Key takeaways
- Until 31 July 2030, toys must meet Directive 2009/48/EC. Testing to the harmonised EN 71 parts gives a presumption of conformity.
- The manufacturer runs the conformity assessment, keeps a technical file, signs the EC declaration of conformity and affixes the CE mark before sale.
- Each toy needs a type, batch or model number, the manufacturer's and importer's name and address, and instructions and warnings in the local language.
- Regulation (EU) 2025/2509 applies from 1 August 2030. It adds a digital product passport that replaces the declaration of conformity, and bans PFAS and certain bisphenols in toys.
- An inspection checks construction, finishes, CE marks, labels and warnings against the tested sample; EN 71 test results come from a lab.
Who it applies to and from when
The Toy Safety Directive 2009/48/EC covers products designed or intended, whether or not exclusively, for play by children under 14 years of age. It has applied since 20 July 2011, and its chemical requirements (Annex II, Part III) since 20 July 2013. Annex I lists products that are not toys. For Indian handicraft exporters, the relevant ones include decorative objects for festivities and celebrations, and folk dolls and decorative dolls sold for collectors when the product or packaging clearly says it is for collectors aged 14 and over.
| Date | What happens |
|---|---|
| 26 Nov 2025 | Regulation (EU) 2025/2509 on the safety of toys adopted |
| 12 Dec 2025 | Published in the Official Journal |
| 1 Jan 2026 | Articles 28 to 44 and 49 to 55 apply (notified bodies, delegated and implementing powers) |
| 1 Aug 2030 | The Regulation applies in full and Directive 2009/48/EC is repealed |
Toys placed on the market in line with the Directive before 1 August 2030 may still be made available after that date, and EC type-examination certificates issued under the Directive stay valid until 1 February 2031 unless they expire earlier. New toys placed on the market from 1 August 2030 must meet the Regulation.
What is required under the Directive and EN 71
| Requirement | What it means |
|---|---|
| EN 71-1, mechanical and physical properties | Small parts, sharp points and edges, cords, projectiles, strength and use-and-abuse tests, warnings |
| EN 71-2, flammability | Burning behaviour of toys and toy materials |
| EN 71-3, migration of certain elements | Release of 19 elements, including lead, cadmium, chromium VI and mercury, from accessible toy materials |
| Element migration limits (Annex II, Part III, point 13) | Three material categories: dry, brittle, powder-like or pliable; liquid or sticky; and scraped-off (such as paint). Lead: 2.0, 0.5 and 23 mg/kg since 28 Oct 2018 |
| Conformity assessment (Article 19) | Internal production control where harmonised standards cover all risks; EC-type examination by a notified body where they do not |
| EC declaration of conformity (Article 15) | States that the toy meets Article 10 and Annex II, follows the model in Annex III, and is kept up to date |
| CE marking (Articles 16 and 17) | Visible, legible and indelible on the toy, a label or the packaging, and on the packaging if it cannot be seen through it |
| Technical documentation (Article 21) | Design, safety assessment and test reports, kept with the DoC for 10 years |
Manufacturers must also mark the toy with a type, batch, serial or model number and their name and contact address. Importers add their own name and address and check that the manufacturer has done its part. Both must keep the DoC for 10 years. The EU General Product Safety Regulation applies alongside for matters the Directive does not cover.
The new Toy Safety Regulation and the digital product passport
Regulation (EU) 2025/2509 keeps the CE mark and the EN 71 approach but changes several obligations from 1 August 2030:
- Digital product passport. Before placing a toy on the market, the manufacturer must create a digital product passport for the toy model (Article 19). It is linked to a unique product identifier through a data carrier on the toy, a label or, if needed, the packaging, and must stay available for 10 years. The passport replaces the EU declaration of conformity.
- Chemicals. The intentional use of PFAS in toys is banned, as is the presence of listed bisphenols. The general bans on CMR substances extend to endocrine disruptors, respiratory sensitisers and other substances once they are classified under the CLP Regulation.
- Online sales. The Regulation adds duties for online marketplaces.
- Connected toys. The safety assessment must consider risks from digitally connected toys, including risks to mental health where relevant.
The technical details of the passport, such as the data carrier and access rights, will follow in Commission delegated and implementing acts.
What this means for toys made in India
- Wooden and lacquered toys from Channapatna and Varanasi need EN 71-3 tests on lac colors and paints, and EN 71-1 checks on turned parts, beads and pegs.
- Soft toys and dolls made of textile need EN 71-2 flammability tests and seam, filling and small-part checks under EN 71-1.
- Toy or décor? A painted wooden animal or a cloth doll sold in a gift shop may still be a toy. Only Annex I items, such as decorative festive objects and collectors' folk dolls clearly labeled 14+, are excluded. Agree the classification with your EU importer before testing.
- Labels and warnings must be in the language of each sale country, and the under-36-months warning must use the wording or pictogram set in Annex V of the Directive, such as “Not suitable for children under 36 months”.
- Records. Keep the test reports, safety assessment and DoC for each model, ready for the importer and authorities.
What inspection can check, and what needs a lab
| An inspector at the factory can check | Needs lab testing |
|---|---|
| CE mark, batch or model number, manufacturer and importer name and address | EN 71-3 migration of elements from paints, coatings and materials |
| Warnings, age grading and instructions match the approved artwork and languages | EN 71-2 flammability |
| Construction, materials and colors match the tested sample | Full EN 71-1 mechanical tests (torque, tension, drop, impact) |
| Visible sharp points and edges, loose parts, weak seams and simple small-parts screening | Chemical tests under REACH and, from 2030, the Regulation's bans |
How Clear To Load checks this in India
Our pre-shipment inspection in India checks toys against the tested sample, the CE mark, traceability marks, warnings and carton labels, and records defects against your AQL. For EN 71 testing, we pull and seal samples for an ISO/IEC 17025-accredited lab you choose or we suggest, through lab testing coordination. We do not issue CE marks or declarations; those are the manufacturer's legal duty.
Reports arrive within 24 hours of the inspection with a verdict of Cleared to load, Hold or Not cleared. To add these checks, book an inspection.