This page describes the requirements of the new Toy Safety Directive 2009/48/EC which came into force on 20 July 2011.
Citation
Directive 2009/48/EC of the European Parliament and of the Council, of 18 June 2009 on the safety of toys, published in Official Journal L 170, 30 June 2009.
Member States were required to bring into force laws, regulations and administrative provisions necessary to comply with the Directive by 20 January 2011. These provisions were required to come into effect on 20 July 2011, when the existing 88/368/EEC Toy Safety Directive was repealed. However, note that Article 2(1) and Part 3 of Annex II of the old Directive are only repealed from 20 July 2013 (these sections deal with chemical migration of harmful elements).
Purpose
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 subject to further local legal controls so long as they are legitimately CE marked.
Scope and exemptions
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 toys;
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 from the Directive.
The definition given in the Directive is not entirely straightforward. UK government guidance from the existing Directive (88/368/EEC) 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 (e.g. types of mobiles) which are intended for very young children 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 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
Obligations
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.
Requirements
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 (i.e. those which 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.
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.
Plastic bag warnings
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.
Future developments
Because this Directive is new and has yet to be implemented, national Regulations and guidance have yet to be published. It will be important for manufacturers, importers and distributors to keep abreast of the situation as it develops. See the Useful Links section below for possible sources of information.
Also 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.
Useful Links
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.
