REACH WORKSHOP Question & Answer Presentation Materials
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM
Dear Professionals,
Value in Compliance Questions & Answers Presentation Materials
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM
01
Will the data not be accepted unless it is generated by the
1)歐盟執行 REACH 法規時，是否只接受歐盟成員國測
institutes located in EU member states according to ECHA?
試機構出具的測試資料？非歐盟成員國的測試機構如
Or the data is allowed under REACH when the data-
通過歐盟 GLP 檢查，其測試資料是否可被接受？2)歐
generating institute located outside the EU gets
盟對測試機構有什麼要求及管理手段？
recognition or certified for compliance with the OECD Principles of Good Laboratory? 02
Are there any enforcement activities upon the automobiles
ECHA 是否會對汽車行業進行執法監督？汽車行業應如
according to ECHA? Any advice for automobile
何做到 REACH 合規，比如強制採用管理系統進行法規
manufacturers to be compliant with REACH regulation?
符合？
Shall management system be a must to automobile manufacturers for their purpose of REACH compliance? A question from a real case we have been through:
1)一家司最初預註冊了 100-1000 噸/年物質 A。最近
substance A has been pre-registered for 100-1000tons/year,
收到 LR 的 LOA 報價，很貴。考慮到這家公司最大的進
and the 2nd deadline is approaching. Considering to take
口商也預註冊了該物質，扣除其預註冊噸位後，剩餘
good advantage of the pre-registration for the same
噸位<100,因此該公司想下調預註冊噸位至 10-100 噸
substance completed by the EU importer, could this pre-
/年。如何操作？ 2)一公司物質 B 預註冊了 10-100 噸
registrant apply for lowering the pre-registered tonnage
/年，截止期到 2018.但據瞭解，越早參與聯合註冊，
band to 10-100tons/year? If yes, how to manipulate it?
LR 收取的 LOA 費用越低，越晚參加，LOA 費用較高。
In another scenario, the potential registrant of substance B
因此，是否該公司也應該儘早參與聯合註冊，比如在
originally plans to complete formal registration by 2018.
2013 年 5 月 31 前完成正式註冊？
03
Considering that some say LOA price will likely go up for those co-registrant joining late, should the company change its strategy to an earlier registration date? 04
Please explain the enforcement activities implemented by
請講解執法部門對唯一代表（Only Representative）
the
的 REACH 法規合規檢查
competent
authorities
in
2013
over
Only
Representatives for their due diligence under REACH. 05
When is the suggested deadline of technical dossiers
1)對於 2013 年需要完成註冊的物質，其提交技術卷宗
We
的時限截止到什麼時候？如果到截止期沒有提交的
assume substance D will be used in product A, B and C (the
話，什麼時候可以再次提交？ 2) 假設一家公司出口
concentration of D in A B C is 50% equally), and each of 3
A,B,C 三种产品，物質 D 分別在產品 A.B.C 中存在，
products are shipped to the EU for at100tons/year. So if in
A.B.C 每年分別出口的量都是 100 噸，D 在 A.B.C 中的
that case, shall substance D be registered compulsorily
含量均為 50%，問 D 需不需要在 2013 年完成註冊？
submission if the registration must be done by 2013?
before May 31 2013? 06
What standards shall be reached for an accredited
1)開展化學品評價的實驗室需要哪些資質，國內有多
laboratory qualified for chemical assessment? Would it be
少這樣的實驗室？2)獨立協力廠商，不從事該物質生
possible to know how many accredited laboratories have
產經營的單位或個人可以作為領頭註冊人嗎？
been populated in China?
As an independent 3rd party
but not a manufacturer neither a distributor of a chemical
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM substance, will it be allowed to take the role of lead registrant for this substance? 07
To those companies exporting biocidal product formulation
對於出口的歐洲的農藥製劑產品，做 REACH 符合性工
to the EU, what might be good advice for their compliance
作的建議？
with REACH? 08
How to make adjustment after registration completed
1)如果完成了 100-1000 噸 REACH 註冊，以後由於產能
for 100-1000tons/year for increasing demands from the
增加或客戶年需求增加需如何操作？更新卷宗重的註
EU? Do I have to update the tonnage band or anything else?
冊噸位資訊就可以了？是否發生費用？發生那些費
How much I would be charged for this update? Will it be
用？費用是多少？是否可以在註冊截止日之後更新註
allowed to update registered volume after corresponding
冊噸位數量級？2)以後的 SDS 中要像荷蘭當局規定一
deadline?
樣包含暴露場景嗎？
According to the Netherlands authority,
exposure scenarios shall be written in SDS, will it be widely required for in other EU member states? 09
According to REACH regulation, the net tonnage will be
REACH 法規規定：超出註冊噸位上線的量，若下游客
covered by downstream users if downstream users do not
戶未要求生產商涵蓋，則預設為由下游客戶涵蓋，則
request manufacturers to cover the imported volume by the
易造成實際出口量>涵蓋量。2013 年後，ECHA，歐洲
registration number. That may lead to the result that real
成員國 RECH 監管機構將于海關聯合執法，通過雙管
export exceeds the registered tonnage band. In 2013, ECHA
齊下的方式規範生產商及下游進口商的行為，是否意
will cooperate with competent authorities of each EU
味著生產商的每一次出口必須主動提供噸位涵蓋證
member state together with Customs to implement REACH
明？
enforcement, aiming at pushing manufacturers and downstream users to fulfill related responsibilities. Does it mean as one of most important part that non-EU manufactures’ OR shall provide quantity coverage statement for each export? 01
Some chemical reagent used for testing in a Chinese
企業實驗室用於實驗測試的某種化學試劑（屬於危險
company’s own laboratory is imported from the source
化學品）是從國外 I 進口，並由物流公司送達。這樣
abroad and delivered by a logistics company. Under this
的話，企業是否屬於進口企業，是否需要辦理登記？
condition, is this kind of companies considered as importers and subject to the obligation of notification under China REACH? 02
Cefaclor as raw material is used to produce antibiotic Ceclor
頭孢克洛作為主要原料來生產抗生素藥希克勞懸混
suspension, but Cefaclor is not listed in IECSC (the inventory
劑，但頭孢克洛目前不在中國現有化學物質名錄中，
of existing chemical substance) currently. The question is in
是否要作為新化學物質申報，還是可以作為有相應藥
China whether Cefaclor needs to be notified as a new
品法規而得到豁免？
chemical substance according to China REACH, or benefits from exemption of notification responsibility due to related pharmaceutical regulation. 03
If a raw material is not included by IECSC, what are the
假設原料未在現有名錄中，供應商和最終用戶法規承
responsibilities the suppliers and final users supposed to
擔責任各是什麼？
undertake respectively? 04
Please explain the cost and duration of notification in a normal case.
新化學物質申報的費用和週期解釋
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM 05
According to the contract of testing management, will
在進行實驗委託工作時，貴公司是否願意提供該物質
REACH24H provide data of the substance, including the
的理化性質、毒理、生物系統相關實驗的資料？
physical & chemical properties, toxicological, and biological system related testing data? 06
Please explain the preparation/mixture complied with
新化學物質法規(China REACH)下, 混合物如何登記。
China REACH. 07
Please explain the obligation of the annual report on new
請解釋新物質在完成登記後所進行的年度活動報告。
chemical substance submitted by notifier to CRC before February 1st each year. 08
Under such a circumstance that a mixture is
1)一種物質為混合物，A 和 B 物理混合，其中 A 經查
compounded physically by substance A and B, among which
為新化學物質且為聚合物。B 物質不是新化學物質也
substance A is known as new substance and a polymer
為聚合物。請問申報時是以 AB 混合物申報，還是只要
through IECSC inquiry while substance B is an existing
申報 A 物質即可代替該混合物新化學物質的申報？2)
substance but also a polymer. The question is how to
由於單體反應生成聚合物比較複雜。例如三種單體反
manage this notification, as a mixture product of AB or
應生成一種聚合物，但由於反應量，溫度的不同。聚合
simply the substance A merely?
的形式會有所不同，請問：同意的反應物質生成不同
The synthesis of polymer by monomer is quite complicated. For example, three monomers are synthesized
的聚合物，聚合物只是鏈的長短不同，是否需要兩次 申報
into one polymer. However, due to the difference of chemical
reaction
and
temperature,
the
ultimate
polymerization type is different. It is possible to generate two distinguishing polymers by 3 same chemical substance that allow for this. The question is given that the 2 polymers has two different chain length, whether or not these 2 polymers will be required for 2 notification. 09
Where to know “chemicals with unidentified hazardous
“危險特性尚未確定的化學品”對怎樣界定？危險化
properties”? How to identify a chemical as a hazardous
學品的界定標準
chemical? 10
To the reuse of hazardous solvent such as methylbenzene,
危險化學品登記是否包括生產過程中回收套用的危險
aniline during production, shall those manufactures be
性溶劑如，甲苯，苯胺類
subject to registration of hazardous chemicals under related regulations? 11
What is the timeline of the publication of new Catalog of
1)危險化學品目錄什麼時候能出來，國家標準（GHS)
Hazardous Chemicals, and whether national standard of
修不修訂？2）今後 GHS 推進的具體計畫表 各級政府
GHS will be revised?
企業雙方的職責等? 3)同一危險化學品出口和國內銷
implementation
at
What is the plan of China GHS next
phase,
and
the
specific
responsibilities of each competent authorities in this regard?
We have noticed that even the same hazardous
chemical products, the GHS labels used have Chinese standard format and exporting country standard format respectively. Under this circumstance, will there be any suggestions to combine these 2 format of labels to save time?
售標籤格式有兩種，如何整合？
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM 12
Before the new Catalog of Hazardous Chemicals being
<危險化學品名錄>未公佈前，中國企業如何做好對化
published, is there any advice for Chinese enterprises to
學物質的分類及管理？目前來看國內較多企業提供的
handle classification and management of chemicals on their
SDS 格式都不合國標。同時法規不斷更新，生產企業對
own? Currently, quite an amount of SDSs provided by
原料供應商要求也越來越嚴格，從國家層面來看，回
Chinese enterprises have failed to meet the format
事怎樣監管？
requirements in many other areas. With continuous strengthening of chemical regulations implementation in China, and moreover the requirements from manufacturers turn to be even stricter to raw material suppliers. From the standpoint of government, how will they implement administration of GHS compliance? 13
If a company purchases some hazardous chemicals and
1) 如果公司只是買某些危險化學品進行機械混合，
chemical
算不算危險化學品生產企業？2) 產品已經知道有物
modification during it. In that case, will this company still be
理危害，還要進行危險性鑒定嗎？3) 產品登記需要
taken as a hazardous chemical manufacturer and subject to
以大類登記還是以单个产品登記？
carry
out
processing
registration?
physically
without
It is already known that a product has
physical hazards; is it compulsory to have hazardous identification?
If in a case, taking painting as an example,
products of one manufacturer are similar in hazardous properties but still with some differences in components, this manufacturer will be allowed to conduct registration for the whole category of his painting products, or each painting product subject to its unique registration? 14
Will a Chinese importer have to apply for registration
首次進口的危險化學品需要辦登記證，還是 591 號令
certificate only for hazardous chemicals imported for the
實施之前（早於 2011 年 11 月）的危險進口化學品也
first time, or even for hazardous chemicals imported before
需要辦證？
Decree 591 by State Council (Regulation on Safe Management of Hazardous Chemicals) released? 15
16
Many chemicals may contain hazards more or less, so it is
危險化學品名錄的制定是按照什麼標準？很多化學品
interesting to know based on what standards, the chemicals
都有危害，一些很輕微，一些很嚴重，按什麼標準收入
in Chinese Catalog of Hazardous Chemicals are decided.
到名錄中？
Regarding the hazardous chemical products of foreign
國外公司在中國保稅區的危險品，是否需要登記？如
companies stored in tariff-free zone in China, shall those
果需要，由誰登記？
products be registered in accordance with regulations? If yes, who should fulfill the registration obligation? 17
Shall the label of chemicals exported to China be pin Chinese?
If a batch of imported chemicals fail to be
labelled according to the requirements under China GHS,
1) 進口的化學品標籤是否一定要中文？ 2) 如果進口 化學品沒符合 GHS 要求的標籤，海關是否會放行,誰來 監管?
how will the enforcement activities implemented, will the Custom involve in? 18
If differences of GHS label and UN code in a SDS indeed
1)化學品 SDS 中設計的 GHS 標籤和 UN 編碼，與其他國
exist according to regulations in different areas, which
家不一致的時候，以誰為準則，如何協調一致？2)如
regulation shall be complied with foremost?
For
果某物質出口到美國，國內 SDS 中沒有 UN 編碼要求，
example, product manufactured in China without any
但是到了貿易國卻要求 UN 編碼，給貿易商造成了損
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM compulsory requirements for UN code in SDS, while
失。以後避免這樣的問題？
exported to US where UN code in SDS is a must, how to bridge this gap? 19
How to handle the classification of chemicals not included
将要出台的新版包含统一分类的危险化学品名录，如
in the Catalog of Hazardous Chemicals in which a number of
果发现物质分类清单中的，又如何分类？
chemicals already with harmonized classification? 20
Please make comparison between SDS, GHS of China and US. 2) What should be especially concerned with when we need to refer to the data for hazardous classification from US?
美國 SDS,GHS,資料的直接引用時的應注意什麼？
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM
1. PETTERI MÄKELÄ (EU REACH) TITLE: HOW TO PREPARE FOR THE 2013 REGISTRATION DEADLINE UNDER REACH CONTENT: The officer from ECHA clearly gave the live statistics of registration status, and stressed the importance of registration before deadline correspondingly. Additionally, Mr. Mäkelä contributed his professional ideas about registration strategy, some key tools used for successful registration. Enforcement activities on national level was also mentioned at the end of his speech.
2. CHIEL BOVENKERK (EU REACH) TITLE: ENFORCEMENT OF REACH & GHS IN EU AND NETHERLANDS CONTENT: The officer from REACH enforcement authority Netherlands at the workshop unfolded his topic majorly focused on REACH and EU CLP; how enforcement is organized in the Community; what the enforcement activities looks like; the priority at the enforcement; the result of enforcement in Netherlands; and the expectation of future enforcement activities.
3. HELEN YE (EU REACH) TITLE: REACH REGISTRATION LOA COST STRUCTURE ANALYSIS CONTENT: The expert from REACH was giving analysis of cost sharing mechanism in co-registration under REACH. The cost to non-lead registrant has been specified by explaining real cases. Why does a copy of LOA cost that much? How much could it be for registration data and specific endpoints? How to decide if a LOA is priced properly? All questions are given answers to in this speech.
4. NIE JINGLEI (CHINA REACH) TITLE: INTRODUCTION TO ENVIRONMENTAL MANAGEMENT OF NEW CHEMICAL SUBSTANCE CONTENT: The officer from CRC-MEP of China gave overview of the environmental management of new chemicals recently in China at the start of his speech. As the core of new chemical management, Order 7 by MEP (China REACH) was specified with obligation of notification, data requests and enforcement activities. Supportive measures and technical documents were also covered.
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM
5. WANG HONG (CHINA REACH) TITLE: THE APPLICATION OF CHEMICAL RISK ASSESSMENT IN CHEMICAL ENVIRONMENTAL MANAGEMENT CONTENT: This is a must-hear speech for professionals who are highly concerned about the risk assessment for chemical in China, especially applied for new chemical notification under Order 7 by MEP. The speech was focused on risk assessment system itself and also developing guidance for the assessment in China. Both qualitative and quantitative assessment for environmental and health risks composed the 2nd part and was given much time at the speech.
6. SERENA SONG (CHINA REACH) TITLE: ECOTOXICOLOGY DATA REQUIREMENTS IN NEW CHEMICAL SUBSTANCE NOTIFICATION CONTENT: Serena Song from REACH24H gave her speech about ecotoxicology data requirements for new chemical notification under Order 7 by MEP. Requirements on tests for eco-toxic data, the quality of data, test methods as well as Chinese test organism were given as the 2nd part at her speech. The rest time was spent on specifying data requirements for difficult substances like the poorly water-soluble, unstable substance, complex mixtures etc.
7. TANG BAOHUA (CHINA REACH) TITLE: TEST REQUIREMENT ON NEW CHEMICAL SUBSTANCE NOTIFICATION AND CASE STUDY CONTENT: Another must-have speech for new chemical notification was from expert of Shenyang Research Institute of Chemical Industry. Mr. Tang contributed a practical lesson of toxic and eco-toxic data requests for notification of each tonnage band (1-10 10-100 100-1000 over 1000). Then the speech went to the introduction of requirements for eco-system, biodegradation and bioaccumulation tests, procedures for eco-toxicological tests.
8. TOMMY KONG (CHINA REACH) TITLE: HOW TO PLAN AN EFFICIENT NEW CHEMICAL SUBSTANCE NOTIFICATION CONTENT: Tommy Kong, the leader of new chemical notification panel in REACH24H, brought with full of his experience on notification work. In his speech this time, he focused on the topic on how to integrate multiple resources for higher-efficient notification: 1) clearly understand the regulation; 2) knowing legal obligations; 3) organizing your financial resources and man-power in proper ways.
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM
9. LUO QIMING (HAZARDOUS CHEMICALS AND CHINA GHS) TITLE: STATUS GHS IMPLEMENTATION IN CHINA AND THE INTERNATIONAL DEVELOPMENT TENDENCY OF GHS CONTENT: Although the Catalog of Hazardous Chemicals is still absent, hazardous chemicals management and China GHS now have been a quite hot topic amongst many companies, associations and institutes around the world. The officer from MIIT disclosed the progress of implementation of China GHS.
10. GUO ZONGZHOU (HAZARDOUS CHEMICALS AND CHINA GHS) TITLE: AN INTRODUCTION ON “MEASURES FOR THE ADMINISTRATION OF HAZARDOUS CHEMICALS REGISTRATION” CONTENT: Mr. Guo, the officer from NRCC-SAWS, came up with the introduction of the measure on hazardous chemical registration (Order 53 by SAWS). According to this new order as the supportive regulation attached to Decree 591 by State Council, Mr. Guo was focused on the questions on who will be affected, competent authorities, registration procedures, registration documents and specific obligations of registrants, penalties and emergency response call (24 ER number).
11. GE YUYING (HAZARDOUS CHEMICALS AND CHINA GHS) TITLE: ENFORCEMENT & SUPERVISION OF DANGEROUS GOODS TRANSPORTED BY WATER CONTENT: The expert offered his experiences of dangerous goods transported by waters in China. Related regulations and definition, regulation scope, management of dangerous and unclassified goods (goods with unknown hazardous properties) were the major points at the speech.
12. SANGHEE PARK (KOREA CHEMICAL LEGISLATION) TITLE: KOREA REACH AND CURRENT ACTIVITIES CONTENT: Ms. Sanghee Park from Chemtopia KOREA brought her research of new chemical management or known as Korea REACH. The introduction of KECL and TCCA, also the overview of legal framework of the regulation was given at the 1st part of the speech. More details including exemption in Korea REACH, tonnage band for registration, data requests, supply chain communication together with penalties wer mentioned at the following part.
REACH WORKSHOP AISA, 2012 | REACH24H Consulting Group | REACH24h.COM
13. LILY HOU (US CHEMICAL LEGISLATION) TITLE: REQUIREMENTS AND SOLUTIONS FOR TSCA COMPLIANCE CONTENT: Toxic Substance Control Act (TSCA) belonged to Lily Hou from Chemadvisor. In her speech, this expert started with the background of the entire law, regulation scope, and competent authorities. At the following part, the content was focused on specific requirements of TSCA, and legal obligations of notification, import certificate and more.
14 CHRISTINE LEPISTO (GLOBAL GHS) TITLE: SOLUTIONS FOR COPING WITH REGIONAL DIFFERENCES IN GHS CONTENT: Christine Lepisto from the WERCS this time came with their excellent experience of global GHS compliant strategy. In her speech, the differences of GHS implemented in various areas were organized for everyoneâ&#x20AC;&#x2122;s information. Building blocks adopted by EU, Australia, Japan, Korea, New Zealand, Brazil, and China were made in several slides for easier understanding.
15 SANDY MA (COMPANY CASE STUDY) DUPONT CHINA TITLE: DUPONT CHEMICAL REGULATION COMPLIANCE PRACTICE INTRODUCTION CONTENT: DuPont sent RA specialist this time showing their serious attitude of regulation compliance around the world. The speech Sandy provided would be a good lesson to learn about how to organize a perfect system of global regulatory compliance by carefully designing specific operating and monitoring procedures inside a company.
16. SIMONE MARGHERITIS (EXTENDED SAFETY DATA SHEET) TITLE: EXTENDED SAFETY DATA SHEETS: MANAGING AND UNDERSTANDING EXPOSURE SCENARIOS CONTENT: Selerant joined in the workshop contributing their experience of safety data sheet and extended safety data sheet under EU REACH. In this speech, Simone shared the knowledge of the generation of extended safety data sheets; types of exposure scenarios; evaluation and scaling methods.