REACH for Mondial - Rev 28 Aug PDF Free Download

EU New Chemical policy REACH Regulation (EC) No 1907/2006 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

欧盟新化学品政策 REACH 法规 (EC) No 1907/2006 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Registration What is REACH? Create a single system to regulate chemicals in EU Substance 1 t/yr Sub. in preparation 1 t/yr Sub. in Article (intended release) 1 t/yr Authorisation SVHCmanufacturing and use is only allowed when authorisation is granted Evaluation Dossier evaluation Substance evaluation Restriction Repeal 76/769/EEC restricts dangerous substances on its own, in preparation and in article

注册什么是 REACH? 建立一个单一系统监管在欧盟境内的所有化学物质物质 1 吨 / 每年配制品中的物质 1 吨 / 每年物品中的物质 ( 有意释放 ) 1 吨 / 每年授权高关注物质 - 只有在已授权的情况下, 才可制造或使用高关注物质评估技术档案评估物质评估限制废除指令 76/769/EEC, 取而代之限制危险物质以及配制品和物品中的危险物质

Glossary Chemical elements and its compounds Mixture of substances Its shape determines its function to a greater degree than its chemical composition

词汇化学物质及其化合物混合物质物品的功能主要取决于物品的形状而非化学成分 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

REACH Main Objectives: To ensure a high level of protection of health and the environment Put articles under regulation Encourage data sharing and reduce animal testing Safeguarding innovation and competitiveness

REACH 主旨 : 高度保护人类健康和环境把物品纳入规管范围鼓励数据共享和减少动物测试保留研发空间以及保持欧盟化工业的竞争力

Penalties for Non-compliance Member States (MS) shall lay down their own provisions on penalties MS shall ensure they are implemented The penalties provided for must be effective, proportionate and dissuasive. MS shall notify the Commission regarding the provisions on penalties no later than 1 December 2008

违规惩罚欧盟成员国必须厘定一套自己的罚则成员国必须切实执行条款罚则须行之有效, 适当和勸阻式的成员国必须在 2008 年 12 月 1 号前通告欧盟委员会有关罚则的详细内容 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

REACH implementation process Jun 1, 2007 REACH ENTERS into FORCE Jun 1, 2008 European Chemical Agency fully operative Pre-registration of EXISTING substances (PHASE IN) Registration of NEW substances (NON PHASE IN) Nov 30, 2008 Pre-registration ends

REACH 实施时间表 2007 年 6 月 1 号 REACH 正式生效 2008 年 6 月 1 号欧盟化学品局全面运作阶段性物质预注册开始非阶段性物质注册开始 2008 年 11 月 30 号预注册截止日期

Pre-registration First Impact Pre-Registration necessary for substances: on their own in Preparations In Articles if substance intended to be released Purpose To facilitate data sharing To reduce testing on vertebrate animals To reduce costs to industry

预注册首要事项预注册范围 : 物质本身配制品中的物质物品中的有意释放的物质预注册目的 : 方便数据共享减少脊椎动物测试减低注册或相关费用 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Pre-registration 1 June 2008 to 1 December 2008 For existing substances 1000 kg per manufacturer / importer Release from an article is intentional

预注册 2008 年 6 月 1 号至 2008 年 12 月 1 号只适合于阶段性物质 1000 千克 / 制造商或进口商物质在物品中属于有意释放 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Pre-registration Name of the substance Einecs and CAS number Name / Address of pre-registrant Contact Person

预注册物质名称 EINECS 号 and CAS 号预注册者姓名和地址联络人 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

How Pre-registration Pre-registration / registration shall be made via internet Two systems IUCLID 5 / REACH IT Provided free by ECHA

预注册如何预注册必须使用互联网预注册 / 注册两个系统 IUCLID 5 / REACH IT 由欧盟化学品局人员设计, 并免费提供于相关人士使用 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Pre-registration IMPORTANT Failure to pre-register a substance means: Until full registration has taken place, that substance cannot be put on the market.

预注册注意如未能在规定时间内预注册 : 只有在完成注册的情况下, 物质才能投放于市场上 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Substances Chemicals Registration Sub. in Preparation Glue Sub. in Article T-shirt Registration required if sub. > 1 t/a per manufacturer or importer Registration required if sub. in preparation > 1 t/a per manufacturer or importer Registration required if sub. in Article is intended to be released, and > 1 t/a per manufacturer or importer for that specific use

物质化学品注册配制品中的物质胶水物品中的物质汗衫物质的注册条件配制品中物质的物品中物质的注册条件注册条件物质有意释放以及按制造商或进口商计按制造商或进口商计按制造商或进口商计 > 1 吨 / 每年 > 1 吨 / 每年 > 1 吨 / 每年

Substance & Substance in preparation Registration Art 6(1) Manufacturer or importer of a substance, either on its own or in preparation, in quantities > 1 t/a shall submit a registration

物质以及配制品中的物质注册第 6 条 (1) 若物质本身或配制品中物质的数量大于或等于 1 吨 / 每年, 制造商或进口商必须为该物质进行注册 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Art 7(1) Substance in Article Registration Any producer or importer of articles shall submit a REGISTRATION to the Agency for any substance contained in those articles, if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is INTENDED TO BE RELEASED under normal or reasonably foreseeable conditions of use.

第 7 条 (1) 物品中的物质注册如果以下两个条件都符合, 任何制造商或进口商必须为其物品中的物质向欧盟化学品局提交注册 : (1) 按制造商或进口商计, 物质在物品中的数量大于或等于 1 吨 / 每年 ; (2) 在正常和可合理遇见的使用情况下, 物品中的物质是有意释放的

Substances intended to be released Markers Textiles impregnated With polish Scented Eraser AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

未有确实定义的产品记号笔含擦亮剂的纺织品有香味的橡皮 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Substances not intended to be released? Clothes (aromatic amines) Tyres (PAH) Shower curtain (Phthalates)

成衣 ( 芳香胺 ) 无意释放的物质轮胎 ( 多環芳香族碳氫化合物 ) 浴帘 ( 邻本二甲酸盐 ) AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

EU Manufacturer / Importer Manufacturer: means any natural or legal person established within the Community who manufactures a substance within the Community; Importer: means any natural or legal person established within the Community who is responsible for import Non-EU manufacturer / importer Appoint an ONLY REPRESENTIVE by mutual agreement To fulfill obligations on your behalf Shall inform along the supplier chain regarding the appointment

欧盟制造商 / 进口商制造商 : 指任何在欧共体内制造物质, 并在欧共体确立的自然人或法人进口商 : 指任何负责进口, 并在欧共体确立的自然人或法人非欧盟制造商 / 进口商在双方协议的基础上, 委任一个唯一代理助你履行相关责任你必须通知供应链中各成员关于是次委任

BUT!!! Registration: Manufacturers / Importers of articles Do not need to register substances If the substance is already registered by another party for that use

Authorisation Included chemicals: Cat 1 & 2 CMR, PBT, vpvb and substance with similar effects Authorisation procedure consists of two steps: a decision is taken via comitology as to which substances on the candidate list will be included in the system, which will be exempted and which deadlines will have to be met apply for an authorization with an analysis of possible substitutes Authorisation will be granted if the applicant demonstrate the risk from the use of the substance is adequately controlled Or authorisation may be granted if socioeconomic benefits outweigh the risks in the absence of suitable alternative

范围 : 第一及第二类致癌, 致诱变或致生殖毒物 (CMR), 持久积累毒物 (PBT), 非常持久及非常积累物质 (vpvb) 和有同等危害的物质授权程序 : 授权欧盟委员会会通过开会决定, 从高关注物质候选名单中挑选哪些落入授权清单, 列出豁免条款和使用期限申请授权时要附带一份替代物质的研究报告申请人若能证实物质的使用有足够的监管, 或者在没有替代物质或技术的情况下, 社会经济利益大于该物质所带来的危险, 申请将会被接纳

Restriction Provide a procedure to regulate that the manufacture, placing on the market or use of certain dangerous substances These dangerous substances shall be either subject to conditions or prohibited Act as a safety net to manage Community wide risks that are otherwise not adequately controlled.

限制提供一个程序管理有害化学品的制造, 使用和销售条文禁止或有条件下限制有害化学品的制造, 使用和销售这法规在欧共体内作为一个安全网, 堵塞法律漏洞 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Art 67(1) Restriction A substances on its own, in preparation or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.

限制第 67 条 (1) 除非能满足附录 XVII 所厘定的限制要求, 否则, 物质本身在配制品或物品中的物质将不能生产, 使用或销售 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Restriction Examples Textiles Aromatic amines Limit: 30 ppm Metal button Nickel release Limit: 0.5 μg/cm 2 /week Plastic eyelet Cadmium Limit: 0.01% by mass

纺织品芳香胺含量上限 : 30 ppm 限制例子金属钮扣镍释放含量上限 : 0.5 μg/cm 2 /week 塑料带眼镉含量上限 : 0.01% 按重量计

Art 7(2) Notification Any producer or importer of articles shall NOTIFY the Agency, if both the following conditions are met : (a) a substance on the candidate list (SVHC) is present in those articles in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0.1% weight by weight (w/w).

通报第 7 条 (2) 如果以下两个条件同时符合, 任何制造商或进口商必须通报欧盟化学品局有关高关注物质的信息 : (1) 按制造商或进口商计, 物品中高关注物质的总量大于或等于 1 吨 / 每年 ; 以及 (b) 该高关注物质在物品中的含量大于或等于 0.1% ( 按重量计 ).

Substance of very high concern (SVHC) Category 1 or 2 carcinogens Category 1 or 2 mutagens Category 1 or 2 toxic for reproduction Persistent, bioaccumulative and toxic (PBT) Very persistent and very bioaccumulative (vpvb) Substances pose serious effects to human health or the environment (e.g. endocrine disruptor)

高关注物质 (SVHC) 第一类或第二类致癌物质 (C) 第一类或第二类致诱变物质 (M) 第一类或第二类致生殖毒物 (R) 持久积累毒物 (PBT) 非常持久及非常积累物质 (vpvb) 有同等危害的物质 ( 例子 : 破坏内分泌的物质 )

Article 7(5) Possible consequences The Agency may require producers or importers of articles to submit a REGISTRATION, if all the following conditions are met: a) the substance is present in those articles > 1 t/a b) the Agency suspects that: (i) the substance is released from the articles, and (ii) the release of the substance from the articles presents a risk to human health or the environment; c) The substance does not registered before because of the intended released requirement

后果第 7 条 (5) 如以下所有条件同时符合, 欧盟化学品局有可能要求制造商或进口商为该物质注册 : a) 物质数量大于 1 吨 / 每年 b) 欧盟化学品局怀疑 : (i) 物质会从物品中释放出来 ; (ii) 物质的释放会危害人体健康和环境 c) 该物质未有因有意释放而被注册

Warning! This T-shirt contains XXX Communicate information on substances in articles Article 33 1. Any supplier of an article containing a SVHC in conc. > 0.1% (w/w) Shall provide the recipient of the article with sufficient information to allow safe use of the article 2. Provide such information to consumer on request The information shall be provided Free of charge within 45 days

传递物品中物质的信息第 33 条 1. 任何供应商, 物品中高关注物质含量 > 0.1% ( 按重量计 ) 必须为买家提供足够的物品安全使用指引注意! 这汗衫含有 XXX 2. 在消费者消费者的要求下供应商必须在 45 天内免费提供相关的安全使用指引

Communicate information on substances in articles Information on SVHCs must be provided to consumers if requested Obligation begins as soon as official list of SVHC is published (candidate list): End 2008 / Early 2009

传递物品中物质的信息若消费者有所要求, 有关物品中高关注物质的讯息是必须提供的当高关注物质候选名单公布时, 供应商就要切实履行其责任高关注物质的候选名单公布时间大概在 2008 年年底至 2009 年年头

Textiles and footwear Should I care about REACH? Why? A. Restriction requirement (repeal 76/769/EEC: Azo dyes, nickel release.) B. Pre-registration of any substance intended to be released (very few in textiles/footwear, e.g., scents; infused deodorants; possibly overdyed denim) C. Notification May lead to registration D. Information in the supply chain E. Authorisation

纺织品及鞋类产品 REACH 对我有没有影响呢? 为什么? A. 限制要求 ( 废除指令 76/769/EEC: 代而管制偶氮染料, 镍等的有害物质 ) B. 有意释放物质的预注册 ( 对纺织品及鞋类产品的影响比较少, 例子有香味, 除臭剂, 或许包括染料过多的牛仔布 ) C. 通报有可能要申请授权 D. 供应链中的资讯传递 E. 授权

A. Restriction REACH will repeal 76/769/EEC in 1 Jun 2009 Change may not to shall not More stringent requirements allow till 2013, list will be published in 2009 Textiles Aromatic amines Limit: 30 ppm Plastic eyelet Cadmium Limit: 0.01% by mass Metal button Nickel release Limit : 0.5 μg/cm 2 /week

A. 限制 REACH 将会在 2009 年 6 月 1 号废除指令 76/769/EEC 更改了条款字眼, 由不可改为不准成员国原有更严格的条例会有效至 2013 年, 条例清单将于 2009 年公布纺织品芳香胺含量上限 : 30 ppm 塑料带眼镉含量上限 : 0.01% ( 按重量计 ) 金属钮扣镍释放含量上限 : 0.5 μg/cm 2 /week

A. Restriction Against 76/769/EEC till 2009 Limit value similar in REACH means they remain the same Azo dyes Cadmium Chromium VI Flame retardants Nickel release PCP Review MSDS Internal / External audit

A. 限制受指令 76/769/EEC 规管直至 2009 年含量限制基本上没有改动偶氮染料镉六价铬阻燃剂镍释放五氯苯酚检阅化学品技术说明书 (SDS) 定期内部 / 请第三方作系统检查

C. Notification Notify the European Chemical Agency Present of SVHC SVHC > 0.1% weight by weight SVHC > 1 t/yr Information required: Identity and contact details of producer and importer Identity of the substance Classification of substance Brief description of the use of substance in the article Tonnage range of the substance Starting??

通报欧盟化学品局 C. 通报物品中含有高关注物质在物品中含量 > 0.1% ( 按重量计 ) 按制造商或进口商计总量 > 1 吨 / 每年通报所需资料 : 制造商或进口商资料和联络详情物质资料物质危险分类简单描述物质在物品中的功用吨位范围 Starting??

Substances of Very High Concern (SVHC) Type Category 1 & 2 Carcinogen, Mutagen, & Toxic to Reproduction Persistent Bioaccumulative & Toxic Abbreviation Cat. 1 & 2 CMR PBT Examples Cadmium Sulfate, Benzene Mercury, Polychlorinate d Biphenyls Status > 1100 types Not published yet very Persistent very Bioaccumulative vpvb Hexachlorobu ta-1,3-diene, Pentachlorobe nzenethiol Not published yet + Substances of Equivalent Level of Concern

种类第一类和第二类致癌, 致诱变, 致生殖毒物持久积累毒物高关注物质缩写例子 Cat. 1 & 2 CMR 硫酸镉, 苯 PBT 汞, 多氯联苯数量 > 1100 种尚未公布非常持久和非常积累物质 vpvb 六氯 -1,3- 丁二烯, 五氯苯硫酚尚未公布 + 有同等危害的物质

D. Information in the supply chain Shall provide information to the recipient Present of SVHC SVHC > 0.1% weight by weight SVHC > 1 t/yr Warning! This T-shirt contains XXX

D. 供应链中的资讯传递须提供买家物品中含有高关注物质高关注物质 > 0.1% 按重量计高关注物质 > 1 吨 / 每年注意! 这汗衫含有 XXX AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

D. Information in the supply chain Look for substitution AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

D. 供应链中的资讯传递寻找替代品

E. Authorisation SVHC present in Article SVHC included in the Authorisation list Cat 1 & 2 CMR, PBT, vpvb Substances identified during registration SVHC Candidate list ECHA Prioritization of sub. for Authorisation (Annex XIV)

物品含有高关注物质 E. 授权授权清单中包括该高关注物质 Cat 1 & 2 CMR, PBT, vpvb 有同等危害的物质 ECHA 高关注物质候选名单挑选物质列于授权清单 ( 附录 XIV)

E. Authorisation Look for substitution Identify SVHC Confirm the source of SVHC Take corrective actions / Search for possible alternatives Consider compatibility of the alternative Trial run Decide whether to substitute

E. 授权寻找替代品确认高关注物质找出源头更改技术或更换供应商 / 研发替代品考虑替代品是否适用于现有生产程序尝试是用替代物质进行生产确定是否取代 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

What are the Frequently Asked Questions For Brands/Retailers? Is the product we import an article or a preparation? Does that article have an intended release? Is it possible that the article contains SVHC s?

给品牌持有者或零售商的常见问题我们所制造的产品是属于物品或配制品呢? 物品中的物质是否属于有意释放? 物品中会否含有高关注物质?

FAQ - preparations What is a preparation? Mixtures or solutions composed of two or more substances (e.g. cosmetics). To comply with REACH, importers need to obtain: composition of the product they import, i.e. names (CAS numbers) quantities of all substances present in the preparation.

常见问题 - 配制品什么是配制品? 混合物或由两种以上物质组成的溶液 ( 如化妆品等 ) 为符合法规要求, 进口商需要收集以下资料 : 所进口产品的化学成分 ( 即化学物质名称和 CAS 号 ) 配制品中各种化学成分的重量百分比

FAQ - articles What is an article? Objects which during production are given a special shape, surface or design, which determines its function to a greater degree, than does its chemical composition.

常见问题 - 物品什么是物品? 物件在生产的过程中被赋予特定的形状, 外观或设计, 该物件的功能主要取决于其形状, 外观或设计而并非其化学成分 AFIRM RSL WORKING GROUP AFIRM RSL WORKING GROUP

Pre-registration and registration What needs to be registered? Substances intended to be released from an article, under certain conditions, require registration, e.g. garments containing anti-perspiration agents. To comply with REACH, importers need to obtain from their suppliers: composition of products they import, i.e. the name (CAS number) of substances intended to be released quantities present in the article

预注册和注册注册所需资料? 在某种情况下, 物品中有意释放的物质有意释放的物质须要注册 ( 例如成衣中的止汗计 ) 为符合法规要求, 进口商需要向供应商收集以下资料 : 进口产品的化学成分 ( 即有意释放物质的名称和 CAS 号 ) 该物质在物品中的数量

FAQ : Notification of Substances of Very High Concern (SVHC) What is an SVHC? All substances which will be included on a list known as the candidate list. First version of the list may be published by end of 2008 on Website of European Chemicals Agency. To comply with REACH, importers must be informed on Substances of Very High Concern present in articles in concentrations above 0,1 % - wt by wt (1000 mg /kg)

常见问题 : 高关注物质的通报什么是高关注物质? 系指所有落入高关注物质候选名单候选名单的物质第一份候选名单将于 2008 年年底, 在欧盟化学品局网站公布假若物品中的高关注物质含量重量比大于 0.1%(1000 毫克 / 每千克 ), 为符合法规要求, 进口商有必要知道相关资料

REACH for Mondial - Rev 28 Aug 2007