1. Japanese and ASEAN GHS Implementation
The Wercs 2009　Global User Group
Albany, New York
Japanese and ASEAN GHS Implementation
Hiroshi SANO
Technical Consultant
Japan Chemical Database Ltd.

2. 1. GHS Implementation in Japan
2. GHS Implementation in East Asia
3. GHS Implementation in ASEAN Countries
4. “Building block approach” and
“cut-off value/concentration limits”
　　in the world

3. 1. GHS Implementation in Japan
1-1. Activities for GHS
implementation in Japan
1-2. GHS Model Classification
Project
1-3. Revision of Industrial
Safety and Health Law
1-4. Supporting tools for GHS
implementation
1-5. Review on GHS implementation in Japan
1-6. GHS implementation, from now on

4. 1-1. Activities for GHS implementation in Japan

5. GHS Classification JIS (Z 7252 - 2009) GHS Classification Guidance
Government
Industry
Inter-ministerial committee
JCIA & Japanese Standards Association
Translation of UN Recommendation on GHS
Revision of MSDS JIS Z
Issue of Labelling JIS Z
(1st Ver. Mar. 2004)
(1st Rev. Mar. 2006)
(2nd Rev. Mar. 2008)
JCIA
GHS Classification Manual
Technical guidance for Classification
Guidelines for Classification, Labelling, and Preparation of MSDS
(April, 2005)
(March, 2006)
Model Classification of Regulated Chemicals
Companies
(May, 2005 – June, 2006)
Ministry of Health, Labour & Welfare
GHS Classification of Products　
　 (single substances & mixtures)
Amendment of Industrial Safety & Health Law (Effective in December, 2006)
Change Labels
Revise MSDS
Preparation & Announcement of Model MSDS
(July, 2006)
JCIA & Japanese Standards Association
GHS Classification JIS (Z )
Seminars on Preparation of SDS for Mixtures
(ｂｙ June, 2009)
(December, 2005 – June, 2006)
JCIA
METI, MHLW, MoE
Work out GHS Classification standard
set of “Building block approach policy”,
and selection of “Concentration limit”
GHS Classification Guidance
(ｂｙ June, 2009)
(March, 2008)

6. Inter-Ministerial Committee on GHS (2001 - )
<Member> Ministry of Foreign Affairs (MOFA), Ministry of Internal Affairs and Communication (MIC), Ministry of Health, Labor and Welfare (MHLW), Ministry of Agriculture, Forestry and Fisheries (MAFF), Ministry of Economy, Trade and Industry (METI), Ministry of Land, Infrastructure and Transport (MLIT), Ministry of Environment (MoE), <Observer> Experts Japan Chemical Industry association (JCIA)
Technical experts group of Inter- Ministerial Committee on GHS
<Member>
Experts from Universities, National/public laboratories and Industries. 6 6

7. Translation of “GHS Recommendation Text” into Japanese:
Supervised by the Inter-Ministerial Committee on GHS
Available from the web-site of :
MHLW :
METI :
MoE :
1st revised edition
(Japanese Ver., Mar. 2006)
2nd revised edition
(Japanese Ver., Mar. 2008)
(Original text) 7

8. “GHS Classification Manual” （1st Ver. Apr. 2005）
（Latest Ver. Feb. 2006）　　
Classification manual is prepared under the supervision of the Inter-Ministerial Committee on GHS Part 1 : Principle of classification Part 2 : Physical and chemical hazards Part 3 : Health hazards Part 4 : Environmental hazards This manual is prepared for the GHS model classification project of the Inter-Ministerial Committee on GHS Use only reliable data sources for the classification of hazards, such as those peer-reviewed by international authorities. 8

9. “Technical Guidance Documents for GHS Classification” （Dec. 2005)
Technical Guidance Documents are prepared by
the members of Technical experts group of Inter-Ministerial
Committee on GHS.　　
This guidance is used as supporting document of expert
judgment, and complement for classification manual.
“GHS Classification Manual” and
“Technical Guidance Documents for GHS Classification”
is available from the web-site of National Institute of Technology and
Evaluation (NITE) :
(Japanese version) 9

10. Issue of Japanese Industrial Standard (JIS) by Japanese Standards association
Revision of JIS Z “Safety data sheet for chemical products – Part 1 : Content and order of sections” （ Dec ）
JIS for preparation of SDS based on GHS.
Transition period up to end of 2010
Revision of JIS Z (based on ISO )
Issue of JIS Z
“Labelling of chemicals based on GHS” （ Mar ）
JIS for preparation of Labels based on GHS. 10

11. Japanese Industrial Standard
JIS Z “Safety data sheet for chemical products – Part 1 : Content and order of sections” （ Dec ）
JIS Z “Labelling of chemicals based on GHS” （ Mar ） 11
(Japanese version and English version)
(Japanese version only)

12. Part 1: General guidelines Part 2: Safety Data Sheet
Issue of “GHS Implementation Guidelines” based on JIS Z 7250 and JIS Z by Japan Chemical Industry Association
Part 1: General guidelines
Part 2: 　　　　　Safety Data Sheet
Part 3: 　 Labelling 12

13. 1-2. GHS Model Classification Project13

14. GHS Model Classification Project (1)
Target chemicals: 1,500 substances under regulation of;
- Industrial Safety and Health Law (MHLW)
- Poisonous and Deleterious Substances Control Law (MHLW)
- Law Concerning Reporting, etc. of Releases to the Environment of
Specific Chemical Substances and Promoting (PRTR Law)
(METI / MoE)
Model classification according to
- “GHS Classification Manual” and
- “Technical Guidance Documents for GHS Classification”
Classification work was performed by experts selected from laboratories
and industries.
Classification results were checked by the member of Technical experts
group of Inter-Ministerial Committee on GHS, so as to eliminate any different
classification results among experts.
Finished classification work in two years (2005~2006)
In Japan SDS are required for approximately 1,400 chemicals which are regulated under the current laws. MHLW, MAFF, METI and MOE decided to classify these chemicals as a joint project, aiming to help industries issuing SDS.
Upon the initiation of the classification of 1,400 chemicals, a GHS classification manual and a technical guidance were developed. The main objectives of them are to facilitate the classification of these chemicals within the limited time schedule, and to eliminate any different classification results among experts. 14 14

15. Model GHS Classification project (2)
Results of GHS Model Classification Project is available from web-site;
NITE: (Japanese)
METI:
(English translation) 　
Results of GHS Model Classification are used for the base data of GHS
classification of mixed compounds, or preparation of label and MSDS in
industries.
The classification results are not authorized by the government.
The results of the project are not compulsive and allow industries to use
their own data, and classify chemicals on the basis of their own judgement.
The classification results are translated into English by METI.
In Japan SDS are required for approximately 1,400 chemicals which are regulated under the current laws. MHLW, MAFF, METI and MOE decided to classify these chemicals as a joint project, aiming to help industries issuing SDS.
Upon the initiation of the classification of 1,400 chemicals, a GHS classification manual and a technical guidance were developed. The main objectives of them are to facilitate the classification of these chemicals within the limited time schedule, and to eliminate any different classification results among experts. 15 15

16. Example of GHS model classification (a)
Xylene CAS [Physical Hazards]
Hazard class
Classification
Rational for the classification 1
Explosives
Not applicable
Containing no atom groups with explosive properties 2
Flammable gases
Classified as "liquid" according to GHS definition 3
Flammable aerosols
Not aerosol products 4
Oxidizing gases 5
Gases under pressure 6
Flammable liquids
Category 3
The flashing points are 32℃ for o-xylene and 27℃ for m-xylene and p-xylene (ICSC 2002) (closed cup
flash test), each of which is classified into Category 3 or Class 3 and Container II-III (UN
Recommendations on the Transport of Dangerous Goods, UN#1307). 7
Flammable solids 8
Self-reactive
substances and
mixtures
No atom groups with explosive or self-reactive properties 9
Pyrophoric liquids
Not classified
Not pyrophoric when in contact with air at ordinary temperatures: the flashing points are 463℃ for o-
xylene and 527℃ for m-xylene and p-xylene (ICSC 2002). 10
Pyrophoric solids 11
Self-heating substances
and mixtures
Classification not
possible
Test methods applicable to liquid substances are not available. 12
Substances and
mixtures, which in
contact with water,
emit flammable gases
Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) 13
Oxidizing liquids
Organic compounds containing no oxygen, fluorine and chlorine 14
Oxidizing solids 15
Organic peroxides
Organic compounds containing no "-O-O-" structure 16
Corrosive to metals
Classified into Class 3 (UN Recommendations on the Transport of Dangerous Goods, UN#1307) 16

17. Example of GHS model classification (b)
Xylene CAS [Health Hazards (1)]
Hazard class
Classification
Rational for the classification 1
Acute toxicity (oral)
Category 5
Based on the rat LD50 (oral route) value of 3,500 mg/kg representing the lower of the two testing data,
3,500mg/kg (CaPSAR, 1993) and 4,300mg/kg (MOE Risk Assessment Vol. 1, 2002).
Acute toxicity (dermal)
Classification not possible
No definitive value available, although the substance can be classified as Category 5 or not classified
based on the rabbit LD 50 (dermal route) value of >4,350 mg/kg, (IUCLID 2000).
Acute toxicity (inhalation: gas)
Not applicable
Due to the fact that the substance is "liquid" according to the GHS definition and inhalation of its gas is
not expected.
Acute toxicity (inhalation: vapour)
Not classified
Based on the rat LC50 (4 hour inhalation exposure) value of mg/L (MOE Risk Assessment Vol.1,
2002) (equivalent to 6,700ppm) was lower than 90% of the saturated vapor concentration (8,000ppm)
under a saturated vapour pressure of 0.8 kPa (20℃), the substance was considered as "vapour
containing substantially no mist" and was classified based on standard values expressed in ppm.
Acute toxicity (inhalation: dust, mist)
No data available 2
Skin corrosion / irritation
Category 2
Based on the description in the report on the rabbit skin irritation test (CERI-NITE Hazard Assessment
No.62, 　2004): "moderate irritant". 3
Serious eye damage / eye irritation
Category 2A
Based on the description in the report on the rabbit eye irritation test (CERI-NITE Hazard Assessment
No.62, 2004): "moderate irritant". 4
Respiratory/skin sensitizer
Respiratory
sensitizer:
not possible
Skin sensitizer:
Classification not
possible
Respiratory sensitizer: No data available
Skin sensitizer: No data available 5
Germ cell mutagenicity
Based on the negative data on human multi-generation epidemiological studies and somatic cell
mutagenicity tests in vivo (micronucleus/chromosome tests) and the absence of data on heritable
mutagenicity tests, germ cell mutagenicity tests in vivo and germ cell genotoxicity tests in vivo,
described in CERI-NITE Hazard
Assessment No.62 (2004), CaPSAR (1993), IARC (1999) and NTP DB (Access on December 2005). 6
Carcinogenicity
Due to the fact that the substance is classified as Category A4 by ACGIH (2001) and Group 3 by IARC (1999). 17

18. Example of GHS model classification (c)
Xylene CAS [Health Hazards (2)]
Hazard class
Classification
Rational for the classification 6
Carcinogenicity
Not classified
Due to the fact that the substance is classified as Category A4 by ACGIH (2001) and Group 3 by IARC (1999). 7
Toxic to reproduction
Category 1B
Based on the evidence of weight reduction and hydrocephalus in foetuses at dosing levels not toxic to
parent animals in mouse developmental toxicity tests, described in CERI-NITE Hazard Assessment (No
62, 2004), EHC 190 (1997) and IRIS (2003). 8
Specific target organs/systemic toxicity following single exposure
Category 1 (respiratory organs, liver, central nervous system, kidneys) Category 3 (narcotic effects)
Based on the human evidence including "throat irritation, severe pulmonary congestion, alveolar hemorrhage, pulmonary edema, congestion accompanying hepatomegaly, centrilobular vacuolation of hepatocytes, nerve cell damage associated with dot hemorrhage, swelling and disappearance of Nissl bodies, limb cyanosis, a transient increase in serum transaminase activity, an increase in the blood level of urea, a decrease in endogenous creatinine clearance in the urine, liver damage, severe kidney damage, amnesia, coma" (CERI-NITE Hazard Assessment No.62, 2004) and "pulmonary congestion, pulmonary edema, focal alveolar hemorrhage" (MOE Risk Assessment Vol.1, 2002) and the evidence from animal studies including "strong narcotic effect (EHC 190, 1997). The basis for the classification includes data on xylene with unknown composition or containing other substances (ethyl benzene, toluene, etc.). 9
Specific target organs/systemic toxicity following repeated exposure
Category 1 (respiratory organs, nervous system)
Based on the human evidence including "eye/nose irritation, thirst" (DFGOT Vol. 15, 2001) and "chronic headache, chest pain, abnormal electroencephalogram, dyspnea, cyanosis of the hands, fever, a decrease in WBC count, discomfort, impairment of pulmonary function, a decrease in working capacity, physical/mental disorders" (CERI-NITE Hazard Assessment No.62, 2004). The basis for the classification includes data on xylene with unknown composition or containing other substances (ethyl benzene, toluene, etc.). 10
Aspiration hazard
Category 2
Based on the description in ICSC(J)(2002) regarding o-xylene, m-xylene and p-xylene: "May cause aspiration and chemical pneumonia if swallowed".
Xylene CAS [Environmental Hazards ]
Hazard class
Classification
Rational for the classification 1
Harzardous to the Aquatic Environment (Acute)
Category 2
Fish (rainbow trout) 96hr LC50 = 3.3mg/L (CERIJ-NITE RAR, 2005);
--> category 2 2
Harzardous to the Aquatic Environment (Chronic)
Low rapid biodegradability (39%, CERIJ Hazard Data Report, 2005), Estimated low bioaccumulation (log Kow = 3.16), and Acute category 2; 18

19. 1-3. Revision of Industrial Safety and Health Law

20. for Chemical Substances based on GHS classification
Partial amendment of “Industrial Safety & Health Law” (Decided by the Cabinet on November 2, 2005)
Improvements of Labels and Document Communications
for Chemical Substances based on GHS classification
criteria, label contents, SDS format.
(Date of Enforcement)
This law was put into force from December 1, 2006.
(Penalty)
The person who violate the provisions regarding labelling
shall be punished with a penal servitude not exceeding
six months or with a fine not exceeding 500,000 yen
( = US$ 5,000). 20

21. Revision of Industrial Safety and Health Law
(Labelling) Article 57. A person who is to transfer or provide substances explosive, combustible, and flammable and other substances which are liable to cause dangers to workers which are liable to inflict health impairment upon workers, shall, as provided for by Ministry of Health, Labour and Welfare Ordinance, label the container or the package.
(Material Safety Data Sheet) Article A person who is to transfer or provide substances which are liable to cause dangers to workers or inflict health impairment upon workers shall notify the party to whom the notifiable substances are to be transferred or provided, of the following matters by means of delivering a document or other manner prescribed by Ministry of Health, Labour and Welfare Ordinance.
[ Number of chemicals targeted under ISH Law ]
Labelling
MSDS 99
640 21

22. 1-4. Supporting tools for GHS implementation22

23. “GHS Classification Working Sheet” Prepared for classification work of the Technical experts group of Inter-Ministerial Committee on GHS.

24. Workshops by Japan Industrial Health and Safety Association (JISHA)
How to classify chemicals especially mixed compounds,
according to GHS criteria and to make labels and SDSs
under GHS requirements. (Nov – Jun. 2006)
The module of Workshop by JISHA
- Introduction of GHS and principle of revised Industrial Safety and Health Law (2 hrs)
- Physical hazard classification (1.5 hrs)
- Health hazard and Environmental hazard classification (2 hrs)
Workshops at 26 places in the whole country, and more than 3,000
participants totally. 24

25. Pamphlet and Web-site (1) Ministry of Environment http://www. env. go
[MoE GHS Pamphlet ]
[MoE GHS Web-site] 25

26. Pamphlet and Web-site (2) Ministry of Health, Labour and Welfare /ghs/index.html
[Industrial Safety & Health Law Pamphlet ]
[Poisonous & Deleterious Substances Control Law Pamphlet ]
[MHLW GHS Web-site] 26

27. Pamphlet and Web-site (3) Ministry of Economy, Trade and Industry
[PRTR Law Pamphlet ]
[MWTI GHS Web-site] 27

28. Model Labels and MSDSs by Japan Industrial Health and Safety Association (JISHA)
Model Labels and MSDS according to the results of GHS model
classification project.
Model Labels for 100 substances under ISH Law:
(in Japanese)
Model MSDSs for 700 substances under ISH Law: 28

29. [JISHA GHS Web-site]
[JISHA Model MSDS]
[JISHA Model Label]

30. Classification software for Mixtures
Development of computer software for GHS classification
of mixture, installed with the classification results of 1500
chemicals.
Only 3 steps ;
1. Input GHS classification results of substances,
2. Input the percentage of substance in mixture,
3. Get the classificatin of the mixture.
Software is available from the site below (in Japanese) 30

31. Educational publication (Books & CD-ROM)
“GHS-Education
CD-ROM” with
narration for an
employer to educate
workers.
Supervision: Dr. Jonai
(Based on GHS 1st rev.
available both in
Japanese and English)
(2006)
“Challenge of GHS”
Supervision: Dr. Jonai
Coauthor　 : Jonai,
　　　　　　　　　Sano,
　Noguchi
The Chemical Daily
(2006)
“Guidebook on Preparation of Labels and MSDS, complying with GHS system ”
Author: Sano
The Chemical Daily
(2007)
“GHS Q&A”
Coauthor: Jonai
　　　　 Miyagawa　
　　 Morita
The Chemical Daily
(2008) 31

32. 1-5. Review on GHS implementation in Japan32

33. Failure 1 Started without deciding governmental policy on
“Building block approach” and
selection of “cut-off value/concentration limits”
Almost chemical companies already finished GHS classification, labeling, and revision of MSDS of their products according to the GHS classification manual (Feb. 2006), in these work, they had to select cut-off limit value for mixture by their own responsibility.
After setting policy on “Building block approach” and “Selection of cut-off value/concentration limits”, all chemical company must repeat all GHS classification, labeling, and must revise their MSDS again. 33

34. Failure 2 Started GHS application simultaneously to
Single substances, and
Mixtures
Transitional periods
Japan Industrial Safety and Health Law (effective on Apr. 2006)
Single chemicals and Mixture : Dec (8 months)
EU REACH and CPL Regulation (effective on Jul. 2007)
Single chemicals : Dec (3.5 years)
Mixture : June (8 years)
Korea Toxic Chemicals Control Act (effective Jul. 2008)
Single chemicals : June (3 years)
Mixture : June (5 years) 34

35. Failure 3 GHS classification is still not fully applicable
to domestic transportation rule.
There are double standards;
Adopted GHS and UNRTDG rule for ;
Sea and Air transportation.　
(Domestic and international transportation)
Not adopted GHS and UNRTDG rule for ;
Road and Rail road transportation.
(Domestic transportation only) 35

36. Failure 4 Started without deciding unified governmental policy on
“Confidential Business Information” (CBI)
“Industrial Safety and Health Law” approve usage of generic name and expression of round number for percentage of components in MSDS.
“ PRTR Law” do not approve usage of generic name and expression of round number for the chemicals regulated under PRTR Law in MSDS.
“Poisonous and Deleterious Substances Control Law” do not have any regulation on CBI. 36

37. Failure 5
Japanese Inter-Ministerial Committee on GHS can not establish “Comprehensive Chemical Control Law”
In Japan, there is no umbrella law on chemical safety management.
There are many laws related chemical safety control, such as;
Fire Defense Law,
High Pressure Gas Safety Law ,
Chemical Substances Control Law (Kashinhou) ,
Industrial Safety and Health Law,
Poisonous and Deleterious Substances Control Law,
Water Pollution Control Law, Air Pollution Control Law, and Soil
Pollution Control Law,
Maritime Transportation Law, Aviation Law, Read Law,
Law Concerning Regulations on the Import/Export of Specific Hazardous
Wastes (Basel Law), and etc. 37

38. 1-6. GHS implementation, from now on38

39. a) Work out GHS Classification standard (March, 2008)
“Preparation of draft plan of GHS classification standard”
Report of the Committee
Supported by Ministry of Economy, Trade and Industry (METI),
Observed by Ministry of Health, Labor and Welfare (MHLW), and
Ministry of Environment (MoE).
　 Adoption of classification based on “Building block approach” do not adopt:　 “Acute toxicity Category 5”, “Skin irritation Category 3”, “Aspiration hazard Category 2” Selection of “Concentration limits” as classification trigger for mixture. ・Adopted same concentration limit for SDS and labelling. ・Select higher limit value if there are two limit value in GHS recommendation “Sensitization”, “Carcinogenicity Category 2”, “Reproductive toxicity”, “STOT- single exposure”. and “STOT- repeated exposure”. 39 39

40. Industrial Safety & Health Law
“Building block approach” in　Japan JIS Z 2752
GHS Recommendation
Industrial Safety & Health Law
Acute toxicity
Cat. 1
Cat. 2
Cat. 3
Cat. 4
Cat.5
Skin Corrosive
/ Irritant
Cat.3
Cat.1
Cat.2
Serious Eye
Damage / Irritant
Cat.2A
Cat.2B
Respiratory
Sensitizer
Skin Sensitizer
Germ Cell Mutagen
Cat.1A
Cat.1B
Carcinogen
Reproductive
Toxicant
Adit. Cat.
TOST (Single
exposure)
TOST (Repeated
Aspiration Hazard
Environmental
Hazard (Acute)
Hazard (Chronic)
Cat.4 40

41. b) Issue of Japanese Industrial Standard (JIS)
by Japanese Standards Association & Japan Chemical Industry Association
Revision of JIS Z “Safety data sheet for chemical products – Part 1 : Content and order of sections” （ Dec ）
JIS for preparation of SDS based on GHS.
Revision of JIS Z (based on ISO )
Issue of JIS Z
“Labelling of chemicals based on GHS” （ Mar ）
JIS for preparation of Labels based on GHS.
Issue of JIS Z
New JIS “Classification of chemicals based on GHS” ( June 2009)
Standardization of GHS classification method is considered to be suitable to clarify the ambiguity of the “Purple Book”, with decision of Japanese policy
on “Building block approach” and “Cut-off value/concentration limits”. 41

42. (Japanese version and English version)
Japanese Industrial Standard
JIS Z “Safety data sheet for chemical products – Part 1 : Content and order of sections” （ Dec ）
JIS Z “Classification of Chemicals
based on GHS”
（ Mar ）
JIS Z “Labelling of chemicals
based on GHS”
（ Mar ）
JIS
Japanese
INDUSTRIAL
STANDARD
JIS Z 7252 – 2009
Classification of chemicals based on GHS
(Japanese version and English version)
(Japanese version only) 42

43. + + + c) New Classification Guidance
“GHS Classification Manual” 　　　　 (Latest Ver. Feb ) +
“Technical Guidance Documents for GHS Classification”　 (Dec ) 　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　 +
“UN GHS Recommendation (2nd ed.)” 　　　 (Japanese ver. Mar. 2008) +
“Draft of New GHS Classification Industrial Standard” (Mar. 2008)
“GHS Classification Guidance” (June 2009) 43

44. of the METI committee on GHS Classification Manual.
New “GHS Classification Guidance” will be issued under supervision
of the METI committee on GHS Classification Manual.
This Guidance was prepared based on “UN GHS Recommendation
2nd ed.” and Japanese governmental policy on “Building block
approach” and selection of “cut-off value” and “concentration limits”
There are two part in “Classification Guidance”
Part A. “Classification Guidance for Governmental administration”
(Classification of Single substances)
Part B. “Classification Guidance for Private enterprises”
(Classification of Single substances and Mixture) 44

45. d) Classification of Non Regulated Chemicals
Japan Industrial Health and Safety Association (JISHA) started GHS model classification of Non-regulated chemicals under the financial support of MHLW.
1,500 chemicals in three years (2008 – 2010)
Japan Chemical Industry Ecology-Toxicology & Information Center
(JETOC) started GHS model classification of the chemicals listed
in SIDS Report (OECD Screening Information Data Set) using
the data in SIDS Report .
200 chemicals (2004 – 2008) . classification work will continue ! 45

46. e) The electronic bulletin board for GHS (J-Chemipedia）
Trial establishment of the electronic bulletin boards for GHS
classification with the data source of comments to the GHS
classification results
Offer for board and initial data
METI
Technical comment for initial data
Reference for data and comment
Experts
Companies
2017/4/14 46

47. f) Risk-based labelling for consumer products (1)
The decision to adopt risk-based labelling for consumer
products.
GHS Inter-Ministerial Committee (Jan. 2007)
_labelling.htm
“Outlook on Risk Assessment for Consumer Products Based
on Exposure for GHS Labeling”
GHS Inter-Ministerial Committee (Jan. 2007) (in English) 47

48. f) Risk-based labelling for consumer products (2)
The guidance documents of risk-based labelling for consumer
products.
National Institute of Technology and Evaluation (NITE)
“Guidance for implementation the GHS of consumer products”
(Draft)
Guidance documents for the implementation of the GHS in collaboration
with Asian countries.
Japan Soap & Detergent Association (JSDA) 48

49. g) Application of GHS to chemical risk management (1)
Use GHS system as the tools of hazard communication
in chemical risk management.
GHS will lead to:
- Logical classification of hazards of chemicals,
- Domestic harmonization of diverse regulations.
Raising awareness on chemical hazards.
Sharing a responsibility of chemical control with the people
to use it. 49

50. g) Application of GHS to chemical risk management (2)
Use GHS classification results as the means of hazard rating
in risk assessment of hazardous chemicals.
UK HSE: COSHH ESSENTIALS  -  Easy steps to control health risks
from chemicals. (use EU R-phrase for hazard rating)
UN ILO: Control Banding - Practical Tools for Controlling Exposure to
Chemicals. (use EU R-phrase and GHS classification for hazard rating)
/index.htm
US NIOSH: Control Banding - Qualitative Risk Characterization and
Management of Occupational Hazards. (use OEL and R-phrase for
hazard rating) 50

51. g) Application of GHS to chemical risk management (3)
Use GHS classification results as the means of hazard rating
in risk assessment of hazardous chemicals.
Japan Industrial Health and Safety Association (JISHA)
JISHA Method Chemical Health Risk Assessment
(use EU R-phrase and GHS classification for hazard rating)
Hazard
Group
EU R-Phrases
GHS Classification (Hazard class / Hazard category) A
R36, R38, R65, R66
All dusts and vapours not
allocated to another band
Acute toxicity, any route, category 5.
Skin irritation category 2 or Eye irritation category 2.
All dusts and vapours not allocated to another band. B
R20/21/22, R40/20/21/22,
R33, R67
Acute toxicity, any route, category 4
STOT (single exposure), any route, category 2. C
R23/24/25, R34, R35, R37,
R39/23/24/25, R41, R43,
R48/20/21/22
Acute toxicity, any route, category STOT (single exposure), any route, category Skin corrosion class 1A, 1B or 1C. Eye damage category 1. Respiratory tact irritation. Skin sensitization.
STOT (repeated exposure), any route, category 2. D
R48/23/24/25, R26/27/28,
R39/26/27/28, R40 Carc.
Cat. 3, R60, R61, R62,R63,
R64
Acute toxicity, any route, category 1 or Carcinogenicity category 2.
STOT (repeated exposure), any route, category 1.
Reproductive toxicity category 1 or 2. E
R42, R45, R46, R49, R68
Germ cell mutagenicity category 1 or Carcinogenicity category 1.
Respiratory sensitization . 51 51

52. 2. GHS Implementation in East Asia
2-1.　Korea
2-2.　China
2-3.　Taiwan

53. 2-1. Republic of Korea
Inter-ministerial Committee (Ministry of Environment[MOE], Ministry
of Labor[MOL], National Emergency Management gency[NEMA])
has been created.
　　Translation of GHS Recommendation into Korean (Completed in 2005)
　　Development of GHS Guideline and Training Program.
MOE revised “Toxic Chemicals Control Act” to reflect GHS regarding
classification and labelling.
Revised in 2007, enforced in 2008/7
Transitional period : 3 years transition period for single chemicals (up to 2011/6),
5 years transition period for mixtures (up to 2013/6).
MOL to reflect GHS classification and labelling in its “Industrial
Safety and Health Act”.
　　 Revised in 2006/12, enforced in 2008/7
Transitional period : 2 years transition period for single chemicals (up to 2010/6),,
5 years transition period for mixtures (up to 2013/6),.
At first, different “Building block approach” are adopted by MOE and MOL,
but, finally adjusted to adopt almost same “Building block approach” and
“Cut-off value/concentration limit” for the mixtures just like EU. 53 53

54. Industrial Safety & Health Law
“Building block approach” in　Korea　MOL
GHS Recommendation
Industrial Safety & Health Law
Acute toxicity
Cat. 1
Cat. 2
Cat. 3
Cat. 4
Cat.5
Skin Corrosive
/ Irritant
Cat.3
Cat.1
Cat.2
Serious Eye
Damage / Irritant
Cat.2A
Cat.2B
Respiratory
Sensitizer
Skin Sensitizer
Germ Cell Mutagen
Cat.1A
Cat.1B
Carcinogen
Reproductive
Toxicant
Adit. Cat.
TOST (Single
exposure)
TOST (Repeated
Aspiration Hazard
Environmental
Hazard (Acute)
Hazard (Chronic)
Cat.4 54

55. Toxic Chemicals Control Law
“Building block approach” in 　Korea　MOE
GHS Recommendation
Toxic Chemicals Control Law
Acute toxicity
Cat. 1
Cat. 2
Cat. 3
Cat. 4
Cat.5
Skin Corrosive
/ Irritant
Cat.3
Cat.1
Cat.2
Serious Eye
Damage / Irritant
Cat.2A
Cat.2B
Respiratory
Sensitizer
Skin Sensitizer
Germ Cell Mutagen
Cat.1A
Cat.1B
Carcinogen
Reproductive
Toxicant
Adit. Cat.
TOST (Single
exposure)
TOST (Repeated
Aspiration Hazard
　 Cat.1
Environmental
Hazard (Acute)
Hazard (Chronic) 55

56. 2-2. People’s Republic of China
The General Administration of Quality Supervision, Inspection and
Quarantine of the People‘s Republic of China (AQSIQ)　
China National Standard(GB)
“List of Dangerous Goods”　 GB UNRTDG
“Classification and Labels of Dangerous chemical Commonly Used
substances” GB Classification
“General rules for preparation of precautionary label for industrial chemicals”
　　 GB Label
“General rules for preparation of chemical safety data sheet”
GB CSDS
(GB and GB quote GB for evaluation of
dangerous chemicals)
“Safety Regulation on Chemicals Classification and Labelling”
GB ~ GB 20602– GHS
Implementation: 2008/1 (Production section)
2008/12 (Distribution section)
(Contents are essentially direct translation of GHS Recommendation 1st ed.) 56 56

57. Recommended National Standard (GB/T)
“Safety Data Sheet for Chemical Products; Content and Order of Sections”
GB/T CSDS
“Standard terminology relating to hazard potential of chemicals”
GB/T
“Labelling of Chemicals based on GHS” GB/T Label
“General provision for hazard evaluation of chemicals”
GB/T Classification
(Cite GB ~ GB as the standard of hazard evaluation)
GB/T 22233～22235 is implementated on 2009/2, but GB/T is only recommended
standard, and not compulsory
New China National Standard (GB)
“General rules for preparation of precautionary label for chemicals”
GB (revision)  GB x ---- Label
“General rules classification and hazard communication of chemicals”
GB (revision )  GB X ---- Classification, CSDS
(China informed draft new GB to WTO, and to be effective on Sep. 2009) 57 57

58. National Standard of the People’s Republic of China : GB “Safety Regulation on Chemicals Classification and Labelling”
Explosives GB
Flammable gases GB
Flammable aerosols GB
Oxidizing gases GB
Gases under pressure GB
Flammable liquids GB
Flammable solids GB
Self-reactive substances and mixtures GB
Pyrophoric liquids GB
Pyrophoric solids GB
Self-heating substances and mixtures GB
Substances and mixtures which, in contact with water, emit flammable gases GB
Corrosive to metals GB
Oxidizing liquids GB
Oxidizing solids GB
Organic peroxides GB
Acute toxicity 　　　　　　　　　　 GB
Skin corrosion/irritation 　　　　　　　 GB
Serious eye damage/eye irritation GB
Respiratory or skin sensitization GB
Germ cell mutagenicity GB
Carcinogenicity GB
Reproductive toxicity GB
Specific target organ systemic toxicity – Single exposure GB
Specific target organ systemic toxicity – Repeated exposure GB
Hazardous to the aquatic environment GB
Note : China National standard implement GHS Recommendation 1st Edition.

59. 2-3. Taiwan “Toxic Chemical Substance Control Act (1986)”, Section 17,
Environmental Protection Agency (EPA)
“Toxic Chemical Substance Control Act (1986)”, Section 17,
“Regulation of Toxic Chemical Substances Labelling and Material Safety Data Sheet, Environmental Protection Administration (1998)”
revised on July 2008, adopting GHS to label and MSDS system.
effective from December 31st 2008.
258 toxic substances enlisted by EPA regarding labelling and MSDS.
Council of Labor Affaires (CLA)
　 “Labor Safety and Health Act (1974）”, Section 5, and 7.
“Regulation of Labelling and Hazard Communication of Dangerous and Harmful Materials”
revised on October 2007, adopting GHS to label and MSDS system.
1,062 prioritized chemicals specified by CLA regarding labelling and
MSDS. 59

60. EPA and CLA use “China National Standard CNS15030-Z1051-2006”
as classification and labelling standard.
“China National Standard CNS15030” revised on December 2008, and
now corresponds to GHS Recommendation 2nd revised edition.
In 2008, CLA drafted amendment in the Labor Safety and Health Act
to include new chemical notification.
Due to the deficiency of chemical inventory, full scale of GHS
implementation in Taiwan is pending on the development of national
chemical substance inventory and new chemical notification schemes.
(CLA notification on Feb. 3, 2009) 60

61. China National Standard “Classification and labelling of chemicals CNS15030-Z1051”
General rule CNS 15030
Explosives CNS
Flammable gases CNS
Flammable aerosols CNS
Oxidizing gases CNS
Gases under pressure CNS
Flammable liquids CNS
Flammable solids CNS
Self-reactive substances and mixtures CNS
Pyrophoric liquids CNS
Pyrophoric solids CNS
Self-heating substances and mixtures CNS
Substances and mixtures which, in contact with water, emit flammable gases CNS
Oxidizing liquids CNS
Oxidizing solids CNS
Organic peroxides CNS
Corrosive to metals CNS
Acute toxicity 　　　　　　　　　　 CNS
Skin corrosion/irritation 　　　　　　　 CNS
Serious eye damage/eye irritation CNS
Respiratory or skin sensitization CNS
Germ cell mutagenicity CNS
Carcinogenicity CNS
Reproductive toxicity CNS
Specific target organ toxicity – Single exposure CNS
Specific target organ toxicity – Repeated exposure CNS
Aspiration hazard CNS
Hazardous to the aquatic environment CNS
Note : China National standard revised in 2008, and implement GHS Recommendation 2nd Rev. Ed.

62. 3. GHS Implementation in ASEAN Countries
3-1.　Malaysia
3-2.　Thailand
3-3.　Philippines
3-4.　Indonesia
3-5.　Vietnam
3-6.　Cambodia
3-7. Lao People's Democratic Republic
3-8. Myanmer
3-9. Singapore

63. 3-1. Malaysia　
Ministry of International Trade and Industry (MITI) to lead the National
Coordinating Committee to examine implementation of GHS.
　Department of Occupational Safety and Health (DOSH) is working
on adoption of GHS classification and labelling by amending its
“Occupational Safety and Health Regulations” - Presented to government and Industry in August 2007, and to put the amended regulations in force with in 2 years.
”Occupational Safety and Health (Classification, Packaging and Labelling
of hazardous chemicals) regulations 1997” [CPL Regulation] : <Repeal>
“Occupational Safety and Health (Chemicals Classification, Labelling and Safety Data Sheets) Regulations 20XX” [CLASS Regulation] : <Establish>
Department of Environment (DOE) is working on the the future notification
scheme of Environmentally Hazardous Substances (EHS) under the
Environmental Quality Act DOE check of Notified data and GHS
　classification of components in the product. 63 63

64. “Seminar Chemicals Managing at Workplace” Malaysia, Ministry of Human Resouces, Department of occupational Safety and Health (DOSH） Jul. 9, at Putra World Trade Centre (PWTC) , Kuala Lumpur
Opening ceremony by Dato’ Nariani, Dupity minister, Ministry of Human Resources.
There were presentation on “CLASS Regulation” by DOSH, and
“Plan of regulation on Environmental Hazardous Substances (EHS)”
at this seminar.
Presentation on “Implementation of GHS in Japan” by Sano 64

65. “GHS Advanced Course Seminar” on classification training (mainly mixture) for DOSH and other agency officers related to GHS, one week course
July / 2008
March / 2009

66. 3-2. Thailand
In 2005, National GHS Implementation Sub-Committee was formed
participated by the representatives of relevant Government agencies.
Under the support of UNITAR, completed Comprehensibility Testing and Gap
Analysis.
　Department of Industrial Works (DIW), Ministry of Industry, took the central
role to complete the translation of the first revised edition of the GHS into
Thai.
　Target date for the implementation of the GHS. Proposed transitional periods:
1 year for substances and 3 years for mixtures and products (by 2012)
controlled under the Hazardous Substance Act. 　
Phased-in implementation is being considered:
Phase I : For Substances
　　　　　　　　　 Physical Hazards
　　　　　　　　　 Part of Health Hazards (Acute toxicity, Skin corrosion/irritation,
Serious eye damage/eye irritation, Mutagenicity, Carcinogenicity)
Phase II : For Substances and Mixtures
　　　　　　　　 　 Physical Hazards
　　　　　　　 All of Health Hazards
　　　　　　　 Environmental Hazards 66 66

67. 3-3. Indonesia
　In 2005 the National Agency for Drug and Food Control (NADFC)
took the lead to establish the National GHS Implementation
Committee involving relevant bodies.
　Under the support of UNITAR, completed Comprehensibility Testing
and Gap Analysis.　Now conducting GHS awareness raising
activities through workshops etc.
　Translation of GHS Recommendation into Indonesian and
preparation of guidance document are underway.
　NADFC published “GHS Comic” in Nov. 2008
KN-RCI (Indonesian Responsiblecare Association) distributed
“GHS Leaflets” since March 2008. 67 67

68. Legislation related to the GHS in Indonesia Ministry of Industry Decree Number 24/M-IND/PER/ (Hazardous material production and usage control for the industry) Ministry of Trade Decree number 04/M-DAG/PER/5/ (Distribution Control of Hazardous Substances) Ministry of Environmental Decree number Per-MENLH No.3/ (Method for using symbol and label of Hazardous chemical substances) Ministry of Industry “New Chemical Act” will be drafted to implement GHS in 2009 68

69. 3-4. Philippines
　A National GHS Implementation Committee was created in 2004
through the initiative of the Board of Investment (BOI), participated
by relevant bodies.
　Under the support of UNITAR, completed Comprehensibility Testing
and Gap Analysis.
Now conducting GHS awareness raising activities through
workshops etc.
　BOI, in cooperation with Environmental Management Bureau(EMB),
is working on GHS implementation by amending RA6969 which is
governed by EMB. Implementation date yet to be determined.
Joint Administrative Order (JAO), to be signed be concerned
government agencies involved in the implementation of GHS. 69 69

70. 3-5. Vietnam Ministry of Industry is in charge of GHS implementation.
　“Government Decree No.68/2005/ND-CP” was issued in 2005.
　The decree defines the Goverment‘s basic stance towards safety of
chemicals.
“Law on Chemicals No.06/2007/QH12” (2007/11/27) effective 208/7
“Decree providing for detailed regulations and guidelines for the
implementation of some articles of the Chemical Law, No.108/2008
/ND-CP” (2008/10/7)
　 (Specific details will be covered in a “Decree” to be issued by the
Ministry of Industry. The Notice is expected to specify the details of
GHS implementation.)
Vietnam intend to adopt GHS according “Chemical Law” by July
2009. 70 70

71. 3-6. Cambodia
During , Cambodia is participating as a pilot country in the
UNITAR/ILO Global GHS Capacity Building Programme.
A capacity building programme has been established for the
development of a draft GHS implementing legislation/regulation for
Four sectors (industrial workplace, agriculture, transport, and
Consumer products) and the development of a strategic plan for
national GHS implementation.
The existing Inter-Ministerial Technical Working Group, responsible
for advising and facilitating the implementation of International
Conventions on chemicals in Cambodia, has been designated as the
coordination/steering body for the implementation of the GHS
National implementation plan (UNECE GHS: status of Implementation) 71

72. 3-7. Lao People's Democratic Republic
Lao People's Democratic Republic has recently drafted the Hazardous
Chemical Strategic Plan for and the Hazardous Chemical
Action Plan for These Plans are designed to provide
a framework for the safe and effective management of chemicals.
In terms of the GHS, Lao People's Democratic Republic has begun to
draft a project proposal and has set up a National Steering Committee.
During , Lao PDR is participating as a pilot country in the
UNITAR/ILO Global GHS Capacity Building Programe.
The results of the comprehensibility training (held in October 2006) as
well as those of the situation and gap analysis will be used for the
development of GHS implementation activities during 2007.
(UNECE GHS: status of Implementation) 72

73. 3-8. Myanmer
There is no specific institution assigned to the task of overall
management of chemicals and waste, but there are a number of
existing frameworks in legislation, classification and labelling standards
that could accommodate the GHS.
Myanmar is currently preparing to revise existing legislation and
administrative procedures to implement the GHS.
(UNECE GHS: status of Implementation)
Occupational Health Department (OHD) is currently focal point for GHS
Implementation in relation with UNITAR and ILO 73

74. 3-9. Singapore
Establishment of a multi-agency public-private GHS implementation
taskforce in 2005 to oversee and coordinate the implementation of the GHS in
Singapore. All government agencies (MOM, NEA, MITI, SCDF) impacted by
GHS as well as chemical industry (SCIC) and SPRING Singapore
representatives are members of the taskforce.
SPRING Singapore (Standards Productivity and Innovation Board)　
Singapore standard 　CP 98： <Repeal>
“Code of Practice for Preparation and use of Material Safety Data Sheets”
Singapore standard 　SS286：1984　　 <Rivision>
“Hazard Communication for Hazardous Substances and Dangerous Goods”
Singapore standard 　SS586： <Establish>
Part 1 Transport and storage of dangerous goods.
　 Part 2 Global harmonized system of classification and labelling of
chemicals – Singapore’s adaptations”
　 Part 3 Preparation of safety data sheets (SDS) 74

75. Singapolian government agencies administratively. Government agencies
The SS 586: 2008 is currently not mandatory. It is however referred to by
Singapolian government agencies administratively. Government agencies
like the National Environment Agency (NEA), Ministry of Manpower
(MOM), Singapore Civil Defence Force (SCDF) and Singapore Police
Force (SPF) have worked out the timeframe for GHS implementation as
follow:
By Whom
For What
By When
Chemical Manufacturers
Single substances
by end 2010
Mixtures
by end 2012
Chemical Users
Single Substances
by end 2011
by end 2013
Singapore adopted most of the hazard classes of GHS, excluding: Flammable Liquids Category 4 (except diesel); Acute Toxicity Category 5; Skin corrosion / irritation Category 3; Aspiration hazard Category 2; Aquatic environment acute hazard Categories 2 and 3; and Aquatic environment chronic hazard Categories 3 and 4.

76. 4. “Building block approach” and “cut-off value/concentration limits”
in the World 76

77. 4-1. Policy on “Building block approach”
4-2. Selection of “Cut-off value/concentration limits”
Competent authority of each country must select
“Cut-off value/concentration limits” for following hazard
classes;
Skin sensitization : Cat. 1
Respiratory sensitization : Cat. 1
Carcinogenicity : Cat. 2
Reproductive toxicity : Cat. 1, Cat. 2, Additional category
Specific target organ toxicity (Single exposure)
: Cat. 1, Cat. 2, Cat. 3
Specific target organ toxicity (Repeated exposure)
: Cat. 1, Cat. 2 77

78. 4-1. Policy on “Building block approach”
Category
GHS EU
JAPAN
KOREA
CHINA
TAIWAN
MALAYSIA
SINGAPORE
2nd Rev.
CLP Reg..
JISZ7252
MOL
MOE GB
CNS
CLASS
SS 586
2.1 Explosives
Unstable Ex ○
Div.1.1
Div.1.2
Div.1.3
Div.1.4
Div.1.5
2.2 Flammable gases
Cat. 1
Cat. 2 X
2.3 Flammable
aerosols
2.4 Oxidizing gases
2.5 Gases under
pressure
Compress.g.
Liquefied g.
Refriger.liq.
Dissilved g.
2.6 Flammable liquids
Cat. 3
Cat. 4

79. 2.7 Flammable solids 2.8 Self-reactive substances and mixtures
Category
GHS EU
JAPAN
KOREA
CHINA
TAIWAN
MALAY SIA
SINGAPORE
2nd Rev.
CLP Reg.
JISZ7252
MOL
MOE GB
CNS
CLASS
SS 586
2.7 Flammable solids
Cat. 1 ○
Cat. 2
2.8 Self-reactive
substances
and mixtures
Type A
Type B
Type E&F
Type C&D
Type G
2.9 Pyrophoric liquids
2.10 Pyrophoric solids
2.11 Self-heating
2.12 Substances which,
in ontact with water,
emit flammable
gases
Cat. 3
2.13 Oxidizing liquids
2.14 Oxidizing solids
2.15 Organic peroxides
2.16 Corrosive to metals

80. 3.7 Reproductive toxicity
Category
GHS EU
JAPAN
KOREA
CHINA
TAIWAN
MALAYSIA
SINGAPORE
2nd Rev.
CLP Reg..
JIS Z7252
MOL
MOE GB
CNS　
CLASS
SS 586
3.1 Acute toxicity
　　Chapter
Cat. 1 ○
Cat. 2
Cat. 3
Cat. 4
Cat. 5 X
3.2 Skin corrosion
　　　/irritation
3.3 Serious eye damage
　　　/eye irritation
Cat. 2A
Cat. 2B
3.4 Respiratory or
　　skin sensitization
3.5 Germ cell
　　mutagenicity
Cat. 1A
Cat. 1B
3.6 Carcinogenicity
3.7 Reproductive toxicity
Add, Cat.
3.8 STOT
　　– Single exposure
3.9 STOT
　– Repeated exposure
3.10 Aspiration hazard

81. 4.1 Hazardous to the aquatic environment (Acute toxicity)
Category
GHS EU
JAPAN
KOREA
CHINA
TAIWAN
MALAYSIA
SINGA PORE
2nd Rev.
CLP Reg..
JIS Z7252
MOL
MOE GB
CNS
CLASS
SS 586
4.1 Hazardous to the
aquatic environment
(Acute toxicity)
Cat. 1 ○
Cat. 2 X
Cat. 3
(Chronic toxicity)
Cat. 4

82. 4-2. Selection of “Cut-off value/concentration limits”
< Acute Toxicity >
GHS Recommendation
Cat. 1
Cat. 2
Cat. 3
Cat. 4
Cat. 5
EU CLP Regulation －
Japan JIS Z
Korea MOL
GHS Recommendation : UN GHS Recommendation, Rev.2 (Jul., 2007)
EU CLP Regulation : Regulation (EC) No. 1272/2008 (16 Dec. 2008)
Japan JIS Z : Japan Industrial Standard (June, 2009)
Korea MOL : Korea Ministry of Labor, Notice No (Jan., 2008)
Red frame  : EU, Korea, or Japan will not adopt GHS criteria
Blue letters : EU will change current criteria 82

83. < Skin corrosion / irritation >
Skin corrosive
Skin irritant
GHS Recommendation
Cat. 1A, 1B, 1C
Cat. 2
Cat. 3
　Skin Category 1
≧5％
≧1% but < 5% －
　Skin Category 2
≧10％
≧1％ but < 10%
　 Skin Category 3
　(10 ×Skin Category 1)＋ Skin Category 2
　(10 × Skin Category 1)＋ Skin Category 2
+ Skin Category 3
EU CLP Regulation
≧10％ → ≧5％
≧1％ but < 5%
≧20％ → ≧10％
　(10×Skin Category 1)＋ Skin Category 2
Japan JIS Z
Korea MOL 　
　 Skin corrosive
　 Skin irritant
　(10× Skin corrosive)＋ Skin irritant

84. < Skin Sensitizer/Respiratory Sensitizer >
All physical states
Solid / Liquid
Gas
GHS Recommendation
≧0.1％ －
≧1.0％
≧0.2％
EU CLP Regulation
≧0.1％　*1
　≧1.0％　*2
　　≧0.1％　*1
　　≧1.0％　*3
　　≧0.2％　*3
Japan JIS Z
≧1.0％　
≧0.2％　
Korea MOL 　
＊1：This concentration limit is generally used for the application of the special labeling requirements of Annex II 2.10 　
　　　to protect already sensitised individuals.
A SDS would be required for the mixture containing an ingredient above this concentration limit .
＊2：This concentration limit is used to trigger classification of a mixture as a skin sensitizer.
＊3：This concentration limit is used to trigger classification of a mixture as a respiratory sensitizer. 84

85. < Carcinogen > GHS Recommendation Category 1 Category 2
Carcinogen Category 1
≧0.1％
Carcinogen Category 2 －
≧1.0％
EU CLP Regulation
Category 1A
Category 1B
Carcinogen Category 1A
Carcinogen Category 1B
　　≧1.0％　*1
Japan JIS Z
Korea MOL
＊１：If a Category 2 carcinogen is present in the mixture as an ingredient at a concentration ≧0.1％
　　　a SDS would be required for the mixture. 85

86. < Reproductive Toxicant >
GHS Recommendation
Category 1
Category 2
Additional Category for
Effects on or via Lactation
Reproductive Toxicant Category 1
≧0.1％ －
≧0.3％
Reproductive Toxicant Category 2
≧3.0％
Additional Category Toxicants for effects on or via Lactation
EU CLP Regulation
≧0.3％　*1
≧5.0％ → ≧3.0％ *1
－ 　
　≧0.3％ *1
Japan JIS Z
Korea MOL ?
＊１：If a Category 1 or Category 2 reproductive toxicant is present in the mixture as an ingredient at
a concentration above 0.1％, a SDS would be required for the mixture.

87. < Specific target organ toxicity / Single exposure >
GHS Recommendation
Category 1
Category 2
Category 3
　Category 1
　 ≧1％ *1
≧1% but < 10% －
≧10％ 　
　 Category 2
≧10％ *1
　 Category 3 *2
EU CLP Regulation
≧10％
　Category 3
Japan JIS Z
Korea MOL
≧20％
*1 : If a Category 1 or 2 specific target organ/systemic toxicant is present in the mixture as an ingredient
at a concentration above 1.0％, a SDS would be required for the mixture.
*2 : Care shall be exercised when extrapolating toxicity of a mixture that contains Category 3 ingredient(s).
A generic concentration limit of 20 % is appropriate; however, it shall be recognised that this
concentration limit may be higher or lower depending on the Category 3 ingredient(s) and that some
effects such as respiratory tract irritation may not occur below a certain concentration while other
effects such as narcotic effects may occur below this 20 % value. Expert judgement shall be exercised.

88. < Specific target organ toxicity / Repeated exposure >
GHS Recommendation
Category 1
Category 2
　Category 1
　 ≧1％ *1
≧1% but < 10%
≧10％ 　
　 Category 2 －
≧10％ *1
EU CLP Regulation
≧10％
Japan JIS Z
Korea MOL
*1 : If a Category 1 or 2 specific target organ/systemic toxicant is present in the mixture as an ingredient
at a concentration above 1.0％, a SDS would be required for the mixture.
*2 : If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a
concentration ≥ 1,0 % a SDS shall be available for the mixture upon request.

89. < Aspiration Hazard >
GHS Recommendation
Category 1
Category 2
Aspiration Hazard Substance Category 1
≧10% *1
---
Aspiration Hazard Substance Category 2
≧10%
EU CLP Regulation
≧10% *1
Japan JIS Z
Korea MOL
≧10%*1
*1 ; A mixture which contains a total of 10 % or more of a substance or substances classified
in Category 1, and has a kinematic viscosity of 20.5 mm2 /s or less, measured at 40 oC,
shall be classified in Category 1. 89 89

90. Thank you for your attention! Arigato-gozaimashita!90