Toy Safety in the US and EU: ASTM F963-23 and the New EU Regulation
Record which ASTM F963-23 sections apply to each toy, and prepare the EU safety assessment and digital passport before 2030.
In Short
- ASTM F963-23 is mandatory in the US.
- EU Directive repealed 1 Aug 2030.
- Keep EU toy records 10 years.
In the US, 16 CFR 1250 makes ASTM F963-23 a mandatory consumer product safety standard for toys, with added rules for water bead toys and infant neck floats. In the EU, Regulation (EU) 2025/2509 will replace Directive 2009/48/EC from 1 August 2030 and brings a safety assessment, a digital product passport and 10-year record keeping. This guide covers what a toy maker or importer should prepare; it is orientation, not legal advice. Sources checked 4 Oct 2026.
What 16 CFR 1250 makes mandatory
Section 1250.2(a) says each toy must comply with all applicable provisions of ASTM F963-23, which is incorporated by reference in section 1250.10. Applicable is the key word: the standard has many sections, and which ones apply depends on the toy's age grade, materials, mechanisms, batteries, magnets and any liquid or projectile parts.
Worked example: applicability record for toy TY-204 (stacking set, 18 months+)
| ASTM F963-23 area | Decision | Evidence |
|---|---|---|
| Small parts and use/abuse tests | Applies (under 36 months) | Lab report LR-881 |
| Heavy elements in coatings | Applies (painted surface) | Lab report LR-882 |
| Batteries | Not applicable (no battery) | Design review, dated |
| Magnets | Not applicable (no magnet) | BOM v3 signed |
- Small parts and use/abuse tests
- Decision
- Applies (under 36 months)
- Evidence
- Lab report LR-881
- Heavy elements in coatings
- Decision
- Applies (painted surface)
- Evidence
- Lab report LR-882
- Batteries
- Decision
- Not applicable (no battery)
- Evidence
- Design review, dated
- Magnets
- Decision
- Not applicable (no magnet)
- Evidence
- BOM v3 signed
More on what 16 CFR 1250 makes mandatory
Your team should record, per toy, which sections were judged applicable and why the others were not. That reasoning is what a tester, retailer or regulator will ask to see when a question comes up.
Added US rules for water beads and neck floats
The current part 1250 adds requirements beyond ASTM F963-23 for water bead toys and for infant neck floats, amended in December 2025 (90 FR 57855). If you make, import or sell either product type, read the specific section in full rather than relying on the base standard.
More on added US rules for water beads and neck floats
Other US requirements, such as third-party testing and children's product certificates under separate CPSC rules, were not opened for this guide; confirm them with the current eCFR and your testing laboratory before launch.
What changes in the EU, and when
Regulation (EU) 2025/2509 repeals Directive 2009/48/EC with effect from 1 August 2030. Toys placed on the market in conformity with the Directive before that date may still be made available.
More on what changes in the EU, and when
Under the Regulation, the manufacturer carries out a safety assessment covering chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards, keeps technical documentation, and creates a digital product passport that replaces the EU declaration of conformity. Manufacturers keep the required information for 10 years after the toy is placed on the market.
Build one technical file that serves both markets
Many toy makers sell the same item in both markets. A practical approach is one product record per toy and version: age grade, bill of materials with supplier declarations, test reports per standard, warnings and their placement, label and instruction versions, and the person who approved each.
One technical file, two markets
More on build one technical file that serves both markets
Keep US and EU conclusions separate inside that record, because the legal tests differ. When a material, supplier or design changes, re-open the safety assessment and decide, with evidence, whether retesting is needed.
Where V5 fits and where people decide
V5 keeps product specifications, supplier documents, test reports, label versions and complaints linked to each toy and lot, with revision history and electronic sign-off. It does not interpret standards or decide applicability.
More on where V5 fits and where people decide
Your qualified safety and regulatory people decide which sections apply, whether a change needs new testing, and when a toy can be placed on the market. Where a complaint suggests a hazard, your team decides on investigation and any notification required by law.
Questions
Is ASTM F963 still voluntary in the US?
No. 16 CFR 1250.2 makes all applicable provisions of ASTM F963-23 mandatory for toys, with added rules for water bead toys and infant neck floats.
When does the new EU toy regulation apply?
Directive 2009/48/EC is repealed with effect from 1 August 2030. Read the Regulation's final provisions for the dates individual articles apply.
What replaces the EU declaration of conformity?
Under Regulation (EU) 2025/2509 the manufacturer creates a digital product passport, which the recitals say replaces the EU declaration of conformity under the Directive.
How long must toy documentation be kept in the EU?
The manufacturer must be able to present the required information for 10 years after the toy has been placed on the market.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
Global Consumer Product Safety Readiness Guide (2026)
California Prop 65 Warnings: Labels, Short Form, Online Sales and Supplier Notices
CPSIA Children's Product Certificate Readiness: Testing, Content and eFiling
EU General Product Safety Regulation (EU) 2023/988: Duties for Manufacturers and Importers
REACH SVHC in Articles and RoHS: Supplier Data Readiness