EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC

EUROPEAN COMMISSIONTOYS SAFETY DIRECTIVE2009/48/EC

Directive 88/378/EEC was adopted in 1988(20 years old)Allows for free movement of safe toys in all27 Member States of the EUContains essential safety requirements/generalprinciplesTechnical details are adopted in harmonisedstandards (EN 71 series and EN 62115)

Changes in the toys market (many kinds of newtoys)Changes in production areas - 80% importsto EUNew scientific evidence of substances usedin toysNeed to enhance controlinside EU/at external borders

Proposal adopted by the European Commission on25 January 2008Proposal 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 2008Text adopted by Council on 11 May 2009Directive signed on the 18th June and published inthe OJEU on 30 June 2009

!"#!$%& '()*OJEU(1) (2) (3) (4)(1) OJEU + 20 days : entry into force i.e. 20 July 2009(2) OJEU + 20 days +18 months: time for MS to transposei.e. 20 January 2011(3) OJEU + 20 days + 2 years: application of the Directive(except chemical requirements) i.e. 20 July 2011(4) OJEU + 20 days + 4 years: application of the Directive forchemical requirements i.e. 20July 2013

$ !"#!$I Clarifying the scope and conceptsII TraceabilityIII Declaration of ConformityIV Safety assessment and conformity assessmentV warnings

$ !"#!$I Clarifying the scope and concepts

$+($$+88/378/EEGDefinition of “Toys” inArticle 1 (1)“any product or materialdesigned or clearlyintended for use in playby children of less than14 years of age”2009/48/ECDefinition of “Toys” inArticle 2 (1)“products designed orintended, whether or notexclusively, for use inplay by children under14 years of age”

+ $, -./= products that do not fulfil the definition of toys butcould be confused with them:- non exhaustive list

+ $, -./Attention!A contrario interpretation should not be drawn fromthe list, that is, if a particular product is notmentioned in the list, it does not mean that it isautomatically a toyThe definition of toy has to always be the basis fordeciding whether a product is a toy or not

+ $, $ -./1. Decorative objects for festivities and celebrations2. Products for collectors, provided that the product or its packaging bears avisible and legible indication that it is intended for collectors of 14 years ofage 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 skateboardsintended for children with a body mass of more than 20 kg4. Bicycles with a maximum saddle height of more than 435 mm, measured asthe vertical distance from the ground to the top of the seat surface, with theseat in a horizontal position and with the seat pillar set to the minimuminsertion mark

+ $, $ -./5. Scooters and other means of transport designed for sport or which areintended to be used for travel on public roads or public pathways6. Electrically driven vehicles which are intended to be used for travel onpublic roads, public pathways, or the pavement thereof7. Aquatic equipment intended to be used in deep water, and swimminglearning devices for children, such as swim seats and swimming aids8. Puzzles with more than 500 pieces9. Guns and pistols using compressed gas, with the exception of water gunsand water pistols, and bows for archery over 120 cm long10. Fireworks, including percussion caps which are not specifically designedfor toys11. Products and games using sharp-pointed missiles, such as sets of dartswith metallic points12. Functional educational products, such as electric ovens, irons or otherfunctional products operated at a nominal voltage exceeding 24 voltswhich are sold exclusively for teaching purposes under adult supervision13. Products intended for use for educational purposes in schools and otherpedagogical contexts under the surveillance of an adult instructor, such asscience equipment

+ $, $ -./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 arespecifically designed for and targeted at children and have a play value ontheir own, such as specially designed personal computers, key boards, joysticks or steering wheels15. Interactive software, intended for leisure and entertainment, such ascomputer games, and their storage media, such as CDs16. Babies' soothers17. Child-appealing luminaires18. Electrical transformers for toys19. Fashion accessories for children which are not for use in play

+ $, -01 $= products that fulfil the definition of toys butare excluded from the scope:- exhaustive list

+ $, -01 $playground equipment intended for public useautomatic playing machines, whether coin operatedor not, intended for public usetoy vehicles equipped with combustion enginestoy steam enginesslings and catapults

$ !"#!$II Traceability

$ !"#!$Unique Identification:a type, batch, serial or model number or other element allowing theiridentificationOn the toy, on the packaging or in a document accompanying the toyAddress:name, registered trade name or registered trade mark and the addressOn the toy, packaging or in a document accompanying the toyNote: unique identification is equal to one on EC DoC

$ !"#!$ Manufacturers shall identify any economicoperator who has supplied them with a toy andany economic operator to whom they havesupplied a toy Manufacturers shall be able to present theinformation for a period of 10 years after theyplaced the toy on the market

$ !"#!$ Importers/distributors shall identify any economicoperator who has supplied them with a toy andany economic operator to whom they havesupplied a toy Importers/distributors shall be able to present theinformation for a period of 10 years after theyhave been supplied with the toy

$ !"#!$III Declaration of Conformity

$ !"#!$Manufacturers shall draw up the required technicaldocumentation and the EC Declaration ofConformityManufacturers shall keep the technicaldocumentation and the EC declaration ofconformity for a period of 10 years after the toy hasbeen placed on the markethttp://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

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$ !"#!$IV Safety assessment and conformity assessment

88/378/EECChoice of the conformity assessmentprocedure1) Self verification if- harmonised standard covering all safetyaspects are complied with2) Third party verification (EC typeexamination) if- harmonised standards do not exist- harmonised standards are not applied oronly in part- harmonised standards are published with arestriction2009/48/ECextends withExplicit obligation to carry out ananalysis of hazards- manufacturers considers thattoy necessitates 3rd partyverification

$ !"#!$V Warnings

2 Marking of the warningsThe manufacturer shall mark the warnings in aclearly visible, easily legible and understandableand accurate mannera Member State may stipulate that those warningsand the safety instructions shall be written in alanguage(s) easily understood by consumers

Marking of the warnings2 The warnings shall be preceded by the words"Warning" or "Warnings"The manufacturer shall mark the warnings on thetoy, on an affixed label or on the packaging and, ifappropriate, on the instructions for use whichaccompany the toySmall toys which are sold without packaging shallhave appropriate warnings affixed to them

Marking of the warnings2 Warnings which determine the decision topurchase the toy, such as those specifying theminimum and maximum ages for users and theother applicable warnings set out in Annex V,shall appear on the consumer packaging or beotherwise clearly visible to the consumer beforethe purchase, including in cases where thepurchase is made on-line

2 User limitationsThe user limitations shall include at least theminimum or maximum age of the user and, whereappropriate, the abilities of the user, themaximum or minimum weight of the user and theneed to ensure that the toy is used only underadult supervision

2 Specific warningsThe warnings shall be used as worded, except forthe toys not intended for children under 36monthsThe economic operator can choose between"Not suitable for children under 36 months" or"Not suitable for children under three years" or awarning in the form of the following graphic

2 Specific warningsToys shall not bear one or more of the specificwarnings where that warning conflicts with theintended use of the toy, as determined by virtueof its function, dimension and characteristics

IdentificationIdentification (wherethe size orthe naturedoes notallow it)AddressAddress(wherethat is notpossible)CE markCE mark(small toy)CE mark(counterdisplay)WarningWarning(small toywithoutpackaging)ToyXXXXXXXpackagingXXXXXXDocument(instructions/leaflet/label)XXXXX (ifappropriate)AffixedlabelXXXXXXXCounterdisplayX (if usedaspackaging)

$ !"#!$2 3 •Particular Safety requirements- Physical and mechanical properties- Chemical properties- Electrical properties- Flammability- Hygiene- Radioactivity

Choking risk+,-$ $,$+ + = inhalation of small parts88/378/EECtoys for children under36 months2009/48/ECExtended with toys whichare intended to be put in themouth ( for example toyinstruments)

+,-$ $,$+ + Suffocation risk88/378/EECexternal airwayobstruction ofmouth and nose2009/48/ECextended withinternal airwayobstruction(Example: suctioncups)

Toys in food88/378/EECno specific provisions+,-$ $,$+ + 2009/48/ECSeparate packagingPackaging: no chokinghazardWarning: “Toy inside;Adult supervisionrecommended ”Ban of toys firmlyattached to a food product(example : some lollypops)

1$ $ -4041Substances that are classified as carcinogenic,mutagenic or toxic for reproduction (CMR), category1A, 1B or 2 shall not be used in toys, in componentsof toys or in micro-structurally distinct parts of toys

+ ,$ 1 $$- these substances and mixtures arecontained in individual concentrations equalto or smaller than the relevantconcentrations established in theCommunity legal acts-or these substances and mixtures areinaccessible to children in any form,-or a decision has been taken

$, $1$nickel in stainles steel is authorizednitrosamines and nitrosatable substances shallbe prohibited for use in toys intended for use bychildren under 36 months or in other toysintended to be placed in the mouth if themigration of the substances is equal to or higherthan 0,05 mg/kg for nitrosamines and 1 mg/kg fornitrosatable substances.

$ $1) Ban for 55 allergenic fragrances2) Labelling for 11 fragrances that are susceptibleto be allergenic for certain persons

$ 1$- List of elements of Directive 88/378/EEC enlargedto those relevant for toys- New strict migration limits for elements in toys- “Bioavailability” limits replaced by migration limitsDistinction of limits as regard toy material(dry/liquid)

,-88/378/EECToys must meet therequirements of hygieneand cleanliness in orderto avoid any risk ofinfection, sickness andcontamination2009/48/EC extends withA toy intended for children under36 months must be designed andmanufactured in such a way that itcan be cleaned.A textile toy shall be washable,except if it contains a mechanismthat may be damaged if soakwashed

1$ $+ ManufacturerAuthorised repImporterdistributorDraw upTechnical docXKeepTechnicalDoc10 y after placing on themarket10 y after placing on themarketMakeavailableTechnical doc10 y after placing on themarketUpon reasoned requestDraw up DoCXXKeep DoC10 y after placing on themarket10 y after placing on themarket10 y after placing on themarketUpon reasoned requestAddressXXIdentificationXAffix CEX

!"#!$MORE INFORMATIONhttp://ec.europa.eu/enterprise/sectors/toys/index_en.htm

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