EUROPEAN COMMISSION TOYS SAFETY DIRECTIVE 2009/48/EC 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) 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 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 "#! $% & ! ' ()* 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 transpose i.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 for chemical requirements i.e. 20July 2013 $ "#! $ ! I Clarifying the scope and concepts II Traceability III Declaration of Conformity IV Safety assessment and conformity assessment V warnings $ "#! $ ! I Clarifying the scope and concepts $ + ($ $ + 88/378/EEG 2009/48/EC Definition of “Toys” in Definition of “Toys” in Article 1 (1) Article 2 (1) “any product or material “products designed or designed or clearly intended, whether or not intended for use in play exclusively, for use in by children of less than play by children under 14 years of age” 14 years of age” + $ , - . / = products that do not fulfil the definition of toys but could be confused with them: - non exhaustive list + $ , - . / 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 + $ , $ - . / 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 + $ , $ - . / 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. 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 luminaires 18. Electrical transformers for toys 19. Fashion accessories for children which are not for use in play + $ , - 01 $ = products that fulfil the definition of toys but are excluded from the scope: - exhaustive list + $ , - 01 $ 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 $ "#! $ ! II Traceability $ "#! $ ! 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, packaging or in a document accompanying the toy Note: unique identification is equal to one on EC DoC $ "#! $ ! Manufacturers shall identify any economic operator who has supplied them with a toy and any economic operator to whom they have supplied a toy Manufacturers shall be able to present the information for a period of 10 years after they placed the toy on the market $ "#! $ ! Importers/distributors shall identify any economic operator who has supplied them with a toy and any economic operator to whom they have supplied a toy Importers/distributors shall be able to present the information for a period of 10 years after they have been supplied with the toy $ "#! $ ! III Declaration of Conformity $ "#! $ ! Manufacturers shall draw up the required technical documentation and the EC Declaration of Conformity Manufacturers shall 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/legislat ion/guide/index.htm $ "#! $ ! $ "#! $ ! $ "#! $ ! IV Safety assessment and conformity assessment 88/378/EEC 2009/48/EC extends with Choice of the conformity assessment procedure Explicit obligation to carry out an 1) Self verification if analysis of hazards - 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 - manufacturers considers that - harmonised standards are published with a toy necessitates 3rd party restriction verification $ "#! $ ! V Warnings 2 Marking of the warnings The manufacturer shall mark the warnings in a clearly visible, easily legible and understandable and accurate manner a Member State may stipulate that those warnings and the safety instructions shall be written in a language(s) easily understood by consumers 2 Marking of the warnings The warnings shall be preceded by the words "Warning" or "Warnings" The manufacturer shall mark the warnings on the toy, on an affixed label or on the packaging and, if appropriate, on the instructions for use which accompany the toy Small toys which are sold without packaging shall have appropriate warnings affixed to them 2 Marking of the warnings Warnings which determine the decision to purchase the toy, such as those specifying the minimum and maximum ages for users and the other applicable warnings set out in Annex V, shall appear on the consumer packaging or be otherwise clearly visible to the consumer before the purchase, including in cases where the purchase is made on-line 2 User limitations The user limitations shall include at least the minimum or maximum age of the user and, where appropriate, the abilities of the user, the maximum or minimum weight of the user and the need to ensure that the toy is used only under adult supervision 2 Specific warnings The warnings shall be used as worded, except for the toys not intended for children under 36 months The economic operator can choose between "Not suitable for children under 36 months" or "Not suitable for children under three years" or a warning in the form of the following graphic 2 Specific warnings Toys shall not bear one or more of the specific warnings where that warning conflicts with the intended use of the toy, as determined by virtue of its function, dimension and characteristics Identificati Identificati Address Address CE mark CE mark CE mark Warning Warning on on (where (where (small toy) (counter (small toy the size or that is not display) without the nature possible) packaging does not ) allow it) Toy X X X X X X X packaging X X X X X X Document X X X X X (if (instructio appropriat ns/leaflet/l e) abel) Affixed X X X X X X X label Counter X (if used display as packaging ) $ "#! $ ! 2 3 •Particular Safety requirements - Physical and mechanical properties - Chemical properties - Electrical properties - Flammability - Hygiene - Radioactivity +,- $ $, $ + + Choking risk = inhalation of small parts 88/378/EEC 2009/48/EC toys for children under Extended with toys which 36 months are intended to be put in the mouth ( for example toy instruments) +,- $ $, $ + + Suffocation risk 88/378/EEC 2009/48/EC extended with external airway obstruction of internal airway mouth and nose obstruction (Example: suction cups) +,- $ $, $ + + Toys in food 2009/48/EC 88/378/EEC Separate packaging Packaging: no choking no specific provisions hazard Warning: “Toy inside; Adult supervision recommended ” Ban of toys firmly attached to a food product (example : some lollypops) 1 $ $ - 4 041 Substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B or 2 shall not be used in toys, in components of toys or in micro-structurally distinct parts of toys + , $ 1 $ $ - these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts -or these substances and mixtures are inaccessible to children in any form, -or a decision has been taken $, $ 1 $ nickel in stainles steel is authorized nitrosamines and nitrosatable substances shall be prohibited for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosatable substances. $ $ 1) Ban for 55 allergenic fragrances 2) Labelling for 11 fragrances that are susceptible to be allergenic for certain persons $ 1 $ - List of elements of Directive 88/378/EEC enlarged to those relevant for toys - New strict migration limits for elements in toys - “Bioavailability” limits replaced by migration limits Distinction of limits as regard toy material (dry/liquid) ,- 88/378/EEC 2009/48/EC extends with Toys must meet the A toy intended for children under requirements of hygiene 36 months must be designed and manufactured in such a way that it and cleanliness in order can be cleaned. to avoid any risk of A textile toy shall be washable, infection, sickness and except if it contains a mechanism contamination that may be damaged if soak washed 1 $ $ + Manufacturer Authorised rep Importer distributor Draw up X Technical doc Keep 10 y after placing on the 10 y after placing on the Technical market market Doc Make 10 y after placing on the Upon reasoned request available market Technical doc Draw up DoC X X Keep DoC 10 y after placing on the 10 y after placing on the 10 y after placing on the Upon reasoned request market market market Address X X Identification X Affix CE X "#! 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MORE INFORMATION http://ec.europa.eu/enterprise/sectors/toys/index_en.htm Questions?