Directive 2009/48/EC on the safety of toys (the “Toy Safety Directive”) contains the rules on the supply and sale of toy products in the EU. It sets out a number of important requirements on toy safety, labelling, warnings and administrative obligations.
It is your responsibility to comply with the Toy Safety Directive and the national implementation of the Toy Safety Directive in EU Member States. This material is for informational purposes only. It is not intended as legal advice. We encourage you to consult your legal counsel if you have questions about the laws and regulations concerning your product.
The Toy Safety Directive sets out obligations for manufacturers, authorised representatives, importers and distributors of toys.
The Toy Safety Directive applies to all toys. Toys are products designed or intended for use in play by children under the age of 14. The product does not have to be intended exclusively for “play”, it could have other functions as well, e.g. a keyring with a teddy bear attached to it or a soft, filled, animal-shaped backpack. Any product designed with a potential play function, being attractive to or marketed for children could be considered a toy in scope of the directive.
There are a number of product types that are excluded from the scope of the legislation. A full list of excluded products is contained in Article 2 and Annex I of the Toy Safety Directive. This includes, by way of example, puzzles with more than 500 pieces, sports equipment such as roller skates intended for children above 20kg, baby soothers, toy steam engines and slings/catapults.
Manufacturers are responsible to ensure that a toy undergoes a safety assessment and conformity assessment procedure. This is done either by (i) self-verification by using the European-harmonised standards or by (ii) third-party verification via a notified body. A list of European-harmonised standards can be found here: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/toys.
A toy must comply with the essential safety requirements listed in Annex II of the Toy Safety Directive, which are both general (e.g. health and safety of children and others such as parents/caregivers) and specific (e.g. relating to physical, chemical and mechanical risks, flammability etc.), before they can be sold in the EU. Toys, including chemicals that they contain, must not jeopardise the health and safety of people when they are used in a foreseeable way.
There are specific requirements for toys intended to be used by children under the age of 36 months or by other specified age groups, e.g. toys for use by children under the age of 36 months must not contain small parts or certain chemicals.
Documentation, markings and warnings
Manufacturers are responsible for ensuring that toys are CE-marked, have a declaration of conformity and are accompanied by instructions, safety language and warnings in the official language of the Member States which the toys are being sold in. Where a warning will determine the decision to purchase the toy (e.g. minimum or maximum age for users), this must be placed on the consumer packaging or otherwise be clearly visible to the consumer before purchase. Manufacturers are also required to maintain a technical file.
The toy must bear a type, batch, serial or model number, or other element allowing its identification. It must also bear the name and an EU address for the manufacturer or importer. An importer is also responsible for checking that the toy bears the manufacturer’s details. If it is not possible to have this information on the toy, it can be placed on the packaging or an accompanying document.
Importers must keep a copy of the declaration of conformity and ensure that the manufacturer has carried out the appropriate conformity assessment, affixed the CE mark and drawn up the required technical documentation. Importers must also ensure that the toy is accompanied by instructions and safety information, and bears the required warnings.
Distributors have to act with due care to ensure that a product complies with the Toy Safety Directive, which may include verifying that the CE marking is affixed to the toy (or on its packaging or affixed label), the toy bears the manufacturer’s identification for traceability (e.g. batch or serial number) and that the toy is accompanied by instructions and safety information.
Toy products may require specific warnings to be listed on the product detail page. It is your responsibility to provide accurate and complete product information, including applicable warning messages. In order to learn more about adding applicable warnings to your product listings, refer here.
If you have reason to believe that a toy you have manufactured or sold does not comply with the Toy Safety Directive, you must take the necessary corrective measures to bring the toy into conformity immediately, or withdraw/recall the toy. If you believe that the toy presents a risk, you must immediately inform the relevant competent authority.
If a competent authority provides you with a reasoned request for information, you must provide them with the information and documentation necessary to demonstrate the conformity of the toy, and cooperate with any action taken to eliminate risks posed by the toy.
We encourage you to visit the following sites for more information on the Toy Safety Directive: