3.3.3. Consideration of information requirements 3.3.3. 考虑信息要求
The next step is for the potential registrant to identify precisely what are the information requirements for the substance that they intend to register, considering in particular the tonnage band that is relevant to them, the physical parameters of the substance (relevant for technical waiving of tests) and uses/exposure patterns (relevant for exposure based waiving). 下一步是潜在注册人准确确定他们打算注册的物质的信息要求是什么，特别是考虑与他们相关的吨位带、物质的物理参数（与技术豁免测试相关）和用途/暴露模式（与基于暴露的豁免相关）。
If, following the inquiry, the potential registrant was informed that there are other potential registrants, they should contact them so all potential registrants can identify their information requirements. 如果在调查后，潜在注册人被告知还有其他潜在注册人，他们应该联系他们，以便所有潜在注册人都能确定他们的信息要求。
NB: Potential registrants are only required to compensate financially for the data required by REACH according to their tonnage band. 注意：潜在注册人只需根据其吨位范围对 REACH 要求的数据进行经济补偿。
As described in more detail in the Guidance on Registration, Article 12 REACH requires registrants to: 如《注册指南》中更详细地描述的那样，REACH 第 12 条要求注册者：
provide all relevant and available physicochemical, toxicological and ecotoxicological information that is available to them, irrespective of tonnage (this includes data from a literature search); 提供他们可获得的所有相关和可用的理化、毒理学和生态毒理学信息，无论吨位如何（这包括来自文献搜索的数据）;
as a minimum, fulfil the standard information requirements as laid down in Column 1 of REACH Annexes VII to XX for substances produced or imported in a certain tonnage band, subject to adaptation possibilities, as described below. 至少满足 REACH 附录 VII 第 1 栏中规定的标准信息要求， XX 适用于在特定吨位范围内生产或进口的物质，但要根据调整的可能性，如下所述。
The simplified list of information requirements is available here: http://echa.europa.eu/regulations/reach/registration/informationrequirements. 此处提供了简化的信息要求列表：http://echa.europa.eu/regulations/reach/registration/informationrequirements。
In case the registrant makes use of a possibility to adapt the information requirement, they should indicate it clearly and justify each adaptation in the registration dossier. Indeed, for each of the REACH Annexes VII to X, Column 2 lists specific criteria (e.g. exposure or hazard characteristics), according to which the standard information requirements for individual endpoints may be adapted or omitted. In addition, registrants may adapt or omit the required standard information set according to the general rules contained in Annex XI of REACH which refer to situations where: 如果注册人利用可能性调整信息要求，他们应在注册档案中明确说明并证明每次调整的合理性。事实上，对于每个 REACH 附录 VII 至 X，第 2 列列出了具体标准（例如暴露或危险特征），根据这些标准，可以调整或省略各个终点的标准信息要求。此外，注册人可以根据 REACH 附件 XI 中包含的一般规则调整或省略所需的标准信息集，这些规则涉及以下情况：
testing does not appear scientifically necessary; 检测似乎没有科学必要;
testing is technically not possible; 测试在技术上是不可能的;
testing may be omitted based on exposure scenarios developed in the chemical safety report (CSR) 根据化学品安全报告 （CSR） 中制定的暴露情景，可以省略测试
Note that ECHA also provides a practical high-level overview of the REACH requirements for registrants of substances manufactured or imported at tonnages of 1-100 tonnes per year. This “Practical guide for SME managers and REACH coordinators” is available on the ECHA website at: https://www.echa.europa.eu/practical-guides. 请注意，ECHA 还为每年生产或进口 1-100 吨的物质的注册者提供了 REACH 要求的实用高级概述。该“中小企业管理者和 REACH 协调员实用指南”可在 ECHA 网站上获得：https://www.echa.europa.eu/practical-guides。
NB: The information requirements have been revised ^(38){ }^{38} and may change again. If there is no longer a need to provide certain information, the potential registrants do not need to provide or negotiate access for this information (even if the data has already been generated and submitted by the existing registrants). 注意：信息要求已修订 ^(38){ }^{38} ，可能会再次更改。如果不再需要提供某些信息，则潜在注册人无需提供或协商访问此信息（即使数据已由现有注册人生成和提交）。
For substances identified in Article 3(20) REACH (eg. EINECS substances), manufactured or imported between 1 and 10 tonnes per year, the full information requirements are only applicable if one or both of the criteria laid down in Annex III of REACH are met ^(39){ }^{39}. In order to support the registrants, ECHA has generated an inventory of substances for which there is evidence that they would possibly fulfil these criteria (i.e. for those substances submitting only physicochemical information will not be sufficient) and support material outlining an effective step by step procedure for companies to consider REACH Annex III in the context of their registration ^(40){ }^{40}. 对于 REACH 第 3 条第 （20） 款中确定的物质（例如。EINECS 物质），每年生产或进口 1 至 10 吨，只有在满足 ^(39){ }^{39} REACH 附件 III 中规定的一项或两项标准时，完整信息要求才适用。为了支持注册者，ECHA 编制了一份物质清单，有证据表明它们可能满足这些标准（即，对于那些物质，仅提交理化信息是不够的）和支持材料，概述了公司在注册 ^(40){ }^{40} 时考虑 REACH 附件 III 的有效分步程序。
When the REACH Annex III criteria are not met, only the physicochemical information requirements in REACH Annex VII need to be fulfilled for phase-in substances below 10 tonnes per year. 当不满足 REACH 附录 III 标准时，对于每年低于 10 吨的分阶段实施物质，只需满足 REACH 附录 VII 中的理化信息要求。
For substances manufactured or imported in quantities of 10 tonnes (or more) per year per registrant, certain information must also be documented in the chemical safety report (CSR). At least all the information required under Article 10(a) REACH for the technical dossier and under Article 10(b) REACH for the chemical safety report (CSR) needs to be documented in the specified reporting formats (Annex I of the REACH Regulation). 对于每个注册人每年生产或进口 10 吨（或以上）的物质，还必须在化学品安全报告 （CSR） 中记录某些信息。至少 REACH 第 10 条 （a） 款规定的技术档案和 REACH 第 10（b） 条规定的化学品安全报告 （CSR） 所要求的所有信息都需要以指定的报告格式（REACH 法规附件 I）进行记录。
The information requirements for certain types of intermediates manufactured and used under strictly controlled conditions are reduced and there is no requirement to carry out a chemical safety assessment for them. If the substance is an intermediate 对在严格控制条件下生产和使用的某些类型的中间体的信息要求有所降低，并且不需要对其进行化学安全评估。如果该物质是中间体
manufactured and used under strictly controlled conditions, the potential registrant needs to provide any information which is freely available to them to ECHA. Thus, the potential registrant does not need to purchase a letter of access in order to submit more information on the substance than what was already available to them. The only exception to that rule concerns the registration of a transported isolated intermediate in quantities of more than 1000 tonnes per year, where requirements of Annex VII REACH apply and thus potential registrants will need to share data and its costs with the existing registrants. 在严格控制的条件下制造和使用，潜在注册人需要向 ECHA 提供他们免费获得的任何信息。因此，潜在注册人无需购买访问函即可提交比他们已经可用的内容更多的内容信息。该规则的唯一例外涉及每年超过 1000 吨的运输分离中间体的注册，其中附件 VII REACH 的要求适用，因此潜在注册人需要与现有注册人共享数据及其成本。
Further information on substances used as intermediates and their possibly reduced information is available in section 2.2.5, Obligations related to registration of intermediates, of the Guidance on registration and in the Practical Guide “How to assess whether a substance is used as an intermediate under strictly controlled conditions and how to report the information for the intermediate registration in IUCLID”, available at https://www.echa.europa.eu/documents/10162/23036412/pg16 intermediate regist ration en.pdf. 有关用作中间体的物质及其可能减少的信息的更多信息，请参阅注册指南的第 2.2.5 节，与中间体注册相关的义务，以及实用指南“如何评估物质是否在严格控制的条件下用作中间体以及如何在 IUCLID 中报告中间体注册的信息”， https://www.echa.europa.eu/documents/10162/23036412/pg16 Intermediate Regist Ration en.pdf 提供。
NB: This step requires the potential registrant to identify precisely what their information requirements are, considering in particular the tonnage band that is relevant to them. In considering its information needs, a potential registrant may consider the possible application of data waivers, for instance on the basis of uses/exposure pattern. 注意：此步骤要求潜在注册人准确确定其信息要求是什么，特别是考虑与他们相关的吨位范围。在考虑其信息需求时，潜在注册人可以考虑可能应用数据豁免，例如根据用途/暴露模式。