Seminar on EU Chemical Regulatory System

1. Seminar on EU Chemical Regulatory System REACH (Part 2) 17th July 2012

2. 欧盟化学制品监管体系专题研讨会 REACH (第二部分) 2012年7月17日

3. Registration Process • If you want export to EU, it is important that, until now, you know: • The substances you want to export • The state in which they are: Substances, mixtures and / or items. • The annual amount will be introduced in the European Union. • If you do not plan to export to the European Union, surely one of its customers will do that and ask you about your products.

4. 注册流程 • 如果你想向EU出口，很重要且需要你了解的是： • 打算出口的物质 • 这些物质的状态：物质、混合物和/或物件 • 引入EU的年进口量 • 如果你不打算向EU出口，肯定会有EU的客户来负责向EU出口，并询问你的产品。

5. Registration Process • Manufacturers and importers will need to obtain information on the substances they manufacture or import and use this information to assess the risks arising from the manufacture and uses of the substances and to ensure that the risks that the substances may present are controlled. “Investment in Knowledge pays the best interest” • Benjamin Franklin

6. 注册流程 • 制造商和进口商需要获得其制造或进口的物质信息并使用这一信息来评估制造和使用这些物质所带来的风险，以确保这些物质的风险可控。 “投资知识，收益无限” • 本杰明·富兰克林

7. Registration Process • If, through a only-representative or an importer, you have a pre-registration, you should prepare a registration dossier for you phase-in substance, and the deadline depends on the tonnage. • For non phase-in substances and for phase-in substances that have not been pre-registered an inquiry must always be submitted before proceeding with the registration of the substance. • Or, before submitting an update of a registration, due to a tonnage band increase, the registrant is obligated to inform ECHA of the additional information.

8. 注册流程 • 如果你已经通过唯一代表或进口商进行了预注册，你还需为分阶段物质准备一份注册档案，截止日期取决于吨位。 • 对于非分阶段物质和未进行预注册的分阶段物质，在进行物质注册前必须提交一份查询单。 • 或者，在提交注册更新前，由于吨位范围增加，注册者必须向ECHA欧洲化学品管理局通告相关的附加信息

9. Data sharing Purpose: • increase the efficiency of the registration system as well as to reduce costs and to reduce testing on vertebrate animals • To facilitate data sharing, prior to registration, all substances must either be pre-registered or an inquiry must be submitted. • The communication mechanism for phase-in substances is the Substance Information Exchange Forum (SIEF) established following pre-registration. • For non phase-in substances the mechanism is the inquiry process.

10. 数据共享 目的: • 提高注册系统的效率，减少开支，减少脊椎动物试验 • 为促进数据共享，在注册前，所有物质都必须进行预注册或提交查询单。 • 分阶段物质的通信机制为在预注册后建立的物质信息交换论坛（SIEF）。 • 非分阶段物质的通信机制为查询程序。

11. Data sharing principles • Data must be shared for the same substance in the case of information involving tests on vertebrate animals. • Before testing is carried out on vertebrate animals, a potential registrant must request available data either in the SIEF or through the inquiry process from the previous registrant. • Information not involving tests on vertebrate animals must be shared if requested by a potential registrant of the same substance. • The potential registrant may request the study he needs within the SIEF or from the previous registrant, as applicable.

12. 数据共享原则 • 如果信息涉及脊椎动物试验，关于同一物质的数据必须进行共享。 • 在对脊椎动物进行试验前，潜在注册者必须向SIEF或通过查询程序向先前的注册者提出获取相关数据的请求。 • 如果信息不涉及脊椎动物试验，但同一物质的潜在注册者提出了数据请求，则该数据也必须进行共享。 • 潜在注册者可以向SIEF或者先前的注册者要求获得相关的信息，若适用。

13. Data sharing mechanisms aims… • To ensure that sharing of studies which are already available and of their related costs is agreed amongst potential registrants in a fair, transparent and non-discriminatory way. • Importantly, in the case of lacking data, the aim of the sharing mechanism is for potential registrants of the same substance to agree who will undertake the necessary data collection to ensure that the test is carried out only once.

14. 数据共享机制的目标… • 确保对于每一位潜在注册者，现有研究数据的共享和相关的费用的收取均公正、透明且没有歧视，并就数据共享和费用收取获得所有潜在注册者的一致认可。 • 在数据不足的情况下，共享机制的目标则是帮助同一物质的潜在注册者来统一决定由谁负责必要的数据采集，以确保试验不会重复进行。

15. Pre-registration of phase-in substances • Each potential registrant of a phase-in substance in quantities of one tonne or more per year should have taken part in the pre-registration process in order to benefit from the later registration deadlines. • The pre-registration mechanism allows potential registrants to get in contact for the purpose of data sharing through the formation of a SIEF

16. 分阶段物质的预注册 • 分阶段物质数量达到或超过一年1吨的所有潜在注册者必须进行预注册，从而享受注册截止日期的推迟。 • 预注册机制允许潜在注册者通过成立SIEF建立相互联系，从而达到数据共享的目的。

17. SIEF formation • Who can join? • All potential registrants and data holders for the same pre-registered phase-in substance. • Companies that intend to register the same phase-in substance will join a Substance Information Exchange Forum (SIEF). • Downstream users and any person or organisation holding data relevant to a phase-in substance can participate in the SIEF if they have identified themselves as a data holder and are willing to share their information.

18. SIEF 组成 • 谁能参加SIEF? • 所有同一预注册的分阶段物质的潜在注册者和数据持有者 • 计划注册同一分阶段物质的公司将加入物质信息交换论坛 • 下游用户和持有与分阶段物质相关数据的任何人或机构，只要其确认数据持有者身份并愿意共享其信息，均可参加SIEF

19. SIEF formation • Joining a SIEF is a legal obligation for all registrants of pre-registered phase-in substances. Potential registrants must get active in their SIEFs now if they intend to register by 31 May 2013 or by 31 May 2018. • The work of a SIEF leads to one joint submission for each substance, therefore reducing costs and avoiding unnecessary animal testing. • Note that the responsibility for defining the ‘sameness’ of the substances lies with the SIEF participants.

20. SIEF 组成 • 所有预注册的分阶段物质的注册者有法律义务参加SIEF。潜在注册者若计划在2013年5月31日或2018年5月31日前进行注册，也必须从现在开始踊跃参加SIEF活动。 • 一个SIEF最后的工作成果是为每种物质进行一次联合提交，这样节省了开支且避免了不必要的动物试验。 • 需注意，定义物质是否为同一物质的责任应由SIEF参加者承担。

21. SIEF / Consortia • SIEFs have no prescribed legal form and they are independently managed by industry. ECHA is not involved in their operations. • The members of the SIEF are free to choose how to organise their cooperation under REACH. The forms of cooperation can vary from a simple structure to a more structured and complex organisation (e.g. legally established consortia). • For large SIEFs, consortia may be a more efficient type of cooperation to provide a binding means of complying with the data-sharing obligations and to prepare the registrations. • There is no requirement to form consortia under the REACH Regulation.

22. SIEF / 公会联盟 • SIEF无法定形式并由行业自主进行管理。ECHA不干涉其运行。 • SIEF的成员在遵守REACH法规的前提下，可自由选择其组织和运行的方式。运行方式可以很简单，也可以很复杂（如 依法成立的公会联盟）。 • 对于大型SIEF来说，公会联盟作为一种更高效的合作方式可提供一种既能履行数据共享义务又能为注册做准备的两全方法。 • REACH法规并未要求成立公会联盟。

23. Roles in a SIEF • Lead registrants. • A lead registrant must act with the agreement of the other co-registrants and submit the lead dossier of the joint submission. The lead registrant also usually coordinates the activities within the SIEF. • REACH does not specify rules on how the lead registrant should be selected. For example, the lead registrant may be the registrant who plans to submit their registration dossier by the earliest registration deadline. • Lead registrants are advised to inform ECHA of their nomination.

24. SIEF中的各个角色 • 主注册者. • 主注册者必须按照其他共同注册者的一致意见行动并负责提交联合提交的主档案。主注册者一般还负责协调SIEF的内部活动。 • REACH并未规定主注册者的选举方式。例如，主注册者可以是计划提交注册档案的注册截止日期最早的注册者。 • 建议主注册者向ECHA通告其当选的信息。

25. Roles in a SIEF • Member registrants. • Member registrants submit dossiers containing only information specific to their company and their substance, for example, information about substance identity, their identified uses and their production volumes. These submissions do not need to include the information already provided by the lead registrant.

26. SIEF中的各个角色 • 成员注册者. • 成员注册者提交的档案需包含其公司和物质的具体信息，如物质标识、物质明确用途和物质产量。提交中无需包含已由主注册者提供的信息。

27. Joint Dossier • Multiple registrants of the same substance are required by the REACH Regulation to jointly submit information on the intrinsic properties of the substance. • The REACH Regulation only requires that the lead registrant submits the joint part of the registration dossier. • Joint registration dossiers shall be submitted first by the lead registrant-

28. 联合档案 • REACH法规要求同一物质的多个注册者联合提交关于物质内在属性的信息。 • REACH法规仅要求主注册者提交注册档案的联合部分。 • 联合注册档案应首先由主注册者提交。

29. Data Sharing Agreements • SIEF members need to get an overview of the studies available among the SIEF members and agree on the need to generate new test data when information is missing. • Before conducting any new study involving testing on vertebrate animals, SIEF members shall request whether the study is already available from other participants within the SIEF. If the owner of an existing study refuses to provide either the proof of costs for the study or the study itself, the REACH Regulation sets rules to settle such data sharing .disputes

30. 数据共享协议 • SIEF 成员需了解各个SIEF成员的现有研究概况并在信息缺失的情况下，就需要形成新的试验数据协商一致。 • 在进行任何脊椎动物试验之前，SIEF成员必须了解SIEF内的其他参与者是否已具备相关研究信息。如果现有研究信息的所有者拒绝提供研究信息和研究成本证明，REACH法规将制定相关规则，解决此类数据共享和争议问题。

31. Data Sharing Agreements (2) • Before conducting any new study not involving testing on vertebrate animals, SIEF members may ask other participants whether they already have those studies. However, if the owner of a study refuses to provide either the proof of costs for the study or the study itself, the other SIEF member(s) need to proceed with registration as if no relevant study is available within the SIEF.

32. 数据共享协议(2) • 在进行不涉及脊椎动物试验的新研究前，SIEF成员可以咨询其他参与者是否持有此类研究信息。然而，如果此研究信息的持有者拒绝提供研究信息或研究成本证明，则当作SIEF内并不存在相关研究信息，其他SIEF成员需继续进行注册手续。

33. Data Sharing Agreements (3) • If a study is not available within a SIEF, only one study per information requirement shall be conducted by a SIEF member acting on behalf of the others. • If the missing study is listed in Annexes IX (and X) of the REACH Regulation (information requirements for tonnage bands > 100 tonnes per annum), the SIEF members cannot proceed with the testing directly but have to first submit a testing proposal in their joint registration dossier.

34. 数据共享协议(3) • 如果在SIEF内不存在某项研究信息，可由一位SIEF成员代表所有其他成员提出信息要求，对每项研究仅（能要求一次。 • 如果缺失的研究信息有列入REACH法规的附录 IX (和X) （对年吨位 > 100吨的信息要求），SIEF成员无法直接继续进行试验，而需首先在其联合档案中提交一份试验计划书。

35. The inquiry dossier • There are two options to prepare and submit an inquiry dossier for non phase-in and non pre-registered phase-in substances: • Preparing an inquiry dossier with REACH-IT • Preparing an inquiry dossier with IUCLID 5

36. 查询档案 • 对于非分阶段物质和分阶段物质有两种制备和提交查询档案的选择： • 使用REACH-IT 制备查询档案 • 使用IUCLID5制备查询档案

37. REACH-IT • The REACH-IT system is a central system that runs at ECHA. REACH-IT has two fundamental groups of parties for which it provides appropriate functions. • Industry interface: this is the place where a company can, for example, sign-up, pre-register substances, obtain contact details of other companies having pre-registered the same substance, submit registrations, download invoices and view the status of submitted registrations and payments. In addition, it allows dossier preparation, e.g. Inquiry. • Users: manufacturers, importers, third party representatives, Only Representatives, downstream users. • Agency interface: this part of REACH-IT supports the day to day work in the regulatory process management of ECHA. • The users of the Agency interface are ECHA staff and MSCA staff.

38. REACH-IT • REACH-IT系统是ECHA运行的中央系统。REACH-IT 主要向两个基础群体提供服务。 • 工业接口: 在这里公司可以，比如说登记、预注册物质，获得已经预注册同一物质的其它公司的联系方式，提交注册，下载发票，查看提交注册和付款状态。另外，也支持档案制备，如查询单。 • 用户: 制造商、进口商、第三方代表、唯一代表、下游用户 • 机构接口: REACH-IT的这个接口支持ECHA监管程序管理的日常工作。 • 机构借口的用户为ECHA（欧洲化学品管理局）和MSCA（会员国主管机构）职员。

39. Differences between REACH-IT and EUCLID 5

40. REACH-IT 和 EUCLID 5的区别

41. REACH-IT

42. REACH-IT

43. IUCLID 5

44. IUCLID 5

45. IUCLID 5 • IUCLID 5 is the software application developed for a provided to Industry, free of charge, to capture and store data on user’sown substances in their local IT environment and submit these data in the correct format to ECHA. • For more information on IUCLID 5, see the IUCLID 5 website at http://iuclid.eu

46. IUCLID 5 • IUCLID 5 是一款为工业服务而研发的免费软件应用程序，用于在用户本地IT环境中捕获和存储关于用户物质的数据并以正确的形式将这些数据提交给ECHA。 • 更多关于IUCLID5的信息参见其网站http://iuclid.eu

47. Steps for creating an inquiry dossier Step 1.- Creating the legal entity for the inquirer. Step 2.- Creating the reference substances related to the inquired about substance. Step 3.- Creating the substance dataset for the inquired about substance. Step 4.- Entering information on the inquired about substance. Step 5.- Creating an inquiry dossier Step 6.- Exporting the inquiry dossier from IUCLID 5 Step 7.- Submitting the inquiry dossier to ECHA.

48. 创建查询档案的步骤 步骤 1.- 创建查询人的法人实体 步骤 2.- 创建关于查询物质相关的参考物质 步骤 3.- 创建查询物质的物质资料组 步骤 4.- 输入查询物质的相关信息 步骤 5.- 创建查询档案Creating an inquiry dossier 步骤 6.- 从IUCLID5中导出查询档案 步骤 7.- 向ECHA提交查询档案

49. The inquiry dossier • “Identity of the inquirer” • This will include contact details and the location of the inquirer's production site, where relevant for the purposes of data sharing. • The “Legal entities” are used in IUCLID 5 to provide contact details on the companies involved in processes under REACH. • “Substance identity” • The information required for substance identity is identical to that required in the technical dossier for registration (Annex VI (2)). Therefore the work done in the inquiry dossier, will serve for the subsequent registration dossier. • In IUCLID 5, the information related to that substance (such as the identity of the substance, its composition, etc.) should be specified in the Substance dataset created for that substance.

50. 查询档案 • “查询者身份” • 这包括联系方式和查询者的生产地址，这都是与数据共享相关的。 • IUCLID5使用“法人实体”提供涉及REACH程序的公司的联系方式。 • “物质标识” • 物质标识要求的信息与注册技术档案（附录VI (2)）所要求的信息完全一致。因此，查询档案的信息可在之后的注册档案中继续使用。 • 在 IUCLID 5中,应该在为该物质创建的物质数据组中，对与该物质相关的信息（如物质标识、组成等）作详细说明