Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry

1. EU Toy SafetyProduct safety training for buyers and sourcing professionalsShanghai, Guangzhou and ShundeAugust-September 2014 Katleen HENDRIX European Commission, Directorate-General Enterprise and Industry Internal Market and its International Dimension

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

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

5. What is a toy? (continued) Some products are not toys • Decorative 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)

6. A toy has to be safe • The manufacturer placing a toy on the EU market has to ensure that it complies with • General safetyrequirement • (see Article 10.2 of the ToySafety Directive) • Particularsafetyrequirements • (seeAnnex II of the ToySafety Directive) • The essential safetyrequirements (= general + particularsafetyrequirements) are mandatory => Standards are notmandatory in the EU!

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

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)

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

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 greaterthan 0.1% by weight of the plasticisedmaterial • DINP, DIDP and DNOP are banned • in toys (and childcare articles) whichcanbeplaced in the mouth by children and • in a concentration greaterthan 0.1% by weight of the plasticisedmaterial Guidance on "whichcanbeplaced in the mouth" availablehttp://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm Q&A http://echa.europa.eu/support/qas-support/qas select "Restrictions" • 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

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 burnswhentouched • 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

12. Typical Business Model Product Cycle Product developed, produced and sold entirely within the EU. EU Production manufacturer distributor 1 Product developed and sold within the EU by an EU Operator, but Developed & Domestic manufacturer distributor 2 produced outside the EU. Unaltered product developed by a supplier, then sold within the 3rd Party & Domestic ( without product manufacturer distributor importer 3 EU by an EU Operator alteration) Supplier product specifically modified (see point 3 below) for or by 3rd Party & Domestic ( with product manufacturer distributor 4 an EU Operator and sold within the EU. alterations) Developed product (by a Non-EU Operator) sold outside of the Direct Import / FOB manufacturer importer 5 EU for Direct Import by an EU Operator. Developed product (by EU Operator) sold outside of Direct Import/FOB - manufacturer is manufacturer distributor 6 the EU for Direct Import by an EU Operator. *5 an EU entity Developed product (by EU or Non-EU Operator) sold outside of the EU by an EU or Non-EU sales agent, for Direct Import by an 3rd Party (Sales Commission) FOB manufacturer importer 7 EU Operator. Product sold by a contracted representative of a Non-EU Manufacturers Authorised Authorised representative manufacturer distributor 8 Operator to hold (but not draw up) Technical File. Representative in EU Product developed exclusively for EU retailer and bought outside Retailer own Brand Product manufacturer 9 the EU. 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/index_en.htm , p. 137

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 therequirements 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

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

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

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 propertiesotherthanelectricalproperties: EN 71 • => For electricalproperties: EN 62115

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

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-typeexamination" => "EC-typeexaminationcertificate" List of Notified Bodies: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=140521

19. Manufacturer: Design and prototyping (continued) If the conformityassessmentprocedure shows that: • the toyiscompliant, then the manufacturer • must draw up the technical documentation • must draw up the EC Declaration of Conformity • must ensureconformity of production at all times • must affix the CE mark • the toyis not compliant, then the manufacturer • must not place the toy on the market • mayimprove the toy in order to becomecompliant

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

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

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 languagerequirements! • keep technical documentation and EC Declaration of Conformity for 10 years

23. Manufacturer: once the toy is on the market The manufacturer must: • takesamples of marketedtoys and test them • investigate complaints on non-conformingtoys • take action if hebelieves or has reason to believethat the toyis not in conformity, including: • bring the toyintoconformity • withdraw/recall the toy if appropriate • if risk: immediatelyinform the competentMember State authorities • cooperatewith the Member State authorities, including: • provide documents provingconformity of the toy • cooperate on authorities' actions to eliminaterisksfromtoys

24. Importer The importer must: • place onlycomplianttoys on the EU market • therefore, ensurethat the manufacturer has donehis job! • ensurethatappropriateconformityassessmentwasdone • ensurethat all the required documents are there • ensurethat the CE marking and the instructions, safety information and warnings are affixed • ensurethat the toyis identifiable/traceable • ensurethat the manufacturer'sname etc. appear • affixhisownname, registeredtradename/trademark and address • monitor and take action if heconsiders or has reason to believethatthe toyis not in conformity • cooperatewith the Member State authorities

25. More information EU toy safety homepage • http://ec.europa.eu/enterprise/sectors/toys/index_en.htm Text of the ToySafety Directive (includingChineseversion!) • http://ec.europa.eu/enterprise/sectors/toys/documents/directives/index_en.htm Guidance (including some Chinese versions!) • http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm Amendments of the Toy Safety Directive • http://ec.europa.eu/enterprise/sectors/toys/documents/index_en.htm#h2-2 Reference documents • http://ec.europa.eu/enterprise/sectors/toys/documents/index_en.htm

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