must have a conformity assessment against the essential safety requirements: EN 71-1, EN 71-2 and EN 71-3 testing, a toy safety assessment, a technical file and an EU Declaration of Conformity. It must carry CE marking, a type/batch number and manufacturer details. GPSR documentation alone is NOT sufficient, and selling it without CE marking is not lawful.
  • It is intended for children under 36 months, so the stricter EN 71-1 requirements for under-3s apply. These cover small parts, torque and tension tests on eyes and ears, seam strength, filling accessibility and cleanliness, and the soaking test for under-18-month toys. Plastic safety eyes fitted by hand are a frequent cause of EU Safety Gate (RAPEX) recalls of handmade amigurumi for choking hazard. Strongly consider replacing them with tightly embroidered eyes for the under-3 version.
  • Do NOT use the 'Not suitable for children under 3 years' warning on this toy. It is intended for babies, and the Toy Safety Directive prohibits that warning on toys clearly intended for under-3s. Using it to avoid the under-3 requirements would be misleading and unlawful.
  • The manufacturer is in the United Kingdom, which is outside the EU. The toy carries CE marking, so Regulation (EU) 2019/1020 Art. 4 requires an economic operator established in the EU, such as an authorised representative or importer, before sale to DE, FR or IE. Their name and address must appear on the toy, packaging, parcel or accompanying document. Under GPSR Art. 16 and 19, these details must also appear in the Etsy listing. UKCA marking is not valid in the EU.
  • Warnings and instructions must be in the language of each destination country: German for DE, French for FR, English for IE. Germany and France will not accept English-only safety information.
  • Handmade, small-batch production does not exempt the toy from testing. Testing can be targeted: test a representative sample of each design, keep supplier certificates for each material lot, and use a consistent, documented construction method.
  • The new EU Toy Safety Regulation (EU) 2025/2509 will replace the Directive after its transition period. It adds a mandatory Digital Product Passport and stricter chemical rules. Plan for it, but the current Directive applies now.

Risk analysis

HazardWhoRiskMeasures adoptedResidual
Choking/airway obstruction from detached safety eye or washerBabies and toddlers under 3, especially teething infantsserious🔒 In the full pack?
Choking/suffocation from accessible polyester stuffing after seam or fabric failureBabies and toddlers under 3serious🔒 In the full pack?
Small parts from detachable ears, tail or decorationsBabies and toddlers under 3high🔒 In the full pack?
Strangulation/entanglement from loose cords, long yarn tails or loopsBabies, especially when unattended in a cotmedium🔒 In the full pack?
Suffocation from soft toy in sleeping areaInfants under 12 monthshigh🔒 In the full pack?
Suffocation from packagingBabies and young childrenhigh🔒 In the full pack?
Burns from flammability of textile and polyester fillingChildren holding the toy; householdmedium🔒 In the full pack?
Chemical exposure from dyes, heavy metals or formaldehyde in yarn and plastic eyesBabies and toddlers who mouth toysmedium🔒 In the full pack?
Hygiene and microbial contaminationBabies, children with allergiesmedium🔒 In the full pack?
Degradation of eye retention after washing or heatBabies and toddlershigh🔒 In the full pack?

EU legislation checked

yes
Toy Safety Directive 2009/48/EC (national implementations in DE, FR, IE)
The product is designed and intended for play by children under 14. It is a soft-filled toy for under-3s.
yes
Regulation (EU) 2023/988 – General Product Safety Regulation (GPSR)
It applies to toys for aspects not covered by the Toy Safety Directive. These include the online/distance-selling information duties (Art. 19), the EU responsible person (Art. 16), accident notification via the Safety Business Gateway (Art. 20) and recalls (Art. 36–37).
yes
Regulation (EU) 2019/1020 – Market Surveillance (Art. 4)
CE-marked toys may only be placed on the EU market if an economic operator established in the EU is responsible for compliance tasks. The manufacturer is in the UK.
yes
REACH Regulation (EC) 1907/2006 – Annex XVII restrictions and Art. 33 SVHC
Several rules apply to the textiles, dyes and plastics. These are the azo dye restriction (entry 43), phthalates in toys (entry 51/52), PAHs in plastic/rubber parts accessible to children (entry 50), and formaldehyde. The Candidate List SVHC information duty also applies.
yes
Toy Safety Directive Annex II Appendix C – formaldehyde and specific limits for toys for under-36-month children
There are specific limit values for chemicals in toys for under-3s and in toys meant to be placed in the mouth, including formaldehyde in textile materials.
check
Toy Safety Regulation (EU) 2025/2509 (successor to Directive 2009/48/EC)
Adopted to replace the Directive after a transition period. It introduces a Digital Product Passport and stricter chemical bans, including on PFAS and endocrine disruptors.
check
Packaging and Packaging Waste Regulation (EU) 2025/40 and national packaging EPR (DE VerpackG/LUCID, FR Triman/EPR)
Shipping packaging placed on the German and French markets may trigger producer registration and labelling obligations, even for distance sellers.
check
Textile Labelling Regulation (EU) 1007/2011
Toys are listed in Annex V as excluded from mandatory fibre-composition labelling.
likely
Product Liability Directive (EU) 2024/2853
The manufacturer, and the EU importer/authorised representative, can be held liable for damage caused by a defective toy.

Standards referenced: EN 71-1:2014+A1:2018 · EN 71-2:2020 · EN 71-3:2019+A1:2021 (check for latest amendment) · CEN/TR 15071 · CEN/TR 15371 · EU Guidance Document No. 11 on the Toy Safety Directive – age classification (and CEN/TR 15071 annexes) · OEKO-TEX Standard 100 (Product Class I)

Safety warnings

  • Check the toy before each use, especially the eyes, ears and seams. Stop using it if any part is loose or damaged.
  • Do not leave in the cot or crib with a sleeping baby.
🔒4 more safety warnings in the full pack

What the full pack adds

🔒39 concrete safety measures, with residual risk per hazard
🔒Action for each law: what the seller must do
🔒8 instructions for safe use, plus care & disposal
🔒8 testing recommendations
🔒Ready-to-paste listing text for Etsy, Amazon, eBay, Shopify
🔒Warnings translated for every EU country you ship to
🔒Technical file PDF to sign and keep for 10 years
🔒Printable label sheet and multilingual parcel insert
🔒15-point compliance checklist
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Read more: the GPSR guide for this product type.

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Example for a sample product, generated by AI from the description shown. It is not a compliance document for any real product and not legal advice.