EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC

1. EUROPEAN COMMISSIONTOYS SAFETY DIRECTIVE 2009/48/EC

2. EXISTING RULES Directive 88/378/EEC was adopted in 1988 (20 years old) Allows for free movement of safe toys in all 27 Member States of the EU Contains essential safety requirements/general principles Technical details are adopted in harmonised standards (EN 71 series and EN 62115)

3. Reasons for a new Directive • Changes in the toys market (many kinds of new toys) • Changes in production areas - 80% imports • to EU • New scientific evidence of substances used • in toys • Need to enhance control inside EU/at external borders

4. TIME FRAME OF REVISION • Proposal adopted by the European Commission on 25 January 2008 • Proposal was under discussion with EU institutions: • Council (27 EU-Member States) • European Parliament (700 deputies from 27 EU-Member states) • Text adopted by EP on 18 December 2008 • Text adopted by Council on 11 May 2009 • Directive signed on the 18th June and published in the OJEU on 30 June 2009

5. Directive 2009/48/EC: time schedule OJEU (1) (2) (3) (4) • OJEU + 20 days : entry into force i.e. 20 July 2009 • OJEU + 20 days +18 months: time for MS to transpose i.e. 20 January 2011 • OJEU + 20 days + 2 years: application of the Directive (except chemical requirements) i.e. 20 July 2011 • OJEU + 20 days + 4 years: application of the Directive for chemical requirements i.e. 20July 2013

6. DIRECTIVE 2009/48/EC I Clarifying the scope and concepts II Obligations of economic operators III Safety assessment and conformity assessment IV Warnings V Requirements

7. DIRECTIVE 2009/48/EC I Clarifying the scope and concepts

8. I SCOPE and CONCEPTS 2009/48/EC Definition of “Toys” in Article 2 (1) “products designed or intended, whether or not exclusively, for use in play by children under 14 years of age” 88/378/EEG Definition of “Toys” in Article 1 (1) “any product or material designed or clearly intended for use in play by children of less than 14 years of age”

10. LIST OF PRODUCTS THAT ARE NOT REGARDED AS TOYS (ANNEX I) • = products that do not fulfil the definition of toys but • could be confused with them: • non exhaustive list

11. LIST OF PRODUCTS THAT ARE NOT REGARDED AS TOYS (ANNEX I) Attention! A contrario interpretation should not be drawn from the list, that is, if a particular product is not mentioned in the list, it does not mean that it is automatically a toy The definition of toy has to always be the basis for deciding whether a product is a toy or not

12. LIST OF PRODUCTS THAT ARE NOT CONSIDERED AS TOYS (ANNEX I) 1. Decorative objects for festivities and celebrations 2. Products for collectors, provided that the product or its packaging bears a visible and legible indication that it is intended for collectors of 14 years of age and above. Examples of this category are: (a) detailed and faithful scale models; (b) kits for the assembly of detailed scale models; (c) folk dolls and decorative dolls and other similar articles; (d) historical replicas of toys; and (e) reproductions of real fire arms. 3. Sports equipment, including roller skates, inline skates, and skateboards intended for children with a body mass of more than 20 kg 4. Bicycles with a maximum saddle height of more than 435 mm, measured as the vertical distance from the ground to the top of the seat surface, with the seat in a horizontal position and with the seat pillar set to the minimum insertion mark

13. LIST OF PRODUCTS THAT ARE NOT CONSIDERED AS TOYS (ANNEX I) 5. Scooters and other means of transport designed for sport or which are intended to be used for travel on public roads or public pathways 6. Electrically driven vehicles which are intended to be used for travel on public roads, public pathways, or the pavement thereof 7. Aquatic equipment intended to be used in deep water, and swimming learning devices for children, such as swim seats and swimming aids 8. Puzzles with more than 500 pieces 9. Guns and pistols using compressed gas, with the exception of water guns and water pistols, and bows for archery over 120 cm long 10. Fireworks, including percussion caps which are not specifically designed for toys 11. Products and games using sharp-pointed missiles, such as sets of darts with metallic points 12. Functional educational products, such as electric ovens, irons or other functional products operated at a nominal voltage exceeding 24 volts which are sold exclusively for teaching purposes under adult supervision 13. Products intended for use for educational purposes in schools and other pedagogical contexts under the surveillance of an adult instructor, such as science equipment

14. LIST OF PRODUCTS THAT ARE NOT CONSIDERED AS TOYS (ANNEX I) 14. Electronic equipment, such as personal computers and game consoles, used to access interactive software and their associated peripherals, unless the electronic equipment or the associated peripherals are specifically designed for and targeted at children and have a play value on their own, such as specially designed personal computers, key boards, joy sticks or steering wheels 15. Interactive software, intended for leisure and entertainment, such as computer games, and their storage media, such as CDs 16. Babies' soothers 17. Child-appealing luminaries 18. Electrical transformers for toys 19. Fashion accessories for children which are not for use in play

15. LIST OF PRODUCTS THAT ARE REGARDED AS TOYS, BUT ARE EXCLUDED • = products that fulfil the definition of toys but • are excluded from the scope: • exhaustive list

16. LIST OF PRODUCTS THAT ARE REGARDED AS TOYS, BUT ARE EXCLUDED playground equipment intended for public use automatic playing machines, whether coin operated or not, intended for public use toy vehicles equipped with combustion engines toy steam engines slings and catapults

17. DIRECTIVE 2009/48/EC II Obligations of economic operators

18. OBLIGATIONS OF ECONOMIC OPERATORS Economic operators are responsible for the compliance of the toy in relation to their role in the supply and distribution chain

19. DIRECTIVE 2009/48/EC Manufacturer

20. DIRECTIVE 2009/48/EC manufacturer means any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark manufacturers shall ensure that the toys have been designed and manufactured in accordance with the requirements set out in the Toy Safety Directive

21. DIRECTIVE 2009/48/EC Manufacturers shall draw up the required technical documentation and carry out or have carried out the applicable conformity assessment procedure Manufacturers shall draw up an EC declaration of conformity and affix the CE marking

22. DIRECTIVE 2009/48/EC The EC declaration of conformity states that the fulfilment of the requirements has been demonstrated The manufacturer assumes responsibility for the compliance of the toy It is translated into the language or languages required by the Member State in whose market the toy is placed or made available

23. DIRECTIVE 2009/48/EC

24. DIRECTIVE 2009/48/EC

25. DIRECTIVE 2009/48/EC Obligation to keep the technical documentation and the EC declaration of conformity for a period of 10 years after the toy has been placed on the market http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

26. DIRECTIVE 2009/48/EC Manufacturers ensure that procedures are in place for series production to remain in conformity Changes in toy design or characteristics and changes in the harmonised standards by reference to which conformity of a toy is declared shall be adequately taken into account

27. DIRECTIVE 2009/48/EC • Manufacturers • carry out sample testing • investigatecomplaints, recalls,… • keep a register of complaints, recalls,… • keep distributors informed

28. DIRECTIVE 2009/48/EC • Unique identification : • A type, batch, serial or model number or other element allowing their identification • On the toy,on the packaging or in a document accompanying the toy • Address: • name, registered trade name or registered trade mark and the address • On the toy, on the packaging or in a document accompanying the toy

29. DIRECTIVE 2009/48/EC Manufacturers ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers

30. DIRECTIVE 2009/48/EC • Manufacturers • immediately take corrective measures • immediately inform the competent national authorities • give detailson the non compliance

31. DIRECTIVE 2009/48/EC • Manufacturers • provide all the information and documentation necessary to demonstrate the conformity of the toy • a language easily understood by the authority • cooperate

32. DIRECTIVE 2009/48/EC Authorized representative

33. DIRECTIVE 2009/48/EC authorised representative means any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks The obligations to manufacturer and the drawing up of technical documentation shall not form part of the authorised representative's mandate

34. DIRECTIVE 2009/48/EC • The authorised representative does at least the following: • keep the EC declaration of conformity and the technical documentation at the disposal of national surveillance authorities for a period of 10 years after the toy has been placed on the market • further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a toy • (c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by toys covered by the mandate.

35. DIRECTIVE 2009/48/EC Importer

36. DIRECTIVE 2009/48/EC importer means any natural or legal person established within the Community who places a toy from a third country on the Community market Notice: an importer is considered a manufacturer where it places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements may be affected

37. DIRECTIVE 2009/48/EC • Importers shall identify any economic operator who has supplied them with a toy and any economic operator to whom they have supplied a toy • Importers shall be able to present the information for a period of 10 years after they have been supplied with the toy

38. DIRECTIVE 2009/48/EC Importers place only compliant toys on the Community market Importers ensure that • the manufacturer carried out the conformity assessment • the manufacturer drew up the technical documentation • the toy bears the CE marking • the toy is accompanied by the required documents • the toy bears an indentification and the manufacturers address

39. DIRECTIVE 2009/48/EC Importers • indicate their name, registered trade name or registered trade mark and the address • ensure that the toy is accompanied by instructions and safety information • ensure that storage or transport conditions do not jeopardise the compliance

40. DIRECTIVE 2009/48/EC Importers • carry out sample testing • investigatecomplaints, recalls,.. • keep a register of complaints , recalls,… • keep distributors informed

41. DIRECTIVE 2009/48/EC Importers • immediately take the corrective measures • immediately inform the competent national authorities • keep a copy of the EC declaration of conformity • ensure that the technical documentation can be made available • cooperate

42. DIRECTIVE 2009/48/EC Distributors

43. DIRECTIVE 2009/48/EC distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market Notice: a distributor is considered a manufacturer where it places a toy on the market under its name or trademark or modifies a toy already placed on the market in such a way that compliance with the applicable requirements may be affected

44. DIRECTIVE 2009/48/EC • Distributors shall identify any economic operator who has supplied them with a toy and any economic operator to whom they have supplied a toy • Distributors shall be able to present the information for a period of 10 years after they have been supplied with the toy

45. DIRECTIVE 2009/48/EC • act with due care • verify that the toy bears the CE marking • verify that the toy is accompanied by the required documents • verify if the instructions are in a language or languages easily understoodby consumers

46. DIRECTIVE 2009/48/EC • inform the manufacturer or the importer, as well as the market surveillance authoritiesof non compliant toys • not make a non compliant toy available on the market

47. DIRECTIVE 2009/48/EC • ensure that storage or transport conditions do not jeopardise its compliance • make sure that the corrective measures necessary are taken • provide the authority with all the information and documentation necessary to demonstrate the conformity of the toy

48. OBLIGATIONS OF ECONOMIC OPERATORS [P1]

49. DIRECTIVE 2009/48/EC III Safety assessment and conformity assessment

50. ASSESSMENT • 88/378/EEC • Choice of the conformity assessment procedure • 1) Self verification if • - harmonised standard covering all safety aspects are complied with • 2) Third party verification (EC type examination) if • harmonised standards do not exist • harmonised standards are not applied or only in part • harmonised standards are published with a restriction 2009/48/EC extends with Explicit obligation to carry out an analysis of hazards - manufacturers considers that toy necessitates 3rd party verification