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Seminar on EU Chemical Regulatory System

Seminar on EU Chemical Regulatory System. REACH 17 th July 2012. 欧盟化学制品监管体系 专题研讨会. REACH 2012 年 7 月 17 日. Understanding REACH. REACH is a regulation of the European Union (EU) and applies to 27 EU Members States, and REACH also apply to Norway, Iceland and Liechestein,

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Seminar on EU Chemical Regulatory System

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  1. Seminar on EU Chemical Regulatory System REACH 17th July 2012

  2. 欧盟化学制品监管体系专题研讨会 REACH 2012年7月17日

  3. Understanding REACH • REACH is a regulation of the European Union (EU) and applies to 27 EU Members States, and REACH also apply to Norway, Iceland and Liechestein, • REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals • It entered into force on 1 June 2007.

  4. REACH解读 • REACH 是欧盟European Union，以下简称EU的一项法规，适用于27个EU成员国和挪威、冰岛及列支敦斯登 • REACH 的意思是Registration, Evaluation, Authorisation and Restriction of Chemicals，即化学制品注册、评估、许可和限制 • 生效于2007年6月1日

  5. AIMS • To provide a high level of protection of human health and the environment from the use of chemicals. • To make the people who place chemicals on the market (manufacturers and importers responsible for understanding and managing the risks associated with their use.) • To allow the free movement of substances on the EU market. • To enhance innovation in and the competitiveness of the EU chemicals industry. • To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

  6. 目的 • 提供高水平的防护，使得人类健康和环境免受化学制品使用带来的危害 • 使得将化学制品投放市场的(制造商和进口商）负责理解和处理其使用带来的相关风险 • 允许在EU市场物质的自由流通 • 提高EU化学制品行业的创新和竞争力 • 促进物质危害性质评估替代方法的使用，例如定量构效关系（QSAR）和交叉参照

  7. Understanding REACH • It placed the burden of proof of safety for chemical on the shoulders of industry and no longer on government authorities. • To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. • They have to demostrate how substance can be safely used and they communicate the risk management measures to the users. • If the risk cannot be managed, authorities can restrict the use of substance. In the log run, the most hazardous substances should be substituted with less dangerous ones.

  8. REACH解读 • 将保证化学制品安全的责任化归于企业，而不再化归于政府当局。 • 根据法规要求，对于在EU进行生产和销售的物质，公司必须对此物质相关的风险进行说明和管理。 • 公司必须说明物质的安全使用方法并告知使用者相关的风险管理措施。 • 若风险不可控，有关当局可限制该物质的使用。从长远来看，应使用危险性小的物质替代危害性大的物质。

  9. REACH Impact Leading regulatory drivers (Chemical Watch survey 2012)

  10. REACH 的影响 主要监管机制(化学观察调查2012)

  11. REACH Impact • Introduction/expansion of REACH-like regulations in many other countries • The registration deadline for Turkey’s chemicals notification regulation drove a lot of activity in the first part of 2011. • China revised its registration scheme to create Decree 7 on the Measures on Environmental Administration of New Chemical Substances • Taiwan pursued its new scheme for existing chemical substance nomination (ECN) and plans for new chemical notification (NCN)

  12. REACH的影响 • 在很多其它国家对类似REACH法规的引进和扩展 • 2011上半年，土耳其化学制品通报法规的注册截止日期促进了很多相关活动的开展。 • 中国对其注册计划进行修订，指定了关于新化学物质的环境管理措施的7号法令。 • 台湾继续进行针对现有化学物质通报(ECN) 的新计划和新化学物质通报(NCN)的计划。

  13. REACH Impact • Serbia also enacted a chemicals management and control system in 2011 • Malaysia now has an Environmentally Hazardous Substances Notification and Registration (EHSNR) Scheme • Japanese REACH – "Chemical Substance Control Law" (CSCL) has been amended which was officially published in May 2009. • Korean REACH – "Toxic Chemicals Control Act" (TCCA)

  14. REACH的影响 • 2011年，赛比亚指定了一套化学制品管理控制体系。 • 马来西亚现已有一套环境有害物质通报和注册(EHSNR)计划。 • 日本的REACH – “化学物质控制法” (CSCL)于2009年5月出台，且现已进行了修订。 • 韩国的REACH – “毒性化学制品控制法案" (TCCA)

  15. REACH Impact • In the US, • TSCA reform was held up in 2011 due to political gridlock, and any further movement will not be likely in 2012 due to the fact that 2012 is an election year • the new Chemical Data Reporting Rule (formerly the Inventory Update rule), which determines what and how exposure-related information on chemicals is collected, was adopted with implementation beginning in 2012

  16. REACH的影响 • 在美国, • 在2011年的TSCA 改革由于政治僵局被搁置，而由于2012年是大选年，在2012年也不太有可能有进展。 • 新的化学资料提报法规(先前的详细目录更新法规), 规定暴露相关信息的采集内容和方式。这一法规于2012年年初获批并开始实施。

  17. REACH Impact • It will be difficult that some REACH do not REACH you. • We can take two options, • A passive option, where we think that in a difficult path, even a straw is a heavy burden ...Or • An active option, and try to anticipate a new global concept of management of chemicals.

  18. REACH的影响 • 如果REACH法规对我们不适用， • 我们有两种选择， • 消极选择，即在困难重重的道路上，即使一根稻草也可成为沉重的负担… • 积极选择，即试着去预测新的全球化学制品管理的新概念。

  19. REACH Impact • In the following slides we will introduce definitions and concepts that are necessary to understand the requirements of REACH • Substances, mixtures and articles. • Manufacturers, Importer, Down

  20. REACH的影响 • 在接下来的幻灯片里，我们将介绍理解REACH法规要求所必备的一些定义和概念。 • 物质、混合物、物品 • 制造商、进口商、下游用户

  21. Substances, mixtures and articles • SUBSTANCES: • It means a chemical element and its compounds. • It includes both • substances obtained by a manufacturing process (for example formaldehyde or methanol) and • substances in their natural state. • It also includes its additives and impurities where these are part of its manufacturing process. • Excludes any solvent which can be separated without affecting the stability of the substance

  22. 物质、混合物和物品 • 物质: • 指的是一种化学元素及其化合物。 • 包括： • 通过加工获得的物质(例如甲醛、甲醇） • 自然状态的物质 • 也包括 一些加工过程中的添加剂和杂质 • 不包括 和物质分离后不影响物质稳定性的溶剂

  23. Substances, mixtures and articles • MIXTURES: • Mixture or solution composed of two or more substances. • Examples: • Paints, • Varnishes • Inks. • REACH obligations apply individually to each subtances.

  24. 物质、混合物和物品 • 混合物: • 包含两种或以上物质的混合物或溶液 • 例如: • 涂料 • 油漆 • 墨水 • REACH 法规的要求单独适用于每种物质

  25. Substances, mixtures and articles • MIXTURES (2): • Alloys: “Specials mixtures”. • The alloy is not subject to registration, the alloying elements (e.g. metals) have to be registered. • Constituents which are not intentionally added to the alloy should be considered as impurities

  26. 物质、混合物和物品 • 混合物(2): • 合金: “特殊混合物”. • 合金无需进行注册，而合金元素（如金属元素）必须进行注册 • 非故意加入合金的成分应被视为杂质

  27. Substances, mixtures and articles • ARTICLES: • Is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition • Examples: textiles, electronic chips, furniture, books, toys, kitchen equipment).

  28. 物质、混合物和物品 • 物品: • 一个在生产过程中被授予了特别的形状、表面或设计的物体，物体的形状、表面或设计比其化学成分更大程度上决定了其功能 • 例如:纺织品、电子芯片、家具、书、玩具、厨房用品等

  29. Substances, mixtures and articles • ARTICLES (2): • An individual substance in an article is subject to the registration obligations in case • it is present in the article in quantities over one tonne per year and • the substance is intended to be released under normal or reasonably foreseeable conditions of use.

  30. 物质、混合物和物品 • 物品(2): • 如果出现以下情况，物品中的单个物质需进行注册 • 物质在物品中的含量超过一年一吨 • 在正常使用和可预见的使用中，物质将被释放

  31. Substances, mixtures and articles PACKAGING • Substances, mixtures and articles can be contained inside of packaging, such as a carton, a plastic wrapping or a tin can. The packaging does not belong to the substance, mixture or article being packaged and is therefore to be considered as a separate article under REACH. • Producers, importers and suppliers of packaging or of packaged substances, mixtures or articles have to fulfil the same requirements for that packaging as for any other article. • Packaging with different functions needs to be considered separately (e.g. if an article is directly wrapped in plastic and then packed in a cardboard box, the plastic and the cardboard box should be considered separate articles).

  32. 物质、混合物和物品 包装 • 物质、混合物和物品可置于包装内，例如用纸箱包装、塑料包装或锡罐包装。包装不属于被包装的物质、混合物或物品，因此应作为一项REACH适用的单独的物品。 • 包装和包装物质、混合物或物品的制造商、进口商和供应商必须保证包装与其它物品一样，满足相同的要求。 • 具有不同功能的包装需单独考虑(例如假如某物品直接用塑料包装后再放入纸箱，则塑料和纸箱应作为两项物品区分开来）

  33. Substances, mixtures and articles Identification process (example) (1) • If you can unambiguously conclude that the shape, surface or design of the object is more relevant for the function than its chemical composition, the object is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture. • A wax crayon consists of paraffin wax and pigments and is used for colouring and drawing on paper. As its shape/surface/design are not more relevant for the function of the crayon (to bring pigment to paper) than its chemical composition, it is to be regarded as a mixture.

  34. 物质、混合物和物品 鉴定过程(范例) (1) • 如果可以清楚的得出结论，即物体的形状、表面和设计比起其化学成分与其功能更相关，则该物体为物品；如果形状、表面和设计的影响等于或小于化学成分的影响，则该物体为物质或混合物。 • 蜡笔由石蜡和色素组成，用作上色和画画。由于蜡笔的形状/表面/设计并不比其化学成分与其功能（给纸张上色）更相关，蜡笔应被视为混合物。

  35. Substances, mixtures and articles Identification process (example) (2) • If it is not possible to unambiguously conclude whether the object fulfils the REACH definition of an article or not, a deeper assessment is needed. • if the object, which may be constructed in a very simple or highly sophisticated manner, contains a substance or mixture that can be physically separated from the object, lets go to answer some question.

  36. 物质、混合物和物品 鉴定过程(范例) (2) • 如果不能清楚的判别物体是否符合REACH对于物品的定义，则需做更深程度的评估。 • 如果物体（其组成有可能很简单，有可能很复杂），包含可从物体中分离出来的物质或混合物，那我们需要回答下面一些问题。

  37. Substances, mixtures and articles • Identification process (example) (3) • If you can answer these questions predominantly with yes (i.e. 2 of 3) rather than no, then the object should be regarded as a combination of an article (functioning as a container or a carrier material) and a substance/mixture. • Question a: If the substance/mixture were to be removed or separated from the object and used independently from it, would the substance/mixture still be capable in principle (though perhaps without convenience or sophistication) of carrying out the function defined under step 1? • Question b: Does the object act mainly (i.e. according to the function defined under step 1) as a container or carrier for release or controlled delivery of the substance/mixture or its reaction products? • Question c: Is the substance/mixture consumed (i.e. used up e.g. due to a chemical or physical modification) or eliminated (i.e. released from the object) during the use phase of the object, thereby rendering the object useless and leading to the end of its service life?

  38. 物质、混合物和物品 • 鉴定过程（范例）(3) • 如果以下问题的答案大部分为“是”(例如3个问题中有2个答案为“是”)，则这一物体应被视为物品（做为容器或运载物质）和物质/混合物的混合。 • 问题a: 如果把物质/混合物从物体中分离开来并单独使用，那该物质/混合物是否仍然可以大体上执行在步骤1里定义的功能（尽管可能不够方便或熟练）？ • 问题b: 物体的主要功能（根据步骤1定义的功能）是不是做为物质/混合物或其反应产物的容器、释放/控释载体？ • 问题c: 在物体的使用阶段，此物质/混合物的耗尽（例如由于化学或物理修饰而用尽）或消失（例如从物体中释放出去）是否会导致物体失效并导致其使用寿命终结？

  39. Substances, mixtures and articles • Printer cartridge • Answering the above indicative questions: • a) if the toner/ink was moved from the cartridge, it would still be possible to bring it to paper, although with a loss of quality and convenience; • b) the function of the cartridge is to hold the toner/ink in place inside a printer and it controls the speed and mode of release; • c) the cartridge is disposed of without the toner/ink, which is consumed during the service life of the cartridge. • The answers to the questions allow the conclusion that a printer cartridge is a combination of an article (functioning as container) and a substance/mixture. • Importers and suppliers of a “combination of an article and a substance/mixture” therefore have to separately check if obligations for the article apply and if obligations for the substance/mixture apply.

  40. 物质、混合物和物品 • 墨水匣（硒鼓） • 上述问题的答案: • a) 如果墨粉/墨水从打印机的墨水匣里移除，打印仍可进行，只不过质量很差且不方便； • b) 墨水匣的功能是在打印机内部放置墨粉/墨水并控制释放的速度和模式； • c) 若墨粉/墨水在墨水匣使用过程中被耗尽，墨水匣将被弃置。 • 对这些问题的回答帮助我们得出结论，即墨水匣是物品(做为容器)和物质/混合物的混合. • 因此，“物品和物质/混合物的混合”的进口商和供应商必须分开确认物品和物质/混合物是否符合各自对应的要求。

  41. Substances, mixtures and articles Identification process (example) (5) • If you can answer these questions with yes rather than no, then the function of the object is likely to be determined rather by the physical properties shape, surface and design, than by the chemical composition. The object is then regarded as an article with an integral substance/mixture (i.e. the substance/mixture forms an integral part of the article)) • Question a: If the substance/mixture were to be removed or separated from the object, would the object be unable to fulfil its intended purpose? • Question b: Is the main purpose of the object other than to deliver the substance/mixture or its reaction products? • Question c: Is the object normally discarded with the substance/mixture at the end of its service life, i.e. at disposal?

  42. 物质、混合物和物品 鉴定过程（范例）(5) • 如果下列问题的答案为“是”而非“否”，则该物体的功能由其物理形状、表面和设计而非其化学成分所决定。该物体被视作内含物质/混合物的物品（例：物质/混合物构成物品必不可少的内在组成部分)) • 问题a: 若物质/混合物从物体中移除或分离开，物体是否不能实现其预期使用目的？ • 问题b:物体的主要使用目的是否不是运输物质/混合物或其反映产物？ • 问题c: 正常情况下，物体在使用寿命终结时，是不是与物质/混合物一起弃置？例如在废弃处理的时候？

  43. Substances, mixtures and articles Example: Thermometer • Answering the above questions: • a) the empty thermometer would fail to show the temperature; thus the object would no longer be useful; • b) the main function of the thermometer is to show the temperature, this is not a delivery of a substance or mixture; • c) the thermometer is normally disposed of together with its chemical content. • So answering these questions leads to the conclusion that a thermometer is an article and the liquid within an integral part of it.

  44. 物质、混合物和物品 范例: 温度计 • 上述问题答案: • a) 空的温度计无法显示温度；因此物体失效; • b) 温度计的主要功能是显示温度，并非物质或混合物的运输; • c) 温度计一般和其所含化学成分一起弃置 • 因此对这些问题的回答帮助我们得出结论：温度计是物品，其内部的液体是其必要组成部分。

  45. Substances, mixtures and articles • More help: • Guidance for articles • http://www.echa.europa.eu/documents/10162/13632/articles_en.pdf

  46. 物质、混合物和物品 • 更多帮助: • 物品指南 • http://www.echa.europa.eu/documents/10162/13632/articles_en.pdf

  47. Substances, mixtures and articles The registration obligations apply therefore to the individual substances themselves, independently of whether they are on their own, in a mixture or in an article. In other words, only substances have to be registered under REACH, mixtures or articles do not. A small recommendation:You should make an inventory of substances, mixtures and / or articles that you manufacture or use in your business.

  48. 物质、混合物和物品 不管物质以单独形式、在混合物或在物品中存在，注册要求总是适用于物质本身。 换句话说，只有物质要进行REACH注册，混合物或物品则不需要。 小建议:应制作一个生产、使用的物质、混合物和/或物品的详细目录。

  49. Substance Identity • Unambiguous substance identification is a pre-requisite to most of the REACH processes. • The correct identification of a substance will enable, for example: • The sharing of information by potential registrants and data holders to prevent the duplication of testing on animals and unnecessary costs • The assessment of the applicability of test data across companies who registered the same substance, the assessment of read-across proposals (categorisation approach) or the use of non test information • The assessment if a substance is included in the Authorisation List, the list of restrictions or if its classification and labelling has been harmonised

  50. 物质鉴定 • 清晰的物质鉴定是大部分REACH流程进行的前提 • 物质的正确鉴定可使以下成为可能，如： • 潜在注册者和数据持有者的信息分享，以避免重复动物试验和非必要开支 • 注册同一物质的公司测试数据适用性评估；交叉参照提议（分类方法）或非测试数据使用的评估 • 评估物质是否列入授权清单、限制清单或其分类和标示是否已被调和。

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