Seminar on EU Chemical Regulatory System

1. Seminar on EU Chemical Regulatory System REACH (Part 4) CSR, SDS & GLP 17th July 2012

2. 欧盟化学监管体制专题讨论会 《化学品注册、评估、许可和限制》 （第四部分） 化学安全报告，安全技术数据表，良好实验室规范 2012年7月17日

3. Chemical Safety Report • For substances manufactured or imported at 10 tonnes or more per year, the registrant needs to submit as part of his registration dossier a chemical safety report (CSR). • The CSR format is defined in Annex I of REACH. • The CSR should document the chemical safety assessment (CSA) performed by the registrant. • The purpose of the CSA is to ensure that the risks arising from the manufacture and use of a substance (on its own, in a mixture or in an article) are under control

4. 化学安全报告 • 对于每年生产或进口超过10吨的物质，注册者需要在提交注册材料的时候包括化学安全报告。 • 《化学品注册、评估、许可和限制》的附件一有定义了化学安全报告的格式。 • 化学安全报告应该包括注册者进行的化学安全评估。 • 化学安全评估的目的是确保物质（以单独形式、在混合物或在物品中存在）生产和使用带来的风险可控。

5. Chemical Safety Report • The CSA of a manufacturer must address the manufacture and all identified uses of the substance while • An importer will have to address only the identified uses. • All stages of the life-cycle of the substance resulting from the manufacture (if applicable) and the identified uses must be considered in the CSA, including, where relevant, the waste stage and the service life of articles.

6. 化学安全报告 • 生产商的化学安全评估必须对物质制造和所有物质明确用途进行说明而 • 进口商只需要指出物质的明确用途。 • 化学安全评估必须考虑到生产（如需要）带来的物质生命周期的所有阶段和明确使用方法，包括相关的废弃阶段和物品使用生命

7. Chemical Safety Report • PART A 1. Summary of risk management measures 2. Declaration that risk management measures are implemented 3. Declaration that risk management measures are communicated • PART B 1. Identity of the substance and physical and chemical properties 2. Manufacture and uses 3. Classification and labelling 4. Environmental fate properties 5. Human health hazard assessment 6. Human health hazard assessment of physicochemical properties 7. Environmental hazard assessment 8. PBT and vPvB assessment 9. Exposure assessment 10. Risk characterisation

8. 化学安全报告 第一部分 • 风险控制措施小结 • 宣告风险控制措施实施 • 宣告风险控制措施交流 第二部分 • 1. 明确物质及其物理和化学特性 • 2. 生产和使用 • 3. 分类和标示 • 4. 环境命运特性 • 5. 人类健康风险评估 • 6. 人类健康的物理化学特性风险评估 • 7. 环境风险评估 • 8.持久、生物累积和毒性物质（PBT）和高生物累积和高持久性（vPvB）评估 • 9. 暴露评估 • 10. 风险特征描述

9. Chemical Safety Report A CSA should include the following steps: • Hazard assessment: - Human health hazard assessment - Physicochemical hazard assessment - Environmental hazard assessment - PBT/vPvB assessment If the substance fulfils the criteria for any of the hazard classes or categories set out in Article 14 (4) or is assessed to be a PBT or vPvB the CSA will have to include the following additional steps: • Exposure assessment. - Generation of exposure scenario(s) - Exposure estimation • Risk characterisation

10. 化学安全报告 化学安全评估应该包括如下步骤： 风险评估： －人类健康风险评估 －物理化学风险评估 －环境风险评估 －持久、生物累积和毒性物质（PBT）和高生物累积和高持久性（vPvB）评估 如果物质满足14（4）条列出的风险种类标准或被评估为持久、生物累积和毒性物质（PBT）和高生物累积和高持久性物质（vPvB），其化学安全评估需要包括如下附加步骤： 暴露评估 －暴露情况说明 －暴露评估 风险特征描述

11. Steps of the chemical safety assessment Hazard assessment. • It should be performed on the basis of all available and relevant information which should be reported in the technical dossier. • Information available in other studies could also be used by the registrant as supporting information.

12. 化学安全评估步骤 • 风险评估 • 应该基于所有可得和相关信息，并需要在技术材料中报告出来。 注册者也可以使用其他研究的可得信息作为支撑信息

13. Steps of the chemical safety assessment Hazard assessment. • Human health hazard assessment. • The objective is to determine the classification and labelling of the substance and to define the level of exposure above which humans should not be exposed. This level of exposure is known as the derived no-effect level(s) (DNEL). • acute effects such as acute toxicity, irritation and corrosivity; • sensitisation; • repeated dose toxicity; and • CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction).

14. 化学安全评估步骤 风险评估 －人类健康风险评估 目的是确定物质的分类和标示，并明确暴露等级，该等级之上不应对人暴露。该暴露等级被称为无获得性反应等级（DNEL）。 －剧烈反应例如剧毒，刺激性和腐蚀性 －敏感性 －重复剂量毒性 －CMR反应（致癌性，生殖细胞致突变性和生殖毒性）

15. Steps of the chemical safety assessment Hazard assessment. • Physicochemical hazard assessment • The objective is to determine the classification and labelling of the substance and to assess, as a minimum, the potential effects to human health for: • explosivity, • flammability and • oxidising potential.

16. 化学安全评估步骤 风险评估 物理化学风险评估 －目的是明确物质的分类和标示，并至少评估出对人类健康的潜在影响，包括： －暴露性 －可燃性 －氧化性

17. Steps of the chemical safety assessment Hazard assessment. • Environmental hazard assessment • The objective is to classify and label the substance and to determine a predicted no effect concentration (PNEC) below which adverse environmental effects in the environmental compartments are not expected to occur.

18. 化学安全评估步骤 • 风险评估 • 环境风险评估 • 目的是对物质进行分类和表签，并明确预估无作用浓度（PNEC），在该浓度以下，预计不会出现不良环境反应。

19. Steps of the chemical safety assessment Hazard assessment. • Environmental hazard assessment • It shall consider the potential effects on the environment, comprising the (1) aquatic, (2) terrestrial, (3) atmospheric. (4) micro-organisms of the sewage treatments systems. • In addition to information on potential effects on the environment, the registrant has also to document the environmental fate (e.g. degradation, bioaccumulation) of the substance.

20. 化学安全评估步骤 风险评估 环境风险评估 应该考虑对环境的潜在影响，包括： （1）水 （2）陆 （3）大气 （4）污水处理系统的微生物 除了对环境潜在影响的信息之外，注册者还应该将物质的环境命运包括在材料中（如恶化，生物累计）。

21. Steps of the chemical safety assessment Hazard assessment. • PBT/ vPvB assessment • The objective is to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance.

22. 化学安全评估步骤 风险评估 持久、生物累积和毒性物质（PBT）/高生物累积和高持久性物质（vPvB）评估。 －目的是明确物质是否满足附件十三给出的标准，如果满足，需要对物质的潜在废弃排放进行描述。

23. Steps of the chemical safety assessment Exposure assessment • It consists of determining quantitatively or qualitatively the dose/concentrations of the substance to which humans and the environmental are or may be exposed. • The assessment must consider all stages of the lifecycle of the substance resulting from the manufacture and identified uses. • The exposure assessment includes two steps: 1) Generation of exposure scenario(s) 2) Exposure estimation

24. 化学安全评估步骤 暴露评估 包括定性和定量地明确人或环境可能接触的物质剂量或浓度。 该评估必须考虑从生产和使用带来的物质生命周期的所有阶段。 暴露评估包括两个步骤： 1）暴露情况说明 2）暴露评估

25. Exposurescenarios • The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s) implemented for the manufacturer's production, the manufacturer or importer's own use, and those recommended by the manufacturer or importer to be implemented for the identified use(s). • An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. • These sets of conditions contain a description of both the risk management measures (RMM) and operational conditions which the manufacturer or importer has implemented or recommends to be implemented by downstream users.

26. 暴露情况说明 • 化学安全报告中关于暴露的部分的主要内容是对产品生产过程、制造商或进口商自己使用产品过程，以及按照制造商或进口商推荐产品用途使用产品过程中的暴露情况的说明。 • 暴露情况是指，对物质在生命周期中如何被生产和使用，以及制造商或进口商如何控制或建议终端使用者控制人和环境接触的一系列情形的描述。 • 这一系列情形包括对风险控制措施（RMM）的描述和制造商或进口商执行或建议终端使用者执行的使用情形的描述

27. Exposurescenarios • The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. • Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s).

28. 暴露情况说明 • 对暴露情况说明的详细程度需视情况而定，取决于物质的使用，其风险特性以及制造商或进口商可得的信息量。 • 化学安全报告的第一部分应包含一份声明，即制造商和进口商在其使用物质的过程中，已经采取了针对相关暴露情况所需的风险控制措施，并且已将物质明确用途中会出现的暴露情况通过安全数据说明传递给分销商和终端使用者。

29. Exposurescenarios Exposure scenarios • The level of detail required in describing an exposure scenario will vary substantially from case to case, depending on the use of a substance, its hazardous properties and the amount of information available to the manufacturer or importer. • Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer or importer and that those exposure scenarios for the identified uses are communicated to distributors and downstream users in the safety data sheet(s).

30. 暴露情况说明 • 使用方法和使用情形的内部 • 信息收集 5. 对化学安全评估中物质暴露情况 的评估，然后统计为最终的物质暴露情况 2. 物质暴露情况的初期形成 （使用物质暴露情况对话模板） 6. 在化学安全报告中对物质 暴露情况进行归档 3. 与抽选消费者进行交流 （反馈，使用物质暴露情况交流模板） 7. 将物质暴露情况转化为产品 暴露情况（合并了安全数据表） 4.物质暴露情况的发展 （基于消费者的输入信息） 8. 宣传产品暴露情况，指导消费者

31. Exposurescenarios • CEFIC (The European Chemical Industry Council) • http://www.cefic.org/Industry-support/Implementing-reach/ • The International Association for Soaps, Detergents and Maintenance Products • http://www.aise.eu/reach/ • European Centre for Ecotoxicology and Toxicology of Chemicals. • http://www.ecetoc.org/tra

32. 暴露情况说明 • CEFIC (欧洲化学工业委员会) • http://www.cefic.org/Industry-support/Implementing-reach/ • 国际肥皂、洗涤剂和维护产品协会http://www.aise.eu/reach/ • 欧洲化学品生态毒理学和毒理学中心 . • http://www.ecetoc.org/tra

33. Risk characterisation • It is the final step in the chemical safety assessment where it should be determined whether risks arising from manufacture/import and uses of the substance are controlled. • The registrant shall compare the no effect levels (DNELs) and the predicted no effect concentrations (PNECs) with the calculated exposure concentrations to human and the environment respectively. • Where no DNEL or PNEC is available for an identified toxicological or ecotoxicological hazard, a qualitative or semi-quantitative risk characterisation is required

34. 风险表征 • 化学安全评估的最后一步是明确物质的生产、进口和使用带来的风险是否可控。 • 注册者应把人和环境的累计接触与无获得性反应等级（DNEL）和预估无作用浓度（PNEC）进行比较。 • 若对于一个明确的毒物或生态毒物风险，没有可行的累计接触与无获得性反应等级（DNEL）和预估无作用浓度（PNEC），那么需要一个定性或半定量的风险特征描述。

35. Risk characterisation • The risk characterisation shall be carried out for each exposure scenario for both the human health and the environment and the results and discussion reported in CSR. • Chesar tool • Chesar stands for Chemical safety assessment and reporting tool. The tool has been developed by ECHA to help registrants perform a CSA and generate a CSR. It provides a structured workflow for carrying out a standard safety assessment for the different uses of a substance. The tool also helps to structure the information needed for the exposure assessment and risk characterisation which will facilitate the generation of a transparent CSR. • http://chesar.echa.europa.eu/

36. 风险表征 • 在化学安全报告中，针对人类健康和环境的每一种暴露情况说明及其相关结果和讨论，都应该有相应的风险特征描述。 • Chesar 工具 • Chesar指化学安全评估和报告工具。该工具由欧洲化学品管理局（ECHA）发明，用以帮助注册者执行化学安全评估并产生化学安全报告。它提供了结构化的工作流程来对物质的不同使用方法展开了标准安全评估。该工具也为暴露评估和风险特征描述所需的信息提供了结构范式，从而有助于形成透明的化学安全报告. • http://chesar.echa.europa.eu/

37. Registrants duty of communication • Safety Data Sheet (SDS) • The supplier has to provide an SDS according to Annex II of REACH to all the downstream users and distributors he supplies as soon as the substance (on its own or in a mixture) falls within one of the following categories: • It meets the criteria for classification as hazardous in accordance with the CLP Regulation or the mixture containing the substance is classified as dangerous under Directive 1999/45/EC ; • it is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with Annex XIII of the REACH Regulation; • it is included in the candidate list of substances which may be subjected to authorisation.

38. 注册者的沟通责任 • 安全数据表 • 只要物质（物质本身或混合物中的物质）满足以下一种情况，供应商需根据《化学品注册、评估、许可和限制》(REACH)的附录II，向所有其供应的分销商和终端使用者提供安全数据表： • －物质满足分类、标示和包装（CLP） 规定中定义为危险，或混合物含有1999/45/EC 指令中定义为危险的物质； • －满足《化学品注册、评估、许可和限制》(REACH)规定的附件十三中相关的持久、生物累积和毒性物质（PBT）和高生物累积和高持久性（vPvB) • －物质列在有待授权审批的物质清单中。

39. Registrants duty of communication • Safety Data Sheet (SDS) • A supplier of a substance could be requested at any time by his customer to provide him with a SDS for any mixture which does not meet the criteria for classification as dangerous but which contains: • ≥ 1% (by weight) for non-gaseous mixtures (or ≥ 0.2% by volume for a gaseous mixture) of a substance posing human health or environmental hazards; or • for non gaseous mixtures, ≥ 0.1% (by weight) of a PBT or a vPvB substance in accordance with Annex XIII or has been included in the candidate list of substances which may be subjected to authorisation; or • a substance for which there are Community workplace limits.

40. 注册者的沟通责任 • 安全数据表（SDS） • 对于不满足危险定义但是包含以下情况的任何混合物混合物，物质供应商可以在任何时候被其使用消费者要求提供安全数据表： • － 物质的非气态混合物中有≥1% (重量)（或 气态混合物的体积中有≥0.2%）的成分能危害人类健康或环境； • －对于非气态混合物，根据附件十三，有≥0.1% (重量)的持久、生物累积和毒性物质（PBT）和高生物累积和高持久性（vPvB)成分，或者物质列在有待授权审批的物质清单中。 • －存在欧共体工作场所限制的物质。

41. 1.1. Product identifier • Substances • From 1 December 2010 the product identifier must be provided in accordance with Article 18(2) of Regulation (EC) 1272/2008 (CLP). • The inclusion of the EC number is optional. • The registration numbers of substances subject to registration must be mentioned by thesuppliers once the substances are registered • Mixtures. • Until 1 June 2015 in the case of a mixture, the trade name or designation must be provided in accordance with DPD. • From 1 June 2015 the product identifier for a mixture must be provided in accordance with CLP.

42. 1.1. 产品标识符 • 物质 • 从2010年12月1日起，必须按照(EC) 1272/2008 (CLP)法规第18条(2) 提供产品标识符。 • 是否包含EC号是选择性的。 • 一旦需进行注册的物质完成注册，供应商必须提到该物质的注册号。 • 混合物 • 针对混合物，在2015年6月1日前，必须按照DPD提供混合物的商标名或外形尺寸。 • 从2015年6月1日起，必须按照CLP提供混合物的产品标识符

43. 1.2. Relevant identified uses of the substance or mixture, and uses advised against • Substances • Suppliers must indicate the relevant identified use(s) of a substance using a brief (understandable) description of what the substance is intended. • This information must be consistent with the identified uses and exposure scenarios (ESs) set out in the annex to the SDS • Mixtures. • Suppliers must indicate the relevant identified use(s) of a mixture using a brief (understandable) description of what the mixture is intended to do.

44. 1.2. 物质或混合物相关的明确用途和不建议用途 • 物质 • 供应商必须在物质用途的简要（易理解的）说明里指出物质的相关的明确用途。 • 这一信息需与SDS的附录中说明的明确用途和暴露情况说明(ESs)一致。 • 混合物 • 供应商在混合物用途的简要（易理解的）说明里指出混合物相关的明确用途。

45. 1.3 Details of the supplier of the safety data sheet • Substances • For registrants, the information must be consistent with the information on the identity of the manufacturer or importer or Only Representative provided in the registration • e-mail address of the competent person responsible for the SDS should be provided. It is recommended to use a generic e-mail address • Mixtures. • e-mail address

46. 1.3 安全数据表提供者的详细信息 • 物质 • 注册者信息必须与在注册中提供的关于制造商或进口商或唯一代表的身份信息一致。 • 应提供负责SDS的相关人员的电子邮箱地址。推荐使用通用邮箱地址。 • 混合物 • 电子邮箱地址

47. 2. Hazards identification • Substances • From 1 December 2010 until 1 June 2015, the classification of a substance according to both the CLP Regulation and Dangerous Substances • After June 1st , 2015, only classification according to CLP is required. • The symbol/pictogram(s) must be represented graphically. • If the substance is subject to authorisation , the authorisation number must be included here. • Information on whether the substance meets the criteria for PBT or vPvB in accordance with Annex XIII must be provided

48. 2. 危害识别 • 物质 • 从2010年12月1日到2015年6月1日，物质的分类应同时参照CLP法规和危险物质指令。 • 2015年6月1日之后，物质分类只要求参照CLP法规。 • 符号/图标必须以图形化的方式呈现。 • 如果该物质需得到授权，则必须包含授权号。 • 根据附录XIII，必须提供关于该物质是否符合PBT或vPvB标准的相关信息。

49. 2. Hazards identification • Mixtures. • Until 1 June 2015, the classification of the mixture according to the DPD must be given. • After June 1st, 2015, only classification according to CLP is required • If any component substance(s) in the mixture is/are subject to authorisation , the authorisation number(s) must be included here. • Information on whether the mixture meets the criteria for PBT or vPvB in accordance with Annex XIII must be provided.

50. 2. 危害识别 • 混合物Mixtures. • 2015年6月1日前，必须根据DPD对混合物进行分类。 • 2015年6月1日后，混合物分类只要求符合CLP法规。 • 如果混合物中存在任何需得到授权的组成物质，则必须提供授权号。 • 根据附录XIII，必须提供关于该混合物是否符合PBT或vPvB标准的相关信息。