The European Union already had some of the strictest toy safety rules in the world, yet dangerous toys continued to reach children, particularly via online sales and imports from non-EU countries. In response, the EU has adopted a new Toy Safety Regulation (EU) 2025/2509 that replaces the Toy Safety Directive and fundamentally reshapes how toy safety is regulated, enforced and documented.
This new framework aims to ensure a high level of protection for children while preserving the free circulation of toys in the internal market. It tightens the rules on chemicals, introduces a digital product passport for every toy, and clarifies the duties of manufacturers, importers, distributors and online platforms. This guide explains those changes in practical terms, with a focus on what they mean for businesses, lawyers and individual consumers.
The Toy Safety Regulation was published in the Official Journal of the European Union on 12 December 2025. The first provisions entered into force on 1 January 2026, with most of the remaining rules applying from 1 August 2030.
From Directive to Regulation: Why EU Toy Law Is Being Overhauled
Since 2009, toys in the EU have been governed by the Toy Safety Directive 2009/48/EC, which set safety requirements and was intended to ensure the free movement of toys across the EU. Over time, however, the European Commission’s evaluation revealed “a number of deficiencies” in its practical application, particularly:
- Shortcomings in ensuring a high level of protection against harmful chemicals in toys.
- Ineffective enforcement, especially for online sales, leaving “many unsafe toys on the EU market”.
The evaluation also showed that the directive, as a legal instrument, created additional problems:
- Member States had to transpose frequent amendments, leading to inconsistent application across the EU and making the process resource‑
- As a measure of total harmonisation, the directive already prevented Member States from adding additional safety requirements. Moving to a regulation would therefore not fundamentally change the policy approach, but would simplify and unify it.
The European Parliament also pushed for reform. In its own initiative report on the implementation of the directive, it called on the European Commission to strengthen protection of children from chemical risks, to ensure that risks posed by internet‑connected toys are addressed in EU law, and to improve enforcement, particularly in relation to online sales. All of this set the stage for the new Toy Safety Regulation.
Why a Toy Regulation instead of a Directive?
The new instrument is a regulation on the safety of toys, which aims both to harmonise health and safety requirements and to remove obstacles to the free movement of toys between EU Member States.
Because it is directly applicable in all Member States, it avoids divergent national transposition and makes it easier for manufacturers to work with a single set of EU rules instead of 27 different national laws. It also provides the legal basis for EU‑wide tools such as the digital product passport and harmonised customs controls.
In short, the EU has moved from a directive to a regulation in order to better deliver its objectives of protecting children’s health and facilitating the free movement of toys.
A New Generation of Chemical Safety Requirements
Generic bans on the most harmful substances
One of the most significant changes introduced by the Toy Safety Regulation is the overhaul of chemical safety rules. Under the previous legal framework, toys were already subject to a general prohibition on substances that are carcinogenic, mutagenic or toxic for reproduction (CMR substances). However, the Toy Safety Directive did not fully address other substances of particular concern, such as endocrine disruptors or chemicals affecting the immune, nervous or respiratory systems.
The new Toy Safety Regulation introduces broad, generic bans on the most harmful categories of substances. It provides that chemicals classified as CMR substances, endocrine disruptors, respiratory sensitisers, or as toxic to a specific organ are, generally, prohibited in toys. As soon as such substances are classified as hazardous under the EU rules on classification, labelling and packaging (CLP), they are automatically banned from use in toys. Only trace amounts that are technologically unavoidable under good manufacturing practice, and that do not make the toy unsafe, are tolerated.
The rationale is grounded in child health. According to the European Commission, chemicals affecting the endocrine system can cause adverse effects even at very low doses if exposure occurs during sensitive developmental stages, such as early childhood. Neurotoxic substances are particularly harmful to the developing brain, and the respiratory system of children is also more vulnerable to sensitisers and toxins. Accordingly, “children should also be adequately protected from allergenic substances and certain metals.”
In legal terms, this reflects a shift from a purely risk‑based to a more hazard‑based approach. Once a substance is recognised as belonging to one of these hazard classes, the regulatory default is prohibition in toys, rather than a case‑by‑case risk assessment for each specific use.
PFAS, bisphenols and other specific bans and restrictions
Beyond these generic bans, the EU-institutions have agreed on specific restrictions for certain well‑known problematic chemicals.
The European Parliament underlines that the new rules explicitly expand the list of prohibited substances to include endocrine disruptors, PFAS (per‑ and polyfluoroalkyl substances) and bisphenols, and ban “the intentional use of per- and polyfluorinated alkyl substances (PFAS) and the most dangerous types of bisphenols” in toys. The Council’s press material clarifies that there is a “limited ban on the intentional use of PFAS in toys,” with exemptions for toy components necessary for electronic or electric functions where the substance is fully inaccessible to children. Toys treated with biocidal products are generally prohibited, except where they are intended to be permanently kept outdoors. The new rules also introduce a general ban on certain categories of skin sensitisers, restrict the use of preservatives, and prohibit fragrance allergens in toys intended for children under three or in other toys designed to be put in the mouth.
Background documents from the Council confirm that, in addition to reinforcing the ban on CMR substances and extending it to endocrine disruptors and substances affecting the respiratory system or specific organs, the new rules introduce “a limited ban on the intentional use of per-and polyfluoroalkyl substances (PFAS) in toys” and a “ban of the presence in toys of 10 bisphenols.”
For businesses, these changes will often require significant adjustments to product design and supply chains. Materials, coatings, inks and electronic components may need to be reformulated to eliminate banned substances or reduce them to acceptable trace levels. Suppliers’ formulations will have to be reassessed, and in some cases, certain product lines may no longer be viable if safe and feasible substitutes do not exist.
Derogations and the role of ECHA
The regulation recognises that a strictly hazard‑based approach needs some flexibility. It allows the European Commission on the basis of scientific opinions from the European Chemicals Agency (ECHA), to permit specific uses of otherwise prohibited substances in toys. To grant such a derogation, ECHA must conclude that the use is safe, taking into account exposure from toys together with “overall exposure from other sources” and the particular vulnerability of children. ECHA must also determine that there are no suitable alternative substances or mixtures, and that the substance is not already prohibited in consumer articles under broader chemicals legislation.
Economic operators and other interested parties may request such assessments from ECHA using a standard format and tools. ECHA is expected to provide technical and scientific guidance, with particular attention to the needs of small and medium-sized enterprises (SMEs). If the European Commission subsequently decides to grant a derogation, the permitted uses are included in the annexes to the Toy Safety Regulation through delegated acts, which can be updated as science and technology evolve.
Practical implications for design, testing and supply chains
The European Commission’s impact assessment, which underpins the chosen policy option, suggests that banning the most harmful substances will have both costs and benefits.
On the benefit side, health gains from avoiding exposure to endocrine disruptors alone are estimated at between EUR 240 million and EUR 1.2 billion per year, taking into account long‑term effects that can span generations.
On the cost side, the assessment estimates that between 8.4% and 12.8% of toy models may be affected by generic bans where no derogation is possible. Around 4.6–7.2% of models may require redesign or chemical substitution, while 3.8–5.6% might no longer be made available if no suitable alternatives can be found. The corresponding one‑off adjustment costs are estimated in the tens to hundreds of millions of euros, with testing costs per toy model expected to rise from about EUR 2,200 to EUR 3,900, adding around EUR 7.31 million to 11.70 million annually across the sector.
For lawyers and compliance teams, this chemical regime means that early substance mapping, supply‑chain due diligence and contract clauses on regulatory changes become central to risk management. For businesses, it may require strategic decisions on which product lines to prioritise, redesign or phase out.
The Digital Product Passport: A New Compliance Backbone
What is the digital product passport?
Alongside the chemical rules, one of the most visible innovations is the digital product passport (DPP). In the new system, the familiar EU declaration of conformity for toys is no longer only a paper document. Instead, it becomes a digital record that can be accessed via a data carrier attached to the product.
Before placing a toy on the EU market, a manufacturer must create a DPP for each toy model. This passport must state that the toy complies with the regulation’s requirements, including the essential safety requirements, and must contain at least the information specified in Annex VI to the Toy Safety Regulation. The DPP must be kept up to date and made available for at least ten years after the toy is placed on the EU market, even in cases of insolvency, liquidation or cessation of activity by the economic operator who created it.
The DPP must be accessible in the languages required by the Member States where the toy is made available and must be accessible to consumers, market surveillance and customs authorities, notified bodies, the European Commission and other economic operators. Access is provided via a data carrier – for example, a linear barcode or a QR code – that is physically present on the toy, on a label or, in the case of very small toys, on the packaging. The data must be machine‑readable, structured and searchable, and must rely on open standards.
Crucially, the toy DPP is designed to fit into a wider EU architecture for sustainable products. It must meet “the same technical requirements for a product passport” as those laid down in the Ecodesign for Sustainable Products Regulation, including registration in a central registry and interconnection with customs IT systems. Where other EU legislation also requires a product passport, the aim is that a single passport can cover both safety and sustainability information, avoiding duplication of effort.
For consumers, the DPP promises easier access to safety information. The European Parliament stresses that it “will also offer consumers easy access to safety information and warnings, via a QR code, for example”. In practice, that could mean that a parent, standing in a shop or browsing online, scans a code and immediately sees the toy’s key safety features, chemical restrictions and age warnings.
Customs controls and the ‘Single Window’
The DPP also lies at the heart of a new approach to customs control. When toys enter the EU, declarants must indicate the toy’s unique product identifier in the customs declaration for release for free circulation.
Customs authorities then automatically verify that this identifier corresponds to one that is stored in the central DPP registry, using the so-called ‘EU Customs Single Window Certificates Exchange System’. If there is no valid reference to the product passport in the registry, the toy cannot be released for free circulation. The European Commission may, through delegated acts, allow customs to check other information stored in the registry, such as certain safety or origin data, against the information provided by the declarant, to enhance risk‑based controls.
The Council emphasises that this system should “facilitate customs control and market surveillance” and will apply equally to toys sold online and offline. For operators, this means that incomplete or inaccurate digital documentation will have a direct and immediate impact on the ability to import toys into the EU.
Benefits and burdens for businesses
Digitalisation also brings additional costs. The European Commission estimates that establishing the DPP systems and creating passports will cost EU manufacturers around EUR 18 million in one‑off investments and about EUR 10.5 million per year thereafter.
However, it also expects significant savings: providing information digitally, rather than on paper, could save around EUR 2.62 million to 3.93 million per year, and a more streamlined approach to inspections could reduce industry’s compliance costs by EUR 13 million to 20 million annually.
For businesses, the practical message is clear. Those that invest early in robust digital compliance systems – integrating DPP information into their existing enterprise resource planning (ERP) and product lifecycle management tools – are likely to see smoother customs processes, fewer disputes with authorities, and a more efficient internal handling of safety documentation. Those that delay will find that compliance gaps are more visible than ever.
Duties Across the Supply Chain: From Manufacturers to Online Platform
The new regulation confirms that all economic operators in the toy supply chain share responsibility for safety, though in different ways.
Manufacturers: safety assessment, documentation and labelling
Manufacturers remain the first line of compliance. They must design and manufacture toys so that they meet both the general safety requirement – that toys must not present risks to users’ or third parties’ health or safety, including psychological well‑being and cognitive development – and the particular safety requirements set out in Annex II to the Toy Safety Regulation.
Before placing a toy on the EU market, manufacturers must carry out and document a comprehensive safety assessment, covering chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards and the potential exposure to each. For chemicals, the assessment must consider exposure to individual substances and any known additional hazards arising from combined exposure to multiple chemicals present in the toy, considering the cumulative effects and obligations under the broader chemicals regime.
Manufacturers must then perform the appropriate conformity assessment procedure, such as internal production control when harmonised standards or common specifications are fully applied, or EU‑type examination by a notified body plus conformity to type in more complex or higher‑risk cases. They must create and maintain the DPP, affix the CE marking and data carrier, and ensure that toys bear identifying marks and the manufacturer’s name and contact details, including an electronic address. Instructions and safety information must be provided in languages easily understood in the Member States where the toy is sold.
Warnings play a crucial role. Toys must include general warnings specifying appropriate user limitations, such as minimum or maximum age, weight ranges and the need for adult supervision where relevant. Certain categories of toys – for example, toys not intended for children under three, activity toys, functional toys, chemical toys, skates and scooters, aquatic toys, toys in food, and toys strung across cradles – require specific warnings laid down in Annex III. These warnings cannot contradict the toy’s intended use. They must be clearly visible to the consumer before purchase, including in distance and online sales, and must be legible and understandable.
Manufacturers must keep technical documentation and the DPP for ten years after the toy is placed on the market, ensure that series production continues to conform even if designs or standards change, and investigate complaints and safety issues. They must maintain an internal register of complaints, recalls and other corrective measures, while keeping only the personal data that are necessary for these investigations and deleting them no later than five years after they were recorded. When they consider, or have reason to believe, that a toy is non‑compliant or presents a risk, they must promptly take corrective action, including withdrawal or recall if needed, and inform market surveillance authorities and consumers through the channels laid down in the General Product Safety Regulation.
Legal obligations for Authorised representatives under the EU Toy Safety Regulation 2026
For non‑EU manufacturers, the Toy Safety Regulations allows the appointment of an authorised representative established in the EU.
The representative’s mandate cannot shift core design or documentation duties away from the manufacturer, but must at least empower the representative to keep technical documentation and ensure that the DPP is available for ten years, to provide information to authorities on request, and to cooperate with them on measures to eliminate risks. Where a manufacturer outside the EU appoints an authorised representative, that mandate must include the tasks set out in Article 4 of the Market Surveillance Regulation, making the representative a key contact point for authorities.
Legal obligations for Importers under the EU Toy Safety Regulation 2026
Importers, as the market operators who first place third‑country toys on the EU market, must ensure that only toys complying with the Toy Safety Regulation are placed on the market.
Before doing so, they must verify that the manufacturer has carried out the necessary conformity assessment and drawn up technical documentation, that instructions and safety information are available in the appropriate languages, that the DPP has been created and registered, and that the CE marking and data carrier are affixed. They must indicate their own name and contact details on the toy or its packaging, ensure that storage and transport conditions do not jeopardise compliance, keep the unique product identifier and ensure authorities can access the technical documentation for ten years.
Importers also have to investigate complaints, maintain relevant records and inform manufacturers, distributors and online marketplaces of any safety issues they identify.
Legal obligations for Distributors under the EU Toy Safety Regulation 2026
Distributors, who supply toys after they have been placed on the EU market, must act with due care in relation to the regulation’s requirements.
That includes checking that toys are accompanied by instructions and safety information in appropriate languages, that the data carrier and CE marking are in place, and that the manufacturer’s and importer’s obligations concerning identification and contact details have been fulfilled. They must ensure that the storage and transport conditions under their responsibility do not compromise safety and are required to take action, including withdrawal or recall and notification to authorities, if they consider that a toy they have made available is non‑compliant or presents a risk.
If an importer or distributor markets a toy under their own name or trademark, or modifies it in a way that may affect compliance, the Toy Safety Regulation treats them as a manufacturer. They then assume all the manufacturer’s obligations and liabilities.
Legal obligations for Online marketplaces and fulfilment service providers under the EU Toy Safety Regulation 2026
Finally, the Toy Safety Regulation recognises the central role of online marketplaces and fulfilment service providers in modern toy distribution.
Given their growing role in the sale and promotion of toys, online marketplaces must ensure that their interfaces allow sellers to display CE marking, safety warnings and links to the DPP. Toys that do not comply with the safety rules are to be treated as “illegal content” under the Digital Services Act (DSA). The Council’s background text stresses that non‑conforming toys will be regarded as illegal content for DSA purposes and that toy‑specific obligations for online marketplaces include making sure that CE marks, pre‑purchase warnings and DPP links can be displayed on their platforms.
Fulfilment service providers, who store and ship products on behalf of traders, are also treated as economic operators under the market surveillance framework, meaning that they, too, can be drawn into enforcement measures where non‑compliant toys are concerned.
For these digital intermediaries, the regulatory message is clear: toy safety is not just an issue for manufacturers “somewhere else”. Platforms may need to redesign their listing flows, require sellers to provide DPP identifiers, and build processes for responding to alerts from market surveillance authorities via systems such as EU Safety Gate.
Enforcement AND Safeguards Mechanisms
The new Toy Safety Regulation does not operate in isolation. It is closely linked to the horizontal Market Surveillance Regulation and the General Product Safety Regulation. Member States must organise their toy market surveillance in line with those rules, including the requirement that toys may be placed on the EU market only if an economic operator established in the EU is responsible for specified tasks, such as providing documentation and cooperating with authorities.
When a market surveillance authority has sufficient reason to believe that a toy presents a risk to health or safety, it must carry out an evaluation covering all relevant requirements of the Toy Safety Regulation, in cooperation with the relevant economic operators. If the authority concludes that the toy is non‑compliant, it must require the operator to take appropriate corrective action within a reasonable period, in particular to bring the toy into conformity, to withdraw it or to recall it. If the operator fails to act, the authority can itself take provisional measures, such as prohibiting or restricting the toy, withdrawing it from the market or ordering a recall, and must inform the European Commission and other Member States of the measure and the reasons for it, including whether the issue lies in the toy, in harmonised standards or in common specifications.
If other Member States or the European Commission object to a national measure, an EU safeguard procedure is triggered. The European Commission then consults with Member States and the relevant economic operator, and evaluates whether the national measure is justified. It adopts an implementing act deciding whether the measure should stand or be withdrawn. If the measure is justified, other Member States must take corresponding measures to ensure that the toy is withdrawn or recalled throughout the EU.
Experience under the Toy Safety Directive showed that some toys, though compliant with the particular safety requirements and harmonised standards at the time of placing on the market, nonetheless posed risks in practice. The new regulation therefore makes it clear that market surveillance authorities may also act against toys that meet the specific requirements but fail to comply with the overarching general safety requirement. It also gives the European Commission the power, in exceptional cases, to adopt EU‑wide measures against such toys or categories of toys when new risks emerge.
Transition period and evaluation
ecause this is a major reform, the Toy Safety Regulation provides for a transition period. It was published in the Official Journal of the European Union on 12 December 2025 and entered into force on 1 January 2026. However, most provisions apply only 30 months after entry into force.
Key transitional rules include:
- Toys that are placed on the market in conformity with the Toy Safety Directive before the application date may continue to be made available for a further 12 months, i.e. up to 42 months after the Toy Safety Regulation’s entry into force.
- EC type‑examination certificates issued under the Toy Safety Directive remain valid until that same 42‑month point, unless they expire earlier.
The Council and Parliament communicate this to stakeholders as a transition period of four and a half years, giving industry time to implement, for example, the DPP and chemical substitutions.
The European Commission will evaluate the Toy Safety Regulations five years after its entry into force and every five years thereafter, assessing its effectiveness, efficiency, relevance, added value and coherence, and reporting to the European Parliament and the Council. Its findings may lead to further legislative or technical adjustments.
The Toy Safety Directive is repealed with effect from 1 August 2030.
Strategic Takeaways
For businesses, such as manufacturing companies, the message is to start early. A structured internal project to map current substance use, testing practices, documentation and IT systems against the new requirements will pay off. Dialogue with suppliers about substitution and data transparency is critical. Investing in digital tools for creating, maintaining and sharing DPPs – ideally integrated into existing systems – will make the difference between smooth market access and friction at EU borders.
For legal professionals, the Toy Safety Regulation opens a broad field of advisory work and potential disputes. Clients will need help understanding and applying the new chemical bans, managing DPP obligations, allocating responsibilities in cross‑border supply chains and complying with overlapping frameworks such as the Market Surveillance Regulation, the General Product Safety Regulation and the Digital Services Act. Keeping track of delegated and implementing acts that refine annexes – for example, lists of substances, passport content or customs commodity codes – will be essential.
For individuals and parents, the Toy Safety Regulation should translate into safer toys and better information. Looking for CE marking, appropriate age warnings and, in future, scannable codes that lead to clear safety information will become part of responsible purchasing. It is wise to be especially cautious with very cheap imported toys and, when in doubt, to check whether such products or similar ones appear on EU recall lists or in EU Safety Gate. It is also important to remember that second‑hand toys are generally not covered by the Toy Safety Regulation. Their safety is addressed under more general product safety rules, so some extra vigilance is warranted.
CONCLUSION
The new Toy Safety Regulation represents a major update to toy safety law and responds to concrete shortcomings identified over more than a decade of experience. It:
- moves from a directive to a regulation to ensure uniform application across the EU;
- introduces far‑reaching generic bans on the most harmful chemicals, including endocrine disruptors, respiratory sensitisers and organ‑toxic substances, as well as specific restrictions on PFAS, bisphenols, skin sensitisers, biocidal treatments and fragrance allergens;
- deploys a digital product passport for every toy, integrated with customs and market surveillance systems, making non‑compliant toys much harder to import and easier to trace; and
- clarifies and strengthens obligations for all economic operators, including online marketplaces, in line with the broader EU digital and product‑safety framework.
For businesses, it demands strategic investment in safer design and digital compliance. For lawyers, it opens a further field of regulatory advice and litigation. For parents and individuals, it promises safer toys and better information, even in an increasingly digital marketplace.
