原创 《化学品注册、评估、许可和限制》（REACH）:中国企业预注册的时间所剩无几？

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Are you still unsure whether or not you need to pre-register, then later register, for the REACH Regulations? US companies must pre-register before 1 December 2008.
是否需要按照REACH法规的要求进行预注册，然后再进行正式注册？ 您是不是到现在还拿不准？
美国企业必需在<?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" />2008年12月1日前进行预注册。

Failure to pre-register means that the substance cannot be manufactured or put on the market until it has been fully registered.
不进行预注册就意味着企业在正式注册以前不能生产或者销售该化学品。

This would require the compilation and submission of a technical dossier which could take months for large volumes or hazardous substances.
由于化学品的数量庞大或本身具有危害，因此企业需要花几个月的功夫编写技术档案。

Pre-registration is optional but failure to do this means that after 1 December 2008 the substance will be treated as a non phase-in substance and from that point the requirement to register becomes immediate.
虽然预注册是非强制性的，但不进行预注册就意味着从2008年12月1起，该化学物质将被视为非分阶段化学物质(Non phase-in substance)。那时，登记的要求也会接踵而至。

Without the required information the European Chemicals Agency (ECHA) would reject the registration and so it would be illegal to manufacture, import or supply the substance.
如果没有提供必需的信息资料，欧洲化学品管理署 (ECHA)将拒绝登记，因此，生产、进口和供应该化学物质将被视为非法行为。

So, who may need to pre-register / register?
那么，哪些企业需要预注册/注册？

An equipment manufacturer imports materials such as alloy, paint, adhesives etc from a supplier outside the European Union (EU).
从欧盟外的供应商进口合金、油漆、粘合剂等产品的设备生产商。

If any of the chemicals contained within these materials exceeds 1 tonne per annum (tpa) then the manufacturer will need to pre-register, and then register, these substances.
如果上述材料每年所包含的化学物质达到1公吨，那么该生产商就需要对这些化学物质进行预注册，然后再进行注册。

Importers of equipment will need to register if equipment releases more than 1 tpa of a substance.
如果设备每年释放的化学物质达1公吨，那么该设备进口商需要注册。

Distributors who are also importers will be responsible for pre-registration and registration as exporters located outside of the EU cannot register.
由于欧盟外的出口商无法进行注册，所以同时为进口商的经销商就负责预注册和注册。

Chinese companies can appoint an “only representative” who pre-registers and registers these substances instead of the distributor.
中国企业可以委派一名“唯一代理人”代替经销商来对这些化学物质进行预登记和登记。

Pre-registration ensures that the chemical will be included in a staggered assessment and registration programme.
预登记确保该化学物质包含在一个没有互相重合的评估和注册计划之中。

This will start with substances of more than 1000 tpa or those of highest concern.
首先从每年超过1000公吨或者受关注程度最高的化学物质开始。

These must be registered along with the required data and information by 30 November 2010.

必须在2010年11月30日以前对这些化学物质及其规定的数据和信息进行注册。

100-1000 tpa must be registered by 31 May 2013 and finally 1-100 tpa by 31 May 2018.
每年含量在100公吨到1000公吨之间的化学物质必须在2013年5月31日前登记；每年含量在1公吨到100公吨之间的必须在2018年5月31日以前进行登记。

Pre-registration is via the ECHA website at http://echa.europa.eu/reachit_en.asp  where various options of how to pre-register are outlined.
可以通过欧洲化学品管理署的官方网站http://echa.europa.eu/reachit_en.asp预登记，上面列出了如何进行预登记的多种选项。

Fees for the actual registration process vary from a standard fee, with increasing levels of discount for medium, small and micro enterprises.
实际登记手续费用根据标准费用进行调整，中型、小型和微型企业可以享受不同的折扣比例。

As an example, the cost of registration for a substance of 10-100 tonnes would start at a standard rate of €4300 reducing to €3010 for a medium enterprise and as low as €430 for a micro enterprise.
例如： 注册10到100公吨化学物质所需的标准费用是4300欧元，中型企业为3010欧元，微型企业是430欧元。

However, the cost of authorisation of substances of high concern comes with a base fee of €50000, reducing to €25000 for a small enterprise.
但是，对受关注程度高的化学物质进行授权的标准费用为50000欧元，而小型企业为25000欧元。

 Under normal circumstances it will be necessary to re-apply for authorisation and pay the relevant fee again every five years.
正常情况是每五年重新申请授权并缴纳相关费用。

 Fees will also be adjusted in line with inflation.
费用会根据通货膨胀做出相应的调整。

Substances of very high concern will be included gradually in Annex XIV of the REACH regulation and cannot be placed on the market or used after a date (known as a “sunset” date) set by the ECHA unless the “use” is authorised.
受关注程度极高的化学物质会被逐渐添加到REACH法规的附件XIV中，且自欧洲化学品管理署设立禁止日期起（日落日），不得在市场上销售或使用，除非 “使用”获得了授权。

At present, no substances of very high concern have been formally identified but a “candidates” list will be published late in 2008 or early 2009. The first list of substances to be included in Annex XIV is expected by 1 June 2009.
目前，受关注程度极高的化学物质还没有正式加以确认，但“候选者”名单将会在2008年底或者2009年初公布，第一批化学物质目录将有望在2009年6月1日被添加到附件XIV中。

Restrictions and authorisations on use can apply to these substances irrespective of volume.
不管数量多少，目前所使用的限制和授权均适用于这些化学物质。