Seminar on EU Chemical
Regulatory System
REACH (Part 2)
17th July 2012
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
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.
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。
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
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
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.
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
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.
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。
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.
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。
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 nondiscriminatory 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.
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。
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
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。
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 phasein 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.
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
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.
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。
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.
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。
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.
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。
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.
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。
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-
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。
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
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。
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.
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。
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.
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。
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
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
REACH-IT
• The REACH-IT system is a central system that runs at ECHA. REACHIT 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.
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。
Differences between REACH-IT and EUCLID 5
REACH-IT
IUCLID 5
Web-based application
1- Client.Server application
2- Stand-alone application
[Decentralised system, installed locally]
Restricted to REACH Regulation
Used globally, and for other regulatory
purposes in addition to REACH (e.g. OECD
High Production Volume chemicals program
(HPV), EU Biocides legislation, etc,…
Application where dossiers are submitted by
users
Application which captures and stores
information on chemicals for various
regulatory purposes, globally.
Multi-party system where Industry and
Authority parties co-exist
Each installation is essentially a single partysystem.
REACH-IT 和 EUCLID 5的区别
REACH-IT
IUCLID 5
基于网络的应用程序
1- 客户端服务器应用程序
2- 独立的应用程序
[本地安装的分散系统]
仅限于REACH法规=
全球通用，除了REACH，还用于其它监管
目的（如OECD高产量化学制品计划HPV、
EU杀菌剂法案等）
由用户提交档案的应用程序
为多种监管目的捕获并存储化学制品信息
的全球性应用程序
行业和机构共存的多方系统
每个安装实质上都是单方系统
REACH-IT
REACH-IT
IUCLID 5
IUCLID 5
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
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
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.
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
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.
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
Reference Substance
• Reference substance is a link to the identity of a
chemical.
• The concept of a Reference substance enables you to
store identification information on a given substance or a
given constituent of a substance, such as chemical
names (EC name, CAS name, IUPAC name, synonyms,
etc), identity codes (e.g. EC number, CAS number),
molecular and structural information, in a central place.
This information can then be re-used in other datasets
without having to retype the information. The Reference
substance inventory is directly maintained by you, in
your local installation.
参考物质
• 参考物质与化学制品的标识相关
• 参考物质的概念使得我们能够将某一给定物质或物质
的组分的标识信息，如化学制品名称（EC名称、CAS
名称、IUPAC名称、同义词等）、标识号（如EC号，
CAS号）、分子和结构信息存储在一个中心位置。这
一信息因而可在其它数据组中被再次使用，而不需要
重新输入。参考物质目录由你在你的本地安装中直接
进行维护。
Reference Substance
• You can download the ca. 70,000 pre-filled Reference
substances from the IUCLID 5 web site and import them
to your local installation.
• You should also download the EC inventory from the
IUCLID 5 web site (unless already done during the IUCLID
5 installation). This inventory consists of a list of
substance identities which is based on a combination of
the following EU inventories: EINECS, ELINCS and NLPlist.
参考物质
• 你可以从IUCLID5的网站上下载ca. 70,000种预填的参
考物质并将其导入到你的本地安装。
• 你应该从IUCLID5的网站上下载EC目录（除非在
IUCLID5安装时已经下载）。这一目录包含根据以下
EU目录总和：EINECS, ELINCS 和NLP的物质标识列表。
Completed reference substance
已完成的参考物质
Substance dataset
• To create an inquiry dossier in IUCLID 5, you need first to
create a Substance dataset. A Substance dataset is the
repository of data, which is used as a basis to create the
dossier to be submitted to the ECHA.
物质数据组
• 在IUCLID 5上创建查询档案，首先要创建物质数据组
。物质数据组是一个数据知识库，用作创建提交ECHA
档案的依据。
Selecting the template from the pick-list
Mandatory sections are marked with red in IUCLID 5 and optional sections in green
从挑选列表中选择模版
Mandatory sections are marked with red in IUCLID 5 and optional sections in green
General Information
– Identification
• Name of the substance (Using reference substance
or creating a new).
• Contact person. Although the contact details of
your company are specified in the “Legal entity”,
you can also indicate the information details of the
contact person for that specific substance.
基本信息
– 标识
• 物质名称 (使用参考物质或创建新的）
• 联系人。尽管公司的联系方式在“法人实体”
中有说明，仍然可以对具体物质的联系人详细
信息进行说明。
General Information
– Composition
• Monoconstituent
–Specify indentity and composition of the
monoconstituent.
• UCVB
–Specify the identity of the UVCB.
–Specify the composition of the UCVB
• Multiconstituent
–Specify the composition of the multiconstituent
–Specify the identity of the multiconstituent
基本信息
– 组成
• 单组分
–说明单组份的标识和组成
• UCVB非结构性材料
–说明UVCB标识
–说明UCVB组成
• 多组分
–说明多组分组成
–说明多组分标识
General Information
Remember to follow the same procedure to complete the impurities and additives fields
基本信息
杂质和添加剂应遵守同样的程序
General Information
基本信息
Analytical information
- Analytical methods and spectral data field
- Describe the analytical methods used to
characterise your substance, and where appropriate,
the impurities and additives
- Optical activity field
- Provide information on the optical activity and
typical ratio of isomers, where applicable.
- Provide the analytical results to characterise the
substance, such as spectral data (UV, IR, NMR, MS,….),
chromatographic data,..
分析信息
- 分析方法和光谱数据领域
- 说明描述物质的分析方法，若适用，还需对杂质和
添加剂进行相关说明
- 光学活动领域
- 提供光学活动和典型同分异构物比例（若适用）
- 提供描述物质的分析结果，例如光谱数据 (UV, IR,
NMR, MS,….), 色谱数据,..
Production site
Specify your role in the supply chain:
-Manufacturer, Importer, Only representative, Producer of
article, Manufacturer and Importer, Manufacturer and
Producer of article, Manufacture and Importer and
Producer of article.
Provide the location of your production site.
-If you are EU manufacturer and EU Producers of articles is
mandatory.
-If you are an importer or only representative, ECHA
recommend this.
生产地址
说明你在供应链中扮演的角色：
-制造商、进口商、唯一代表、物品生产商、制造商和
进口商、物品制造商和进口商、物品制造商进口商和生
产商。
提供生产厂址地址
-如果你是物品的EU制造商和EU生产商，则必须提供生
产地址。
-如果你是进口商或唯一代表，ECHA只是建议提供生产
地址。
Tonnage band : information band
•
•
•
•
ANNEX VII (1 tonne or more)
ANNEX VIII (10 tonnes or more)
ANNEX IX (100 tonnes or more)
ANNEX X (1000 tonnes or more)
吨位范围: 信息范围
•
•
•
•
附录 VII (1 吨或以上)
附录 VIII (10 吨或以上)
附录 IX (100 吨或以上)
附录 X (1000 吨或以上)
ANNEX VII (1 tonne or more)
7 Information on the physicochemical properties of the substance
– 7.1 State of the substance (at 20 ºC and 101,3 kPa)
– 7.2 Melting/freezing point
– 7.3 Boiling point
– 7.4 Relative density
– 7.5 Vapour pressure
– 7.6 Surface tension
– 7.7 Water solubility
– 7.8 Partition coefficient n-octanol/water
– 7.9 Flash point
– 7.10 Flammability
– 7.11 Explosive properties
– 7.12 Self ignition temperature
– 7.13 Oxidising properties
– 7.14 Granulometry
附录 VII (1 吨或以上)
7 物质物理化学性能信息
– 7.1 物质状态 (在 20 ºC 和 101,3 kPa)
– 7.2 熔点/冰点
– 7.3 沸点
– 7.4 相对密度
– 7.5 汽压
– 7.6 表面张力
– 7.7 水溶性
– 7.8 正辛醇-水分配系数
– 7.9 闪点
– 7.10 可燃性
– 7.11 爆炸性
– 7.12 自然温度
– 7.13 氧化特性
– 7.14 粒度
ANNEX VII (1 tonne or more) (2)
8 Toxicological information
– 8.1 Skin irritation or skin corrosion (in vitro)
– 8.2 Eye irritation (in vitro)
– 8.3 Skin sensitisation (in vivo)
– 8.4.1 Mutagenecity (gene mutation in bacteria)
– 8.5.1 Acute toxicity (by oral route)
9 Ecotoxicological information
– 9.1.1 Short term aquatic toxicity on invertebrates(Daphnia)
– 9.1.2 Growth inhibition aquatic plants (algae)
– 9.2.1.1 Ready biodegradability
附录VII (1 吨或以上) (2)
8 毒性资料
– 8.1 皮肤过敏或皮肤腐蚀（体外）
– 8.2 眼部刺激（体外）
– 8.3 皮肤过敏（体内）
– 8.4.1 突变性（细菌基因突变）
– 8.5.1 急性毒性（通过口服）
9 生物毒理学信息
– 9.1.1无脊椎动物短期水生生物毒性 (水蚤)
– 9.1.2水生植物生长抑素(藻类）
– 9.2.1.1快速生物降解性
ANNEX VIII (10 tonnes or more)
8 Toxicological information
8.1.1 Skin irritation (in vivo)
8.2.1 Eye irritation (in vivo)
8.4.2 Cytogenicity in mammalian cells (in vitro)
8.4.3 Gene mutation in mammalian cells (in vitro)
8.5.2 Acute toxicity (by inhalation)
8.5.3 Acute toxicity (by dermal route)
8.6.1 Short-term repeated dose toxicity test (28 days)
8.7.1 Screening for reproductive/developmental toxicity
8.8.1 Toxicokinetics
9 Ecotoxicological information
9.1.3 Short-term aquatic toxicity to fish
9.1.4 Activated sludge respiration inhibition test
9.2.2.1 Hydrolysis as a function of pH
9.3.1 Adsorption/desorption screening
附录 VIII (10 吨或以上)
8 毒性资料
8.1.1 皮肤刺激（体内）
8.2.1 眼部刺激（体内）
8.4.2在哺乳动物细胞内的细胞遗传性（体外）
8.4.3在哺乳动物细胞基因突变（体外）
8.5.2急性毒性（吸入）
8.5.3急性毒性(由真皮）
8.6.1短期反复给药毒性试验（28天）
8.7.1筛查生殖和发育毒性
8.8.1毒代动力学
9生物毒理学信息
9.1.3鱼类短期水生生物毒性
9.1.4活性污泥呼吸抑制试验
9.2.2.1 水解做为pH值的函数
9.3.1吸附/解吸筛查
ANNEX IX (100 tonnes or more)
7 Information on the physicochemical properties of the substance
7.15 Stability in organic solvents and identity of relevant degradation products
7.16 Dissociation constant
7.17 Viscosity
8 Toxicological information
8.6.1 Short-term repeated dose toxicity test (28 days)
8.6.2 Sub-chronic toxicity (90 days)
8.7.2 Pre-natal developmental toxicity
8.7.3 Two-generation reproductive toxicity
附录 IX (100 吨或以上)
7 物质物理化学性质信息
7.15 在有机溶剂中的稳定性和相关降解产物的标识
7.16 离解常数
7.17 粘度
8 毒性资料
8.6.1短期反复给药毒性试验(28天）
8.6.2 亚慢性毒性（90天）
8.7.2产前胎儿发育毒性
8.7.3 两代繁殖毒性
ANNEX IX (100 tonnes or more) (2)
9 Ecotoxicological information
9.1.5 Long-term aquatic toxicity on invertebrates (Daphnia)
9.1.6 Long-term aquatic toxicity on fish
9.2.1.2 Ultimate degradation in surface water
9.2.1.3 Soil simulation testing
9.2.1.4 Sediment simulation testing
9.2.3 Identification of degradation products
9.3.2 Bioaccumulation in aquatic species (fish)
9.3.3 Further information on adsorption/desorption
9.4.1 Short-term terrestrial toxicity on invertebrates
9.4.2 Effects on soil micro-organisms
9.4.3 Short-term terrestrial toxicity to plants
附录 IX (100 吨或以上) (2)
9 生物毒理学信息
9.1.5对无脊椎动物的长期水生生物毒性（水蚤）
9.1.6对鱼类的长期水生生物毒性
9.2.1.2地表水最终退化
9.2.1.3土壤模拟测试
9.2.1.4沉积物模拟测试
9.2.3降解产物识别
9.3.2水生物种生物富集 （鱼类）
9.3.3 吸附/解吸的更多信息
9.4.1对无脊椎动物的短期陆地毒性
9.4.2 对土壤微生物影响
9.4.3对植物的短期陆地毒性
ANNEX X (1000 tonnes or more)
8 Toxicological information
8.6.3 Long-term repeated dose toxicity (≥ 12 months)
8.7.2 Developmental toxicity
8.7.3 Two-generation reproductive toxicity
8.9.1 Carcinogenicity
9 Ecotoxicological information
9.2 Further biotic degradation testing
9.3.4 Further information on the environmental fate and behaviour of the
substance and/or degradation products
9.4.4 Long-term terrestrial toxicity to invertebrates
9.4.6 Long-term terrestrial toxicity to plants
9.5.1 Long-term toxicity to sediment organisms
9.6.1 Long-term or reproductive toxicity to birds
附录 X (1000 吨或以上)
8 毒性资料
8.6.3长期反复给药毒性（12个月）
8.7.2发育毒性
8.7.3 两代繁殖毒性
8.9.1 致癌性
9 生物病理学信息
9.2进一步的生物降解测试
9.3.4 更多关于物质及/或降解产品的环境命运和性能的信息
9.4.4对无脊椎动物的长期陆地的毒性
9.4.6对植物的长期陆地的毒性
9.5.1对沉淀物有机体的长期毒性
9.6.1对鸟类的长期或生殖毒性
Create Inquiry Dossier from EUCLID
从EUCLID创建查询档案
Create Inquiry Dossier from EUCLID
从EUCLID创建查询档案
Submitting an inquiry dossier
• Go to ECHA website to access REACH-IT.
• In REACH-IT, “sign-up as a company”
– User account
– Company information. For consistency with IUCLID,
you should import the Legal Entity Object.
– Billing Information
– Contacts
– Validation
• Submit the IUCLID 5 inquiry dossier
提交查询档案
• 进入ECHA网站，使用 REACH-IT系统
• 在REACH-IT系统中， “作为公司登记”
– 用户帐户
– 公司信息 为与IUCLID保持一致，应导入法人实体对
象
– 结算信息
– 联系方式
– 确认
• 提交 IUCLID 5 查询档案
I submit my inquiry dossier to ECHA. What happens next?
• Once ECHA has received your inquiry dossier it will go
through some mandatory submission checks and then
the dossier will be assessed.
• If ECHA is able to process your inquiry dossier, you will
receive via REACH IT a communication which states your
inquiry number and information on previous registrants
and other inquirers of the same substance as well as
details of available (robust) study summaries, as
appropriate .
• If ECHA is not able to process your inquiry dossier, due to
insufficient and/or inconsistent information provided on
substance identification, you will receive via REACH IT a
communication detailing additional information required
将查询档案提交EHCA后，接下来？
• 查询档案一旦由ECHA收到，即会对档案进行一些必须
的提交审核，然后进行评估。
• 如果ECHA能够处理你的查询档案，你将会通过
REACH-IT收到一份通告单，上面有你的查询号、先前
注册者的信息和同一物质的其它查询以及现有（可靠
）研究信息总结（视情况而定）。
• 如果由于物质标识的相关信息不全和/或不一致而导
致ECHA无法处理你的查询档案，你会通过REACH-IT收
到一份通告单，告知你需要的详细附加信息。
I submit my inquiry dossier to ECHA. What happens next?
• You need to wait until you have received a
communication from ECHA stating your inquiry number
before submitting your registration as you may have legal
obligations to submit a joint registration and share data.
• The information submitted for the purposes of inquiry
will be treated as confidential and will not be published
on the dissemination website.
• If ECHA has indicated some changes to be done in our
inquiry dossier but has provided us with an inquiry
number, you do not need to submit another inquiry
dossier for this substance.
将查询档案提交EHCA后，接下来？
• 在提交注册前，你需要一直等到收到ECHA发来的通告
单，告知你的查询号。因为你有可能要承担提交联合
注册和共享数据的法律义务。
• 用于查询的提交信息将被保密且不会在信息发布网站
上发布。
• 如果ECHA指示你需要对查询档案做一些修改，但是给
了你查询号，你无需为这个物质再次提交查询档案
Data sharing process following an inquiry
查询后的数据共享流程
PPORD Exemption
• Substances intended to be used for product and process
orientated research and development (PPORD) can be exempted
from the obligation of registration for a period of five years.
Companies that wish to benefit from this exemption must submit
a PPORD notification to ECHA.
• Companies have to include in the notification the information on
substance identity, its classification, information related to the
PPORD programme, and the quantity of the substance expected to
be manufactured or imported during the five-year period of
exemption
• You can submit a PPORD notification to ECHA in order to be
exempted from the obligation to register using IUCLID 5, in a
similar way as Inquiry Dossier.
PPORD 豁免
• 用于产品与工艺研发（PPROD）的物质可得到五年的注册豁免
希望享受这一豁免的公司必须向ECHA提交PPROD通报。
• 公司必须在通报里包含物质标识、分类、和PPROD计划相关信
息和载豁免五年期内计划制造或进口的物质数量的信息。
• 和查询档案相似，为了免除使用IUCLID5注册的义务，你可以
向EHCA提交PPROD通告。
PPORD Dossier
PPORD 档案
Registration dossier
• The registration dossier is the set of information
submitted electronically by a registrant for a particular
substance
• Structure of the registration dossier.
– a technical dossier, always required for all substances
subject to the registration obligations;
– a chemical safety report, required if the registrant
manufactures or imports a substance in quantities of
10 tonnes or more per year.
注册档案
• 注册档案是由某个特定物质的注册者提交的一套资料
• 注册档案结构
– 技术档案，所有需要进行注册的物质都需要
– 化学安全报告,，若注册者制造或进口的某种物质
达到或超过每年10吨则需要
Chemical safety report
• It contains a detailed summary of information on the
environmental and human health hazard properties of
the substance, together with an assessment of exposure
and risk where such an assessment is required.
• It is the key source from which the registrant provides
information to all users of chemicals through the
exposure scenarios.
• The CSR format is defined in Annex I of REACH.
化学安全报告
• 化学安全报告包含物质环境和人身健康危害属性的详
细汇总信息、物质接触及风险评估（若需要）。
• 它是注册者向所有接触化学制品的使用者提供信息的
关键来源。
• CSR格式在REACH附录I 中有定义。
Registration dossier
• Format of the registration dossier
– The format of the registration dossier must be IUCLID.
• Submission of the registration dossier
– Each manufacturer or importer or only representative
is individually obliged to submit a registration dossier
for each of his substances
注册档案
• 注册档案格式
– 注册档案的格式必须是IUCLID。
– 注册档案提交
每名制造商或进口商或唯一代表都单独承担为每
种物质提交注册档案的义务。
Joint submission of data
• The joint submission of data applies both for the
registration of phase-in substances and that of non
phase-in substances.
• Registrants are required to jointly submit information on
the intrinsic properties of the substance (studies and
testing proposals, if any) and its classification and
labelling and can, if they agree to do so, also jointly
submit the guidance on safe use and the chemical safety
report (CSR)
• The joint submission of data does not eliminate the
obligation for each registrant (manufacturer, importer or
only representative) to also submit an individual dossier
数据的联合提交
• 数据的联合提交对分阶段物质和非分阶段物质均适用
• 注册者需要联合提交关于物质内在属性（包括研究实
验计划，如果有）、物质分类、标示的信息。如果注
册者同意，还可联合提交安全使用指南和化学安全报
告(CSR)。
• 数据的联合提交并不免除各个注册者（制造商、进口
商 或唯一代表）提交个人档案的义务。
Information requirements in joint submissions
Information requirements
Lead dossier
Joint
information
Member
Dossier
Individual
information
Individual
information
(a) Technical dossier
(i) identity of the manufacturer or
importer
X
X
(ii) identity of the substance
X
X
(iii) manufacture and use(s) of the
substance and if relevant use and
exposure categories
X
X
upon
agreement
upon
agreement
(iv) classification and labelling
(v) guidance on safe use
(vi) study summaries of information
derived from the application of
Annexes VII to XI
X
upon
agreement
X
联合提交的信息需求
信息需求
主档案
联合信息
成员档案
单个信息
单个信息
(a) 技术档案
(i) 制造商或进口商身份
X
X
(ii) 物质标识
X
X
(iii) 物质的制造和使用及相关的使用
和接触类别
X
X
协商一致
协商一致
(iv) 分类和标示
(v) 安全使用指南
(vi) 从附录VII到附录XI中衍生而来的
数据研究小结
X
协商一致
X
Information requirements in joint submissions
Information requirements
Lead dossier
Joint
information
Member
Dossier
Individual
information
Individual
information
(a) Technical dossier
(vii) robust study summaries of the
information derived from the
application of Annexes VII to XI if
required under Annex I
X
(viii) indication regarding the review
by an assessor of information submitted
under (iii), (iv), (vi), (vii) and (b)
X
(ix) proposals for testing
X
(x) exposure information for substances
in quantities of 1 to 10 tonnes
X
X
X
X
联合提交的信息需求
信息需求
主档案
联合信息
成员档案
单个信息
单个信息
(a) 技术档案
(vii) 若附录I有要求，对从附录VII到附
录XI中衍生而来的数据进行可靠研究
总结
X
(viii)有关在(iii), (iv), (vi), (vii) and (b)下
进行提交的信息的评估员 所做的审核
的指示
X
(ix) 试验计划
X
(x) 数量在1到10吨的物质的暴露信息
X
X
X
X
Information requirements in joint submissions
Information requirements
Lead dossier
Joint
information
Member
Dossier
Individual
information
Individual
information
(a) Technical dossier
(xi) request as to which information
in Article 119(2) should not be made
available on the Internet
(b) Chemical safety report
X
X
X
upon
agreement
upon
agreement
upon
agreement
联合提交的信息需求
信息需求
主档案
联合提交
成员档案
单个信息
单个信息
(a) 技术档案
(xi)关于第 119(2)中的哪些信息不应在
因特网上公开的请求
(b) 化学安全报告
X
X
X
协商一致
协商一致
协商一致
Joint submission of data
• Only once the lead dossier for the joint submission is
accepted for processing, in other words has passed the
business rules check step, may members submit their
member dossiers.
• When a potential registrant prepares to register a non
phase-in substance and the inquiry process results in
finding that one or several registrations have previously
been submitted for the same substance, the potential
registrant will not only need to share data with the
previous registrants, but he will also need to be part of
the joint submission
数据的联合提交
• 只有联合提交的主档案被批准进行处理后，即通过业
务规则审核步骤后，成员才可提交其成员档案。
• 当潜在注册者准备注册一项非分阶段物质且查询过程
的结果显示对这一物质已有一次或多次注册提交，则
潜在注册者不仅需要和先前的注册者进行数据共享，
还需要加入联合提交。
Opt-out possibilities
A manufacturer or importer may submit certain information
of the registration dossier separately (opt-out) in cases where
at least one of the following reasons (listed in Article 11(3) or
for substances in intermediates respectively in Article 19(2))
applies:
a) it would be disproportionately costly for him to submit this
information jointly; or
(b) submitting the information jointly would lead to disclosure of
information which he considers to be commercially sensitive and is likely
to cause him substantial commercial detriment; or
(c) he disagrees with the lead registrant on the selection of the
information submitted in the lead registration.
•The registrant remains a member of the joint submission and will
be able to submit his dossier only after the lead dossier has been
accepted for processing
退出联合提交的可能性
若至少由于以下一种原因（见第11条（3））或者符合第
19条（2）中关于分别存在于中间体中的物质的规定，则
制造商或进口商可以单独提交（退出联合提交）注册档案
的一些信息。
a) 联合提交这一信息将耗费其极大的开支；或
(b) 联合提交这一信息将暴露一些其认为具有商业敏感性的信息且
很可能给其带来巨大的商业损失；或
(c) 其不认同主注册者在主注册中提交的信息选择
•这样注册者仍作为联合提交的成员，且可以在主档案获批进
行处理后再提交其档案。
Access to information and confidential data
If justified, some pieces of information can be claimed
confidential for reasons to commercial interest of the
registrant or any other part.
– the degree of purity of the substance and the identity
of impurities and/or additives.
– the total tonnage band,…
The registrant may identify certain information listed in
Article 119 as confidential in his registration dossier for
reasons of commercial interests,
信息和保密数据的获取
如果合理，出于注册者或其他任意方的利益，可对有些
信息进行保密。
– 物质的纯度及杂质和/或添加剂的标识
– 总吨位范围…
出于商业利益，对第119条所涵盖的其注册档案中的一
些信息，注册者可对其保密。
Preparation of the registration dossier
注册档案的制备
Preparation of the registration dossier
General information on the registrant and on the registered
substance.
– Information regarding the registrant identification.
– Information regarding the role(s) of the registrant.
– Information required for traceability purposes.
– Information regarding the joint submission if
applicable.
– Information required for the identification of the
substance
注册档案制备
注册者和注册物质的基本信息
– 注册者身份相关信息
– 注册者角色相关信息
– 追溯性所要求的信息
– 联合提交相关信息（若适用）
– 物质识别所要求的信息
Preparation of the registration dossier
Classification and labelling.
– The registrant has to determine the classification and
labelling of his substance with respect to physicochemical properties, environment and human health.
– Within a joint submission, the lead dossier can
propose several classifications. If a registrant
disagrees, then he needs the “opt-out” option.
– Registration dossiers submitted from 1 December
2010, must include information according to the CLP
criteria.
– Classification and labelling inventory from ECHA.
Contain information from substances.
注册档案制备
分类和标识
– 注册者必须根据物质的物理化学性质，考虑环境和
人身健康来决定其物质的分类和标识。
– 在联合提交中，主档案可建议几种分类方法。如果
有注册者不同意，则其需选择“退出联合提交”。
– 从2010年12月1日起提交的注册档案必须包含CLP标
准所规定的信息。
– ECHA的分类和标识目录。包含物质信息。
Preparation of the registration dossier
Manufacture, use and exposure.
– Section 3 of Annex VI.
– At least the following data must be provided:
• Tonnage manufactured, imported or used for article
•
•
•
•
•
production in tonnes per year
Brief description of the technological process used (not
applicable for importers).
Information on the form and the physical state.
Information on waste quantities and composition of waste.
Brief description of the identified uses of the substance.
Information on the uses advised against and why
注册档案制备
制造、使用和接触
– 附录VI第三节
– 至少应提供以下数据：
• 制造、进口的吨位或用于物品生产的年吨位
•
•
•
•
•
使用的工艺流程的简单描述（不适用于进口商）
形式和物理状态的信息
废弃物数量和废弃物组成的信息
物质确认用途的简单介绍
不建议的用途和其原因
Preparation of the registration dossier
Manufacture, use and exposure.
•For substances manufactured or imported between 1 and
10 tonnes per year for which no CSR is required, the
registrant will have to provide information on exposure as
specified under section 6 of Annex VI.
•This information will include at least the types of use for
the substance (industrial, professional or consumer), the
significant routes for human and environmental exposure
and the pattern of exposure .
注册档案的制备
制造、使用和接触
•对于无CSR要求的制造和进口量位于年吨位1到10吨的
物质，注册者必须按照附录VI第六节提供与物质接触的
相关信息
•这一信息需至少包括物质的使用类型（工业、专业或
消费者）、接触人体和环境的主要途径以及接触模式。
Preparation of the registration dossier
Information requirements on intrinsic properties
•All relevant available information on the physicochemical,
toxicological and ecotoxicological properties of the substance as
specified under Annexes VII to X (and its adaptations according to
Annex XI) have to be provided in the form of study summaries or
robust study summaries.
•It is recommended to provide robust study summaries for all key
studies including for substances manufactured or imported at less
than 10 tonnes per year.
•A robust study summary is a detailed summary of the objectives,
methods, results and conclusions of a full study report providing
sufficient information to make an independent assessment of the
study minmising the need to consult the full study report
注册档案制备
关于内在属性的要求信息
•附录VII到附录X（及其根据附录XI所做的更改）所提及的物质的
物理化学性质，毒性性质和生物病理学性质的所有相关可得信息
都必须以研究总结或可靠研究总结的方式提供。
•建议向所有的关键研究，包括制造和进口量年吨位在10吨以下
的物质相关研究，提供可靠研究总结。
•可靠研究总结是对整套研究报告的目标、方法、结果和结论的
详细总结，可最小化查询整套研究报告的需要，为研究的独立评
估提供充足信息。
Preparation of the registration dossier
Guidance on safe use
•The registrant will have to report the following information (as
required under section 5 of Annex VI):
– First aid measures
– Fire-fighting measures
– Accidental release measures
– Handling and storage
– Transport information
•Where a CSR is not required, the following additional information is
also required:
– Exposure controls and personal protection measures
– Stability and reactivity
– Disposal information
注册档案制备
安全使用指南
•注册者须报告以下信息（根据附录VI第5节的要求）：
– 急救措施
– 防火措施
– 泄漏应急措施
– 处置和存放
– 运输说明
•若无CSR要求，亦需要以下附加信息:
– 接触控制和人员安全措施
– 稳定性和 反应性
– 废弃物处置方法
Preparation of the registration dossier
Review by an assessor
The registrant is required to indicate in the technical dossier which of
the following information has been reviewed by an assessor chosen
by him with appropriate experience in the field:
– Information on the manufacture and use
– Classification and labelling of the substance
– (Robust) Study summaries on the information requirements
defined in Annexes VI to X
– Chemical Safety Report
注册档案制备
评估员审核
注册者须在技术档案中说明以下信息中哪些是由其选择的具有相
关领域经验的评估员已经审核过的信息：
– 制造和使用信息
– 物质分类和标识
– 附录VI到附录X中规定的要求信息的（可靠）研究总结
– 化学安全报告
Dossier Submission
• ECHA assigns a submission number to each received
dossier. This number is used as a reference in all
correspondence relating to this registration until a
registration number is assigned.
• Dossier submission and all correspondence are done via
REACH-IT.
• Administrative checks
– All dossiers undergo administrative checks called
‘‘Business Rules'' checks to ensure that the dossiers
fulfil the pre-requisites for ECHA to handle them.
– If there is a business rules failure, the registrant would
need to correct the dossier and submit it again.
档案提交
• ECHA为每个收到的档案分配一个号码，直到分配注册
号之前，这一号码用作所有与这一注册相关的所有通
信中的查阅号
• 档案提交和所有的通信均通过REACH-IT进行。
• 行政审核
– 所有的档案都必须通过名为“业务规则”审核的行
政审核以确保档案满足接受ECHA处理的先决条件
– 如果不符合某项业务规则，注册者则需要改正档案
并进行再次提交
Dossier Submission
• The next step is the technical completeness check.
• If there is any missing information, the registrant will be
given a reasonable deadline to re-submit a complete
dossier. Only one additional submission attempt is
allowed in this case.
• In parallel to the technical completeness check, the
invoice is sent to the registrant via REACH-IT and must be
paid within the given due dates.
档案提交
• 下一步进行技术完整性审核
• 如果有任何信息缺失，注册者将在给定的合理截止日
期前重新提交一份完整的档案。此种情况仅允许一次
额外提交尝试。
• 技术完整性审核的同时，发票通过REACH-IT系统寄往
注册者且必须在指定日期前完成支付。
Dossier Submission
• Decision.
– Once the technical completeness check is successful
and the invoice is paid, the dossier is considered
complete and a registration number is assigned. The
registration date is the date of the registration
dossier's submission.
– If there is a second completeness check failure or a
failure in paying the relevant fee, the dossier is
rejected.
档案提交
• 决定
– 一旦技术完整性审核成功通过，完成发票支付，档
案将被视作完整档案，并分配注册号。注册日期为
注册档案的提交日期。
– 如果出现二次完整性审核失败，或相关费用支付失
败，档案将被拒绝。
Communication in the supply chain
• Companies that supply registered substances need to
include the registration number and exposure scenarios
in the safety data sheets that are to be provided to their
customers.
供应链内的交流
• 供应注册物质的公司需将注册号和物质接触情况包含
在提供给客户的安全数据表中。
Registration update
• Registrants have a responsibility to keep their dossiers
updated.
• Some of the reasons are:
– Change of the substance composition,
– The increase of the tonnage band or
– The availability of additional information
• The new information has to be submitted to ECHA
without undue delay.
注册更新
• 注册者有责任更新其档案
• 更新原因包括:
– 物质组成变化
– 吨位范围的增加
– 附加信息的可获得性
• 新的信息必须提交给ECHA，并不得无故拖延。