EU Toy Safety Regulation 2025/2509: Protecting Children in Europe

Claire Pierrefeu
22 hours ago
3 min read

On 26 November 2025, the European Parliament and the Council adopted Regulation (EU) 2025/2509, a major update that repeals Directive 2009/48/EC to raise toy safety standards across the European Union. The regulation defines a toy as any product designed for play by children under 14, even if that function is not exclusive.

Children are a particularly vulnerable group, and ensuring their protection from physical and chemical risks is crucial. This regulation aims not only to safeguard young consumers but also to harmonize toy safety rules across EU Member States, including the online marketplace.

Chemical Safety of Toys: Ban on Harmful Substances

One of the major advances of this regulation concerns chemical safety. Generic bans now apply to the most dangerous substances: carcinogenic, mutagenic, or toxic for reproduction (CMR) substances, as well as endocrine disruptors and respiratory and skin sensitizers.

The regulation also introduces:

A strict ban on the intentional use of PFAS (per- and polyfluoroalkyl substances) and certain bisphenols, to protect the developing hormonal system of young children.

A list of substances subject to specific limit values, such as heavy metals, nitrosamines, and allergenic fragrance substances.

The European Chemicals Agency (ECHA) plays a central role in assessing these risks and managing potential exemptions, which are only granted if no safe alternative exists.

Responsibilities of Manufacturers, Importers, and Distributors under EU Toy Safety Regulation 2025/2509

The regulation clarifies the obligations of each operator:

Manufacturer Responsibilities

Conduct a full safety assessment
Prepare technical documentation
Create a digital passport containing compliance and safety information

Importer Responsibilities

Ensure the manufacturer has fulfilled their obligations before placing the product on the EU market

Responsibilities of Distributors and Online Marketplace Providers

Act diligently and ensure safety warnings are clearly visible, even during remote purchases
Immediately inform authorities via the Safety Business Gateway portal and take corrective actions, such as withdrawing or recalling the toy, in case of a dangerous product

Safety Gate Alerts 2025: Chemical Hazards in Toys

As an example in 2025:

326 chemical alerts were recorded on 261 toys, concerning hazardous chemical substances now mostly covered by the new Regulation.

Alertes d'ordre chimique recensées sur les jouets en 2025

Methodologies for Assessing Children’s Exposure to Chemicals in Toys

Methodologies for assessing children’s chemical exposure have evolved over the years:

Timeline of Methodologies

2002: Information sheet on children’s toys – Assessing consumer risks (RIVM report 612810012/2002)
2008: Chemicals in toys – General methodology for assessing chemical safety of toys – Focus on elements (RIVM report 320003001/2008)
2003-2024: European Commission guidance on toy safety to help supply chain actors comply with the Directive
2016: ANSES study on children under 3 years using plastic toys
2024: OECD study on methodologies for estimating children’s exposure to toys

These publications gradually build a solid methodological framework for risk assessment, particularly regarding chemical safety. CEHTRA aligns with this approach: these methodologies structure our evaluations, and we support actors in transforming these references into product compliance evidence.

CEHTRA: Your Partner for Securing Toy Safety

Regulation (EU) 2025/2509 represents a major step forward for toy safety in Europe, strengthening the protection of children and clarifying the responsibilities of all supply chain actors. Faced with these new requirements, it is essential to rely on solid regulatory expertise to ensure product compliance and protect young consumers.

At CEHTRA, we support manufacturers, importers, and distributors in risk assessment, technical documentation, and regulatory compliance. Discover our solutions and approach on our Expertise page, and contact us via our contact form to discuss your projects and secure your toys today.

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