REFERENCE GUIDE EU TOY SAFETY DIRECTIVE 2009/48/EC This guide is provided to help UL-STR s clients gain a greater understanding of the complex requirements of this updated directive and to assist in their ongoing efforts toward full compliance. The information provided herein is based upon the most current information available*, including European Commission (EC) Enterprise Directorate general guidance. strquality.com * As of August 2, 2012
OVERVIEW Background For the past 20 years, the EU Toy Safety Directive 88/378/EEC* has been the foundation of toy safety legislation and enforcement in the European market. As more toys with new functions, using new materials were introduced to the market, it became clear that the directive needed to be updated. In order to address emerging concerns, the new EU Toy Safety Directive 2009/48/EC was published in the Official Journal of the European Commission on June 30, 2009, and became effective on July 20, 2011. The outlines stricter requirements in areas such as noise, chemicals, and choking hazards. It also provides clarification for the rules on warnings and describes the use of risk assessments on products. Implementation Timeline The will be implemented in the following stages: December 2008 Parliament votes to replace Directive 88/378/EEC July 2009 Directive 2009/48/EC enters into force 20 days after publication in OJEC (June 30) January 2011 Deadline for Member States to make national legislation July 2011 Implementation (Except chemical requirements) July 2013-2014 Implementation of chemical requirements Timing for Updates to Related European Harmonized Standards PUBLISHED Standard Referenced in Official Journal of the European Commission EN71-1:2011 Physical JUNE 18 2011 EN71-2:2011 Flammability JULY 21 2011 EN71-8:2011 Activity Toys OCTOBER 19 2011 EN62115 A2:2011 AC:2011 Electrical OCTOBER 19 2011 PENDING 2013 2014 EN71-4 Chemistry Sets EN71-3 Toxicity EN71-5 Other Chemical Sets EN71-7 Finger Paints EN71-X Nitrosamines and N-nitrosatable Substance EN71-Y Trampolines for Domestic Use EN71-Z Olfactory Board Games, Cosmetic Kits and Gustative Games Major Changes from EU Toy Safety Directive 88/378/EEC to 2009/48/EC Risk Assessment The manufacturer has the responsibility to carry out a risk assessment addressing the physical, chemical, mechanical, electrical, flammability, hygienic and radioactivity hazards of a toy before placing it on the market. European Commission (EC) Declaration of Conformity The manufacturer is mandated to supply and keep up to date legal documentation for an EC Declaration of Conformity which signifies their responsibility for the toy and its compliance with the Directive. Production Control The manufacturer is required to control their manufacturing process, including internal monitoring, to ensure that their products continue to be safe, and comply with the directive s requirements. New Chemical Requirement Substances that are classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) are not allowed in the toy. * Council Directive 88/378/EEC of May 3, 1988 was published in the Official Journal of the European Communities on July 16, 1988, and became effective January 1, 1990. Directive 88/378/EEC, except Article 2(1) and Part 3 of Annex II, was repealed July 20, 2011. Article 2(1) thereof and Part 3 of Annex II thereto are repealed with effect beginning July 20, 2013.
ROLES & RESPONSIBILITIES For products imported into the EU after July 20, 2011, the following must be carried out by the respective party: Manufacturers Manufacture safe toy as defined in the Compile and maintain Technical File (retain for 10 years) Document conformity assessment procedure Draw up EC Declaration of Conformity (retain for 10 years) Print instructions in the national languages of the countries of distribution Maintain register of complaints Inform distributors of issues Keep tested samples of marketed toys Print/label batch and serial numbers on toy Print/label name and address of manufacturer on toy Print/label CE Mark on toy and/or packaging (must be visible at point of sale) Authorized Representative Keep EC Declaration of Conformity Provide Member State (MS) authority with information and documentation necessary to demonstrate conformity Cooperate on any action taken to eliminate risk Importers Verify manufacturer has performed and completed all responsibilities Check that language is correct for country of distribution Perform testing on marketed toy to ensure that the product is still safe (e.g., storage conditions, transportation, etc. are not affecting toy) Print/label name and address of importer on product Maintain register of complaints Recall non-conforming toys Inform manufacturers, distributors and authorities of issues Distributor Verify toy displays the CE marking, indicating conformity to the Essential Safety Requirements (ESR) Confirm that toy is accompanied by documents and instruction in language of country of distribution Ensure that if the toy is not in conformity with the ESR, the toy is not made available to the marketplace Ensure that storage or transport conditions do not jeopardize compliance with the new toy safety directive Where the toy presents a risk, the distributor shall inform the manufacturer or the importer and market surveillance authorities
NEW DOCUMENTATION REQUIREMENTS Technical File must include: Detailed description of the design and manufacture of the product, including: - List of components and materials used in the toy - Safety data sheets on chemicals used (to be obtained from chemical suppliers) Safety assessment(s) determining the risks/hazards of the product Description of the conformity assessment procedure Copy of the EC Declaration of Conformity* The addresses of the places of manufacture and storage Copies of documents that the manufacturer has submitted to a Notified Body, if involved Test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonized standards, if the manufacturer followed the internal production control procedure referred to in Article 19(2) Copy of the EC-type examination certificate A description of the means whereby the manufacturer ensured conformity of the production with the product type as described in the EC-type examination certificate Copies of the documents that the manufacturer submitted to the Notified Body, if the manufacturer submitted the toy to EC-type examination and followed the conformity procedure referred to in Article 19(3) EC Declaration of Conformity must include: Unique identification number of the toy(s) Name and address of the manufacturer or his authorized representative Object of the declaration (identification of toy allowing traceability), including a color image of sufficient clarity to enable the identification of the toy Documentation showing that the object of the declaration is in conformity with relevant harmonized standards References to the relevant harmonized standards used, or references to the specifications in relation to which conformity is declared A description of intervention by a Notified Body when applicable Authorized signature including: Manufacturer s name on behalf of which Declaration is being made Name and Signature (manufacturer, or authorized representative of company making the declaration) Title and Company Name Address of Signee Date of Issue * The EC Declaration of Conformity is issued under the sole responsibility of the manufacturer.
NEW CHEMICAL SUBSTANCES AND MIGRATION LIMITS Element mg/kg in dry, brittle powder-like or pliable toy material Revised Toy Safety Directive Existing EN 71 Standard mg/kg in liquid or sticky toy material mg/kg in scraped-off toy material mg/kg Aluminium 5,625 1,405 70,000 Antimony 45 11.3 560 60 Arsenic 3.8 0.9 47 25 Barium 4,500 1,125 56,000 1,000 Boron 1,200 300 15,000 Cadmium 1.9 0.5 23 75 Chromium (III) 37.5 9.4 460 60 Chromium (VI) 0.02 0.005 0.2 Cobalt 10.5 2.6 130 Copper 622.5 156 7,700 Lead 13.5 3.4 160 90 Manganese 1,200 300 15,000 Mercury 7.5 1.9 94 60 Nickel 75 18.8 930 Selenium 37.5 9.4 460 500 Strontium 4,500 1,125 56,000 Tin 15,000 3,750 180,000 Organic tin 0.9 0.2 12 Zinc 3,750 938 46,000 These limits apply to accessible toys or accessible components of toys GLOSSARY Definitions Accreditation Shall have the meaning assigned to it by Regulation (EC) No 765/2008 Activity Toy A toy for domestic use in which the support structure remains stationary while the activity is taking place and which is intended for the performance by a child of any of the following activities: climbing, jumping, swinging, sliding, rocking, spinning, crawling and creeping, or any combination thereof Aquatic Toy A toy intended for use in shallow water which is capable of carrying or supporting a child on the water Authorized Representative Any natural or legal person established within the EU who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks CE Marking A marking by which the manufacturer indicates that the toy is in conformity with the applicable requirements set out in Community harmonization legislation providing for its affixing Chemical Toy A toy intended for the direct handling of chemical substances and mixtures and which is used in a manner appropriate to a given age-group and under the supervision of an adult Community Harmonization Any EC legislation harmonizing the conditions for the marketing of products Legislation Conformity Assessment The process demonstrating whether specified requirements relating to a toy have been fulfilled
GLOSSARY CONTINUED Definitions Conformity Assessment Body Cosmetic Kit Design Speed Distributor Economic Operators Functional Product Functional Toy Gustative Game Harm Harmonized Standard Hazard Importer Intended For Use By Making Available On The Market Manufacturer Market Surveillance Olfactory Board Game Placing On The Market Recall Risk Withdrawal A body that performs conformity assessment activities, including calibration, testing, certification and inspection A toy the purpose of which is to assist a child to learn to make products such as fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners Representative potential operating speed that is determined by the design of the toy Any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market The manufacturer, the authorized representative, the importer and the distributor A product which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation A toy which performs and is used in the same way as a product, appliance or installation intended for use by adults, and which may be a scale model of such product, appliance or installation A toy the purpose of which is to allow children to make sweets or dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas Physical injury or any other damage to health, including long-term health effects A standard adopted by one of the European standardization bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Community in accordance with Article 6 of that Directive A potential source of harm Any natural or legal person established within the EU who places a toy from a third country on the EU market That a parent or supervisor shall reasonably be able to assume by virtue of the functions, dimensions and characteristics of a toy that it is intended for use by children of the stated age group Any supply of a toy for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge 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 The activities carried out and measures taken by public authorities to ensure that toys comply with the applicable requirements set out in Community harmonization legislation and do not endanger health, safety or any other aspect of public interest protection A toy the purpose of which is to assist a child to learn to recognize different odors or flavors The first making available of a toy on the EU market Any measure aimed at achieving the return of a toy that has already been made available to the end user The probable rate of occurrence of a hazard causing harm and the degree of severity of the harm Any measure aimed at preventing a toy in the supply chain from being made available on the market UL and the UL logo are trademarks of UL LLC 2012. Form EUTSD/08.02.12
GLOSSARY CONTINUED Commonly Used Acronyms AC CENELEC CMR s COM CLP CNAS Alternating Current European Committee for Electrotechnical Standardization Carcinogens, Mutagens and Reproductive Toxins Communication of the Commission Classification, Labeling and Packaging Regulation China National Accreditation Service CPSIA Consumer Product Safety Improvement Act of 2008 DC DG-SANCO DoC EC ECHA EMC ESR EU Euratom FCM GPSD HKAS HOKLAS LEDs NB RAC Direct Current Directorate General for Health and Consumer Affairs Declaration of Conformity European Commission European Chemicals Agency Electromagnetic Emissions Directive Essential Safety Requirements European Union European Atomic Community Food Contact Material General Product Safety Directive Hong Kong Accreditation Service The Hong Kong Accreditation Scheme Light Emitting Diode Notified Body Committee for Risk Assessment REACH Registration, Evaluation, Authorization and Restriction of Chemicals (EC 1907/2006) RIVM TSD UKAS How UL-STR Can Help National Institute for Health and Environment (Rijksinstituut voor Volksgezondheid en Milieu [Dutch]) Toy Safety Directive United Kingdom Accreditation Service Through its global network of well-trained and experienced staff, UL-STR provides testing, audit, inspection and quality assurance services in compliance with the testing requirements mandated by the including: Design Evaluations and Safety Assessments Toxicological Risk Assessments Restricted Substance Evaluations Technical File Assessment Proprietary Online Storage and Maintenance of all Technical File Documents EC Type Examinations, and EC Declaration of Conformity Preparation Trusted the world over, UL-STR is an independent provider of quality assurance testing, audit, inspection and responsible sourcing services for the consumer products industry. Our reach encompasses over 30 countries across five continents and the capability to provide audit services in over 140 countries. Our customized solutions help clients produce products that comply with industry standards, and meet consumer expectations. For more information on all the ways you can rely on UL-STR to help you effectively manage toy safety and quality, contact the ToyTeam@ul.com or visit strquality.com/toys. THIS DOCUMENT IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE. UL-STR DOES NOT PROVIDE LEGAL ADVICE REGARDING TOY SAFETY AND QUALITY THROUGH ITS PROGRAMS.