【正文】 進口商執(zhí)行或建議終端使用者執(zhí)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 manufacturer39。 暴露評估包括兩個步驟： 1）暴露情況說明 2）暴露評估 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 manufacturer39。 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. 化學安全評估步驟 風險評估 持久、生物累積和毒性物質(zhì)（ PBT） /高生 物累積和高持久 性物質(zhì)（ vPvB）評估。explosivity, 187。 – repeated dose toxicity。 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 lifecycle 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. 化學安全報告 ? 生產(chǎn)商的化學安全評估必 須對物質(zhì)制造和 所 有物質(zhì)明確用途進行說明而 ? 進 口商只需 要指出物質(zhì)的明確用途。 GLP 17th July 2020 歐盟化學監(jiān)管體制專題討論會 《 化學品注冊、評估、許可和限制 》 （第四部分） 化學安全報告，安全技術(shù)數(shù)據(jù)表，良好實驗室規(guī)范 2020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 化學安全報告 ? 對于每年生產(chǎn)或進口超過 10噸的物質(zhì)，注冊者需要在提交注冊材料的時候包括化學安全報告。 ? 《 化學品注冊、評估、許可和限制 》 的附件一有定義了化學安全報告的格式。 ? 化學安全評估必須考慮到生產(chǎn)（如需要）帶來的物質(zhì)生命周期的所有階段和明確使用方法，包括相關(guān)的廢棄階段和 物品使 用生命 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 municated ? 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 化學安全報告 第一部分 1. 風險控制措施小結(jié) 2. 宣告風險控制措施實施 3. 宣告風險控制措施交流 第二部分 ? 1. 明確物質(zhì)及其物理和化學特性 ? 2. 生產(chǎn)和使用 ? 3. 分類 和標示 ? 4. 環(huán)境命運特性 ? 5. 人類健康風險評估 ? 6. 人類健康的物理化學特性風險評估 ? 7. 環(huán)境風險評估 ? 、生物累積和毒性物質(zhì)（ PBT）和高生物累積 和高持久性（ vPvB）評估 ? 9. 暴露評估 ? 10. 風險特征描述 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 化學安全報告 化學安全評估應(yīng)該包括如下步驟： 風險評估： －人類健康風險評估 －物理化學風險評估 －環(huán)境風險評估 －持久、生物累積和毒性物質(zhì)（ PBT）和高生物累積 和高持久性（ vPvB）評估 如果物質(zhì)滿足 14（ 4）條列出的風險種類標準或被評估為持久、生物累積和毒性物質(zhì)（ PBT）和高生物累積 和高持久性物 質(zhì)（ vPvB），其化學安全評估需要包括如下附加步驟： 暴露評估 －暴露情況說明 －暴露評估 風險特征描述 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. 化學安全評估步驟 ? 風險評估 ? 應(yīng)該基于所有可得和相關(guān)信息，并需要在技術(shù)材料中報告出來。 and – CMR effects (carcinogenity, germ cell mutagenicity and toxicity for reproduction). 化學安全評估步驟 風險評估 －人類健康風險評估 目的是確定物質(zhì)的分類 和標示， 并明確暴露等級，該等級之上不應(yīng)對人暴露。flammability and 187。 －目的是明確物質(zhì)是否滿足附件十三給出的標準，如果滿足，需要對物質(zhì)的潛在廢棄排放進行描述。s production, the manufacturer or importer39。s or importer39。s or importer39。 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. ? 風險表征 ? 在化學安全報告中，針對人類健康和環(huán)境的每一 種暴露情況說明及 其相關(guān)結(jié)果和討論，都應(yīng)該有相應(yīng)的風險特征描述。該工具也為暴露評估和風險特征描述所需的信息提供了結(jié)構(gòu)范式，從 而有助于形成透 明的化學安全報告 . ? Registrants duty of munication ? 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 co