《REACH法规》预注册常见问题的解答 中英文对照

欧洲化学品管理署(ECHA)对于《REACH法规》预注册常见问题的解答

1. What is pre-registration?

Pre-registration is a REACH process taking place between 1 June and 1 December 2008. During this period all manufactures and importers of phase-in-substances in quantities of 1 tonne or more per year and producers/importers of articles containing substance(s) intended to be released in quantities of 1 tonne or more per year have the possibility to inform ECHA about which substances they intend to register.

Companies taking this opportunity are granted extended registration deadlines for their substances (see also question 1.4). Without

pre-registration, substances need to be registered before they are manufactured in the Community or placed on the market. These registration obligations apply from 1st June 2008.

1.什么是预注册？

预注册是欧盟REACH法规在2008年6月1日至2008年12月1日期间的一个实施步骤。在这期间，如符合以下两种情况下，这些物质和物品的生产商或进口商都将可能在这期间向欧洲化学品管理署（以下简称ECHA）通报其所打算要注册的物质：（1）如直接生产或进口分阶段物质（phase-in substances）且每年生产或进口量达到或超过1吨，（2）如生产或进口物品(articles)且物品中含有的这些物质将故意或打算释放，当其量达到或超过每年1吨时。凡预注册的公司，都可以享受相应的注册过渡期（详见问题1.4）如没有进行预注册，物质必须在欧盟境内生产或上市之前注册。这项预注册义务从2008年6月1日开始。

2. What is meant with extended registration deadlines?

Article 23 of the REACH Regulation provides for a scheme with staggered

registration deadlines for so-called ?phase-in substances?, depending on the tonnage

band and hazards of the substance:

? 30 November 2010 for CMR1 ≥ 1 t/y, R 50-532 ≥ 100 t/y and other substances ≥1000 t/y; or

? 31 May 2013 for other substances ≥ 100 t/y; or

? 31 May 2018 for other substances ≥ 1 t/y;

2.什么是延期注册时限？

REACH的第23条款规定了对于分阶段物质的注册时限，根据其生产量和物质有害程度的不同而加以区别。

对于CMR1每年生产含量大于1吨的，或是R 50-532 每年生产含量大于100吨的，以及其他分阶段物质每年生产含量大于1000吨的，注册时限为2010年11月30日；

对于其他分阶段物质每年生产含量大于100吨的，注册时限为2013年5月31日；

对于其他分阶段物质每年生产含量大于1吨的，注册时限为2018年5月31日。

3. How do I calculate the tonnage for pre-registration in order to

determine the envisaged registration deadline?

The actual amount of production and/or import and the forecasted tonnages will define the relevant registration deadline (depending on the tonnage band and hazards of the substance 30 November 2010 or 31 May 2013 or 31 May 2018). This should be taken into account for

pre-registration. The envisaged yearly quantity shall be calculated per calendar year. Detailed guidance and practical examples are provided in the Guidance on Registration (Section 1.6.2 – Calculation of volume to be registered and Article 3 (30) of the REACH Regulation).When

pre-registering substances that have different uses (intermediates, normal industrial use, PPORD3), only the estimated tonnage band corresponding to the quantities of the normal registration has to be filled in

3. 如何计算预注册时用于决定注册时限的物质吨位含量？

生产和/或进口的实际数量和预计的物质吨位含量决定了相关注册的时限（取决于吨位重量和物质有害程度，时限分为2010年11月30日、2013年5月31日和2018年5月31日三个时限）。在预注册时应考虑此问题。每年预计的含量应该在日历年基础上计算。具体的操作指南和实际案例详见《注册指南》第1.6.2小节“注册含量的计算” 和REACH法规第3（30）条款的规定。在预注册时，分阶段物质往往具有不同功用（中间体，常规工业生产使用，PPORD3），只需填写用于常规工业生产的分阶段物质的含量。

4. Which substances can be pre-registered?

Pre-registration applies only to so-called …phase-in? substances. If you wish to be nefit from the extended registration deadlines set out in the REACH Regulation, and you are a potential registrant of a phase-in substance manufactured or imported in quantities of 1 tonne or more per year, you should pre-register the phase-in substances concerned in order to benefit from the extended registration deadline.

4. 什么物质可以预注册？

预注册只适用于“分阶段物质”。如果贵公司希望得到REACH规定中的延期注册时限的待遇，并且贵公司生产或进口分阶段物质每年达到1吨或者1吨以上，那么贵公司应该进行预注册以享受延期注册时限的待遇。

5. What are phase-in substances?

Substances fulfilling at least one of the following criteria are phase-in substances(Article 3(20) of the REACH Regulation):

? Substances listed in the European INventory of Existing Commercial chemical

Substances (EINECS);

? Substances that have been manufactured in the EU (including accession countries on 1 January 2007) but have not been placed on the EU market after 1

June 1992;

? Substances that qualify as a so-called …no-longer polymer?;

Detailed information can be found in the guidance document …Guidance on registration? (section 1.7.1.1 – Phase-in substances).

5. 什么是分阶段物质

按照REACH法规第3（20）条款的规定，凡符合至少以下一种标准的，即为分阶段物质。

在“欧洲已存在商业化学物品目录”（EINECS）中列示的产品物质

自1992年6月1日以来，已经在欧盟地区生产（包括2007年1月1日起获准进入欧盟的国家）但还未进入欧盟市场的物质符合“不再视为聚合物”定义的物质。

详细信息请见《注册指南》第1.7.1.1小节“分阶段物质”。

6. Can I pre-register non-phase-in substances?

No, you cannot pre-register non-phase-in substances. Non-phase-in substances are substances that do not meet the definition of phase-in substances as provided in

Article 3(20) of the REACH Regulation. Non-phase-in substances are therefore normally new substances. For such substances, it will be important to proceed with registration as soon as possible from 1 June 2008 in order to minimize disruptions of manufacturing, placing on the market or use.

6. 非分阶段物质能否预注册？

不可以。非分阶段物质不能进行预注册。非分阶段物质是指不符合REACH法规第3（20）条款的规定的分阶段物质标准的物质。非分阶段物质通常是新的物质。对于此类物质，应在2008年6月1日起尽快注册，以降低注册给产品生产、市场流通和使用方面带来的不便。

7. Must recycled substances be pre-registered?

If the recycled substance is a phase-in substance, it is recommended that the recycler pre-registers this substance in order to benefit from the transitional provisions laid down in Article 23 and later on be exempted from the registration requirements if another pre-registrant registers the substance. Pre-registration of recycled substances is not obligatory but a decision against pre-registration may result in immediate registration obligations. Detailed information on recycled substances can be found in the guidance document …Guidance on registration?

(section 1.6.4.5 - Recycled or recovered substance already registered).

7. 再循环物质必须预注册吗？

如果再循环物质是分阶段物质，则建议对此类物质进行预注册以享受第23条款规定的过渡期条款，之后，如果有另外的生产商或进口商预注册了同类物质，则可以免去注册义务。再循环物质的预注册并非强制性的，但是如果不进行预注册，则可能导致立即履行注册的义务。对于再循环物质的详细信息请见《注册指南》第1.6.4.5小节，“已注册的再循环物质和再回收物质”。

8. What information do I have to submit when pre-registering?

Pre-registration takes place when the company submits electronically the required information to ECHA (Article 28(1) of the REACH Regulation). This information includes:

? The name of the substance identified by the EINECS, CAS, IUPAC-name or

other identity codes.

? The name of your company, the address and the name of the contact person:

o When your company consists of several legal entities, manufacturing in the EU or importing the same substance, each legal entity has to

pre-register separately;

o You can appoint a third party representative to represent you for all the proceedings involving discussions with other manufacturers, importers and downstream users. If you do not wish to make your contact details available to other pre-registrants you should use a third party representative.

? The envisaged registration deadline and the tonnage band; ? Optionally, identifiers of related substances which may be rele vant for deriving data for the substance pre-registered. This is a way to indicate which data can be shared by read-across, (quantitative) structure-activity relationships ((Q)SARs)) and grouping of substances.

Detailed information can be found in the guidance document …Guidance on data sharing?4 (Section 3.8 – How to pre-register a substance) and in the document…Practical Steps for Pre-registration? (What information has to be provided for pre-registration?).

8. 在预注册阶段，需要提供那些信息？

预注册时公司须按照REACH法规第28条第1款的规定用电子的方式向ECHA提供相关信息。具体需要提供的信息如下：由EINECS, CAS, IUPAC规定的物质的名称或其他号码

公司名称，地址和联系人姓名

如果公司是由多个在欧盟生产或进口同一物质的法人实体组成，则每个法人实体都应分别进行预注册。

可以指定第三方代表进行预注册，包括与其他生产商、进口商和下游用户的讨论事宜等。如果公司不希望向其他预注册者公布公司具体联系方式，则可以指定第三方代表进行预注册。

预计的注册时限和物质吨位含量

此外，可以为预注册物质推导数据的相关标识符。这种方法可有助于分析哪些数据可以通过类推共享，可以帮助建立（数量上的）结构-活动关系((Q)SARs))和物质分组分类。

详细信息请见《注册指南》数据共享指南第3.8节“如何进行预注册”和文件《预注册实施程序》“预注册需要哪些信息”。

9. What are the advantages of pre-registration?

Besides the fact that pre-registration allows companies to benefit from extended registration deadlines, it also allows industry to adapt gradually to the new system.

More specifically pre-registration:

? Allows you to continue manufacturing or importing phase-in substances until the relevant registration deadline;

? Gives you additional time to organize the collection and assessment of available data, the sharing of existing data, and th e collective generation of missing information;

? Provides the basis to make existing informati on on substances e.g. non-testing information, substance to substance read-across, data from testing accessible to those who need the information for registration;

? Ensures that there will be no interruption in the supply to downstream users using your s ubstances.

9. 预注册的好处有哪些？

公司进行预注册，除了可以享受延期注册时限的待遇外，还可以使公司和产业能够有时间逐步适应新体系和新制度。具体地说，进行预注册，可以使公司能够在注册时限之前，仍旧继续生产或进口分阶段物质；

进行预注册，可以使公司有额外的时间来收集和评估可获得的数据，分享已有的数据，集体生成缺失信息。

进行预注册，可以提供基础平台，使那些需要相关信息注册的公司获得相关物质的已有的信息，比如非试验信息、从一个物质到另一个物质的推导，试验数据等等，

进行预注册，可以向下游用户保证使用公司的产品不会造成供应链的中断。

10. Do I have to pay a pre-registration fee?

Pre-registration is free of charge and does not establish any obligation to maintain production or import of substances.

10. 进行预注册，是否需要付费？

预注册不需付费，也无保证维持物质生产或进口的义务

11. Who can pre-register?

Any company (legal entity) that is required to register a phase-in substance as of 1 June 2008 may pre-register. These companies include: ? Manufacturers and importers established within the European Community of phase-in substances on their own or in preparations in quantities of 1 tonne or more per year, including intermediates;

? Producers and importers established within the European Community of articles containing substances intended to be released under normal or reasonably foreseeable conditions of use and present in those articles in quantities of 1 tonne or more per year;

Conversely, companies that manufacture substances, formulate preparations or produce articles outside the Community cannot pre-register as they have no obligations under REACH. They can nominate an only representative established within the Community to carry out the required pre-registration of their substances that are imported into the Community.

Detailed information can be found in the guidance document …Guidance on data sharing? (Section 3.4 – Who can pre-register?).

11. 那些公司可以进行预注册？

任何需要进行分阶段物质注册的公司（法人实体），均可以在2008年6月1日开始进行预注册。包括：

在欧共同体境内每年生产或进口分阶段物质本身或在配置品中的数量在1吨或1吨以上的公司，包括中间体；

在欧共同体境内物品的生产商或进口商，其产品中包含的物质在正常状态或合理可预见的使用条件下，打算释放出来且在这些物品中含量达到每年1吨及以上的；

具体信息请见指南文件“数据分享指南”第3.4节“哪些公司可以预注册？”

相反，不在欧共同体境内生产物质、制造配置品或生产物品的公司，由于其无义务履行REACH，因而不能进行预注册。他们可指定在欧共同体境内的唯一代表，来对他们销往欧共同体的物质进行预注册。

12. May a non-Community manufacturer pre-register?

No, non-Community manufacturers cannot pre-register their substances that are imported into the EU. Either the pre-registration is done by their importer(s) or, alternatively, non-Community manufacturers may appoint an …only representative?, a natural or legal person located in the Community (Article 8 of the REACH Regulation). The only representative is then legally responsible to fulfil the REACH obligations of importers which, in turn, are regarded as downstream users. Detailed information on the …only representative? can be found in the guidance documents …Guidance on registration? (section 1.5.3.4 - Only representatives of …non-Community manufacturer?) and …Guidance on data sharing? (Section 3.4 – Who can pre-register?).

12. 非共同体生产商是否可以进行预注册？

不可以。非共同体生产商不能对其销往欧盟的产品进行预注册。可由进口商或指定一个在共同体内的自然人或法人作为唯一代表，进行预注册（REACH法规第8条条款）。之后，唯一代表就承担进口商在REACH法规下的相关法律义务，进口商此时可视为下游用户。

有关“唯一代表”的详细信息请参见《注册指南》第1.5.3.4小节“非共同体生产商的唯一代表”和《数据共享指南》第3.4小节“哪些公司可以预注册？”

13. May a non-Community manufacturer of phase-in substances appoint an only representative for the purpose of pre-registration only?

Once appointed, the only representative shall be responsible for registration and thus also for all other obligations of importers under REACH, including pre-registration.

This does not only pertain to registration, but also all other relevant obligations, such as communication in the supply chain, notification of substances of very high concern(SVHC), classification and labeling and any obligations resulting from authorizations or restrictions etc. (see

Article 8(2) of the REACH Regulation). He will also become a participant of a Substance Information Exchange Forum (SIEF) (See Guidance on data sharing section 3.4 - Who can pre-register?).

Detailed information on the …Only Representative? can be found in the guidance documents …Guidance on registration? (section 1.5.3.4 - Only representatives of …non-Community manufacturer?).

13. 生产分阶段物质的非共同体生产商是否可仅为了预注册而指定一名唯一代表？

唯一代表一旦指定，其将负责注册，因而也将履行进口商在REACH法规下的其他义务，包括预注册。这不仅仅局限于注册，同时还包括了其他相关的义务，如在供应链中的沟通、高度关注物质的通报（SVHC）、分类和标签以及其他因授权或限制而引发的义务。（见REACH法规第8条第2款）。唯一代表还将参加物质信息交换论坛(SIEF)。详见《数据共享指南》第3.4小节“哪些公司可以预注册？”

有关唯一代表的详细信息请参看《注册指南》第1.5.3.4小节“非共同体生产商的唯一代表”。

14. How can a non-Community manufacturer help an only representative or an importer in preparing for pre-registration?

In most cases it is anticipated that …non-Community manufacturers? will provide all necessary data for the pre-registration by the only representative appointed by him or to his EU-based importer. The …non-Community manufacturer? may wish to make himself aware of the information requirements laid down in REACH and start collecting the relevant information. This may include the correct naming of the

su bstance and information on its composition. This is explained more in detail in the …Guidance for identification and naming o f substances under REACH?. It also includes assessment of all information available to the non-Community manufacturer about the intrinsic properties of the substances (see REACH annex VII to XI).

14. 非共同体生产商如何协助唯一代表或进口商准备预注册工作？

大多数情况下，非共同体生产商需要向其指定的唯一代表或其在欧共体境内的进口商提供所有预注册所需的数据。非共同体生产商可了解并开始收集REACH法规中规定的相关信息。这可能包括相关物质的正确名称和成份信息。这些内容在“REACH法规中物质鉴定和命名指南”中有详细解释。同时还包括非共同体生产商可以进行的对物质内在特性相关信息的评估。（见REACH法规附录第7至11条）

15. Does a downstream user have pre-registration obligations?

A downstream user who is not manufacturing or importing substances has no registration obligations and consequently he is not obliged to

pre-register a phase-in substance. However, after the publication of the list of pre-registered substances by ECHA (1 January 2009), a downstream user of a substance that does not appear on the list may notify ECHA of his interest in the substance, his contact details and the details of his current supplier. Following this publication, ECHA can provide contact details of the downstream user to this potential registrant. 15. 下游用户是否有预注册义务？

不生产或进口物质的下游用户没有注册的义务，因而其并没有义务对分阶段物质进行预注册。在ECHA 2009年1月公布所有已预注册的分阶段物质清单后，如果物质的下游用户发现一种物质没有出现在清单中，可向ECHA通报他对此物质感兴趣、并提供其公司的联系信息和目前其上游供应商的信息。公布清单之后，ECHA会向潜在注册人提供下游用户的联系信息。

16. How do I as a downstream user, know whether my supplier will pre-register the substances that he supplies to me?

If a supplier is located outside the EU, a downstream user established within the EU is reminded that he has registration obligations as an importer unless an only representative has been appointed (see also question 1.12). Downstream users established within the EU are encouraged to contact their EU-based suppliers as soon as possible and well before the end of the pre-registration period (1 December 2008) in order to find out about their intentions and to look for alternative future sources of supply in case the current supplier is not intending to register the substance. Likewise, manufacturers and importers are encouraged to inform their downstream users about their intention to (pre-) register the substance. The downstream users may wish to make appropriate contractual arrangements with their suppliers to ensure that they will comply with REACH and the pre-registration takes place within the pre-registration period. We recommend consulting the Navigator that is designed to help companies to learn more about their roles and obligations under REACH.

16. 作为下游用户，如何知道上游供应商是否对其供应的分阶段物质进行了预注册？

如果供应商不在欧盟境内，那么欧盟境内的下游用户则需履行其作为进口商的注册义务，除非供应商另外指定了唯一代表。（详见问题1.12）。鼓励欧盟境内的下游用户在预注册期结束前（2008年12月1日前）尽快联系其在欧盟境内的供应商，以便了解供应商是否会注册，并且在当前的供应商不打算对其物质进行注册时，寻找将来其他的供应渠道。相应地，鼓励生产商和进口商积极与其下游用户联系沟通，告知其是否会进行注册和预注册。下游用户可与上游供应商签订合同协议，以确保供应商执行REACH法规的规定，并在预注册期限内进行预注册。我们建议通过浏览器（Navigator）进行咨询，Navigator就是为了帮助企业更好了解其角色和履行REACH法规义务。

17. How can I find out which substances have been pre-registered?

ECHA will publish a list of pre-registered substances on its website by 1 January 2009 (Article 28(4) of the REACH Regulation). The published list will contain the names of substances and related identity codes. It will also include the names and other identifiers of substances that pre-registrants have indicated as being related substances on which e.g. read-across of test results could be possible. The list to be published will not contain information on the companies.

17. 如何知道某类物质已经进行了预注册？

ECHA将于2009年1月1日在其网站上公布已经进行预注册的物质清单（REACH法规第28条第4款）。公布的清单中将包括物质的名称和相关名称编号。名单中还将包括与预注册物质相关的物质名称和其他标识符号，比如试验结果的类推是否可行等等。公布的清单中将不会包括公司的信息。

18. Will the list of pre-registered substances be published only after pre-registration is closed?

Yes, the list of pre-registered substances will be published after closure of the pre-registration. ECHA will publish on its website a list of pre-registered substances

(Article 28(4) of the REACH Regulation) by 1 January 2009

18. 预注册物质清单只有在预注册结束之后才公布吗？

是的。预注册物质清单将在预注册结束之后公布。ECHA将于2009年1月1日在其网站上公布已经预注册物质的清单（REACH 法规第28条第4款）。

19. What will happen to companies that do not pre-register a substance?

A company that has not pre-registered a phase-in substance must have submitted a complete registration dossier for the substance to ECHA and received a decision on registration, including a registration number, from ECHA before it can further manufacture or import the substance.

19. 公司如果不进行预注册，会产生什么后果？

公司如果不对分阶段物质进行预注册，则必须向ECHA提交完整的物质注册档案并获得注册认可，包括注册号后，才能够继续生产或进口该物质。

20. Is it possible to pre-register after 1 December 2008?

You may pre-register after 1 December 2008 if you are:

? manufacturing or importing phase-in substances (on their own or in a preparation) after 1 December 2008 in quantities of 1 tonne or more per year and be able to prove that you do this for the first time; or

? producing or importing articles with an intended release of substances after 1 December 2008 in quantities of 1 tonne or mo re per year and are able to prove that you do this for the first time

If this is the case, the following deadlines apply:

? At the latest six months after manufacturing or importing exceeds the one-tonne threshold; and

? At least 12 months before the relevant transitional de adline for registration.

In this context, the manufacture or import …for the first time? means for the first time after the entry into force of the RE ACH Regulation (1 June 2007). Detailed information can be found in Article 28(6) of the REACH Regulatio n, in the guidance documents …Pre-registration and Data-sharing? (Section 3.6 –First time Manufacturers or Importers?) and …Guidance on requirements for substances in articles? (Section 6.4 - Time of checking compliance).

20. 2008年12月1日之后还能预注册吗？

凡符合以下条件，可以在2008年之后进行预注册。

在2008年12月1日后，生产或进口分阶段物质（物质本身或在配制品中存在的物质）每年达到1吨及以上的，并且能够证明是首次生产或进口这种物质的；

2008年12月1日之后，生产或进口的物品所含的打算释放物质的量每年达到1吨及以上的，并能够证明是首次生产或进口此种产品的

凡符合以上条件的，预注册期限为：

生产或进口该物质超过一吨标准线的随后六个月内；

相关注册过渡期结束前至少12个月之前；

在这种情况下，第一次生产或进口的含义是：2007年6月1日REACH法规实施之后的第一次生产或进口。详细信息可以参见《预注册与数据共享》第3.6小节“第一次生产或进口”和《对成形品中物质相关要求的指南》第6.4小节“检验执行的时间” 。

21. If I miss pre-registration and I submit a full registration dossier, do I have to wait to continue manufacturing or importing?

In these circumstances, you will have to submit a registration dossier and receive a registration number for that substance before you can continue manufacturing or importing it in quantities of 1 tonne or more per year starting from 1 June 2008

21. 如果错过了预注册，并且我方提交了完整的注册文件，那么是否必须停止生产或进口，等待注册批准？

从2008年6月1日起，对于年生产量在1吨及以上的物质，公司必须提交注册文件，等到获得注册号之后才能继续生产或进口该物质。

22. Is pre-registration of substances contained in articles required?

Producers or importers of articles containing substances intended to be released in quantities of 1 tonne or more per year have to

pre-register between 1 June and 1 December 2008 and may benefit from the option that other registrants in the Substance Information Exchange Forum (SIEF) include their use of the substance in the article in their registration dossier (Article 7(6) of the REACH Regulation).

22. 产品中含有的物质是否需要进行预注册？

对于生产或进口会释放分阶段物质的产品的生产商或进口商，如果其释放量达每年1吨及以上的，则需要在2008年6月1日至2008年12月1日期间对产品进行预注册，并可享受其他注册商在SIEF上的待遇，包括对于产品中含有的物质的使用方面的条款等等。（REACH法规第7款第6条）

23. What if I, as an article producer, find out after 1 December 2008 that my supplier did not pre-register? What if I as an article importer have missed the deadline to pre-register?

Please note that this only concerns articles containing substances intended to be released in quantities of 1 tonne or more per year. If an article supplier identifies a registration requirement after 1 December 2008 for a substance in articles he has been producing or importing already, he cannot submit a pre-registration any more and he has to limit his production/import to less than 1 tonne per year until：

? he has made a registration and received a registration number; or

? someone else registers his use or the substance.

23. 如果我方作为物品生产商，发现在2008年12月1之后，我的供应商没有进行于注册，该怎么办？如果我是物品进口商，错过了预注册期限，该怎么办？

应该注意的是，预注册是针对产品中释放相关物质每年达一吨及以上的产品进行的。如果产品供应商在2008年12月1日之后发现了在其生产或进口的产品中有需要进行注册的物质，供应商不可以提请进行预注册。此时供应商需要将其生产或进口限制在每年一吨以下的范围内。直到：

其注册获得批准，得到了一个注册号；

其他注册者注册了这种用途或者物质。

24. If a substance has not been pre-registered, can a downstream user benefit from Article 28(6) of the REACH Regulation and become a first time importer in order to register the substance himself after 1 December 2008?

Article 28(6) of the REACH Regulation also allows downstream users to become a first time importer, benefiting from the phase-in period corresponding to the respective tonnage band for substances that have not been pre-registered (the so called late pre-registration procedure). Article 28(5) of the REACH Regulation entitles downstream users to contact ECHA and indicate their interest in a missing substance. ECHA

will relay this interest, and a manufacturer/importer will potentially respond. The decision to pre-register and to further register, if taken, lies with the manufacturer/importer. Detailed information can be found in the …Guidance on data sharing? (see section §4.4 – What happens after the Pre-registration?).

24. 如果物质还没有进行预注册，下游用户能否享受REACH法规第28条第6款的待遇并且获得首次进口商资格，从而能够在2008

年之后自行对其物质进行注册？

REACH法规的第28条第6款规定允许下游用户具有首次进口商资格，从而对于没有进行预注册的物质能够根据不同吨位对应的注册期限享受过渡阶段的待遇（所谓“后预注册程序”）。REACH法规的第28条第5款规定下游用户有权向ECHA表达他们对没有注册物质的关注。ECHA将会向供应商和出口商转达下游用户的意见，并要求生产商和出口商做出回应。是否进行预注册或进一步注册的决定权在生产商和进口商方面。详见《数据共享指南》第4.4节“预注册之后的事宜”部分。

25. Should documentary evidence demonstrating the phase-in status of a substance without an EC number be submitted in parallel with

pre-registration?

The pre-registration of a phase-in substance without an EC number does not require the potential registrant to submit documentary evidence demonstrating the phase-in status of a substance within the meaning of Article 3(20)(c) of the REACH Regulation in his pre-registration (see Art. 28(1) of the REACH Regulation). The pre-registrant has nevertheless to confirm in the pre-registration that he is willing to claim phase-in status for his substance. Manufacturers/importers need to keep this information at the disposal of the enforcement authorities of the Member States at any time.

25. 证明没有欧盟编号的某物质是分阶段物质的文件证明材料是否需要与预注册材料一并提交？

在REACH法规第3条第20款c的规定下（详参REACH法规第28条第1款），对于没有欧盟编号的分阶段物质的预注册，并不需要注册商提交证明材料来证明物质为分阶段状态。不过，申请预注册的公司应当确认其所提交预注册的物质为分阶段物质。生产商或进口商应当准备好相关信息材料，以备任何时候成员国的执行机构检查。

26. What are the duties following from pre-registration?

All companies that pre-register will become a member of a Substance Information Exchange Forum (SIEF) for the substance concerned. The aim of a SIEF is to avoid duplication on the testing of substances and to agree on their classification and labelling. In a SIEF, companies are obliged to share animal testing studies to keep these tests to an absolute minimum. They may also share other data relevant for REACH. It is an opportunity to generate and obtain required information for registration required by the REACH Regulation in a cost-effective manner.

26. 预注册之后有什么需要履行的义务？

所有进行预注册的公司都将成为物质信息交流论坛（SIEF论坛）的成员。论坛的目的是为了避免在物质检测方面的重复，统一物质的分类和标签。在SIEF论坛内，将共享动物检测信息，从而使动物实验降低到最小程度。成员之间还将共享其他数据信息。这是一种生成和获得产品注册所需信息的低成本高效率的方法。

27. Can a downstream user participate in a SIEF and share data?

In accordance with the provisions of Article 28(7) of the REACH Regulation, downstream users may submit information on pre-registered substances as well as any other relevant information for those substances, with the intention of becoming a participant (Data Holder) of the corresponding SIEF.

When downstream users have data regarding safety, including hazard data, uses, exposure and risks, it is recommended that they communicate as early as possible with their suppliers in order to ensure the best possible use of their data. They can share data for fair recompense in the SIEF for that substance.

Detailed information can b e found in the …Guidance on data sharing? (see section 4.5 – How and when will a SIEF be formed?- and section 7 – Cost sharing).

27. 下游用户能否参加物质信息交流论坛（SIEF论坛）并分享数据？

根据REACH法规第28条第7款的规定，下游用户为了成为物质信息交流论坛的成员（数据持有者），可以提供预注册物质的信息和这些物质的任何其它相关信息。如果下游用户拥有关于物质的安全方面的信息，包括危害性数据，产品使用数据，风险暴露数据

等等，那么建议下游用户与其供应商尽早联系，以使数据能够得到最大限度的利用。下游用户对于数据的共享，将会在物质信息交流论坛中获得相应的报偿。