What is the CPSIA and who enforces it?

The CPSIA (Consumer Product Safety Improvement Act) is a federal law passed by the US Congress in August 2008, in response to the mass recalls of lead-contaminated toys imported in 2007. It is enforced by the CPSC (Consumer Product Safety Commission), an independent federal agency established in 1972. The CPSIA expands the CPSC mandate, lowers the chemical limits applicable to products intended for children, and imposes third-party testing at a CPSC-Accepted laboratory for every children's product placed on the US market. Implementing rules are codified at Title 16 of the Code of Federal Regulations (16 CFR).

What is a children's product under the CPSIA?

A children's product is a product designed or intended primarily for children 12 years of age or younger. The legal definition appears at section 3(a)(2) of the Consumer Product Safety Act as amended by the CPSIA. CPSC published an interpretive rule (16 CFR Part 1200) that details the qualifying criteria: product labelling, stated age, marketing representations, design and features, consumer perception. A product meeting this definition triggers the Children's Product Certificate (CPC) obligation based on tests at a CPSC-Accepted laboratory. Toys, children's clothing, child care articles and most school supplies fall within scope.

What is ASTM F963 and is it mandatory?

ASTM F963 is the US consensus toy safety standard, published by ASTM International. It covers mechanical, physical, electrical, chemical and flammability requirements for toys intended for children under 14 years of age. Section 106 of the CPSIA makes ASTM F963 mandatory for toys: the standard ceases to be voluntary and becomes a federal rule, codified at 16 CFR Part 1250. The version referenced by CPSC is the one stated in the current 16 CFR Part 1250. ASTM publishes new editions periodically (F963-17, F963-23, etc.) and CPSC adopts the applicable version through rules published in the Federal Register.

What is the total lead limit for children's products?

The total lead limit in the accessible substrate of a children's product is set at 100 ppm (parts per million) by the CPSIA, effective since August 2011. This limit replaced the older CPSC threshold of 600 ppm. The lead limit in paint and similar surface coatings on any children's product is set at 90 ppm by 16 CFR Part 1303. The two limits apply in parallel: substrate (the product material) and paint are tested separately. Testing uses CPSC published methods (notably CPSC-CH-E1001 for metallic substrates and CPSC-CH-E1002 for non-metallic substrates).

Which phthalates are banned in toys and child care articles?

16 CFR Part 1307 sets the current list of phthalates banned above 0.1 percent by mass in toys and certain child care articles. The list has evolved: the CPSIA originally banned six phthalates (DEHP, DBP, BBP on a permanent basis, and DINP, DIDP, DnOP on an interim basis), and the 2017 CPSC final rule modified that list. The applicable list is the one stated in 16 CFR Part 1307 in force at the date the product is placed on the market, and it must be consulted directly before testing. Manufacturers should not rely on dated lists cited in secondary literature.

What must tracking labels contain?

Section 103 of the CPSIA requires, since August 2009, permanent tracking marks on every children's product and on its sale packaging. The label must identify the manufacturer or private labeler, the place and date of production, and a batch or run code allowing the affected production to be isolated in case of a recall. CPSC does not prescribe a specific format: the label must be legible and permanent under normal use conditions. Common practice combines a manufacturer mark, a YYMM (year + month) production code and a batch or serial number on the product itself and on the sale packaging.

What is the difference with the EU Toy Safety Directive?

Both regimes (CPSIA + ASTM F963 in the United States and Directive 2009/48/EC + EN 71 in the European Union) cover related hazards (mechanical, chemical, electrical, flammability, choking) but are not equivalent. Technical standards differ on some limits, on age categorisation, on test methods and on marking. The CE mark is affixed under the manufacturer's responsibility or that of an EU authorised representative, without mandatory third party for most toys, while the US CPC relies on mandatory testing at a CPSC-Accepted laboratory. See the companion guide [EN 71, EU toy safety](/en/guides/en-71-toy-safety-eu/) for the European counterpart.

CPSIA and ASTM F963: toy safety in the United States

Q: What is a Children's Product Certificate (CPC)?

The CPC is the written attestation by which the importer or the domestic manufacturer certifies that the children's product complies with all applicable CPSC rules, based on testing by a third-party CPSC-Accepted laboratory. It does not need to be filed with CPSC, but must accompany every shipment and be made available on request to distributors, retailers and customs authorities. Its content is fixed by section 14(g) of the CPSA as amended by the CPSIA: product identification, citation of applicable rules, importer or manufacturer contact details, date and place of manufacture, date and place of testing, laboratory identification.

Author Hugues Orgitello Last updated 27 May 2026 ~13 min read

Guide · CPSIA / ASTM F963, United States

The CPSIA (Consumer Product Safety Improvement Act) is the 2008 US federal law that governs the safety of products intended for children, passed in the wake of the mass recalls of lead-contaminated toys in 2007. It is enforced by the CPSC (Consumer Product Safety Commission). For toys, its technical backbone is ASTM F963, made mandatory by section 106 of the CPSIA and codified at 16 CFR Part 1250. Every children's product placed on the US market must be covered by a Children's Product Certificate (CPC) based on testing at a third-party CPSC-Accepted laboratory. This page sets out the CPSC governance, the scope of ASTM F963, the required content of the CPC, the chemical limits (100 ppm lead in substrate, 90 ppm in paint, phthalates under 16 CFR Part 1307), the tracking label requirement of section 103, small parts testing and age categorisation, and the substantive differences from the European EN 71 regime.

Governance: CPSC and CPSIA scope

Before any technical detail, it helps to set the institutional map.

CPSC and its statutory framework

The CPSC (Consumer Product Safety Commission) is an independent federal agency established by the Consumer Product Safety Act (CPSA) of 1972. It regulates general consumer products in the United States, except where another agency holds explicit jurisdiction (food and drugs at the FDA, vehicles at NHTSA, radio equipment at the FCC for emissions). Its headquarters is in Bethesda, Maryland. The CPSC is composed of five commissioners appointed by the President and confirmed by the Senate.

The CPSIA, enacted in August 2008, strengthened the CPSC mandate on three principal axes:

Lowering of chemical limits (lead, phthalates) for products intended for children.
Introduction of the Children's Product Certificate (CPC) based on third-party testing.
Public notification mechanism (the SaferProducts.gov database, brought online in 2011).

The implementing text is codified at Title 16 of the Code of Federal Regulations (16 CFR), available on ecfr.gov.

Children's product: the qualifying step

A children's product is a product designed or intended primarily for children 12 years of age or younger. This qualification is the trigger for the CPSIA obligation: if the product is not a children's product, the CPSIA still applies on other grounds (general recall authority, labelling), but the CPC obligation grounded in third-party testing does not. The definition appears at section 3(a)(2) of the CPSA as amended. CPSC has published a detailed interpretation at 16 CFR Part 1200, which examines four families of criteria:

Product labelling: statements such as "for ages 3-6", "for children under 12", etc.
Stated age and marketing representations: visuals, packaging, online listings.
Design and features: size, materials, themes (childlike characters, bright colours).
Consumer perception: studies, documented purchasing behaviour.

A product not explicitly intended for children but clearly suited to them (for example a cartoon-character keychain sold in the checkout aisle of a general retailer) may be reclassified as a children's product by CPSC, with the full set of attendant obligations.

ASTM F963, a consensus standard made mandatory

ASTM F963 is the US consensus toy safety standard, published by ASTM International (a Pennsylvania-based private standards body, formerly the American Society for Testing and Materials). The standard covers toys intended for children under 14 years of age.

CPSIA section 106 and 16 CFR Part 1250

Section 106 of the CPSIA makes ASTM F963 mandatory: the standard ceases to be a voluntary text for manufacturers and becomes federal rule. 16 CFR Part 1250 designates the applicable version of ASTM F963 and publishes each update in the Federal Register. ASTM releases new editions periodically (for example F963-17, F963-23). The version currently referenced by CPSC is the one stated in the current 16 CFR Part 1250; that text should be consulted directly before any test planning, as the applicable version is subject to revision.

Technical scope of ASTM F963

The standard is structured in sections covering:

Section 4.6, Small parts: standardised cylinder test for toys intended for children under 3 years.
Section 4.7, Accessible edges: accessible edges, burrs, hot spots.
Section 4.8, Projections: protruding points and pins.
Section 4.9, Wires or rods: wires and rods, deformation behaviour.
Section 4.14, Static and dynamic strength of toys: use and abuse testing.
Section 4.18, Sound-producing toys: permissible sound levels.
Section 4.21, Stability and overload requirements: stability of ride-on toys.
Section 4.25, Battery-operated toys: electrical and thermal tests.
Annexes A and B: chemical substances (soluble lead, other migrating elements), flammability.

Use and abuse tests reproduce the mechanical stresses expected from a child in the target age range: drop, traction, torsion, impact, bite for the youngest age groups. A part that detaches under these tests becomes testable in the small parts cylinder.

Children's Product Certificate (CPC) and third-party testing

The CPC (Children's Product Certificate) is the attestation by which the importer (for imported goods) or the domestic manufacturer (for products made in the United States) certifies that the children's product complies with all applicable CPSC rules, based on testing at a third-party CPSC-Accepted laboratory.

Required CPC content

Section 14(g) of the CPSA as amended by the CPSIA sets the minimum content:

Product identification covered by the certificate (model, references, product line).
Citation of each applicable CPSC safety rule covering the product (for example 16 CFR Part 1250 for ASTM F963, 16 CFR Part 1303 for lead paint, 16 CFR Part 1307 for phthalates).
Importer or domestic manufacturer contact details: name, postal address, phone number.
Test record holder contact details: the entity that keeps the test reports.
Date and place of manufacture, or date range for a production run.
Date and place of testing supporting the CPC.
Identification of the CPSC-Accepted laboratory that performed the tests: name, address, CPSC registration number.

The CPC does not need to be filed with CPSC. It must accompany every shipment and be made available on request to distributors, retailers and customs authorities (US Customs and Border Protection) at the port of entry. An electronic CPC is acceptable provided it is accessible and faithful to the original.

CPSC-Accepted laboratories

The official wording is CPSC-Accepted Laboratory. CPSC maintains a public list of laboratories accepted for each section of 16 CFR (for example, a laboratory may be accepted for 16 CFR Part 1250 covering ASTM F963 but not for 16 CFR Part 1303 covering lead paint). CPSC acceptance is distinct from general ISO/IEC 17025 accreditation: an ISO 17025 laboratory cannot perform CPC tests unless it appears on the CPSC list for the targeted rule. The list is maintained on the CPSC website and is updated as laboratories add or lose scope.

Three categories of laboratories are recognised by the CPSC framework:

Independent third-party laboratories, the default case for the general CPC obligation. These laboratories must be wholly independent of the manufacturer and the importer, both in ownership and in operational control.
Firewalled CPSC-Accepted laboratories, used in narrow conditions where a manufacturer-owned laboratory is permitted, subject to specific firewall rules separating testing from production decisions.
Governmental CPSC-Accepted laboratories, used by some foreign governments under bilateral arrangements.

The dominant case in practice is the independent third party. The firewalled path is rarely used and is heavily constrained.

Chemical limits: lead and phthalates

The CPSIA sets the most consequential chemical thresholds.

Total lead in substrates

The total lead limit in the accessible substrate of a children's product is set at 100 ppm (parts per million, i.e. 0.01 percent) by the CPSIA, effective from 14 August 2011. This limit replaced an intermediate threshold of 300 ppm and, before that, the older CPSC limit of 600 ppm. Tests follow CPSC published methods, in particular:

CPSC-CH-E1001 for metallic substrates.
CPSC-CH-E1002 for non-metallic substrates.

Testing covers accessible parts. CPSC defines accessibility as anything liable to be touched, licked or ingested by a child in reasonably foreseeable use, including after abuse testing.

Lead in paint and similar surface coatings

16 CFR Part 1303 bans lead-containing paint on any children's product, with a maximum threshold of 90 ppm. This pre-CPSIA rule had its limit lowered from 600 ppm to 90 ppm by the CPSIA in 2009. Testing applies to applied coatings (paints, varnishes, similar inks).

The two limits apply in parallel: substrate at 100 ppm and paint at 90 ppm are tested separately. A product may comply on the substrate and fail on the paint, or the other way round.

Phthalates under 16 CFR Part 1307

16 CFR Part 1307 sets the list of phthalates prohibited above 0.1 percent by mass in toys and certain child care articles. The list has evolved since 2008:

Originally, the CPSIA banned six phthalates: DEHP, DBP, BBP on a permanent basis, and DINP, DIDP, DnOP on an interim basis in articles that can be placed in the mouth.
The 2017 CPSC final rule extended and modified that list.
The applicable list is the one stated at 16 CFR Part 1307 in force at the date the product is placed on the market.

Manufacturers should not rely on dated lists cited in secondary literature; direct consultation of 16 CFR Part 1307 on ecfr.gov is the necessary framing step before testing. Test methods are generally based on CPSC-CH-C1001-09.

Tracking labels

Section 103 of the CPSIA requires, since 14 August 2009, permanent tracking marks on every children's product and on its sale packaging. The purpose is to allow rapid isolation of a defective batch in case of a recall.

Minimum content

The tracking label must identify:

The manufacturer or private labeler: name or recognisable mark.
The place of manufacture: city or region, and country.
The date of manufacture: year and month at minimum.
A batch, lot or serial code: allowing the affected production to be isolated.

CPSC does not prescribe a specific format. Common practice combines a manufacturer mark + a YYMM (year + month) code + a batch or serial number. The label must be permanent under normal use conditions: it should not fade or peel off over the reasonable lifetime of the product. A removable label (simple sticker) is generally not accepted.

On the product AND on the packaging

The obligation applies both to the product itself and to the sale packaging, to the extent practical. For small or design-constrained products, CPSC accepts that the marks appear on the packaging only, provided they are legible at the point of purchase. A written justification of the constraints may be requested in case of audit.

Coordination with the recall workflow

Tracking labels are the operational hinge of any CPSC recall action. When a hazard is identified, the recall notice can reference batch codes that isolate the affected production, limiting commercial impact and supporting consumer claims. A toy without legible tracking marks degrades the recall to a general product withdrawal, with significantly broader exposure. The same logic underpins the importer record-keeping rules of CPSA section 14 as amended: the test record holder must retain test reports and CPC supporting evidence for at least five years.

Small parts test and age categorisation

The small parts test is the historic protection criterion against choking for children under 3 years.

Small parts: 16 CFR Part 1501 and ASTM F963 section 4.6

16 CFR Part 1501 sets the method for identifying toys and other articles intended for children under 3 years, and mandates the use of the standardised cylinder (small-parts cylinder). A detachable part or whole toy that fits entirely inside the cylinder (standardised dimensions, approximately 31.7 mm x 57.1 mm in height) is deemed to present a choking hazard.

ASTM F963 section 4.6 takes up and extends this logic across all toys, with adaptations for some categories (pull toys, bath toys, etc.).

Mandatory warnings: FHSA section 24

For toys intended for children 3 to 6 years that contain small parts, section 24 of the Federal Hazardous Substances Act (FHSA) mandates a standardised warning:

WARNING: CHOKING HAZARD - Small parts. Not for children under 3 years.

The exact format (size of the WARNING signal word, layout, alert symbol) is set by rule. The warning must appear on packaging and, generally, in the online product listing on US marketplaces. Toys intended for children under 3 years must not contain small parts, and the warning has no place there.

FHSA and Flammable Fabrics Act

Beyond the CPSIA and ASTM F963, two complementary federal statutes routinely apply to children's toys and textile articles.

Federal Hazardous Substances Act (FHSA)

The FHSA, codified at 15 USC chapter 30 and enforced by CPSC, governs hazardous substances in consumer products. For toys, it mandates choking hazard warnings (section 24, above), restricts accessible toxic substances, and bans certain categories of toys deemed inherently dangerous (for example toys containing accessible corrosive or irritant substances).

Flammable Fabrics Act (FFA)

The FFA, codified at 15 USC chapter 25, regulates flammability of textiles, clothing and certain stuffings. For textile toys (plush, fabric dolls) and children's costumes, the FFA applies in addition to ASTM F963 and mandates specific flammability tests (16 CFR Part 1610 for wearing apparel, 16 CFR Part 1500.44 for stuffings). A plush toy compliant with ASTM F963 but non-compliant with the FFA remains in violation.

Summary table: CPSIA requirements for a typical toy

Domain	Applicable text	Limit or requirement	Mandatory test
Toy standard	ASTM F963 via 16 CFR Part 1250	Compliance with current version	CPSC-Accepted laboratory
Substrate lead	CPSIA section 101	100 ppm max (accessible parts)	CPSC-CH-E1001 / E1002
Paint lead	16 CFR Part 1303	90 ppm max	CPSC-Accepted laboratory
Phthalates	16 CFR Part 1307	0.1 percent max per listed phthalate	CPSC-Accepted laboratory
Small parts	16 CFR Part 1501 + ASTM F963 sec. 4.6	Standardised cylinder	CPSC-Accepted laboratory
3-6 yr warning	FHSA section 24	Standardised WARNING format	Labelling check
Textile flammability	16 CFR Part 1610 / 1500.44	Max flame spread rate	CPSC-Accepted laboratory
Tracking	CPSIA section 103	Manufacturer + place + date + batch	Marking verification
Certificate	CPSA section 14(g)	Complete CPC per shipment	Recap document

Each row represents a distinct path to non-compliance. A product must satisfy all of them to enter the US market without withdrawal.

CPSIA vs EU Toy Safety Directive

Criterion	CPSIA + ASTM F963 (United States)	Directive 2009/48/EC + EN 71 (EU)
Framework text	CPSIA 2008 + 16 CFR	Directive 2009/48/EC
Technical standard	ASTM F963 (16 CFR Part 1250)	EN 71 (multiple parts)
Authority	CPSC	European Commission + national market surveillance authorities
Product mark	No imposed physical mark	CE marking
Third-party testing	Mandatory at a CPSC-Accepted laboratory	Optional for most toys (with limited exceptions: see directive)
Attestation	CPC per shipment	EU Declaration of Conformity, kept 10 years
Substrate lead	100 ppm	Migration limits (EN 71-3), different logic
Phthalates	16 CFR Part 1307 (list)	REACH annex XVII entries 51 and 52
Tracking	Permanent label (CPSIA section 103)	Manufacturer ID + batch or serial number (article 4.5 of the directive)
Warnings	FHSA section 24 (standardised format)	Annex V of the directive (translated statements)
Market surveillance	CPSC + Customs and Border Protection	National authorities (DGCCRF in France, etc.)
Incident notification	SaferProducts.gov + section 15(b) CPSA reporting	Safety Gate (formerly RAPEX)

Both regimes cover related hazards but they are not equivalent. Chemical thresholds do not transpose mechanically: the CPSIA sets a total lead limit in the substrate (100 ppm), whereas EN 71-3 operates on migration limits (the amount extractable by a solvent simulating saliva or gastric fluid). US compliance does not entail EU compliance, and the converse is also true.

For manufacturers targeting both markets, see the guide on EU and US dual certification.

Common pitfalls

Pitfall	Consequence
Treating ASTM F963 as voluntary and skipping testing at a CPSC-Accepted laboratory	Product without a valid CPC, customs hold and federal penalties
Relying on an ISO 17025 accredited laboratory not accepted by CPSC for the targeted rule	Test report inadmissible for the CPC, tests to redo
Reciting a phthalate list from a dated source	Outdated list, product not compliant with 16 CFR Part 1307 in force
Conflating the substrate limit (100 ppm) with the paint limit (90 ppm)	Incomplete test plan, late discovery of non-compliance
Omitting tracking labels on the assumption that a CE mark on packaging suffices	Section 103 non-compliance, recall exposure
Affixing a choking-hazard warning not compliant with the FHSA section 24 layout	Formal label non-compliance
Assuming that a textile toy compliant with ASTM F963 is automatically compliant with the Flammable Fabrics Act	Late discovery of flammability non-compliance, textile recall
Importing on the strength of a Chinese manufacturer CPC without checking CPSC acceptance of the cited laboratories	Test report contested by CBP at the port of entry
Failing to reclassify as a children's product an article presented as generic but clearly intended for children	CPSC reclassification, retroactive obligations
Ignoring the version update of ASTM F963 referenced by 16 CFR Part 1250	Tests run against an obsolete edition, CPC inadmissible