REACH Regulatory Trends&
SIEF & Consortia Approach
Tokyo, Japan

25 February 2009

DaeYoung PARK (Brussels, Belgium)

Kwe-Ho LEE (Seoul, Korea)
Yong-Ik CHOI (Seoul, Korea)

Overview,

Trends of Global Chemical Regulations,,

Trends of EU REACH Enforcement Regulations,,, 5+'(%QPUQTVKC,9%5#KP5+'(

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9,, %5#'5KP%JKPC,CRCP-QTGCWhat Happened on Chemicals in 2008 - 2009•

Globally, around 580 chemical policies & regulations amended & adopted between
Jan. 2008 and Jan. 2009.

•

Namely, 44 chemicals policy & regulatory issues are out each month.

•

Amongst others, more than 42% of chemical policy and regulatory issues from EU& Member States.
Chemical Regulatory Developments
in 2008 & 2009
Jan. 2009
Dec. 2008
Nov. 2008
Oct. 2008
Sep. 2008
Aug. 2008
Jul. 2008
Jun. 2008
May 2008
Apr. 2008
Mar. 2008
Feb. 2008
Jan. 2008

Regional Chemical Policies & Regulations

59
53
40

NA, 34.8%

46

EU, 42.3%

38
43
42
54
34
32
40
55
44

LA, 3.9%

APEC,
19.1%

EU Chemical Policies & Regulations in 2008 - 2009•Highest Regulatory Development in EU & MS is due to REACH- & GHS-related
Policies & Regulations.

•

Around 110 chemical-related policies & regulations in EU & MS adopted,
amended & proposed between 2007 - 2009.

•

In 2008, 81 REACH-related policies & regulations amended or adopted, and 10
proposed.
REACH-related Regulatory Developments

0
,1
ed
os
op
Pr

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op
Ad
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ed

2008

81

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ed
os 8
1
op
Pr ted ,
op
Ad

2007

0

20

40

60

80

100

Amongst others, Member States
having REACH-related
enforcement regulations include:

Austria, Bulgaria, Cyprus, Czech
Republic, Denmark, Finland,
France, Germany, Hungary,
Ireland, Italy, Netherlands, Norway,
Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, United
Kingdom

REACH Enforcement Regulations in MSs
Country

Legislation

Date

Croatia

Law on Adoption of the Regulation EC/1907/2006 of European Parliament and theCouncil of the EC registration, evaluation, authorization and limitation of chemicals (NN53/08)

25-Apr-08

LatviaChemical Substances and Chemical Preparations Law

01-Nov-07

Malta

Dangerous Substances Regulations, 2008

21-Nov-08

Austria

Chemicals Ordinance13-Nov-08

Lithuanianiaa

Up to EUR
120.000EC/1907/2006
for placing
on ng theResolution No. 687 on thethe Implementationof Regulation
concerning
Registration, Evaluation
Evaluation,
on, Auon
Authorization
and Restrictionof Chemicalsof very
the market
a substance

11-Jul-07

Slovakiaia

Regulation
on Placing
on the Market
Pyrotechnic
Government Regulat
atio
ation No.
io
No 485/2008
highColl.
concern(SVHC)
without
Articles06-Nov-08

Spain

Royal Decree 1802/2008
180
802/2008 m
80
modifying the Regulation on the notification of new subst
substancesstand classificati
classification,tiontion, packaging and labeling of dangerous substanceson

03-Nov-08

ed
Unitedm
Kingdom

REACH En
Enfo
forcement Regulations 2008 (SI No. 2852)
fo
Enforcement

10-Nov-08

aryyHungary

XXVI
VIII. of 2008 on the amendment of several Acts related to health
VI
Act XXVIII.

01-Sep-08

Romanianiaa

Deci
Decision
cisi
ci
sion
si
on No. 1238/2008 stating new inspection competencies of the National
Envi
Environmentalvirovironmental Guardro

01-Oct-08

CzechhRepublicic

Act Amending Act No. 356/2003 on Chemical Substances and Preparations
Ac

23-Sep-08

aryyHungary

Government Decree No. 224/2008. (IX. 9.) on detailed rules of the application ofchemical fines (224/2008. (IX. 9.)09-Sep-08

Finlandd

Act 491/2008 amending the Chemicals Act 744/1989

18-Jul-08

Ireland

Chemicals Act 2008 (S.I No. 13 of 2008)

09-Jul-08

obtaining an authorization.

Italy

Draft Legislative Decree including: Sanctions for the violation of the provisions of
REACH Regulation EC/1907/2006 (n. 55)

22-Jan-09

“REACH Enforcement”= MS, not ECHA!

SIEF – Unknown Animal in Asia
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through the HPV Program in ICCA and the Japan Challenge Program.

•

The Ministry of the Environment (Korea) sponsored around 10 substances in
the OECD HPV Program.

SIEF Formation Facilitator – Whom to believe?
Example 5

TOLUENE
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Dear M
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Dear Sir, 203-625-9
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isocyanatomethyl-3,5,5-trimethylcyclohexyl
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LOA REACH
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Regards
1061 Budapest

SIEF & Consortia - Eligibility

CSR is Optional in SIEF
Mandatory Joint
Submission••••

Classification andLabelling
Study Summaries
Robust Study
Summaries
Proposal of Testing

Individual Submission•Identify of manufacturer orimporter of the substance•Identity of substance•Information on the
manufacture and use of thesubstance•For substances inquantities of 1 to 10 tons,
exposure information

Optional•••

Chemical Safety
Assessment(CSA)
Chemical Safety
Report (CSR)
Guidance on
Safe UseSIEF & Consortia on CSA & TD

25 February 2009, Current Status
Source: LOA ConsortiumSIEF & Consortia on CSA & TD••

Core data set
IUCLID 5 file - Common elements of
the registration dossier to the level
required by the registration type
F Classification and Labelling
proposals
F Derivation of DNELs and PNECs
F Chemical Safety Report•

As necessary (Optional)
F Exposure scenarios for hazardous
substances
F Risk characterisation for agreed
common uses
F Elements of a Safety Data Sheetthat need change to reflect theconclusions of the dossier andthe Chemical Safety Report
Detailed guidance on how to use theinformation•

Source: LOA ConsortiumDifficult Part – Exposure Scenario in CSRPART A

1. Summary of Risk Management Measures
2. Declaration that Risk Management Measures are Implemented
3. Declaration that Risk Management Measures are CommunicatedPART B

1. Identity Of The Substance And Physical / Chemical Properties
2. Manufacture & Uses
3. Classification And Labelling
4. Environmental Hazard Assessment (e.g. degradation, bioaccumulation)
5. Human Health Hazard Assessment
6. Human Health Hazard Assessment of Physicochemical Properties
7. Environmental Hazard Assessment (e.g. acquatic, atmosphericcompartment)
8. PBT & vPvB Assessment
9. Exposure Assessment (9.1 Exposure Scenario, 9.2 Exposure
Estimation)
10. Risk Characterisation* China, Japan and Korea – Traditionally Hazard-based Chemical
Management

Exposure Scenario – Use & Application, e.g.
Methnol•CRRNKECVKQPUYGTGKPYQTMGTWUG– DSSOLFDWLRQVZHUHIRXQGIURPWKHPHDVXUHPHQWUHJLVWHURI77/ 
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VFHQDULRV,QIRUPDWLRQDERXWDPRXQWVZDVDFKLHYHGIURP.(78DVDGGLWLRQDOVHUYLFH

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol
1. Loading, unloading and packing in vessels/GVJCPQN$ERXW W FXVWRPV VWDWLVWLFVWUDQVSRUWDWLRQ LVRXWVLGH5($&++ORQTVJCTDQWTU
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1.4 Packing in barrels

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol
2. Manufacturing of chemical products: formaldehyde and chlorine dioxideand slime preventing agent/'6*#01.C D EVQIGVJGT CDQWV V -'67
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4.2.2 Urea andmelamine resins/CPWHCEVWTKPI QH
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6.3 Plywood, chipwood, wood fiber products
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6.6 Mineral and glass fiber industry(0,5 % in fixing agents)
6.7 Foundry industry
In foundry resins <0,4 % MeOH
/CPWHCEVWTKPI QHCDTCUKXGU)L[LQJ DJHQW
9CUJKPIUQNXGPV

6.4 Coating
Wood, laminatesetc.

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Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

3. Manufacturing of chemical products/'6*#01.C D EVQIGVJGT CDQWV V -'67(QTOKE CEKF
QR0H2+
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2.7
Sodium boron
hydride(< 0,2 % MeOH)

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6.14
Additive in welding(In soldering fluid 60 % MeOH)

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

4. Manufacturing of chemical products/'6*#01.C D EVQIGVJGT CDQWV V -'67

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8.2
Use of biodiesel ?
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6#/'*DVROLQH R[\JHQDWHV

8.
Use of MTBE ?
(< 1 % MeOH in final product)

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

5. Use as a process chemical/'6*#01.VC ITQYKPI/GVJCPQN CUECTDQP UQWTEG KPYCUVGYCVGT VTGCVOGPV
LQ)LQODQGXQLWV XVH

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

6. Manufacturing of products containing methanol as a solvent/'6*#01.PDQXIDFWXULQJDQGXVHRIZLQGVKLHOGZDVKHUIOXLGVDERXWW .(78 
4.1
Manufacturing of paints
and pigments and paintremoving products


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PD[0H2+ 
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4.4
Manufacturing of
automotive fuels(< 10 % MeOH)

8.1 Use ofwindshieldwashing
fluids

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

7. Use of methanol as solvent in industry/'6*#01.-'67  #$176V/GFKEKPG CPFRJCTOCEGWVKEC
N RTQFWEVU/CPWHCEVWTKPI QHTGUKPU2CRGT KPFWUVT[
4GRCKTKPI
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6.8
Printing and textile industry(silk printing) and otherindustry(in printing colours, solventand cleaning agent, in
washing solvents)

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5.8
Natural gas
pipelines(inhibitor)

/CPWHCEVWTKPI QH
UKVQUVGTQN

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

8. Use of methanol and products containing methanol in industry andworkplaces (this includes products having methanol as solvent)/'6*#01.

6.8
Printing and textile
industry (silk printing)and other industry(in printing colours,
solvent and cleaning agent,in washing solvents
7UG QHINQUU[CFFKVKXG KPICNXCPK\CVKQPDCUKPU7UG QHOCTMKPIEQNQWTU CPFRCKPVTGOQXKPI RTQFWEVU

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

9. Laboratory use of methanol/'6*#01.CDQWV VC -'67

7.1 preparation of reagents, purification of methanol
7.2 manufacturing mediciinal products at the chemistsº
7.3 various analysis (like ocratoxines, ligniine, PAH-analysis, fatty acid, vitamines)
7.4 use as cooling agent
7.5 colouring of tissues
7.6 HPLC-analysis (high pessure liquid chromatography)
7.7 cleaning agent in glue removing
7.8 tasks in mass spectrometry

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

10. Use of products containint methanol in professional traffic/'6*#01.LQPDQXIDFWXULQJ DQGXVH RIZLQGVKLHOG ZDVKHU IOXLGV DERXW W
.(78
7UG QHYKPFUJKGNF YCUJGT HNWKFU

Source: RV Chem Oy

Exposure Scenario - Use, e.g. Methnol

11. Consumer exposure to products containing methanol
241&7%65%106#+0+0)/'6*#01.

10.1
Dilution and use ofwindshield washer
fluids(max 60 % MeOH in
retail products)

10.2
Manufacturing and use of
automotive fuels
Model aeroplanes, model
cars, speeding race,
speedway motorbikes(in fuels 60 - 100 % MeOH)
7UG QHHWGNU KPECORKPIEQQMGTU0H2+

10.4
Use of paint and colours
removing products(in paint removing
products max 20 %MeOH)

Source: RV Chem Oy

Exposure categories (EC) and exposure scenarios (ES)- Methnol

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0HWKDQRODVFDUERQVRXUFHLQZDVWHZDWHUWUHDWPHQW (60DQXIDFWXULQJRISURGXFWVFRQWDLQLQJPHWKDQRODVVROYHQWSURGXFWLRQRIZLQGVKLHOGZDVKHUIOXLGV (6Source: RV Chem Oy

Exposure categories (EC) and exposure scenarios (ES)8VHRIPHWKDQRODVDQLQGXVWULDOVROYHQWLQH[WUDFWLRQSURFHVVHV HJPHGLFLQV  (&8VHRIPHWKDQRODVVROYHQWLQGLIIHUHQWILHOGVRILQGXVWU\ (&/DERUDWRU\XVHRIPHWKDQRO (&8VHRISURGXFWVFRQWDLQLQJPHWKDQROLQSURIHVVLRQDOWUDIILF (6– 8VHRIZLQGVKLHOGZDVKHUIOXLGV&RQVXPHUXVHRISURGXFWVFRQWDLQLQJPHWKDQRO (6– 8VHRIZLQGVKLHOGZDVKHUIOXLGV&RQVXPHUXVHRISURGXFWVFRQWDLQLQJPHWKDQRO (6– 8VHRIPHWKDQRODVDXWRPRWLYHIXHO

Source: RV Chem Oy

Example: Laboratory use of methanol, preliminary exposure scenario(only worker exposure)
1. Short title

Branch: Research (Natural science and technology)
Process category: PROC 15 use as laboratory reagent,
professional use

2. Description of activities and processes
coveredUse of methanor in various laboratory functions:Preparation of reagents, preparation of medical agents inthe chemistºs shop, various analysis, use as refrigerant,colourant for tissues, HPLC-analysis, use for glue
cleaning and MS-tasks. Maintenance of laboratory
equipment and waste handling in the laboratory

Conditions of use
3 Duration and frequency of use

8h, 200 d/a. (Needs more specification?)

4.1 Physical form of the substance

Liquid solvent, flammable, volatile

4.2 Concentration of substance in the
product (% substance in the mixture
or preparation)

Maximum 100 % methanol

4.3 Amount used per time

Variable use depending on the function (needs
specification?)

5. Other operational conditions
Temperature, pressure, volume of theenvironment/room size

Temperature inside about 20 C

Source: RV Chem Oy

Example: Laboratory use of methanol, preliminary exposure scenario(only worker exposure)

Risk management measures (RMM) which together with the conditions of use
guarantee safe use.
6.1. Worker exposure RMM(The details are found in the RMM
library, effectiveness must be desribed,
also details of exposure from various
ways of exposure)Handling of methanol should always be in fume
cupboard.
Use of protective gloves (buthyl rubber,
fluorinated rubber, teflon, laminated plastic
materials) in all tasks where skin contact ispossible. Use of goggles during all methanoltasks. Beware of flammSuojalasien käyttö
kaikissa metanolitöissä. Beware of
inflammability.

6.2 RMM in environmental exposure(wastewater, air and soil)

Not handled in this exposure scenario

7. Waste handling and RMM

Worker exposure during waste handling in one
target was <27 mg/m3. Total exposure to allsolvents is however above the occupational
limit values. How is this dealed in REACH?

Source: RV Chem Oy

Example: Laboratory use of methanol, preliminary exposure scenario(only worker exposure)
Exposure assessment and the methods how the downstream user canestimate that he/she follows the conditions of the use described in
the exposure scenario
8.a Estimation of the exposurelevel (e.g. mg/l tai mg/m3) andreference to the source of
information

Based on the measured concentrations the estimatedmean concentrations of the whole workday exposures
were below 27 mg/m3 (except the work of glue
removal). In this case the dose would be lower thanthe DNEL value (see previous risk characterisation).
According to modelling of the dermal exposure (?)
protective gloves should be used to reduce theexposure (so far no good model, development is
continuing).

9. Guidance to the downstream
user to assess the exposureand circumstances

In the final exposure scenario guidance is given e.g.
about the correlation between the amount of use andexposure time to the exposure.

Source: RV Chem Oy

CSA & ES in China, Japan and Korea•

2008: Comprehensive chemical test standards, e.g. Chemicals - Test Method of
Toxicokinetics Studies (GB/T 21750-2008), Chemicals - Test Method of In-Vivo
Mammalian Erythrocyte Micronucleus (GB/T 21773-2008), Testing of Chemicals - Alga
Growth Inhibition Test (GB/T 21805-2008•

Dec. 2008, Review Report of Public Consultation on the Revision of the Law on theControl of Examination and Manufacture of Chemical Substances (e.g. risk assessment
on priority chemicals (ඃඛホ౯໬Ꮫ≀㉁))
NEDO Comprehensive Chemical Substance Assessment and Management Program(Development of Chemical Risk Assessment, Preliminary Risk Assessment, Exposure
Route Data Sheets)
Japan Challenge Program

China

Japan

•

•
•
•

Korea

•
•
•

Feb. 2009: Chemical Release and Transfer Survey in Life Cycle (Ministry of theEnvironment)
Feb. 2009: Development and Operation of Chemical Test Data Search System (Ministry of
the Environment)
Jan. 2009: Exposure Scenario Development (Korea Institute of Industrial Technology)
Jun. 2008: Chemical Information Exchange System in Supply Chain (Ministry of theEnvironment)
Feb. 2008: Guidance on the Development of Integrated Exposure Assessment (Ministry of
the Environment)

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