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European Parliament and Council Approve First Reading of Toy Safety Regulation
22 Apr 2025
European Parliament and Council Approve First Reading of Toy Safety Regulation
Keywords
The European Parliament and the Council of the European Union have voted to adopt the first reading of a new Toy Safety Regulation, which aims to replace the current EU Toy Safety Directive. The proposed regulation seeks to ensure the safety of toys sold across the EU, protect children's health, and facilitate the free movement of compliant toys within the internal market.
Scope of the Regulation
The regulation applies to toys intended for use by children under 14 years of age, including products designed or expected to be used for play. It excludes items such as playground equipment for public use, toy vehicles powered by combustion engines, and steam-powered toys.
Key Safety Requirements
1. General Safety Requirements
Toy safety assessments must account for children’s behavioral characteristics, including their lack of risk awareness, and foreseeable misuse. For digital toys, psychological and cognitive risks, as well as data protection and cybersecurity, must also be considered.
2. Specific Safety Requirements
2.1 Physical and Mechanical Properties
2.1.1 Choking and Swallowing Hazards: Small parts must comply with EN 71 standards to prevent ingestion by children under 36 months. Packaging must be designed to eliminate suffocation risks.
2.1.2 Mechanical Strength: Toys must withstand stress during regular use without breaking or deforming. Moving parts must be secured to prevent injury or detachment.
2.1.3 Sound Safety: Continuous noise must not exceed 85 dB, and impulse noise must not exceed 115 dB, in line with Directive 2003/10/EC.
2.2 Flammability
Materials must be non-flammable or have controlled burning rates (e.g., flame-resistant plush toys). The use of explosive substances, such as certain foaming agents, is prohibited.
2.3 Chemical Restrictions
2.3.1 Prohibited Substances: Toys must not contain CMRs (carcinogenic, mutagenic, or reproductive toxicants), endocrine disruptors (e.g., BPA), or persistent pollutants (e.g., PFAS).
2.3.2 Migration Limits: Heavy metals like lead (≤2.0 mg/kg) and cadmium (≤1.3 mg/kg) must meet strict thresholds. Trace impurities are permitted only if technically unavoidable and aligned with Good Manufacturing Practices.
2.3.3 Electrical Safety
Toys must operate at ≤24V (AC or DC). Components must be insulated to prevent electric shock, and overheating must be prevented. Electronic systems must feature fault-tolerant designs.
2.4 Hygiene and Radiation
Toys intended for oral contact must be easily cleanable to prevent microbial growth. Liquid-filled toys must be protected against contamination. Compliance with Euratom legislation is required for radioactive content.
3. Digital Toy Safety
Connected toys must comply with EU cybersecurity and data privacy standards. AI-integrated toys must meet the requirements of the upcoming EU AI Act, including psychological risk assessments.
Responsibilities of Economic Operators
1. Definitions and Roles
Economic operators include manufacturers, importers, distributors, authorized representatives, and online marketplaces.
2. Manufacturer Obligations
2.1 Ensure product compliance with all safety requirements and conduct thorough risk assessments.
2.2 Apply appropriate conformity assessment procedures (internal checks or third-party verification).
2.3 Affix the CE mark visibly and permanently, and create a Digital Product Passport (DPP) containing compliance documents, safety assessments, and traceability data.
2.4 Provide appropriate labels, instructions, and warnings. Report accidents and recall unsafe products.
3. Importer Obligations
3.1 Verify product compliance before entering the EU market.
3.2 Ensure clear labeling and proper storage.
3.3 Cooperate in risk mitigation and provide consumer support where necessary.
4. Distributor Obligations
4.1 Ensure no alteration of product safety during distribution.
4.2 Verify labeling and documentation.
4.3 Monitor risk and suspend sales if necessary.
5. Online Marketplace Obligations
5.1 Remove non-compliant toys upon regulator request.
5.2 Display safety information and establish a complaint mechanism.
5.3 Require sellers to provide conformity evidence (CE mark, DPP, etc.).
6. Authorized Representatives
6.1 Act on behalf of non-EU manufacturers.
6.2 Manage documentation and liaise with market authorities.
6.3 Cannot assume design or production responsibilities.
7. Other Key Duties
7.1 Comply with GDPR when handling personal data.
7.2 Maintain supply chain traceability.
7.3 EU to provide technical guidance and translation tools to support SMEs.
Compliance and Certification Framework
1. CE Marking
1.1 Required on all toys to indicate compliance
1.2 Must be visible on the toy, packaging, or instructions.
1.3 For small or complex toys, CE may appear only on the packaging or accompanying leaflet.
2. Conformity Assessment Procedures
2.1Module A (Internal Production Control): For low-risk toys conforming to harmonized standards (e.g., EN 71).
2.2 Module B + C (Third-Party Verification): For high-risk toys or those not covered by harmonized standards. A notified body will conduct a type examination and issue a certificate.
3. Digital Product Passport (DPP)
3.1 Mandatory for all toys, containing detailed compliance information.
3.2 Must be accessible via QR code or RFID tag.
3.3 Must follow EU standard formats with encrypted sensitive data.
3.4 To be finalized before product launch and retained for 10 years.
4. Notified Bodies
4.1 Third-party certification bodies must be accredited by EU member states and approved by the European Commission.
4.2 Responsible for testing, documentation review, and production audits.
4.3 Subject to regular oversight by EU authorities.
Market Surveillance and Enforcement
Monitoring: National authorities will inspect products and share information via the EU Safety Gate system.
Penalties: Non-compliant products may be recalled, removed from shelves, or trigger financial and legal penalties.
Transition Period: Products compliant with the 2009/48/EC directive can remain on the market until a specified transition deadline in 2025.
Essential Compliance Documents
Technical Documentation: Includes design files, material lists, test reports, and risk assessments. Must be retained for 10 years.
EU Declaration of Conformity: Signed by the manufacturer, stating full regulatory compliance, including CE marking details.
Disclaimer: Blooming reserves the right of final explanation and
revision for all the information.