Implementation of GHS in Japan

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Implementation of GHS in Japan

• Hiroshi SANO
• Technical Consultant
• Japan Chemical Database Ltd.
• Lecturer
• Dep. of Occupational Health and Toxicology
• KITASATO University

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The Globally Harmonized System of
Classification and Labelling of Chemicals
GHS so called Purple book
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)

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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

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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 Issue of
Labelling JIS Z 7251-2006 Issue of Classification
JIS (Z 7252 -2009)
(1st Ver. Mar. 2004) (1st Rev. Mar. 2006) (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)
Preparation Announcement of Model MSDS
(July, 2006)
Seminars on Preparation of SDS for Mixtures
(December, 2005 June, 2006)
Model Classification of Non Regulated Chemicals
(April, 2007 --)
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Inter-Ministerial Committee on GHS (2001 - )

• ltMembergt
• 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),
• ltObservergt
• Experts
• Japan Chemical Industry association (JCIA)

Technical experts group of Inter- Ministerial
Committee on GHS
lt Member gt Experts from Government offices,
Academia, National/public laboratories and
Industries.
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• 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/anzeneisei
07/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.
2nd Edition (Mar. 2008)
1st revised version (Mar. 2006)
(Original text)
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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.
GHS Classification Manual
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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)
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Issue of Japanese Industrial Standard (JIS)by
Japanese Standards association

• Revision of JIS Z 7250 - 2005Safety 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.
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JIS Z 7250 - 2005Safety data sheet for chemical
products Part 1 Content and order of
sections ( Dec. 2005 )
Japanese Industrial Standard
JIS Z 7251 - 2006Labelling of chemicals based
on GHS ( Mar. 2006 )
(Japanese version and English version)
(Japanese version only)
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Issue of GHS Implementation Guidelines based
on JIS Z 7250 and JIS Z 7251 by Japan Chemical
Industry Association
Part 1 General guidelines
Part 3 Labelling
Part 2 Safety Data Sheet
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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
  (20052006)

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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.

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Example of GHS model classification (a)
Xylene CAS 1330-20-7 Physical Hazards
Hazard class Hazard class 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, UN1307).
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 o- xylene 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, UN1307)
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Example of GHS model classification (b)
Xylene CAS 1330-20-7 Health Hazards (1)
Hazard class 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 gt4,350 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).
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Example of GHS model classification (c)
Xylene CAS 1330-20-7 Health Hazards (2)
Hazard class 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 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) --gt 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 --gt category 2
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3. Revision of Industrial Safety and Health Law
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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).

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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.
(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
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4. Supporting tools for GHS implementation
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GHS Classification Working
SheetPrepared for classification work of the
Technical experts group of Inter-Ministerial
Committee on GHS.
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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.

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Pamphlet and Web-site (1)Ministry of
Environmenthttp//www.env.go.jp/chemi/ghs/
MoE GHS Pamphlet
MoE GHS Web-site
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Pamphlet and Web-site (2)Ministry of Health,
Labour and Welfare http//www.mhlw.go.jp/topics/b
ukyoku/roudou/ghs/index.html
Industrial Safety Health Law Pamphlet
Poisonous Deleterious 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/c
hemical_management/int/ghs.html
PRTR Law Pamphlet
MWTI GHS Web-site
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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_ind
  ex.htm
• (in Japanese)
• Model MSDSs for 700 substances under ISH Law
  http//www.jaish.gr.jp/anzen_pg/GHS_MSD_FND.aspx
• (in Japanese)

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JISHA GHS Web-site http//www.jaish.gr.jp/user/
anzen/kag/kag_main01.html
JISHA Model MSDS
JISHA Model Label
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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/G
  HS/land20of20thousand20of20GHS20classificatio
  n.htm

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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)

Guidebook on Preparation of Labels and MSDS,
complying with GHS system Author Sano The
Chemical Daily (2007)
Challenge of GHS Supervision Dr.
Jonai Coauthor Jonai, Sano,
Noguchi The Chemical Daily
(2006)
GHS QA Coauthor Jonai
Miyagawa Morita The Chemical
Daily (2008)
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5. GHS implementation, development hereafter
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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 !
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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.

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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.
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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/

Offer for board and initial data
METI
Technical comment for initial data
Reference for data and comment
Companies
Experts
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1. Select the substance to modify in the list
2. Select the classification to modify and insert
the comment
3. Display the classification and the comment
4. Vote on trust in the comment, and display the
result of vote
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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_managemen
  t/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_label_interministri
  al080218set.doc

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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)
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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.

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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/protec
tion/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/to
pics/ctrlbanding/
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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 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 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. Carcinogenicity category 1. Respiratory sensitization .
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Terima Kasih !Arigato-gozaimashita!