Directive 2009/48/EC

Safety requirements

The Directive establishes the essential safety requirements that toys placed on the EU market must comply to. A toy is a product designed or intended, whether or not exclusively, for use in play by children under 14 years of age.

For guidance on different types of toys, please follow the link below.  

The objective is to follow:
• Fundamental health and safety requirements relating to age, behavior and the regulation of the use of chemicals.
• Specific health and safety requirements (listed in Annex II) relating to physical, mechanical, electrical and chemical properties, flammability, hygiene and radioactivity.

Products must be clearly labelled with warnings which specify appropriate conditions and limitations for use.

Requirements for determining the toys' conformity with the fundamental requirements can be found in the council’s decision regarding CE marking and conformity. The assessment of a toy’s conformity is to be made either by a notified body appointed by the member states or by the manufacturers themselves.

Before a toy is released onto the market it must be issued with a CE mark to certify that it conforms to the Directive. The CE mark is to be applied to the product by the manufacturer or the manufacturer’s authorised EU representative.

When a toy is covered by other Directives which prescribe CE marking, the marking indicates that the toy also fulfils the requirements of these Directives. Other labelling may also be affixed to a toy provided that this labelling is not likely to be confused with the CE mark.

To show compliance with the requirements, product can be tested according to relevant EN 71 standard.

Clas Ohlson requirements

For toys sold to Clas Ohlson, Clas Ohlson Toy safety requirement document must be signed. Supplier must also provide below documentation for the toy before order can be placed.

Chemical testing for the toy is stated in the Toy safety requirement document. 

Product type


All toys

  • Signed Toy safety requirements document
  • EC declaration of conformity
  • Bill of Materials for the Toy (BOM)
  • Safety assessment in English with 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 has been performed. The safety assessment includes intended user and what warnings must be on the toy.
  • Picture of marking and labelling on the toy and on the consumer packaging.


Additional for chemical products

E.g. finger paints, chemical sets, bubbles

  • Safety data sheet
  • Pdf on warning label if applicable
  • Pre-registration number / document for substances in the mixtures
  • Reach registration number if applicable.
  • Tonnage certificate if applicable


Additional for RC Toys

  • DoC and test report according to R&TTE directive

Additional for electrical toys

  • Test report according to EN 62115
  • RoHS BOM report

Additional for toys intended for children > 14 years, but likely to be used by children <14 years

  • EN 71 test report according to Toy Safety document, but no CE marking required.


Chemical requirements

Since 20 July 2011, the Toy Safety Directive requires a chemical risk assessment on all toys to ensure that they do not contain any harmful chemical substances or pose any other risks to the user. From 20 July 2013 new rules for chemical migration from toys are effective. A general requirement is that toys must pose no risk to human health. Besides this general requirement there are a number of specific requirements.

For 19 substances there are limits on how much of the substance are allowed to leak out (migrate) from the toy. This applies to:

Aluminium, Antimony Arsenic Barium, Lead, Cadmium, Cobolt, Copper, Chromium, Chromium(III), Chromium (VI), Mercury, Manganese, Nickel, Organic tin, Selenium, Strontium, Tin. Compared with the earlier directive, there are now more substances covered by the restrictions, and the migration limits for the substances are stricter.

The migration limits vary depending on the type of material the toy is made of. The material categories are:

  • Dry, brittle, powder-like or pliable toy material
  • Liquid or sticky toy material
  • Scraped-off toy material

In order to show compliance with this requirement, the product can be tested according to EN 71-3:2013 standard.

Ban on CMR substances

Substances which are classed as CMR substances, i.e. carcinogenic, mutagenic or toxic for reproduction in category 1A, 1B or 2 are prohibited for use in toys, in components of toys or in micro-structurally distinct parts of toys above the classified limit in accordance with EC Regulation for the classification and labelling of substances and mixtures, EC/1272/2008 (CLP).

In the Directive, these CMR substances are allowed to be used if concentration is below their classification limits. This means that substances which are classified as carcinogenic or mutagenic according to category 1A or 1B may be used in concentrations below 0.1 %, and in category 2 in concentrations up to 1 %. Substances which are classified as toxic for reproduction according to category 1A or 1B may be used in concentrations up to 0.3 %, and in category 2 in concentrations up to 3 %.

Ban on 55 allergenic fragrances. Further 11 must be clearly labelled on the packaging.

55 allergenic fragrances are prohibited in toys in concentrations of 100 mg/kg (100 ppm). These fragrances are also regulated by the EU Cosmetics Directive. The Cosmetics Directive prohibits 40 of these 55 substances, the remaining 15 are subject to labelling.

A further 11 substances must be labelled if they are added to toys in concentrations exceeding 100 mg/kg (100 ppm). These substances must be labelled on the toy, on an affixed label, on the packaging or in an accompanying leaflet.

Nitrosamines and nitrosatable substances are prohibited for use in toys for children under 36 months or in other toys intended to be placed in the mouth.

The concentration of N-Nitrosamines (0.05 ppm) and N-nitrosatable substances (1 ppm) must not migrate from toys intended for use by children under 36 months or in other toys intended to be placed in the mouth. N- Nitrosamines are normally present in rubber and are carcinogenic. Until now the substance has mainly been found in balloons, but it could also be present in other toys made of natural rubber and in certain finger paints.

In order to show compliance with this requirement, the product can be tested according to standards EN 71-12:2013 and EN 71-7:2013 can be used.