物質、混合物、物品制造商.ppt

1、Seminar on EU Chemical Regulatory System,REACH 17th July 2012,歐盟化學制品監(jiān)管體系專題研討會,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, REACH stands for Registration, Evaluation,

2、 Authorisation and Restriction of Chemicals It entered into force on 1 June 2007.,REACH解讀,REACH 是歐盟European Union，以下簡稱 EU的一項法規(guī)，適用于27個EU成員國和挪威、冰島及列支敦斯登 REACH 的意思是Registration, Evaluation, Authorisation and Restriction of Chemicals，即化學制品注冊、評估、許可和限制 生效于2007年6月1日,AIMS,To provide a high level of protecti

3、on 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 i

4、nnovation 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.,目的,提供高水平的防護，使得人類健康和環(huán)境免受化學制品使用帶來的危害 使得將化學制品投放市場的 (制造商和進口

5、商 ）負責理解和處理其使用帶來的相關風險 允許在EU市場物質的自由流通 提高EU化學制品行業(yè)的創(chuàng)新和競爭力 促進物質危害性質評估替代方法的使用，例如定量構效關系（QSAR）和交叉參照,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

6、 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 h

7、azardous substances should be substituted with less dangerous ones.,REACH解讀,將保證化學制品安全的責任化歸于企業(yè)，而不再化歸于政府當局。 根據(jù)法規(guī)要求，對于在EU進行生產和銷售的物質，公司必須對此物質相關的風險進行說明和管理。 公司必須說明物質的安全使用方法并告知使用者相關的風險管理措施。 若風險不可控，有關當局可限制該物質的使用。從長遠來看，應使用危險性小的物質替代危害性大的物質。,REACH Impact,Leading regulatory drivers (Chemical Watch survey 2012),

8、REACH 的影響,主要監(jiān)管機制 (化學觀察調查2012),REACH Impact,Introduction/expansion of REACH-like regulations in many other countries The registration deadline for Turkeys chemicals notification regulation drove a lot of activity in the first part of 2011. China revised its registration scheme to create Decree 7 on t

9、he 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),REACH的影響,在很多其它國家對類似REACH法規(guī)的引進和擴展 2011上半年，土耳其化學制品通報法規(guī)的注冊截止日期促進了很多相關活動的開展。 中國對其注冊計劃進行修訂，指定了關于新化學物質的環(huán)境管理措施的

10、7號法令。 臺灣繼續(xù)進行針對現(xiàn)有化學物質通報(ECN) 的新計劃和新化學物質通報(NCN)的計劃。,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 ame

11、nded which was officially published in May 2009. Korean REACH Toxic Chemicals Control Act (TCCA),REACH的影響,2011年，賽比亞指定了一套化學制品管理控制體系。 馬來西亞現(xiàn)已有一套環(huán)境有害物質通報和注冊(EHSNR)計劃。 日本的REACH “化學物質控制法” (CSCL)于2009年5月出臺，且現(xiàn)已進行了修訂。 韓國的 REACH “毒性化學制品控制法案 (TCCA),REACH Impact,In the US, TSCA reform was held up in 2011 due to

12、 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 imp

13、lementation beginning in 2012,REACH的影響,在美國, 在2011年的TSCA 改革由于政治僵局被擱置，而由于2012年是大選年，在2012年 也不太有可能有進展。 新的化學資料提報法規(guī) (先前的詳細目錄更新法規(guī)), 規(guī)定暴露相關信息的采集內容和方式。這一法規(guī)于2012年年初獲批并開始實施。,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 d

14、ifficult path, even a straw is a heavy burden .Or An active option, and try to anticipate a new global concept of management of chemicals.,REACH的影響,如果REACH法規(guī)對我們不適用， 我們有兩種選擇， 消極選擇，即在困難重重的道路上，即使一根稻草也可成為沉重的負擔 積極選擇，即試著去預測新的全球化學制品管理的新概念。,REACH Impact,In the following slides we will introduce definitions

15、and concepts that are necessary to understand the requirements of REACH Substances, mixtures and articles. Manufacturers, Importer, Down,REACH的影響,在接下來的幻燈片里，我們將介紹理解REACH法規(guī)要求所必備的一些定義和概念。 物質、混合物、物品 制造商、進口商、下游用戶,Substances, mixtures and articles,SUBSTANCES: It means a chemical element and its compounds.

16、 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 affectin

17、g the stability of the substance,物質、混合物和物品,物質: 指的是一種化學元素及其化合物。 包括： 通過加工獲得的物質 (例如甲醛、甲醇） 自然狀態(tài)的物質 也包括 一些加工過程中的添加劑和雜質 不包括 和物質分離后不影響物質穩(wěn)定性的溶劑,Substances, mixtures and articles,MIXTURES: Mixture or solution composed of two or more substances. Examples: Paints, Varnishes Inks. REACH obligations apply indivi

18、dually to each subtances.,物質、混合物和物品,混合物: 包含兩種或以上物質的混合物或溶液 例如: 涂料 油漆 墨水 REACH 法規(guī)的要求單獨適用于每種物質,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 int

19、entionally added to the alloy should be considered as impurities,物質、混合物和物品,混合物 (2): 合金: “特殊混合物”. 合金無需進行注冊，而合金元素（如金屬元素）必須進行注冊 非故意加入合金的成分應被視為雜質,Substances, mixtures and articles,ARTICLES: Is an object which during production is given a special shape, surface or design which determines its function to

20、a greater degree than does its chemical composition Examples: textiles, electronic chips, furniture, books, toys, kitchen equipment).,物質、混合物和物品,物品: 一個在生產過程中被授予了特別的形狀、表面或設計的物體，物體的形狀、表面或設計比其化學成分更大程度上決定了其功能 例如:紡織品、電子芯片、家具、書、玩具、廚房用品等,Substances, mixtures and articles,ARTICLES (2): An individual substanc

21、e 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.,物質、混合物和物品,物品(2): 如果出現(xiàn)以下情況，物品中的單個物質需進行注冊 物質在物品中的含量超過一年一噸 在正常使用和可

22、預見的使用中，物質將被釋放,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

23、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 i

24、s directly wrapped in plastic and then packed in a cardboard box, the plastic and the cardboard box should be considered separate articles).,物質、混合物和物品,包裝 物質、混合物和物品可置于包裝內，例如用紙箱包裝、塑料包裝或錫罐包裝。包裝不屬于被包裝的物質、混合物或物品，因此應作為一項REACH適用的單獨的物品。 包裝和包裝物質、混合物或物品的制造商、進口商和供應商必須保證包裝與其它物品一樣，滿足相同的要求。 具有不同功能的包裝需單獨考慮 (例如假如某物

25、品直接用塑料包裝后再放入紙箱，則塑料和紙箱應作為兩項物品區(qū)分開來）,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

26、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

27、to paper) than its chemical composition, it is to be regarded as a mixture.,物質、混合物和物品,鑒定過程(范例) (1) 如果可以清楚的得出結論，即物體的形狀、表面和設計比起其化學成分與其功能更相關，則該物體為物品；如果形狀、表面和設計的影響等于或小于化學成分的影響，則該物體為物質或混合物。 蠟筆由石蠟和色素組成，用作上色和畫畫。由于蠟筆的形狀/表面/設計并不比其化學成分與其功能（給紙張上色）更相關，蠟筆應被視為混合物。,Substances, mixtures and articles,Identification

28、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

29、 be physically separated from the object, lets go to answer some question.,物質、混合物和物品,鑒定過程(范例) (2) 如果不能清楚的判別物體是否符合REACH對于物品的定義，則需做更深程度的評估。 如果物體（其組成有可能很簡單，有可能很復雜），包含可從物體中分離出來的物質或混合物，那我們需要回答下面一些問題。,Substances, mixtures and articles,Identification process (example) (3) If you can answer these questions

30、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 independent

31、ly 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 r

32、elease 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

33、 useless and leading to the end of its service life?,物質、混合物和物品,鑒定過程（范例）(3) 如果以下問題的答案大部分為“是” (例如3個問題中有2個答案為“是”)，則這一物體應被視為物品（做為容器或運載物質）和物質/混合物的混合。 問題 a: 如果把物質/混合物從物體中分離開來并單獨使用，那該物質/混合物是否仍然可以大體上執(zhí)行在步驟1里定義的功能（盡管可能不夠方便或熟練）？ 問題 b: 物體的主要功能（根據(jù)步驟1定義的功能）是不是做為物質/混合物或其反應產物的容器、釋放/控釋載體 ？ 問題 c: 在物體的使用階段，此物質/混合物的耗盡（

34、例如由于化學或物理修飾而用盡）或消失（例如從物體中釋放出去）是否會導致物體失效并導致其使用壽命終結？,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

35、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 prin

36、ter 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

37、.,物質、混合物和物品,墨水匣（硒鼓） 上述問題的答案: a) 如果墨粉/墨水從打印機的墨水匣里移除，打印仍可進行，只不過質量很差且不方便； b) 墨水匣的功能是在打印機內部放置墨粉/墨水并控制釋放的速度和模式； c) 若墨粉/墨水在墨水匣使用過程中被耗盡，墨水匣將被棄置。 對這些問題的回答幫助我們得出結論，即墨水匣是物品 (做為容器)和物質/混合物的混合. 因此，“物品和物質/混合物的混合”的進口商和供應商必須分開確認物品和物質/混合物是否符合各自對應的要求。,Substances, mixtures and articles,Identification process (example)

38、 (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.

39、 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

40、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?,物質、混合物和物品,鑒定過程（范例）(5) 如果下列問題的答案為“是”而非“否”，則該物體的功能由其物理形狀、表面和設計而非其化學成分所決定。該物體被視作 內含物質/混合物的物品（例：物質/混合物構成物品必不可少的內在組成部分) 問題 a: 若物質/混合物從物體中移除或分離開，物體是否不能實現(xiàn)其預期使用目的？

41、 問題 b:物體的主要使用目的是否不是運輸物質/混合物或其反映產物？ 問題 c: 正常情況下，物體在使用壽命終結時，是不是與 物質/混合物一起棄置？例如在廢棄處理的時候？,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

42、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

43、 it.,物質、混合物和物品,范例: 溫度計 上述問題答案: a) 空的溫度計無法顯示溫度；因此物體失效; b) 溫度計的主要功能是顯示溫度，并非物質或混合物的運輸; c) 溫度計一般和其所含化學成分一起棄置 因此對這些問題的回答幫助我們得出結論：溫度計是物品，其內部的液體是其必要組成部分。,Substances, mixtures and articles,More help: Guidance for articles http:/www.echa.europa.eu/documents/10162/13632/articles_en.pdf,物質、混合物和物品,更多幫助: 物品指南 ht

44、tp:/www.echa.europa.eu/documents/10162/13632/articles_en.pdf,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

45、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.,物質、混合物和物品,不管物質以單獨形式、在混合物或在物品中存在，注冊要求總是適用于物質本身。 換句話說，只有物質要進行REACH注冊，混合物或物品則不需要。 小建議:應制作一個生產、使用的物質、混合物和/或物

46、品的詳細目錄。,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

47、 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 li

48、st of restrictions or if its classification and labelling has been harmonised,物質鑒定,清晰的物質鑒定是大部分REACH流程進行的前提 物質的正確鑒定可使以下成為可能，如： 潛在注冊者和數(shù)據(jù)持有者的信息分享，以避免重復動物試驗和非必要開支 注冊同一物質的公司測試數(shù)據(jù)適用性評估；交叉參照提議（分類方法）或非測試數(shù)據(jù)使用的評估 評估物質是否列入授權清單、限制清單或其分類和標示是否已被調和。,Substance Identity,Phase-in substances: Substances listed in the E

49、uropean INventory of Existing Commercial chemical Substances (EINECS); Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1 June 1992; Substances that qualify as a so-called no-longer polymer).,物質鑒定,分階段物質

50、: 列入歐洲現(xiàn)有商業(yè)化學物質名錄( EINECS)的物質； 在EU (包括2007年1月1日的新入成員國)生產，但在1992年6月1日以后未投放市場的物質; 滿足稱作“不再作為聚合體的物質”的物質。,Substance Identity,Non-Phase-in substances: All substances that do not fulfil any of the criteria for phase-in substances are considered as non-phase-in substances. Normally, non-phase-in substances h

51、ave not been manufactured, placed on the market or used in the EU before 1 June 2008, unless they were notified under Directive 67/548/EEC. Potential manufacturers and importers of non-phase-in substances have to submit an inquiry to ECHA and subsequently register the substance in accordance with RE

52、ACH before they can manufacture or import the substance.,物質鑒定,非分階段 物質: 所有不滿足階段物質任何標準的其它物質被視為非分階段物質。 一般，非分階段物質在2008年6月1日以前均未在歐盟進行生產，市場投放或使用，除非其按照 指令67/548/EEC進行了通報. 非分階段物質的潛在制造商和進口商在進行生產和進口前，必須向歐洲化學品管理局（ECHA）提交一份調查單，并隨后根據(jù)REACH法規(guī)對物質進行注冊。,ESIS: European Chemical Substances Information System,http:/esis

53、.jrc.ec.europa.eu/,ESIS: 歐洲化學物質信息系統(tǒng),http:/esis.jrc.ec.europa.eu/,Substance Identity,Substances of well defined chemical composition Monoconstituent substance As a general rule, a substance, defined by its composition, in which one main constituent is present to at least 80% (w/w). Multi-constituent

54、substance As a general rule, a substance, defined by its composition, in which more than one main constituent is present in a concentration 10% (w/w) and 1%, or classified as dangerous, to be specified,化學成份明確的物質 單組分物質 一般來說，物質組成中的一主要成分超過 80% （w/w）重量重量比。重量. 多組分物質 一般來說，物質組成中，多于一種成分的含量達到10% (w/w) 以上而 1%

55、, 或被定義為危險物質（另作說明）。,物質鑒定,Substance Identity,UVCB SUBSTANCES Substances of Unknown or Variable composition, Complex reaction products or Biological materials The number of constituents is relatively large and/or The composition is, to a significant part, unknown and/or The variability of composition i

56、s relatively large or poorly predictable. UVCB substances require other types of information for their identification, in addition to what is known about their chemical composition,UVCB 物質 即未知或易變合成物、負責反應產物或生物材料 成分種類更多且/或 組成中有很大一部分未知，且/或 組成的可變性強且難以預測 UVCB 物質在鑒定過程中除其化學組成相關信息外還需要其它類型的信息。,物質鑒定,Substance

57、 Identity,More Help Guidance for identification and naming of substances under REACH http:/echa.europa.eu/documents/10162/13643/substance_id_en.pdf Guidance for monomers and polymers http:/www.echa.europa.eu/documents/10162/13632/polymers_en.pdf,更多幫助 Guidance for identification and naming of substan

58、ces under REACH http:/echa.europa.eu/documents/10162/13643/物質_id_en.pdf 單體或聚合物指南 http:/www.echa.europa.eu/documents/10162/13632/polymers_en.pdf,物質鑒定,More help,http:/echa.europa.eu/web/guest/information-on-chemicals/registered-substances,http:/echa.europa.eu/web/guest/information-on-chemicals/registe

59、red-substances,更多幫助,More help,更多幫助,More help,Substances identified by industry to be registered by 31 May 2013. http:/echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2013 Substances identified but not registered (Data as of 15th September 2011) http:/echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2010,2013年5月前由行業(yè)鑒定需進行注冊的物質 http:/echa.europa.eu/information-on-chemicals/registered-substances/identified-substances-for-registration-in-2013 經鑒定但未注冊的物質 (2011年9月15日數(shù)據(jù))