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Regulation (EU) 2025/2509: The New EU Framework for Toy Safety and Compliance

This blog was originally posted on 18th December 2025. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.

AUTHORED BY CATHERINE BURKE, SENIOR QUALITY ASSURANCE LEAD (REGULATORY CONTENT), COMPLIANCE & RISKS

Introduction

Regulation (EU) 2025/2509 establishes the new legal framework for the safety of toys in the European Union, replacing the Toy Safety Directive 2009/48/EC. It introduces updated safety requirements, obligations for manufacturers, fulfillment service providers, and online marketplaces, and a digital product passport system to ensure traceability and compliance.

Manufacturers must conduct comprehensive safety assessments covering mechanical, chemical, electrical, and other hazards, taking into account children’s vulnerabilities, and document these assessments in technical files. The Regulation strengthens protections against hazardous substances, including endocrine disruptors and PFAS, and sets clear timelines for implementation, market surveillance, and conformity assessment.

Key Dates

The Safety of Toys Regulation (EU) 2025/2509 was published in the Official Journal of the European Union on 12 December 2025. It will enter into force on 1 January 2026 and will apply from 1 August 2030, with the exceptions of Articles 28 to 44 and Articles 49 to 55, which apply from its effective date. Articles 28 to 44 relate to Notification of Conformity Assessment Bodies and Articles 49 to 55 relate to Delegated Powers and Committee Procedures.

The Commission may adopt implementing acts to determine whether certain products or product categories fall within the scope of the Regulation. These adopting acts can be implemented no sooner than 18 months from the date of entry into force i.e. 12 June 2027, unless there are duly justified cases.

Requests can be made to the European Chemicals Agency (ECHA) for an assessment of a substance or mixture that is prohibited under Part III, point 4, 5 or 6, of Annex II of the Regulation. Before 2 February 2027, the ECHA will draw up and make publicly available a format for the submission of requests for assessment. Before then, the ECHA will also draw up and make publicly available technical and scientific guidance on how to submit requests and on how the analysis supporting these requests is to be conducted.

The Toy Safety Directive 2009/48/EC will be repealed on 1 August 2030. EC type-examination certificates issued under the Directive will remain valid until 1 February 2031, unless they have expired before this date.

Chapter VIII, regarding Market Surveillance, will apply mutatis mutandis to toys that are placed on the market in accordance with the Toy Safety Directive before 1 August 2030 in place of Articles 42, 43 and 45 of the Toy Safety Directive.

Warnings

Article 6 of Regulation (EU) 2025/2509 applies to warnings and, similar to the Toy Safety Directive, provides that toys should bear warnings which specify appropriate user limitations. These user limitations include the minimum age of the user. This is a minor deviation from the Directive, which required the minimum or maximum age of the user.

Annex III sets out the specific warnings that each category of toy should bear. Per Annex III warnings should be preceded by the word ‘Warning’ or with the following pictogram:

The pictogram should be displayed prominently and does not need to be repeated before each warning. It should be at least 10 mm in black triangle, yellow background and black exclamation mark. The font size of the warnings should be such that the x-height is equal to or greater than 1,2 mm with sufficient enough contrast between the print and the background to ensure legibility and visibility, notwithstanding the foregoing minimum height of pictograms, which will be not less than 10 mm. Where the warning is added to the packaging or containers where the surface area is 80 cm2 or less, the x-height of the font size will be equal to or greater than 0,9 mm.

Digital Product Passport

Regulation (EU) 2025/2509 introduces a digital product passport for toys. A digital product passport is a set of data specific to a toy that contains certain information and that is accessible via electronic means through a data carrier. The digital product passport should correspond to a specific toy model; should show that the toy is in compliance with the Regulation and other essential safety requirements; contain at least the information set out in Part I of Annex VI of the Regulation; be accurate, complete and up to date; be available in the language or languages required by the Member State where the toy is placed on the market; be accessible; be available for a period of 10 years after the toy was placed on the market; and be connected to a persistent unique product identifier through a data carrier. The digital product passport demonstrates conformity with the Regulation.

The data carrier, defined as a linear barcode symbol, a two-dimensional symbol or other automatic identification data capture medium that can be read by a device, should be physically present on the toy or on a label attached to the toy.

Per Annex VI, the digital product passport must contain:

unique product identifier of the toy;
the name and address of the manufacturer and, when applicable, of the manufacturer’s authorised representative, along with the unique operator identifier;
the name and address of the economic operator responsible for carrying out the tasks set out in Article 4 of Regulation (EU) 2019/1020 relating to products subject to certain Union harmonisation legislation, along with the unique operator identifier;
a mention that the passport is issued solely under the responsibility of the manufacturer;
the object of the passport (identification of toy allowing traceability and including a colour image of sufficient clarity to enable the toy to be identified);
the commodity code, where applicable, per Council Regulation (EEC) No 2658/87 (the first four digits shall be 9880, the fifth and the sixth digit shall correspond to the Combined Nomenclature chapter to which the goods of the component part belong and the seventh and the eighth digit shall be 0) under which the toy is classified when the passport is created;
references to all EU law that the toy complies with;
a mention that this Digital Product Passport replaces the EU Declaration of conformity under Regulation (EU) 2024/1689 or (EU) 2024/2847, Directive 2011/65/EU, 2014/30/EU, 2014/35/EU or 2014/53/EU or Delegated Regulation (EU) 2019/945 where applicable;
references to the relevant harmonised standards used, or references to common specifications in relation to which conformity is declared;
the notified body name and number which has intervened in the conformity assessment procedure and issued a certificate, as well as the reference to the certificate, where applicable;
the CE marking;
a list of allergenic fragrances that are present in the toy and that are subject to specific labelling requirements;
a communication channel such as a telephone number, an electronic address, a dedicated section of their website; and
a reference to the digital product passport service provider that is hosting a backup copy of the digital product passport.

Further to this, the digital product passport may contain safety information and warnings and instructions for use.

The digital product passport should be fully interoperable with other digital product passports required by other EU legislation in relation to the organisation, semantic and technical aspects of end-to-end communication and data transfer.

All data included in the digital product passport should be based on open standards developed with an interoperable format and should be machine readable, structured, searchable and transferable. It is typically in the form of a QR code. Access should be free. It should be stored by the economic operator who created it or by digital product passport service providers. If a new digital product passport is created for a toy that already has one, it should be linked to the original passport(s). The passport should be designed to ensure security, privacy and fraud prevention. It is prohibited to store personal data related to the customer in the passport.

Safety Assessments

Before placing a toy on the market, manufacturers must carry out a safety assessment of any hazards that the toy might exhibit, along with an assessment of the likelihood of encountering such hazards. The safety assessment should cover all mechanical, flammability, physical, hygiene, electrical and radioactivity hazards and the likelihood of encountering such hazards. It should take into account potential exposure to individual chemicals and any known hazards from combined exposure to different chemicals present in the toy.

It should take into account the particular vulnerabilities of children in relation to the use of toys as intended in relation to toys that fall under the scope of Regulation (EU) 2024/1689 or (EU) 2024/2847 or Directive 2014/53/EU. It should also be updated when any additional information becomes available. The safety assessment should be included in the technical documentation referred to in Article 27 of the Safety of Toys Regulation.

Obligations of Fulfilment Service Providers

Regulation (EU) 2025/2509 establishes obligations for fulfilment service providers in Article 11. Fulfilment service providers are required to act with due care when they are contributing to making toys available on the market. They must ensure that the conditions during warehousing, packaging, addressing or dispatching do not compromise the toy’s compliance with the essential safety requirements. They must participate in product recalls and withdrawals. And, if they have reason to believe that toys are not in conformity with the Regulation, they must not support making them available on the market until the toys have been brought back into conformity.

Obligations of Online Marketplaces

Regulation (EU) 2025/2509 further establishes toy safety obligations for providers of online marketplaces. These are set out in Article 14 of the Regulation and include an obligation on providers of online marketplaces to ensure that their online interface is designed in a way that allows economic operators to provide the CE marking, any warnings that should be visible to customers before they make any purchases online and the weblink or data carried where the digital product passport is accessible.

Toys that do not comply with safety requirements, or that do comply with safety requirements but pose a risk to the health and safety of children or other persons will be considered to be a dangerous product for the purpose of meeting the requirements of Article 22 of the General Product Safety Regulation EU) 2023/988.

Harmful Chemicals

Regulation (EU) 2025/2509 prohibits the presence, in toys or in micro-structurally distinct parts of toys, of harmful substances (substances classified in Part 3 of Annex VI of the CLP Regulation) with endocrine-disrupting properties for human health categories 1 or 2. It also prohibits the presence of harmful substances categorised as skin sensitisation category 1A.

Further, Regulation (EU) 2025/2509 introduces a ban on the intentional use of PFAS (per- and polyfluoroalkyl substances) in toys or micro-structurally distinct parts of toys.

These substances may be used in toys if they are listed in Part C of the Appendix. Part C of the Appendix relates to toys and toy components made of stainless steel, toy components which are intended to conduct an electric current and neodymium-based magnets used in toys where the magnets cannot be swallowed or inhaled.

Toys should not have a biocidal function and should not be treated as biocidal products. They should not be treated with, or intentionally include, biocidal products, unless they are intended to be always kept outdoors.

The allergenic fragrances which are listed in Part B, point 1, of the Appendix to Annex II are not permitted in toys that are intended to be used by children under 36 months or toys that are intended to be placed in the mouth, unless it is unavoidable and the level does not exceed 10 mg/kg.

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