Legislation of the European Union

On July 20, 2011, Directive 2009/48/EC on the Safety of Toys, which repeals Directive 88/368/EEC on toy safety rules, entered into force in the European Union. The Directive provides a common standard for the safety of toys and their free movement throughout the European Community.

The new Directive 2009/48/EC on the Safety of Toys is a significant overhaul of the Directive 88/368/EEC and the main changes are the following:

• Alteration of the definition of a toy;
• Update of the list of excluded products;
• Requirements for a Declaration of Conformity;
• Extension of requirements for electrical toys;
• A ban of chemicals that are susceptible to provoke cancer, change genetic information or harm reproduction, so-called CMR (Carcinogenic, Mutagenic or toxic for Reproduction) substances in accessible parts of toys;
• Restrictions on the use of a number of fragrances and substances which provoke allergies;
• Rules for toys in food. Toys must be packaged so that they are separated from the food, and that packaging should present no choking hazard;
• Stronger requirements for labelling and warnings;
• Strengthening the rules on choking to cover small parts in toys intended to be put in the mouth;
• Setting out certain obligations for manufacturers, importers, distributors, economic operators and other entities.

The Directive defines toys as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age." This definition does not include the following toys: playground equipment for public use, toy vehicles equipped with combustion engines, toy steam engines, automatic playing machines intended for public use, and slings and catapults. Moreover, products listed in Annex I of the Directive shall not be considered as toys within the meaning of the Directive. The regulations shall apply to all toys that fall within the definition, whether they are new or used and whether they are sold or given away.

Manufacturers are obliged to ensure that toys placed on the market are designed and manufactured according to requirements set out in the Directive, especially those contained in Article 10 and Annex II, or must be type tested by a notified body in order to demonstrate that they comply with the essential requirements of the Directive. Thus, prior to market placement of new toys, manufacturers are required to carry out safety assessment procedures and conduct an assessment of the toys' conformity to Directive requirements in order to ensure that the toys meet the general safety requirements.

Additionally, the directive requires that the manufacturer should do the following:

• Create a declaration of conformity and affix the CE logo to the product;
• Keep the technical documentation and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market;
• Protect the health and safety of consumers, carry out sample testing of marketed toys, investigate, and, if necessary, keep a register of complaints, of non-conforming toys and toy recalls, and keep distributors informed of any such monitoring;
• Ensure the toys bear a type, batch, serial or model number or other element allowing their identification, or, where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy;
• Indicate on the toy their name, registered trade name or registered trade mark and the address at which they can be contacted (or if not possible then include the information on the packaging or an accompanying document);
• Supply appropriate instructions and safety information “in a language or languages easily understood by consumers”;
• Take the corrective measures necessary to bring the toy into conformity, to withdraw it or recall it, if appropriate, to deal with toys they have placed on the market that they consider or have reason to believe are not in conformity with the relevant requirements.

Furthermore, the Directive establishes that if an importer or distributor places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements may be affected, an importer or distributor shall be considered as a manufacturer and be subject to the obligations of the manufacturer for the purposes of the Directive. For more information please see: eur-lex.europa.eu/LexUriServ/LexUriServ.do

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