| Ministerial Decree |
| Number: | Decree of 10 December 2010 |
| Title: | Transitional amendments to the annexes to Legislative Decree No 313 of 27 September 1991 implementing Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008, amending previous directives in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, limited to Article 2 relating to the amendments to be made to Directive 88/378/EEC concerning the safety of toys. (11A01763) |
| Scope of application: | • Transitional amendments to the annexes to Legislative Decree No 313 of 27 September 1991 implementing Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008, amending previous directives in order to adapt them to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, limited to Article 2 relating to the amendments to be made to Directive 88/378/EEC concerning the safety of toys;
• Toys which, for reasons essential to their functioning, contain dangerous mixtures as defined in Council Directive 67/548/EEC pursuant to Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, in particular materials and equipment for chemistry experiments, model assembly, plastic or ceramic moulding, enamelling, photography or similar activities, must not contain, as such, substances or preparations which may become flammable due to the loss of non-flammable volatile components;
• Toys must not contain dangerous mixtures within the meaning of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations, or substances which meet the criteria of one of the following hazard classes or categories pursuant to Annex I to Regulation (EC) No 1272/2008;
• without prejudice to the application of the provisions laid down in Regulation (EC) No 1272/2008, the instructions for using toys which contain inherently dangerous mixtures or substances which meet the criteria of one of the following hazard classes or categories pursuant to Annex I to Regulation (EC) No 1272/2008;
• the first aid to be given in the event of serious accidents resulting from the use of this type of toy shall also be mentioned. It shall also be stated that the toy must be kept out of reach of children under a certain age. |
| Any technical standard indicated in the DM: | |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2011-02-15&atto.codiceRedazionale=11A01763 |
| Number: | Decree of 18 May 2012 |
| Title: | Amendments to Annex II to Legislative Decree No 54 of 11 April 2011 implementing 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 on toy safety. (12A08302) |
| Scope of application: | • Amendments to Annex II to Legislative Decree No 54 of 11 April 2011 implementing 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 on toy safety;
• in Point 13 of Part III of Annex II to Legislative Decree No 54 of 11 April 2011, the entry relating to cadmium is replaced by the following:
1.3 mg/kg cadmium for dry toy material; 0.3 mg/kg cadmium for liquid or sticky toy material; 17 mg/kg cadmium for scraped-off toy material. |
| Any technical standard indicated in the DM: | |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2012-07-26&atto.codiceRedazionale=12A08302 |
| Number: | Decree of 3 February 2015 |
| Title: | Amendments to Annex II to Legislative Decree No 54 of 11 April 2011 on toy safety, implementing Commission Directives 2014/84/EU of 30 June 2014, 2014/79/EU of 20 June 2014 and 2014/81/EU of 23 June 2014, as regards nickel, TCEP, TCPP and TDCP and bisphenol A (15A03085) |
| Scope of application: | • Appendix A to Annex II to Legislative Decree No 54 of 11 April 2011 is replaced by the following: ‘Appendix A:
• Nickel CMR 2 in toys and in toy components made of stainless steel. In toy components which are intended to conduct an electric current;
Appendix C to Annex II to Legislative Decree No 54 of 11 April 2011 is replaced by the following: ‘Appendix C Specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth adopted in accordance with Article 46(2) Substance CAS No Limit value TCEP 115-96-8 5 mg/kg (content limit) TCPP 13674-84-5 5 mg/kg (content limit) TDCP 13674-87-8 5 mg/kg (content limit) Bisphenol A 80-05-7 0.1 mg/l (migration limit) in accordance with the methods laid down in EN 71-10:2005 and EN 71-11:2005’. |
| Any technical standard indicated in the DM: | |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2015-04-28&atto.codiceRedazionale=15A03085 |
| Number: | Decree of 2 November 2018 |
| Title: | Amendment to Annex II to Legislative Decree No 54 of 11 April 2011 implementing Council Directive (EU) 2017/738 amending, for the purpose of adaptation to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on toy safety, as regards lead. (18A07904) |
| Scope of application: | • Amendment to Annex II to Legislative Decree No 54 of 11 April 2011 implementing Council Directive (EU) 2017/738 amending, for the purpose of adaptation to technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the Council on toy safety, as regards lead;
amendments to the table in Point 13 of Part III of Annex II to Legislative Decree No 54 of 11 April 2011 and its entry into force. In the table in Point 13 of Part III of Annex II to Legislative Decree No 54 of 11 April 2011, the entry for lead is replaced by the following: <Lead 2.0 0.5 23>. |
| Any technical standard indicated in the DM: | |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2015-04-28&atto.codiceRedazionale=15A03085 |
| Number: | Decree of 5 December 2018 |
| Title: | Transposition of Commission Directive (EU) 2017/898 of 24 May 2017 amending, as regards bisphenol A, Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, in order to adopt specific limit values for chemicals used in toys. |
| Scope of application: | • Transposition of Commission Directive (EU) 2017/898 of 24 May 2017 amending, as regards bisphenol A, Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, in order to adopt specific limit values for chemicals used in toys.
Amendments to the table in Annex II, Appendix C of Legislative Decree No 54 of 11 April 2011 and its entry into force. In the table in Appendix C of Annex II to Legislative Decree No 54 of 11 April 2011, the entry for bisphenol A is replaced by the following: ‘Bisphenol A 80-05-07 0.04 mg/l (migration limit) in accordance with the methods set out in EN 71-10:2005 and EN 71-11:2005’ |
| Any technical standard indicated in the DM: | EN 71-10:2005, EN 71-11:2005 |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2019-01-11&atto.codiceRedazionale=19A00141 |
| Number: | Decree of 5 December 2018 |
| Title: | Transposition of Commission Directive (EU) 2017/898 of 24 May 2017 amending, as regards bisphenol A, Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, in order to adopt specific limit values for chemicals used in toys |
| Scope of application: | • Transposition of Commission Directive (EU) 2017/898 of 24 May 2017 amending, as regards bisphenol A, Appendix C of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, in order to adopt specific limit values for chemicals used in toys.
Amendments to the table in Annex II, Appendix C of Legislative Decree No 54 of 11 April 2011 and its entry into force. In the table in Appendix C of Annex II to Legislative Decree No 54 of 11 April 2011, the entry for bisphenol A is replaced by the following: ‘Bisphenol A 80-05-07 0.04 mg/l (migration limit) in accordance with the methods set out in EN 71-10:2005 and EN 71-11:2005’ |
| Any technical standard indicated in the DM: | EN 71-10:2005, EN 71-11:2005 |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2019-01-11&atto.codiceRedazionale=19A00142 |
| Number: | Decree of 02 August 2019 |
| Title: | Amendment to paragraph 13 of Part III of Annex II to Legislative Decree No 54 of 11 April 2011 implementing Commission Directive (EU) 2018/725 of 16 May 2018 amending paragraph 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, in order to adapt it to technical and scientific developments, as regards chromium VI. (19A06411) |
| Scope of application: | • Amendment to paragraph 13 of Part III of Annex II to Legislative Decree No 54 of 11 April 2011 implementing Commission Directive (EU) 2018/725 of 16 May 2018 amending paragraph 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, in order to adapt it to technical and scientific developments, as regards chromium VI;
• amendments to the table in Annex II, Part III, paragraph 13 of Legislative Decree No 54 of 11 April 2011 and its entry into force. 1. In the table in Annex II, Part III, paragraph 13 of Legislative Decree No 54 of 11 April 2011, the entry corresponding to chromium VI is replaced by the following: Element mg/kg of dry, brittle, powdered or flexible toy material mg/kg liquid or sticky toy material mg/kg of scraped-off toy material |
| Any technical standard indicated in the DM: | |
| Link: | https://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2019-10-14&atto.codiceRedazionale=19A06411 |
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