Toy safety requirements in the EU and US: EN 71, the new Toy Safety Regulation, CPSIA and ASTM F963

EU today: the Toy Safety Directive and CE marking

Until 31 July 2030, toys placed on the EU market must meet Directive 2009/48/EC. The manufacturer assesses conformity, draws up the technical documentation and the EU declaration of conformity, and affixes the CE marking under Articles 16 and 17. Applying the harmonised EN 71 standards gives a presumption of conformity with the requirements they cover.

Toys are also listed in Article 4(5) of the Market Surveillance Regulation (EU) 2019/1020, so a toy may be placed on the market only if an economic operator established in the EU (an EU manufacturer, an importer, an authorised representative or, in some cases, a fulfilment service provider) is responsible for keeping the declaration available and cooperating with authorities. Their name and contact details, including postal address, go on the product, its packaging, the parcel or an accompanying document.

EN 71 and other harmonised toy standards

The harmonised standards for toys are listed in Commission Implementing Decision (EU) 2023/740. The table reflects the consolidated list of 14 September 2026, which added EN 71-4:2020+A1:2025. Check the current consolidated Decision before relying on a version: only cited versions give a presumption of conformity.

EU warnings and age labelling

Article 11 and Annex V of the Directive set the warning rules. They are a frequent cause of non-compliance in online offers, because the rule on visibility before purchase applies to web shops as well as to physical packaging.

• Warnings must state user limitations: at least the minimum or maximum age and, where relevant, required abilities, weight and the need for adult supervision.
• Warnings are preceded by the word “Warning” or “Warnings”.
• Warnings that drive the purchase decision, such as minimum or maximum age, must be visible before purchase, including when the toy is bought online.
• Toys that could be dangerous for children under 3 carry “Not suitable for children under 36 months”, “Not suitable for children under three years” or the 0–3 pictogram, together with a brief indication of the specific hazard (which may be in the instructions). The warning is not used on toys that are manifestly unsuitable for under-3s.
• Specific category warnings apply, for example “Only for domestic use” on activity toys and “To be used under the direct supervision of an adult” on functional toys, with further texts for chemical toys, skates, aquatic toys, toys in food and others.
• Member States may require warnings and safety instructions in their own language or languages.

The new Toy Safety Regulation (EU) 2025/2509: timeline

Regulation (EU) 2025/2509 on the safety of toys replaces the Directive with a directly applicable regulation. It is already in force, but most of its obligations apply only from 1 August 2030. Toys placed on the market in conformity with the Directive before that date may continue to be made available afterwards.

What changes under the Regulation

The biggest structural change is the Digital Product Passport (DPP). Under Article 19 the manufacturer must create a DPP before placing a toy on the market, and according to recital 54 it replaces the EU declaration of conformity. The DPP is per toy model, in the language(s) of the Member State, available for 10 years, and linked through a data carrier to a persistent unique product identifier. The manufacturer also uploads the product and operator identifiers to the EU DPP registry. Annex VI Part I sets the minimum content: the product identifier; manufacturer, authorised representative and responsible economic operator details; toy identification with a colour image; commodity code; the Union law complied with; standards or common specifications used; the notified body where relevant; the CE marking; labelled allergenic fragrances; a communication channel; and the DPP back-up service provider.

Other changes that affect product data and listings:

• Chemicals: substances classified as CMR category 1A, 1B or 2, endocrine disruptors (human health) category 1 or 2, and certain other hazard classes are prohibited, as are intentionally added PFAS and listed bisphenols. Technically unavoidable traces are allowed if the toy stays safe.
• Fragrance allergens: some are banned above 10 mg/kg; others must be named on the toy, label, packaging or leaflet and in the DPP when present above 10 mg/kg.
• Warnings must be clearly visible to the consumer before purchase, including in distance sales (Article 6(3)).
• Legibility: the word “Warning” or a generic pictogram of at least 10 mm, text x-height of at least 1.2 mm (0.9 mm where the largest pack surface is under 80 cm²), and an under-36-months pictogram at least 10 mm in diameter.
• Online marketplaces (Article 14) must let sellers display the CE marking, the warnings and the DPP data carrier or a weblink to it; non-compliant toy offers count as illegal content under the Digital Services Act.

US: CPSIA and the ASTM F963-23 toy standard

In the US, a children’s product is one designed or intended primarily for children 12 years or younger. Toys must meet the mandatory toy standard in 16 CFR part 1250, which incorporates ASTM F963-23 and has applied since 20 April 2024. Section 4.2 and Annex 5 (flammability) and provisions that restate other CPSC or FDA mandates are not part of the mandatory standard.

In December 2025 CPSC added product-specific requirements to part 1250: water beads in § 1250.4 (size and expansion limits, an acrylamide limit and warning labels) and neck floats in § 1250.5 (performance and labelling). Check the Federal Register notices and the current eCFR for their effective dates and any third-party testing deadlines.

Children’s Product Certificates, third-party testing, and eFiling

Every children’s product subject to a CPSC rule needs a Children’s Product Certificate (CPC) based on testing by a CPSC-accepted third-party laboratory (16 CFR 1107 and 1110). For imports the importer certifies; for domestic products the manufacturer, or the private labeler where the product is privately labelled. One certificate covers one product. It must be in English, furnished to distributors and retailers, made available to CPSC or CBP within 24 hours of a request, and its records kept for at least 5 years.

Since 8 July 2026, importers must eFile the certificate data in CBP’s ACE at entry, either in full or as a reference to a certificate stored in CPSC’s Product Registry. This also covers de minimis entries. Products imported into a foreign trade zone and later entered for consumption or warehousing have until 8 January 2027.

US small-parts warnings and tracking labels

Under 16 CFR 1500.19, toys and games for children aged 3 to under 6 that contain small parts (parts that fit the test cylinder in 16 CFR 1501) need the choking-hazard statement on the package, descriptive material and retail bins: “WARNING: CHOKING HAZARD—Small parts. Not for children under 3 yrs.” with the safety-alert triangle. Separate statements apply to latex balloons, small balls (1.75 in / 44.4 mm diameter or less) and marbles. Statements must be in English, blocked together, on the principal display panel, and in the specified type sizes. CPSIA extended them to internet advertisements from 12 December 2008; catalogues and other printed materials are covered by 16 CFR 1500.20.

According to CPSC’s tracking-label guidance, children’s products made on or after 14 August 2009 need permanent distinguishing marks on the product and its packaging, to the extent practicable, showing the manufacturer or private labeler, the location and date of production, batch or run information, and other information that helps identify the source.

US lead and phthalate limits

Chemical limits are a core part of every CPC. These are the headline limits; exemptions and alternatives exist, so check the rule text for your materials.

EU vs US toy requirements compared

The two systems reach similar safety goals by different routes. The EU relies on the manufacturer’s own conformity assessment against harmonised standards, while the US requires third-party testing for children’s products.

Online listings and a seller checklist

For toys sold online to EU consumers, the structure of the GPSR suggests its distance-sales article (Article 19) applies alongside the toy rules, so check the Commission’s GPSR guidelines. Article 19 requires the offer to show the manufacturer’s details, the responsible person where the manufacturer is not established in the EU, product identification with a picture, and the warnings and safety information that apply to the toy. Under the Directive, purchase-relevant warnings such as age limits must also be visible before purchase. In the US, the required choking-hazard statements must appear in internet advertisements for the toys they apply to.

Most of this information is already in supplier documents: test reports, declarations, certificates and label artwork. Doc2Shelf extracts it from supplier PDFs, drafts EU and US declaration documents and listing copy with missing items flagged for review, and can export DPP-oriented structured data as preparation for a downstream DPP implementation. It does not test toys, assess conformity or issue certificates.

1. Confirm the product is a toy (EU) and a children’s product (US) and identify the age grade.
2. List the applicable EN 71 parts and the cited versions in the current consolidated Decision (EU) 2023/740.
3. Collect the EU declaration of conformity, test reports and technical documentation; confirm the EU economic operator.
4. Draft warnings with “Warning”, age limits and hazard indications in each target language.
5. Obtain ASTM F963-23 and lead and phthalate test reports from a CPSC-accepted lab and prepare the CPC.
6. Set up eFiling data for each import entry and keep certificate records for at least 5 years.
7. Check tracking labels and small-parts statements on product, packaging and listings.
8. Publish listings with images, identifiers, CE marking and warnings visible before purchase.
9. Plan DPP data, chemical reformulation and new warning layouts ahead of 1 August 2030.