EU Market Access for Safety of Toys

Directives

If your product(s) fall(s) within the Toys sector the following Directive (2009/48/EC) applies.

• Directive (2009/48/EC) on the safety of toys
• Factsheet http://publications.europa.eu/s/cU0a
• For further information on the Directive (2009/48/EC) that relates to the safety of toys, please visit the Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs webpage dedicated to this sector by following this link: http://ec.europa.eu/growth/sectors/toys_en
• For further reference documents on the Directive (2009/48/EC) that relates to the safety of toys, please visit: http://ec.europa.eu/growth/sectors/toys/safety/guidance_en

Verify requirements

The Directives established for CE marking have been designed by the European Union in such a manner that they cover all requirements for products from each of the aforementioned sectors.

The Directive (2009/48/EC) on toy safety specifies in detail the essential requirements to be fulfilled by you as a manufacturer, importer or distributor, to prove that your product complies with EU regulations and finally, to be able to affix the CE marking.

The Directive (2009/48/EC) applies within all EEA countries as of 20 July 2011. The only exception concerns the chemicals provisions, for which a further two-year transition period applies – until 20 July 2013.

The 2009 Directive replaces the one adopted in 1988 (88/378/EEC). Toys that are compliant with the 1988 Directive can continue to be placed on the market until 19 July 2011, or 19 July 2013 in the case of the rules relating to chemicals.

The new Directive defines a toy as “any product or material designed or intended, whether or not exclusively, for use in play by children under 14 years of age".

The first step that a manufacturer should take is to check if his product falls into the scope of the Directive. Then, in order to ensure that a toy will be compliant with the Directive, the manufacturer has to check which European Harmonised Standards are applicable. The Commission’s Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website lists the Harmonised European Standards for toys.

Annex I to the Directive lists types of products excluded from the Directive and not considered toys. The list features products such as puzzles with more than 500 pieces or babies’ soothers, which are not considered toys but could easily be confused as such. The list is indicative only.

Annex II to the Directive specifies the safety requirements products have to comply with. Annex V specifies that when appropriate, toys have to bear a warning specifying a minimum age for users of toys and/or the need to ensure that they are used only under adult supervision where appropriate.

Please consult the Directive for the entire catalogue of requirements.

Need for notified body?

Before proceeding with the assessment procedure, it is important to establish whether you, the manufacturer, can assess your product by yourself or only with the involvement of a Notified Body.

With regard to the safety of toys on the European market, the Directive (2009/48/EC) on toy safety requires the assistance of a Notified Body in case the toy in question does not comply fully (or in part) with the harmonised standards as laid out in Article 13 (and therefore conformity has to be determined directly to the requirements of the Directive) or in case the manufacturer feels the toy requires a verification by a Notified Body.

A Notified Body verifies the compliance of a product by conducting conformity assessment. It also ensures that the technical documentation sufficiently supports product compliance.

When the Notified Body is convinced of a product’s compliance, it issues a certificate of conformity to confirm this. The manufacturer will then draw up the Declaration of Conformity (DoC) to attest on his sole responsibility for conformity to the relevant Directive. The establishment of the DoC is a legal obligation.

The Declaration of Conformity must include the manufacturer’s details, such as name and address, essential characteristics the product complies with, any European standards and performance data and the identification number of the Notified Body, as well as a legally binding signature on behalf of the organisation. For further details, please consult Annex III of Directive 2009/48/EC.

To find the Notified Bodies appointed by the Member States to carry out conformity assessment, please consult NANDO – the New Approach Notified and Designated Organisations database. You can search for Notified Bodies by Directive or by country via the NANDO homepage.

Check conformity

For toys that have been manufactured in compliance with European Harmonized Standards covering all relevant safety aspects, the manufacturer himself carries out internal checks on the product and draws up and signs the EC Declaration of Conformity.

Before starting the assessment of the conformity of the product, the manufacturer must also carry out a separate safety assessment of potential hazards related to the toy and an assessment of the potential exposure to those hazards.

If harmonised standards do not exist, have been only partly applied to the toy in question, or have been published with a restriction, or if the manufacturer feels that the toy requires third party verification, then it must be submitted to a Notified Body for an EC-type examination. This body assesses whether the technical design of the toy is compliant with the requirements of the Directive.

The manufacturer must also ensure that the production of the toy is compliant with the Directive, but this part of the process does not require the involvement of a Notified Body.

Details about the assessment procedures are specified under Chapter IV in the Directive (2009/48/EC) on toy safety.

Whether a Notified Body has been involved or not, the manufacturer must draw up and sign the EC Declaration of Conformity.

Manufacturers are required to work with the market surveillance authorities in each country where the toys are placed on the market. A list of these authorities can be downloaded (114 kB) from the Commission’s Directorate-General (DG) for Internal Market, Industry, Entrepreneurship and SMEs website.

Technical documentation

Upon successful assessment, Directive (2009/48/EC) requires a technical documentation as laid out in Article 21. The technical documents must enable the conformity of the toy with the requirements of the Directive to be assessed. The following documentation is required:

• a description of the means (such as the use of a test report or technical file) whereby the manufacturer ensures conformity of production with the standards referred to in Article 13
• where appropriate: an EC type-certificate drawn up by an notified body; copies of the documents the manufacturer has submitted to the notified body; a description of the means whereby the manufacturer ensures conformity with the approved model,
• the addresses of the locations used for manufacture and storage of the product, detailed information concerning the design and manufacture of the product.

The manufacturer, or his authorised representative established in the European Community, is requested to keep copies of the technical documentation for a period of 10 years after the last product has been placed on the market.

Affix CE marking

Once the necessary steps have been successfully completed, the logo must be affixed to the product.

The marking must be placed visibly and legibly and indelibly to the toy, to an affixed label or to the packaging. In the event where this is not possible due to the size of the product, CE marking may alternatively be affixed to a label or an accompanying leaflet. If the CE mark is not visible from outside the packaging, it shall as minimum be affixed to the packaging. The CE marking shall consist of the initials 'CE' taking the following form:

The various components of the CE marking must have the same vertical dimension, which may not be less than 5mm. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing must be respected.

When the product is subject to other Directives covering other aspects and which also provide for the CE marking, the accompanying documents must indicate that the product also conforms to those other Directives.

However, when one or more of those Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking has to indicate conformity with the Directives applied by the manufacturer. In this case, the particularities of the Directives applied, as published in the Official Journal of the European Union, must be given in the documents, notices or instructions required by the Directives and accompanying such products.

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