欧盟玩具新指令2009-48-EC
2009-48-EC对玩具中化学品要求的释意
2011年4月26日有關新玩具指令(2009/48/EC)對玩具中化學品要求的釋意新玩具指令中有關玩具中化學品的規定不會於2011年7月20日付諸實施，因為現行指令88/378/EEC的化學要求直到2013年7月20日才廢止。
儘管如此，為在有限的時間內針對即將實施的化學品要求做好準備，許多生產商已經開始考慮如何應對其中的一項重要限制，即玩具中的CMR化學物質。
CMR指具有致癌性、誘導有機體突變和/或生殖毒性；根據法規1272/2008(亦稱CLP法規) CMR的規定，CMR物質被分為1A, 1B和2三個類別。
挑戰：新指令2009/48/EC要求，CMR物質不得用於玩具、玩具的部件或具有不同微觀結構的玩具部件中。
其中最後一項與RoHS指令所指的“均質材料”相似，其目的是確保玩具中所有與兒童健康相關的區域都能顧及。
目前，已經有大量的物質被歐盟分類為CMR，其中大部分是從石油和煤中提取出來的化學品。
最受關注的是那些可揮發的CMR，它們大多用於溶劑或作為塑料的單體；因此如果玩具或其部件帶有塗層、塑料(尤其是軟塑料)或粘合劑時可能含有這些物質的殘留。
典型的CMR包括苯、甲苯、苯酚、二氯甲烷、氯乙烯和正己烷等。
建議玩具生產商評估產品中是否含有這些CMR，以便及時符合新玩具指令的要求，避免對生產和業務造成影響。
備注：類別1A：依據大量的人類證據顯示，已知對人體具有潛在的致癌性類別1B：依據動物證據顯示，估計對人體具有潛在的致癌性類別2：依據有限證據顯示，猜測對人體具有潛在的致癌性新的玩具指令還規定了其它幾項新的化學品要求/ 限制，包括致敏的芳香物質、亞硝胺和亞硝胺化合物的含量水平，以及對19種化學品的遷移量限值。
Intertek將及時提供各項新要求的具體信息，以及相關的解決方案，幫助您未雨綢繆並有效應對，希望您持續關注。
2009 48 EC中文
（依据欧同体条约及欧洲原子能共同体条约须公开发表的法令）2009年6月18日通过的欧洲议会和理事会关于玩具安全的第2009/48/EC号指令（全文适用于欧洲经济区）欧洲议会和理事会注意到建立欧洲共同体的《条约》，特别是第95条，注意到委员会的提案，注意到欧洲经济和社会委员会的意见1，按照《条约》第251条规定的程序2，鉴于：(1) 为协调各成员国玩具安全水平，消除成员国间玩具贸易障碍，1988年5月3日通过了旨在建立统一内部市场的《关于协调各成员国有关玩具安全法规的理事会第88/378/EEC号指令》3。
（2）《第88/378/EEC号指令》以欧共体理事会1985年5月7日通过的《技术协调与标准化新方法》所规定的新方法原则为基础4。
因此，其仅仅规定了涉及玩具的基本安全要求，包括与物理和机械性能、易燃性、化学性能、电气性能、卫生和放射性相关的特殊安全要求。
而技术细节则由欧洲标准化委员会(CEN)和欧洲电工技术标准化委员会(CENELEC)制定通过，其依据是1998年6月22日通过的《欧洲议会和理事会关于制定技术标准和规章领域内信息供应程序的第98/34/EC号指令》及信息社会服务的有关规定5。
如与索引号已在《欧盟官1《欧盟官方公报》 C 77，2009年3月31日，第8页2 2008年12月18日（《官方公报》中尚未发布）的欧洲议会意见以及2009年5月11日的理事会决议3《欧盟官方公报》L 187，1988年7月16日，第1页4《欧盟官方公报》C 136，1985年6月4日，第1页5《欧盟官方公报》L 204，1998年7月21日，第37页方公报》上公布的协调标准相一致，则可推定为符合《第88/378/EEC号指令》的要求。
经验已经证明这些基本原则行之有效，应该予以保留。
（3）然而，玩具市场的技术进步引发了有关玩具安全性的新问题，并由此日益受到消费者的关注。
考虑到上述发展，并旨在澄清有关玩具如何销售的框架问题，必须对《第88/378/EEC号指令》的某些方面进行修订和强化，而且为了清楚起见，以上指令应被本指令所取代。
欧盟修订玩具安全指令调低玩具表面刮出物六价铬限值
欧盟修订玩具安全指令调低玩具表面刮出物六价铬限值方晔【期刊名称】《中国质量技术监督》【年(卷),期】2018(000)009【总页数】1页(P80)【作者】方晔【作者单位】【正文语种】中文近日，欧洲委员会在欧盟《官方公报》刊登第2018/725号指令，修订第2009/48/EC号指令(玩具安全框架指令)。
新指令对玩具表面刮出物，例如玩具上的涂料、软硬聚合物、木、纺织品等，实施更严格的六价铬含量限制。
根据玩具安全框架指令，六价铬被视为一种别具毒性的物质，因此其限值应定在欧盟相关科学委员会认为安全水平的一半。
目前玩具表面刮出物的六价铬限值为每公斤0.2毫克。
不过，欧盟的健康与环境风险科学委员会审视了最新的科学证据后，提出关于玩具六价铬含量的意见，建议采取更低的实际安全剂量，即人体体重每公斤每日0.0002毫克，基于此来决定玩具所含六价铬的限值。
因此，健康与环境风险科学委员会建议，修订玩具表面刮出物所含六价铬的限值至每公斤0.0094毫克。
然而，现有的测试方法无法在如此低的浓度下可靠地测量六价铬，因此该委员会决定把相关的六价铬限值修订为每公斤0.053毫克，这是目前测试方法能够可靠测量的最低浓度。
虽然限值修订至每公斤0.053毫克，欧洲标准化委员会也正审视测试方法，希望能在较低浓度下可靠地检测出六价铬。
据悉，欧委会预期修改的测试方法很快会面世，新方法能够可靠地测量低至每公斤0.0025毫克六价铬的浓度。
当新测试方法面世后，六价铬的限值将会进一步下降。
值得注意的是，玩具安全框架指令不仅适用于玩具，而且也适用于14岁或以下儿童在游戏时使用的产品。
欧盟成员国将于2019年11月17日前通过及公布必要的法例，以遵行以上的修订内容，并于2019年11月18日起实施有关法例。
欧盟玩具安全新指令2009,48／EC浅析
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2009-48-EC 欧洲玩具标准原版
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents ►B DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 18 June 2009on the safety of toys(Text with EEA relevance) (OJ L 170, 30.6.2009, p. 1)Amended by:Official Journal No page date ►M1 Commission Directive 2012/7/EU of 2 March 2012 L 64 7 3.3.2012 ►M2 Commission Regulation (EU) No 681/2013 of 17 July 2013 L195 16 18.7.2013 ►M3 Commission Directive 2014/79/EU of 20 June 2014 L 182 49 21.6.2014 ►M4 Commission Directive 2014/81/EU of 23 June 2014 L 183 49 24.6.2014 ►M5 Commission Directive 2014/84/EU of 30 June 2014 L 192 49 1.7.2014Corrected by: ►C1 Corrigendum, OJ L 355, 31.12.2013, p. 92 (2009/48/EC)DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENTAND OF THE COUNCILof 18 June 2009on the safety of toys(Text with EEA relevance)THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Economic and SocialCommittee ( 1), Acting in accordance with the procedure laid down in Article 251 ofthe Treaty ( 2), Whereas:(1) CouncilDirective 88/378/EEC of 3 May 1988 on the approxi mation of the laws of the Member States concerning the safety oftoys ( 3) was adopted in the context of establishing the internal market in order to harmonise the safety levels of toys throughout the Member States and to remove obstacles to trade in toys between Member States.(2) Directive88/378/EEC is based on the New Approach principles, as set out in the Council Resolution of 7 May 1985 on a newapproach to technical harmonisation and standards ( 4). Thus, it sets out only the essential safety requirements with regard to toys, including the particular safety requirements regarding physical and mechanical properties, flammability, chemical prop erties, electrical properties, hygiene and radioactivity. Technical details are adopted by the European Committee for Standardisation (CEN) and the European Committee for Electro technical Standardisation (Cenelec) in accordance with Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulationsand of rules on Information Society services ( 5). 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. Experience has shown that these basic principles have worked well in the toys sector and should be maintained. ( 1 ) OJ C 77, 31.3.2009, p. 8. ( 2 ) Opinion of the European Parliament of 18 December 2008 (not yet published in the Official Journal) and Council Decision of 11 May 2009.( 3 ) OJ L 187, 16.7.1988, p. 1.( 4 ) OJ C 136, 4.6.1985, p. 1. ( 5 ) OJ L 204, 21.7.1998, p. 37.(3) Technologicaldevelopments in the toys market have, however, raised new issues with respect to the safety of toys and have given rise to increased consumer concerns. In order to take account of those developments and to provide clarification in relation to the framework within which toys may be marketed, certain aspects of Directive 88/378/EEC should be revised and enhanced and, in the interests of clarity, that Directive should be replaced by this Directive.(4) Toysare also subject to Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on generalproduct safety ( 1), which applies in a complementary manner to specific sectoral legislation.(5) Regulation(EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketingof products ( 2) lays down horizontal provisions on the accredi tation of conformity assessment bodies, on the CE marking and on the Community market surveillance framework for, and controls of, products entering the Community market which also apply to the toys sector.(6) DecisionNo 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for themarketing of products ( 3 ) provides common principles andreference provisions for the purposes of legislation based on the New Approach principles. In order to ensure consistency with other sectoral product legislation, it is appropriate to align certain provisions of this Directive to that Decision, in so far as sectoral specificities do not require a different solution. Therefore, certain definitions, the general obligations of economic operators, the presumption of conformity, formal objections against harmonised standards, rules for the CE marking, requirements for conformity assessment bodies and notification procedures and the provisions concerning procedures dealing with products presenting a risk should be aligned to that Decision.(7) Inorder to facilitate the application of this Directive by manu facturers and national authorities, the scope of this Directive should be clarified by completing the list of products which are not within its scope, in particular as regards certain new products, such as videogames and peripherals.(8) Itis appropriate to provide for certain new definitions specific to the toys sector in order to facilitate the understanding and uniform application of this Directive. ( 1 ) OJ L 11, 15.1.2002, p. 4. ( 2 ) OJ L 218, 13.8.2008, p. 30.( 3 ) OJ L 218, 13.8.2008, p. 82.(9) Toysthat are placed on the Community market should comply with the relevant Community legislation, and economic operators should be responsible for the compliance of toys, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of public interests, such as health and safety, and the protection of consumers and of the environment, and to guarantee fair competition on the Community market.(10) All economic operators are expected to act responsibly and in fullaccordance with the legal requirements applicable when placing or making toys available on the market.(11) All economic operators intervening in the supply and distributionchain should take appropriate measures to ensure that under normal and reasonably foreseeable conditions of use, the toys they place on market do not jeopardise the safety and health of children and that they make available on the market only toys which comply with the relevant Community legislation. This Directive provides a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution process.(12) As certain tasks can be executed only by the manufacturer, it isnecessary to distinguish clearly between the manufacturer and operators further down the distribution chain. It is also necessary to distinguish clearly between the importer and the distributor, as the importer introduces toys from third countries to the Community market. The importer has thus to make sure that those toys comply with the applicable Community require ments.(13) The manufacturer, having detailed knowledge of the design andproduction process, is best placed to carry out the complete conformity assessment procedure for toys. Conformity assessment should therefore remain the obligation of the manufacturer alone.(14) It is necessary to ensure that toys from third countries enteringthe Community market comply with all applicable Community requirements, and in particular that appropriate assessment procedures have been carried out by manufacturers with regard to those toys. Provision should therefore be made for importers to make sure that the toys they place on the market comply with the applicable requirements and that they do not place on the market toys which do not comply with such requirements or which present a risk. For the same reason, provision should also be made for importers to make sure that conformity assessment procedures have been carried out and that product marking and documentation drawn up by manufacturers are available forinspection by the supervisory authorities.(15)Where the distributor makes a toy available on the market afterthe toy has been placed on the market by the manufacturer or theimporter, it should act with due care to ensure that its handling ofthe toy does not adversely affect the compliance of the toy. Bothimporters and distributors are expected to act with due care inrelation to the requirements applicable when placing or makingtoys available on the market.(16)When placing a toy on the market, importers should indicate onthe toy their name and the address at which they can becontacted. Exceptions should be provided for in cases wherethe size or nature of the toy does not allow for such an indication.This includes cases where importers would have to open thepackaging to put their name and address on the product.(17) Any economic operator that either places a toy on the marketunder its own name or trademark or modifies a toy in such a waythat compliance with applicable requirements may be affectedshould be considered to be the manufacturer and should assume the obligations of the manufacturer.(18) Distributors and importers, being close to the market place,should be involved in market surveillance tasks carried out bycompetent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the toy concerned.(19) Ensuring traceability of a toy throughout the whole supply chainhelps to make market surveillance simpler and more efficient. Anefficient traceability system facilitates market surveillance authorities' task of tracing economic operators who made non-compliant toys available on the market.(20) Certain essential safety requirements which were laid down inDirective 88/378/EEC should be updated to take account oftechnical progress since the adoption of that Directive. Inparticular, in the field of electrical properties, technical progresshas made it possible to allow the limit of 24 volts set in Directive88/378/EEC to be exceeded, while guaranteeing the safe use ofthe toy concerned.(21) It is also necessary to adopt new essential safety requirements. Inorder to ensure a high level of protection of children against riskscaused by chemical substances in toys, the use of dangeroussubstances, in particular substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR), and allergenicsubstances and certain metals, should be subject to carefulattention. It is therefore in particular necessary to completeand update the provisions on chemical substances in toys tospecify that toys should comply with general chemicalslegislation, in particular Regulation (EC) No 1907/2006 of theEuropean Parliament and of the Council of 18 December 2006concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a EuropeanChemicals Agency (1). Those provisions should, however, also beadapted to the particular needs of children, who are a vulnerablegroup of consumers. Therefore, new restrictions on CMR substances, in accordance with applicable Community legislationon the classification, labelling and packaging of substances andmixtures, and on fragrances in toys should be provided for onaccount of the special risks that these substances may entail forhuman health. Nickel in stainless steel has proven to be safe, andconsequently it is appropriate that it can be used in toys.(22) The specific limit values laid down in Directive 88/378/EEC forcertain substances should also be updated to take account of thedevelopment of scientific knowledge. Limit values for arsenic,cadmium, chromium VI, lead, mercury and organic tin, whichare 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 safeaccording to the criteria of the relevant Scientific Committee, inorder to ensure that only traces that are compatible with goodmanufacturing practice will be present.(23) Toys or their parts and their packaging that can reasonably beexpected to be brought into contact with food should complywith Regulation (EC) No 1935/2004 of the European Parliamentand of the Council of 27 October 2004 on materials and articlesintended to come into contact with food (2).(24)In order to ensure adequate protection in the case of toysinvolving a high degree of exposure, it should be possible toadopt implementing measures establishing specific limit valuesfor chemicals used in toys intended for use by children under36 months and in other toys intended to be put in the mouth,taking into account the requirements of Regulation (EC) No 1935/2004 and the differences between toys and materialswhich come into contact with food.(25) The general and specific chemical requirements laid down by thisDirective should aim at protecting the health of children fromcertain substances in toys, while the environmental concernspresented by toys are addressed by horizontal environmentallegislation applying to electrical and electronic toys, namelyDirective 2002/95/EC of the European Parliament and of theCouncil of 27 January 2003 on the restriction of the use ofcertain hazardous substances in electrical and electronic equipment (3) and Directive 2002/96/EC of the European Parliament(1) OJ L 396, 30.12.2006, p. 1.(2) OJ L 338, 13.11.2004, p. 4.(3) OJ L 37, 13.2.2003, p. 19.and of the Council of 27 January 2003 on waste electrical andelectronic equipment (1). In addition, environmental issues onwaste are regulated by Directive 2006/12/EC of the EuropeanParliament and of the Council of 5 April 2006 (2), those onpackaging and packaging waste by Directive 94/62/EC of theEuropean Parliament and of the Council of 20 December1994 (3) and those on batteries and accumulators and wastebatteries and accumulators by Directive 2006/66/EC of theEuropean Parliament and of the Council of 6 September 2006 (4).(26) The system established by this Directive should also encourage,and in certain cases ensure, that dangerous substances andmaterials used in toys are replaced by less dangerous substancesor technologies, where suitable economically and technicallyviable alternatives are available.(27) In order to protect children from the risk of impairment ofhearing caused by sound-emitting toys, more stringent andcomprehensive standards to limit the maximum values for bothimpulse noise and continuous noise emitted by toys should beestablished. It is therefore necessary to lay down a new essentialsafety requirement concerning the sound from such toys.(28) In line with the precautionary principle, it is appropriate to laydown specific safety requirements to cover the potential specifichazard presented by toys in food, since the association of a toyand food could be the cause of a risk of choking that is distinctfrom the risks presented by the toy alone and which is, therefore,not covered by any specific measure at Community level.(29) Since it is possible that toys which present hazards which are notcovered by a particular safety requirement laid down in thisDirective might exist or be developed, it is necessary to set ageneral requirement of safety as the legal basis for taking actionin respect of such toys. In this respect, the safety of toys shouldbe determined by reference to the intended use, while taking intoaccount the foreseeable use, and bearing in mind the behaviour ofchildren, who do not generally show the same degree of care asthe average adult user. Where a hazard cannot be sufficientlyminimised by design or safeguards, the residual risk could beaddressed by product-related information directed at the supervisors, taking into account their capacity to cope with theresidual risk. According to acknowledged methods of riskassessment, it is not appropriate for information to supervisorsor a lack of history of accidents to be used as a substitute fordesign improvements.(1) OJ L 37, 13.2.2003, p. 24.(2) OJ L 114, 27.4.2006, p. 9.(3) OJ L 365, 31.12.1994, p. 10.(4) OJ L 266, 26.9.2006, p. 1.(30)In order to further promote safe conditions of use of toys, it isnecessary to supplement the provisions on warnings which shouldaccompany the toy. In order to prevent the misuse of warnings tocircumvent the applicable safety requirements, which has occurred in particular in case of the warning stating that thetoy is not suitable for children under 36 months, it is necessaryto provide explicitly that the warnings provided for certain categories of toy may not be used if they conflict with theintended use of the toy.(31)The CE marking, indicating the conformity of a toy, is the visibleconsequence of a whole process comprising conformity assessment in a broad sense. General principles governing theCE marking are set out in Regulation (EC) No 765/2008.Rules governing the affixing of the CE marking should be laiddown in this Directive.(32)It is crucial to make clear to both manufacturers and users that byaffixing the CE marking to the toy, the manufacturer declares thatthe toy is in conformity with all applicable requirements and thatthe manufacturer takes full responsibility therefor.(33)The CE marking should be the only marking of conformity indicating that the toy is in conformity with Community harmonisation legislation. However, other markings may be used aslong as they contribute to the improvement of consumer protection and are not covered by Community harmonisationlegislation.(34)It is appropriate to lay down rules on the affixing of CE markingwhich ensure sufficient visibility of the marking in order tofacilitate market surveillance of toys.(35)In order to ensure compliance with the essential safety requirements, it is necessary to lay down appropriate conformity assessment procedures to be followed by the manufacturer. Tocomplete the legal obligations of the manufacturer which aim atensuring the safety of toys, an explicit obligation to carry out ananalysis of the various hazards that the toy may present and anassessment of the potential exposure to them, which for chemicals includes an assessment of the likelihood of the presence in the toy of prohibited or restricted substances, should be included in this Directive, and manufacturers shouldbe obliged to keep this safety assessment in the technical documentation to allow market surveillance authorities to performtheir tasks efficiently. Internal production control based on themanufacturer’s own responsibility for the conformity assessmenthas proven adequate in cases where it has followed the harmonised standards, the reference number of which has beenpublished in the Official Journal of the European Union,covering all the safety requirements for the toy. In cases wheresuch harmonised standards do not exist, the toy should besubmitted to third party verification, in this case EC-type examination. The same should apply if one or more such standards hasbeen published with a restriction in the Official Journal of theEuropean Union, or if the manufacturer has not followed suchstandards completely, or only in part. The manufacturer shouldsubmit the toy to EC-type examination in cases where itconsiders that the nature, design, construction or purpose of thetoy necessitates third party verification.(36) Since it is necessary to ensure a uniformly high level ofperformance of bodies performing conformity assessment oftoys throughout the Community, and since all such bodiesshould perform their functions to the same level and underconditions of fair competition, obligatory requirements shouldbe set for conformity assessment bodies wishing to be notifiedin order to provide conformity assessment services under thisDirective.(37)In order to ensure a consistent level of quality in the performanceof conformity assessment of toys, it is necessary not only toconsolidate the requirements that conformity assessment bodieswishing to be notified must fulfil, but also, in parallel, to setrequirements that notifying authorities and other bodies involved in the assessment, notification and monitoring ofnotified bodies must fulfil.(38) Where the available scientific evidence is insufficient to allow anaccurate risk assessment, Member States, when taking measuresunder this Directive, should apply the precautionary principle,which is a principle of Community law outlined, inter alia, inthe Communication from the Commission of 2 February 2000,while taking due consideration of the other rules and principlescontained in this Directive, such as the free movement of goodsand the presumption of conformity.(39) Regulation (EC) No 765/2008 complements and strengthens theexisting framework for the market surveillance of productscovered by Community harmonisation legislation, including toys. Member States should therefore organise and carry outmarket surveillance of toys in accordance with that Regulation.In accordance with that Regulation, its application does notprevent the market surveillance authorities from taking morespecific market surveillance measures as are available underDirective 2001/95/EC. Furthermore, specific measures concerningthe possibility for a market surveillance authority to requestinformation from a notified body and to give instructions to itshould be included in this Directive in order to strengthen thepossibilities for action by market surveillance authorities in thecase of toys covered by an EC-type examination certificate.(40) Directive 88/378/EEC already provides for a safeguard procedureallowing the Commission to examine the justification for ameasure taken by a Member States against toys it considers tobe non-compliant. In order to increase transparency and to reduceprocessing time, it is necessary to improve the existing safeguardprocedure, with the aim of making it more efficient and ofdrawing on expertise available in the Member States.(41) The existing system should be complemented by a procedureallowing interested parties to be informed of measures takenwith regard to toys presenting a risk to the health and safety ofpersons or other issues of public interest protection. It should alsoallow market surveillance authorities, in cooperation with therelevant economic operators, to act at an earlier stage in respectof such toys.(42)Where Member States and the Commission agree as to the justification for a measure taken by a Member State, no furtherinvolvement of the Commission should be required.(43) The measures necessary for the implementation of this Directiveshould be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures forthe exercise of implementing powers conferred on the Commission (1).(44) In particular, the Commission should be empowered to adaptrequirements concerning chemical properties in certain well-defined cases and to grant exemptions from the prohibitionof CMR substances in certain cases, as well as to adapt thewording of the specific warnings for certain categories of toy.Since those measures are of general scope and are designed toamend non-essential elements of this Directive, inter alia, bysupplementing it with new non-essential elements, they must beadopted in accordance with the regulatory procedure withscrutiny provided for in Article 5a of Decision 1999/468/EC.(45)Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions ofthe Member States concerning liability for defective products (2)applies, inter alia, to toys which are not in conformity withCommunity harmonisation legislation. Manufacturers and importers who have placed non-compliant toys on the Community market are liable for damages under that Directive.(46) Member States should provide for penalties applicable toinfringements of this Directive. Those penalties should beeffective, proportionate and dissuasive.(1) OJ L 184, 17.7.1999, p. 23.(2) OJ L 210, 7.8.1985, p. 29.(47) In order to allow toy manufacturers and other economic operatorssufficient time to adapt to the requirements laid down by thisDirective, it is necessary to provide for a transitional period oftwo years after the entry into force of this Directive during whichtoys which comply with Directive 88/378/EEC may be placed onthe market. In the case of chemical requirements, this periodshould be set at four years so as to allow the development ofthe harmonised standards which are necessary for compliancewith those requirements.(48)Since the objective of this Directive, namely to ensure a highlevel of safety of toys with a view to ensuring the health andsafety of children whilst guaranteeing the functioning of theinternal market by setting harmonised safety requirements fortoys and minimum requirements for market surveillance, cannotbe sufficiently achieved by the Member States and can therefore,by reason of its scale and effects, be better achieved atCommunity level, the Community may adopt measures, inaccordance with the principle of subsidiarity set out inArticle 5 of the Treaty. In accordance with the principle ofproportionality, as set out in that Article, this Directive doesnot go beyond what is necessary in order to achieve thatobjective,HAVE ADOPTED THIS DIRECTIVE:CHAPTER IGENERAL PROVISIONSArticle 1Subject-matterThis Directive lays down rules on the safety of toys and on their free movement in the Community.Article 2Scope1. This Directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys).The products listed in Annex I shall not be considered as toys within the meaning of this Directive.thefollowingtoys:2. ThistoapplyshallDirectivenot(a) playground equipment intended for public use;(b) automatic playing machines, whether coin operated or not, intendedfor public use;(c) toy vehicles equipped with combustion engines;(d) toy steam engines; and(e) slings and catapults.Article 3DefinitionsFor the purposes of this Directive the following definitions shall apply: 1. ‘making available on the market’ means any supply of a toy fordistribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;2. ‘placing on the market’ means the first making available of a toy onthe Community market;3. ‘manufacturer’ means any natural or legal person who manufacturesa toy or has a toy designed or manufactured, and markets that toyunder his name or trademark;4. ‘authorised representative’ means 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;5. ‘importer’ means any natural or legal person established within theCommunity who places a toy from a third country on the Community market;6. ‘distributor’ means any natural or legal person in the supply chain,other than the manufacturer or the importer, who makes a toy available on the market;7. ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;8. ‘harmonised standard’ means a standard adopted by one of theEuropean standardisation bodies listed in Annex I to Directive 98/34/EC on the basis of a request made by the Commission in accordance with Article 6 of that Directive;9. ‘Community harmonisation legislation’ means any Communitylegislation harmonising the conditions for the marketing of products;10. ‘accreditation’ shall have the meaning assigned to it byRegulation (EC) No 765/2008;11. ‘conformity assessment’ means the process demonstrating whetherspecified requirements relating to a toy have been fulfilled;12. ‘conformity assessment body’ means a body that performsconformity assessment activities, including calibration, testing, certification and inspection;。
盟玩具指令88-378-EEC玩具指令2009-48-EC
欧盟玩具指令|88/378/EEC|玩具指令2009/48/EC欧盟玩具指令(88/378/EEC)于1988年推出，已实行了二十多年。
在保证玩具产品安全及消除欧盟各国间的贸易壁垒方面取得了巨大的成功，然而，随着时代的变迁，指令的不足之处日渐暴露，为适应快速发展中的玩具产业，欧洲议会于2008年提出新玩具指令草案，并于2008年12月18日投票通过。
欧盟理事会于今年5月11日通过了全新的《欧盟新玩具安全指令》，2009年6月30日新玩具安全指令刊登在欧盟《官方公报》上(第2009/48/EC号指令)。
新指令在现有指令88/378/EEC的基础上作了大面积更新，其条款规定更为严格、严谨、严密。
《欧盟新玩具安全指令》(2009/48/EC)共有十个章节。
与88/378/EEC对比，主要更新有：第三章“玩具合格”的条款9“必要的安全要求”，条款10“警告语”，条款14“EC符合性声明”，条款16“CE标志的规定和条件”；第二章“经济经营者(Economicoperators)”；第四章“符合性评估”；第五章“符合性评估机构的通报”；第六章“市场监督”；第七章“安全措施程序”；第八章“委员会程序”；第九章“特殊管理规定”。
本文将针对与玩具企业息息相关的有“必要的安全要求”及其附件2“特殊的安全要求”，“警告语”，“EC符合性声明”，“CE标志的规定和条件”，“经济经营者(Economicoperators)”，“符合性评估”这六个部分来具体阐述其中的新旧版本的区别。
一、“必要的安全要求”下附件2“特殊的安全要求”。
1、物理和机械性能现行指令规定“玩具及部件及其包装不得存在引起儿童被勒死和窒息的危险”，新指令在此基础上新增“玩具包装不得因阻塞嘴和鼻的外部呼吸道而引起儿童窒息的危险”。
现行指令规定“针对年龄小于36个月的儿童使用的玩具及其配件与附属件应防止被此年龄段儿童吞咽和吸入的危险”，新指令将此规定范围延伸至“可放入口中的玩具及其配件与附属件”。
2009 84 EC法令对玩具及儿童产品出口欧盟的革命性影响
4756-19-8
(7) Diethyl maleate
141-05-9
(8) Dihydrocoumarin
119-84-6
(9) 2,4-Dihydroxy-3-methylbenzaldehyde
6248-20-0
(10) 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)
(30) 7-Methylcoumarin
2445-83-2
(31) 5-Methyl-2,3-hexanedione
13706-86-0
(32) Costus root oil (Saussurea lappa Clarke)
8023-88-9
(33) 7-Ethoxy-4-methylcoumarin
1 结构机械强度 2 玩具上的边，角，突出部件，绳索，紧固件等在设计制造过程中应避免出现机 械物理伤害 3 误食风险-小部件 4 窒息的危险-小部件，包装，绳索 5 食品玩具-玩具与食品应有各自的包装 6 水上玩具-失去浮力导致溺水的危险 7 密封空间-可自行离开 8 乘骑玩具-限制速度，有刹车系统 9 弹射玩具-不能伤害使用者和第三者 10 升温玩具-避免烫伤和冻伤伤害 11 发声玩具-避免对听力系统的伤害 12 活动玩具-避免对身体造成陷入，剪切，挤压伤害
25677-40-1
(37) 3.6,10-Trimethyl-3.5,9-undecatrien-2-one
1117-41-5
(38) Verbena oil (Lippia citriodora Kunth)
8024-12-2
(39) Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene)
欧盟新玩具指令2009-48-EC培训资料
欧 盟 新 指 令 2009/48/EC 的 改 变 玩具的协调标准(强制的 玩具的协调标准 强制的): 强制的
ESO CEN CEN CEN CEN Reference and title of the harmonized standard EN 71-1:2005+A9:2009 Safety of toys – Part 1: Mechanical and physical properties EN 71-2:2006+A1:2007 Safety of toys – Part 2: Flammability EN 71-3:1994/AC:2002 Safety of toys – Part 3: Migration of certain elements EN 71-4:2009 Safety of toys – Part 4: Experimental sets for chemistry and related activities CEN EN 71-5:1993 + A1:2006 + A2:2009 Safety of toys – Part 5: Chemical toys (sets) other than experimental sets EN 71-7:2002 Safety of toys – Part 7: Finger paint – Requirements and test methods
6
欧 盟 新 指 令 2009/48/EC 的 改 变 经济运作 体的定义 经济运作实体的定义:
• 制造商 制造商是指任何自然人或法人，他们从事制造玩具，或拥有玩具设计或 制造并以其名称或商标销售那些玩具; • 授权代表 是指任何自然人或在欧盟设立的法人，他们从制造商获得书 在 立的法人 面授权，代表他们履行有关指定的任务; • 进口商是指任何自然人或在欧盟设立的法人，他们将玩具从第三国家（ 口商是 欧盟成员国以外的国家）投放到欧盟市场; • 分销商是指供应链中的，除了制造商或进口商之外的任何自然人或法人 ，他们在市场上出售玩具。
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CAS号
97676-35-2 57-06-7 140-29-4 98-54-4 8006-99-3 4756-19-8 141-05-9 119-84-6 6248-20-0 40607-48-5 17874-34-9 34131-99-2 531-59-9 150-76-5
物质名称
Dimethyl citraconate 7,11-Dimethyl-4.6,10-dodecatrien-3-one 6,10-Dimethyl-3.5,9-undecatrien-2-one Dephenylamine Ethyl acrylate Fig leaf fresh and preparations Trans-2-Heptenal Trans-2-Hexenal diethyl acetal Trans-2-Hexenal dimethyl acetal Hydroabietyl alcohol 4-Ethoxy-phenol Hexahydrocoumarin Peru balsam, crude (Exudation of Myroxylon peireirae (Royle) Klotzsch) 2-Pentylidene-cyclohexanone
of 18 June 2009 on the safety of toys
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What
管控范围：为14岁以下儿童而设计，或供其玩耍用的产品，无论是否 专门为其设计或供其使用
公用活动场地的设备 供公共使用的自动游戏机，无论是否需要投币.
不适用 本指令 的玩具
4
EN71-3：重金属
EN71-4：化学实 验类用具
EN71-7：手指画 化学玩具
EN71-6：年龄警告标签图示
What
物理和机械性能
1 4
电性能
卫生要求
2 5
燃烧 放射性要求
6
化学安全要求
3
特别安全要求
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物理机械性能新要求
CAS号
8024-12-2 83-66-9 122-57-6 122-40-7 101-85-9 100-51-6 118-58-1 107-75-5 31906-04-4 97-54-1 90028-68-5 90028-67-4 1117-41-5
化学性能新要求
表2：浓度超过100ppm需要标明的香料
装配有内燃机的玩具车 玩具蒸汽机 弹弓和投石器
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What
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What
EN71-1:物理机械性能 EN62115：电 玩具完全性能
1
9
2
EN71-2：易燃性
EN71-8：秋千、 滑梯类玩具
8
3 玩具协调标
欧盟玩具新指令 2009/48/EC
Contents
1. 2009/48/EC概述 2. 欧美玩具新法规对比 3. 企业应对 4. Q & A
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2009/48/EC
4W-1H
n W he
who
how hat w why
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化学性能新要求
☆ 迁移元素限制种类大幅增加、限量大幅降低 ☆ 对玩具材料将按“干燥、易碎、粉状或易弯的玩具材料”、“液态或
粘性玩具材料”、以及“刮漆玩具材料”分别设定高低不同的限量要求
☆ 亚硝胺以及亚硝胺化合物被禁止用于三岁以下儿童的玩具中以及
☆ 致癌的、致基因突变的或有生殖毒性的物质（CMR）不得在玩
具组件或具有不同微观结构的玩具部件中使用。
☆ 玩具中不应含有列表1中的55种致敏性芳香物质，只有在技术
上无法避免时，允许存在，其含量应低于100mg/kg。
☆ 如果玩具或其部件中添加列表2中的香料浓度超过100mg/kg，
必须在玩具、标签、包装或随附单页上标明。
CAS号
617-54-9 26651-96-7 141-10-6 122-39-4 140-88-5 68916-52-9 18829-55-5 67746-30-9 18318-93-7 13393-93-6 622-62-8 700-82-3 8007-00-9 25677-40-1
化学性能新要求
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化学性能新要求
表1：致敏性芳香物质
物质名称
Alanroot oil (Inula helenium) Allylisothiocyanate Benzyl cyanide 4 tert-Butylphenol Chenopodium oil Cyclamen alcohol Diethyl maleate Dihydrocoumarin 2,4-Dihydroxy-emethylbenzaldehyde 3,7-Dimethyl-2-octen-1-ol (6,7Dihydrogeraniol) 4,6-Dimethyl-8-tertbutylcoumarin 6-Isopropyl-2decahydronaphthalenol 7-Methoxycoumarin 4-Methoxyphenol
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卫生新要求
•给三岁以下儿童使用的玩具，要求在设计和生产时必须保证其能够 得到清洁。清洗后，玩具同样必须满足所有安全要求。
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电气性能新要求
● 如果能确保即使产品损坏也不产生电击伤害，内部电压可以超过24V ● 必须提供保护措施以防止由于电源而引起的电伤害及火伤害 ● 激光，LED灯，或其它类型的辐射光不应造成健康伤害及风险
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Why
1
2
3
改善产品质 量，提高玩 具安全法规 的效率
简化现有的经 济运作实体和 市场管理机构 的法规
确保只有符 合基本安全 要求的玩具 才能被投放 市场
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Why—When
1988年5月3日发布，玩具安全指令88/378/EEC
正式发布 2009/48/EC
2009年7月 20日生效
生产商执行新指 令的最后期限
针对化学方面，对 生产商要求执行新 指令的最后期限
2009年6月30日
2009年7月20日
2011年7月20日
2013年7月20日
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What
欧盟玩具新指令
对涉及玩具的基本安全要求进行了严格规定 DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
新要求 液体或粘性玩具 材料（mg/kg） 1406 11.3 0.9 1125 300 0.5 9.4 0.005 2.6 156 3.4 300 1.9 18.8 9.4 1125 3750 0.2 938 可刮下的玩具材料 （例如油漆涂层） （mg/kg） 70000 560 47 56000 15000 23 460 0.2 130 7700 160 15000 94 930 460 56000 180000 12 46000
CAS号
104-27-8 623-43-8 92-48-8 2445-83-2 13706-86-0 8023-88-9 87-05-8 104-54-1 104-55-2 5392-40-5 91-64-5 97-53-0 106-24-1 943-88-4
物质名称
Verbena oil (Lippia citriodora Kunth) Musk ambrette (4-tert-Butyl-3-methoxy2,6- dinitrotoluene) 4-Phenyl-3-buten-2-one Amyl cinnamal Amylcinnamyl alcohol Benzyl alcohol Benzyl salicylate Hydroxy-citronellal Hydroxymethylpentylcyclohexenecarboxaldehyde Isoeugenol Oakmoss extracts Treemoss extracts 3.6,10-Trimethyl-3.5,9-undecatrien-2-one
表1（续）：致敏性芳香物质
物质名称
1-(p-Methoxyphenyl)-1-penten3-one Methyl trans-2-butenoate 6-Methylcoumarin 7-Methylcoumarin 5-Methyl-2,3-hexanedione Costus root oil (Saussurea lappa Clarke) 7-Ethoxy-4-methylcoumarin Cinnamyl alcohol Cinnamal Citral Coumarin Eugenol Geraniol 4-(p-Methoxyphenyl)-3-butene2-one
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What
制造商
经 济 从 业 者
进口商 授权代表 分销
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What –Who (制造商的责任)
向被放到嘴里的其它玩具
☆ 允许在不锈钢中使用镍
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元素