1. EU Toy Safety Product safety training for buyers and sourcing professionals Shanghai, Guangzhou and Shunde August-September 2014 Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry Internal Market and its International Dimension

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3. DIRECTIVE 2009/48/EC ("Toy Safety Directive") Applicable in all EU Member States since 20 July 2011; chemical requirements applicable since 20 July 2013 Clear definitions and obligations for all economic operators Clear requirements on identification, warning labels, technical documentation including EC Declaration of Conformity, safety assessment, conformity assessment procedures, … Stricter safety requirements Free movement of safe toys in all EU Member States 3

4. What is a toy? A toy is a product: -designed or intended -whether or not exclusively -for use in play -by children under 14 years of age according to the Toy Safety Directive 4

5. What is a toy? (continued) Some products are not toys  D ecorative objects for festivities and celebrations  Puzzles with more than 500 pieces  Fireworks  etc. (see Annex I of the Toy Safety Directive, non-exhaustive list) Some toys are not covered by the Toy Safety Directive  Playground equipment intended for public use  Automatic playing machines intended for public use  Toy steam engines  etc. (see Article 2 of the Toy Safety Directive) 5

6. A toy has to be safe The manufacturer placing a toy on the EU market has to ensure that it complies with General safety requirement (see Article 10.2 of the Toy Safety Directive) Particular safety requirements (see Annex II of the Toy Safety Directive) The essential safety requirements (= general + particular safety requirements) are mandatory => Standards are not mandatory in the EU! 6

7. A toy has to be safe (continued) General safety requirement Toys must not jeopardise the health and safety of the child playing, nor of others (parents, child carers, …) when used as intended or in a foreseeable way Bear in mind the behaviour of children! Particular safety requirements Physical and chemical properties (incl. small parts, sound) Flammability Chemical properties (incl. allergenic fragrances, 19 elements) Electrical properties Hygiene (incl. microbiological safety aspects) Radioactivity 7

8. Physical and mechanical properties (example) Choking risk = swallowing or inhalation of small parts cf the "small parts cylinder" Small parts are banned: in toys clearly intended for children under 36 months and in other toys intended to be put in the mouth (e.g. toy musical instruments) 8

9. Chemical properties (examples) Ban in principle: substances classified as carcinogenic, mutagenic and toxic for reproduction (CMR) Ban: 55 named allergenic fragrances Labelling requirements: 11 named fragrances susceptible to be allergenic for certain persons Migration limits for 19 named "heavy elements" like cadmium, lead and mercury From end 2015: specific limit values recently laid down for TCEP, TCPP, TDCP and bisphenol A (and more coming) in toys intended for children under 36 months and in other toys intended to be placed in the mouth 9

10. Chemical properties (examples - continued) EU legislation on chemicals must also be respected! Especially relevant: REACH restrictions on phthalates DEHP, DBP and BBP are banned in toys (and childcare articles) and in a concentration greater than 0.1% by weight of the plasticised material DINP, DIDP and DNOP are banned in toys (and childcare articles) which can be placed in the mouth by children and in a concentration greater than 0.1% by weight of the plasticised material Guidance on "which can be placed in the mouth" available http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/ind ex_en.htm http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/ind ex_en.htm Q&A http://echa.europa.eu/support/qas-support/qas select "Restrictions"http://echa.europa.eu/support/qas-support/qas From end 2015: REACH restriction on PAH 0.5 mg/kg by weight of rubber or plastic components in direct, prolonged or repetitive skin or oral cavity contact 10

11. Electrical properties (examples) Cables and conductors of electricity must be protected so as to prevent risk of electric shock Wires and conductors must be protected so that they do not come into contact with burrs that may damage their insulation Directly accessible surfaces cannot cause burns when touched Batteries of toys intended for children under 36 months must have secure battery compartment cover or must be removable only with the aid of a tool 11

12. What type of economic operator am I / is the entity for which I am sourcing? TSD explanatory guidance document Rev 1.7 at http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/ind ex_en.htm, p. 137 http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/ind ex_en.htm 12

13. Obligations of economic operators Each economic operator has different obligations, according to his role in the supply and distribution chain Manufacturer (EU or non EU) Design and manufacture in accordance with the requirements Importer (only EU) Place only compliant toys on the EU market Distributor Act with due care in relation to the applicable requirements Authorised representative An importer or distributor is considered to be a manufacturer if: he places the toy on the EU market under his name or trademark he modifies a toy already placed on the market in such way that compliance with the requirements may be affected level of responsibility 13

14. Manufacturer: Design and prototyping The manufacturer has to perform a safety assessment for the toy: An analysis of the hazards (chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity) that the toy may present An assessment of the potential exposure to such hazards 14

15. Manufacturer: Design and prototyping (continued) The manufacturer has to submit the toy to a conformity assessment There are 2 possible conformity assessment procedures: 1.by the manufacturer himself 2.by a Third Party ("Notified Body" = "Conformity Assessment Body") In both cases the manufacturer assumes responsibility for compliance and affixes the CE mark 15

16. Manufacturer: Design and prototyping (continued) 1.Conformity assessment by the manufacturer himself ("self-certification") If he applies harmonised standards, whose references have been published in the Official Journal of the EU, and all the relevant safety requirements for the toy are covered by those harmonised standards => For properties other than electrical properties: EN 71 => For electrical properties: EN 62115 16

17. Manufacturer: Design and prototyping (continued) Latest publication of references of harmonised standards: OJ C 181, 13.6.2014, p. 1 http://ec.europa.eu/enterprise/policies/european- standards/harmonised-standards/toys/index_en.htm http://ec.europa.eu/enterprise/policies/european- standards/harmonised-standards/toys/index_en.htm 17

18. Manufacturer: Design and prototyping (continued) 2.Conformity assessment by a Third Party ("Notified Body") If the relevant safety requirements for the toy are not entirely covered by harmonised standards whose references have been published in the Official Journal of the EU If the manufacturer has applied the harmonised standards only in part or not at all If the harmonised standards have been published with a restriction (currently not the case) If the manufacturer considers that the toy needs to be assessed by a Third Party "EC-type examination" => "EC-type examination certificate" List of Notified Bodies: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=140521 http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=140521 18

19. Manufacturer: Design and prototyping (continued) If the conformity assessment procedure shows that: the toy is compliant, then the manufacturer must draw up the technical documentation must draw up the EC Declaration of Conformity must ensure conformity of production at all times must affix the CE mark the toy is not compliant, then the manufacturer must not place the toy on the market may improve the toy in order to become compliant 19

20. Manufacturer: Design and prototyping (cont'd) Draw up the EC Declaration of Conformity: 20

21. Manufacturer: Design and prototyping (cont'd) Draw up the technical documentation: 21

22. Manufacturer: placing the toy on the market The manufacturer must make the toy identifiable/traceable: type, batch, serial or model number on the toy make himself identifiable: his name, registered trade name/trademark and address on the toy, the packaging or an accompanying document add instructions and safety information, including warnings, on the toy, an affixed label or the packaging Some warnings are mandatory! See Annex V of the Toy Safety Directive Member States impose language requirements! keep technical documentation and EC Declaration of Conformity for 10 years 22

23. Manufacturer: once the toy is on the market The manufacturer must: take samples of marketed toys and test them investigate complaints on non-conforming toys take action if he believes or has reason to believe that the toy is not in conformity, including: bring the toy into conformity withdraw/recall the toy if appropriate if risk: immediately inform the competent Member State authorities cooperate with the Member State authorities, including: provide documents proving conformity of the toy cooperate on authorities' actions to eliminate risks from toys 23

24. Importer The importer must: place only compliant toys on the EU market therefore, ensure that the manufacturer has done his job! ensure that appropriate conformity assessment was done ensure that all the required documents are there ensure that the CE marking and the instructions, safety information and warnings are affixed ensure that the toy is identifiable/traceable ensure that the manufacturer's name etc. appear affix his own name, registered trade name/trademark and address monitor and take action if he considers or has reason to believe that the toy is not in conformity cooperate with the Member State authorities 24

25. More information EU toy safety homepage http://ec.europa.eu/enterprise/sectors/toys/index_en.htm Text of the Toy Safety Directive (including Chinese version!) http://ec.europa.eu/enterprise/sectors/toys/documents/directi ves/index_en.htmhttp://ec.europa.eu/enterprise/sectors/toys/documents/directi ves/index_en.htm Guidance (including some Chinese versions!) http://ec.europa.eu/enterprise/sectors/toys/documents/guidan ce/index_en.htmhttp://ec.europa.eu/enterprise/sectors/toys/documents/guidan ce/index_en.htm Amendments of the Toy Safety Directive http://ec.europa.eu/enterprise/sectors/toys/documents/index_ en.htm#h2-2http://ec.europa.eu/enterprise/sectors/toys/documents/index_ en.htm#h2-2 Reference documents http://ec.europa.eu/enterprise/sectors/toys/documents/index_ en.htmhttp://ec.europa.eu/enterprise/sectors/toys/documents/index_ en.htm 25

26. Thank you for your attention! Any Questions? For questions in the future: ENTR-TOYS@ec.europa.eu 26