Toys and due diligence testing

Toys placed on the market within the EU must comply with the health and safety requirements of the European Toy Safety Directive 2009/48/EC.

Compliance with the Toy Safety Directive (TSD) ensures that toys do not contain parts or substances that may cause harm to the user when the intended end use and foreseeable misuse are considered. Once a toy has met all the relevant requirements, it must be labelled with the CE mark.

The TSD defines a toy as 'a product designed or intended, whether or not exclusively, for use in play by children under 14 years of age'. The use of the wording 'whether or not exclusively' means 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. There are a number of exemptions listed within the TSD of items that are not considered as a toy, such as Christmas decorations and detailed scale models intended for adult collectors.

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 developed. 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 placed on the market 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 relatively 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 either self-certification or Notified Body 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.

Obligations

Under the TSD, the responsibility for ensuring that a product is safe lies with anyone who makes the toy available on the EU market. This includes manufacturers, importers and distributors. If importers or distributors within the EU market the products under their own names, they also take on the manufacturer’s responsibilities. Sufficient information on the design and production of the product must be provided to the importer or distributor because they will be assuming the legal responsibility when affixing the CE mark.

Manufacturers

Manufacturers have a responsibility to draw up a technical file with the specifications of the toy and carry out an assessment to determine whether the toy meets the requirements. This technical file should include:

• a description of the product including its dimensions and a colour photograph
• a detailed description of the design and manufacture (including technical drawings)
• a list of the components and materials used (including the supplier name and address and the Materials Safety Data Sheets (MSDS) for any chemicals used)
• a copy of the risk assessment carried out for the product
• user information and warnings
• a description of the conformity procedure followed – for example, self or Notified Body assessment
• a copy of the EC declaration of conformity
• the address of the place of manufacture and storage
• any relevant test reports.

The manufacturer must then complete a declaration of conformity. This should contain:

• the unique identification number of the toy
• the name and address of the manufacturer
• a colour image of the toy, as well as a description of the product including size and colour
• the manufacturer’s signature and the date on which the document was signed.

By drawing up the EC declaration of conformity, the manufacturer assumes responsibility for the compliance of the toy. Both the declaration and the technical file must be kept for a minimum of ten years after the product was last placed onto the market, and must be translated into the languages of the member states in which the product will be sold. The manufacturer must also ensure that the toy bears the CE mark as well as the batch or model number of the toy, in order to show that the toy conforms to the TSD. The manufacturer’s name and address must also be present on the toy or its packaging. While the address may be abbreviated, a website address alone would not be sufficient to meet this requirement.

Importers

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, 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.

Distributors

The distributor has similar obligations to that of the importer. Before placing a toy on the market, the distributor should ensure 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.

Essential safety requirements

The Toy Safety Directive requires that toys are only placed onto the market if they comply with the essential safety requirements. This applies to the general and particular safety requirements. The general safety requirements state that:

• toys placed on the market must comply with the essential safety requirements during their foreseeable and normal period of use.
• toys (including the chemicals they contain) must not jeopardise the safety or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the behaviour of children.

There are also specific safety requirements relating to the following areas:

• physical and mechanical properties
• flammability
• chemical properties
• electrical properties
• hygiene
• radioactivity.

Physical and mechanical properties

For a toy to be considered safe, it must have the requisite mechanical strength to withstand stresses occurring during use without breaking or distorting in a way which could cause injury. This does not assess the quality of the product, and the toy will not necessarily fail to comply if it breaks, provided that it does so in a safe manner. Any accessible edges, protrusions, cords, cables, fastenings or moving parts must be designed and constructed to prevent physical injury. There are also additional requirements for toys intended for children under the age of three. Such toys, and any detachable parts from the toys, must be of certain dimensions so that they cannot be swallowed or inhaled. In addition, both the toy and its packaging should not pose a risk of strangulation or suffocation.

The EN 71-1:2014+A1:2018 testing standard provides a series of clauses that must be met in order for a toy to be considered to meet the essential safety requirements. EN 71-1 also includes information on warnings that may be needed as part of labelling. These 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, must 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 are to 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. Toys that are not suitable for children under the age of three must carry a warning – either ‘Warning! Not suitable for children under 36 months’ or ‘Warning! Not suitable for children under 3 years’, or bear the warning mark shown in figure 1.

The warning must also indicate the specific associated hazard – for example, ‘strangulation hazard’. It is not sufficient to indicate the cause of the hazard alone, except in the case of small parts, as it considered to be common knowledge that these present a choking hazard.

Flammability

EN 71-2:2011+A1:2014 specifies the categories of flammable materials which are prohibited in all toys. These include cellulose nitrate, materials with a piled surface which produce surface flash, highly flammable solids and flammable gases, liquids or gels. This standard also gives requirements concerning flammability of certain toys when they are subjected to a small source of ignition. These toys include:

• toys to be worn on the head
• toy disguise costumes and toys intended to be worn by a child in play
• toys intended to be entered by a child
• soft-filled toys over 15cm in height.

Due to the more intimate contact associated with these toys, there are specific requirements relating to the rate of flame spread across the toy, how long the toy burns for and how far across the surface of the toy the flame spreads. Toys with multiple components or removable accessories are tested in their most onerous combination. Because certain treatments can be applied to the toy to improve flame retardancy, toys are tested after washing in accordance with the care label instructions to ensure that the washing does not adversely affect the performance of the toy.

Chemical properties

The EN 71-3:2019 – ‘Migration of certain elements’ standard specifies requirements and test methods for the migration of certain elements from accessible toy materials. This is to address the risks associated with young children swallowing, biting, chewing, licking or sucking on the toy. The accessibility of the material is determined after testing in accordance with EN 71-1, as the test methods listed under clause 5, may cause materials to become accessible if the toy is damaged during these tests.

For the purposes of the testing, toy materials have been separated into the following three categories:

• category I: dry, brittle, powder like or pliable materials (for instance and chalk)
• category II: Liquid or sticky materials (such as slimes and finger paints)
• category III: Scraped off materials – solid materials that could be ingested (for example, leathers, textiles, dried paints and varnishes).

Each category has different maximum limits for the migration of the substances listed in the standard (see table 1). Each accessible material must be tested separately and, where a material is available in different colours, each colour is to be tested separately. This is because the elements can be present in the pigments or dyes used to colour the material, and the amount of the substances can vary between different colours.

Other chemical substances that need to be considered are those restricted under Annex XVII of Regulation (EC) No 1907/2006 (REACH). The restrictions apply to each material within a product, not to the product as a whole. If a toy contains several different materials, each material must comply with the appropriate requirements of REACH, regardless of the amount of material used in the final product. When testing for substances restricted under REACH, the applicable testing will depend upon the types of materials used, and this can therefore vary between different products. Some of the commonly tested substances listed under REACH Annex XVII are azo colourants in dyed leather and textiles, chromium VI in leathers and phthalates in plasticised materials.

Table 1: Migration limits as set out in EN 71-3:2019
Element	Category I	Category II	Category III
	(mg/kg)	(mg/kg)	(mg/kg)
Aluminium	5,625	1,406	70,000
Antimony	45	11.3	560
Arsenic	3.8	0.9	47
Barium	1,500	375	18,750
Boron	1,200	300	15,000
Cadmium	1.3	0.3	17
Chromium (III)	37.5	9.4	460
Chromium (VI)	0.02	0.005	0.053
Cobalt	10.5	2.6	130
Copper	622.5	156	7,700
Lead	2	0.5	23
Manganese	1,200	300	15,000
Mercury	7.5	1.9	94
Nickel	75	18.8	930
Selenium	37.5	9.4	460
Strontium	4,500	1,125	56,000
Tin	15,000	3,750	180,000
Organic Tin	0.9	0.2	12
Zinc	3,750	938	46,000

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