Guidance Directive 2009/48/EC on the Safety Toys - Rev. 1.10 2021
These guidelines are intended to be a manual for all parties directly or indirectly affected by Directive 2009/48/EC, commonly referred to as the TSD (Toy Safety Directive). Readers’ attention is drawn to the fact that this guide is intended only to facilitate the application of Directive 2009/48/EC and it is the relevant national transposition of the text of the directive which is legally binding. However, this document does represent a reference for ensuring consistent application of the directive by all stakeholders. The guidelines are intended to help ensure the free movement of toys in the Community territory by consensus amongst Member States’ government experts and other parties concerned.
These guidelines have been prepared by the relevant services of the Directorate General for Internal Market, Industry, Entrepreneurship and SMEs of the European Commission in consultation with Member States, European industry, European standardisation bodies, European consumer organisations and Notified Bodies.
The Commission accepts no responsibility or liability whatsoever with regard to the information in this guide and aims at giving advice only.
This information is:
- οf a general nature only and is not intended to address the specific circumstances of any particular individual or entity;
- sometimes refers to external information over which the Commission services have no control and for which the Commission assumes no responsibility;
- a living document which will be regularly updated and subject to review;
- no legal advice.
All references to the CE marking and EC declaration of conformity in this Guide relate only to Directive 2009/48/EC.
Rev. 1.10 2021 - 22.09.2021
Rev 1.10 Section 1.2.3 on Article 2(2) now explains how to deal with secondhand toys.
Rev 1.10 Section 2.1.1 on Articles 4 to 9 now clarifies regarding Article 4(7) that instructions and safety information on the web cannot replace those that have to accompany the toy on the packaging, in a leaflet or notice.
Rev 1.10 Section 2.1.4 on Articles 4 to 9 now clarifies regarding Article 7 that instructions and safety information on the web are not sufficient.
Rev 1.10 Section 3.2.7 on Article 11(3) now refers to good practice for the visibility and legibility of warnings, markings and instructions for use.
Rev 1.10 Section 3.3 on Article 12 now refers to other pieces legislation which impose safety and other requirements on toys.
Rev 1.10 Section 3.6.2 on Article 15(2) now refers to multilingual EC declarations of conformity.
Rev 1.10 Section 4.4.4 on Article 21(4) now clarifies that notified bodies are also empowered to carry out a test under Article 21(4).
Rec 1.10 Section 6.2 on Article 40 clarifies that Regulation (EC) No 765/2008 was amended by Regulation (EU) 2019/1020.
Rev 1.10 Section 7.1.1 on Article 46 (1), first subparagraph now refers to the two amendment Directives on allergenic fragrances.
Rev 1.10 Section 8.2 on Article 49 clarifies that Regulation (EC) No 765/2008 was amended by Regulation (EU) 2019/1020.
Rev 1.10 Section 10.1.1 on Point 1 of Annex I now also refers to Guidance document No 20 on decorative products and products for collectors.
Rev 1.10 Section 10.1.2 on Point 2 of Annex I now refers to Guidance document No 6 on the treatment of 'grey zone' products
Rev 1.10 Section 10.1.2.3 on Folk dolls and decorative dolls and other similar articles now also refers to Guidance document No 20 on decorative products and products for collectors.
Rev 1.10 Section 10.1.17 on Point 17 of Annex I now clarifies that childappealing luminaires are no toys. Previous (wrong) web link deleted.
Rev 1.10 Section 11.1.19 on Point 11 of Annex II, Part I clarifies that activity toys shall fulfill also other applicable requirements in the EN 71-series of standards.
Rev 1.10 Section 11.3.7 on Point 7 of Annex II, Part III clarifies that the reference to Regulation (EC) No 1935/2004 is no longer applicable since 21 July 2017. The previous explanations on that Regulation were deleted.
Rev 1.10 Section 11.3.8 on Point 8 of Annex II, Part III now clarifies that also water balloons are intended to be placed in the mouth.
Rev 1.10 Section 11.3.11 on Point 11 of Annex II, Part III: 3 allergenic substances that will be prohibited as of 5.7.2022 added to the table.
Explanatory text adapted.
Rev 1.10 Section 11.3.11 on Point 11 of Annex II, Part III: 61 allergenic substances added to the table that will have to be labelled as of 5.7.2022. Entries 4 and 10 adapted (see the related footnotes).
Explanatory text adapted.
Rev 1.10 Section 11.3.13 on Point 13 of Annex II, Part III:
− Update of the limit values for the elements. Explanations added;
− Squishy toys added as an example for pliable toy material in the table on “Dry, brittle, powder-like or pliable toy material”
Rev 1.10 Section 11.7 on Appendix A: Deletion of the reference to the application date, since Appendix A now fully applicable.
Rev 1.10 Section 11.9 on Appendix C: Update on the substances in Appendix C.
Rev 1.10 Section 14.2.1 on Annex V, Part B, Point 1: Addition of references to age-related sources of information
Rev 1.10 Section 15 on Overview of standards and guidelines:
− References to harmonised standards referenced in the OJEU replaced with the relevant web link;
− References added to explanations within this document about the meaning of “referenced” and “not referenced”.
Rev 1.10 Section 16 on Explanation I – Obligations of economic operators:
− Update of the table summarising the obligations of economic operators;
− Update of link to national language requirements for warnings, information and documentation.
Rev 1.10 Section 17 on Explanation II: Clarified. References added to guidance on the visibility and legibility of warnings, markings and instructions for use.
Rev 1.10 Section 18 on Explanation III: Table referring to superseded Directive 88/378/EEC deleted.
Rev 1.10 Section 21 on guidance outlining the relationship between the General Section 21 on guidance outlining the relationship between the General
Product Safety Directive and Regulation (EC) No 765/2008 deleted, since superseded.