Seminar on EU Chemical Regulatory System

Seminar on EU Chemical Regulatory System

REACH (Part 4)CSR, SDS & GLP

17th July 2012

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

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

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。


• 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.

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


• PART A1. Summary of risk management measures2. Declaration that risk management measures are implemented3. Declaration that risk management measures are communicated

• PART B1. Identity of the substance and physical and chemical properties2. Manufacture and uses3. Classification and labelling4. Environmental fate properties5. Human health hazard assessment6. Human health hazard assessment of physicochemical properties7. Environmental hazard assessment8. PBT and vPvB assessment9. Exposure assessment10. Risk characterisation

化学安全报告第一部分1. 风险控制措施小结2. 宣告风险控制措施实施3. 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


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

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

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.

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


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).

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）


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.

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


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.

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。


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.

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）。


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.


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。


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


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

Exposure scenarios

• 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.

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

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).

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。

Exposure scenarios

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).

暴露情况说明

1. 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

Exposure scenarios

• CEFIC (The European Chemical Industry Council)• http://www.cefic.org/Industry-support/Implementing-re

ach/• 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

暴露情况说明• CEFIC ( 欧洲化学工业委员会 )• http://www.cefic.org/Industry-support/Implem

enting-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

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

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。

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/

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/

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.

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。

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.

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。

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.

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

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.

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。

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

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

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

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。

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.

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。

3. Composition / information on ingredients

• Substances– The chemical identity of the main constituents and any

impurity, stabilising additive or individual constituent which is itself classified and contributes to the classification of the substance must be provided

3.成分组成 / 信息

• 物质– 必须提供物质中主要成分的化学特性，和任何本身已经被

分类或影响该物质分类的杂质、稳定添加剂或单个组分的化学特性。

3. Composition / information on ingredients

• Mixtures– The criteria for determining which component substances in a

mixture must be indicated together with their concentration (range) in this section are expanded from 1 December 2010 to include health or environmental hazards according to CLP as well as those according to 67/548/EEC. From 1 June 2015 only CLP criteria are applicable.

– In the case of mixtures, PBT/vPvB substances and substances included in the candidate list, have to be disclosed if present at 0.1% or above with registration number (if applicable)

– The registration numbers of at least a certain predefined group of component substances in the mixture must be mentioned by the suppliers

3.成分组成 / 信息

• 混合物– 根据 CLP 和 67/548/EEC ，决定需对混合物中哪些组成物质

及其浓度进行说明的标准与 2010 年 12 月 1 日的标准相比，进行了扩充，添加了健康和环境危害。从 2015 年 6 月 1日起，将只有 CLP 标准适用。

– 针对混合物：必须公布具有注册号（若适用）且含量达到或超过 0.1% 的 PBT/vPvB 物质和列入候选名单的物质。

– 供应商必须至少提到混合物中一种组成物质的预定义组的注册号。

7. Handling and storage

• Substances– Where a chemical safety report is required, the information in

this section must be consistent with the information given for the identified uses in the chemical safety report and, where applicable, the exposure scenarios annexed to the safety data sheet.

– If an ES is attached, reference may be made to it.– For substances designed for specific end use(s), detailed and

operational recommendations relating to the identified use(s) referred to in subsection 1.2 must be made.

7. 处置和存储

• 物质– 若要求具备化学安全报告，则这一节的信息必须与化学安

全报告中给出的明确用途相关信息保持一致。若适用，暴露情况说明可附加在安全数据表中。

– 如果附加了 ES （暴露情况说明），则可参照它– 对专为特殊最终用途而设计的物质，必须对在 1.2 分节中提

到明确用途作出相关的详细操作建议。

7. Handling and storage

• Substances / Mixtures– Where a chemical safety report is required, the information in

this section must be consistent with the information given for the identified uses in the chemical safety report and, where applicable, the exposure scenarios annexed to the safety data sheet.

– For mixtures, The SDS may include cross-references to an Exposure Scenario for the mixture where applicable.

– If an ES is attached, reference may be made to it.– For substances / mixtures designed for specific end use(s),

detailed and operational recommendations relating to the identified use(s) referred to in subsection 1.2 must be made.

7. 处置和存储

• 物质 / 混合物– 若要求具备化学安全报告，则这一节的信息必须与化学安

全报告中给出的明确用途相关信息保持一致。若适用，暴露情况说明可附加在安全数据表中。

– 针对混合物，若适用， SDS 可以包含对混合物暴露情况说明的交叉参照。

– 如果附加了 ES （暴露情况说明），则可参照它。– 对专为特殊最终用途而设计的物质 / 混合物，必须对在 1.2

分节中提到明确用途作出相关的详细操作建议。

8. Exposure controls/ personal protection

• Substances – List applicable DNELs, OELs, and PNEC : Substance specific

information (the DNELs for human health hazards and the PNECs for hazards to the environment) need to be given under the appropriate sub-section in this section.

– Where a chemical safety report is required, the risk management measures for the identified uses must be consistent with the information in this section.

• Mixtures– The risk management measures given in the sub-

sections of this section and any annexed exposure scenario(s) must be consistent.

8. 暴露控制 / 人员防护

• 物质– 列出适用的 DNEL （衍生无影响程度）、 OEL （职业接触限值）、和 PNEC （预估无显著影响浓度） : 在这一节的合适的分节中需给出物质详细信息（ DNEL针对人类健康危害；PNEC针对环境危害）。

– 若要求具备化学安全报告，则与物质的明确用途相关的风险管理措施必须与这一节的信息一致。

• 混合物–这一节的分节中的风险管理措施需与所有附加的暴

露情况说明一致。

8. 2. Exposure controls

• Substances – Suppliers will mention here risk management measures for

control of occupational and environmental exposure for the use of the substance.

– Where a substance has been registered as an isolated intermediate (on-site or transported), the supplier must indicate that this safety data sheet is consistent with the specific conditions relied on to justify the registration in accordance with Article 17 or 18 of REACH.

8. 2. 暴露控制

• 物质– 供应商将在这一节提到物质使用中职业和环境暴露控制所采取的风险管理措施。

– 若某种物质被注册为隔离中间体（待运输或已运输），其供应商必须说明该物质的安全数据表与根据 REACH 法规第17 或 18 条能证明注册合法的具体条款一致。

11. Toxicological information

• Substances – For substances subject to registration, summaries of the

information derived from the application of Annexes VII to XI of REACH must be given.

– If a CSR is required, the information should be consistent with it. Where appropriate, information on toxicokinetics, metabolism and distribution should be included.

– From 1 December 2010 there are requirements to give information in SDSs for substances on Specific Target Organ Toxicity (STOT) for single exposure and repeated exposure. Also information must now be provided on the specified (extended) list of hazard classes.

11. 毒理学资料• 物质

– 对需注册的物质，必须给出从 REACH 法规附录 VII 到附录XI 的应用程序衍生而来的信息的总结。

– 如果要求有 CSR ，相关信息需与 CSR 一致。若合适，还应包括与独立动力学、代谢和分布相关的信息。

– 自 2010 年 12 月 1 日起，必须在物质的 SDS 中提供单次接触和反复接触该物质所产生的特异性靶器官毒性 (STOT) 的相关信息。而且现在还必须提供危险产品类型的规范（扩充）列表信息。

11. Toxicological information

• Mixtures – If substances in a mixture may interact with each other in the

body and alter any toxic action as a result, this must be taken into account when providing toxicological information in this section.

– From 1 June 2015 there are requirements to give information in SDSs for mixtures on Specific Target Organ Toxicity (STOT) for single exposure and repeated exposure. Also information must now be provided on the specified (extended) list of hazard classes.

11. 毒理学资料• 混合物

– 如果混合物中的物质有可能产生相互作用并导致毒性作用产生变化，在这一节中提供毒理学资料时，必须考虑到这一点。

– 从 2015 年 6 月 1 日起，必须在混合物的 SDS 中提供单次接触和反复接触该物质所产生的特异性靶器官毒性 (STOT) 的相关信息。而且现在还必须提供危险产品类型的规范（扩充）列表信息。

12. Ecological information

• Substances – Where a Chemical Safety Report is required, the results of the

PBT and vPvB assessment, as set out in the chemical safety report, must be given. This information is only likely to exist when a chemical safety report has been generated.

12. 生态学资料• 物质

– 若要求具备化学安全报告，则按照化学安全报告的要求，需给出 PBT 和 vPvB 评估结果。只有当已经形成化学安全报告后，才有可能存在这一信息。

13. Disposal considerations

• Substances – In addition to giving waste management measures in this

section of the SDS, where an exposure assessment is required, the waste management measures must be consistent with the exposure scenarios in the annex.

13. 废弃处理意见• 物质

– 除了在 SDS 中的这一节中给出废物管理措施，若要求具备暴露评估，废物管理措施必须与附件中的暴露情况说明一致。

15. Regulatory Information

• Substances / Mixtures– Information on substances subject to authorisation and details

about any authorisation granted or denied must be given in sub-section 15.1.

– Uses of the substances subject to restrictions must be stated here.

– It must be indicated in sub-section 15.2 if a Chemical Safety Assessment has been carried out for the substance by the supplier.

– Labelling information is no longer included in SECTION 15 and must now be given in SECTION 2.

15. 监管信息• 物质 / 混合物

– 需得到授权的物质信息和任何已得或拒绝授权的详细信息都必须在第 15.1 分节中给出。

– 若物质的用途受限，必须在此进行说明。– 必须在第 15.2 分节中说明供应商是否对该物质进行了化学

安全评估。– 第 15节中不再包含标示信息，标示信息现在必须在第 2节

中给出。

16. Other information

• Substances – Advice on training for workers can also be included in this

section.– The full text of any R phrases, hazard statements, safety

phrases and/or precautionary statements, which are not written out in full under Sections 2 to 15 must be given here.

16. 其它信息• 物质

– 关于工人培训的建议可包括在这一节中。– 在第 2节到第 15节中没有写明全称的所有警示性标准词、危险说明、安全标准词和 / 或防范说明必须在这里给出全称。

16. Other information

• Mixtures – Until 1 June 2015, information on CLP classification can, on a

voluntary basis, be included here for mixtures for which full CLP labelling has not yet been implemented rather than in SECTION 2 (as SECTION 2 should be aligned with the current label)

16. 其它信息• 混合物

– 在 2015 年 6 月 1 日前，若混合物的完整 CLP 标示还未在第2节（第 2节应该与现有标签保持一致）中实施，则可在自愿的基础上，把 CLP 分类信息包含在这里。

Exposure Scenario (annex)

• Substances • For substances for which a chemical safety assessment is required

by REACH and has been completed, the relevant exposure scenario(s) (i.e. generally those for uses identified in Section 1 of the SDS) must be attached as an Annex to the SDS. The ES extends the information given in the main body of the SDS, but needs to be considered together with (and be consistent with) the information within the SDS main body in order to maximise its usefulness.

暴露情况说明 ( 附件 )

• 物质• 若 REACH 法规要求对物质进行化学安全评估，且评估已完成

，相关的暴露情况说明（即与 SDS 第一节中指出的用途相关的暴露情况说明）必须做为附件附在 SDS 中。 ES ( 暴露情况说明 ) 对 SDS 的主要内容中给出的信息进行了扩展，但是 ES 必须和 SDS主要内容中的信息一起进行考虑（并与该信息一致），以使效用处最大化。

Exposure Scenario (annex)

• Mixtures• If an exposure scenario is prepared for a mixture , it needs to be

compiled by evaluating the relevant available information on the component substances including the information from the substances’ suppliers.

暴露情况说明 ( 附件 )

• 混合物• 如果某混合物具备暴露情况说明，需通过评估其组成物质的相

关可得信息，包括该物质供应商提供的信息，对暴露情况说明进行编辑。

Information and description of measures to be documented in CSR and SDS

Information CSR SDS

"Physico-chemical properties (e.g. flammability, explosivity, oxidizing""potential, flash point, explosive limits…)”

X X

Classification based on phys-chem hazards X X

Description of activities which may cause minor accidents at workplace or during consumer use (e.g. during maintenance, cleaning of equipment, open use)

X

Estimation of severity in the event of occurrence (qualitatively based on assumed amount during event, operational conditions of use and volatility of the substance)

X

Measures taken to avoid dangerous situations (e.g. inherently safe equipment, exclusion of ignition sources by organisational measures, ventilation …)

X

Recommended risk management measures to avoid occurrence of event X X

Measures to be taken if event occurs (e.g. fire fighting…) X

Restrictions in transportation and storage X

R-phrases X

记录在 CSR 和 SDS中的信息和措施说明

信息 CSR SDS

“物理化学性质（如可燃性、爆炸性、氧化性、闪点、爆炸极限……）”

X X

基于物理化学危害的分类 X X

在工作场所或消费者使用过程中可能会导致小型事故的活动说明 ( 如设备维护、设备清洗、开放式使用 )

X

若发生事故，对事故严重程度的估计（根据事件中假定的物质数量、物质使用的运行条件、和物质的挥发性进行量化估计 )

X

为避免危险情形所采取的措施 ( 如固有安全设备。通过采取组织措施排除火源、通风…… )

X

为避免事故产生建议采取的风险管理措施 X X

若事故发生，应采取的措施 ( 如灭火…… .) X

运输和存储限制 X

警示性标准词 X

Good Laboratory Practice (GLP) policy

OECD MAD (Mutual Acceptance of Data) agreement states that data generated in the testing of chemicals, in accordance with the principles of GLP, shall be accepted in all other OECD countries and in those countries that have provisional or full adherence to this agreement thus avoiding the duplication of animal testing. REACH Regulation requires that ecotoxicological and toxicological tests and analyses are carried out in compliance with the principles of GLP

良好实验室规范 (GLP) 政策

OECD （经济合作与发展组织） MAD ( 数据互认 ) 协议指出根据 GLP原则形成的化学制品试验数据应得到所有其它 OECD国家和临时或完全遵守该协议的国家的认可，从而避免重复动物试验。 REACH 法规要求按照 GLP原则进行生态毒理学和毒理学试验和分析。


• Since 2008, ECHA accepts data as GLP compliant where this data comes:– (i) from countries which are OECD Member States or full

adherents to the OECD Mutual Acceptance of Data (MAD) system and

– (ii) from countries which are provisional adherents to the OECD MAD system and in which laboratories have been inspected jointly by the GLP Monitoring Authority concerned and by an OECD GLP Monitoring Authority.

良好实验室规范 (GLP) 政策• 从 2008 年起，若数据来自于以下来源， ECHA将认为

该数据符合 GLP原则 :– (i) 来自 OECD成员国或者完全遵守 OECD 数据互认（ MAD

）系统的国家，和– (ii) 来自临时遵守 OECD MAD 系统的国家，且在这些国家的

实验室已经通过了由相关的 GLP 监管机构和一个 OECD GLP监管机构的联合检查。


• Studies that are conducted in a laboratory situated in a country which has not joined the OECD MAD system can be accepted by ECHA as GLP compliant studies under the following conditions:– Prior to the performance of the study the GLP compliance of the

laboratory has been inspected by: • an EU GLP Monitoring authority (including Norway through EEA agreement) or• GLP Monitoring Authorities in Israel, Japan and Switzerland with whom the EU

holds Mutual Recognition Agreements or• other GLP Monitoring Authorities of OECD member states or full adherents to

the OECD Mutual Acceptance of Data (MAD) system on a case-by-case basis and

– the laboratory has been found to be operating in compliance with GLP principles.

良好实验室规范 (GLP) 政策• 未参加 OECD MAD 系统的国家的实验室所进行的研究

在满足以下条件的情况下，可被 ECHA认作为符合GLP原则的研究：– 在研究进行之前，实验室已经过了以下机构的 GLP符合性检查：

• EU GLP 监管机构（通过欧洲经济区协定将挪威的监管机构包含在内）或

• 以色列、日本和瑞典的 GLP 监管机构， EU与这些国家签订了互认协议，或

• 其它 OECD成员国的 GLP 监管机构或根据具体情况完全遵守 OECD数据互认系统的国家的 GLP 监管机构和

– 已认定按照 GLP原则进行运行的实验室。


• However, if required by further evaluation, additional (more adequate) tests (e.g. on organisms not included in OECD test guidelines) may be selected from the lists of guidelines developed by other regulatory bodies.

• Acceptable alternatives to the OECD test guidelines are published by the OPPTS, US-EPA, various EU countries (national standard methods) and organisations such as ASTM, ISO.

良好实验室规范 (GLP) 政策• 然而，若进一步评估有要求，可能会从其它监管机构

制定的指南列表中选取附加（更充分的）试验（如对OECD试验指南中未包括的有机体进行的试验）。

• OECD试验指南的可行替代品由 OPPTS( 预防、农药及有毒物质办公室 ) 、 US-EPA (美国联邦环境保护署 ) 、不同的 EU国家（国家标准方法）和 ASTM (美国材料与试验协会 ) 、 ISO (国际标准化组织 ) 等机构发布。

Seminar on EU Chemical Regulatory System

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