Since the recalls of 2007 there has been an increased focus on toy safety around the world, but especially in the US, the EU and the main production zone, China. The regulators in these regions have been very busy – with new rules in China and a new law in the USA. In the EU the European Commission is poised to adopt a significantly toughened revision of the toy safety directive (88/378/EEC).
In the present economic climate it is essential that resources devoted to toy safety are used in the most effective and efficient way. ToyNews has asked some of the technical experts in the BTHA for their top tips for navigating the maze of laws and safety standards that affect toys.
Firstly there is a common misconception that possession of test reports is pretty much all that needs to be done. The toy safety regulations themselves require much more.
Here are seven vital steps for manufacturers and importers, whatever their size, that will help ensure the safety of toys and the safety of children.
1. Ensure all toys have been through a design safety assessment that demonstrates the design is safe.
2. Ensure the factory has implemented an effective quality assurance process that delivers consistently safe toys to pre-defined product specifications and/or bills of materials.
3. Ensure samples that are representative of production have been tested for conformity with all applicable safety standards and any special customer requirements.
4. Ensure that consignments have been inspected to ensure they are free from obvious safety related manufacturing defects and meet the agreed specification.
5. Periodically select samples from the market place for safety review and/or testing.
6. Ensure that procedures for feedback of consumer complaints are effective and lead to product improvements where appropriate.
7. Collate documentation for points one to six into a technical file (a legal obligation) and retain this file.
For anyone that is unsure about whether their company safety procedures are appropriate, there are many sources of help, including local trading standards, test houses, trade associations and independent consultants. BTHA members have been taking part in special technical file workshops and this programme is on-going.
Conformity with the toy safety regulations is the responsibility of the manufacturer and failure to comply could result in a visit from a Trading Standards officer with powers to launch a prosecution in the event of violations. Penalties are a maximum fine of £5,000 per offence. There is also a possibility of six months’ imprisonment; however there have been no instances of this being applied in relation to the Toys Directive. Perhaps the greatest penalty is the prospect of a recall and the ensuing costs and damage to reputation.
Retailers are not immune from enforcement action if it is believed that they have not taken appropriate steps to ensure they sell safe toys. It is common practice for test reports and certificates to be provided as a condition of business when buying toys from a manufacturer or importer. The standards that form the basis of test reports are the familiar EN71 series of standards (parts one to eight) together with the electrical safety standard EN62115:2005. They are all listed on the Europa website together with additional notes that must be considered: http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/toys.html.
Compliance of a toy with these standards allows a manufacturer to state that the toy meets the safety requirements of the UK regulations and so the toy may bear the CE marking. It is important to note that this is only valid if the standards cover all the potential risks that the toy might pose. For risks that are not covered by the standards it is appropriate to seek further advice from a Notified Body because in some cases a special approval (EC type examination approval) will be required before the toy can bear the CE marking.
Assessment against the harmonised standards can be performed by anyone with sufficient competence and expertise but it has become common practice (and a requirement of major retailers) that the testing is conducted by accredited third party laboratories.
Test reports and certificates have an undefined period of validity but re-evaluation is necessary if:
• There is any change to the toy design, or;
• A change of materials, or;
• A change to the method of production, or;
• A change to the harmonised standards
Retail customers may also specify contractual arrangements that set out testing regimes and frequency of retesting. These must be carefully considered prior to entering into such arrangements.
Once a toy design has been assessed as safe it is imperative that all production items are made to the same standard. This is best achieved by a robust quality assurance process in the factory. If expertise in this area does not exist in the manufacturer’s organisation then it is prudent to seek outside experts and organisations that can offer suitable advice.
Failure to implement a rigorous quality assurance system is one of the root causes of many product withdrawals, product recalls and legal action by the enforcement authorities.
Those EC directives
Apart from the toy safety regulations and related harmonised standards, there are many other pieces of legislation that affect the legality and safety of toys. Here are some of the more commonly encountered examples:
• Azo dyes directive (2002/61/EC)
Restricts the use of certain dyes in textiles toys that come into direct and prolonged skin contact.
• Phthalates directive (2005/84/EC)
Affects toys that incorporate softened plastics such a flexible PVC and
The Magnetic Toys (Safety) Regulations 2008
Requires toys with magnets or magnetic parts to bear a specific warning concerning the risk of internal injury if swallowed.
• Cadmium directive (91/338/EEC)
This environmental directive governs the total concentration of cadmium in certain plastics and other materials.
• RoHS (2002/95/EC)
Environmental directive that affect certain electrical toys and is concerned with environmental safety. Restricts certain heavy elements and fire retardant chemicals.
• REACH Regulations
New EU chemicals law that affects all toys and packaging but as a priority it affects toys that release chemicals or toys that are chemical preparations. Specialist advice is normally necessary but a good starting point is the information on the BTHA’s website under ‘Toy Safety’ [Note: Website is being revamped so link is not provided.]
• The Food Imitations (Safety) Regulations: SI 1989 No 1291
Places restrictions on toys that might be confused with foods and confectionery.
• Packaging Essential Requirements: SI 2003 No 1941
Contains requirements that restrict heavy elements in packaging and also requirements intended to prevent excessive packaging.
One category of toys that requires a special mention is electrical toys. These toys could be subject to restrictions under the following laws and standards:
• Transformers and battery chargers have specific standards of safety
• Electromagnetic compatibility directive (89/336/EEC) applies to most electrical toys.
• The batteries and accumulators directive (2006 / 66 / EC) applies
to batteries and the batteries
• Radio controlled toys are subject to the directive on Radio and Telecommunications Terminal Equipment (R&TTE) SI 1999 No 930
This listing is not exhaustive and so it is always advisable to seek out expert advice as to what requirements apply and how they are commonly addressed. Remember that exhaustive testing is not always necessary nor appropriate. Declarations of conformity that are passed along the supply chain can be an efficient way of demonstrating compliance. This process is known to work well for RoHS, REACH, Packaging Essential Requirements, and the Cadmium directive.
A safe future
The toy safety directive is presently being revised by the European Commission and a revised directive is expected to be agreed just before Christmas, adopted in January and likely to enter force in spring 2009. There will be a two-year transition period, meaning that toys imported into the EU after spring 2011 must comply with the new requirements. There is likely to be an additional transition period of perhaps two years for toys to comply with the strict new requirements relating to chemicals.