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Selling toys in the EU

In the EU, toys must meet the Toy Safety Directive 2009/48/EC before they are marketed. The manufacturer carries out a safety assessment and a conformity assessment, draws up technical documentation and an EC declaration of conformity, and affixes the CE marking. The Toy Safety Regulation (EU) 2025/2509 replaces the Directive from 1 August 2030.

Updated · Each section links to the official source it comes from

Main text
Directive 2009/48/EC on the safety of toys
Before sale
Safety assessment, conformity assessment and CE marking
Conformity routes
Harmonised standards, or EC-type examination by a notified body
Records
Technical documentation and declaration kept for 10 years
Chemicals
Limits on CMR substances, 19 heavy elements and allergenic fragrances
Next
Regulation (EU) 2025/2509 applies from 1 August 2030

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Has a safety assessment covered the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards? Read more
  2. 2Do the materials meet the limits for CMR substances, heavy elements and fragrances? Read more
  3. 3Which conformity route applies, and are the technical documentation and declaration drawn up? Read more
  4. 4Does the toy carry the CE marking, the names and addresses, and a batch or serial number? Read more
  5. 5Are the warnings, instructions and safety information right, and visible before purchase online? Read more
  6. 6What changes when the Toy Safety Regulation applies? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Safety requirements

The essential safety requirements a toy must meet before it is marketed.

  • The Directive lays down the safety criteria toys must meet before they can be marketed in the EU; toys must also comply with any other EU legislation that applies to them.
  • The essential safety requirements cover general risks to the health and safety of children and others such as parents or caregivers, and particular risks: physical and mechanical, flammability, chemical, electrical, hygiene and radioactivity.
  • The Directive has applied since 20 July 2011, and its chemical requirements since 20 July 2013.
  • Before a toy is placed on the market, the manufacturer, whether in the EU or outside it, carries out a safety assessment of its hazards and of the potential exposure to them.

How we help: Compliant Always keeps the safety assessment and test reports with each toy, dated, so the file shows what was assessed and when. Ask about this

Chemicals in toys

The chemical limits that apply to toys.

  • Substances that may cause cancer, change genetic information or harm fertility or an unborn child (CMR substances) are not allowed in accessible parts of toys beyond the concentration limits set under the CLP Regulation, unless considered safe after a rigorous scientific evaluation.
  • 19 'heavy elements', such as mercury and cadmium, are not allowed in toy parts accessible to children beyond the limits in the Directive.
  • 55 allergenic fragrances are banned; some of them, and another 11, may be used in certain toys if they are indicated on the label and meet further requirements.
  • REACH restrictions also apply: the restriction on intentionally added microplastics applied from 17 October 2023 to toys containing loose plastic glitter.
  • Under REACH entry 51, articles may not be placed on the market containing DEHP, BBP, DBP or DIBP at 0.1% or more by weight, individually or in any combination, in any plasticised material.

How we help: Compliant Always reads your material test reports against these limits and watches for new restrictions on the substances your toys contain. Ask about this

Conformity assessment and documentation

How a manufacturer shows a toy meets the requirements.

  • There are two routes: self-verification, applying harmonised standards covering the relevant safety requirements under internal production control; or EC-type examination by a notified body, followed by conformity to type.
  • The technical detail sits in harmonised standards developed by the European standardisation organisations CEN and CENELEC.
  • The manufacturer draws up technical documentation and an EC declaration of conformity; by drawing up the declaration, it takes responsibility for the toy's compliance.
  • Manufacturers keep the technical documentation and the EC declaration of conformity for 10 years after the toy is placed on the market (Article 4).
  • Notified bodies are designated by EU countries and listed in the NANDO database.

How we help: Compliant Always keeps the technical documentation, declaration and any EC-type examination certificate with the toy, and shows what is missing or out of date. Ask about this

CE marking, traceability and recalls

What identifies a toy and who stands behind it.

  • Only toys bearing the CE marking can be placed on the EU market; it is affixed to the toy, an affixed label or the packaging.
  • The manufacturer affixes its name and address and an element allowing the toy to be identified, such as a batch or serial number; an importer adds its own name and address.
  • Importers check the conformity assessment, technical documentation, marking and warnings, and keep a copy of the declaration; distributors verify the CE marking, names, addresses, instructions and warnings.
  • A manufacturer that believes a toy is not in conformity takes corrective measures, withdraws or recalls it, and informs national authorities where it presents a risk (Article 4).
  • EU country authorities check toys on the market and can withdraw or recall a toy, or prohibit its availability.

How we help: Compliant Always ties each document to the batch it covers, so an importer's or retailer's question is answered from the record. Ask about this

Warnings and instructions

What the toy and its packaging tell the buyer.

  • Warnings are preceded by the word 'Warning' or 'Warnings' and marked clearly on the toy, an affixed label or the packaging; small toys sold without packaging have them affixed.
  • Warnings that decide the purchase, such as minimum and maximum ages, appear on the consumer packaging or are otherwise clearly visible before purchase, including when the purchase is made online (Article 11).
  • The specific warnings in Part B of Annex V are used as worded there, and are not used where they conflict with the toy's intended use.
  • Toys come with instructions and safety information in a language or languages easily understood by consumers, as determined by the member state.

How we help: Compliant Always reads your packaging and listings against the warning rules and shows where a warning is missing. Ask about this

The Toy Safety Regulation

The Regulation that replaces the Directive.

  • Regulation (EU) 2025/2509 on the safety of toys, repealing Directive 2009/48/EC, was adopted on 26 November 2025.
  • It entered into force on 1 January 2026 and applies from 1 August 2030, after a transition period of four and a half years.
  • It targets chemicals that are particularly harmful for children, and relies on digital technologies for enforcement.
  • Toys will need a digital product passport holding compliance and other information, immediately accessible through a data carrier.

How we help: Compliant Always watches the Commission's toy safety pages for the acts that implement the new Regulation and shows which of your toys they touch. Ask about this

Who answers for what

WhoWhat they answer forHow we help
ManufacturerSafety and conformity assessment, technical documentation, the declaration, CE marking, identification, warnings and corrective action.The toy's file kept together, by toy and batch, for the 10 years it is needed.
ImporterChecking the manufacturer's assessment and documentation, keeping the declaration, and adding its own name and address.Suppliers' files read and dated before the goods arrive.
DistributorVerifying the CE marking, names, addresses, instructions and warnings before selling.The marking and warnings checked from the record.
Notified bodyEC-type examination and certificates, where the manufacturer uses that route.Certificates kept with the toys they cover, with their dates.

Member states

The Directive is applied through national law, and EU country authorities enforce it. Member states may set the language of warnings and safety instructions, and designate the notified bodies.

Shipping out of the EU?

Exporting toys from the EU

Questions businesses ask

Does a toy need CE marking to be sold in the EU?
Yes. Only toys bearing the CE marking can be placed on the EU market. It is the manufacturer's declaration that the toy meets the essential safety requirements.
What is the Toy Safety Regulation and when does it apply?
Regulation (EU) 2025/2509, adopted on 26 November 2025, replaces the Toy Safety Directive. It entered into force on 1 January 2026 and applies from 1 August 2030.
Do I need a notified body to test my toys?
Not always. A manufacturer can self-verify by applying harmonised standards, or have a notified body carry out an EC-type examination.
How long must toy technical documentation be kept?
For 10 years after the toy is placed on the market, together with the EC declaration of conformity.
What warnings must a toy carry in the EU?
Warnings preceded by 'Warning' or 'Warnings', using the wording in Annex V where it applies. Age warnings and others that decide the purchase must be visible before purchase, online included.
Which chemicals are restricted in toys in the EU?
CMR substances in accessible parts beyond set limits, 19 heavy elements such as mercury and cadmium beyond set limits, and 55 allergenic fragrances. REACH restrictions apply too.
What must an importer of toys do?
Check the manufacturer's conformity assessment and technical documentation, keep a copy of the declaration, check the CE marking, identification, instructions and warnings, and add its own name and address.
What must a distributor of toys check?
That the CE marking is affixed, the manufacturer's and importer's names and addresses and a batch or serial number are there, and the toy has its instructions, safety information and warnings.
Will toys need a digital product passport?
Yes, under the Toy Safety Regulation. Toys will need a digital product passport holding compliance and other information, accessible through a data carrier.
Who enforces toy safety in the EU?
EU country authorities check that toys on the market meet the requirements, and can withdraw or recall a toy, or prohibit it.
How does Compliant Always help with selling in the EU?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

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