The Toy Safety Directive lays out the legal requirements that all toys sold within the EEA must comply with. Manufacturers, importers and suppliers must ensure their products comply, including mechanical and physical safety, flammability, and the migration of certain elements. Specialist testing is usually the easiest way of proving that a toy meets these requirements. There are also some administrative obligations that should be met, including creating and keeping a Technical File, producing a Declaration of Conformity and applying the CE mark to the toy.

The Toy Safety Directive (Directive 2009/48/EC) was published in June 2009, and the previous version of the Directive (88/368/EEC) was repealed in July 2011. However, Article 2(1) and Part 3 of Annex II of of the old Directive will not be repealed until 20 July 2013 - these sections deal with chemical migration of harmful elements.

The Directive is intended to provide a common standard for the safety of toys throughout the whole of the EEA. All toys which are sold within the EEA are required to meet the requirements of the Directive, and may be sold without any further local legal controls so long as they are legitimately CE marked.

Toys are defined in the Directive as:

“Products designed or intended, whether or not exclusively, for use in play by children under 14 years of age”

With the exception of the following products;

• Playground equipment intended for public use
• Automatic playing machines, whether coin operated or not, intended for public use
• Toy vehicles equipped with combustion engines
• Toy steam engines
• Slings and catapults

Further to this, Annex I to the Directive gives a list of products specifically excluded from the Directive.

The definition given in the Directive is not entirely straightforward. UK government guidance suggests that (at least) the following factors are considered in deciding whether or not a product falls within the scope of the Directive:

• not every item sold in a toy shop will necessarily be a toy within the meaning of the above definition

• the packaging of an item may give an indication of the intended purpose of the item but should not on its own be taken as conclusive

• it must not be assumed that all items intended for use by children will be toys

• items which are intended for very young children (e.g. types of mobiles) and which the manufacturer considers could not be 'used in play' by them could be 'used in play' by their older brothers or sisters. The manufacturer must consider any reasonably foreseeable use of the product

• the fact that a relevant national standard does not cover an item - or indeed that such a standard specifically states that it does not cover an item - does not necessarily mean that the item is not a toy for the purpose of the Regulations

• an item may be a toy as well as having another function

• there will be some products (e.g. toy steam engines) which might be regarded as toys but are specifically excluded from the definition of toy in the Regulations

• any label or statement on, or with, an item indicating that it is not a toy, or is not intended for anyone under 14 years, would not necessarily be regarded as conclusive by enforcement authorities

The Directive applies to all toys within its scope and irrespective of whether they are sold or given away, new or second-hand. Manufacturers, authorised representatives, importers and distributors all have defined obligations and may be held responsible for supplying toys which do not comply with the Directive's requirements.

Someone in the chain of supply must take responsibility for CE marking the toys - most often this will be the manufacturer, but where the manufacturer is based outside the EU, their authorised representative or the importer of the goods will be held responsible.

The primary requirement is that toys meet the essential safety requirements of the Directive. In order to do this, toys must either be manufactured in accordance with harmonised standards, or must be type tested by a notified body in order to demonstrate that they comply with the essential requirements of the Directive.

For products which are manufactured fully in accordance with the requirements of the harmonised standards, manufacturers may self-certify to the Directive without involving a notified body. However, many large retailers will require an independent report as a condition of supply, even though this is not a legal requirement.

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

1. Create a declaration of conformity and affix the CE logo to the product

2. Maintain a technical file containing certain information about the toys (for a period of 10 years after the toy has been placed on the market)

3. Ensure procedures are in place for series production to remain in conformity. If appropriate for the toy, manufacturers should also carry out sample testing and, if necessary, keep a register of complaints of non-conforming toys

4. Ensure the toys bear a type, batch, serial or model number (or if not possible then include the information on the packaging or an accompanying document)

5. 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)

6. Supply appropriate instructions and safety information in an appropriate language

7. Take appropriate corrective actions 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 Community harmonisation legislation.

Second hand toys that were first sold within the European Community before 1 January 1990 do not have to be CE marked, but they must meet the essential safety requirements.

The essential safety requirements for toys are contained in Annex II of the Directive. These are concerned with issues such as labelling to provide traceability to the manufacturer, safety warnings, the construction of the toys to avoid hazards such as sharp edges, hot parts, risks of entrapment etc., and the avoidance of toxic substances such as heavy metals, harmful chemicals and allergenic fragrances. The Annex contains extensive references to specific problem substances and the maximum concentrations they must be below.

Many toys are often packaged in plastic bags, yet there is little information available regarding the minimum specification of this packaging. After researching the issue, Conformance have created the following informative web page on plastic bag warnings, which includes a downloadable specification sheet.

Due to the added complexity of the new requirements of the Directive relating to prohibited toxic chemicals, it should be noted that these will come into force on 20 July 2013. The sections of the old Directive relating to migration of certain elements will remain in force until then.

The Directive contains a section on ‘amendments and implementing measures’, outlining changes that may be made to specific parts of the Directive for the purposes of adapting them to technical and scientific developments. Apart from amendments to the list of exclusions in Annex I, these deal with amendments to the lists of allergenic fragrances, chemicals and heavy metals, and also relevant warnings. It will be important for manufacturers to be aware of these changes when/if they are made.

The Directive also requires Member States to send the Commission a report every five years on the Directive, containing an evaluation of the situation concerning the safety of toys, the effectiveness of the Directive and an outline of the market surveillance activities performed by that Member State.

The BIS web site contains information regarding the Toys Safety Regulations 2011 and also contains downloads of the Regulations and associated Guidance Notes.

The European Commission has produced a very detailed and extremely useful explanatory guidance document on the new Directive. It is huge ­(174 pages ) but picks apart the meaning of the Directive as clearly as you could hope for.

The European Commission has also produced an equally detailed and extremely useful explanatory guidance document on the technical documentation requirements of the new Directive. This one is also huge ­(114 pages) but very specific.

The European Commission web site also has excellent guidance documents from the Expert Group on Toy Safety covering ‘difficult’ areas of the Directive with respect to specific toys, and also has a basic page on the Toy Safety Directives.

A wide range of consumer information and advice regarding toy safety can be found on the Toys Advice web site.

For further advice please contact us at Conformance where we will be pleased to discuss your needs.