EU Safe Toys Regulation

The Safe Toys Regulation in the European Union (EU) is designed to ensure the safety of toys sold within the EU market. The aim is to protect children’s health and safety and prevent the sale of potentially dangerous toys.

In 2009, the EU adopted the Safe Toys Directive. This directive outlines the essential safety requirements that toys must meet before being placed on the EU market. Many of the requirements are described in the norm EN71. In 2025, the EU legislators agreed on the revision of the Directive and its transformation into the Safe Toys Regulation. This means that all EU member states have to implement the Regulation as it is and cannot make adaptions on national level.

EU Toy Safety Directive (2009/48/EC) vs. EU Toy Safety Regulation (2025)

Category	Directive 2009/48/EC	Regulation (2025)
Legal Instrument	Directive – requires transposition into national laws by EU Member States	Regulation – directly applicable and enforceable across all EU Member States without national transposition
Scope	Applies to toys intended for children under 14 years	Same age range; however, certain products like scooters over 20 kg and paper-based books for children over 36 months are excluded
Chemical Safety	Bans carcinogenic, mutagenic, and reprotoxic (CMR) substances outside the toy; restricts 19 heavy metals and 55 allergenic fragrances in accessible parts of toys	Expands bans to include endocrine disruptors, PFAS, certain bisphenols, and other hazardous substances; lowers maximum limits for several substances; extends certain chemical restrictions to all toys, not just those for children under 36 months
Safety Assessment	Requires manufacturers to conduct safety assessments focusing on physical, mechanical, and chemical hazards	Mandates comprehensive safety assessments covering chemical, physical, mechanical, electrical, flammability, hygiene, and radioactivity hazards; includes evaluation of risks to children’s mental health and cognitive development, especially for digital toys
Conformity Documentation	Requires a Declaration of Conformity (DoC) and CE marking	Introduces a Digital Product Passport (DPP) accessible via a QR code, replacing the traditional DoC; includes detailed product information such as manufacturer details, compliance references, and safety warnings
Online Sales	Limited provisions specific to online marketplaces	Imposes obligations on online marketplaces to ensure toys comply with safety requirements; platforms must allow display of CE marking, safety warnings, and DPP links before purchase completion
Market Surveillance	Relies on national authorities for market surveillance	Enhances enforcement by providing authorities with access to DPPs for efficient checks; introduces IT systems to screen DPPs at EU borders, facilitating the identification of non-compliant toys
Warnings & Labelling	Requires clear labelling indicating recommended age range and specific warnings; CE marking must be affixed to the toy or its packaging	Specifies that warnings must be clearly visible and may be accompanied by standardized pictograms; mandates inclusion of safety information in the DPP
Transition Period	Applied since 20 July 2011; chemical safety requirements applied since 20 July 2013	Enters into force 20 days after publication in the EU Official Journal; most obligations apply after a 30-month transition period, with DPP requirements applying after 48 months

Manufacturers, importers, and distributors must stay informed about the latest regulations and standards in the EU, as these requirements may change over time to address emerging safety concerns. Compliance with these regulations is crucial to ensure the safety of children and avoid legal consequences for non-compliance.

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