下游用户化学品安全报告应包含哪些内容？

下游用户化学品安全报告应包含哪些内容？

What should the downstream user chemical safety report contain?

实用指南 17：“如何准备下游用户化学品安全报告”包含有关如何执行下游用户化学品安全报告 (DU CSR) 的实用信息。当您对纳米形态执行 DU CSR 时，建议您遵循指南中详述的步骤，同时考虑到下面详述的纳米形态的特殊性，以确定您应该遵循以下三种方法中的哪一种。DU CSR 的内容取决于您是否需要评估和描述：新的纳米形态（由本体创建或由纳米形态修改而成），或者仅仅是暴露场景中已经涵盖的纳米形态的新用途或新使用条件，或者新的纳米形态以及新用途和使用条件。每当有新的纳米形态时，您很可能必须遵循实用指南中的方法 C（其中包括审查危害评估）。纳米形态信息如果您得出结论，您创建的纳米形态包含在供应商安全数据表 (SDS) 中的信息中，您可以遵循以下部分（有关用途和使用条件的信息）的建议。如果您得出结论，您创建的纳米形态未包含在内，并且您打算自行评估，则必须确定供应商执行的危害评估是否适用于你的纳米形态。你不能简单地假设你的纳米形态在供应商进行的危害评估的范围内。你必须对原因有合理的解释，记录你的结论，并在执法机构要求时提供（见下文原则）。指南“注册和物质识别指南的纳米形态附录”在第 4 节中提供了一系列原则的建议，这些原则有助于定义一组纳米形态的边界，其中这些边界内的变化（REACH 附件 VI 的 2.4.2 至 2.4.5 中的表征参数）不会影响危害评估。下游用户（你）可以应用相同的原则来确定你创建的纳米形态及其危害评估是否在供应商的纳米形态/危害评估范围内。本指南还提供了必须考虑哪些因素才能证明供应商进行的危害评估涵盖您的纳米形态。如果遵循上述原则后，您仍无法断定供应商的危害评估适用于您的纳米形态，则必须对您的纳米形态进行危害评估。虽然并非明确要求，但为了对纳米形态进行危害评估，预计需要遵循附件 VII 至 X 中规定的信息要求。您可以应用横向参照或其他调整措施来处理与您的纳米形态相关的危害端点。 《适用于 QSAR 和化学品分组指南的纳米形态附录 R.6-1》提供了有关如何证明在同一物质的纳米形态和/或纳米形态组与非纳米形态（本体）之间使用危害数据的建议。如果只能通过测试获得危害评估所需的信息，则应遵循 IR&CSA 指南（端点特定指南）的三个纳米特定附录（第 R.7a、R.7b 和 R.7c 章）中提供的建议。如果只能通过测试根据附件 IX 和 X 标准信息要求获得此信息，则必须根据第 38 条向机构提交测试策略提案。有关用途和使用条件的信息如果在检查供应商确定的用途或适用于这些用途的使用条件时，您得出结论认为（某些）用途未涵盖（参见问答 1833），则必须执行此步骤。这涉及到识别供应商 SDS 中未涵盖的用途和使用条件，并生成这些用途的暴露场景。可以遵循实用指南 17：“如何编制下游用户化学品安全报告”中的建议。但是，应注意以下几点：当供应商已经确定并评估了用途，但您确定您的纳米形态不同时，您不能假设您创建的纳米形态的暴露潜力/（例如尘埃含量）是相同的。暴露估算可能需要改进。在执行暴露估算步骤时，应注意所采用的方法（直接测量或暴露估算建模工具）必须适用于纳米形态。

Practical Guide 17: “How to prepare a downstream user chemical safety report” contains practical information on how to perform a downstream user chemical safety report (DU CSR). When you perform a DU CSR for a nanoform, it is advisable to follow the steps detailed in the guide, taking into account the specificities for nanoforms detailed below to determine which of the three approaches explained you should follow.The content of the DU CSR would depend on whether you need to assess and describe:a new nanoform (created from bulk or modified from a nanoform), oronly new uses or new conditions of use of a nanoform already covered by an exposure scenario, orboth a new nanoform and new uses and conditions of use.Whenever there is a new nanoform, it is likely that you will have to follow Approach C in the Practical guide (which includes reviewing the hazard assessment).Information on the nanoformsIf you conclude that the nanoform you created is covered by the information in your supplier’s safety data sheet (SDS), you can follow the advice of the section below (information on uses and conditions of use).If you conclude that the nanoform you have created is not covered and you intend to assess it by yourself, you must determine whether the hazard assessment performed by your supplier is applicable to your nanoform.You cannot simply presume that your nanoform is covered by the hazard assessment performed by the supplier. You must have a justification on why this is the case, document your conclusion and make it available to enforcement authorities upon request (see principles below).The Guidance ‘Appendix for nanoforms to the Guidance on Registration and Substance Identification’, provides advice in section 4 on a set of principles that helps to define the boundaries of a set of nanoforms, where variation (in the characterisation parameters in 2.4.2 to 2.4.5 of REACH Annex VI) within these boundaries does not affect the hazard assessment. The same principles could be applied by a downstream user (you) to determine whether the nanoform you have created and its hazard assessment falls within the boundaries of your supplier’s nanoform/ hazard assessment. The Guidance also gives some indication of what must be considered to justify that the hazard assessment performed by the supplier covers your nanoform.If, after following the above principles, you cannot conclude that the hazard assessment from your supplier is applicable to your nanoform, you must perform a hazard assessment for your nanoform. Though not an explicit requirement, the information requirements as specified under Annexes VII to X would be expected to be followed in order to perform the hazard assessment on the nanoform.You have the possibility to apply read-across or other adaptations to address hazard endpoints related to your nanoform. The ‘Appendix R.6-1 for nanoforms applicable to the Guidance on QSARs and Grouping of Chemicals’ gives advice on how to justify the use of hazard data between nanoforms and/or sets of nanoforms, and the non-nanoforms (bulk) of the same substance.If the information required to conclude on the hazard assessment can only be obtained by testing, you should follow the advice provided in the three nano-specific appendices to the Guidance on IR&CSA (endpoint specific Guidance), Chapter R.7a, R.7b and R.7c. Where this information can only be obtained by testing for Annex IX and X standard information requirements you must submit a proposal for a testing strategy to the Agency in accordance with Article 38.Information on use and conditions of useIf, when checking the uses identified by your supplier or the conditions of use applicable to the uses, you conclude that (some) are not covered (see Q&A 1833) you must perform this step. This involves the identification of uses and conditions of use that are not covered by the information in your supplier’s SDS and the generation of exposure scenario for these uses.The advice in the Practical Guide 17: “How to prepare a downstream user chemical safety report” can be followed. However, attention should be paid to the following:When the uses have been identified and assessed by the supplier but you have determined that your nanoform is different, you cannot assume that the exposure potential/ (e.g. dustiness) of the nanoform you have created is the same. The exposure estimation may need refinement.When performing the exposure estimation step, it should be noted that the method adopted (either direct measurement or an exposure estimation modelling tool) must be applicable to the nanoforms.