Case studies coping with REACH in Korea

September 2010

Samrae Cho, Director
Korea Chemicals Management Association

C.O.N.T.N.T.S▪ Case of KCMA coping with REACH▪ Case of REACH implementation at individual company(LG Chem)▪ Case of REACH collaboration between Korea companies

Case of KCMA coping with REACH▪ Background▪ Pilot project for REACH registration▪ Project utilizing Toxicity test data
▪ Future plan

Background
KCMA have supported the exporters with Ministry ofEnvironment(MOE) to cope with REACH in several ways
since the EU REACH took effect in 2007
Research the companies which needs REACH registration or notificationand monitor the preparation status by companies periodicallyClassify the companies by the level of preparation status and provide 1:1
consulting and technical support, and visiting service
Hold the training workshops by industry and REACH EXPO, etc.

Provide direct support since the preparation of REACH
registration started in earnest from 2009
1. Running the “Registration” pilot project by selecting the substance for thecompanies lacking in ability coping with REACH or having difficulties due
to no activities in SIEF, or selecting the substance2. Running the project enabling domestic and foreign companies to utilize
Toxicity test data belong to MOE
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Pilot project for REACH registration
Overview
KCMA’s research in 2008 shows that 321 companies completed
the pre-registration.
The number of SME’s was 259 companies(80.7%) and major
companies were 62 companies(19.3%) among them. Because the
SME’s are lack of specialty and manpower, they will havedifficulties in REACH registration by themselves.
Confirmed that there may be problems for preparation ofregistration because there are no Consortium or SIEF for some
substances.
Therefore, KCMA in cooperation with MOE started pilot project forthe companies need technical and administrative support and forsome substances from 2009.
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Pilot project for REACH registration (cont’d)Selecting the substance
5 substances which SMEs having problems with REACH registration and 5
substances whose consortium or SIEF that have to be led by Korean
companies because there no consortium or SIEF for them.
Considering Tonnage, SIEF trend, Data gap and KCMA’s budget, 3
substances in 2009 and 7 substances in 2010 were selected.

Participating organization and their roles
Companies preparing the REACH registration, Consulting companies andexperts organized consultative group with KCMA as the center andexecuted the primary process for the registration
KCMA oversees the whole project and companies produce the test data
and make contracts with the OR. Consulting companies analyze the Data
gap and communicate with the OR. Experts review the test report andtechnical data and MOE supports whole process.
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Pilot project for REACH registration (cont’d)Contents
Project provides technical and administrative support for whole process
which are from the preparation to completing the registration. Consultative
group holds the meeting periodically to review the status of project and to
discuss the directions of it.
Confirm the homogeneity of substance, Data gap analysis and selection oftest item, Selection of GLP and supervision of process, review the test
report, Technical Dossier & CSR, Checking the SIEF trend, communicatingwith OR, etc.

Project status(August. 2010)
For the 4 substances falling under ≥1,000t, secured the LoA andcompleted the Toxicity test, now preparing the registration document
The 6 substances falling under ≥100t, toxicity test is in progress.
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Project utilizing Toxicity test data
Overview
MOE carried out safety assessment for the HPV program from1988 and produced Toxicity test data of 575 substances for 1,298
items for OECD SIDS until 2007.
– OECD SIDS 17 substances, HPV Program 558 substances
Support the REACH registration by enabling domestic and foreigncompanies to use the Toxicity test data and promote sharing andbusiness transaction of test data
MOE started the project from 2009 and appointed the KCMA as
the contact point to increase the usage of Toxicity test data

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Project utilizing Toxicity test data (cont’d)
Credibility of Toxicity test data
Reviewed the list and status of test data belongs to MOE prior to theproject and evaluated the credibility of data based on ‘Klimisch et al.’scoring system
Categorized data after ’98 as ‘score 1. reliable without restriction’, anddata before ’97 as ‘score 2. reliable with restriction or 3. not reliable ’# ofsubstances

Test item

Total

575

1,298

ʼ98˜ʼ07

235

672

1

ʼ88˜ʻ97340

626

2 or 3score

Evaluation basis- GLP Criteria- Non GLP Criteria
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Project utilizing Toxicity test data (cont’d)Applicants and Data usage
Anyone(domestic and foreign), who needs Toxicity test data, can apply toregister the substance including REACH or assessment
Provide the Letter of Access(LoA) regarding the test data

Application and Approval Process
Applicants submit the application for LoA to KCMA, then KCMA asks
for MOE’s approval after KCMA reviews the application and negotiate
the terms
MOE issues the certificate after review of application and send it to
KCMA. Then KCMA provide the dossier(certificate and test report) after
confirmation of deposit for usage fee
Applicants
Apply

KCMA
Negotiation
and ask forapproval

MOE

KCMA

ApplicantReview ofapplication
and approval

Confirmationof deposit andprovidedossier

Secure thecertificate and
LoA

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Project utilizing Toxicity test data (cont’d)Data Usage Fee
30% of original test cost when the number of applicants is less than 6
persons
5% will be added for each additional applicant when the number of applicants
is more than 6 persons

Status of Approval
By the end of August this year, 654 companies were approved andprovided test data for 7 substances.
Most of them applied to use them for REACH registration

Cancellation of Approval
When accredited person let the others who were not accredited use them
When use the data outside of the original purpose
When approved with false entry of application
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Future Plan
Publish and provide ‘The Cases of Registration’ after thecompletion of REACH registration pilot project so othercompanies can use them to prepare the registration(December 2010)
Promote the MOE’s Toxicity test data so they can be usedin various purposes such as the registration in othercountries or risk assessment
Especially, follow up the usage of approved data whether
they are used for the original purpose by the accredited
person12/30

Case of REACH implementation at
individual company(LG Chem)▪ Overview▪ Substances▪ Polymers & Preparations▪ Status of REACH registration

Overview
LG Chem is the leading chemical company in Korea in both size andPerformance, and have 25 Subsidiaries around the world.
This company produces from Substance to Article, and they are taking
steps for REACH implementation of each products exported EU.
Category

LG Chem Products

Substance• Acrylate/ Plasticizer: DOP,DINP,AA,BA etc• NCC/PO : Ethylene, Propylene etc• ABS/EP : SM,
PVC : VCM, NaOH
• Rubber & Specialty : Phenol, BPA etc

Polymer• ABS/EP : ABS, SAN, EP etc
• PVC
: PVC
• NCC/PO : PE, PP etc• Rubber & Specialty : SBS, SBL etc

Preparation• ABS/EP : ABS, EP Compʼd etc• NCC/PO : PO Compʼd etc• Electronic materials : Toner, Electrolyte etc

REACH Regulation• All substances exported to EU more than 1
Metric ton per year.
• Polymer consists of 2wt % or more monomer
substance or other substance in the form ofchemically bound substance.
• Total quantity of such substance makes up
over 1 ton per year.
• All substances exported to EU in preparations
more than 1 Metric Ton per year per
manufacturer or importer.

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Substances
Process• Make a list of EU export Product(Tonnage, Importer information,
Export method, ˜ʼ07.2)▶

• Decision of Pre-registration items(˜ʼ07. 4)

Decision of Pre-registration items◈Confirmation of phase-in substance▷Substance which meets at least one of the following criteria
1. EINECS (European Inventory of Existing Commercial Chemical Substance)
2. NLP (No Longer Polymer)• Substance Identification Data
collection (˜ʼ07.10)• Investigation of Indirect tonnageof EU Export by customer (˜ʼ08.1)

3. It was manufactured in the Community, but not placed on the market
by the manufacturer or importer, at least once in the 15 years before
the entry into force of this Regulation• Joining of REACH Pre-Cs (˜ʼ08.3)• Selection of Only Representative(˜ʼ08.4)• Pre-registration (˜ʼ08.9)• Investigation of D/Uʼs usage of
products (˜ʼ09.6)• Making TD, CSR, SDS (˜ʼ10.6)• Registration (˜ʼ10 .11)

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Substances (cont’d)
Process

Confirmation of identification• Make a list of EU export Product(Tonnage, Importer information,
Export method, ˜ʼ07.2)

GC data• Decision of Pre-registration items(˜ʼ07. 4)▶

• Substance Identification Data
collection (˜ʼ07.10)• Investigation of Indirect tonnageof EU Export by customer (˜ʼ08.1)• Joining of REACH Pre-Cs (˜ʼ08.3)• Selection of Only Representative(˜ʼ08.4)• Pre-registration (˜ʼ08.9)• Investigation of D/Uʼs usage of
products (˜ʼ09.6)• Making TD, CSR, SDS (˜ʼ10.6)• Registration (˜ʼ10 .11)

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Substances (cont’d)
Process• Make a list of EU export Product(Tonnage, Importer information,
Export method, ˜ʼ07.2)

Investigation of Indirect EU export tonnage
C urre nt E U export situation s urvey
C u rre n t E U e x p o rt s itu a tio n① M a te ria l
Nam e② ID C o d e③ P u rc h a s in g
to n n a g e(M T /Y e a r)

④ E x p o rt p ro d u c ts c ate g o ry
(O ,X )
M a te ria l its e lf

P o lym er

P re p a ra tio n⑤ E xp o rt ro o t(O ,X )
A rtic leD ire c t

In d irec t⑥ Y o u r S tra te g y P la n
(O ,X )P re -re g is tra tio n

R e g is tra tio n⑦ E x p o rt T o n n a g e o f
L G C h e m m a teria l
M T /Y e a r• Decision of Pre-registration items(˜ʼ07. 4)• Substance Identification Data
collection (˜ʼ07.10)▶

• Investigation of Indirect tonnageof EU Export by customer (˜ʼ08.1)◈ Co m pany

◈ Co m m ent◈ Team◈ Nam e• Joining of REACH Pre-Cs (˜ʼ08.3)• Selection of Only Representative(˜ʼ08.4)◈ e-m ail
◈ TE L* G u id a n ce *
ㅤ ① N am e o f M aterial that yo u're p urchasin g from LG C hem .
ㅤ ② Y ou r com p any's Identification Co de for m aterials.
ㅤ ③ An nual pu rchasing tonn age (M etric T on / Y ear)

• Pre-registration (˜ʼ08.9)

ㅤ ④ C ateg ory of you r product that is exp orted to E U (O, X )- M aterial itself : If you don't m ake any chan ges our m aterial an d export to EU, p lease m ark 'O '.

• Investigation of D/Uʼs usage of
products (˜ʼ09.6)- P olym er : If yo u m an ufactu re the p olym er w ith our m aterials an d export to EU , please m ark 'O '.
- P reparation : If you fo rm u late the p reparation w ith our m aterials and expo rt to EU , please m ark 'O '.
- Article : If you m anufacture the article w ith ou r m aterials and expo rt to EU , please m ark 'O '.
ㅤ ⑤ W hat is you r expo rt ro ot?
- D irect : If you exp ort to EU custo m er directly, please m ark 'O'.
- In direct : If you expo rt to EU custo m er th rou gh im p orter or d ealer, please m ark 'O '.

• Making TD, CSR, SDS (˜ʼ10.6)• Registration (˜ʼ10 .11)

ㅤ ⑥ D o you plan to pre-register or reg ister for ou r m aterials? (O ,X )
ㅤ ⑦ E xported m aterial's to nnage to EU by inclued ed your p rod ucts. (M T/ Y ear, average value from 2005 to 2007)☞ E xported T on na ge of L G Ch em 's m ate ria l to EU (M T /Ye ar) =P erc en tag e o f L G C he m 's m a terial in you produ cts (% ) X Y ou r p rodu ct's e xport ton n age to EU (M T /Ye ar) X 1 00

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Substances (cont’d)
Process• Make a list of EU export Product(Tonnage, Importer information,
Export method, ˜ʼ07.2)• Decision of Pre-registration items(˜ʼ07. 4)

Making TD, CSR, SDS• Essential Documents for REACH Registration- TD: Technical Dossier- CSR : Chemical Safety Report- SDS : Safety Data Sheet• Substance Identification Data
collection (˜ʼ07.10)• Investigation of Indirect tonnageof EU Export by customer (˜ʼ08.1)

SDS : Safety Data Sheet• Joining of REACH Pre-Cs (˜ʼ08.3)• Selection of Only Representative(˜ʼ08.4)• Pre-registration (˜ʼ08.9)

CSR : Chemical Safety Report

TD: Technical Dossier• Investigation of D/Uʼs usage of
products (˜ʼ09.6)▶

• Making TD, CSR, SDS (˜ʼ10.6)• Registration (˜ʼ10 .11)

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Polymers & Preparations
Process

Investigation of Product recipe• Make a list of EU export
Product

▶

PBL1)

ABS

Preparation

Polymer

Substance

ABS DP2)

LUPOY• Investigation of Productrecipe• Survey of Vendorʼs
REACH implementation
status (˜ʼ07.10)• 1st, 2nd REACH Educationfor vendor (ʼ07.9, ʼ07.11)

ABS/EP
Div.

LG
Chem

PBL

ABS

ABS DP

Comp’dingComp’ding

.

BD4)

SM3)

LUPOY

BPA

SAN

• Material composition
survey (˜ʼ08.2)• Classification of vendors(˜ʼ08.2)

1stVender• 3rd REACH Education forvendor (˜ʼ08.3/12)• Environmentally Friendly
Materials Supply Contract• Substitution or Pre-reg.
by ourselves (˜ʼ08.12/1)

Add 1

AN5)

A

B

Phosgene

2nd
VenderPolymer
1) PBL : Poly butadiene Latex
4) BD : Butadiene

PC6)

Sb2O3

Add 2

Colorant

C

D

E

F

Add 3

Add 4

I

J

Preparation
2) ABS DP : Dry powder5) AN : Acrylonitrile

3) SM : Styrene Monomer
6) PC : Polycarbonate

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Polymers & Preparations (cont’d)
Process

Survey of Vendor’s REACH implementation status• Make a list of EU export
Product• Investigation of Productrecipe▶

C om pa ny Nam e :Company Name :1. Could you describe how your company is organizing itself to prepare its REACH implementation work?

1. How much do you know about REACH ?

Just aware of the REACH briefly. (e.g. Effective date, Duty of suppliers, etc)•

for vendor (ʼ07.9, ʼ07.11)

We ha ve RE A CH Tea m directly responsible to the CEO.
We ha ve RE A CH Tea m belon ging to the opera tion division.
A few people a re in cha rge of com pa ny's RE A CH im plem enta tion.
The relevant team is in charge of com pany's REA CH im plem entation .

Have sufficient information for REACH implementation.(e.g. Registration/Pre-registration)

We don 't have any organiza tion or people for REA CH.

The Others (Please write down your own answer)
2. Please let us know your REACH Contact Point. (M andatory)

2. Could you describe REACH Implementation level of your Company?

1st, 2nd REACH Education

REACH Survey

REACH Implementation

Don't have any information about REACH.

• Survey of Vendorʼs
REACH implementation
status (˜ʼ07.10)

2nd Survey

1st Survey

Gathering information about REACH Regulation.
Have performed an initial REACH impact analysis.
Have Launched a project to implement of REACH.
Collecting the data for pre-registration / registration of our products.

1) Responsible person

2) Person in charge* Team :* T eam :* Position :* Name :* e-mail :* Position :* Name :* e-mail :* TEL* T EL::The others (Please write down your own answer)• Material composition
survey (˜ʼ08.2)• Classification of vendors(˜ʼ08.2)• 3rd REACH Education forvendor (˜ʼ08.3/12)

3. Could you classify your products which are supplied to LG Chem. (Allow ing multiple response)

3. What's the most difficult factor to implement REACH to your company?
(Allowing multiple response)
REACH(Regulation 1907/2006) is too complex to understand.
Don't have expert or team for REACH.
Too much expense. (Test , consulting, Registration Fee etc)
Insufficient consciousness of crisis about REACH.

P repa ration

Defin ition

A rticle[Substance] 4. Could you provide us w ith the information of substances w hich are supplied to LG Chem?
* Product nam e / LG Chem part N o. / Chem ical na m e / CA S No / P urity (%)

4. What's your plan to implement REACH in future?
[Substance] 5. Do you plan to pre-register all products you supplied to LG Chem?

Through our REACH TeamTo Join the Consortium.

Yes
No
Not yet decided

The others (Please write down your own answer)[Substance] 6. Which data do you have for identification of Substances?
(Allow ing multiple response)

5. Do you have any organization for REACH?

• Substitution or Pre-reg.
by ourselves (˜ʼ08.12/1)

P olym er

The others (Please write down your own answer)

Through REACH Consulting Company• Environmentally Friendly
Materials Supply Contract

Substance

Na m e or other identifier of ea ch substance (CA S N o, E INECS N o)Inform a tion related to m olecular and structural form ula of each substan ce

Yes

No

Com position of each substance (P urity, Im purity inform a tion)
Spectra l da ta (UV, IR, NM R or M ass spectrum )If yes, let us know next information

High-pressure liquid chrom atogram , ga s chrom atogram

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Polymers & Preparations (cont’d)
Process• Make a list of EU export
Product

Material Composition Survey
Material• Investigation of Productrecipe• Survey of Vendorʼs
REACH implementation
status (˜ʼ07.10)

Preparation• 1st, 2nd REACH Educationfor vendor (ʼ07.9, ʼ07.11)▶

• Material composition
survey (˜ʼ08.2)• Classification of vendors(˜ʼ08.2)

Polymer• 3rd REACH Education forvendor (˜ʼ08.3/12)• Environmentally Friendly
Materials Supply Contract

Substance• Substitution or Pre-reg.
by ourselves (˜ʼ08.12/1)

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Polymers & Preparations (cont’d)
Process• Make a list of EU export
Product

Environmentally Friendly Materials Supply Contract
Korean version

English version• Investigation of Productrecipe• Survey of Vendorʼs
REACH implementation
status (˜ʼ07.10)• 1st, 2nd REACH Educationfor vendor (ʼ07.9, ʼ07.11)• Material composition
survey (˜ʼ08.2)• Classification of vendors(˜ʼ08.2)• 3rd REACH Education forvendor (˜ʼ08.3/12)▶

• Environmentally Friendly
Materials Supply Contract• Substitution or Pre-reg.
by themselves (˜ʼ08.12/1)

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Preparing Registration
Since the collaboration in supply chain is very important, LG
Chem is making efforts to communicate with suppliers &customers.

Raw material constituent

Only Representative
information

Implementation status
Survey for registration

Registration planUse, Exposure & tonnage
coverage check
Warranty for REACH
compliance

Monitoring

Use, Exposure & tonnage
information
Warranty for REACH
compliance

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Status of REACH registration
LG Chem is making required documents through both SIEFs
and consortia.
This company will register over 20 substances through
REACH-IT by Nov.30.2010
9/16

11/30

Category

Current Status

Plan

•ARTF
•PC/BPA global group
Consortium •SM REACH•EURO chloro•DOTP• Registration completnese(2 substances (AA,BA) )• Review on TD,CSR• Making SIP documents(Substance Identification Profile• Token• Joint Submission Name

• Communication with customer• Making e-SDS• Purchasing Letter of Access• Making SIP documents(Substance Identification• Review on SIEF agreement• Purchasing Letter of Access• Registration

SIEF•Some Substances

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The REACH collaboration between
Korea companies▪ Overview▪ Chemical category in KPRC
▪ KPRC organization and function▪ KPRC activities

Overview
Seven petrochemical companies in Korea formed aconsortium to cope with REACH registration together.
– Korean Petrochemicals REACH Consortium(KPRC)– Members : Kumho petrochemical, Korea Petrochemical Ind.,
Samsung Total, Yeochun NCC, KP chemical, SK energy,
Hyosung

Consortium agreement entered into the May 15 2009
The purposes ;Sharing information between members, joint preparationof REACH registration to meet the registration timeline
and cost saving(Only representative and local consulting
fee)
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Chemical category in KPRC
Main four categories and 13 substances which are
manufactured by 7 companies covered by KPRC.
Group
C2C3
C4

BTX

OthersChemical Name

CAS No.

Ethylene

74-85-1

Propylene
1,3-Butadiene
1-Butene
iso-Butene
BenzeneTolueneo-Xylene
m-Xylenep-Xylene
XyleneStyreneSolvent naphtha …..

115-07-1
106-99-0
106-98-9
115-11-7
71-43-2
108-88-3
95-47-6
108-38-3
106-42-3
1330-20-7
100-42-564742-95-6
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KPRC organization and function
BeforeEU

KOREA
Only Representative

Consulting Firm

Company 1

B substance

Only Representative

Consulting Firm

Company 2

C substance

Only Representative

Consulting Firm

Company 3

D substance

Only Representative

Consulting Firm

Company 4

E substance

Only Representative

Consulting Firm

Company 5

Only Representative

Consulting Firm⁝

A substance

After
EU

KOREA KPRC

A substanceCompany 1

B substanceCompany 2

C substanceD substance⁝E substance

Only Representative

Consulting Firm

Company 3
Company 4
Company 5

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KPRC activities
The collaboration between members for same substance– The information sharing to reach the decision of relevant
consortium, SIEF communication, the lead registrant’s
activity follow up– The cost saving through streamlining work flow between
Only representative and member companies or avoiding
duplicate work for same substanceThe development of supply chain management tool to survey
supply chain jointly and the preparation of individual dossier
The follow up of chemical regulatory status in main exporting
foreign countries and information exchange– USA, EU, Japan, China, Taiwan, Turkey, Malaysia, etc.
– Chemical notification related regulation, GHS or CLP, etc.
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Supply chain management survey form
developed by the KPRC (sample)

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Thank you