EU TOY DIRECTIVE 2009/48/EC: OVERVIEW - REGULATORY CONTEXT AND MAJOR The EU Toy Directive was revised in order to take into account the new technological developments and increasing child safety requirements. On 30 June 2009 the new Toy Safety Directive (TSD) 2009/48/EC was published: It substantially amends the 24-year old 88/378/EEC Directive across virtually all safety aspects; It fulfils to the highest level the newest health and safety standards; It improves the existing rules for the marketing of toys that are produced in and imported into the EU in view to reducing toy related accidents and achieving long-term health benefits. The final text was formally published in the OJEU on 30 June 2009 and came into force on 21 July 2011 except chemical requirements which have been in force since 20 July 2013. The objective of the TSD is to reduce toy related accidents by identifying hazards in toys not covered by the standards, taking into account the foreseeable use, bearing in mind children s behaviour. 1. REGULATORY CONTEXT 1.1 Scope The Directive 2009/48/EC applies to toys defined as "products designed or intended, whether or not exclusively, for use in play by children under 14 years of age". The words whether or not exclusively have been added to the definition to indicate that the product does not have to be exclusively intended for playing purposes in order for it to be considered as a toy, but it can have other functions as well. The aim of the change is to clarify the scope rather than to change the scope. This means that products with double function or grey area products are included and can be considered as toys. E.g.: A key-ring with a teddy bear attached to it is considered as a toy; A sleeping bag in the shape of a soft filled toy is considered as a toy; Art materials intended for children are considered as toys; Bath sponges in the shape of a toy figure are considered as toys. In Annex I of the TSD 19 products are listed that are not to be considered as toys within the meaning of the Directive. Also 5 types of toys are excluded from the scope of the Directive (for example, toy steam engines, slings etc). REFERENCES GUIDANCE DOCUMENTS are available at http://ec.europa.eu/enterprise/sectors/toys/documents/guidance/index_en.htm 1.2 Timelines of implementation 2009 20 July 2011 20 January 2011 20 July 2013 20 July New Toy Safety Directive came into force Deadline for the translation into national legislation by Member States Implementation of general requirements (except chemicals) end of transitional period of 2 years Implementation of chemical requirements end of transitional period of 4 years The general provisions of the 2009/48/EC TSD are applicable to toys placed on the market as of 20 July 2011, while the chemical provisions are applicable to toys placed on the market as of 20 July 2013 (additional 2-year transition period for chemical properties).
Know if your product is considered as a toy; SGS offers Consultancy & Training to help you understand the changes, how they impact your products and what actions to set up. 2. MAJOR OF THE EU TOY SAFETY DIRECTIVE The revised Toy Safety Directive defines the new obligations of economic operators: Manufacturers; Importers; Distributors; Authorised Representatives (only if formally appointed by a manufacturer). Traditional roles no longer apply. The role and obligations need to be assessed on a case by case basis. e.g. Modifying a product can make you a Manufacturer; Role depends on business model. The TSD increases the level of responsibility. For each operator type there are obligations that they are legally required to meet when supplying or purchasing toys. 2.1 Manufacturer s obligations Ensure toys comply with essential safety requirements; Perform safety assessment to identify hazards that a toy may present; Draw technical documentation with stringent requirements for chemicals (keep 10 years); Draw EC declaration of conformity (keep 10 years); Ensure production control; Test samples. 2.2 Importer s obligations Place only compliant toys on the market; Check manufacturer used appropriate production control; Check manufacturer s technical documentation and marking; If appropriate test and investigate. 2.3 Distributor s obligations Make toys available on the market with due care to requirements applicable; Verify CE-marking, EC declaration of conformity, relevant documentation, instructions supplied in relevant language(s), type, batch number and manufacturer s and importer s name and address. DEFINITIONS Manufacturer : 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. Authorized representative : 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. Importer : any natural or legal person established within the Community who places a toy from a third country on the Community market. Distributor : any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a toy available on the market. Identify your role, your obligations and how to implement them; SGS offers Consultancy & Training to help you identify your role and obligations and what actions to set up.
3. SAFETY ASSESSMENT The new directive defines a new obligation for all toys: all toys placed on the market after 20 July 2011 must have been subject to a safety assessment (includes chemical safety assessment). The toy should be designed in such a way that as many hazards as possible are eliminated or that residual risk is minimized to an acceptable level. Responsibility of the manufacturer; Must be provided upon request to the authorities in one of the official languages of the Community (30 days or in the case of serious risk, in a shorter time); Must be kept for 10 years. Risk is defined as Hazard x Exposure The safety assessment is therefore a form of risk assessment. It requires: Analysis of hazards (chemical, physical, mechanical, electrical, flammability, hygiene and radioactivity) that the toy may present to a child Analysis of potential exposure to these hazards (normal, intended and foreseeable use bearing in mind behaviour of children) by identifying the risks and solutions to limit flammability, radioactivity, hygiene hazards that a toy may present. The safety assessment enables to identify hazards (going beyond standards) and check that toys comply with the new requirements. Perform your own safety assessment or use third party; SGS offers Training to help you know how to perform your own risk assessment; SGS can perform the safety assessment of your toys and help you identify potential hazards, determine the level of risk and help you make design changes to design /produce a safer toy. 4. CONFORMITY ASSESSMENT Each toy to be placed on the market is submitted to a conformity assessment procedure. Conformity assessment is the procedure by which a manufacturer establishes that his toy fulfills the applicable safety provisions of the directive. It provides demonstrable evidence that the toy is in conformity with the legal requirements under the 2009/48/EC TSD. Responsibility of the manufacturer Option 1: Self verification o This procedure is used if harmonized standards cover all relevant aspects of the toy o The manufacturer must also put in place an internal production procedure in accordance with Module A of Annex II to Decision No. 768/2008/EC (no need of a Notified Body) Option 2: Third party verification o EC type examination and certification is required in cases where harmonized standards do not exist or harmonized standards have not or only partly been applied by a manufacturer. o Manufacturer submits a model of the toy to a Notified Body for EC-type examination. Using Module B, the Notified Body examines the technical design of a toy and verifies and attests that the technical design of the toy meets the requirements of the 2009/48/EC TSD by issuing an EC-type examination certificate. Set up internal production control or use third party SGS offers inspections and factory audits to help you demonstrate your toys placed on the market fulfil the legal requirements
5. TECHNICAL DOCUMENTATION The Technical Documentation must contain all relevant data used by toy manufacturers to ensure compliance with the essential safety requirements of the TSD. Manufacturers shall draw up the required technical documentation, keep it for a period of 10 years after the toy has been placed on the market and be able to present it to surveillance authorities, at their request, within 30 days. The TSD is more specific on the contents of the Technical Documentation: A detailed description of the design and manufacture, including a list of components and materials (BOM) used in toys as well as the safety data sheets (SDS) on chemicals used, to be obtained from chemical suppliers; A safety assessment for each toy before it is placed on the market. This should include an analysis of the chemical, physical, mechanical, electrical, flammability and other hazards that the toy may present to a child; A description of the conformity assessment procedure followed. In other words, how the manufacturer ensures that all toys are manufactured to the required standards; A copy of the EC declaration of conformity (DoC). In other words, a formal certificate signed by a senior officer of the company, confirming that the toys is designed and manufactured to the appropriate legislation and standards; Addresses of places of manufacture and storage; Test reports and description of the means whereby the manufacturer ensured conformity of production with the harmonised standards, if the manufacturer followed the internal production control procedure; A copy of EC type examination certificate (if applicable) and a copy of documents that the manufacturer has submitted to a Notified Body, if involved. These requirements mean that, for the first time, manufacturers of toys will need to know exactly what materials and substances are used for making the toy. A manufacturer will not comply with the Toy Directive if the Technical Documentation has not been kept or is not up-to-date, even if the product meets legal and safety requirements. Collect information on design description: suitable age + Bill of Materials (BOM) + design information and check you have all required data; SGS offers training on how to draw up a technical documentation, technical assistance (SDS preparation, SVHC screening, etc) and can help validate the whole technical documentation by reviewing data you provided. 6. EC DECLARATION OF CONFORMITY The EC Declaration of Conformity (DoC) is a new requirement set by the new TSD. The manufacturer shall prepare a complete EC DoC, referring to all relevant standards including EMC, REACH, etc and translate it in all languages of EU countries where the toy will be placed on the market. The manufacturer has to sign the document and keep it for 10 years after the toy has been placed on the market. Prepare the document and translate it in necessary languages; SGS can provide you with the template and help you check the information.
7. ESSENTIAL SAFETY REQUIREMENTS The new TSD has strengthened some existing essential safety requirements. 7.1 Mechanical requirements (implemented since 20 July 2011) For instance, the TSD defines new requirements for choking hazards (under and over 3 years), new requirements for toys attached to food. Electrical toys having internal voltage over 24V are allowed only if there is no risk of a harmful electric shock. Know how the new requirements impact your toys; SGS offers testing services to comply with new requirements of the TSD. 7.2 Marking and warning that accompany toys (implemented since 20 July 2011) Warnings must meet several requirements to ensure an appropriate and safe use of the toys. The manufacturer must know the following: Location of the warnings: Warnings shall appear on the toy, on an affixed label or on the consumer packaging: clearly visible and understandable to the consumer before the purchase; Warnings shall be written in a language or languages easily understood by consumers (translated in the country languages as specified by the Member States); Small toys which are sold without packaging shall have appropriate warnings affixed to them. Specific warnings: Warnings shall specify appropriate user limitations (e.g.; minimum and maximum ages and weights for users); Warnings shall indicate if a toy needs to be used under supervision of an adult. Warning Not suitable for children under 36 months: The wording and/or the pictogram must be preceded by the word Warning or warnings as appropriate. The specific warning Not suitable for children under 3 years and pictogram described in Part B of Annex V of the 2009/48/EC TSD in relation to children under 3 years cannot be used for toys intended for children under 3 years; Toys shall not bear one or more of the specific warnings set out in Part B Annex V where that warning conflicts with the intended use of the toy. Check you understand new warning and labelling requirements applicable to your toys; SGS offers training, consultancy and labelling verification services. 7.1 Chemical requirements (implemented since 20 July 2013) All toys placed on the EU market have to comply with all EU standards and regulations related to chemicals, including chemical requirements under TSD and REACH regulation (EC) 1907/2006. In brief: Substances classified as CMR (Carcinogenic, Mutagenic or Toxic for Reproduction) are banned; 55 listed allergenic fragrances may not be used in toys, only technically unavoidable traces are allowed up to 100 ppm. Another 11 allergenic fragrances must be declared if present in concentrations higher than 0.01% by weight; New migration limits for 19 restricted elements (currently 8 elements). Heavy metals which are particularly toxic, like lead or mercury, may no longer be intentionally used in toys (limits apply to accessible toys or accessible components of toys); N-nitrosamines / N-nitrosatable substances may not be used in toys for children under 36 months and in toys intended to be placed in the mouth.
Review the content of the materials used and phase out any materials that use any of the new restricted elements; SGS offers comprehensive chemical testing services. CONTACT For any questions, you can email the global team at consumer.products@sgs.com and visit our website at www.sgs.com/toys. 2014 SGS All rights reserved. This document content is subject to changes due to new market requirements. Users are reminded that legislation is the only authentic legal reference and that information in this document does not constitute legal, technical or other professional advice. SGS does not accept any liability with regard to the contents of this document. SGS reserves its rights to change the content of this document without notice.