Technical Insight

GAR INSIGHT
EU Toy Safety: Directive 2009/48/EC, Regulation (EU) 2025/2509 & CE Marking
GAR INSIGHT · TOY SAFETY & CE MARKING

Toys placed on the European Union market must be designed and manufactured so that children can use them without unacceptable risks to their health or safety, taking account of their intended use and reasonably foreseeable use.

As of 2026, European toy manufacturers are operating during an important regulatory transition. Directive 2009/48/EC remains the principal product safety framework for toys placed on the EU market until 31 July 2030, while the new Toy Safety Regulation (EU) 2025/2509 has entered into force and will become generally applicable from 1 August 2030.

Toy conformity can involve mechanical and physical hazards, flammability, chemical exposure, electrical safety, hygiene, radioactivity, warnings, age suitability, traceability and manufacturing controls. Manufacturers must evaluate these risks before CE marking their products.

The new Regulation also represents a significant evolution of the system. It strengthens chemical restrictions and introduces a Digital Product Passport that will become an important part of toy conformity and market-surveillance controls.

This GAR Insight explains the current CE marking route under Directive 2009/48/EC and helps manufacturers understand how to prepare for the incoming Regulation (EU) 2025/2509.

ARTICLE GUIDE

Navigate This Article

Explore toy scope, safety assessment, mechanical, chemical, electrical and flammability requirements, harmonised standards, conformity assessment, technical documentation, CE marking and the transition to Regulation (EU) 2025/2509.

01
REGULATORY FOUNDATION

Understanding the EU Toy Safety Framework

The European toy safety framework is currently in a transition period. Directive 2009/48/EC continues to govern toys placed on the EU market until the new Toy Safety Regulation becomes generally applicable.

Current Framework Directive 2009/48/EC
New Framework Regulation (EU) 2025/2509
New Rules Apply 1 August 2030
CE Marking Required
Manufacturers should distinguish between legal status and application date. Regulation (EU) 2025/2509 is already in force, but most of its substantive requirements apply from 1 August 2030. Directive 2009/48/EC therefore remains directly relevant to toys being placed on the market today.
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02
PRODUCT SCOPE

What Is Considered a Toy?

The EU toy safety framework generally concerns products designed or intended, whether exclusively or not, for use in play by children under 14 years of age.

Determining whether a product is a toy is therefore not always as simple as reading its commercial description. Design, function, presentation, intended users and reasonably foreseeable use can all influence classification.

Traditional Toys

Dolls, figures, construction toys, puzzles, vehicles and similar products intended for children’s play.

Activity Toys

Products intended for recreational activity that may involve climbing, jumping, swinging or other physical play.

Electronic Toys

Toys incorporating electronic circuits, batteries, motors, lights, sound functions or interactive features.

Connected Toys

Toys incorporating wireless, connected or digital functionality may also trigger other applicable EU legislation.

Age grading does not by itself determine whether a product is legally a toy. Manufacturers should assess the product’s characteristics, intended use and foreseeable appeal to children rather than relying only on a label stating an age or intended audience.
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03
RISK EVALUATION

Toy Safety Assessment

Before placing a toy on the EU market, the manufacturer must analyse the hazards that the toy may present and assess potential exposure to those hazards.

Chemical

Substances and materials capable of creating harmful exposure.

Physical & Mechanical

Choking, cutting, crushing, entrapment and structural hazards.

Electrical

Electrical shock, heating, battery and related electrical risks.

Flammability

Ignition behaviour and the spread or persistence of flame.

Hygiene

Risks associated with cleanliness, contamination and hygienic design.

Radioactivity

Potential hazards associated with radioactive materials where relevant.

The safety assessment comes before the testing programme. Testing should be selected because it addresses identified hazards and applicable requirements—not simply because a laboratory offers a standard package for a particular type of toy.
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04
PHYSICAL SAFETY

Mechanical & Physical Requirements

Mechanical and physical safety is one of the most visible areas of toy compliance because children interact directly with the product through touching, pulling, pushing, dropping, climbing, throwing or mouthing it.

Small Parts

Components capable of creating choking hazards require particular attention, especially for toys intended for young children.

Sharp Edges & Points

Accessible edges and points should not create unacceptable cutting or puncture hazards.

Strength & Durability

Toys should withstand relevant foreseeable mechanical stresses without creating dangerous failures.

Entrapment

Openings, mechanisms and moving components should be assessed for finger, head, limb and other entrapment hazards.

Projectiles

Toys capable of launching projectiles require assessment of impact energy and foreseeable misuse.

Cords & Straps

Cords, loops and similar features can create strangulation or entanglement hazards.

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05
FIRE SAFETY

Flammability Requirements

Toys should not present unacceptable fire hazards in the child’s environment. Materials, construction and intended use can all influence flammability requirements.

Ignition

Materials should be selected and used with appropriate consideration of their tendency to ignite.

Flame Spread

Where ignition occurs, applicable requirements can limit the speed at which flame propagates.

Costumes & Disguises

Toy costumes and materials worn by children can require particular attention because of proximity to the body.

Soft-Filled Toys

Textile and filling materials can require appropriate flammability assessment.

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06
CHEMICAL EXPOSURE

Chemical Safety Requirements

Chemical safety is one of the most technically demanding parts of toy conformity because children can be exposed through skin contact, inhalation, ingestion and mouthing behaviour.

The current Directive already establishes significant restrictions concerning hazardous chemicals, including controls relating to CMR substances, migration of certain elements and allergenic fragrances.

Materials & Coatings

Plastics, paints, inks, metals, adhesives and coatings should be evaluated for relevant chemical hazards.

Migration of Elements

Applicable toy materials must satisfy relevant migration limits for specified elements.

CMR Substances

Carcinogenic, mutagenic and reprotoxic substances are subject to strict restrictions and defined exceptions.

Allergenic Fragrances

Certain fragrances are prohibited or subject to labelling and other conditions.

The incoming Toy Safety Regulation strengthens chemical controls further. Manufacturers developing products for long market lifecycles should therefore consider future Regulation (EU) 2025/2509 requirements during material selection rather than waiting until 2030.
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07
ADDITIONAL HAZARDS

Electrical, Hygiene & Other Safety Requirements

Modern toys increasingly combine mechanical, electronic and digital functions. The safety assessment must therefore address all relevant hazards created by the complete product.

Electrical Safety

Electrical toys require appropriate protection against shock, excessive temperatures and electrical hazards.

Batteries

Battery accessibility, compartments, charging arrangements and foreseeable misuse should be considered.

Hygiene

Toys should be designed and manufactured so that hygiene and cleanliness risks are appropriately controlled.

Radioactivity

Applicable requirements also address hazards associated with radioactivity.

Connected toys can trigger more than toy legislation. Depending on their functions, radio-enabled or connected toys may also require assessment against other applicable EU legislation. The complete CE marking assessment should therefore identify all applicable acts.
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08
PRESUMPTION OF CONFORMITY

Harmonised Toy Safety Standards

Harmonised European standards provide recognised technical methods manufacturers can use to demonstrate conformity with relevant toy safety requirements.

EN 71 Series

The EN 71 family addresses major areas of toy safety, with individual parts covering different hazards and test methods.

Electrical Toys

Electrical toys may require relevant electrical toy safety standards in addition to applicable EN 71 requirements.

Product-Specific Standards

Certain toy categories may be covered by additional or specialised standards.

OJEU Citation

The manufacturer should verify the current harmonised status and cited edition before relying on presumption of conformity.

Passing one EN 71 test does not establish complete toy conformity. The manufacturer must identify all applicable hazards, requirements and standards for the specific toy.
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09
CONFORMITY ASSESSMENT

Self-Verification or Notified Body Assessment?

Under the current Toy Safety Directive, two principal conformity assessment routes are available.

Internal Production Control

Where harmonised standards covering all relevant safety requirements are correctly applied, the manufacturer can use the applicable internal production control route.

EC-Type Examination

Where the conditions for the harmonised-standard route are not met, a Notified Body may be required to perform EC-type examination.

01

Classify

Confirm that the product falls within toy legislation.

02

Assess Hazards

Complete the required toy safety assessment.

03

Select Standards

Identify applicable harmonised standards.

04

Select Route

Determine internal control or third-party assessment.

05

Test

Complete applicable laboratory and product verification.

06

Document

Compile the technical documentation.

07

Declare

Prepare the required Declaration of Conformity.

08

CE Mark

Apply CE marking before EU market placement.

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10
TECHNICAL FILE

Toy Safety Technical Documentation

The technical documentation is the manufacturer’s evidence that the toy placed on the market corresponds to the product that was assessed and satisfies the applicable safety requirements.

01
Product description. Identify the toy, models, variants, intended age group and intended use.
02
Design information. Maintain relevant drawings, specifications and construction details.
03
Safety assessment. Document identified hazards and potential exposure.
04
Materials and components. Maintain information necessary to support chemical and physical conformity.
05
Standards matrix. Identify applicable harmonised standards and editions.
06
Test reports. Maintain relevant mechanical, chemical, flammability, electrical and other test evidence.
07
Warnings and instructions. Maintain the safety information accompanying the marketed product.
08
Manufacturing controls. Demonstrate how continued production conformity is maintained.
09
Notified Body documentation. Include applicable EC-type examination certificates and supporting records.
10
Declaration of Conformity. Maintain the final conformity declaration for the marketed toy.
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11
CONSUMER INFORMATION

Warnings, Instructions & Product Traceability

Toy safety does not end with laboratory testing. Information supplied with the product can be essential to ensuring safe use.

Age Warnings

Applicable age limitations and associated hazards should be communicated in accordance with the relevant requirements.

Safety Instructions

Where safe use depends on particular precautions, appropriate instructions should accompany the toy.

Product Identification

Type, batch, serial or other identifying information should allow the product to be traced.

Economic Operator Details

Required manufacturer and importer information should be provided in accordance with applicable legislation.

A warning cannot replace safe design. Warnings are used to communicate relevant residual risks and conditions of safe use; they should not be used as a substitute for eliminating hazards that can reasonably be addressed through design.
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12
EU MARKET ACCESS

Declaration of Conformity & CE Marking

Toys placed on the EU market must carry CE marking. The CE mark represents the manufacturer’s declaration that the toy satisfies the applicable EU safety requirements.

Complete Assessment

Confirm that all applicable toy safety requirements have been addressed.

Technical Evidence

Ensure the technical documentation supports the marketed configuration.

Declaration

Prepare and maintain the applicable Declaration of Conformity.

CE Marking

Apply CE marking in accordance with the applicable visibility, legibility and permanence requirements.

CE marking is not issued by a test laboratory. The manufacturer ultimately assumes responsibility for the conformity of the toy placed on the EU market, whether testing is performed internally or by external laboratories.
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13
2030 TRANSITION

Preparing for Regulation (EU) 2025/2509

The new Toy Safety Regulation strengthens the European framework and introduces changes that manufacturers should begin considering well before its general application date of 1 August 2030.

Digital Product Passport

Toys will require a Digital Product Passport containing prescribed compliance and product information accessible through a data carrier.

Stronger Chemical Controls

The new framework expands restrictions on substances considered particularly harmful to children.

Digital Market Surveillance

Product-passport information will support more effective customs and market-surveillance checks.

Online Sales

The regulatory framework expressly addresses toys supplied through distance and online sales channels.

1 August 2030 should not be treated as the date to begin preparing. Toy development cycles, tooling, material qualification, supplier agreements and technical documentation can extend over several years. Manufacturers planning products that will remain on the EU market after 2030 should incorporate the new requirements into their transition planning.
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14
COMPLIANCE RISK

Common Toy Safety Compliance Failures

Common Issue Why It Creates Risk
No documented safety assessment Testing may fail to address hazards specific to the toy and its foreseeable use.
Using only a generic EN 71 test package Applicable hazards or specialised requirements may be omitted.
Incorrect age grading Test requirements, warnings and foreseeable behaviour may be assessed against the wrong user group.
Material changes after testing New plastics, coatings, paints or suppliers can invalidate chemical evidence.
Component changes after mechanical testing Fasteners, cords, wheels, magnets or small components can change physical safety performance.
Warnings used instead of safer design Foreseeable hazards should be reduced through design where reasonably possible.
Incomplete traceability Authorities may be unable to connect the marketed toy with its conformity evidence and production batch.
No planning for Regulation (EU) 2025/2509 Products intended to remain on the market after the transition may require significant documentation, material or digital-system changes.
Toy conformity should follow the production configuration. A test report for an earlier sample does not automatically establish conformity of later production if materials, suppliers, components, dimensions or manufacturing processes have changed.
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From Toy Design to Demonstrable European Conformity

Effective toy compliance begins before laboratory testing. It starts with defining the intended users, understanding foreseeable play behaviour, identifying hazards and selecting materials and design solutions capable of satisfying the applicable safety requirements.

Testing then verifies the relevant characteristics, while technical documentation connects the tested product to its design, materials, manufacturing process, warnings and production configuration.

During the present transition period, manufacturers should also consider whether products being developed today will remain on the EU market after Regulation (EU) 2025/2509 becomes generally applicable in 2030.

The Safety Question

Have the hazards associated with the toy, its intended users and reasonably foreseeable use been systematically identified and controlled?

The Evidence Question

Can the manufacturer demonstrate through traceable assessment, testing and production records that the marketed toy corresponds with the product declared compliant?

The defining toy safety compliance question is: can the manufacturer demonstrate that the actual toy placed on the European market has been appropriately assessed for its users, hazards, materials, construction and foreseeable use—and that the evidence remains valid for continuing production?
Technical note: As of August 2026, Directive 2009/48/EC remains applicable to toys placed on the EU market, while Regulation (EU) 2025/2509 is in force and will become generally applicable from 1 August 2030. Certain provisions of the Regulation already apply from 1 January 2026. Product-specific requirements depend on toy classification, intended age group, hazards, materials, functions, harmonised standards and other applicable EU legislation. Manufacturers should verify the legislation and harmonised-standard references current at the time of conformity assessment. This article provides general technical information and does not replace a product-specific conformity assessment.
GLOBAL ALLIANCE REGISTER

How Global Alliance Register Can Support You

Global Alliance Register supports manufacturers, suppliers and responsible economic operators with independent technical-assurance services relevant to directive 2009/48/ec, regulation (EU) 2025/2509 & CE marking. Based on the article's emphasis on regulatory review, technical-documentation review and conformity assessment, GAR can coordinate competent specialists, laboratories, inspectors, auditors and accredited conformity-assessment resources as appropriate to the actual technical need. Within the context of this article, Global Alliance Register can support you in the following areas:

01

Review test records, inspection evidence, calculations, reports and other technical documentation relating to directive 2009/48/ec, regulation (EU) 2025/2509 & CE marking for completeness, consistency and traceability.

02

Review the applicable regulatory, technical and scope requirements for directive 2009/48/ec, regulation (EU) 2025/2509 & CE marking and define the responsibilities, classifications and assurance pathway relevant to the product or equipment.

03

Determine the applicable conformity-assessment route for directive 2009/48/ec, regulation (EU) 2025/2509 & CE marking, coordinate the required technical evidence and support independent third-party or Notified Body involvement where the governing framework requires it.

04

Map the applicable standards, specifications, acceptance criteria and technical requirements for directive 2009/48/ec, regulation (EU) 2025/2509 & CE marking to the evidence needed to demonstrate compliance, quality or performance.

05

Identify the changes affecting directive 2009/48/ec, regulation (EU) 2025/2509 & CE marking, perform a structured impact assessment and develop a transition plan covering responsibilities, timing, documentation and implementation evidence.

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