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Amigurumi Safety Compliance for Sellers: EN71 & CPSIA Rules, Testing, and Labels Explained

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January 5, 202619 min read
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Amigurumi Safety Compliance for Sellers: EN71 & CPSIA Rules, Testing, and Labels Explained

Step-by-step guide to materials, small-parts rules, safety eyes, stuffing, age grading, testing options, tracking labels, and documentation to legally sell crochet toys under EN71 (EU) and CPSIA (US).

Amigurumi Safety Compliance for Sellers: EN71 & CPSIA Rules, Testing, and Labels Explained

If you sell crocheted toys, your work is legally a “toy” in most jurisdictions and must meet toy safety laws. Two regimes dominate: the EU’s Toy Safety Directive (with testing under EN 71 standards) and the U.S. Consumer Product Safety Improvement Act (CPSIA) with the ASTM F963 toy standard. This guide translates those rules into concrete decisions about yarns, safety eyes, stuffing, age grading, testing, labels, and paperwork—so you can sell confidently without guesswork.

Short version: amigurumi can be 100% compliant and sale-ready. The path is: design for safety, decide an honest age grade, test what’s applicable, label correctly, and keep the right documents. Avoid “collector’s item, 14+” as a shield—regulators look at foreseeable use, not what you print on the tag.

Note: This guide is practical and opinionated, but it is not legal advice. Always read the actual rules and talk with your lab or a compliance professional when in doubt.

  1. Who must comply and which rules apply?
  • Selling in (or into) the EU/EEA: You must meet the Toy Safety Directive 2009/48/EC and “presumption of conformity” via EN 71 testing: EN 71-1 (mechanical/physical), EN 71-2 (flammability), and EN 71-3 (chemical migration). You affix the CE mark after doing a conformity assessment and creating a technical file and EU Declaration of Conformity.
  • Selling in the U.S.: Children’s toys must comply with CPSIA and the ASTM F963 toy safety standard. Most children’s products require third-party testing by a CPSC-accepted laboratory and a Children’s Product Certificate (CPC). You also need CPSIA tracking labels.
  • Selling online across borders: You must comply with the rules of each destination market. If you ship to both the EU and the U.S., plan for both regimes.
  • UK after Brexit: Requirements mirror the EU in many ways (UKCA, UK designated standards), but there are differences. If you sell into the UK, confirm current UK-specific marking and documentation rules.

Opinion: If you have to pick one baseline to guide your design, design to pass EN 71-1 small parts and attachment strength, and ASTM F963 use-and-abuse tests. If you can’t honestly meet those, the toy is not ready for sale to children.

  1. Design-first safety: safer choices at the pattern and materials stage

A toy that’s “born compliant” is easier and cheaper to test. Start with hazard elimination.

  • Eyes and noses

    • Embroidered or crocheted eyes are best for 0+ toys. This avoids small parts hazards and pull/torque attachment issues.
    • “Safety eyes” with washers are not inherently compliant. Under-3 toys must not have accessible small parts under foreseeable use and abuse. In practice, plastic eyes are almost never acceptable for 0–36 months; use embroidered features instead.
    • For 3+ toys, tested safety eyes may pass, but only if attachment strength and small parts tests are satisfied. Use large-diameter posts and washers, consider a reinforcement washer/backing fabric inside the head, and avoid thin or loose stitch structures.

  • Stuffing

    • Use clean polyester fiberfill from reputable suppliers. EU rules require hygienic filling materials. Avoid natural seeds, grains, or plant material—these raise hygiene and choking concerns.
    • Beads/pellets: For under-3 toys, don’t use pellets. For 3+ toys, if you do, put them in a robust inner liner, and design for seam strength. A pellet leak is a fast fail in small parts testing.

  • Yarn choices and fabric structure

    • Mainstream cotton or acrylic yarns from known brands are usually better than novelty yarns. Textiles are typically low-risk for lead and phthalates, but dye/finish chemistry still matters (especially for EN 71-3 migration of elements). OEKO-TEX certification or supplier chemical assurance is helpful.
    • Avoid long, loose pile and easily shed fibers for under-3 toys. Shedding can become a small parts or ingestion hazard.
    • Use dense stitches and tight gauges in stress areas (muzzles, eye locations, joints). Reinforce if needed with felt backing or an inner fabric panel.

  • Embellishments and fasteners

    • No buttons, sequins, bells, or glued-on parts for under-3. For 3+, assume they will be pulled, chewed, torqued, and drooled on—choose accordingly.
    • Ribbons, cords, and loops: Keep short. Both EU and U.S. rules limit cords and loops to prevent strangulation. Avoid neck ribbons for under-3; embroider a bow instead.

  • Seams, closures, and tails

    • Use multiple passes and locking knots. Bury ending tails deeply and secure them. Consider backstitching critical seams rather than relying on single crochet alone.
    • An inner seam or fabric liner in high-stress areas (head, limbs) increases durability.

  • Flammability

    • Most crochet yarns are not highly flammable like pile fabrics, but flammability testing still applies. Avoid hair and long pile; avoid spray adhesives or coatings that can fuel ignition.

Design principle: The most economical compliance path is to design for a younger age group without small parts and with embroidered features. If you choose plastic eyes, accept the higher testing burden and age-grade to 3+.

  1. Age grading that regulators will accept

Age grading is not marketing; it’s a safety determination. Both regimes expect age grading consistent with the toy’s features, functions, and foreseeable use.

  • Typical age grades for amigurumi

    • 0+ (or 0–36 months): Only if there are no small parts, no accessible sharp points or edges, no long cords, and fabric/seam strength is robust. Eyes, noses, and features should be embroidered/crocheted.
    • 3+ years: If the toy includes plastic eyes or other rigid attachments that could become small parts under abuse tests. You may also choose 3+ to allow accessories (e.g., a removable scarf) that would be unsafe for toddlers.
    • “14+ collector’s item”: Regulators often reject this for plush/amigurumi because they have obvious play value for children. If it looks like a toy and is marketed like a toy, it will be treated as a toy. Don’t rely on a 14+ label to escape toy rules.

  • U.S. specifics

    • Use ASTM F963 age grading guidance (Annex A) and CPSC staff age determination guidelines. If a toy is reasonably foreseeable to be used by children under 12, it is a children’s product.
    • If a 3+ toy contains small parts, it requires the specific choking hazard warning on packaging per 16 CFR 1500.19.

  • EU specifics

    • The EU Toy Safety Directive expects age grading aligned to the toy’s characteristics. “Not suitable for children under 36 months” with the 0–3 symbol is only allowed when justified by a specific hazard (e.g., small parts). If your plush is obviously for babies, you cannot label it away from that.

Practical advice: Write a one-page age grading rationale and keep it in your file. If your toy is 0+, explain how the features avoid small parts and strangulation hazards. If it’s 3+, identify which features require that grade.

  1. Small parts, sharp points/edges, and use-and-abuse testing

Small parts rules are core in both regimes.

  • What is a “small part”?

    • A part that fits entirely within a standardized cylinder (the “small parts cylinder”) is a choking hazard for under-3 children. Any component that can detach and fit in the cylinder fails for toys intended for under-3.
    • In testing, the lab performs use-and-abuse procedures—pulls, torques, drops, impacts, seam strength, and flexing—to see if parts become detached or if stuffing/beads are released.

  • Implications for crochet toys

    • Plastic safety eyes are usually treated as potential small parts under force. That is why they’re generally incompatible with 0–3 toys, even if installed with washers.
    • Beads/pellets are small parts by definition. If a seam breaks and releases them, that’s a fail for under-3 and likely for 3+ unless adequately enclosed.
    • Seams on snouts, ears, limbs, tails, and any attachment points will be yanked and twisted. Design with redundancy: more stitches, reinforcement, and broader attachment areas.

  • What about sharp points/edges?

    • Metal components, wire armatures, or stiff plastic inserts cannot create accessible sharp points/edges under abuse testing. In practice, avoid wire unless fully encapsulated with no chance to protrude.

Opinion: A “maker pull test” is good practice—grip the feature and pull/torque as hard as you reasonably can. If anything loosens, redesign it. But only a lab will tell you definitively if it passes under the standard protocols.

  1. EN 71 for EU sales: what you must do

  • EN 71-1: Mechanical and physical properties

    • Covers small parts, cords/loops, attachments, tip-over, and use-and-abuse tests relevant to soft-filled toys. Labs will perform pulls/torques on rigid parts, seam strength on soft toys, and evaluate ear/limb attachments.

  • EN 71-2: Flammability

    • Evaluates ease of ignition and flame spread. Soft toys must not ignite too easily or support rapid flame spread. Long hair/fur is higher risk.

  • EN 71-3: Migration of certain elements

    • Tests the migration of specific metals (e.g., lead, cadmium) from accessible materials. Textiles are generally low risk, but pigments, coatings, and plastic components (eyes, snaps) need attention. Using reputable, documented materials lowers surprises.

  • Conformity assessment and CE marking

    • Risk assessment: You must systematically identify hazards (mechanical, chemical, flammability, hygiene, etc.) and show how they are controlled.
    • Technical documentation: Keep a technical file including product description and photos, bill of materials, safety/risk assessment, test reports for EN 71-1/-2/-3, labels and instructions, production controls, and traceability.
    • EU Declaration of Conformity (DoC): A one-page legal document stating the toy meets the Toy Safety Directive and the specific EN 71 standards used, signed by you. Keep it for 10 years after the last unit is sold and provide it to authorities on request.
    • CE marking and traceability: Affix CE to the toy or a label, along with your name/trade name, postal address, and a batch/serial number. If you use packaging-only labeling, ensure the toy still has traceability.

  • Warnings and instructions

    • If you age grade 3+, and small parts are a hazard, include the “Not suitable for children under 36 months” warning and 0–3 symbol, along with the specific hazard (“contains small parts”). Only use this warning if justified.
    • Care instructions are not mandated by EN 71, but are practical. Ensure washing does not compromise safety (colors, attachments, fillers). If hand-wash only, say so.

  • Notified bodies and when to use them

    • Most crocheted toys can follow the internal production control route (self-certification) using EN 71. A Notified Body is not typically required unless you deviate from standards or use non-harmonized methods. However, third-party lab testing is strongly recommended to substantiate your file.

Opinion: Even micro-brands should commission at least EN 71-1 and -2 once on a representative product. EN 71-3 risk depends on your components; if you use plastic eyes or coated materials, test them. For fully textile/embroidery-only toys with known yarns, a lab may advise a reduced EN 71-3 scope.

  1. CPSIA and ASTM F963 for U.S. sales: the moving parts

  • ASTM F963 toy standard (incorporated by reference in CPSIA)

    • Mechanical/physical tests similar in spirit to EN 71-1: small parts, use-and-abuse (pull, torque, tension, compression, drop), seam strength for soft toys, projections, cords/loops, and more. A CPSC-accepted lab must perform these tests for children’s toys.

  • Lead content and lead in paint/surface coatings

    • Textile substrates are largely exempt from lead content limits. However, surface coatings (e.g., painted eyes, coatings on accessories) and non-textile components (plastic eyes, snaps, metal parts) must meet lead limits, often requiring testing.

  • Phthalates

    • Applies to accessible plasticized components of children’s toys and child care articles. Many polypropylene safety eyes are not plasticized and may not contain restricted phthalates, but labs often screen them. If you use PVC components or soft vinyl parts, expect phthalates testing.

  • Flammability

    • Toys have flammability requirements in ASTM F963. Apparel flammability (16 CFR 1610) is a separate rule and typically not applicable to toys, but labs will check the appropriate toy flammability sections.

  • Mandatory third-party testing and CPC

    • Most children’s products (including toys) require third-party testing at a CPSC-accepted lab. After testing, you issue a Children’s Product Certificate (CPC) listing each applicable rule (e.g., ASTM F963, lead, phthalates), manufacturer/importer info, lab info, place/date of manufacture, and date of testing.
    • Small batch manufacturer relief is limited. Registration does not exempt you from ASTM F963 third-party testing. At best, you can leverage component part testing and supplier certifications to reduce redundant tests.

  • CPSIA tracking labels (Section 103)

    • Toys and packaging must bear permanent, distinguishing tracking information: manufacturer name, location and date (month/year) of production, batch/lot number, and any other info to trace the product. Sew-in fabric labels are ideal for amigurumi. Packaging should repeat the info.

  • Choking hazard warnings (16 CFR 1500.19)

    • If a toy intended for children 3–6 contains small parts (e.g., a removable accessory), the packaging needs the specific cautionary statement: “CHOKING HAZARD—Small parts. Not for children under 3 years.” This is in addition to ensuring the toy meets small parts rules for its intended age. If your toy is 3+ and contains small parts accessory, use the statement on the retail packaging.

Documentation retention: Keep your test reports and CPC for at least 5 years and be prepared to furnish them to marketplaces and regulators.

  1. Testing strategies and cost control for micro-brands

  • Test a “worst-case” representative sample

    • Group similar toys into families (same construction, materials, and attachment methods). Pick the most challenging case (largest eyes, smallest seam allowances, most accessories) as the test article. Labs can often justify extending results to similar SKUs, but changes in materials or design can invalidate coverage.

  • Component testing and supplier documentation

    • Request chemical compliance statements from component suppliers: e.g., EN 71-3 reports for eyes and snaps, phthalates/lead declarations, OEKO-TEX or REACH SVHC statements for yarns and stuffing.
    • In the U.S., 16 CFR 1109 allows component part testing to support your CPC, but you’re still responsible for ensuring the final product meets mechanical and other requirements. In the EU, supplier declarations help your risk assessment and can reduce EN 71-3 scope.

  • Budgeting

    • Expect a few hundred to over a thousand USD/EUR for a full suite per representative SKU, depending on lab, scope, and iterations. Combining EN 71-1/-2/-3 or ASTM F963 + chemical screens can bundle costs.

  • Pre-testing at home

    • Buy a small parts cylinder. Pull and torque on attachments aggressively. Perform drop tests on hard surfaces. Soak and launder once if you plan to claim washable. These won’t replace lab tests but will reduce re-test cycles.

  • When to re-test

    • Material changes (new yarn brand, different eyes, new stuffing), structural changes (different stitch density, new seam methods), or added accessories may require a new assessment and possibly re-testing.

Opinion: For under-3 toys, avoid safety eyes and avoid pellets—this can eliminate the most expensive failures. For 3+ toys, spec high-quality eyes with supplier test data and reinforce the attachment area.

  1. Labels and markings that pass scrutiny

  • EU (EN 71/TSD)

    • On toy (or a label) and, if needed, on packaging:
      • CE marking
      • Manufacturer’s name and postal address (and importer’s, if applicable)
      • Batch/lot or serial number
      • Age grade and warnings when justified (e.g., 0–3 symbol + “Not suitable for children under 36 months. Contains small parts.”)
    • Keep labels legible and durable. A small sew-in woven label is ideal for name/address, batch, CE; warnings can be on a hangtag if space is limited, but traceability should stay with the toy.

  • U.S. (CPSIA/ASTM F963)

    • On toy and packaging:
      • CPSIA tracking label with manufacturer name, production date/location, and batch/lot code
      • Age grade and required cautionary statements (if applicable under 16 CFR 1500.19)
    • Keep a CPC (not on the toy, but in your records and available to retailers/platforms). Some marketplaces will require uploading your CPC and test reports.

  • Practical label construction for amigurumi

    • Use a small, soft woven label sewn into a seam for permanent identifiers and tracking.
    • Hangtags can carry marketing info, care instructions, warnings, and QR codes linking to your EU Declaration of Conformity (EU) or product info.
    • Avoid hard or sharp label hardware (e.g., metal pins) on under-3 toys.
  1. Packaging, instructions, and e-commerce realities

  • Polybags and suffocation warnings

    • Plastic bag suffocation warnings are governed by state/local laws in the U.S. and retailer policies. If you use thin bags, add a standard suffocation warning and keep bag thickness and hole sizes in line with requirements where you sell. Better: ship in paper or cardboard.

  • Care instructions

    • If hand-wash only, say so. If machine washable, make sure colorfastness and attachment strength survive laundering. Avoid instructions that could create a hazard (e.g., tumble-dry high). Testing after wash cycles is wise if you’ll make washability claims.

  • Marketplaces

    • Etsy, Amazon, and others increasingly request compliance documents. Have your EN 71 reports, EU DoC, CPC, lab reports, and tracking label info ready. Keep PDFs organized by SKU and batch.
  1. Documentation checklists

  • EU technical file (keep 10 years)

    • Product description and photos
    • Bill of materials and supplier info (yarn brand and fiber content, stuffing type, eye supplier, etc.)
    • Safety/risk assessment covering mechanical, chemical, flammability, hygiene
    • EN 71-1/-2/-3 test reports (and any other relevant reports)
    • Labels, warnings, CE marking artwork
    • EU Declaration of Conformity (signed)
    • Traceability scheme (batch coding and records)
    • Production controls (how you ensure each unit matches the tested design)

  • U.S. compliance file

    • ASTM F963 test report(s) from a CPSC-accepted lab
    • Lead and phthalates test reports as applicable (or component test substantiation)
    • Children’s Product Certificate (CPC) listing each rule, your business info, place/date of manufacture, testing lab info, and test dates
    • CPSIA tracking label scheme and records tying batch codes to materials/dates
    • Age grading rationale and any cautionary statements
  1. Frequently asked questions and common pitfalls

  • Can I sell without testing if I only use yarn and stuffing? EU: You still need a risk assessment and, in practice, EN 71-1 and -2 testing evidence. EN 71-3 risk may be lower with all-textile toys, but labs often recommend at least a screening. U.S.: Toys require third-party testing to ASTM F963 regardless of materials.

  • Are “safety eyes” always allowed at 3+? Only if they pass use-and-abuse tests on your actual toy construction. Eye quality and the fabric’s stitch density matter. Do not assume brand marketing equals compliance.

  • If I put “not a toy” on the label, am I exempt? No. If the product has play value and is reasonably foreseen to be used by children, it is a toy/children’s product in the eyes of regulators.

  • Do I need to test every colorway? If materials are identical except dye color and you have supplier proof that chemistry is consistent, many labs will let you test one representative color. If you switch yarn brands/fiber content or eye suppliers, reassess.

  • Do I need stuffing sterilization permits in the U.S.? Some U.S. states regulate stuffed articles (bedding/upholstered items). These are separate from CPSIA and mainly apply to bedding/furniture, but rules vary. If you sell widely in the U.S., research state “stuffed article” labeling/registration. Many small toy sellers avoid claims or channels triggering those laws, or use pre-sterilized, labeled stuffing.

  • What if my toy includes electronics (e.g., a rattle box)? Then additional rules can apply. EU: EMC/RED may apply for electronics; small battery compartments add strict mechanical and chemical requirements. U.S.: battery safety sections in ASTM F963, and small parts considerations escalate. Consider avoiding electronics in early product lines.

  1. A realistic step-by-step compliance plan

  • Step 1: Decide the target age and design for it

    • 0+: embroidered features only, no pellets, no cords, dense stitches, robust seams.
    • 3+: if using safety eyes or accessories, reinforce attachment points and limit accessory size/length.

  • Step 2: Lock down materials and suppliers

    • Choose yarn and stuffing brands you’ll consistently use. Get supplier chemical assurances when available. If using plastic eyes, choose a supplier with EN 71-3 and relevant declarations.

  • Step 3: Build a pre-test prototype and abuse it

    • Pull on limbs/ears, torque eyes/noses, drop it multiple times on hard floors, and check seams. Adjust pattern and construction for strength.

  • Step 4: Book lab testing

    • EU: Request EN 71-1 and -2 as a baseline. Discuss EN 71-3 scope based on your BOM.
    • U.S.: Book ASTM F963. If applicable, add lead (substrate/coating) and phthalates screens for non-textile parts.
    • Ask about family grouping to cover variations cost-effectively.

  • Step 5: Create labels and paperwork

    • EU: Prepare CE artwork, traceability label content, and the EU DoC. Assemble the technical file.
    • U.S.: Prepare the CPC and CPSIA tracking labels. Draft cautionary statements if required.

  • Step 6: Set up batch control

    • Assign batch/lot numbers tied to production date and materials used. Record any material changes.

  • Step 7: Go to market—with discipline

    • If you change a component (new eyes, different yarn), pause and reassess. Keep copies of all test reports, CPC/DoC, and label proofs ready for marketplaces.

Opinion: The biggest wins come from: (1) ditching plastic eyes for under-3, (2) reinforcing everything, (3) testing a worst-case SKU once well rather than many SKUs poorly, and (4) documenting everything like a manufacturer—even if you’re a one-person studio.

References and official guidance

Closing thought: Compliance isn’t about bureaucracy; it’s a design discipline. The moment you choose embroidered eyes over plastic for a baby toy, or reinforce a seam for a preschooler’s strength, you’re doing the real work. The paperwork just records the good decisions you already made.