Gapfile

Product categories / Toys

GPSR technical documentation for toys — template and requirements

Toys are one of the most scrutinised product groups in the EU. The technical file must include a safety assessment, EN 71 test reports and an EU declaration of conformity — and the requirements change with the age group, small parts and electrical functions.

Which rules apply?

The Toy Safety Directive governs the safety requirements, technical documentation and CE marking. The GPSR covers what the directive does not — above all the rules for online sales (Art. 19) and accident reporting (Art. 20). From 1 August 2030 the directive is replaced by Regulation (EU) 2025/2509.

LegislationRole
(EC) No 1907/2006
REACH — Annex XVII (restrictions)
Phthalates, PAHs
(EU) 2019/1020
Market Surveillance Regulation
Art. 4: economic operator in the EU
(EU) 2023/988
General Product Safety Regulation (GPSR)
Art. 19–20: online sales and accidents
(EU) 2025/2509
Toy Safety Regulation (new)
Replaces the directive from 1 August 2030
2009/48/EC
Toy Safety Directive
Primary legislation

Standards

  • EN 71-1:2014+A1:2018 — Safety of toys — Mechanical and physical properties
    Harmonised under 2009/48/EC.
  • EN 71-2:2020 — Safety of toys — Flammability
    Harmonised under 2009/48/EC.
  • EN 71-3:2019+A1:2021 — Safety of toys — Migration of certain elements
    EN 71-3:2019+A2:2024 is published; check whether it has been cited in the OJ before listing it as harmonised.
  • EN IEC 62115:2020+A11:2020 — Electric toys — Safety
    Harmonised under 2009/48/EC.

Template: what the technical file must contain

This structure is the same as in the technical file generated by the tool. Requirements that only apply to some products show their condition.

Product details and economic operators

  • Economic operator in the EUCritical

    The product may not be placed on the market unless an economic operator established in the EU is responsible for it. Name and contact details must appear on the product, its packaging, the parcel or an accompanying document.

    GPSR Art. 16(1) / Reg. (EU) 2019/1020 Art. 4 · Information · Applies if “Is the manufacturer established outside the EU?” Yes

  • Description of design and manufacture, components and materialsCritical

    The technical documentation must contain a detailed description of the design and manufacture, including a list of components and materials used in the toy.

    2009/48/EC Art. 21, Annex IV(a) · Information

  • Addresses of places of manufacture and storageMajor

    The technical documentation must state the addresses of the places where the toy is manufactured and stored.

    2009/48/EC Annex IV(e) · Information

  • Manufacturer name and addressCritical

    The manufacturer's name, registered trade name or trade mark and contact address must be indicated on the toy or, where that is not possible, on its packaging or in an accompanying document.

    2009/48/EC Art. 4(6) · Information

Risk analysis and assessments

  • Safety assessmentCritical

    Before placing the toy on the market, the manufacturer must analyse the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards the toy may present, and assess the potential exposure to them.

    2009/48/EC Art. 18 and Annex IV(b) · Document

Test reports and certificates

  • Safety data sheets for chemicals usedMajor

    Safety data sheets for the chemicals used in manufacture must be included in the technical documentation.

    2009/48/EC Annex IV(a) · Test report / certificate

  • EN 71-1 test report (mechanical and physical properties)Critical

    Shows that the toy meets the requirements on small parts, sharp edges and points, cords, magnets and strength, among others.

    2009/48/EC Art. 13 and Annex II Part I; Annex IV(g) · Test report / certificate

  • EN 71-2 test report (flammability)Major

    Shows that the toy does not present a dangerous flammability risk.

    2009/48/EC Annex II Part II · Test report / certificate

  • EN 71-3 test report (migration of certain elements)Critical

    Shows that migration of lead, cadmium and chromium VI, among others, from accessible materials is below the limits in Annex II Part III.

    2009/48/EC Annex II Part III point 13 · Test report / certificate

  • EN IEC 62115 test report (electric toys)Critical

    Shows electrical safety, including temperatures, battery compartments and protection against button batteries becoming accessible.

    2009/48/EC Annex II Part IV · Test report / certificate · Applies if “Does the toy have electrical functions or batteries?” Yes

  • Phthalates and PAH test reportCritical

    Plasticised material must not contain more than 0.1 % by weight of DEHP, DBP, BBP or DIBP (entry 51), and toy parts that can be placed in the mouth must not contain DINP, DIDP or DNOP (entry 52). Rubber and plastic parts in contact with skin or mouth must not contain more than 0.5 mg/kg of listed PAHs (entry 50, point 6).

    REACH Annex XVII entry 50(6), entries 51 and 52 · Test report / certificate · Applies if “Does the toy contain plasticised material (e.g. PVC) or rubber?” Yes

Declarations, instructions and procedures

  • Product listing with mandatory informationMajor

    The listing must clearly show: the manufacturer's name, postal and email address; the responsible person in the EU if the manufacturer is outside the EU; a picture and identification of the product (type and other identifier); and warnings and safety information in a language consumers easily understand.

    GPSR Art. 19 · Document · Applies if “Is the product sold through a webshop or marketplace (e.g. Amazon)?” Yes

  • Accident reporting procedureMinor

    The manufacturer must ensure that accidents caused by the product are notified without undue delay to the competent authority via the Safety Business Gateway.

    GPSR Art. 20 · Document

  • EU declaration of conformityCritical

    Signed declaration that the requirements of Art. 10 and Annex II are fulfilled, following the structure in Annex III. A copy must be included in the technical documentation.

    2009/48/EC Art. 15, Annex III; Annex IV(d) · Document

  • Instructions and safety information in the target market languageMajor

    The toy must be accompanied by instructions and safety information in a language consumers easily understand, as determined by the Member State.

    2009/48/EC Art. 4(7) · Document

Marking and warnings

  • CE markingCritical

    The CE marking must be affixed visibly, legibly and indelibly to the toy, a label or the packaging before the toy is placed on the market.

    2009/48/EC Art. 16 and 17 · Marking

  • Product identification (type, batch, serial or model number)Major

    The toy must bear a type, batch, serial or model number or other element allowing its identification — or, where that is not possible, on the packaging or in an accompanying document.

    2009/48/EC Art. 4(5) · Marking

  • Warnings preceded by “Warning”Major

    Warnings must be clearly visible, easily legible and understandable and preceded by the word “Warning” or “Warnings”. Warnings that affect the purchase decision must be visible on the packaging.

    2009/48/EC Art. 11(1)–(2), Annex V · Marking

  • Warning: not suitable for children under 36 monthsCritical

    Toys that might be dangerous for children under 36 months must bear the warning “Not suitable for children under 36 months” (or the equivalent pictogram) together with a brief indication of the specific hazard, e.g. small parts.

    2009/48/EC Annex V Part B point 1 · Marking · Applies if “Is the toy intended for children under 36 months?” No and “Does the toy contain small parts or parts that can come loose?” Yes

Start the gap analysis for your product

Answer 6 questions — you'll see straight away which of the 19 requirements apply and what is missing.

Is the manufacturer established outside the EU?
If yes, an economic operator in the EU is required (importer, authorised representative or fulfilment service provider).
Is the product sold through a webshop or marketplace (e.g. Amazon)?
GPSR Art. 19 sets out what the product listing must show.
Is the toy intended for children under 36 months?
Affects the small-parts requirements and whether the under-36-months warning is used.
Does the toy contain small parts or parts that can come loose?
Assessed with the small-parts cylinder in EN 71-1.
Does the toy have electrical functions or batteries?
Does the toy contain plasticised material (e.g. PVC) or rubber?
Decides whether phthalate and PAH testing is required.
Free for up to 3 products. An account is needed to save.

Reviewed by an expert. Rule set version 2, last reviewed 2026-10-10. This page helps you find gaps and does not replace an assessment by an expert or test laboratory.