Implementation of GHS
in Japan
Hiroshi
SANO
Technical Consultant
Japan Chemical Database Ltd.
Lecturer
Dep. of Occupational Health and Toxicology
KITASATO University
1
UN GHS Recommendation
The Globally Harmonized System of Classification and
Labelling of Chemicals ： GHS so called “Purple book”
Recommendation by :
United Nations Economic and Social Council
(UN ECOSOC),
Committee of Experts on the Transports of
Dangerous Goods and on the Globally Harmonized
system of Classification and Labelling of Chemicals,
Sub-Committee of Experts on the Globally
Harmonized System of Classification and
Labelling of Chemicals.
First Ed.
Jul. 2003
First Revised Ed.
Jul. 2005
Second Revised Ed. Mar. 2007
(Revised every other year)
Implementation of GHS in Japan
1. Activities for GHS implementation in Japan
2. GHS Model Classification Project
3. Revision of Industrial Safety and Health Law
4. Supporting tools for GHS implementation
5. GHS implementation, development hereafter
1. Activities for GHS implementation in Japan
4
Activities for ＧＨＳ Implementation in Japan
Government
Industry
Inter-ministerial committee
JCIA & Japanese Standards Association
Translation of UN Recommendation on GHS
(1st
Ver. Mar. 2004)
(1st Rev. Mar. 2006)
(2nd Rev. Mar. 2008)
Revision of MSDS JIS Z 7250-2005
Issue of Labelling JIS Z 7251-2006
Issue of Classification JIS (Z 7252 -2009)
Classification Manual
Technical guidance for Classification
(April, 2005)
Model Classification of Regulated Chemicals
Ministry of Health,
Labour & Welfare
JCIA
Guidelines for Classification, Labelling,
and Preparation of MSDS
(May, 2005 – June, 2006)
Amendment of Industrial Safety & Health
Law (Effective in December, 2006)
Companies
GHS Classification of Products
(single substances & mixtures)
Preparation & Announcement of Model MSDS
(July, 2006)
Change Labels
Revise MSDS
Seminars on Preparation of SDS for Mixtures
(December, 2005 – June, 2006)
Model Classification of
Non Regulated Chemicals
5
(April, 2007 --)
Inter-Ministerial Committee on GHS (2001 - )
<Member>
Ministry of Foreign Affairs (MOFA),
Ministry of Internal Affairs and Communication (MIC),
Ministry of Health, Labour 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 Government offices, Academia, National/public laboratories
and Industries.
6
Translation of “GHS Recommendation Text” into Japanese:
Supervised by the Inter-Ministerial Committee on GHS
Available from the web-site of :
MHLW : http://www.mhlw.go.jp/bunya/roudoukijun/anzeneisei07/index.html
METI : http://www.meti.go.jp/policy/chemical_management/int/ghs_text.html
MoE : http://www.env.go.jp/chemi/ghs/kariyaku2.html
* It is very important and takes long time to harmonize the technical terminology in the Japanese
GHS text, because there were several inconsistent uses of the terms among the Japanese laws.
1st revised version
(Original text)
(Mar. 2006)
2nd Edition
(Mar. 2008)
7
“GHS Classification Manual”
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
“Technical Guidance Documents for GHS Classification”
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) :
http://www.safe.nite.go.jp/ghs/ghsi.html (Japanese version)
9
Issue of Japanese Industrial Standard (JIS)
by Japanese Standards association
Revision of JIS Z 7250 - 2005
“Safety data sheet for chemical products – Part 1 : Content and
order of sections” （ Dec. 2005 ）
JIS for preparation of SDS based on GHS.
Transition period up to end of 2010
Revision of JIS Z 7250- 2000 (based on ISO 11014-1-1994)
Issue of JIS Z 7251 - 2006
“Labelling of chemicals based on GHS” （ Mar. 2006 ）
JIS for preparation of Labels based on GHS.
10
Japanese Industrial Standard
JIS Z 7250 - 2005
“Safety data sheet for chemical
products – Part 1 : Content and order
of sections” （ Dec. 2005 ）
(Japanese version and English version)
JIS Z 7251 - 2006
“Labelling of chemicals based on
GHS”
（ Mar. 2006 ）
(Japanese version only)
11
Issue of “GHS Implementation Guidelines”
based on JIS Z 7250 and JIS Z 7251
by Japan Chemical Industry Association
Part 1:
General guidelines
Part 2:
Safety Data Sheet
Part 3:
Labelling
12
2. GHS Model Classification Project
13
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)
14
Model GHS Classification project (2)
Results of GHS Model Classification Project is available from the
web-site of NITE :
http://www.safe.nite.go.jp/ghs/index.html
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.
15
Example of GHS model classification (a)
Xylene CAS 1330-20-7
Hazard class
[Physical Hazards]
Classification
Rational for the classification
1
Explosives
Not applicable
Containing no atom groups with explosive properties
2
Flammable gases
Not applicable
Classified as "liquid" according to GHS definition
3
Flammable aerosols
Not applicable
Not aerosol products
4
Oxidizing gases
Not applicable
Classified as "liquid" according to GHS definition
5
Gases under pressure
Not applicable
Classified as "liquid" according to GHS definition
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
Not applicable
Classified as "liquid" according to GHS definition
8
Self-reactive
substances and
mixtures
Not applicable
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 oxylene and 527℃ for m-xylene and p-xylene (ICSC 2002).
10
Pyrophoric solids
Not applicable
Classified as "liquid" according to GHS definition
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
Not applicable
Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)
13
Oxidizing liquids
Not applicable
Organic compounds containing no oxygen, fluorine and chlorine
14
Oxidizing solids
Not applicable
Classified as "liquid" according to GHS definition
15
Organic peroxides
Not applicable
Organic compounds containing no "-O-O-" structure
16
Corrosive to metals
Not classified
Classified into Class 3 (UN Recommendations on the Transport of Dangerous Goods, UN#1307)
Example of GHS model classification (b)
Xylene CAS 1330-20-7 [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).
1
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).
1
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.
1
Acute toxicity
(inhalation:
vapour)
Not classified
Based on the rat LC50 (4 hour inhalation exposure) value of 29.08 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.
1
Acute toxicity
(inhalation: dust,
mist)
Classification not
possible
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:
Classification
not possible
Skin sensitizer:
Classification not
possible
Respiratory sensitizer: No data available
Skin sensitizer: No data available
5
Germ cell mutagenicity
Not classified
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
Not classified
Due to the fact that the substance is classified as Category A4 by ACGIH (2001) and Group 3 by IARC
(1999).
17
Example of GHS model classification (c)
Xylene CAS 1330-20-7 [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 1330-20-7 [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)
Category 2
Low rapid biodegradability (39%, CERIJ Hazard Data Report, 2005), Estimated low bioaccumulation
(log Kow = 3.16), and Acute category 2;
--> category 2
18
3. Revision of Industrial Safety and Health Law
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
( = RM17,000).
20
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 57-2. 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
4. Supporting tools for GHS implementation
22
“GHS Classification Working Sheet”
Prepared for classification work of the Technical experts group of
Inter-Ministerial Committee on GHS.
Workshops
by Japan Industrial Safety and Health Association (JISHA)
How to classify chemicals especially mixed compounds,
according to GHS criteria and to make labels and SDSs
under GHS requirements. (Nov. 2005 – 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
Pamphlet and Web-site (1)
Ministry of Environment
http://www.env.go.jp/chemi/ghs/
[MoE GHS Pamphlet ]
[MoE GHS Web-site]
25
Pamphlet and Web-site (2)
Ministry of Health, Labour and Welfare
http://www.mhlw.go.jp/topics/bukyoku/roudou
/ghs/index.html
[Poisonous & Deleterious
Substances Control Law
Pamphlet ]
[Industrial Safety
& Health Law
Pamphlet ]
[MHLW GHS Web-site]
26
Pamphlet and Web-site (3)
Ministry of Economy, Trade and Industry
http://www.meti.go.jp/policy/chemical_management/int/ghs.html
[MWTI GHS Web-site]
[PRTR Law
Pamphlet ]
27
Model Labels and MSDSs
by Japan Industrial Safety and Health Association (JISHA)
Model Labels and MSDS according to the results of GHS model
classification project.
• Model Labels for 100 substances under ISH Law:
http://www.jaish.gr.jp/anzen/gmsds_label/label_index.htm
(in Japanese)
• Model MSDSs for 700 substances under ISH Law:
http://www.jaish.gr.jp/anzen_pg/GHS_MSD_FND.aspx
(in Japanese)
28
[JISHA GHS Web-site]
http://www.jaish.gr.jp/user/anzen/kag/kag_main01.html
[JISHA Model Label]
[JISHA Model MSDS]
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 classification of the mixture.
Software is available from the site below (in Japanese)
http://www.meti.go.jp/policy/chemical_management/GHS/land%20of%20thousand
%20of%20GHS%20classification.htm
30
Educational publication (Books & CD-ROM)
“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-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)
“GHS Q&A”
Coauthor: Jonai
Miyagawa
Morita
The Chemical Daily
(2008)
31
5. GHS implementation, development hereafter
32
a) Classification of Non Regulated Chemicals
Japan Industrial Safety and Health Association (JISHA) started
GHS model classification of Non-regulated chemicals under the
financial support of MHLW.
1,500 chemicals in two years (2008 – 2009)
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 !
33
b) Issue of New Industrial Standard
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 limit value”.
New “GHS Classification JIS” will be issued as
“JIS Z 7252 – 2009” in early next year.
34
c) Classification Manual for Mixture
Classification manual for mixture will be issued under the
supervision of the METI Sub-committee on GHS
Classification Manual.
This manual will be prepared based on new “GHS
Classification JIS”, and will be issued in early next year.
35
d) 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. http://www.ghs-net.jp/
METI
Technical
comment
for initial
data
Experts
2016/3/23
Offer for
board and
initial data
Reference
for data and
comment
Companies
36
1. Select the substance
to modify in the list
4. Vote on trust in the
comment, and display
the result of vote
2. Select the
classification to
modify and insert
the comment
3. Display the
classification and
the comment
37
e) Risk-based labelling for consumer products (1)
The decision to adopt risk-based labelling for consumer
products.
GHS Inter-Ministerial Committee (Jan. 2007)
http://www.meti.go.jp/policy/chemical_management/GHS/Consumer_product
_labelling.htm
“Outlook on Risk Assessment for Consumer Products Based
on Exposure for GHS Labeling”
GHS Inter-Ministerial Committee (Jan. 2007) (in English)
http://www.meti.go.jp/policy/chemical_management/03kanri/risk_based_lab
el_interministrial080218set.doc
38
e) Risk-based labelling for consumer products (2)
The guidance documents of risk-based labelling for consumer
products.
National Institute of Technology and Evaluation (NITE)
http://www.safe.nite.go.jp/ghs/risk_consumer.html
“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)
39
f) 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.
40
f) 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)
http://www.coshh-essentials.org.uk/
UN ILO: Control Banding - Practical Tools for Controlling Exposure to
Chemicals. (use EU R-phrase and GHS classification for hazard rating)
http://www.ilo.org/public/english/protection/safework/ctrl_banding
/index.htm
US NIOSH: Control Banding - Qualitative Risk Characterization and
Management of Occupational Hazards. (use OEL and R-phrase for
hazard rating)
http://www.cdc.gov/niosh/topics/ctrlbanding/
41
f) 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 Safety and Health Association (JISHA)
JISHA Method Chemical Health Risk Assessment
(use EU R-phrase and GHS classification for hazard rating)
Hazard
Group
EU R-Phrases
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 3. 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 3. STOT (single exposure), any route,
category 1. 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 2. 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 2.
Respiratory sensitization .
GHS Classification (Hazard class / Hazard category)
Carcinogenicity category 1.
42
Terima Kasih !
Arigato-gozaimashita!
43