Agnes Botos GHS & REACH & ADR consultant in Hungary

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1 Seminar on EU regulatory system EU GHS - CLP Regulation How does it work?
Agnes Botos GHS & REACH & ADR consultant in Hungary MSc of Chemical engineering & Environmental law 18 July 2012, Jingzhou, China

2 欧盟法规系统专题研讨会 EU GHS - CLP 法规 如何运作?
波托斯·阿哥尼斯 匈牙利GHS & REACH & ADR 咨询师 化学工程和环境法硕士 中国 荆州 2012年7月18日

3 UN GHS history 1992 - UN Conference on the Environment and Development
„A globally harmonized hazard classification and compatible labelling system, including material safety data sheets and easily understandable symbols, should be available for chemicals, if feasible, by the year 2000.” United Nations prepared „Globally Harmonized System of Classification and Labelling of Chemicals” called UN GHS

4 联合国（UN）GHS 历史 1992 – 联合国环境发展大会
“如果可行，应该在2000年建立起一个针对化学制品的全球性的调和风险分类和兼容的标签系统。这一系统应包括材料安全数据表和容易理解的符号。” . 2003 –联合国制定了“全球性的调和风险分类和兼容的标签系统”，即UN GHS(Globally Harmonized System ),全球调和制度。

5 UN GHS implementation globally
Since 2003 UN GHS provides: • Harmonized criteria for classification of substances and mixtures – according to their physical, health and environmental hazards • Harmonized hazard communication elements – including requirements for labels and safety data sheets Implementation of UN GHS worldwide has started Differences country by country: 1. UN GHS is revised every 2nd year: 2005 GHS, Rev 1, 2007 GHS, Rev 2 2009 GHS, Rev 3, 2011 GHS, Rev 4 2. „Building blocks approach”

6 UN GHS 在全球的实施 自 2003年以来， UN GHS 提供了: • 物质和混合物的分类调和标准
– 根据其带来的物理、健康和环境危险 • 调和危险通识要素 – 包含对标签和安全数据表的要求 UN GHS 已经开始在全球进行实施 根据不同国家有所差异: 1. UN GHS 每两年修订一次: 2005 GHS, Rev 1, 2007 GHS, Rev 2 2009 GHS, Rev 3, 2011 GHS, Rev 4 2. “’建楼式’”的渐进方法”

7 China GHS China: Publication of the following standards implementing the GHS : GB (packaging): implements the 15th revised edition of the UN recommendations on the Transport of Dangerous Goods GB T 16483–2008: Safety Data Sheet for chemical products content and order of sections (applicable as from 1 February 2009) GB 13690–2009: General rules for preparation of precautionary labels for chemicals (applicable as from 1 May 2010) GB 15258–2009 General rule for classification and hazard communication of chemicals  (applicable as from 1 May 2010).

8 GHS在中国的现状 中国: 以下标准的发布是对GHS的实施: GB 190-2009 (包装):实施了关于危险货物运输的联合国建议第15版
GB T 16483–2008: 化学产品内容安全数据表 (从2009年2月1日起实施) GB 13690–2009: 关于配制化学制品警示标签的一般规则（从2010年5月1日起实施） GB 15258–2009 化学制品的分类和危险通识的一般规则（自2010年5月1日起实施）

9 USA GHS USA: USA implemented the criteriums of UN GHS Rev 3 into a U.S. legislation called Revised HCS (Hazard Communication Standard) HCS: OSHA 29 CFR Parts 1910, 1915, 1917, 1918 and 1926 Effective: 25 May 2012 Mandatory: 1 June 2015 for substances and mixtures called chemicals Full text available: EU GHS (CLP)(UN GHS Rev 3) U.S. GHS (UN GHS Rev 3) UK English GHS label may different from U.S. English GHS label (Precautionary statements, classification differencies specially at mixtures, no U.S. harmonized list)

10 GHS在美国的现状 USA: 美国将UN GHS Rev 3的标准植入本国立法，并称其为
修订版HCS (Hazard Communication Standard危险通识标准) HCS: OSHA 29 CFR 部分 1910, 1915, 1917, 1918 和 1926 有效期始于: 2012年5月25日 强制实施将始于: 从2015年6月1日起对所有称作化学制品的物质和混合物生效 全文见: EU GHS (CLP) U.S. GHS 英国英语 GHS 标签可能有别于美国英语 GHS 标签 (特别是关于混合物的警示声明，分类的差别，不存在美国调和列表）

11 EU GHS = CLP Regulation EU implemented the criteriums of UN GHS Rev 2 into a EU regulation called CLP CLP: Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures Entry into force: 20 Jan 2009 Mandatory: 1 Dec 2010 for substances and 1 June 2015 for mixtures EU implemented the criteriums of UN GHS Rev 3 into a EU regulation called CLP Rev 1 CLP Rev 1: Regulation (EU) No 286/2011 on the Classification, Labelling and Packaging of substances and mixtures Entry into force: 19 Apr 2011 Mandatory: 1 Dec 2012 for substances and Full text available:

12 EU GHS = CLP 条规 EU 将UN GHS Rev 2 的标准植入EU法规并称其为 CLP（ 分类, 标示 和 包装）
CLP: 法规 (EC) No 1272/2008 关于物质和混合物的分类、标示和包装法规 实施始于: 年1月20日 强制实施始于: 对于物质：2010年12月1日1 对于混合物：2015年6月1日 EU 将UN GHS Rev 3 的标准植入EU法规并称其为 CLP Rev 1 CLP Rev 1: 法规 (EU) No 286/2011 关于物质和混合物的分类、标示和包装法规 实施始于: 2011年4月19日 强制实施始于: 对于物质：2012年12月1日 全文见:

13 Basic legal information
Regulation (CLP) the strongest legislation of EU member states need to apply it word by word Translated at issue to 23 EU languages Directive (DSD, DPD) member states implement the content of it into their legislation member states legislation can be stricter from directive Substance chemical elements and its compounds CAS# ( global) EU # = EC# = EINECS# / ELINCS# (EU) Mixture = preparation Compositon of 2 or more substances Chemical substance or mixture (USA use this term, EU not)

14 基本法律信息 法规 (CLP) 欧盟最强有力的法案 成员国必须按照其规定逐字逐句的实施 翻译成23种欧盟内部使用的语言并发布
指令 (DSD, DPD) 成员国将其内容植入其国内立法 成员国的立法可比指令更加严厉 物质 化学元素及其化合物 CAS# ( 全球性) EU # = EC（欧共体）# = EINECS（欧洲现有商用化学物质名录）# / ELINCS（欧洲已通报化学物质名录）# (EU) 混合物 = 配制 由两种或以上物质组成 化学制品 物质或混合物 (美国使用这一术语, 欧盟不使用)

15 Transition of old & new legislations in EU
Transitional period for the implementation of the new GHS system: Old EU directive for substances: DSD: Dangerous Substance Directive 67/548/EEC Old EU directive for mixtures: DPD: Dangerous Preparation Directive 1999/45/EC New EU regulation for substances and mixtures: CLP & CLP ver 1 (EU GHS)

16 欧盟新旧立法的过渡 新GHS系统实施的过渡期： 旧EU指令（物质）: DSD: 危险物质指令67/548/EEC 旧 EU 指令（混合物）:
DPD: 危险配制指令1999/45/EC 新 EU 法案（物质和混合物） : CLP & CLP 版本 1 (EU GHS)

17 Old & new legislations in EU
Old EU directive for substances: DSD: Dangerous Substance Directive 67/548/EEC Old EU directive for mixtures: DPD: Dangerous Preparation Directive 1999/45/EC R & S phrases Orange pictograms New EU regulation for substances (2010) and mixtures (2015): CLP & CLP ver 1 ( EU GHS) H & P statements Red frame rombus pictograms

18 EU新 &旧法案 旧EU指令（物质）: DSD:危险物质指令67/548/EEC 旧 EU 指令（混合物）:
DPD:危险配制指令1999/45/EC R & S标准词 橙色 图标 新 EU 法案物质 (2010) 和混合物 (2015): CLP & CLP 版本 1 ( EU GHS) H & P 声明 红框菱形图标

19 CLP exemptions CLP exemptions (Article 1): Radioactive chemicals
Chemicals subject to customs supervision Chemicals in transit Non-isolated intermediates Research & development chemicals Waste Medicinal products, Veterinary medicinal products Cosmetic products Medical devices Food or feeding stuffs Not exempted: Active pharmaceutical ingredients, plant production products, biocide products

20 CLP 豁免特例 CLP豁免特例(第一条): 放射性化学制品 海关监管的化学制品 在运输途中的化学制品 不可被隔离的中间体
进行研发的化学制品 废弃物 药用品, 兽医医药用品 化妆品 医疗设备 食品和饲料 不被豁免: 原料药、 植物栽培产品、杀虫产品

21 Suppliers Manufacturer
Manufacture a substance (not manufature a mixture) Importer Bring into EU from a non-EU country a substance or mixture or an article Import is „placing on the market” Downstream user uses the substance, either on its own or in a mixture, in the course of his industrial or professional activites. There is exposition to the chemical A distributor or a consumer is not a downstream user Distributor Stores and places on the market a substance, on its own or in a mixture, for third parites (retailer) No exposition with the chemical maximum changing of label or outside packaging Only representative Non-EU manufacturer of a substance, mixture or article can appoint an EU company to represent him in case of REACH regulation

22 供应商 生产厂家 生产物质（而不是混合物） 进口商 从欧盟以外的国家引入欧盟某种物质或混合物或物品 进口即“投放市场” 下游用户
在其从事的专业性或工业性活动中，使用这一物质本身，或配制品中的物质。对化学制品有相关说明。 经销商或消费者不属于下游用户。 经销商 为第三方（零售商）储存或将物质本身，或配制品中的物质投放市场 对于化学制品的标签的最大改变和外包装均无说明 唯一代表 非欧盟内部的某物质、混合物或物品的制造商可以指定一家欧盟公司来担任其在化学制品立法方面的代表。

23 Aim of CLP regulation Aim of CLP regulation (Classification, Labeling, Packaging) C- Classification Decision if the substance or mixture is hazardous or non-hazardous based on CLP ( EU GHS) harmonized hazard criteriums Hazard classification done on the basis of intrinsic properties of chemicals Required for both hazardous and non-hazardous chemicals L -Labelling Harmonized labeling of hazardous substances and mixtures Required just for hazardous chemicals P- Packaging Harmonized packaging of hazardous substances and mixtures

24 CLP 法规的目的 CLP (分类、标志、包装) 法规的目的 C- 分类 物质和混合物的分类
根据CLP（EU GHS）调和危险标准决定物质或混合物是否危险 根据化学制品的内在属性进行危险分类 对危险和不危险的化学制品均作要求 L -Labelling 标示 危险物质和混合物的调和标示 仅对危险化学制品作要求 P- Packaging 包装 危险物质和混合物的调和包装

25 CLASSIFICATION: WHO? WHAT?
Who need to classify? EU manufacturer EU importer EU downstream users (downstream users should take over the classification from the importer or manufacturer through Safety Data Sheets (SDS)) What shall we classify and at which quantity in EU? Substances and mixtures placed on the market in EU (0 t/y) Substances not placed on the market, but are subject to REACH registration or REACH notification (over 1 t/y) (on-site isolated intermedier ) Explosive articles placed on the market inEU(0 t/y ) MESSAGE: NON-EU COMPANIES NEED TO GIVE DATA TO EU CUSTOMERS

26 分类: 谁来分类? 对什么进行分类? 谁需要来进行分类? EU 制造商 EU 进口商
EU 下游用户 (下游用户应通过安全数据表（SDS）从进口商或者制造商手中接手进行分类） 在欧盟，怎样进行分类？对其数量是怎么样规定的？ 投放在欧盟市场上的物质和混合物 (0 t/y) 未投放于市场，但受限于REACH 法规或REACH 通告 (超过 1 t/y) (现场的不可被隔离的中间体) 投放欧盟市场的爆炸性物品 (0 t/y ) 补充信息: 非欧盟公司需向欧盟客户提供数据

27 CLP ( EU GHS) HAZARDS What is the deadline of the new CLP ( EU GHS) classification? For substances: 1 Dec 2010 For mixtures: 1 June 2015 How can I see if the new CLP (EU GHS) classification is completed? The label will contain H statements (GHS pictogram, Signal word) Safety Data Sheet point 2 & 3 will contain the new H statements (the old R phrases as well until 2015)

28 CLP ( EU GHS) 危害 新CLP ( EU GHS) 分类的截止日期是？ 物质: 2010年12月1日
物质: 2010年12月1日 混合物: 2015年6月1日 怎样判别新CLP ( EU GHS) 分类是否完成？ 标签将包含H声明 (GHS 图标, 信号词) 安全数据表的2 & 3 点将包含新的危险说明 (在2015年之前也将同时包含旧的警示性标准词）

29 Classification rule Classification = decision if the chemical is hazardous or non- hazardous CLP contains 28 hazard class (1-4 hazard category / class) Criteriums of each class should be checked If our substance or mixture is in compliance with the criterium, it will get a hazard statement (H statement with H #) Each Hazard statement ( H#) automatically get: Precautionary statement (P statement with P#) Signal word ( Hazard or Danger) or not GHS pictogram The H statement indicates if the chemical is hazarodus, since there are some categories where no pictogram.

30 分类规则 分类 = 决定此化学制品是否有危害 CLP 包含 28 个危险等级(1-4 危险类别/ 级别) 应该对每个级别的标准都进行核对
如果物质或混合物符合标准，即可获得危险说明（带有H #的H说明） 每份危险说明 ( H#) 自动获得: 防范说明(含 P#的P说明) 信号词( 危害 或 危险) 或者不存在危害或危险 GHS 图标 H说明意味着此化学制品是否具有危害性，有些类别不使用图标。.

31 Label elements for flammable liquids
Classification Category 1 Category 2 Category 3 GHS Pictograms Signal Word Danger Warning Hazard Statement H224: Extremely flammable liquid and vapour H225: Highly flammable liquid and vapour H226: Flammable liquid and vapour Precautionary Statement Prevention P210 P233 P240 P241 P242 P243 P280 Precautionary Statement Response P303 + P361 + P353 P370 + P378 Precautionary Statement Storage P403 + P235

32 可燃性液体的标签要素 分类 1类 2类 3类 GHS 图标 信号词 危险 警示 危险说明 H224: 极度易燃性液体和气体
防范说明 预防 P210 P233 P240 P241 P242 P243 P280 反应 P303 + P361 + P353 P370 + P378 防范说明 存放 P403 + P235

33 Physical hazards Explosives (Unstable explosives, Divisions 1.1, 1.2, 1.3, 1.4, 1.5, and 1,6) Flammable gases (Category 1 and 2) Flammable aerosols (Category 1 and 2) Oxidising gases (Category 1) Gases under pressure (Compressed gas, liquefied gas, refrigerated liquefied gas, dissolved gas) 6. Flammable Liquids (Category 1, 2 and 3) Flammable solids (Category 1 and 2) Self-reactive substances and mixtures (Type A, B, C, D, E, F, & G) (Types A and B) 9. Pyrophoric liquids (Category 1) 10. Pyrophoric solids (Category 1) 11. Self-heating substances and mixtures (Category 1 and 2) 12. Substances and mixtures which in contact with water emit flammable gases (Category 1,2 and 3) 13. Oxidising liquids (Category 1, 2 and 3) (Cat 1 and 2) 14. Oxidising solids (Category 1, 2 and 3) (Cat 1 and 2) 15. Organic peroxides, (Type A, B, C, D, E, F & G) (Types A to F) 16. Corrosive to metals (Category 1)

34 物理性危害 炸药 （不稳定炸药、 第1.1、 1.2、 1.3、 1.4、 1.5 和 1.6条） 可燃气体 （第 1 和第 2 类）
易燃气溶胶 (第 1 和第 2 类) 氧化气体(第1类) 受压气体 (压缩气体、 液化气、 冷冻液化气、 溶解气体) 6. 易燃液体 (第 1、2 和 3 类) 易燃固体(第 1 和第 2 类) 自反应物质和混合物( A, B, C, D, E, F, & G型) (A 和 B型) 9. 发火性液体(第 1 类) 10.发火性固体 (第1类) 11.自动加热物质和混合物 (第 1 和第 2 类) 12.遇水放出易燃气体的物质和混合物 (第 1、2 和 3 类) 13. 氧化液体(第 1、2 和 3 类) (第 1 和第 2 类) 14. 氧化固体(第 1、2 和 3 类) (第 1 和第 2 类) 15.有机过氧化物, A, B, C, D, E, F & G型) (A型至F型) 16.金属腐蚀物(第1类)

35 HEALTH & ENVIRONMENTAL HAZARDS
HEALTH HAZARDS 17. Acute toxicity, (Category 1, 2, 3 and 4) 18. Skin corrosion/irritation, (Category 1A, 1B, 1C and 2) 19. Serious eye damage/eye irritation, (Category 1 and 2) 20. Respiratory or skin sensitisation (Category 1) 21. Germ cell mutagenicity, (Category 1A, 1B and 2) 22. Carcinogenicity, (Category 1A, 1B and 2) 23. Reproductive toxicity (Category 1A, 1B and 2) plus additional category for effects on or via lactation 24. Specific target organ toxicity (STOT) – single exposure ((Category 1, 2) and Category 3 for narcotic effects and respiratory tract irritation, only) 25. Specific target organ toxicity (STOT) – repeated exposure (Category 1 and 2) 26. Aspiration hazard (Category 1) ENVIRONMENTAL HAZARDS 27. Hazardous to the aquatic environment (Acute Category 1, Chronic Category 1, 2, 3, & 4) 28. Hazardous to the ozone layer

36 健康 & 环境危害 健康危害 17. 急性毒性, (第 1 、2、3&4 类)
18. 皮肤腐蚀/刺激, (第 1A, 1B, 1C 和 2类) 19. 严重眼部危害/眼部刺激, (第 1 和第 2 类) 20. 呼吸或皮肤敏化作用(第 1 类) 21生殖细胞突变性, (第 1A, 1B 和 2类) 22. 致癌性, (第 1A, 1B 和 2类) 23. 生殖毒性(第 1A, 1B 和 2类) 加上对哺乳产生影响或通过哺乳产生影响的额外类别 24. 特异性靶器官毒性(STOT) – 单次接触((第 1 和第 2 类) 和第3类 仅适用于麻醉效果和呼吸道刺激) 25. 特异性靶器官毒性(STOT) – 反复接触 (第 1 和第 2 类) 26. 吸入性危害物质(第1类) 环境危害 27. 对水生环境有害(急性类别1, 慢性类别1, 2, 3, & 4) 28. 对臭氧层有害

37 CLASSIFICATION: DATA NEEDS
PHYSICAL HAZARDS The classification of physical hazards based on hazardous goods transportation classification (UN#) It is obligatory to do tests in EU, except if you have reliable data Test method: UN Manual of Tests and Criteria (Transport classification) Solid, liquid and gas states count at the classification HEALTH & ENVIRONMENTAL HAZARDS It is not obligatory to do tests for classification according to CLP guidance, however REACH registration requires tests over 1t/y Read –across is recommended Expert knowledge is required at some classes

38 分类: 数据需求 物理性危害 物理性危害的分类基于危害物质运输分类 (UN#) 除非具有可靠的数据，不然必须在欧盟进行试验
试验方法: 联合国试验和标准手册 (运输分类) 根据分类确定固体、液体和气体状态 健康 & 环境危害 不要求按照CLP指导进行分类试验，但是REACH注册要求超过1t/y 的要进行试验 建议交叉参照 有一些类别要求专家知识

39 Harmonised classification CLP Annex VI
CLP Annex VI. Table 3.1 contains about 4136 harmonised CLP substances Manufacturers and importers should apply this classification, but may classify in a more severe hazard category if they have reliable data of it. EU member state authority or the industry can recommend substances to the harmonized list If a subsance is not on the harmonised list, than self-classification needed according to CLP Annex I

40 调和分类CLP 附录 VI CLP 附录 VI. 表 3.1 包含 大约 4136种 调和 CLP 物质 制造商和进口商 应 使用这一分类, 但是如果有可靠数据的话，可以使用更加严格的危害分类 EU成员国当局或行业可向调和列表推荐并添加新的物质 如果某物质 不在调和列表之上, 则根据CLP 附录 I ，需进行自主分类

41 Self – classification CLP Annex I
Criteria for flammable liquids class 1 category: Flash point < 23 oC and initial boiling point ≤ 35 oC 2 category: Flash point < 23 oC and initial boiling point > 35 oC 3 category: Flash point ≥ 23 oC and ≤ 60 oC (1) Note For the purpose of this Regulation gas oils, diesel and light heating oils having a flash point between ≥ 55 oC and ≤ 75 oC may be regarded as Category 3. Aerosols shall not be classified as flammable liquids. KEY ELEMENT AT THIS CLASS: flash point and boiling point Evaluate information against the classification criteria

42 自主分类 CLP 附录 I 可燃性 液体等级标准 1 类别: 闪点< 23 oC 和 初沸点≤ 35 oC
这一等级的关键要素: 闪点和沸点 分类 标准 的评估信息

43 CLP guidance decision logic:

44 CLP 指南 决策逻辑:

45 Label elements for flammable liquids
Classification Category 1 Category 2 Category 3 GHS Pictograms Signal Word Danger Warning Hazard Statement H224: Extremely flammable liquid and vapour H225: Highly flammable liquid and vapour H226: Flammable liquid and vapour Precautionary Statement Prevention P210 P233 P240 P241 P242 P243 P280 Precautionary Statement Response P303 + P361 + P353 P370 + P378 Precautionary Statement Storage P403 + P235

46 可燃性液体的标识要素 分类 类别 1 类别 2 类别 3 GHS 图标 信号词 危险 警示 危险说明
防范说明 预防 P210 P233 P240 P241 P242 P243 P280 防范说明 反应 P303 + P361 + P353 P370 + P378 防范说明 存放 P403 + P235

47 Translation from old classifaciton
CLP Annex VII. Translation table from old legislation (DSD) based on R phrases Classification based on hazardous goods transportation UN numbers (physical hazards) Translation is not 100% in compliance with CLP requirements, since each classes should be evaluted.

48 从旧分类而来的转换 CLP 附录 VII.根据 警示性质标准词，从旧立法 (DSD) 而来的转换表
分类 根据联合国危险货物编号 (物理性危害) 转换并不是100% 的符合CLP的要求,因为每个等级都 应 进行评估。

49 Substance classification in EU
Agree with a notification. Not 100% compliance Harmonized classification or SIEF classified it? Yes Accept classification No No No No Self-classification Annex I. R # available? (DSD) UN# available? Self-classification Annex I. Yes Yes Self-classification Annex I., but using translation from old classification Self-classification Annex I., but using haz good transportation classification fo physical hazard

50 欧盟内部的物质分类 符合通报. 并非100%符合 是 接受分类 否 否 否 否 自主分类附录 I. 是否有R #? (DSD)
调和分类 或 自主分类? 是 接受分类 否 否 否 否 自主分类附录 I. 是否有R #? (DSD) 是否有UN#? 自主分类 附录 I. 是 是 自主分类 附录 I., 但是使用从旧分类的转换 自主分类 附录 I., 但是使用针对物理性危害的危险物品 运输分类

51 MIXTURE CLASSIFICATION
Mixture= composed of 2 or more substances (individual ingredients) The classification of mixtures under CLP is for the same hazards as for substances. There are three kind of mixture classification: 1. The mixture itself has data Obligatory for physical hazards and Optional for health and environmental hazards 2. Similar tested mixture has data (bridging principle) 3. The individual ingredients have data Shall not be used for physical hazards and Shall be used for health and environmental hazards

52 混合物 分类 混合物= 由 2 种或2种以上物质组成 (个别成分) 根据CLP进行的混合物分类对物质或危害物质一视同仁 有三种混合物 分类:
1. 混合物 本身 具备数据 对物理性危害具有强制性 对健康和环境危害具可选性 2. 类似的经试验的混合物 具备数据 (衔接原则) 3. 个别成分具备数据 不用于物理性危害 用于健康和环境危害

53 Mixture classification flowchart

54 混合物 分类 流程图

55 Mixture or similar mixture has data
1. The mixture itself has data Apply the substance criteria of CLP Annex I (Special requirement at „CMR” hazards and „hazardous to the aquatic environment”) 2. Similar tested mixtures and ingredient substances has data Bridging principles: Dilution Batching Concentration on highly hazardous mixtures Interpolation with one toxicity category Substantionally similar mixtures

56 混合物 或 类似 混合物 具备数据 1. 混合物本身 具备数据 使用CLP 附录 I的物质标准
(对 “CMR” 危害物（致癌物、突变剂和生殖毒性物质） 和 “对水生环境产生危害的物质”还有特殊要求 ) 2. 类似经试验混合物和成分物质 具备数据 衔接原则: 稀释 定量 集中关注高度危害性混合物 对一毒性类别进行插补 实质相似的混合物

57 Individual ingredient has data
3. The individual ingredient has data A, Classification based on calculation (Example :Acute toxicity oral) where ATEi=LD50 oral of ingredients where ATEmix=LD50 oral of mixture Ci=ingredient concentration We calculate ATE mix We check ATEmix result in the substance Table

58 单个成分具备数据 3. 单个成分 具备数据 A, 根据计算进行分类 (例如 :急性毒性口摄取量) 在公式中ATEi=LD50成分口摄 取量
在公式中 ATEmix=LD50混合物口摄取量 Ci= 成分浓度 计算ATE mix 根据物质表 3.1.1确 ATEmix 结果.

59 Individual ingredient has data cont
B, Classification based on concentration tresholds Check in the specific section for each hazard class in CLP Annex I Generic concentration treshold 1. Generic cut-off value (relevant ingredient) 2. Generic concentration limits (GCL) Specific concentration treshold 3. Specific Concentration limit(SCL) ( Harmonised list) 4. M-factors (Acute and Chronic Aquatic hazard Cat 1) C, Additivity of hazards Relevant substances summed up

60 单个成分 具备数据内容 B,根据浓度门限进行分类 在CLP 附录 I 中通用浓度门限的特定部分查找各个危害等级 1.通用截止值(相关成分)
2. 通用浓度限制 (GCL) 特定浓度门限 3. 特定浓度限制(SCL) ( 调和列表) 4. M-因素 (急性和 慢性水生危害物，第1类) C, 危害相加性 相关物质汇总

61 CLP notification CLP notification: The CLP classification should be submitted through REACH-IT to the C&L Inventory of ECHA if the substance is placed on the market. Who need to notify and what? Manufacturer and importer if they: Manufacture or import a substance and it is subject to REACH registration (Hazardous + non-hazardous substance > 1 t/y ); -or Manufacture or import hazardous substance irrespective of the quantity (hazardous substance > 0 t/y); or Import a hazardous mixture which contains a hazardous substance above the relevant concentration limit, which results in the classification of the mixture as hazardous) (The hazardous ingredient > 0 t/y should be registered not the hazardous mixture) ; or Import an article containing substances which are subject to REACH registration (The hazardous + non-hazardous intended to released substance > 1 t/y should be registered not the article)

62 CLP 通报 CLP 通报: 若物质被投放市场，CLP分类应该通过REACH-IT 系统提交到 ECHA即欧洲化学品管理局的C&L 详细目录。 谁进行通报？通报内容是什么？ 如果制造商 和 进口商符合以下要求，则由其进行通报 : 根据REACH法规需进行注册的物质的制造商和进口商 (危害性 + 无危害性 物质 > 1 t/y ); -或 凡生产和进口危害物质不论数量 (危害 物质 > 0 t/y); 或 生产和进口混合物且混合物内包含危害物质的含量超过相关浓度限额而致使这一混合物被分类为危害物质 (应对> 0 t/y的危害成分进行注册，而不是注册危害性混合物) ; 或 进口某物品，且此物品包含根据REACH法规需进行注册的物质 (应对> 1 t/y释放物质的危害性 + 无危害性 进行注册，而不是对此物品进行注册)

63 OR or importer should notify?
Only Representative (OR) submits the CLP notification as part of the REACH dossier. >1 t/y If no REACH dossier submission, EU importer(s) would normally have to submit the notification. If non-EU operators, for confidentiality reasons, do not want to disclose the composition of their substances or mixtures to their EU importers, they may appoint one of the importers to notify on behalf of the other importers (notification as a group).  Alternatively, OR who is not itself a manufacturer or importer may submit a group notification on behalf of the EU importers, but cannot take over the obligations of the importers that are part of the group. OR need a written documentation that the importers fully responsible to fulfil all their obligations associated with the notification.

64 唯一代表 或 进口商 是否应进行通报? 唯一代表(OR) 将CLP 通报做为REACH 档案的一部分进行提交。 >1 t/y
如果因保密原因，非欧盟的经营者不愿向欧盟进口商透露其物质或混合物的构成，则其可指定一家进口商代表其他的进口商进行通报（做为整体进行通报）。 或者，本身非制造商 或 进口商的唯一代表，则可代表欧盟的进口商提交团体通报 但不能代替团体内部的进口商履行义务。 唯一代表需要一份关于进口商全权负责履行其与通报相关的所有义务的书面文件。

65 CLP notification deadline
CLP notification first deadline was: 3 Jan 2011 CLP notification continous deadline: within 1 month of placing a substance on the market. For importers, 1 month delay is counted from the day when a substance or mixture, is physically introduced in the customs territory of the EU. CLP notification price: free of charge

66 CLP 通报 截止日期 CLP 通报 最开始的截止日期是: 2011年1月3日 CLP 通报 连续性截止日期: 在将物质投放市场后的一个月内
对进口商，一个月的计时是从把物质或混合物实体投放到欧盟关税领域的那天开始算起。 CLP 通报价格: 免费

67 CLP notification through REACH-IT
CLP notification through REACH-IT (Mo-Fri) Link: Type: alone or in group Current user: login New user: Sign up as a company

68 通过REACH-IT 系统进行CLP 通报 通过REACH-IT 系统进行CLP 通报 (周一至周五)
链接: 类型: 单个 或 团体 现有用户: 登录 新用户:以公司名义注册

69 Title Methods: On-line REACH-IT
IUCLID 5 CLP notification dossier preparation and submit it through REACH-IT Excel file prepares an xml file and submit it through REACH-IT GHS-expert software prepares an xml file and submit it to REACH –IT

70 标题 方法: 在线 REACH-IT IUCLID 5（国际统一化学品资料数据库5）CLP 通报档案制备，然后通过REACH-IT进行提交
使用Excel 文档制作一份 xml 文档，然后通过REACH-IT进行提交 使用GHS-专家 软件制作一份xml文档，然后通过REACH-IT进行提交

71 Online REACH-IT notification
Link: Classification and Labelling / Notify C&L online/ Create a new dossier Fill the fields indicated with * You can choose harmonised classification Group notification is possible You can agree with other’s classification

72 在线 REACH-IT 通报 链接: 分类 和标示 / 在线通报 C&L / 创建新档案 填写带*的部分 可以选择调和分类 团体通报是可能的 赞同其他人的分类

73 C & L notification with IUCLID 5
Choose CLP notification Fill the following parts: 1.1 Identification 1.2 Composition 2.1 GHS 3.3 Sites Prepare CLP notification dossier Run TCC tool Export it to your computer Attach dossier to REACH-IT (Notify C&L using IUCLID)

74 使用IUCLID 5进行 C & L 通报 选择 CLP 通报 填写下表: 1.1 标识 1.2 成分 2.1 GHS 3.3 位置
运行技术完整性核查（TCC）工具 将其输出至你的电脑 把档案附在REACH-IT (使用IUCLID 通报C&L)

75 C & L notification with GHS-expert software
After preparing the classification the GHS-expert software makes an xml file with 1 click Need to attach this xml file into REACH-IT (Notify a Bulk C&I)

76 使用GHS-专家 软件进行C & L 通报 分类制作完成后，单击，GHS-专家 软件即可生成一份xml文档
需将这份xml文档附在REACH-IT（批量通报C&L）

77 C&L notification report
The result of C&L notification is a report C&L notification reference number, which is checked by the authority

78 C&L 通报 报告 C&L通报的结果是份报告 C&L通报参考编号，经由当局核对

79 Update a C&L notification
Compatibilty between the different submission tools REACH registration updates the previous notifications If C&L notification was submitted in a joint REACH registration dossier, than only the lead-registrant can modify it

80 更新 C&L 通报 不同提交工具间的兼容性 REACH注册对以前的通报进行更新

81 Next program 13.00 – 13.30          Lunch 13.30 – Labelling, EU C&L inventory (Practical steps: How Chinese companies can use EU classification data?) 15.00 – 15.15           Break 15.15 – 18.00           Open Forum for Question and Answers

82 接下来的安排 13.00 – 13.30 午饭 13.30 – 15.00 标示, EU C&L 详细目录
13.00 – 13.30         午饭 13.30 – 标示, EU C&L 详细目录 (实践步骤: 中国公司怎样使用EU分类数据?) 15.00 – 15.15           休息 15.15 – 18.00           问答方式的公开讨论会

83 Labelling What is the deadline of the new CLP labels?
Substances: 1 Dec 2010 Mixtures: 1 June 2015 Who need to label? Suppliers (manufacturer, importer, downstream user, distributor) must label a hazardous substance or a hazardous mixture contained in packaging before placing it on the market. (Downstream user, distributor should use the label of the importer or manufacturer) Which language should we label? The label shall be written in the official language(s) of the Member State(s) where the substance or mixture is placed on the Market. (CLP Article 17.2) We have 23 official languages in EU.

84 标示 新CLP标识的截止日期是？ 物质: 2010年12月1日 混合物: 2015年6月1日 谁来进行标示？
供应商(制造商, 进口商, 下游用户, 经销商) 必须在投放市场之前，对其包装含有的某种危害性物质或危害性混合物进行标示 (下游用户, 经销商应使用该进口商或制造商的标识) 应使用哪种语言进行标示？ 应使用该物质或混合物投放市场所在成员国的官方语言进行标示。（CLP 第17.2条）欧盟（EU）内部有23种官方语言。

85 Label content Minimal label content:
The name, address and telephone number of the supplier The nominal quantity of a substance or mixture in the packages Product identifiers (CAS # or EC# or IUPAC name) Hazard pictograms, Hazard signal words (Danger or Warning) Hazard statements (H#) Precautionary statements (P #) Supplemental information required by other legislation See also: CLP Annex I. 1.3 : (gas cylinders, gas containers, aerosols, alloys, polymers, explosive chemicals)

86 标示内容 标示内容的最低标准: 供应商的姓名, 地址和电话号码 包装上物质或混合物的标称值
产品标识 (CAS # 或 EC# or IUPAC（国际理论和应用化学联合会） 名) 危险图标 危险信号词 (危险或警示) 危险说明 (H#) 防范说明(P #) 其他法案要求的补充信息 另见: CLP 附录 I. 1.3 : (储气瓶,储气器,气溶胶,合金, 聚合物, 易爆炸的化学制品)

87 H & P statements after R & S phrases
All hazard statements (H#) shall appear on the label ( CLP Art 27) Not more than 6 precautionary statements (P#) shall appear on the label, unless necessary to reflect the nature and the severity of the hazards. (CLP Art 28) More languages is possible on the label P & H statements available in23 languages in CLP Annex III & IV Up-date of labelling changes: (CLP Art 30) Immediately if the new hazard is more severe Within 18 months if the danger is less severe

88 R & S 标准词后的H & P说明 所有危险说明(H#) 应出现在这个标识上( CLP 第 27条)
若没有必要反映危害的性质和严重性，数目不到6个的防范说明 (P#) 应出现在这个标识上 (CLP 第 28条) 这个标识上可使用多种语言 23种语言的P&H说明在CLP 附录 III & IV 可见 标示变化的更新: (CLP 第30条) 如果新危害比原来的严重，则立即更新 如果危险没有原来的严重，则可在18个月内完成更新

89 Sample example de, en, hu

90 范例 de, en, hu

91 LABEL & PICTOGRAM SIZE*
Capacity of package Label size /mm/ Pictogram size /mm/ Not exceeding 3 litres If possible, at least 52x74 At least 16x16 Greater than 3 litres but not exceeding 50 litres At least 74x105 At least 23x23 Greater than 50 litres but not exceeding 500 litres At least 105x148 At least 32x32 Greater than 500 litres At least 148x210 At least 45x45 * Different possible in special cases

92 标识 & 图标 大小* 包装容量 标识大小 /mm/ 图标大小/mm/ 不可超过 3 升 若可能, 至少52x74 至少 16x16
大于 3 升 但不可超过 50 升 至少74x105 至少 23x23 大于 50 升 但不可超过500 升 至少 105x148 至少 32x32 大于500 升 至少 148x210 至少 45x45 *特殊情况会有所不同

93 PICTOGRAMS New CLP (H#) Old DSD, DPD (R#) EU transportation label
Old and new pictograms cannot be together on the label, but can be with the transportation label

94 图标 新CLP (H#) 旧 DSD, DPD (R#) EU 运输标识 新旧图标不能同时出现在这个 标识上，但是可以和运输标识 放在一起

95 Special labelling requirements
Where the signal word ‘Danger’ is used on the label, the signal word ‘Warning’ shall not appear on the label. (CLP Art 20) Principle of precedence for hazard pictograms (CLP Art 26) in order to reduce the number of hazard pictograms Please read the CLP & CLP Ver 1 legislation (CLP Art 26) for further details

96 特殊标示要求 标识上使用信号词“危险”的地方，不能出现信号词“警示”。（CLP 第20条）
详情请参阅CLP & CLP 第一版法案 (CLP 第26条)

97 Outer packaging not require CLP label
As a general rule, the transport labelling or marking is sufficient when the outer packaging of a hazardous substance is subject to both the transport and the CLP rules. The CLP labelling does not need to appear on the outer packaging Similarly, when a hazard pictogram required by CLP relates to the same hazard as in the rules for the transport of dangerous goods, the CLP pictogram does not need to appear on the outer packaging.  CLP label (flammable) Transport label (flammable)

98 外包装不要求 CLP 标识 按照一般规则, 当危害物质的外包装受到运输法则和CLP法则的双重限制时，外包装只要有运输标示或标记就足够了，无需CLP标示。 同样地，当CLP要求的危害图标与危险货物运输规则中所述的危害相同时，外包装上也无需CLP图标。 CLP 标识(易燃) 运输标识 (易燃)

99 CLP and transport labelling
Slide text

100 CLP和运输标示 Slide text

101 Packaging Art 35 The packaging of hazardous substances and hazardous mixtures shall be deemed to satisfy the requirements of the rules on the transport of dangerous goods by air, sea, road, rail or inland waterways. content cannot escape chemical resistant should be checked strong enough for transport Cannot attract the curiosity of children Cannot be similar to food / medicine packaging Child-resistant fastening and tactile warnings at special cases

102 包装 第35 条 危害物质和危害混合物的包装应符合危险货物运输规则的要求。这些危险货物可由空运、海运、公路运输、铁路运输或内陆水路运输等运输方式运输。 包装保证使产品不发生泄漏 应对耐化学物品进行检查 包装结实，足够承受运输 包装不应吸引儿童注意 包装不能与食品或药品包装相似 特殊情况下，包装上要求有儿童防范装置和 接触预警

103 EU C&L inventory How non-EU companies can use EU database?
Harmonised list CLP Annex VI. Table 3.1 contains about 4136 harmonised CLP substances 2. EU C & L inventory contains: CLP notified substances REACH regitered substances Harmonised classification (Non-hazardous classification is not in the inventory)

104 EU C&L 详细目录 非欧盟公司怎样使用EU数据库? 调和列表
CLP 附录 VI. 表 3.1 包含大约4136 种调和 CLP 物质 2. EU C & L 详细目录所包含的内容如下: CLP 已通报的 物质 已在REACH 注册的物质 调和分类 (该详细目录不包含无危害分类)

105 Search EU C&L inventory

106 搜索 EU C&L 详细目录

107 Search EU C&L inventory cont.
Joint entry (green pipe) shows the REACH lead-registrant classification, which should be reliable. Click View for the details of the classification

108 搜索 EU C&L 详细目录内容 “Joint Entry”（联合条目）中 (绿色对勾) 显示的是REACH领头注册人分类，应该可信。
点击“View” （查看）即可获得此分类的详情

109 Enforcement Enforcement: national authorities verify the compliance of the duty holders with CLP Regulation Who is responsible for enforcement? National responsibility Each member states have a system of controls including penalties What is the role of European Chemical Agency (ECHA) at enforcement? ECHA has no enforcement responsibility (EU level) ECHA host the Forum for Exchange for Information on Enforcement Forum contains: 1 member /national enforcement authorites Link:

110 强制执行 强制执行: 由国家当局核实承担义务者是否遵守CLP法规 谁负责强制执行？ 国家责任 各个成员国都有一套含惩治机制的控制体系
欧洲化学品管理署（ECHA）在强制执行中扮演什么角色？ ECHA没有强制执行的责任（从EU层面上来说） ECHA主办关于强制执行信息的交流论坛 该论坛包含: 1个成员或国家的强制执行机构 链接:

111 Forum tasks Spread good practice and highlight problems at Community level Propose, coordinate and evaluate harmonised enforcement projects and joint inspections Coordinate exchange of inspectors Identify enforcement strategies, as well as best practice in enforcement Develop working methods and tools of use to local inspectors Develop an electronic information exchange procedure Liaise with industry, taking particular account of the specific needs of SMEs, and other stakeholders, including relevant international organisations, as necessary Examine proposals for restrictions with a view to advising on enforceability (Art.77(4)) Agree common issues to be covered in the annual reports from the Member States in relation to enforcement (Art. 127).

112 论坛任务 应在共同体层面上，推广最佳实践，并突出问题。 提议，协调并评估调和强制执行项目和联检。 协调检查员之间的交流
确定强制执行战略和强制执行的最佳方法 研制地方检查员使用的工作方法和工具。 研制一套电子信息交流程序 与业界保持联络，要特别考虑中小企业（SMEs）及其他股份持有者（包括相关的国际组织在内）的特定需要 对限制性提议进行检验，并对其可行性提出建议(第77(4)条) 同意成员国在有关强制执行的年度报告中对常见问题进行报告 (第 127条).

113 Member State inspection: Hungary
The work of the Hungarian inspectors is coordinated at regional level and supported by the National Institute of Chemical Safety. The company visits may take the form of both spot and targeted checks. (Companies with REACH pre-registration , 82% checked in 2010) In case of non-compliance the inspectors take a binding decision and/or impose a fine (chemical load penalty) on the companies concerned. Penalty related to infringement of CLP regulation in Hungary : 340 Euro – Euro (medium amount in Eu)

114 成员国匈牙利的检查 匈牙利检查员的工作由区域协调，并得到国家化学品安全局支持。
对于公司，可采用现场检查和针对性检查两种形式。（在REACH预先注册的公司，82%在2010年已接受检查。） 对违反规定的相关公司，检查员可通过具有约束力的决议和/或对其进行罚款（化学制品负荷惩罚） 匈牙利有关违反CLP法规的惩罚: 340 欧元 – 欧元 (相当于欧盟中等程度的罚款数目)

115 Inspection agenda Plant visit, technology check
Legal entity and owner check Identification of roles (manufaturer, importer, OR, DU, distributor) Exemption check (cosmetics, medicine…) Substance or mixture, hazardous or non-hazardous CLP notification check CLP label check (thorough check at the authority) Safety data sheets (thorough check at the authority) Other chemical safety tasks (chemical risk assessment)

116 检查的日常工作事项 参观工厂，检查技术 检查法人和业主 确定各自的职能 (制造商, 进口商,唯一代表, 下游用户, 经销商)
检查豁免特例(化妆品, 药物…) 物质或混合物，是否有危害 检查CLP 通报 检查CLP 标识 (由当局彻查) 安全数据表 (由当局彻查) 其他化学制品安全任务 (化学制品危险评估)

117 References European Chemical Agency homepage: http://echa.europa.eu/
CLP: Regulation (EC) No 1272/2008 on the Classification, Labelling and Packaging of substances and mixtures CLP Rev 1: Regulation (EU) No 286/2011 on the Classification, Labelling and Packaging of substances and mixtures Introductory Guidance on the CLP Regulation Guidance on the Application of the CLP Criteria How to notify Substances to the Classification & Labelling Inventory FAQ on Classification and Labelling Guidance on labelling and packaging in accordance with Regulation (EC) 1272/2008

118 参考文献 欧盟化学物品管理局主页: http://echa.europa.eu/
CLP: 法规(EC) No 1272/2008 关于物质和化合物的分类、标示、包装法规 CLP Rev 1: 法规 (EU) No 286/2011 关于物质和化合物的分类、标示、包装法规 CLP 法规的入门指南 CLP 标准的应用指南 怎样对物质的分类和标示详细目录进行通报 分类和标示的常见问题 按照法案 (EC) 1272/2008进行标示和包装指南

119 Thank you for your invitation
Thank you for your attention Agnes Botos Managing director of GHS-expert Ltd REACH, GHS consultant & Part-time PhD student in Hungary Link: Link:

120 多谢邀请 谢谢大家 波托斯·阿哥尼斯 电子邮箱: agnes.botos@GHSexpert.com
匈牙利REACH, GHS 咨询师&非全日制博士生 电子邮箱: 链接: 链接:

121 Back up slides BACK UP SLIDES

122 备用幻灯片 备用幻灯片

123 GHS softwares Hungarian GHS-expert (AGATE2 )software www.GHSexpert.com
Belgian LISAM ExESS ( American 3E Company (Arial) French Ecomundo Catalan …….

124 GHS 软件 匈牙利GHS-专家(AGATE2 )软件 www.GHSexpert.com
比利时 LISAM ExESS ( 美国 3E 公司(Arial) 法国 Ecomundo 加泰罗尼亚 …….

125 GHS-expert software: AGATE2
GHS-Expert software AGATE2 : Hungarian desiqn Multi-language function possible Many user can use it WEB technology No maintenance cost Continouos legislation changes follow up Platform-dependent Works as a service or self-service You pay as much you use it Euro / substance classification You can access from the internet Safe data protection Safe server Mixture classification part is available from Oct 2012

126 GHS-专家 软件: AGATE2 GHS-专家软件 AGATE2 : www.ghsexpert.com 匈牙利人设计 有多语言功能
可多用户使用 WEB 技术 不需维修费 跟进连续立法变化 依赖于平台 作为一种服务或自助服务进行工作 根据使用量付款， 一般使用1个物质分类需支付50-75 欧元 可以通过互联网进入 安全数据保护 安全服务器 从2012年10月起，混合物分类可用

127 GHS-expert software: AGATE2
Classification process is 100% CLP compliant CLP regulation guidelines decision logics followed Not just R phrases and UN# converter it is much more Harmonised classification automaticly filled Optimal pathway of the classification Effective search and filters Substance identification Classification questionnaires by CLP Annex I Classification documented for authority Label printing in all EU languages (Chinese translation needed) Chemical resistant labels for printing CLP Notification XML file preparation with 1 click

128 GHS-专家 软件: AGATE2 分类过程100%符合CLP相关规定 遵行了CLP法规指南决策逻辑
不只有R 标准词和 UN# 转换器，还有包含更多东西 自动填写调和分类 是分类的最优路径 有效的搜索和过滤 确定物质 CLP 附录 I的分类问卷 为当局制作分类的文件证明 使用所有EU语言印发标签 (需要中译版) 要求印发的耐化学制品标签 单击，即可制作CLP 通报 XML 文档

129 www.GHSexpert.com: AGATE2 software

130 www.GHSexpert.com: AGATE2 软件

131 www.GHSexpert.com: AGATE2 software

132 www.GHSexpert.com: AGATE2 软件

133 Substance identification

134 物质鉴定

135 Quick classification

136 快速分类

137 Title Slide text

138 标题 Slide text

139 6 Precautionary statements (P#) choosing
Slide text

140 选择6个防范说明 (P#) Slide text

141 Documentation of classification reasoning

142 分类推理的记录

143 CLP notificiation XML file
Slide text

144 CLP 通报 XML 文档 Slide text

145 Labels in 23 EU languages

146 用23种EU语言显示的标签

147 Chemical resistant label in 3 languages

148 三种语言的耐化学制品标签

149 Thank you for your invitation
Thank you for your attention Agnes Botos Managing director of GHS-expert Ltd REACH, GHS consultant & Part-time PhD student in Hungary Link: Link:

150 多谢邀请 谢谢大家 波托斯·阿哥尼斯 电子邮箱: agnes.botos@GHSexpert.com
匈牙利REACH, GHS 咨询师&非全日制博士生 电子邮箱: 链接: 链接:

151 Questions QUESTION TIME

152 提问 提问时间