Takara Research

CPSIA for Plush Toys: The US Importer’s Guide to Testing, CPC and eFiling (2026)

Everything a plush toy needs before it can enter and sell in the United States: the tests, the certificate, the new eFiling rule, the labels, and the mistakes that hold shipments at the port.

Amy Nguyen · · 19 min read
Jul 8, 2026
CPSC eFiling of certificates became mandatory
7
Required elements on a Children’s Product Certificate
Cover: CPSIA for plush toys, the US importer’s guide, with Mira pointing at the checklist
Insights fromAmy NguyenCEO & Co-founder, Takara

Summary in 60 seconds

  • Who it covers: a plush toy designed or intended primarily for children 12 and under is a children’s product. That covers most plush, including promotional and giveaway plush distributed in the US.
  • The core tests: ASTM F963-23 (mandatory since April 20, 2024), lead in substrates (100 ppm) and in paint or coatings (90 ppm), and eight phthalates (0.1%) in plasticized parts, all at a CPSC-accepted third-party lab.
  • The certificate: the US importer issues a Children’s Product Certificate with 7 required elements, based on those lab reports, in English.
  • New in 2026: since July 8, 2026, importers must eFile certificate data with CBP at entry, through ACE or by reference to the CPSC Product Registry.
  • Labels: permanent tracking labels on the product and packaging, choking-hazard warnings where small parts apply, and a stuffed-article law label with a registration number for Pennsylvania, Ohio and Massachusetts.
  • Retesting: production runs over a year need periodic testing (at least yearly under a periodic testing plan). A material change, a new eye supplier or a new factory means new third-party testing.
  • Where it goes wrong: vinyl faces and plastic eyes that were never tested for phthalates, EN 71 reports presented as US reports, and certificates that list the wrong factory.
100 ppmLead limit in accessible substrate (CPSIA)
90 ppmLead limit in paint and surface coatings
0.1%Limit for each of 8 phthalates in plasticized parts
5 yearsHow long certificates and test records must be kept

1. Does CPSIA apply to your plush?

The Consumer Product Safety Improvement Act of 2008 (CPSIA) defines a children’s product as one designed or intended primarily for children 12 years of age or younger. Plush toys almost always fall inside that definition. The Consumer Product Safety Commission (CPSC) decides intended age from the product itself: the manufacturer’s stated age, how it is packaged and marketed, where it is sold, and whether children would recognize it as meant for them. A soft, cuddly character is read as a toy, whatever the hangtag says.

Three situations cause most of the confusion for brands buying plush overseas:

Promotional plush

Giveaways count. A branded mascot plush handed out at a US event or shipped to customers is distributed in commerce. The same testing and certificate rules apply as for plush sold in a store.

“Adult collectible”

A label does not change the product. Calling a plush “for collectors 15+” only holds if the design, marketing and sales channel genuinely target adults. Keychain plush and vinyl-face plush sold through toy channels are usually treated as children’s products.

Licensed character

The licensor adds rules, not exemptions. Licensed plush meets the same federal rules, and most licensors add their own test protocols and factory audits on top.

Made outside the US

The importer carries the duty. For a plush made in Vietnam or China, the US importer is the party that certifies compliance. The factory and its sourcing partner supply the evidence.

2. The requirements at a glance

The table lists the federal and state requirements a typical custom plush meets before it can enter and sell in the US. Not every row applies to every design: a plush with embroidered eyes and no plastic parts has a much shorter test list than one with a vinyl face, safety eyes and a zipper pouch.

RequirementRuleWhen it applies to plushWho does it
Toy safety standardASTM F963-23, mandatory under 16 CFR part 1250 since April 20, 2024All toys; the lab selects the sections that apply to the designCPSC-accepted lab tests, importer certifies
Lead in substrateCPSIA section 101: 100 ppm total leadAccessible parts: plastic eyes and noses, zippers, snaps, pellets, metal trimsLab tests; some materials are exempt by CPSC determination
Lead in paint and coatings16 CFR part 1303: 90 ppmPainted or printed parts, coated trimsLab tests
Phthalates16 CFR part 1307: 8 phthalates at 0.1% eachAccessible plasticized parts: PVC or vinyl faces, soft plastic eyes, printed transfersLab tests
Small parts16 CFR part 1501Toys for children under 3, after use-and-abuse testingLab tests
Sharp points and edges16 CFR 1500.48 and 1500.49Toys for children under 8Lab tests
Children’s Product Certificate16 CFR part 1110Every children’s productImporter issues
eFiling of certificate dataCertificates of Compliance rule, in force July 8, 2026Every import entry of the productImporter or customs broker files in ACE
Tracking labelsCPSIA section 103Product and packaging, to the extent practicableFactory applies, importer specifies
Choking-hazard warning16 CFR 1500.19Toys for ages 3 to 6 that contain small partsPackaging and listing
Stuffed-article law labelPennsylvania, Ohio, MassachusettsStuffed toys sold in those statesManufacturer registers and labels
Proposition 65CaliforniaWhen the product contains listed chemicals above safe-harbor levelsWarning or reformulation

Two things follow from the table. First, the materials list decides the cost of testing: every plastic, vinyl, painted or printed component adds lab work. Second, most of the paperwork sits with the importer, while most of the evidence comes from the factory and the lab. A sourcing partner’s job is to make sure that evidence exists, matches the production and arrives before the goods do.

3. ASTM F963-23: what the lab tests on plush

ASTM F963 is the US consumer safety specification for toys. Congress made it mandatory in 2008; the CPSC adopted the 2023 revision, ASTM F963-23, as the mandatory standard from April 20, 2024 (16 CFR part 1250). Not every section is part of the mandatory third-party testing scope, and the lab decides which sections apply to a given toy. For a typical plush, the work concentrates on four areas:

Section 4.27

Stuffed and beanbag-type toys. Requirements specific to plush and pellet-filled toys, including how seams and closures hold their filling.

Use and abuse

Eyes, noses and seams are pulled and twisted. Torque and tension tests, drop and seam tests, scaled to the age group. Whatever comes loose is then checked against the small-parts cylinder.

Heavy elements

Eight soluble heavy elements. Antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium in accessible surface coatings and substrates.

Materials

Stuffing must be clean. Filling materials have to be new or properly processed and free of hard or sharp contaminants; this is also what the state law labels declare.

Age grading drives everything else. Most plush is graded for all ages, including children under 3, which means no small parts may come loose after the use-and-abuse tests. Design choices make a measurable difference here: embroidered eyes and noses remove the torque and tension risk entirely, while plastic safety eyes need locking washers that survive the pull test, and a lab report showing they did.

4. Lead and phthalates: where plush fails

Polyester plush fabric and fiberfill rarely cause chemical failures. The risk sits in the small hard and soft components that make a design distinctive. CPSC has determined that certain materials do not exceed the lead limits, including textiles without after-treatments such as screen prints, transfers or vinyl, so a lab can often exclude plain fabric from lead testing. Everything else needs evidence.

ComponentWhat can failHow to manage it
Vinyl or PVC face (vinyl-face plush)Phthalates, lead in coatingsUse a phthalate-free compound and test the component before production. See why vinyl-face plush took off.
Plastic safety eyes and nosesLead, phthalates (soft plastics), detachmentBuy from one approved component supplier, keep its test reports, never swap suppliers mid-run.
Screen prints, heat transfers, patchesLead in coatings, phthalates in plastisolSpecify phthalate-free inks; printed areas are tested separately from the base fabric.
Zippers, snaps, metal trimsLead in substrate, sharp edgesCoated metal parts need both substrate and coating results.
Plastic pellets (beanbag fill)Lead, phthalates, small parts if releasedPellets go in an inner bag; seam strength matters as much as chemistry.

Component testing is allowed under CPSC’s rule on component part testing (16 CFR part 1109): a certifier may rely on test results for a component, such as an eye supplier’s report, if the component is traceable to what went into the finished product. In practice that means keeping supplier reports, lot numbers and purchase records together with the production file.

5. The Children’s Product Certificate

Under section 14 of the Consumer Product Safety Act and 16 CFR part 1110, domestic manufacturers and importers of children’s products must certify, in a written Children’s Product Certificate (CPC), that the product complies with every applicable children’s product safety rule, based on test results from a third-party CPSC-accepted laboratory. For plush made in Vietnam or China, the US importer issues it. The CPC and supporting test reports must be in English. There is no required template, but there are seven required elements:

  1. Product identification. Enough detail to match the certificate to each product it covers and no others: style number, description, colorways.
  2. Citation of each rule. Every CPSC children’s product safety rule the product is certified to, for example 16 CFR part 1250 (ASTM F963-23), lead and phthalates.
  3. The certifying party. Name, full mailing address and phone number of the importer certifying compliance.
  4. Records contact. Name, address, email and phone of the person who keeps the test records.
  5. Date and place of manufacture. At least month and year, and city or region and country; a street address if the manufacturer has more than one site in that city.
  6. Date and place of testing. When and where the product was tested.
  7. The lab. Name, address and phone number of each CPSC-accepted third-party lab that tested the product.

Element five is where sourcing changes bite. A CPC names the place of manufacture, so moving a style to a different factory, or to a different country, is not a paperwork edit. It requires testing of the product made at the new site. The guide on moving plush production from China to Vietnam covers that transition step by step.

6. eFiling: certificates at the border since July 8, 2026

Until 2026, a CPC only had to accompany the shipment and be available on request. Under the Certificates of Compliance final rule published on January 8, 2025, importers of most regulated consumer products must electronically file certificate data with US Customs and Border Protection (CBP) from July 8, 2026, through a Partner Government Agency (PGA) Message Set.

  1. Who filesThe importer of record, or its customs broker.

    CPSC treats the importer of record as responsible. A broker that lacks product knowledge can identify the owner, purchaser or consignee as the party responsible for certification.

  2. HowFull data in ACE, or a reference to the Product Registry.

    The certificate data can travel with each entry in CBP’s Automated Commercial Environment, or be stored once in CPSC’s Product Registry and referenced at entry. The Product Registry is set up by the importer, using its importer of record number.

  3. WhenAt entry, not after.

    The data has to be ready when the entry is filed. A shipment that arrives before its certificate data exists is the shipment that waits at the port.

  4. RecordsFive years.

    Certificates and the test records behind them must be kept for five years.

7. Tracking labels, warnings and state law labels

Tracking labels. CPSIA section 103 requires permanent, distinguishing marks on children’s products and their packaging, to the extent practicable, that let the manufacturer or private labeler, the location and date of production, and cohort information such as the batch or run number be identified. On plush, this information usually sits on a sewn-in fabric label, repeated on the polybag or retail packaging and the carton. A hangtag alone is not permanent.

Choking-hazard warnings. Toys intended for children aged 3 to 6 that contain small parts must carry the cautionary statement set out in 16 CFR 1500.19 on the packaging, and in online listings and catalogs where the product is sold remotely. Plush graded for all ages should have no small parts at all, so no warning applies.

Stuffed-article law labels. Pennsylvania, Ohio and Massachusetts regulate stuffed toys. Each requires the manufacturer to register, and the toy to carry a law label declaring the filling material, for example “All New Material” with the fiber content, and a registration number. Points that trip up imported plush:

  • Pennsylvania registrations are tied to a specific manufacturing facility and cannot be shared or transferred between facilities. A new factory needs its own registration.
  • Pennsylvania does not accept registrations issued by other states, while Ohio and Massachusetts have accepted a Pennsylvania registration number on a uniform label (Toy Association summary). Check each state’s current rules before printing labels.
  • The registration must be current when the goods are sold, and is renewed annually in Pennsylvania.

Large US retailers typically require the law label on every stuffed item they buy, whichever states they sell in, so in practice most imported plush carries one.

8. Testing in practice: when, how often, what triggers a retest

The test plan follows the product’s life: before the first shipment, during long runs, and every time something material changes.

  1. At inquiryDeclare every market and every retailer.

    The destination decides the test scope. A plush for the US and the EU needs a program that covers ASTM F963 and EN 71 together; adding a market after production has started can mean re-sampling and more testing.

  2. SamplingFix the bill of materials.

    Fabric, fill, eyes, prints and trims are chosen with testing in mind. Component reports from suppliers are collected at this stage.

  3. Pre-productionTest the approved sample and risky components.

    Testing vinyl faces, eyes and prints early catches a failure while it is still cheap to change.

  4. ProductionCertify on production units.

    The certificate rests on third-party testing of samples representative of what ships. Representative-sample records are kept for five years.

  5. Long runsPeriodic testing.

    If a product stays in production for more than a year, the manufacturer must run periodic third-party testing: at least once a year under a periodic testing plan, or every three years where an ISO/IEC 17025-accredited lab runs production testing (16 CFR 1107.21). Runs shorter than a year have no periodic obligation.

  6. Any changeMaterial change means retest.

    A new eye supplier, a different vinyl compound, a new print ink or a new factory are material changes that require new third-party testing of the affected parts.

CPSC accepts labs for specific test scopes, and accepted labs operate in Vietnam as well as China. STC Vietnam, for example, states that its Ho Chi Minh City lab is CPSC-accepted for CPSIA and ASTM F963 testing. Always confirm a lab’s current acceptance and scope in CPSC’s lab search before relying on its reports.

9. State chemical laws and retailer requirements

Federal law sets the floor. Several states and most large retailers add requirements on top:

California

Proposition 65. Products sold in California need a clear warning if they expose consumers to listed chemicals above safe-harbor levels. Most brands avoid the warning by specifying compliant materials.

Chemical reporting

Washington, Oregon, Vermont. These states require manufacturers of children’s products to report certain chemicals of concern, and restrict some of them.

PFAS

A growing list of state restrictions. A growing number of states restrict intentionally added PFAS in textiles and children’s products. Ask for PFAS-free fabric and finishes in the specification.

Retailers

Their own rulebooks. Marketplaces such as Amazon ask for the CPC and test reports before a toy can be listed. Big-box retailers often add their own test protocols and social-compliance audits such as amfori BSCI, Sedex SMETA or, for Disney licensed goods, FAMA.

Higher-tier audit programs such as FAMA, BSCI and SMETA are held by a limited number of qualified facilities with higher overheads, and are generally practical for orders of relatively large quantity. For smaller runs, product-safety testing to the destination market’s standard is the right level of assurance.

10. Eight mistakes that hold up plush shipments

  1. Sending an EN 71 report to a US buyer. EN 71 and ASTM F963 test different things with different methods. A European report does not cover US lead, phthalate or ASTM requirements.
  2. Testing the sample, shipping something else. Certificates rest on production-representative units. If eyes, fabric or prints changed after sampling, the report no longer describes the product.
  3. Forgetting the vinyl face. Vinyl-face and printed plush need phthalate testing on the plasticized parts. Plain-plush habits miss it.
  4. Swapping a component mid-run. A cheaper eye or zipper supplier is a material change and needs testing before the parts go into production.
  5. Listing the wrong factory on the CPC. The certificate names the place of manufacture. A style moved between factories needs testing of the new production.
  6. Using another facility’s law-label number. Pennsylvania registrations belong to one facility. A label printed with the previous factory’s number is a labeling violation.
  7. Missing eFiling data at entry. Since July 8, 2026, the certificate data must be filed when the entry is made. Missing data means holds and demurrage.
  8. Calling a toy an adult collectible. If the design, channel and marketing say toy, CPSC treats it as one.

11. How Takara runs US compliance on a plush order

Takara is a creative-manufacturing partner, not a factory owner, and holds no certifications itself. Accredited labs test the products, partner factories hold their audit certificates, and the US importer issues the CPC. Takara’s role is to make sure all of that lines up before the goods ship:

  • Specify the requirements with you at inquiry: markets, retailers, age grade, licensor rules.
  • Assign a partner factory that is eligible for those requirements, including retailer or licensor audits where the volume justifies them.
  • Plan component and finished-product testing at a CPSC-accepted lab into the quote and the schedule.
  • Prepare tracking-label and law-label artwork with the right factory, batch and registration details.
  • Hand over test reports, factory address and production dates in time for your CPC and your broker’s eFiling.

This is how Takara ran ThreeSixty Group’s Vietnam program: 120,000 plush dolls produced at a FAMA-audited partner factory and delivered to Walmart and Target. Reference terms for US orders, including the 1,000-piece export minimum per design and FOB or DDP delivery, are on the page for US brands.

Selling in more than one country? The US export checklist sits alongside guides for the EU, UK, Japan, Canada and other markets.

12. Frequently asked questions

Does CPSIA apply to plush toys made outside the US?

Yes. CPSIA applies to children’s products distributed in the US wherever they are made. For imported plush, the US importer must certify compliance in a Children’s Product Certificate based on testing at a CPSC-accepted third-party lab.

Who issues the Children’s Product Certificate for imported plush?

The US importer issues the CPC. The factory and its sourcing partner provide the evidence: third-party test reports, the place and date of manufacture, and the lab details. The certificate must be in English and contain seven required elements.

What is CPSC eFiling and when did it start?

Since July 8, 2026, importers of most regulated consumer products, including children’s products, must electronically file certificate data with CBP at entry, either as full data in ACE or by reference to a certificate stored in CPSC’s Product Registry.

Which tests does a custom plush toy need for the US?

Typically ASTM F963-23 (including section 4.27 for stuffed toys, use-and-abuse tests and heavy elements), lead in substrates and coatings, and phthalates in any plasticized parts, all at a CPSC-accepted lab. The lab sets the exact scope from the design and age grade.

Is an EN 71 test report enough for the US?

No. EN 71 is the European toy standard. The US requires ASTM F963 and CPSIA testing at a CPSC-accepted lab. Where a plush is sold in both markets, one test program can cover both if every market is declared upfront.

Do giveaway or promotional plush toys need CPSIA testing?

Yes. Promotional plush distributed to the public in the US is a consumer product like any other, and a plush aimed at children needs the same testing and certificate as one sold in a store.

Which states require a stuffed toy law label?

Pennsylvania, Ohio and Massachusetts regulate stuffed toys and require registration and a law label with a registration number. Pennsylvania registrations are tied to one manufacturing facility. Most large US retailers require the law label on all stuffed items.

How often does a plush toy need to be retested?

Production runs longer than a year need periodic third-party testing, at least once a year under a periodic testing plan. Any material change, such as a new eye supplier, a different vinyl or a new factory, needs new testing of the affected parts.

Sources

Rules checked on 9 November 2026 against CPSC, eCFR and Federal Register sources. This guide is general information for planning, not legal advice; confirm the requirements for your product with your lab, customs broker or counsel.

  1. CPSC, Children’s Product Certificate (CPC)
  2. Federal Register, Certificates of Compliance final rule (Jan 8, 2025)
  3. CPSC, eFiling for importers
  4. Federal Register, Safety Standard Mandating ASTM F963 for Toys (Jan 18, 2024)
  5. eCFR, 16 CFR part 1250: Safety standard mandating ASTM F963 for toys
  6. CPSC, Toy Safety FAQ
  7. eCFR, 16 CFR part 1303: Lead-containing paint
  8. eCFR, 16 CFR part 1307: Prohibition of children’s toys containing specified phthalates
  9. eCFR, 16 CFR 1500.91: Determinations regarding lead content for certain materials
  10. eCFR, 16 CFR part 1501: Small parts
  11. eCFR, 16 CFR part 1110: Certificates of compliance
  12. 16 CFR 1107.21: Periodic testing (Cornell LII)
  13. CPSC, Periodic testing
  14. CPSC, Statement of policy: tracking labels for children’s products
  15. Pennsylvania Department of Labor & Industry, Stuffed toys
  16. The Toy Association, Stuffed toy licensing and labeling laws
  17. OEHHA, Proposition 65 warnings
  18. STC, Testing in Vietnam (CPSC-accepted lab in Ho Chi Minh City)

Making plush for the US market?

Send the design, age grade and every market you will sell in. Takara replies within 3 business days with a quote that includes the testing plan.