Toys and due diligence testing

Toys sold within the EU must comply with the essential health and safety requirements of the toy safety directive (88/378/EEC).

Compliance with the toy safety directive ensures that toys do not contain parts or substances that may cause harm to the user under consideration of both the intended end use and also that of foreseeable misuse. Once a toy has met all the relevant requirements of the toy safety directive, it must be labelled with the CE mark.

What is a toy?

Within the directive, a toy is defined as ‘any product designed or intended, whether or not exclusively, for use in play by children under 14 years of age’.

There are a number of exemptions listed within the directive which include, for example Christmas decorations and detailed scale models intended for adult collectors. The specific products listed are not legally required to meet with the criteria for toys.

As the list of exempted products is relatively small, it is clear that the range of possible toys available is vast and therefore it is impossible for the directive to give specific requirements for individual products. However, to allow for a judgment to be made on the safety of a specific product or item, a number of harmonised standards have been published. These standards give requirements and test methods for assessing specific potential hazards. Within the remit of the directive, a toy may be considered safe if all of the potential risks associated with the product are addressed using all the relevant harmonised standards. In this case, the CE mark is placed on the product by the manufacturer and it can be sold within the EU without further controls.

This self-certification type-approval using harmonised standards is the most common form of assessment for toys and is a quick and easy route for manufacturers or importers to follow. Where there are potential risks not covered by the harmonised standards, then a longer process involving type-approval by an authorised Notified Body must be undertaken.

Once type-approval has been achieved, the person deemed responsible for the product draws up a declaration of conformity in which they declare that bulk production of the product and the materials used will be the same as the item(s) originally tested and shown to be safe. Any changes to the product must be documented and records kept, including the results of any additional testing.

Is this enough to ensure that a product continues to perform in a safe manner? Often the answer is ‘no’ and additional information may be required to prove this. This is known as ‘due diligence’.

The concept of ‘due diligence’

Due diligence is a legal requirement for anyone placing products, not just toys, onto the European market. It is a process whereby a person or persons can show that they have taken reasonable precautions to avoid unsafe products reaching the market. In simple terms, this means that production and material supply is controlled and that appropriate checks are made on these materials and finished goods. What is reasonable and appropriate can vary from product to product and will depend on a number of factors including:

• the size of the business (how many items are being produced)
• the level of risk and the impact of failure on the user
• the age and vulnerability of the user
• whether the failure is likely to be obvious to the user
• the extent to which any information provided with the product warns of risks
• the level of documentation and controls in place at the site of manufacture.

However, regardless of the type of product, ignorance of legal responsibilities will not be considered as a defence in case of litigation.

What do you need to do?

Firstly, a system of checks must be established, operated, regularly reviewed and updated. This may involve some simple check testing of production – for example a toy containing wooden components, samples could be removed from bulk and checked to ensure that the corners were correctly rounded and there were no sharp edges or splinters. More involved testing of materials or finished products may be required by an external accredited laboratory, including checking for the presence of heavy metals such as lead in paints or surface coatings.

Traceability of materials and production is an important element of any due diligence system as this allows for the recall of batches of products should a problem occur and is now included in EN71 part 1 – the European toy safety standard. This standard requires model, serial and batch numbers to be placed on products, providing traceability at a later date should it be required.

Regular testing can provide useful data on how a product performs. This, in turn, can be used to justify a reduction in future testing of a particular item or for a particular hazard. Equally, regular auditing of the manufacturing process by a qualified person can also provide useful information about the product and materials being used. It can also highlight changes in production (for example a change in a finish or paint), which may otherwise have gone unnoticed.

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