Technical documentation and risk assessment

In order to demonstrate conformity of a toy the manufacturer must document all information related to the manufacturing of the toy, i.e. draw up technical documentation/a technical file.

The manufacturer must carry out risk assessment to assess potential risks related to the toy.

The technical file of a toy

The technical file must include:

  • details about product design and manufacture, including a list of the components and materials used, and a chemical safety data sheet;
  • risk assessment;
  • description of the conformity assessment procedure;
  • copy of the EC Declaration of Conformity;
  • manufacture and storage location addresses;
  • test reports and description of the methods used by the manufacturer to ensure conformity with harmonised standards;
  • copies of the documents that the manufacturer has submitted to the notified body, if it is involved in the process, and a copy of the type examination certificate with appendices; and
  • a colour picture of the toy.

The manufacturer must keep the technical documentation for 10 years after the product has been placed on the market, i.e. made available to consumers.

Detailed information on drawing up technical documentation is available at the European Commission website. The website also has instructions for drawing up the EC Declaration of Conformity.

Toy risk assessment

The manufacturer must carry out a risk assessment on toys before placing them on the market. The importer of the toys must ensure that the risk assessment has been carried out.

The risk assessment is used to assess the following types of features and the potential dangers related to them:

  • mechanical
  • physical
  • chemical and
  • electrical features
  • radio activity and flammability; and
  • cleanliness and hygiene of the toy.

Example of a risk assessment carried out on a doll

1.Examine and consider different risks related to the doll

Is the doll intended for children under the age of 3?

  • Toys intended for children under the age of 3 must not contain easily detachable small parts.
  • The age restriction “Not suitable for children under the age of 3” must not be included in toys intended for young children.

Can the doll speak?

  • How loud is the sound?
  • Are tools needed to access the batteries?

What materials are the doll and its clothing made of?

  • Soft plastic
    • Do they contain phthalates?
    • Do they contain short-chained chlorinated paraffins?
  • Stuffing
    • Can the toy be cleaned?
    • Is there a danger of fire?
  • Coloured fabric
    • Is the fabric dyed with azo dyes?

Phthalates, short-chained chlorinated paraffins and azo dyes

  • Certain phthalates, short-chained chlorinated paraffins and azo dyes are prohibited in toys.
  • If a product you are selling contains a substance listed on the REACH candidate list information on the substance must be provided to consumers upon request.

What details does the doll have?

  • Soother: is there a choking hazard?
  • Eyes and eye lashes: are small parts easily detached?
  • Clothing: are there buttons, accessories or other small parts that easily detach?


2. Consider what risks and requirements there are

Danger/risk Standard Legislation
Small parts

EN 71-1, 5.1

Toy Safety Act
Choking hazard EN 71-1, 5.4 Toy Safety Act
Loud noise EN 71-1, 4.20 Toy Safety Act
Battery compartment EN 62115, 14.6-14.9 Toy Safety Act
Phthalates, azo dyes different laboratories have their own analysis methods REACH liite XVII
Short-chained chlorinated paraffins, SVHC different laboratories have their own analysis methods POP Regulation, environmental hazard
Cleanability/hygiene   Toy Safety Act, Section 27
Fire hazard   Toy Safety Act, Section 24
Other risks discovered during assessment    


3. Does the toy meet all requirements?

  • Can the manufacturer demonstrate the toy’s conformity with requirements?
  • Are you prepared to take responsibility for placing the toy on the market?

You can also use the notifications on potentially dangerous toys from the Safety Gate system as support for the risk assessment. The system can be used to find out whether there are notifications on similar toys and what dangers they have caused.