legislation-profile

Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys

Scope

This Directive lays down rules on the safety of toys with regards to human health and on their free movement in the Community. (Art. 1) It applies to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys). (Art.2 (1)) No definition of a 'substance' included in the Directive; also no definition of a 'product'. Definitions of a 'functional product' and a 'functional toy' included in Article 3 of the Directive.

Exemptions

This Directive shall not apply to the following toys: (Art. 2 (2)) (a) playground equipment intended for public use (b) automatic playing machines, whether coin operated or not, intended for public use (c) toy vehicles equipped with combustion engines (d) toy steam engines; and (e) slings and catapults. The products listed in Annex I shall not be considered as toys within the meaning of this Directive. (Art. 2 (1)). Annex I is a non-exhaustive list (emphasis added): ''List of products that, in particular, are not considered as toys within the meaning of this Directive''. The list contains 19 items including - Decorative objects for festivities and celebrations; - Products for collectors …; - Sports equipment …; - Aquatic equipment intended to be used in deep water, and swimming learning devices for children …; - Puzzles with more than 500 pieces; - Guns and pistols using compressed gas, with the exception of water guns and water pistols, and bows for archery over 120 cm long; - Fireworks …; - Products intended for use for educational purposes …; - Electronic equipment, such as personal computers and game consoles …; - Interactive software, intended for leisure and entertainment, such as computer games, …; - Babies' soothers.

Regulatory activities

There are two possible conformity assessments allowing a toy to be sold in the EU. The manufacturer has to demonstrate the conformity of the toy by: • self-verification if European harmonised standards cover all relevant safety requirements for the toy (Art.19) • third party verification through a notified body (EC-type examination. (Art. 20)) All toys made available on the market in the EU must carry a CE marking. (Art. 16) This is the manufacturer's declaration that the toy satisfies the applicable requirements. When placing their toys on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with requirements set out in Article 10 (general safety requirement) and Annex II (specific safety requirements). (Art. 4 (1)) Safety assessment.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. (Article 18) Before placing a toy on the market, manufactures shall use the conformity assessment procedures referred to in paragraphs 2 and 3 to demonstrate that the toy complies with the requirements set out in Article 10 and Annex II.(Art. 19(1)) EC-type examination. An application for EC-type examination, performance of that examination and issue of the EC-type examination certificate shall be carried out in accordance with the procedures set out in Module B of Annex II to Decision No. 768/2008/EC.

Relevant product types

No reference data needed.

Reference documents

Yes. Directive 98/34/EC/ Regulation (EC) No 765/2008 Decision No 768/2008/EC Regulation 1935/2004 Regulation (EC) No 1272/2008 Regulation (EC) No 1907/2006 Directive 76/768/EEC Regulation (EC) No 1935/2004

Obligations based on CLP hazard class

Yes. Annex II, Part III-Chemical properties, point 2. Toys that are themselves substances or mixtures must comply with Regulation No. 1272/2008 relating to classification, labelling and packaging of substances and mixtures.

Obligations based on properties of concerns

Yes. Regarding CMRs: Annex II, Section III-Chemicals properties, points 3, 4, 5 and 6. No reference to PBT/vPvB, ED or substances of equivalent concern.

EU-level emission limit values

No provision

Substance-centric data source(s) at the EU level

The Toy Safety Directive is not generating data on substances, it is only using the data from other pieces of legislation, such as the CLP Regulation. Note: Exchange of Information- Community Rapid Information Exchange System. (Art.44) The Rapid Alert System (RAPEX) enables quick exchange of information between 31 European countries and the European Commission about dangerous non-food products posing a risk to health and safety of consumers.

Industry submission system in place

No electronic system in place that should be used by the industry for submission of information.

Format for industry submission

Not applicable

Owner

DG GROW , as being the 'legislation owner' with regards to updates of list of substances mentioned above (Annex II)

Update process

The Commission may, for the purpose of adapting them to technical and scientific development, amend the following: (Art. 46(1)). (a) Annex I (b) points 11 and 13 of Part III of Annex II (c) Annex V If the Commission intends to permit the use of a CMR substance or mixture, it mandates the relevant Scientific Committee (as mentioned in Annex II, Section III, points 4 c and 5 c) to evaluate whether the use of the substance or mixture is safe, in particular in view of exposure. The Commission shall mandate the relevant Scientific Committee to re-evaluate CMR substances or mixtures as soon as safety concerns arise and at the latest every 5 years from the date that a decision to permit the use in accordance with Article 46 (3) was taken.

Amendments

Corrigendum to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys Commission Directive 2012/7/EU of 2 March 2012 amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy safety Commission Regulation (EU) No 681/2013 of 17 July 2013 amending part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys Commission Directive 2014/79/EU of 20 June 2014 amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards TCEP, TCPP and TDCP Commission Directive 2014/81/EU of 23 June 2014 amending Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards bisphenol A Commission Directive 2014/84/EU of 30 June 2014 amending Appendix A of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards nickel Commission Directive (EU) 2015/2115 of 23 November 2015 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards formamide Commission Directive (EU) 2015/2116 of 23 November 2015 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards benzisothiazolinone Commission Directive (EU) 2015/2117 of 23 November 2015 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chloromethylisothiazolinone and methylisothiazolinone, both individually and in a ratio of 3:1 Council Directive (EU) 2017/738 of 27 March 2017 amending, for the purpose of adapting to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards lead Commission Directive (EU) 2017/774 of 3 May 2017 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards phenol Commission Directive (EU) 2017/898 of 24 May 2017 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards bisphenol A Commission Directive (EU) 2018/725 of 16 May 2018 amending, for the purpose of adaptation to technical and scientific developments, point 13 of part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chromium VI Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 Commission Directive (EU) 2019/1929 of 19 November 2019 amending Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council for the purpose of adopting specific limit values for chemicals used in certain toys, as regards formaldehyde

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