EU Technical Documentation Requirements for Toys

This guide explains how to create technical documentation for toys, in accordance with Annex IV of the Toy Safety Directive. The format and information included in the technical documentation depend on the toy product and whether or not you follow EN 71 parts or other harmonised standards.

Toy Safety Regulation: The Directive will be replaced by a newer Toy Safety Regulation. You can find information about the new regulation and related technical documentation requirements in this guide.

(a) Product information

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Full text: a detailed description of the design and manufacture, including a list of components and materials used in the toy as well as the safety data sheets on chemicals used, to be obtained from the chemical suppliers

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The toy covered by the technical documentation must be readily identifiable. To achieve this, it’s often necessary to include the following information:

• Toy name
• Article number/SKU
• Batch number format
• Serial number format
• Age group
• Functionality

Note that this information should match what is specified in the Declaration of Conformity and on the product and packaging labelling for the same SKU.

In addition, you must provide information and reference documentation detailing the product’s physical and chemical composition. These files are normally part of the standard product specification that you’d need to manufacture the toy in the first place.

Examples

• Design drawings
• CAD files
• Bill of materials
• Safety data sheets (SDS)

You can also include product and packaging label files and copies of the user instructions.

(b) the safety assessment(s) carried out in accordance with Article 18

Article 18 states that you must perform a risk assessment covering the following factors:

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Manufacturers shall, before placing a toy on the market, carry out an analysis of the chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity hazards that the toy may present, as well as an assessment of the potential exposure to such hazards.

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The exact information depends on the type of toy. However, our understanding is that the following can be written in this section:

1. A list detailing potential risks that the toy can pose

This can, for example, include theoretical risks that arise in the case of manufacturing defects or contamination. Here are two examples:

• Chemical contamination resulting in increased phthalate content
• Manufacturing defects cause small parts to break off

2. An assessment of the potential exposure

Detail how and under what circumstances an inherent risk could harm a child using the toy. For example, manufacturing defects could result in chemical contamination of phthalates or small parts breaking off, resulting in choking hazards.

Such risks should be mitigated by ensuring compliance with applicable EN 71 standards, followed by toy safety testing.

(c) a description of the conformity assessment procedure followed

Toys that comply with EN 71 parts and other harmonised standards are generally deemed to be compliant with the Toy Safety Directive. Article 19 explains that you can apply the internal production control procedure when you ensure compliance with harmonised standards:

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2. If the manufacturer has applied harmonised standards, the reference number of which has been published in the Official Journal of the European Union, covering all relevant safety requirements for the toy, it shall use the internal production control procedure set out in Module A of Annex II to Decision No 768/2008/EC.

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This means that the manufacturer can self-manage the CE marking procedure by creating the documentation, affixing labels, and arranging testing without the need to have their toy certified by a Notified Body.

However, you will need to apply Module B and Module C, which require EC-type examination from a Notified Body, if you have not applied EN 71 or other harmonised standards to the toy.

Option A: Harmonised standards applied

Module A: Internal production control

Option B: Harmonised standards not applied

Module B: EC-type examination

Module C: Conformity to type based on internal production control

(d) a copy of the EC declaration of conformity

You must include a copy of the Declaration of Conformity. The exact information can be found in Annex III of the Toy Safety Directive.

I recommend that you read our guide on how to create a Declaration of Conformity for toys for more information on how to create this document.

(e) the addresses of the places of manufacture and storage

You need to specify the address of the factory that made the toys and the warehouse location. Note that the factory address is not necessarily the same as the company deemed to be the manufacturer.

Example

Manufacturing address: Building 3, Xingda Industrial District, Toufen Village, Fengxiang Street, Shantou, Guangdong, China

Storage address: Anchoragelaan 32, 1118 LD Schiphol, Netherlands

(f) copies of documents that the manufacturer has submitted to a notified body, if involved

In the event that you apply Module B and C, you must also provide copies of the documentation sent to the Notified Body prior to certification. This can include the following:

• Product specification
• Bill of materials
• Label files
• Packaging artwork
• Product photos
• Physical product samples
• Declaration of Conformity copy
• List of harmonised standards applied in full or in part
• User instructions
• Test reports
• Technical safety evaluations
• Risk assessment and mitigating measures

(g) Test report information

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Full text: test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonised standards, if the manufacturer followed the internal production control procedure referred to in Article 19(2)

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This part is only relevant if you follow harmonised standards and thus apply Module A for internal production control. In this case, you must provide test reports demonstrating that your toy is compliant with the EN 71 parts and other harmonised standards applicable.

You can also include information about the issuing company, test report numbers, dates, test methods, label reviews, and how compliance will be continuously monitored. The latter can often be achieved through a combination of the following:

a. Periodic lab testing

b. Factory and assembly monitoring

c. Quality control

(h) EC-type examination certificate information

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Full text: A copy of the EC-type examination certificate, a description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the EC-type examination certificate, and copies of the documents that the manufacturer submitted to the notified body, if the manufacturer submitted the toy to EC-type examination and followed the conformity to type procedure referred to in Article 19(3).

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Assuming you followed Modules B and C, which require the involvement of a Notified Body, you will also need to include a copy of the EC-type examination certificate. This certificate can only be obtained after you have:

a. Submitted the required files to the Notified Body

b. Completed the certification process for your toy

The supporting documentation must also be provided.

FAQ

Is technical documentation mandatory for toys?

Yes, technical documentation is mandatory for toys. This is explained in Article 2(4) of the Toy Safety Directive, which outlines manufacturer obligations.

Who is responsible for creating the technical documentation?

The technical documentation must be created by the manufacturer of the toy. Note that manufacturers, in this context, include the following:

• Toy factories
• Companies ordering custom-designed toys from contract manufacturers
• Companies ordering private-label toys from contract manufacturers

For example, an EU company importing toys with its brand from a factory in China would likely be defined as a manufacturer, despite not operating a factory. As a result, they would be responsible for compiling the technical documentation in accordance with Annex IV of the Toy Safety Directive.

Do we need to create technical documentation for each toy?

Yes, you need to create a technical documentation set for each toy model. That said, you may be able to group together different colours and size variations of the same toy model.