Seminar on EU Chemical
Regulatory System
REACH
17th July 2012
欧盟化学制品监管体系
专题研讨会
REACH
2012年7月17日
Understanding REACH
• REACH is a regulation of the European Union (EU) and
applies to 27 EU Members States, and REACH also
apply to Norway, Iceland and Liechestein,
• REACH stands for Registration, Evaluation,
Authorisation and Restriction of Chemicals
• It entered into force on 1 June 2007.
REACH解读
• REACH 是欧盟European Union，以下简称 EU的一项
法规，适用于27个EU成员国和挪威、冰岛及列支敦
斯登
• REACH 的意思是Registration, Evaluation,
Authorisation and Restriction of Chemicals，即化学
制品注册、评估、许可和限制
• 生效于2007年6月1日
AIMS
•
•
•
•
•
To provide a high level of protection of human health and the
environment from the use of chemicals.
To make the people who place chemicals on the market
(manufacturers and importers responsible for understanding
and managing the risks associated with their use.)
To allow the free movement of substances on the EU market.
To enhance innovation in and the competitiveness of the EU
chemicals industry.
To promote the use of alternative methods for the assessment
of the hazardous properties of substances e.g. quantitative
structure-activity relationships (QSAR) and read across.
目的
•
•
•
•
•
提供高水平的防护，使得人类健康和环境免受化学制品使用
带来的危害
使得将化学制品投放市场的 (制造商和进口商 ）负责理解和
处理其使用带来的相关风险
允许在EU市场物质的自由流通
提高EU化学制品行业的创新和竞争力
促进物质危害性质评估替代方法的使用，例如定量构效关系
（QSAR）和交叉参照
Understanding REACH
•
It placed the burden of proof of safety for chemical on the
shoulders of industry and no longer on government authorities.
• To comply with the regulation, companies must identify and
manage the risks linked to the substances they manufacture
and market in the EU.
• They have to demostrate how substance can be safely used
and they communicate the risk management measures to
the users.
• If the risk cannot be managed, authorities can restrict the
use of substance. In the log run, the most hazardous
substances should be substituted with less dangerous ones.
REACH解读
•
将保证化学制品安全的责任化归于企业，而不再化归于政府
当局。
• 根据法规要求，对于在EU进行生产和销售的物质，公司
必须对此物质相关的风险进行说明和管理。
• 公司必须说明物质的安全使用方法并告知使用者相关的
风险管理措施。
• 若风险不可控，有关当局可限制该物质的使用。从长远
来看，应使用危险性小的物质替代危害性大的物质。
REACH Impact
Leading regulatory drivers (Chemical Watch survey 2012)
REACH 的影响
主要监管机制 (化学观察调查2012)
REACH Impact
•
Introduction/expansion of REACH-like regulations in many
other countries
 The registration deadline for Turkey’s chemicals notification
regulation drove a lot of activity in the first part of 2011.
 China revised its registration scheme to create Decree 7 on
the Measures on Environmental Administration of New
Chemical Substances
 Taiwan pursued its new scheme for existing chemical
substance nomination (ECN) and plans for new chemical
notification (NCN)
REACH的影响
•
在很多其它国家对类似REACH法规的引进和扩展
 2011上半年，土耳其化学制品通报法规的注册截止日期
促进了很多相关活动的开展。
 中国对其注册计划进行修订，指定了关于新化学物质的
环境管理措施的7号法令。
 台湾继续进行针对现有化学物质通报(ECN) 的新计划和新
化学物质通报(NCN)的计划。
REACH Impact
•
•
•
•
Serbia also enacted a chemicals management and control
system in 2011
Malaysia now has an Environmentally Hazardous
Substances Notification and Registration (EHSNR) Scheme
Japanese REACH – "Chemical Substance Control Law" (CSCL)
has been amended which was officially published in May
2009.
Korean REACH – "Toxic Chemicals Control Act" (TCCA)
REACH的影响
•
•
•
•
2011年，赛比亚指定了一套化学制品管理控制体系。
马来西亚现已有一套环境有害物质通报和注册(EHSNR)计
划。
日本的REACH – “化学物质控制法” (CSCL)于2009年5月出
台，且现已进行了修订。
韩国的 REACH – “毒性化学制品控制法案" (TCCA)
REACH Impact
•
In the US,
• TSCA reform was held up in 2011 due to political
gridlock, and any further movement will not be likely in
2012 due to the fact that 2012 is an election year
• the new Chemical Data Reporting Rule (formerly the
Inventory Update rule), which determines what and
how exposure-related information on chemicals is
collected, was adopted with implementation beginning
in 2012
REACH的影响
•
在美国,
• 在2011年的TSCA 改革由于政治僵局被搁置，而由于
2012年是大选年，在2012年 也不太有可能有进展。
• 新的化学资料提报法规 (先前的详细目录更新法规), 规
定暴露相关信息的采集内容和方式。这一法规于2012
年年初获批并开始实施。
REACH Impact
It will be difficult that some REACH do not REACH you.
We can take two options,
A passive option, where we think that in a difficult path, even
a straw is a heavy burden ...Or
An active option, and try to anticipate a new global concept
of management of chemicals.
REACH的影响
如果REACH法规对我们不适用，
我们有两种选择，
消极选择，即在困难重重的道路上，即使一根稻草也可成
为沉重的负担…
积极选择，即试着去预测新的全球化学制品管理的新概念。
REACH Impact
In the following slides we will introduce definitions and
concepts that are necessary to understand the requirements of
REACH
-Substances, mixtures and articles.
-Manufacturers, Importer, Down
REACH的影响
在接下来的幻灯片里，我们将介绍理解REACH法规要求所必
备的一些定义和概念。
-物质、混合物、物品
-制造商、进口商、下游用户
Substances, mixtures and articles
SUBSTANCES:
•It means a chemical element and its compounds.
•It includes both
 substances obtained by a manufacturing process
(for example formaldehyde or methanol) and
 substances in their natural state.
•It also includes its additives and impurities where these
are part of its manufacturing process.
•Excludes any solvent which can be separated without
affecting the stability of the substance
物质、混合物和物品
物质:
•指的是一种化学元素及其化合物。
•包括：
 通过加工获得的物质 (例如甲醛、甲醇）
 自然状态的物质
•也包括 一些加工过程中的添加剂和杂质
•不包括 和物质分离后不影响物质稳定性的溶剂
Substances, mixtures and articles
MIXTURES:
•Mixture or solution composed of two or more
substances.
•Examples:
• Paints,
• Varnishes
• Inks.
•REACH obligations apply individually to each subtances.
物质、混合物和物品
混合物:
•包含两种或以上物质的混合物或溶液
•例如:
• 涂料
• 油漆
• 墨水
•REACH 法规的要求单独适用于每种物质
Substances, mixtures and articles
MIXTURES (2):
•Alloys: “Specials mixtures”.
•The alloy is not subject to registration, the alloying
elements (e.g. metals) have to be registered.
•Constituents which are not intentionally added to the
alloy should be considered as impurities
物质、混合物和物品
混合物 (2):
•合金: “特殊混合物”.
•合金无需进行注册，而合金元素（如金属元素）必须
进行注册
•非故意加入合金的成分应被视为杂质
Substances, mixtures and articles
ARTICLES:
•Is an object which during production is given a special
shape, surface or design which determines its function to
a greater degree than does its chemical composition
•Examples: textiles, electronic chips, furniture, books,
toys, kitchen equipment).
物质、混合物和物品
物品:
•一个在生产过程中被授予了特别的形状、表面或设计
的物体，物体的形状、表面或设计比其化学成分更大
程度上决定了其功能
•例如:纺织品、电子芯片、家具、书、玩具、厨房用品
等
Substances, mixtures and articles
ARTICLES (2):
•An individual substance in an article is subject to the
registration obligations in case
 it is present in the article in quantities over one
tonne per year and
 the substance is intended to be released under
normal or reasonably foreseeable conditions of use.
物质、混合物和物品
物品(2):
•如果出现以下情况，物品中的单个物质需进行注册
 物质在物品中的含量超过一年一吨
 在正常使用和可预见的使用中，物质将被释放
Substances, mixtures and articles
PACKAGING
•Substances, mixtures and articles can be contained inside of
packaging, such as a carton, a plastic wrapping or a tin can. The
packaging does not belong to the substance, mixture or article being
packaged and is therefore to be considered as a separate article
under REACH.
•Producers, importers and suppliers of packaging or of packaged
substances, mixtures or articles have to fulfil the same requirements
for that packaging as for any other article.
•Packaging with different functions needs to be considered
separately (e.g. if an article is directly wrapped in plastic and then
packed in a cardboard box, the plastic and the cardboard box should
be considered separate articles).
物质、混合物和物品
包装
•物质、混合物和物品可置于包装内，例如用纸箱包装、塑料包
装或锡罐包装。包装不属于被包装的物质、混合物或物品，因此
应作为一项REACH适用的单独的物品。
•包装和包装物质、混合物或物品的制造商、进口商和供应商必
须保证包装与其它物品一样，满足相同的要求。
•具有不同功能的包装需单独考虑 (例如假如某物品直接用塑料包
装后再放入纸箱，则塑料和纸箱应作为两项物品区分开来）
Substances, mixtures and articles
Identification process (example) (1)
•If you can unambiguously conclude that the shape, surface
or design of the object is more relevant for the function
than its chemical composition, the object is an article. If
the shape, surface or design is of equal or less importance
than the chemical composition, it is a substance or mixture.
– A wax crayon consists of paraffin wax and pigments and is used for
colouring and drawing on paper. As its shape/surface/design are not more
relevant for the function of the crayon (to bring pigment to paper) than its
chemical composition, it is to be regarded as a mixture.
物质、混合物和物品
鉴定过程(范例) (1)
•如果可以清楚的得出结论，即物体的形状、表面和设
计比起其化学成分与其功能更相关，则该物体为物品；
如果形状、表面和设计的影响等于或小于化学成分的影
响，则该物体为物质或混合物。
– 蜡笔由石蜡和色素组成，用作上色和画画。由于蜡笔的形状/表面/设计
并不比其化学成分与其功能（给纸张上色）更相关，蜡笔应被视为混
合物。
Substances, mixtures and articles
Identification process (example) (2)
•If it is not possible to unambiguously conclude whether
the object fulfils the REACH definition of an article or not, a
deeper assessment is needed.
•if the object, which may be constructed in a very simple or
highly sophisticated manner, contains a substance or
mixture that can be physically separated from the object,
lets go to answer some question.
物质、混合物和物品
鉴定过程(范例) (2)
•如果不能清楚的判别物体是否符合REACH对于物品的定
义，则需做更深程度的评估。
•如果物体（其组成有可能很简单，有可能很复杂），
包含可从物体中分离出来的物质或混合物，那我们需要
回答下面一些问题。
Substances, mixtures and articles
• Identification process (example) (3)
• If you can answer these questions predominantly with
yes (i.e. 2 of 3) rather than no, then the object should be
regarded as a combination of an article (functioning as a
container or a carrier material) and a substance/mixture.
• Question a: If the substance/mixture were to be removed or separated from the
object and used independently from it, would the substance/mixture still be
capable in principle (though perhaps without convenience or sophistication) of
carrying out the function defined under step 1?
• Question b: Does the object act mainly (i.e. according to the function defined
under step 1) as a container or carrier for release or controlled delivery of the
substance/mixture or its reaction products?
• Question c: Is the substance/mixture consumed (i.e. used up e.g. due to a
chemical or physical modification) or eliminated (i.e. released from the object)
during the use phase of the object, thereby rendering the object useless and
leading to the end of its service life?
物质、混合物和物品
• 鉴定过程（范例）(3)
• 如果以下问题的答案大部分为“是” (例如3个问题中
有2个答案为“是”)，则这一物体应被视为物品（做
为容器或运载物质）和物质/混合物的混合。
• 问题 a: 如果把物质/混合物从物体中分离开来并单独使用，那该物质/混合
物是否仍然可以大体上执行在步骤1里定义的功能（尽管可能不够方便或熟
练）？
• 问题 b: 物体的主要功能（根据步骤1定义的功能）是不是做为物质/混合物
或其反应产物的容器、释放/控释载体 ？
• 问题 c: 在物体的使用阶段，此物质/混合物的耗尽（例如由于化学或物理
修饰而用尽）或消失（例如从物体中释放出去）是否会导致物体失效并导
致其使用寿命终结？
Substances, mixtures and articles
• Printer cartridge
– Answering the above indicative questions:
• a) if the toner/ink was moved from the cartridge, it would still be
possible to bring it to paper, although with a loss of quality and
convenience;
• b) the function of the cartridge is to hold the toner/ink in place inside a
printer and it controls the speed and mode of release;
• c) the cartridge is disposed of without the toner/ink, which is
consumed during the service life of the cartridge.
– The answers to the questions allow the conclusion that a printer cartridge is
a combination of an article (functioning as container) and a
substance/mixture.
• Importers and suppliers of a “combination of an article and a
substance/mixture” therefore have to separately check if
obligations for the article apply and if obligations for the
substance/mixture apply.
物质、混合物和物品
• 墨水匣（硒鼓）
– 上述问题的答案:
• a) 如果墨粉/墨水从打印机的墨水匣里移除，打印仍可进行，只不
过质量很差且不方便；
• b) 墨水匣的功能是在打印机内部放置墨粉/墨水并控制释放的速度
和模式；
• c) 若墨粉/墨水在墨水匣使用过程中被耗尽，墨水匣将被弃置。
– 对这些问题的回答帮助我们得出结论，即墨水匣是物品 (做为容器)和物
质/混合物的混合.
• 因此，“物品和物质/混合物的混合”的进口商和供应商必须
分开确认物品和物质/混合物是否符合各自对应的要求。
Substances, mixtures and articles
Identification process (example) (5)
•If you can answer these questions with yes rather than no, then the
function of the object is likely to be determined rather by the physical
properties shape, surface and design, than by the chemical
composition. The object is then regarded as an article with an
integral substance/mixture (i.e. the substance/mixture forms an
integral part of the article))
•Question a: If the substance/mixture were to be removed or separated from the
object, would the object be unable to fulfil its intended purpose?
•Question b: Is the main purpose of the object other than to deliver the
substance/mixture or its reaction products?
•Question c: Is the object normally discarded with the substance/mixture at the
end of its service life, i.e. at disposal?
物质、混合物和物品
鉴定过程（范例）(5)
•如果下列问题的答案为“是”而非“否”，则该物体的功能由
其物理形状、表面和设计而非其化学成分所决定。该物体被视作
内含物质/混合物的物品（例：物质/混合物构成物品必不可少的
内在组成部分))
•问题 a: 若物质/混合物从物体中移除或分离开，物体是否不能实现其预期使
用目的？
•问题 b:物体的主要使用目的是否不是运输物质/混合物或其反映产物？
•问题 c: 正常情况下，物体在使用寿命终结时，是不是与 物质/混合物一起弃
置？例如在废弃处理的时候？
Substances, mixtures and articles
Example: Thermometer
•Answering the above questions:
– a) the empty thermometer would fail to show the temperature;
thus the object would no longer be useful;
– b) the main function of the thermometer is to show the
temperature, this is not a delivery of a substance or mixture;
– c) the thermometer is normally disposed of together with its
chemical content.
•So answering these questions leads to the conclusion that a
thermometer is an article and the liquid within an integral part of it.
物质、混合物和物品
范例: 温度计
•上述问题答案:
– a) 空的温度计无法显示温度；因此物体失效;
– b) 温度计的主要功能是显示温度，并非物质或混合物的运
输;
– c) 温度计一般和其所含化学成分一起弃置
•因此对这些问题的回答帮助我们得出结论：温度计是物品，其
内部的液体是其必要组成部分。
Substances, mixtures and articles
• More help:
• Guidance for articles
• http://www.echa.europa.eu/documents/10162/13632/a
rticles_en.pdf
物质、混合物和物品
• 更多帮助:
• 物品指南
• http://www.echa.europa.eu/documents/10162/13632/a
rticles_en.pdf
Substances, mixtures and articles
The registration obligations apply therefore to the
individual substances themselves, independently of
whether they are on their own, in a mixture or in an
article.
In other words, only substances have to be registered
under REACH, mixtures or articles do not.
A small recommendation:
You should make an inventory of substances, mixtures
and / or articles that you manufacture or use in your
business.
物质、混合物和物品
不管物质以单独形式、在混合物或在物品中存在，注
册要求总是适用于物质本身。
换句话说，只有物质要进行REACH注册，混合物或物品
则不需要。
小建议:
应制作一个生产、使用的物质、混合物和/或物品的详
细目录。
Substance Identity
• Unambiguous substance identification is a pre-requisite
to most of the REACH processes.
• The correct identification of a substance will enable, for
example:
– The sharing of information by potential registrants and data
holders to prevent the duplication of testing on animals and
unnecessary costs
– The assessment of the applicability of test data across
companies who registered the same substance, the assessment
of read-across proposals (categorisation approach) or the use
of non test information
– The assessment if a substance is included in the Authorisation
List, the list of restrictions or if its classification and labelling
has been harmonised
物质鉴定
• 清晰的物质鉴定是大部分REACH流程进行的前提
• 物质的正确鉴定可使以下成为可能，如：
– 潜在注册者和数据持有者的信息分享，以避免重复动物试
验和非必要开支
– 注册同一物质的公司测试数据适用性评估；交叉参照提议
（分类方法）或非测试数据使用的评估
– 评估物质是否列入授权清单、限制清单或其分类和标示是
否已被调和。
Substance Identity
• Phase-in substances:
– 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’).
物质鉴定
• 分阶段物质:
– 列入欧洲现有商业化学物质名录( EINECS)的物质；
– 在EU (包括2007年1月1日的新入成员国)生产，但在
1992年6月1日以后未投放市场的物质;
– 满足称作“不再作为聚合体的物质”的物质。
Substance Identity
• Non-Phase-in substances:
– All substances that do not fulfil any of the criteria for
phase-in substances are considered as non-phase-in
substances.
– Normally, non-phase-in substances have not been
manufactured, placed on the market or used in the EU
before 1 June 2008, unless they were notified under
Directive 67/548/EEC.
– Potential manufacturers and importers of non-phasein substances have to submit an inquiry to ECHA and
subsequently register the substance in accordance
with REACH before they can manufacture or import
the substance.
物质鉴定
• 非分阶段 物质:
– 所有不满足阶段物质任何标准的其它物质被视为非
分阶段物质。
– 一般，非分阶段物质在2008年6月1日以前均未在欧
盟进行生产，市场投放或使用，除非其按照 指令
67/548/EEC进行了通报.
– 非分阶段物质的潜在制造商和进口商在进行生产和
进口前，必须向欧洲化学品管理局（ECHA）提交
一份调查单，并随后根据REACH法规对物质进行注
册。
ESIS: European Chemical Substances Information System
http://esis.jrc.ec.europa.eu/
ESIS: 欧洲化学物质信息系统
http://esis.jrc.ec.europa.eu/
Substance Identity
Substances of well defined chemical composition
– Monoconstituent substance
• As a general rule, a substance, defined by its
composition, in which one main constituent is
present to at least 80% (w/w).
– Multi-constituent substance
• As a general rule, a substance, defined by its
composition, in which more than one main
constituent is present in a concentration 10%
(w/w) and < 80% (w/w).
– Impurities and Additives.
• impurities > 1%, or classified as dangerous, to be specified
物质鉴定
化学成份明确的物质
– 单组分物质
• 一般来说，物质组成中的一主要成分超过 80%
（w/w）重量重量比。重量.
– 多组分物质
• 一般来说，物质组成中，多于一种成分的含量
达到10% (w/w) 以上而 < 80% (w/w)。
– 杂质和添加剂
• 杂质 > 1%, 或被定义为危险物质（另作说明）。
Substance Identity
UVCB SUBSTANCES
• Substances of Unknown or Variable composition,
Complex reaction products or Biological materials
– The number of constituents is relatively large and/or
– The composition is, to a significant part, unknown
and/or
– The variability of composition is relatively large or
poorly predictable.
• UVCB substances require other types of information for
their identification, in addition to what is known about
their chemical composition
物质鉴定
UVCB 物质
•即未知或易变合成物、负责反应产物或生物材料
– 成分种类更多且/或
– 组成中有很大一部分未知，且/或
– 组成的可变性强且难以预测
•UVCB 物质在鉴定过程中除其化学组成相关信息外还需
要其它类型的信息。
Substance Identity
• More Help
• Guidance for identification and naming of substances
under REACH
– http://echa.europa.eu/documents/10162/13643/subs
tance_id_en.pdf
• Guidance for monomers and polymers
– http://www.echa.europa.eu/documents/10162/1363
2/polymers_en.pdf
物质鉴定
• 更多帮助
• Guidance for identification and naming of substances
under REACH
– http://echa.europa.eu/documents/10162/13643/物
质_id_en.pdf
• 单体或聚合物指南
– http://www.echa.europa.eu/documents/10162/1363
2/polymers_en.pdf
More help
• http://echa.europa.eu/web/guest/information-onchemicals/registered-substances
更多帮助
• http://echa.europa.eu/web/guest/information-onchemicals/registered-substances
More help
更多帮助
More help
• Substances identified by industry to be registered by 31
May 2013.
– http://echa.europa.eu/information-onchemicals/registered-substances/identifiedsubstances-for-registration-in-2013
• Substances identified but not registered (Data as of 15th
September 2011)
– http://echa.europa.eu/information-onchemicals/registered-substances/identifiedsubstances-for-registration-in-2010
更多帮助
• 2013年5月前由行业鉴定需进行注册的物质
– http://echa.europa.eu/information-onchemicals/registered-substances/identifiedsubstances-for-registration-in-2013
• 经鉴定但未注册的物质 (2011年9月15日数据)
– http://echa.europa.eu/information-onchemicals/registered-substances/identifiedsubstances-for-registration-in-2010
Roles under REACH
It is very important that companies correctly identify
their role or roles in the supply chain for each substance
they handle
REACH规定的角色
非常重要的一点是，公司要正确明确在处理各个物质
的供应链时，其所扮演的角色。
企业
Roles under REACH
MANUFACTURER (M)
- Any natural o legal person established within the EU
who manufactures a substance within the EU.
MANUFACTURING
- Production or extraction of substances in the natural state
REACH规定的角色
制造商 (M)
- 在EU境内生产物质的任何自然人或法人
生产
- 生产或提取自然状态的物质
Roles under REACH
IMPORTER (I):
- Any natural o legal person established within the EU
who is responsible for import
Import
-The physical introduction into the customs territory of the EU.
Placing on the market
-Supplying or making available, whether in return for payment or
free of charge, to a third party. Import shall be deemed to be
placing on the market
REACH规定的角色
进口商(I):
- 在EU境内，任何负责进口的自然人或法人
进口
-将实体引入EU关税领土
投放市场
-向第三方有偿或无偿供应或提供。进口应被视作投放市场
Roles under REACH
ONLY REPRESENTATIVE (OR):
-Any natural o legal person established within the EU and
appointed by a manufacturer, formulator or producer of
an article established outside the EU to fulfil the
obligations of importers.
REACH规定的角色
唯一代表(OR):
-EU境内，由非EU境内的物品的制造商、生产商指定承
担进口商义务的任何自然人和法人
Roles under REACH
DOWNSTREAM USER (DU):
-Any natural o legal person established within the EU,
other than the manufacturer or the importer, who uses a
substance, either on its own or in a mixture, in the course
of his industrial or professional activities.
Use:
•Any processing, formulation, consumption, storage,
keeping, treatment, filling into containers, transfer from
one container to another, mixing, production of any
article or any other utilisation
REACH规定的角色
下游用户(DU):
-在EU境内，除制造商或进口商之外，在行业或专业活
动中使用物质或含此物质的混合物的任何自然人或法
人。
使用:
•任何加工、配制、消耗、存储、放置、处理、装箱、
换箱、混合、任何物品的生产或其它利用
Different roles and responsibilities for industry
• A REACH navigator tool has been developed by the
Commission to help the users identifying their
obligations under REACH. It can be found on:
http://echa.europa.leu/reach_en.htm
• Features:
– Interactive tool on the Agency website
– Sequence of questions (supported by guidance) to be
answered by the user
– The outcome is a list of obligations for the user
– Each of the obligations will be linked to guidance (RIP projects)
describing how to fulfil the users’ obligations
企业的不同角色和责任
• 委员会研发了一种导航工具，帮助用户确认REACH法
规规定的义务。在以下网站可以找到：
http://echa.europa.leu/reach_en.htm
• 特点:
–
–
–
–
在机构网站上的互动工具
由用户回答的问题顺序 (由指南支持)
结果是用户需履行的义务列表
每项义务均有指南链接(REACH实施项目)，对用户履行义务
的方式进行描述
Registration
The obligation to register a substance applies only to
certain actors established in the EU.
•EU manufacturers and importers of substances on their own or in
mixtures in quantities of one tonne or more per year.
•EU producers and importers of articles in case that the article
contains a substance in quantities over 1 tonne per year and the
substance is intended to be released under normal or reasonably
foreseeable conditions of use
•‘Only representatives’ established in the EU and appointed by a
manufacturer, formulator or article producer established outside
the EU to fulfil the registration obligations of importers
注册
注册物质的义务只针对EU内的某些参与者
•达到或超过的单质或混合物形式的物质的制造商和进口商
•EU境内物品的生产商和进口商，物品包含的某物质达到或超过，
且该物质在正常或可预见的合理使用情况下会被释放
•EU境内，由非EU境内的物品的制造商、生产商指定承担进口商
注册义务的“唯一代表”
When registration is needed
• A manufacturer of a substance who uses the manufactured
substance himself has a duty to register each substance
manufactured in quantities of 1 tonne or more per year, unless
exemptions apply, and will have to include information on his own
use(s) and any identified uses of his customers.
• An importer of a mixture has to register those substances which
are present in the imported mixture in quantities of 1 tonne or
more per year, unless exemptions apply. He will have to include
information in his registration on the identified use(s) of the
substance(s) in the mixture. There is no obligation for importers of
mixtures to register the mixtures as such; indeed mixtures cannot
be registered. his registration
什么时候需要注册
• 除非满足豁免条件，使用其制造物质的物质制造商有责任对产
量每年一吨的所有物质进行注册，且注册需包括与自己使用和
任何确认的用户用途相关的信息。
• 除非满足豁免条件，混合物的进口商必须对进口的混合物里含
量达到或超过的物质进行注册。注册应包含混合物中该物质的
确定用途。混合物的进口商无需对混合物进行此类注册；实际
上混合物无法进行注册
When registration is not needed
• Any user of substances not manufactured or imported by himself,
is a downstream user and has no obligation to register these
substances.
• An importer of a substance, a mixture or an article, who is
importing from a non-EU company who has appointed an ‘only
representative’ will be considered as a downstream user and
therefore does not need to register.
• A manufacturer or importer of a substance which is exempted
from registration under REACH has no obligation to register that
substance.
什么时候不需要注册
• 任何不进行制造和进口的物质的使用者均为下游用户，不承担
注册物质的义务。
• 物质、混合物或物品的进口商，从非EU的公司进口，且该公
司已指定“唯一代表”。这样的进口商应被视作下游用户，因
而不需要注册。
• 根据REACH拥有注册豁免的物质的制造商和进口商无需注册该
物质。
Legal personality and boundaries.
• Only a natural or legal person established in the EU can be a
registrant. REACH-IT and IUCLID use the term ‘legal entity’ to refer
to such a natural or legal person having rights and obligations
under REACH.
• Customs boundaries for manufacturing and import REACH applies
to the European Economic Area (EEA), i.e. the 27 EU Member
States and Iceland, Liechtenstein and Norway. This means that
imports from Iceland, Liechtenstein and Norway are not
considered imports for the purposes of REACH
法人和法定范围
• 只有EU境内的自然人和法人才可成为注册者。REACH-IT和
IUCLD使用“法人实体”这一术语代指根据REACH法规享受权
利和履行义务的自然人和法人。
• 根据REACH法规，制造和进口的海关范围即欧洲经济区(EEA),
包含27个EU成员国，冰岛、列支敦士登和挪威。也就是说从
冰岛、列支敦士登和挪威的进口不被视为REACH定义下的进口
Who is responsible for the registration in case of…
• … Manufacturing?
 the registration should be made by the legal entity who
undertakes the process of manufacturing.
 The registration obligation also applies in the case that the
substance is not marketed in the EU but exported outside the
EU after manufacturing.
• … toll manufacturing?
 the legal entity that manufactures the substance on behalf of
the third party is to be considered a manufacturer for the
purposes of REACH and is required to register the substance he
manufactures.
在各个活动中，谁负责注册
• … 制造?
 注册由进行制造过程的法人实体进行
 若物质未在EU市场流通但在制造后出口到EU之外，也需进
行注册
• … 来料加工?
 代表第三方进行物质制造的法人实体按照REACH法规应被视
作制造商，因而需对其制造的物质进行注册
Who is responsible for the registration in case of…
• … import?
 the registration should be made by the legal entity established
in the EU who is responsible for the import.
 The responsibility for import depends on many factors such as
who orders, who pays, who is dealing with the customs
formalities, but this might not be conclusive on its own.
– Examples:
• A ‘sales agency’ established in the EU and acting as an
intermediary, i.e. transmitting an order from a buyer to a
non-EU supplier (and being paid for that service). The sales
agency is not responsible for the physical introduction of
the goods.
• In many instances it will be the ultimate receiver of the
goods (the consignee) who is the legal entity that is
responsible for the import
在各个活动中，谁负责注册
• … 进口?
 由EU境内负责进口的法人实体进行注册
 进口责任由多种因素决定，如谁下的订单，谁付款，谁负
责报关单等，但是这本身可能不是决定性的
– 范例:
• 在EU境内设立的做为中介的“经销处”，例：将订单从
买方传递至非EU供应商（由此收取服务费）。这个经销
处不负责货物的实际引入
• 很多情况下，它会成为货物的最终接收者（受货人），
即负责进口的法人实体
Who is responsible for the registration in case of…
在各个活动中，谁负责注册
Only representative of a ‘non-EU manufacturer’
• Under REACH, a natural or legal person established
outside the EU, who manufactures a substance,
formulates a mixture or produces an article can appoint
an only representative to carry out the required
registration of the substance that is imported (as such, in
a mixture or in an article) into the EU.
• ‘Non-EU distributors’ are not mentioned in Article 8(1)
and can therefore not appoint an only representative.
“非EU制造商”的唯一代表
• 根据REACH规定,任何在EU境外制造物质，配制混合物
或生产物品的自然人或法人均可指派其唯一代表执行
对进口到EU的物质（在混合物或物品中）的注册。
• “非EU经销商”在物品 8(1) 里没有提及，因此无法指
定唯一代表。
Only representative of a ‘non-EU manufacturer’
• An only representative is a legal entity established in the
EU which has sufficient background in the practical
handling of substances and the information related to
them to be able to fulfil the obligations of importers.
• It should be noted that an only representative is not the
same as a third party representative
• It is neither necessary nor advisable for an only
representative to appoint a third party representative
because an only representative is not obliged to disclose
to the other participants in the data sharing process the
identity of the ‘non-EU manufacturer’ he is representing.
“非EU制造商”的唯一代表
• 唯一代表是在EU境内的具备物质实际处理相关背景和
了解相关信息，能履行进口商义务的法人实体。
• 需要注意的是唯一代表不同于第三方代表
• 由于唯一代表没有义务向其它数据共享的参与者公布
其所代表的“非EU制造商”，由唯一代表指定第三方
代表的做法既无需要也不可取。
Only representative of a ‘non-EU manufacturer’
• The ‘non-EU manufacturer’ needs to inform all the EU importers in
the same supply chain that he has appointed an only
representative to conduct the registration.
• A ‘non-EU manufacturer’ can only appoint one only
representative per substance.
• The only representative’s registration should clearly specify which
quantity of the imported substance it covers.
• The only representative can represent one or several ‘non-EU
manufacturers.
• The only representative will have to submit separate registrations
for each of the companies he is representing
“非EU制造商”的唯一代表
• “非EU制造商”需要通知同一供应链上的所有EU进口商，其
已指定唯一代表进行注册。
• 每种物质，“非EU制造商”只能指定一个唯一代表。
• 唯一代表的注册需清楚说明其所涵盖的进口物质的数量。
• 一个唯一代表可代表一个或几个“非EU制造商
• 唯一代表需为其代表的每一个公司提供单独的注册。
Only representative of a ‘non-EU manufacturer’
“非EU制造商”的唯一代表’
What to register?
• Registration is required for all substances manufactured
or imported in quantities of one tonne or more per year
per manufacturer or importer unless they are exempted
from the scope of registration.
• The registration requirement applies to all substances
irrespective of whether they are hazardous or not
• For all registrations, a registration dossier has to be
prepared and submitted electronically to ECHA.
注册内容?
• 除非从注册范围内得到豁免，所有制造或进口数量达
到或超过的物质都必须进行注册
• 注册要求适用于所有物质，不论其是否具有危害性。
• 所有的注册都必须要制备注册档案并将电子版提交给
ECHA欧洲化学品管理局。
What is ECHA?
• European Chemicals Agency
• ECHA was founded in 2007 and is based in Helsinki,
Finland. It is a modern, science-driven organisation
which has grown rapidly to become one of the largest EU
agencies.
• 500 staff from 27 European countries.
“Working for the safe use of chemicals”
echa.europa.eu
ECHA是什么?
• 欧洲化学品管理局
• ECHA 成立于2007年，本部在芬兰的赫尔辛基。它是
一个成长迅速的以科学为动力的现代化组织，已成为
EU最大的机构之一。
• 拥有来自27个欧洲国家的500名员工。
“致力于化学制品的安全使用”
echa.europa.eu
Exemptions
• Substances exempted from the REACH Regulation.
Radioactive substances
Substances under customs supervision
Substances used in the interest of defence and
covered by national exemptions.
Waste
Non-isolated intermediates.
Transported substances.
豁免
• 从REACH法规豁免的物质
放射性物质
海关监管物质
国防使用，由国家豁免的物质
废弃物
不可被隔离的中间体
运输物质
Exemptions
• Substances exempted from registration.
Food or feedingstuffs
Medicinal products
Substances included in Annex IV of the REACH
Regulation.
Substances covered by Annex V of the REACH
Regulation
Recovered substance already registered.
Re-imported substance.
Polymers
Substances used for the purpose of research and
development
豁免
• 获得注册豁免的物质
食品和饲料
医药产品
REACH法规附录IV包含的物质
REACH法规附录V包含的物质
已注册的再生物质
复进口 物质
聚合物
用于研发的物质
Exemptions
• Substances regarded as registered.
Substances for use in biocidal products.
Substances for use in plant protection products
Notified substances according to Directive
67/548/EEC.
 European Inventory of Existing Commercial Chemical Substances
(EINECS) contains, in principle, all substances on the Community market
on 18 September 1981.
 European List of Notified Chemical Substances (ELINCS). European List
of Notified Chemical Substances (ELINCS).
豁免
• 当作已注册的物质
生物农药产品中使用的物质
植物保护产品中使用的物质
根据指令67/548/EEC进行通报的物质
 欧洲现有商业化学物质名录 (EINECS) 大体上包含1981年9月18日欧
共体市场上的所有物质。
 欧洲已通报化学物质名录 (ELINCS). European List of Notified Chemical
物质s (ELINCS).
Exemptions
• Isolated intermediates.
On-site isolated intermediate
Transported isolated intermediates
A manufacturer or importer of an isolate intermediate
in quantities of one tonne or more per year is
required to register his substance under REACH.
He may benefit from reduced registration
requirements provided the manufacture and use of
the substance takes place under strictly controlled
conditions.
豁免
• 隔离中间体
待运输隔离中间体
已运输隔离中间体
制造和进口隔离中间体数量达到或超过每年一吨的
制造商和进口商必须按照REACH要求对其物质进行
注册。
如果物质的制造和使用在严格控制的条件下进行，
注册要求有可能减少。
Volume
• The registration requirement is tightly bound to the
volume of the substance manufactured or imported (or
present in an article, if applicable).
• The volume of the substance will also determine the
information to be submitted in the registration dossier.
• REACH defines four tonnage bands:
1 to <10 tonnes,
10 to <100 tonnes,
100 to <1000 tonnes,
1000 tonnes or more per year
含量
• 注册要求和制造或进口（或出现在物品中，若适用）
的物质的含量紧密相关。
• 物质的含量还将决定需提交的注册档案里的信息。
• REACH 对四个吨位进行了定义:
1 到 <10 吨,
10 到 <100 吨,
100 到 <1000 吨,
一年1000 吨或以上
Volume
• If certain exemptions to registration apply (such as in
food or medicinal products or for PPORD purposes) the
potential registrant does not need to include those
quantities in his calculation to determine the volume he
has to register.
• In the case that the same registrant manufactures and/or
imports the same substance at different sites which
belong to the same legal entity, then the volume of the
substance to be registered is the total volume of the
substance manufactured and/or imported at the
different sites, because the sites are not separate legal
entities
含量
• 若某些注册豁免适用（例如食品或医药产品或用于产
品工业研发），潜在注册者不需要把此数量计算入需
注册的含量。
• 如果同一注册者在属于同一法人实体的不同地址制造
和/或进口同一物质，需注册的物质含量为各个不同
地址所制造和/或进口的物质含量总和。这是因为这
些地址并不属于不同的法人实体。
Volume
• If a substance is imported in several mixtures, the
volume of the substance in each mixture will have to be
agregated.
• if a substance is imported in several articles from which
it is intended to be released, the potential registrant
needs to sum up all quantities of the substance present
in those articles.
• he needs to count only those articles from which the
substance is intended to be released. Whenever a
substance is intended to be released from an article, the
total volume present in that article needs to be counted
and not only the volume intended to be released
含量
• 如果进口一种存在于几种混合物中的物质，则应将各
个混合物中的物质含量累加。
• 如果进口一种存在于几种物品中的物质，且该物质将
被释放，则潜在注册者需将这些物品中的物质数量相
加。
• 只需计算物质将被释放的这些物品。任何时候只要物
质将从物品中释放，都需要计算物品中的物质的总含
量，而不只是将被释放的含量。
Registration deadlines
• Phase-in substances
– There is a special transitional regime for substances
which, under certain conditions, were already
manufactured or placed on the market before
REACH's entry into force.
– Companies can benefit from the transitional regime if
they pre-registered their substances by 1 December
2008.
– The deadlines set for the registration of phase-in
substances have been based on the tonnage
manufactured or imported per manufacturer or
importer or producer of articles
注册截止日期
• 分阶段物质
– 对于在REACH生效前，在某些条件下，已经制造或
投放市场的物质，有一套特别过渡制度。
– 如果公司在2008年12月1日前就对其物质进行了预
注册，则可享受过渡制度。
– 分阶段物质的注册截止日期由各个物品制造商或进
口商或生产商所制造或进口的吨位来决定。
Registration deadlines
• Calculation of the tonnes per year for the registration of
phase in-substances
– In the case of a phase-in substance that has been imported or
manufactured for at least three consecutive years, the tonnes
per year shall be calculated on the basis of the average tonnes
manufactured or imported in the three preceding calendar
years.
– If the substance has not been manufactured or imported for
three consecutive years then the tonnes manufactured or
imported in a calendar year should be used.
• The highest tonnage per year (calculated as the average
of the three preceding years or per calendar year, as
applicable) manufactured or imported after 1 June 2007
will determine the deadline for registration
注册截止日期
• 分阶段物质注册年吨位的计算
– 对于那些已经连续三年被进口或制造的分阶段物质，年吨
位的计算应基于前三日历年制造和进口的平均吨位来计算
。
– 若没有达到连续三年制造或进口，则应使用一日历年的制
造或进口吨位。
• 2007年6月1日后制造或进口的最高年吨位（前三日历
年或每个日历年的平均值，若适用）将决定注册截止
日期
Registration deadlines
• Non-Phase-in substances
– Non phase-in substances do not benefit from the
transitional regime provided for phase-in substances
and need to be registered before they can be
manufactured, imported or placed on the market in
the EU, unless they have already been notified under
Directive 67/548/EEC. (The substance will in that case
also appear on the European List of Notified Chemical
Substances (ELINCS)).
注册截止日期
• 非分阶段物质
– 非分阶段物质无法享受针对分阶段物质的过渡制度
，且需要在其被制造、进口或投放EU市场前就进
行注册，除非其已根据指令 67/548/EEC进行了通报
（若已通报，该物质会显示在欧洲已通报化学物质
名录ELINCS上）。
Registration deadlines
• Calculation of the tonnes per year for the registration of
non phase-in substances
– The tonnes per year of a non-phase-in substance to
be reported in a registration dossier is the estimated
quantity in tonnes that is expected to be
manufactured and/or imported in the calendar year (1
January - 31 December) of registration.
注册截止日期
• 非分阶段物质年吨位的计算
– 在注册档案中报告的分阶段物质的年吨位指的是将
于注册日历年（1月1日至12月31日）进行制造和/
或进口的以吨为单位的数量值。
Registration deadlines
注册截止日期
Registration deadlines - Example 1.
• A company, based on its manufacture projections, has determined
that it should register a phase-in substance by the 31st May 2013
(as its manufacture volume is expected to be in the 100-1000
tonnes range).
• Each year the company needs to calculate its yearly tonnage as the
average over the three preceding years, e.g. in 2007 it is the
average over 2004-2006.
• The deadline for registration is based on the highest tonnage
calculated starting in 2007.
• In case this tonnage reaches 1000 tonnes, the registration is then
due before the 1st December 2010. If this happens in 2011 or 2012
the registration is due without delay..
• If the tonnage stays in the 100-1000 tonnage band, then the
registration should be submitted by the 31st May 2013.
注册截止日期 - 范例 1.
• 某公司，根据其制造计划决定必须在2013年5月31日前注册一
种分阶段物质（因其制造量预计为100-1000吨之间）。
• 每年公司都需要计算其年度吨位，即前三年的平均值，例如，
2007年的年吨位为2004-2006年的平均值。
• 注册截止日期根据从2007年起计算的最高吨位。
• 如果这一吨位达到1000吨，注册就必须在2010年12月1日年完
成。如果在2011或2012年出现这种情况，注册不得延迟。
• 如果吨位保持在100-1000吨之间，则注册须在2013年5月31日
前提交。
Registration deadlines - Example 2.
• The volume manufactured by Company V is 600 tonnes in 2007,
900 tonnes in 2008, 1400 tonnes in 2009 and 2000 tonnes in 2010.
The 3 year-average tonnage in 2010 is 966 tonnes per year, but the
3 year-average tonnage in 2011 is 1433 tonnes per year.
• In this case company V will have to register the substance as soon
as possible in 2011 as the registration deadline for the substances
on 1000 tonnes or more per year has passed on 30 November
2010.
• The registration requirements should be based on the 2011
tonnage calculated as the average over 2008-2010, i.e. 1433
tonnes
注册截止日期 - 范例 2.
• V公司2007的产量是600吨，2008年是900吨，2009年是1400 吨
，2010年是2000吨。2010年的三年平均吨位是每年966吨，但
2011年的这一数值为每年1433吨
• 这种情况下，V公司必须在2011年尽快完成物质注册，因为每
年1000吨或以上的物质的注册截止日期为2010年11月30日。
• 注册要求应根据2011的吨位，即2008-2010间的平均指，也就
是1433吨。
Registration deadlines - Example 3.
• The volume manufactured by Company V is 900 tonnes in 2007, 0
tonnes in 2008, 1000 tonnes in 2009. As the substance has not
been manufactured during three consecutive years then the
calendar year tonnage should be used.
• In this case the 1000 tonnes threshold has been reached in 2010,
meaning that a registration is due on 30 November 2010 at the
Latest.
• The information requirements for the registration will be based on
the 2010 tonnage, i.e. 1000 tonnes.
注册截止日期 - 范例 3.
• V公司2007的产量是900吨，2008年是0吨，2009年是1000 吨。
由于物质并未连续三年进行制造，所以使用日历年吨位。
• 在这种情况下，2010年达到了1000吨的门槛值，意味着有一项
注册最迟要在2010年11月30日完成。
• 注册的信息要求应根据2010年的吨位，即1000吨。
Registration deadlines
Is it possible to pre-register a phase-in substance after 1
December 2008?
•You may pre-register after 1 December 2008 if you are:
– able to prove that you are established in the European
Community and manufacturing or importing phase-in
substances (on their own or in a preparation) for the first time
after 1 December 2008 in quantities of 1 tonne or more per
year; or
– able to prove that you are established in the European
Community and producing or importing articles that contain
substances intended to be released under normal and
reasonably conditions of use for the first time after 1
December 2008. In addition, the substance needs to be present
in those articles in quantities of 1 tonne or more per year
注册截止日期
在2008年12月1日后是否有可能进行分阶段物质的预注
册？
•如果你满足以下条件，你可以在2008年12月1日后进行预注册：
– 能证明你是在欧共体内设立，并是自2008年12月1日以来第
一次生产或进口每年一吨或以上分阶段物质（物质本身或
配置中的物质）；或
– 能证明你是在欧共体内设立，自2008年12月1日以来第一次
生产或进口物品，且物品包含在正常和合理使用条件下会
被释放的物质，且该物质的含量等于或超过一年1吨
Registration deadlines
• Therefore first-time manufacturers or importers have to
submit their late pre-registration before 1 June 2017 if
the tonnage threshold of the substance are 1-100 tonnes
per year.
• Companies manufacturing or importing substances for
which the first and second registration deadlines applied
cannot benefit from the late pre-registration and need to
go through an inquiry process before being entitled to
manufacture or import in the European market
注册截止日期
• 因此如果物质的吨位门槛是每年1-100吨，初次进行
制造和进口的制造商和进口商必须在2017年6月1日前
提交预注册。
• 制造或进口物质的公司，若初次和二次注册截止日
期适用于该物质，则该公司无法享受首次出口预注册
且在获得在欧盟市场进行制造和进口的权利前需要经
过一系列查询流程。
Registration deadlines
Manufacturers and importers of substances below 1 tonne
per year.
•Manufacturers and importers of phase-in substances or
article producers and importers containing phase-in
substances in quantities of less than 1 tonne per year do
not need to (late) (pre-)register. However, they may decide
to late pre-register based on their intention to manufacture
or import the substance in quantities of 1 tonne or more in
the future
注册截止日期
年吨位低于每年1吨的物质制造商和进口商
•分阶段物质的制造商和进口商，或者包含分阶段物质
的物品的生产商和进口商，若分阶段物质少于每年1吨
，则不需要进行（预）注册。然而，若将来有打算生产
或进口等于或超过1吨的物质，则可决定进行预注册。