Criteria to be applied from 20 July 2011 until 31 May 2015: The substance fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F; hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; The mixture is dangerous within the meaning of Directive 67/548/EEC. Since it is possible that toys which present hazards which are not covered by a particular safety requirement laid down in this Directive might exist or be developed, it is necessary to set a general requirement of safety as the legal basis for taking action in respect of such toys. Limit values for arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic, and which should therefore not be intentionally used in those parts of toys that are accessible to children, should be set at levels that are half of those considered safe according to the criteria of the relevant Scientific Committee, in order to ensure that only traces that are compatible with good manufacturing practice will be present. Small toys which are sold without packaging shall have appropriate warnings affixed to them. Conformity with harmonised standards so set, the reference number of which is published in the Official Journal of the European Union, provides a presumption of conformity with the requirements of Directive 88/378/EEC. Directive 88/378/EEC is based on the New Approach principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards (4). the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006. In accordance with Article 4(7), a Member State may, within its territory, stipulate that those warnings and the safety instructions shall be written in a language or languages easily understood by consumers, as determined by that Member State. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 24(1) to (5). 3. Furthermore, specific measures concerning the possibility for a market surveillance authority to request information from a notified body and to give instructions to it should be included in this Directive in order to strengthen the possibilities for action by market surveillance authorities in the case of toys covered by an EC-type examination certificate. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies for the purposes of this Directive, and for the monitoring of notified bodies, including compliance with Article 29. Adult supervision recommended’. The personnel responsible for carrying out the conformity assessment activities shall have: sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified; satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments; appropriate knowledge and understanding of the essential requirements, of the applicable harmonised standards and of the relevant Community harmonisation legislation and of its implementing regulations; the ability to draw up certificates, records and reports demonstrating that assessments have been carried out. In the light of the Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union. 2. Market surveillance authorities may request a notified body to provide information relating to any EC-type examination certificate which that body has issued or withdrawn, or which relates to any refusal to issue such a certificate, including the test reports and technical documentation. Without prejudice to Article 42, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned: that the CE marking has been affixed in violation of Article 16 or 17; that the CE marking has not been affixed; that the EC declaration of conformity has not been drawn up; that the EC declaration of conformity has not been drawn up correctly; that technical documentation is either not available or not complete. Toys must be designed and manufactured in such a way that they do not present any health hazards or risk of injury to eyes or skin from lasers, light-emitting diodes (LEDs) or any other type of radiation. The manufacturer has to demonstrate the compliance of a toy by. Member States shall presume that toys bearing the CE marking comply with this Directive. Formal objection to a harmonised standard. 2. shortcomings in the harmonised standards referred to in Article 13 conferring a presumption of conformity. The remuneration of the top level management and assessment personnel of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments. Stakeholders have signed voluntary agreements with the European Commission to improve toy safety, Internal Market, Industry, Entrepreneurship and SMEs, Electrical and Electronic Engineering Industries, Raw materials, metals, minerals and forest-based industries, Textiles, Fashion and Creative Industries, CP-DS: Legislation on substances in construction products, European Sustainable Chemicals Support - Self Assessment Tool, Noise emissions for outdoor equipment - Database, Public procurement - ex-ante assessment of large infrastructure projects, Small Business Act - database of good practices, Regulation on Classification, Labelling and Packaging of substances and mixtures, Voluntary agreement between the European Commission and the Toy Industries of Europe, Voluntary agreement between the European Commission and Eurocommerce, the European Retail Round Table, Toy Traders of Europe and the European Promotional Products Association, Chemicals that are susceptible to cause cancer, change genetic information, harm fertility or harm an unborn child (so-called CMR substances) are no longer allowed in the accessible parts of toys beyond the concentration limits set in the, 19 so-called 'heavy elements' like mercury and cadmium are not allowed in toy parts accessible to children beyond the limits laid down in. This also applies to other toys which are intended to be put in the mouth, and to their component parts and any of their detachable parts. 2. 3. 3. Functional toys shall bear the following warning: ‘To be used under the direct supervision of an adult’. 2. A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can be cleaned. In so doing, they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the toy with this Directive. Community legal acts governing the use of certain substances for the purposes of points 4(a) and 5(a) of Part III. 4. A textile toy shall, to this end, be washable, except if it contains a mechanism that may be damaged if soak washed. From 20 July 2011 until 31 May 2015, the relevant concentrations for the classification of mixtures containing the substances shall be those established in accordance with Directive 1999/45/EC. SGS offers a wide range of services to ensure that your products comply with the EU Toy Safety Directive. The Directive came into force in two stages on 20 July 2011 and for the chemical requirements on 20 July 2013. Notified bodies shall provide the other bodies notified under this Directive which carry out similar conformity assessment activities covering the same toys with relevant information on issues relating to negative and, on request, positive conformity assessment results. The first aid to be given in the event of serious accidents resulting from the use of this type of toy shall also be mentioned. 1. The substance or mixture fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008: 2. The same should apply if one or more such standards has been published with a restriction in the Official Journal of the European Union, or if the manufacturer has not followed such standards completely, or only in part. Without prejudice to the application of the provisions laid down in applicable Community legislation on the classification, packaging and labelling of certain substances or mixtures, the instructions for use of toys containing inherently dangerous substances or mixtures shall bear a warning of the dangerous nature of these substances or mixtures and an indication of the precautions to be taken by the user in order to avoid hazards associated with them, which shall be specified concisely according to the type of toy. Member States shall take all measures necessary to ensure that toys may not be placed on the market unless they comply with the essential safety requirements set out, as far as the general safety requirement is concerned, in paragraph 2, and, as far as the particular safety requirements are concerned, in Annex II. Toys made available on the market shall bear the CE marking. Toys shall be designed and manufactured in such a way that there are no risks of adverse effects on human health due to exposure to the chemical substances or mixtures of which the toys are composed or which they contain when the toys are used as specified in the first subparagraph of Article 10(2). 6. 2. An application for EC-type examination, performance of that examination and issue of the EC-type examination certificate shall be carried out in accordance with the procedures set out in Module B of Annex II to Decision No 768/2008/EC. Point 5 of Part III concerns substances classified as CMR category 2 under Regulation (EC) No 1272/2008. Where the conformity assessment body concerned cannot provide an accreditation certificate, it shall provide the notifying authority with the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 26. 4. 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