Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
in Japan
Hiroshi SANO
Technical Consultant
Japan Chemical Database Ltd.
Lecturer
Dep. of Occupational Health and Toxicology
KITASATO University
1
UN GHS Recommendation
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
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Activities for GHS Implementation in Japan
Government Industry
Inter-ministerial committee JCIA & Japanese Standards Association
Translation of UN Recommendation on GHS Revision of MSDS JIS Z 7250-2005
(1st Ver. Mar. 2004) Issue of Labelling JIS Z 7251-2006
(1st Rev. Mar. 2006)
Issue of Classification JIS (Z 7252 -2009)
(2nd Rev. Mar. 2008)
Classification Manual
Technical guidance for Classification JCIA
(April, 2005)
Guidelines for Classification, Labelling,
and Preparation of MSDS
Model Classification of Regulated Chemicals
(May, 2005 – June, 2006)
Ministry of Health,
Labour & Welfare
Companies
Amendment of Industrial Safety & Health
Law (Effective in December, 2006) GHS Classification of Products
(single substances & mixtures)
Model Classification of 5
Non Regulated Chemicals (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)
* 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.
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“GHS Classification Manual”
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“Technical Guidance Documents for GHS Classification”
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Issue of Japanese Industrial Standard (JIS)
by Japanese Standards association
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Japanese Industrial Standard
JIS Z 7250 - 2005 JIS Z 7251 - 2006
“Safety data sheet for chemical “Labelling of chemicals based on
products – Part 1 : Content and order GHS” ( Mar. 2006 )
of sections” ( Dec. 2005 )
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2. GHS Model Classification Project
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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)
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Model GHS Classification project (2)
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.
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Example of GHS model classification (a)
Xylene CAS 1330-20-7 [Physical Hazards]
Hazard class Classification Rational for the classification
1 Explosives Not applicable Containing no atom groups with explosive properties
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).
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).
11 Self-heating substances Classification not Test methods applicable to liquid substances are not available.
and mixtures possible
12 Substances and Not applicable Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)
mixtures, which in
contact with water,
emit flammable gases
13 Oxidizing liquids Not applicable Organic compounds containing no oxygen, fluorine and chlorine
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 No definitive value available, although the substance can be classified as Category 5 or not classified
possible based on the rabbit LD 50 (dermal route) value of >4,350 mg/kg, (IUCLID 2000).
1 Acute toxicity Not applicable Due to the fact that the substance is "liquid" according to the GHS definition and inhalation of its gas is
(inhalation: gas) not expected.
1 Acute toxicity Not classified Based on the rat LC50 (4 hour inhalation exposure) value of 29.08 mg/L (MOE Risk Assessment Vol.1,
(inhalation: 2002) (equivalent to 6,700ppm) was lower than 90% of the saturated vapor concentration (8,000ppm)
vapour) 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.
2 Skin corrosion / Category 2 Based on the description in the report on the rabbit skin irritation test (CERI-NITE Hazard Assessment
irritation No.62, 2004): "moderate irritant".
3 Serious eye damage / Category 2A Based on the description in the report on the rabbit eye irritation test (CERI-NITE Hazard Assessment
eye irritation No.62, 2004): "moderate irritant".
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).
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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 Category 1 Based on the human evidence including "throat irritation, severe pulmonary congestion, alveolar
organs/systemic (respiratory organs, hemorrhage, pulmonary edema, congestion accompanying hepatomegaly, centrilobular vacuolation of
toxicity following liver, central hepatocytes, nerve cell damage associated with dot hemorrhage, swelling and disappearance of Nissl
single exposure nervous system, bodies, limb cyanosis, a transient increase in serum transaminase activity, an increase in the blood
kidneys) Category 3 level of urea, a decrease in endogenous creatinine clearance in the urine, liver damage, severe kidney
(narcotic effects) 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 Category 1 Based on the human evidence including "eye/nose irritation, thirst" (DFGOT Vol. 15, 2001) and "chronic
organs/systemic (respiratory organs, headache, chest pain, abnormal electroencephalogram, dyspnea, cyanosis of the hands, fever, a decrease
toxicity following nervous system) in WBC count, discomfort, impairment of pulmonary function, a decrease in working capacity,
repeated exposure 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".
2 Harzardous to the Category 2 Low rapid biodegradability (39%, CERIJ Hazard Data Report, 2005), Estimated low bioaccumulation
Aquatic Environment (log Kow = 3.16), and Acute category 2;
(Chronic) --> category 2
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3. Revision of Industrial Safety and Health Law
Partial amendment of “Industrial Safety & Health Law”
(Decided by the Cabinet on November 2, 2005)
(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).
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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.
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“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)
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Pamphlet and Web-site (1)
Ministry of Environment
http://www.env.go.jp/chemi/ghs/ [MoE GHS Pamphlet ]
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Pamphlet and Web-site (2)
Ministry of Health, Labour and Welfare
http://www.mhlw.go.jp/topics/bukyoku/roudou [Industrial Safety
/ghs/index.html & Health Law
[Poisonous & Deleterious Pamphlet ]
Substances Control Law
Pamphlet ]
[MHLW GHS Web-site]
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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 ]
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Model Labels and MSDSs
by Japan Industrial Safety and Health Association (JISHA)
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[JISHA GHS Web-site] [JISHA Model MSDS]
http://www.jaish.gr.jp/user/anzen/kag/kag_main01.html
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Educational publication (Books & CD-ROM)
“GHS-Education
“Guidebook on CD-ROM” with
Preparation of narration for an
“Challenge of GHS” Labels and MSDS, employer to educate
Supervision: Dr. Jonai workers. “GHS Q&A”
Coauthor : Jonai, Sano,
complying with Supervision: Dr. Jonai Coauthor: Jonai
Noguchi GHS system ” (Based on GHS 1st rev. Miyagawa
Author: Sano available both in Morita
The Chemical Daily
The Chemical Daily Japanese and English) The Chemical Daily
(2006) (2007) (2006) (2008)
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5. GHS implementation, development hereafter
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a) Classification of Non Regulated Chemicals
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b) Issue of New Industrial Standard
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c) Classification Manual for Mixture
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d) The electronic bulletin board for GHS (J-Chemipedia)
Offer for
board and
METI initial data
Technical
comment Reference
for initial for data and
data comment
Experts Companies
2019/11/27 36
1. Select the substance 2. Select the
to modify in the list classification to
modify and insert
the comment
3. Display the
classification and
4. Vote on trust in the the comment
comment, and display
the result of vote
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e) Risk-based labelling for consumer products (1)
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e) Risk-based labelling for consumer products (2)
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f) Application of GHS to chemical risk management (1)
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f) Application of GHS to chemical risk management (2)
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f) Application of GHS to chemical risk management (3)
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Terima Kasih !
Arigato-gozaimashita!
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