The Safety of Toys Directive
Stricter legislation has been introduced on toys intended for sale in the European market.
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All companies in the supply chain will be affected by the new European Toy Safety Directive (2009/48/EC), which was published in the Official Journal of the European Union and came into force on 20th July 2009. This replaces the replaces 20-year-old Directive 88/378/EEC and takes into account the development of technology in toys and the safety issues associated with new toys placed on the market.
In order to allow the development of harmonised standards, there is a two-year transitional period where both the old and new Directives may be applied, and a four-year transitional period for the chemical requirements. In practice, this means that toys compliant with Directive 88/378/EEC are allowed to be placed on the market until 19th July 2011, with an extension until 19th July 2013 for certain chemical aspects.
There are several changes of which manufacturers and importers of toys and children’s products should be aware. These include chemical requirements, definitions, warnings and toys sold with food items.
The definition of a toy has been clarified as ‘a product designed or intended, whether or not exclusively, for use in play by children under 14 years of age’. The change in wording of ‘whether or not exclusively’ is intended to clarify that a product does not have to be solely intended for playing purposes in order for it to be considered a toy, but can have other functions as well. For example, a key ring with a teddy bear attached would be considered a toy.
The new Directive updates the essential safety requirements with regard to toys, in order to ensure a high level of protection for children against risks caused by certain chemical substances. This applies particularly to chemicals classed as CMRs, (carcinogenic, mutagenic, or toxic for reproduction). These chemicals are restricted in the 2009 Directive to a concentration below 0.1 per cent.
There are 55 allergenic fragrances – including several plant extracts – listed in the Directive that are now restricted in toys. However, a trace amount of these below 100ppm would be allowable, providing it is technically unavoidable. A further 11 fragrances must be declared on the product labelling if they are present above 100ppm.
The requirements for extractable metal limits in toys covered by EN 71-3:1994 – ‘Migration of certain elements’, has been updated. These requirements have been made more stringent to take into account developments in scientific knowledge, and the list of these elements increased from 8 to 19. The additional elements include aluminium, boron, cobalt, copper, manganese, nickel, strontium, tin, zinc, organic tin compounds and chromium VI. Toy materials have been separated into three categories with regards to element migration limits, these are ‘dry, brittle, powder-like or pliable toys materials’, ‘liquid or sticky toy materials’, and ‘scraped-off toy materials’. Each of these categories has its own metal requirements.
Nitrosamines and nitrosatable substances that may be present in rubber toys are not to be used in toys for children under the age of 36 months, nor in toys intended to be placed in the mouth (such as balloons).
The new Directive also states that chemical substances in toys should comply with the requirements of Regulation 1907/2006, concerning the registration, evaluation, authorisation and restriction of chemicals (REACH).
Toys sold with food
This new Directive now covers safety issues associated with toys sold with foods, and its requirements are to prevent children choking on such products. Toys contained in food or mixed with food should be contained in their own packaging, separating the toy from the food. This packaging should be of such dimensions to prevent it being swallowed or inhaled. For example, a toy contained within a breakfast cereal box must have its own packaging which should prevent the product from being swallowed, however, if the toy were attached to the outside of the cereal box, it would not be subjected to the requirement.
Toys contained within food products that require the food to be consumed in order to gain access to the toy are to be prohibited. Examples of such products are lollypops where the toy only becomes accessible once the lollypop has been consumed. Products that are intended to be placed in the mouth and products that are intended to come into contact with food are now required to meet with food contact regulations (EC) No. 1935/2004.
Stricter rules concerning safety warnings are part of the 2009 Directive – these are intended to prevent the misuse of safety warnings where the warning conflicts with the intended use of the toy. For example, misuse has occurred in the past when the warning ‘not suitable for children under 36 months’ has been used on products to circumvent the requirement to be assessed for small parts. Warnings should be clearly legible and in a language that is understandable to the consumer. Warnings which affect the decision to purchase a toy, such as those that specify the age of a user and other applicable warnings, shall appear on the packaging or otherwise be clearly visible at the point of sale, and this includes for purchases made online. Small toys which are sold without packaging shall have any warnings affixed to them or on a label on the toy – it is not enough for the warnings to be displayed only on a counter display box.
There are also new obligations for manufacturers, importers and distributers under Directive 2009/48/EC, which are outlined below.
There is a now a requirement for an EC declaration of conformity by the manufacturer, which brings the toy Directive in line with other CE-marking Directives. By doing so, the manufacturer certifies and assumes responsibility for compliance of the toy with the essential safety requirements of the 2009 Directive. A copy of this declaration must be kept in the technical documentation for ten years after the toy has been placed on the market by the European manufacturer or European importer. The declaration should be translated into the language of the member state in which the product is being sold or made available.
The manufacturer will also be responsible for carrying out a safety assessment, which should identify any hazards that the product may present (including chemical, mechanical, electrical, flammable, hygienic and radioactive). This assessment must be carried out before placing a toy on the market and should be kept for a period of ten years as part of the technical documentation. Many of the aspects of the safety assessment will be covered by the harmonised toy safety standards. However, the manufacturer is obliged to consider all safety aspects of the toy to identify if any potential hazards exist which are not covered by the standard. The outcome of this safety assessment will determine which testing procedure the toy should follow, such as EC type-examination or self-certification.
The importer is obliged to place only compliant toys on the market. Before placing a toy on the market the importer should ensure that the correct conformity assessment procedure has been carried out and that correct technical documentation is available upon request. If the importer has reason to believe that a toy is not in compliance with the Directive, then the product should not be placed on the market until it is made compliant. The importer is also obliged to keep a copy of the EC declaration of conformity for a period of ten years after the product has been placed on the market.
The distributor has similar obligations to that of the importer. The distributor should ensure before placing a toy on the market that it will bear the correct marking, be accompanied by the required documentation, and that any instructions or safety information provided with the product is in a language easily understood by the consumer.
How can we help?
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SATRA can help manufacturers, retailers and importers with their toy testing requirements. We have accredited laboratories which can carry out toy testing in accordance with the EN 71 safety of toy standard, as well as a chemical testing facility to assist with food contact and REACH enquiries. Please email firstname.lastname@example.org for further information.