RoHS20最新环境危害物质管制要求

1、RoHS最新環境危害物質管制要求補充說明-2008年7月Halogen Free無鹵素要求PAHs多環芳烃(德國安規GS認證要求)PFOS(全氟辛烷磺酸) & PFOA(全氟辛酸)REACH化學品注冊登記及許可法規學習此類國際/國家/客戶要求的關鍵重點作為常識整體瞭解尤其是化學方面的專業，逐步掌握重點掌握英文縮寫的正確含意瞭解客戶以及客戶的客戶即將面對的問題或要求，主動為客戶提出或準備解決方案供應鏈與各過程管理模式將相關要求與專業向公司內部以及供應鏈上游傳遞業務：收集客戶要求、回覆客戶相關調查與詢問品保：整理客戶要求、將要求整合到公司內部規範、內部及上游廠商培訓、填寫/整理客戶的相關調查資料、

2、稽核/檢驗是否滿足客戶要求採購：向供應商宣導/傳遞公司內部規範、取得供應商符合要求的證明材料、尋找符合客戶要求的材料研發：材料承認應滿足客戶要求、客戶送樣時整理提交相關資料Contents内容概要: 有关强制实施PAHs要求的法规背景为什么把PAHs要求纳入GS认证评估项目材料分类和限值要求，举例相关产品新要求对制造商的影响及其应对措施如何开始新的GS申请，原GS证书的有效性客观认识GS认证了解GS认证的其它要求了解德国乃至欧洲的市场监督情况 德国GS 认证新增PAHs 要求PAHs 法规背景ZEK decision 01-08The German Central Experience Exc

3、hange Group (ZEK) has announced an additional mandatory requirement for GS certification, taking effect with the first of April 2008 accessible materials of consumer products must be tested against a possible contamination with PAHs. 德国安全技术认证中心经验交流办公室通过决议ZEK-01-08, 要求自2008年4月 1日开始, GS认证应增加对产品的PAHs含量

4、符合性进行评估.没有符合PAHs要求的产品不能取得GS认证证书。什么是PAHs PAHs (Polycyclic Aromatic Hydrocarbons) 多环芳香烃, 是一种由二至七个不等的苯环所组成的线状, 角状或一团状的化学物质。PAHs主要是在含碳化合物不完全燃烧的情况下产生, 比如煤炭、油、木头、垃圾或其它有机物质在不完全燃烧的情况下都会产生PAHs, 另外在石化燃料的使用过程中也会产生， 如煤焦油、石油、木炭、原油、矿物油、润滑油、染料中都可能发现PAHs。目前已知的PAHs 有100多种，而被美国环保组织列明需要管制的有16种 为什么把PAHs纳入GS要求 PAHs几乎无处不

5、在, 甚至存在于食物当中. 但通常食物当中PAHs是天然产品, 无法避免,其含量是微乎其微甚至可以忽略的。 研究证明PAHs物质具有致癌性。为避免人体从接触到的PAHs污染物品或食用入被污染的食品中吸入更多的PAHs从而增加其在人体当中的累计数量, 应该采取必要的措施来保证人体日常接触的物品的PAHs 污染含量没有超标, 保证人们吃的食物不受到日常所用的含有PAHs 物质的器具的进一步污染。德国的产品安全当局向来对安全和健康更加关注, 要求比较严格, 因而把PAHs的要求纳入GS认证的评估项目之一。 PAHs相关材料/部件The ZEK decision 01-08 shows the fol

6、lowing examples of affected materials： ZEK-01-08决议列举了以下受影响的材料和部件black or dark coloured polymers and rubbers (e.g. cable insulation, gaskets) 黑色或深色聚合物, 橡胶材料 (如电线绝缘层, 垫圈等) elastomeres (rubber and plastic materials) 弹性材料 (塑料及橡胶材料) coatings and varnishes 表面涂层, 清漆preservatives (e.g. naphthalene, used for

7、 storage or transportation) 防腐剂 （如储存和运输过程中使用的萘球）impregnation materials such as for brushes, wood, leather, etc. 化学防护剂处理过的产品 (如毛刷, 木料, 皮革等) Besides the assessment of the above shown examples， the notified GS laboratories are bound to assess all other accessible material which might contain PAHs. 除了以上

8、所列的部件, GS发证机构也将评估其它可能含有PAHs物质的易触及材料PAHs 相关材料评估,分类及限值要求According to ZEK decision 01-08，It is in the responsibility of the notified GS laboratories to assign which parts of a product have to be tested. 根据ZEK 01-08决议要求， GS发证机构有义务评估认证产品的哪些部件需要进行测试Based on the GPSG Law, This assessment is based on the in

9、tended use, careless use and foreseeable misuse of any product 根据GPSG法令(德国设备安全法) 的要求，GS认证机构对产品的评估必须是基于设备正常使用、不小心误操作或可预见的操作不当的情况Based on the evaluation， the assigned parts are subject to a classification as shown in the following table. 经过评估，被认定需要做测试的部件/材料分别按照以下几种类别分类PAHs 相关材料评估,分类及限值要求（Cont.)类别一类二类三

10、类材料/部件1a). Materials in contact with foodstuff与食物接触的材料1b) Materials intended to be put in the mouth直接放入口中的材料1c) Toys for children under 36 months of age36个月以内儿童的玩具 2a) Materials with foreseeable contact to skin for longer than 30 seconds (long-term skin contact) 经常性与皮肤接触且接触时间超过30秒的部件 2b) Toys, not c

11、overed by Category1一类中未包含到的玩具 3a) Materials with foreseeable contact to skin up to 30 seconds (short-term skin contact)非经常性与皮肤接触且接触时间在30秒以内的部件3b) Materials without intended skin contact 正常使用时不会与皮肤接触的部件 Benzoapyrene BaP (mg/kg)苯并芘不得检测到(相当于检测值 0.2 mg/kg)检测值小于1 mg/kg检测值20 mg/kg16项(备注1)PAHs 物质总含量mg/kgNo

12、t detectable(相当于检测值 0.2 mg/kg)检测值小于10 mg/kg检测值200 mg/kgPAHs 相关材料分类例举Examples: 各类部件相关产品举例 Category 1:1a).Kitchen appliances, food storage containers 厨房类产品, 食物储存器1b).Milk bottles, teething rings, toys for infants 奶瓶, 勺子, 婴儿玩具1c).All toys intended for children under 36 months of age 所有36个月以内幼儿的玩具Catego

13、ry 2:2a).Handles, tools, handheld equipment ( handlamp, computer mouse,mobile phones, headphones, glasses, desk surface, heating pads 器具或工具的手柄, 按钮, 手持式的设备( 电热毯, 手电筒, 电脑鼠标),手 机, 耳机, 眼镜,桌面等等 PAHs 相关材料分类例举(Cont.)2b). All toys intended for children over 36 months of age 所有36个月以上儿童的玩具Category 3 :3a). Reg

14、ulating and switching knobs, bushings, cords and plugs, computer keyboards, parts which are touched during maintenance and cleaning 开关按钮, 按键, 电线, 插头, 电脑键盘, 在设备维护和清洁时会碰 到的部件 3b). Main enclosures, voluminous or large covers and plating, materials under permanent thermal strain 设备主要外壳, 器具大外盖, 绝缘隔板，正常使用

15、时常处于较高 温度的部件等 外殼(Enclosure)外殼考漆塗層(Coating)鍵盤印刷油墨(Ink)線材端子(Plug)線材本體(Cord)線材網尾(SR)如果和Plug為同一廠商生產則不需重測標籤(Label)腳架(Foot)PAHs 相关材料分类例举(電腦鍵盤的高風險材料)决议对制造商的影响Influence to manufacturers, production sites, trading companies 该决议对制造商, 工厂以及贸易商都会造成一定影响This requirement means new challenges for manufacturers and s

16、uppliers since suspicious materials must be tested or the manufacturer or supplier must provide proof that the material is free from PAH contamination respectively the contamination is below the limits settled by the ZEK decision 01-08. 这一要求意味着制造商和供应商在材料管控上将面临新的挑战， 因为所有可疑的材料将必须进行检测或者制造商或是供应商必须提供不含PA

17、H污染物的证明，特别是ZEK-01-08决议中低于限定物质含量的符合性证明决议对制造商的影响(续.1)Especially production sites must check their production processes (e.g. moulding process) for a possible PAH contamination by usually used operational substances such as oils, separating agents, coatings and varnishes or similar 尤其是生产厂， 必须检查它的生产流程（如

18、注塑流程）中使用的辅助性材料，如油、分离剂、涂料、漆等类似物质可能导致哪些部件受PAHs污染Producers of raw materials or components should be informed about this new requirement for GS certification and ensure it is free from PAHs respectively the content of PAHs is within the limits of one of the three categories. Therefore they should provid

19、e information for which products the raw material or component is suitable and what has to be avoid during further production processes to prevent from a contamination with PAHs. 原材料供应商或(电源线、插头、开关、包装材料)等零部件供应商必须被告知关于GS的这项新要求。 供应商提供证据保证他们所供应的产品不含PAH、特别是PAH含量低于ZEK-01-08所规定的相应三类限用物质的含量。供应商们还应提供信息告知成品生产

20、厂特定的原材料和零部件分别适用于哪些部件或产品，并指出在成品加工生产过程中应该注意或避免哪些事项以防止零部件受到进一步的PAHs污染。决议对制造商的影响(续.2)In many cases trading companies or wholesalers do require an individual packing and this packing might be produced in a different factory, assigned by the trading company or wholesaler. In this case the certification bo

21、dy must require additional proof for the packing materials and colours as well as for possibly used preservatives protecting the goods during the shipment and storage process. 很多时候， 贸易商或批发商会要求另外采用它们要求的独立包装并且这些包装品可能在贸易商或批发商指定的另外的工厂加工制造。这种情况下， 认证机构必须要求他们提供关于包装材料和颜色以及在产品装运和存储过程中有可能用到的防腐剂符合PAHs 要求的有效证明文

22、件。 制造商的应对措施With reference to the decision ZEK 01-08, documents proving to meet the PAHs requirement and follow up of material properties can be:根据ZEK 01-08决议的规定，证明产品符合PAHs要求并满足材料性能可追索性的方式包括:Case 1: Proof by testing 通过测试来证明 The testing must be performed according to the procedure issued by ZEK, and d

23、ocumentation should be a test report where the test result is clearly evident. The testing laboratory must have at least a national official accreditation and a recognized/registered working scheme in compliance to the ISO/IEC 17025 (General requirements for the competence of testing and calibration

24、 laboratories) 测试必须按照ZEK要求的程序进行，出具的文件必须是包含清楚的测试结论的报告. 测试实验室必须具有至少一个国家官方实验室的认可资格和一个经认可符合ISO/IEC 17025（ 实验室测试和校准能力要求）的工作规划制造商的应对措施 (续1)Case 2: Proof by documentation 通过文件证明 Test reports or certificates issued by an accredited laboratory (e.g. notified GS certification body) are accepted. Also the resu

25、lts from laboratories with an accreditation according to ISO/IEC 17025 can be accepted. 授权实验室（如ZLS认可的GS发证机构）所颁发的测试报告或证书可以被接受由通过ISO/IEC 17025认可的实验室出具的测试结果也可以接受 Case 3: Self declaration by manufacturers 制造商自我申明 For this case a complete and detailed bill of materials is required, Nemko performs an asse

26、ssment to check if any of the used materials might contain PAHs in a considerable concentration, In case of doubt this material must be subject to a chemical analysis, Self declarations should be based on test reports or certificates from accredited laboratories. 自我声明必须附带需要提供完整、详细的材料BOM清单。NEMKO会对根据B

27、OM清单进行评估，看产品是否采用了可能含有PAHs的材料。如果有所怀疑， 则必须对这种材料做相应的化学分析、检测。自我申明应该要建立在授权认可实验出具的合格报告或证书的基础上的。 制造商的应对措施 (续2)Alternatively similar documents/declarations from raw material suppliers based on the above shown requirement can be accepted but must be checked for each case individually. 由原材料供应商提供的类似证明文件或申明, 只要

28、符合上述的要求，也可以被接受， 但必须逐个案子进行评估。For different goods produced by the use of the same materials it is not necessary to test every single appliance. However, in case of doubt the certification body might require an additional testing. 对于不同产品上所用的同种材质不需要分别进行测试。 但是， 如果认证机构对此有疑问的话， 也可能要求进行加测。 The manufactures

29、shall have frequently follow up of the production process and used operational substances, random sampling testing of semi-finished or final products, pre-shipment inspections or any other measure to ensure that the products brought into circulation are complying with PAHs requirement. 制造商应经常对生产流程和所

30、用辅助性材料进行跟踪评估， 定期对半成品和成品进行随机采样测试， 进行出货前检验或任何其它可行的措施来保证出口市场上的产品符合PAHs的要求。如何开始新的GS申请The process will be as usual but in addition you need to send us a bill of materials in which all materials incl. plastics, varnishing, coatings, preservatives are listed in detail. 申请程序照常， 只是要增加提供一份详细的材料清单， 其中必须详细列明包括塑

31、料、漆、涂层、防腐剂在内的所有材料This list shall also include information which outer (accessible) part of the product is made of which material. 清单必须列明产品外表可触及部件的详细材质。If you have PAHs test reports or certificates for the materials at hands, please send them in too. 如果你手上有相关材料的PAHs测试报告和证书，请提供给我们参考We check the docume

32、nts and do evaluate the sample. 我们会根据所有提供的材料对样品进行PAHs评估。The next step is a risk analysis for possible hazards to consumers or other user of the product (technicians, employees, maintenance staff) 下一步就是对可能危及消费者或其它使用者（技术人员、职员、维护员）健康的材料进行风险分析。 已获得的GS证书有效期As a result we send you a document showing for w

33、hich documents we cannot accept and the reason therefore as well as the product parts for which we require evidence for PAHs compliance, either by testing through our laboratory or by receiving suitable documents from the material supplier. 最后， 我们会发给你一个文件， 上面会列清楚哪些文件是我们不能接受的及其原因， 哪些部件需要符合PAHs的要求进行测试

34、或提供有效的测试报告。 What is with the certificates issued before the first of April 2008? Are they still valid until the listed expiration date? If not, is there a transition period for renewing/updating these certificates? 对于2008年4月1日前取得的GS证书，是否在证书所列的有效期内保持有效？或者有没有更新的过渡期限？All so far issued certificates are

35、still valid. But we have to check each certificate whether or not the certified product can be affected by the PAHs requirement. The ZLS is allowing a transition period of one year, beginning in April 2008. After this transition period all GS certified products with a valid certificate must comply w

36、ith the PAHs requirement. 到目前为止， 所颁发的证书都是有效的。 但是我们需要检查每一张证书，看一看认证的产品是否受PAHs要求的影响。ZLS允许之前所发的这些证书有一年的过度期，2008年4月1日起，1年内更新现有GS证书 ，过渡期后， 所有GS证书必须满足PAHs的要求。 已获得的GS证书更新For already certified products, do you have to issue a new certificate showing the PAHs compliance? 现有的GS证书， 是否一定需要重新发证并显示PAHs符合性？ No, thi

37、s is not a mandatory requirement. However, per request we can issue an updated GS certificate at which the PAHs requirement is listed.已经获得的GS证书，只需要对产品材料/部件的PAHs符合性进行评估并留档相应的证明文件，不需要重新发证。 ZLS不强制要求把PAHs的符合性直接体现在GS证书上。但是 如果申请人希望在证书上体现，我们也可以根据客户的要求把产品符合PAHs的结论体现在GS证书上。 认识 GS-Mark Market driven requireme

38、ntsIt is a symbol for approved product safety 安规标志It is requested by the German market 德国市场要求的认证标志It is well known throughout Germany as well as in some countries outside Germany 在德国乃至整个欧洲被广泛认可It is a mark for consumer products and helps to sell the products 针对成品It is based on testing and certificat

39、ion by an accredited GS certification body 必须经授权机构测试和认证It stands for production surveillance 代表产品安全管控It is a property of the German Product Safety Authority “ZLS” 标志属于ZLSIt provides certainty, that a product complies with the relevant legal requirements of the GPSG 代表产品符合德国相关法令要求GS-Mark 和CE-Marking

40、对比CE markingCE-marking is mandatory 强制Compliance with relevant CE-directives 符合CE指令Tested by manufacturer or third party test lab 制造商或第三方机构测试Self declaration 原则上是自我声明No factory inspection 不需要工厂检查CE is an administrative sign for authorities (“European passport of the product”) 进入欧洲市场的通行证Products must

41、 comply with harmonized EN standards and European directives 依据欧洲协调标准GS MarkGS mark is a market driven mark not mandatory 市场驱动，非强制Tested by accredited GS laboratory 符合德国GPSG法令，和欧洲CE指令Certificate must be issued by ZLS authorized certification body 证书必须由ZLS授权的认证机构颁发Factory inspection according to CIG-

42、023 rules is mandatory 需要工厂检查GS mark is a property of the German Safety Authority “ZLS” Products must comply with harmonized EN standards, European directives and special requirements of the GPSG 依据协调标准A GS mark certificate is valid for a max. of 5 years 证书最长有效期5年GS-Mark 和 CE-Marking 对比(续1）GS-Mark 和

43、 CE-Marking 对比 （续2）That means A product which complies with the GPSG requirement can be sold in the whole European marketNote: Products bearing the GS mark must also bear German text for warnings and other required information ensuring a safe use of the product. GS marked products sold outside Germa

44、ny must also comply with other relevant national requirements, e.g. language of marking为什么要申请GS标志Market Driven Requirements-German Trade StructureLargest consumer market within the EU 欧盟最大的消费者市场Huge retailers are dominating the market, big portions are purchased directly from manufacturers 零售商主裁市场，大

45、部分产品直接从制造商采购German brands completing their product ranges by imported products 众多德国品牌的产品都是进口 （OEM贴牌产品）Professional trading companies require more than CE to satisfy their due diligence toward product liability 专业贸易商要求更高于CE标志的符合性证明Professional trading companies therefore ask for testing and product s

46、upervision by notified bodies before purchasing products 因此贸易商需要第三方机构进行评估Manufacturers can get a proof of compliance with valid directives and surveillance of their production by applying the well established GS mark 对制造商来说，满足买家要求最有效的方式就是申请GS标志认证申请GS认证的要求 Requirement towards manufacturersGeneral 针对制

47、造商The applicant can be the manufacturer or his representative in the European Community 申请人可以是制造商或其在欧洲的代表/贸易商The applicant can be a trading company，if a contract with its manufacturer exists, who has to accept the GS requirement 如申请人是贸易商， 必须与制造商签订协议, 确保制造商接受GS要求The layout of GS mark has to be obtain

48、ed from the certification body GS标志必须从相应认证机构获取Clear identification of the product must be assured 产品上必须有清楚的标识The manufacturing site must have annual factory inspections 生产厂必须接受年度工厂监督检查Offences against the GS LawMarket surveillance inspectors are very active in all member states of the EU and they ar

49、e looking for any goods which might not be in compliance to ANY valid standard, directive or law. 欧洲市场上严格的市场监督抽查Offences against the GS-Law will be treated by suspension of GS approval and notification to the state authorities (e.g. ZLS) and objected goods will be banned from the European market. Th

50、e ZLS will notify the relevant market surveillance groupInformation about these products will be published at the official websites, e.g. following links http:/ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfmhttp:/=5508&callId=2&winId=1PFOS/PFOA管制PFOS/PFOA的特性及应用PFOS/PFOA的健康危害欧盟指令提议对工业的影响及各国的行

51、动SGS测试能力简介什么是全氟辛烷磺酸 (PFOS)? PFOS属高氟化合物，市场上常见的种类有C8F17SO2X，其中X可以是羟基，金属盐，卤化物，氨基，和其他聚合物的衍生物基团;各种 PFOS分别由 从C4, C5, C6, C7, 到C8碳链组成，或以PFOS卤化物或PFOS氨基化合物形式表现市场上最广泛使用的属 PFOS-C8;全氟辛烷磺酸及其常用的盐类如下：什么是全氟辛烷磺酸 (PFOS)? (Cont)Potassium saltCAS No. 2795-39-3Perfluorooctane sulphonic acidCAS No. 2795-39-3什么是全氟辛烷磺酸 (PF

52、OS)? (Cont)Lithium saltCAS No. 29457-72-5Ammonium saltCAS No. 29081-56-9什么是全氟辛酸 (PFOA)?PFOAPerfluorooctanoic acid, 又称C8，是一种人工合成的而非天然的工业原料。PFOA这个缩写并不仅仅指全氟辛酸，还包括它的盐类，其中应用最广和最受关注的就是它的铵盐Ammonium perfluorooctanoate (APFO or C8)什么是全氟辛酸 (PFOA)? (Cont)Perfluorooctanoic acidCAS No. 336-67-1Ammonium perfluoro

53、octanoateCAS No. 3825-26-1PFOS/PFOA在工业及日用品中的主要应用PFOS是3M公司的ScotchgardTM 系列产品的主要成分，该产品主要用作纺织品及地毯、皮革的防水防污处理剂；与PFOA一起，用于制造水成膜泡沫（Aqueous Film Forming Foam AFFFTM）及Alcohol-Type Concentration (ATCTM)，两者均是3M公司生产的泡沫灭火剂的成分之一；PFOA 在工业上的主要用途是作为生产PTFE (polytertra-fluoroethylene)，即铁氟龙（Teflon）的工业助剂，该材料广泛用于不粘涂层的生产。

54、在半导体工业中，应用于光产酸剂（ photoacid generators PAGs）及增透膜（ anti-reflective coating ARCs）等平板印刷术(photolithographic)用的化学试剂；PFOA还是化工厂生产过程中调聚反应（telomeriztion process）的副产物，而该反应所制备的perfluorinated alcohol 主要用于各种家具的表面抛光处理及食品软包装材料，如微波炉用的爆米花袋、快餐和糖果的包装纸及批萨饼的衬纸等。在蜡制品、光亮剂、油漆、清漆、清洁剂、金属表面中也有应用；还广泛地被使用在合成洗涤剂、洗发香波及其他表面活性剂产品中。P

55、FOS/PFOA在工业及日用品中的主要应用(Cont)PFOS/PFOA的健康危害危害特性及评估：难降解性 (i.e. 抗微生物降解)生物积聚 (i.e. 积聚在生物体内)经济合作与发展组织（OECD）2002年的一项危险评估认为PFOS 对哺乳类动物具有毒性 (i.e. 本身具毒)PFOS是目前世界上发现的最难降解的有机污染物之一，具有很高的生物蓄积性和多种毒性，动物实验表明每公斤2毫克的“PFOS”含量即可导致死亡。美国EPA 2006年也发布了一项评估认为PFOA可能具有致癌性PFOS/PFOA的健康危害(Cont)PFOS/PFOA在生物体内及环境中的残留调查表明，在人体的血液中发现有

56、微量的PFOS、PFOA残留；在鸟类、鱼类的器官组织，地表水、底泥、废水处理厂底排污口、下水道排污管及垃圾填埋厂的渗出液中，均发现有PFOS；据估计，美国人体内的PFOA有20来源于微波炉用的爆米花袋，其报道的半衰期为四年以上；对生殖系统、细胞功能、荷尔蒙系统均会产生影响。欧盟指令提议欧共体委员会 欧盟议会及理事会指令的提议(2006)10-25：关于限制销售和使用全氟辛磺酸PFOS（欧盟指令76/769/EEC 修改版本）不可于市场销售全氟辛磺酸化合物，其在成品中的浓度不得相等于或超过总体的0.005%； 不得销售全氟辛磺酸化合物浓度相等于或超过总体0.1%的半制成品或半制成品的部件； 在纺织品或其他涂层物料，全氟辛磺酸化合物含量必须少于每平方米1微克； 欧盟指令提议(Cont) 用于制造照相平版印刷防反光涂层的物质及制剂,以及覆盖于胶片、纸张或印板表面的感光涂层等,可含有较大量的全氟辛磺酸化合物、非装饰性硬铬所含的抑制剂、航空用液压液体亦然；豁免灭火泡沫的建议被欧洲议会否决。因此,所有新推出的灭火泡沫必须不含碳氟化合物；在指令生效前12个月推出市场的灭火泡沫，可于指令生效后最多54个月内使用；PFOA可能具有与PFOS类似的危害，因此，需持续对其进行风险评估、寻找相关替