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

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Presentation on theme: "1 Japanese and ASEAN GHS Implementation Hiroshi SANO Technical Consultant Japan Chemical Database Ltd. The Wercs 2009 Global User Group Albany, New York."— Presentation transcript:

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

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

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

6 6 Inter-Ministerial Committee on GHS ( ) 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), Experts Japan Chemical Industry association (JCIA) Experts from Universities, National/public laboratories and Industries. Technical experts group of Inter- Ministerial Committee on GHS

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

8 8 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” ( 1 st Ver. Apr ) ( Latest Ver. Feb )

9 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)http://www.safe.nite.go.jp/ghs/ghsi.html

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 ) 10 Issue of JIS Z “Labelling of chemicals based on GHS” ( Mar ) JIS for preparation of Labels based on GHS.

11 11 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 ) (Japanese version and English version) (Japanese version only) Japanese Industrial Standard

12 12 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

13 1-2. GHS Model Classification Project 13

14 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 GHS Model Classification Project (1)

15 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 Model GHS Classification project (2) Results of GHS Model Classification Project is available from web-site; NITE: (Japanese)http://www.safe.nite.go.jp/ghs/index.html METI:http://www.meti.go.jp/policy/chemical_management/int/ghs.html (English translation)

16 16 Example of GHS model classification (a) Hazard classClassificationRational for the classification 1 ExplosivesNot applicableContaining no atom groups with explosive properties 2 Flammable gasesNot applicableClassified as "liquid" according to GHS definition 3 Flammable aerosolsNot applicableNot aerosol products 4 Oxidizing gasesNot applicableClassified as "liquid" according to GHS definition 5 Gases under pressureNot applicableClassified as "liquid" according to GHS definition 6 Flammable liquidsCategory 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 solidsNot applicableClassified as "liquid" according to GHS definition 8 Self-reactive substances and mixtures Not applicableNo atom groups with explosive or self-reactive properties 9 Pyrophoric liquidsNot 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 solidsNot applicableClassified 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 applicableContaining no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) 13 Oxidizing liquidsNot applicableOrganic compounds containing no oxygen, fluorine and chlorine 14 Oxidizing solidsNot applicableClassified as "liquid" according to GHS definition 15 Organic peroxidesNot applicableOrganic compounds containing no "-O-O-" structure 16 Corrosive to metalsNot classifiedClassified into Class 3 (UN Recommendations on the Transport of Dangerous Goods, UN#1307) Xylene CAS [Physical Hazards]

17 17 Hazard classClassificationRational for the classification 1 Acute toxicity (oral)Category 5Based 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 applicableDue 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 classifiedBased 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. 1 Acute toxicity (inhalation: dust, mist) Classification not possible No data available 2 Skin corrosion / irritation Category 2Based 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 2ABased 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 mutagenicityNot classifiedBased 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 CarcinogenicityNot classifiedDue to the fact that the substance is classified as Category A4 by ACGIH (2001) and Group 3 by IARC (1999). Xylene CAS [ Health Hazards (1)] Example of GHS model classification (b)

18 18 Hazard classClassificationRational for the classification 6 CarcinogenicityNot classifiedDue to the fact that the substance is classified as Category A4 by ACGIH (2001) and Group 3 by IARC (1999). 7 Toxic to reproductionCategory 1BBased 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 hazardCategory 2Based on the description in ICSC(J)(2002) regarding o-xylene, m-xylene and p-xylene: "May cause aspiration and chemical pneumonia if swallowed". Hazard classClassificationRational for the classification 1 Harzardous to the Aquatic Environment (Acute) Category 2Fish (rainbow trout) 96hr LC50 = 3.3mg/L (CERIJ-NITE RAR, 2005); --> category 2 2 Harzardous to the Aquatic Environment (Chronic) Category 2Low rapid biodegradability (39%, CERIJ Hazard Data Report, 2005), Estimated low bioaccumulation (log Kow = 3.16), and Acute category 2; --> category 2 Xylene CAS [ Health Hazards (2)] Xylene CAS [ Environmental Hazards ] Example of GHS model classification (c)

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

20 20 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, (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).

21 Revision of Industrial Safety and Health Law [ Number of chemicals targeted under ISH Law ] 21 LabellingMSDS (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.

22 1-4. Supporting tools for GHS implementation 22

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 25 [MoE GHS Web-site] [MoE GHS Pamphlet ]

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

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

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: (in Japanese) 28

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

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) %20of%20GHS%20classification.htm 30

31 31 Educational publication (Books & CD-ROM) “GHS-Education CD-ROM” with narration for an employer to educate workers. Supervision: Dr. Jonai (Based on GHS 1 st 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)

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

33 Failure 1 Started without deciding governmental policy on “Building block approach” and selection of “cut-off value/concentration limits” 33 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.

34 Failure 2 Started GHS application simultaneously to Single substances, and Mixtures 34 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 2015 (8 years) Korea Toxic Chemicals Control Act (effective Jul. 2008) Single chemicals : June 2011 (3 years) Mixture : June 2013 (5 years)

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) 36 “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.

37 Failure 5 Japanese Inter-Ministerial Committee on GHS can not establish “Comprehensive Chemical Control Law” 37 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.

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

39 39 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”. “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). a) Work out GHS Classification standard (March, 2008)

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

41 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 ) 41 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”. b) Issue of Japanese Industrial Standard (JIS)

42 42 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 ) (Japanese version and English version)(Japanese version only) Japanese Industrial Standard JIS Z “Classification of Chemicals based on GHS” ( Mar ) JIS Japanese INDUSTRIAL STANDARD JIS Z 7252 – 2009 Classification of chemicals based on GHS

43 43 “Technical Guidance Documents for GHS Classification” (Dec. 2005) “GHS Classification Guidance” (June 2009) c) New Classification Guidance “GHS Classification Manual” (Latest Ver. Feb. 2006) “Draft of New GHS Classification Industrial Standard” (Mar. 2008) “UN GHS Recommendation (2 nd ed.) ” (Japanese ver. Mar. 2008) + + +

44 44 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 2 nd 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)

45 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 !

46 2015/5/446 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 Reference for data and comment Technical comment for initial data Experts Companies METI

47 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) el_interministrial080218set.doc el_interministrial080218set.doc

48 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)

49 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.

50 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)

51 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-PhrasesGHS 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.

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

53 53 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 Republic of Korea

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

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

56 56 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 1 st ed.) 2-2. People’s Republic of China

57 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 ~ 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)

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 59 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 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. effective from December 31st ,062 prioritized chemicals specified by CLA regarding labelling and MSDS Taiwan

60 60 EPA and CLA use “China National Standard CNS15030-Z ” 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)

61 China National Standard “Classification and labelling of chemicals CNS Z1051” General rule CNS 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 2 nd Rev. Ed.

62 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 GHSImplementation in ASEAN Countries 3. GHS Implementation in ASEAN Countries

63 63 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] : “Occupational Safety and Health (Chemicals Classification, Labelling and Safety Data Sheets) Regulations 20XX” [CLASS Regulation] : 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 Malaysia

64 “Seminar Chemicals Managing at Workplace” Malaysia, Ministry of Human Resouces, Department of occupational Safety and Health (DOSH ) Jul. 9, 2008 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 / 2008March / 2009

66 66 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 3-2. Thailand

67 67 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 KN-RCI (Indonesian Responsiblecare Association) distributed “GHS Leaflets” since March Indonesia

68 Legislation related to the GHS in Indonesia Ministry of Industry Decree Number 24/M-IND/PER/2006 ( Hazardous material production and usage control for the industry ) Ministry of Trade Decree number 04/M-DAG/PER/5/2006 ( Distribution Control of Hazardous Substances ) Ministry of Environmental Decree number Per-MENLH No.3/2008 ( Method for using symbol and label of Hazardous chemical substances ) Ministry of Industry “New Chemical Act” will be drafted to implement GHS in

69 69 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 Philippines

70 70 Ministry of Industry is in charge of GHS implementation. “Government Decree No.68/2005/ND-CP” was issued in 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 Vietnam

71 71 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) 3-6. Cambodia

72 72 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 (UNECE GHS: status of Implementation) 3-7. Lao People's Democratic Republic

73 73 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 3-8. Myanmer

74 74 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 : 2003 “Code of Practice for Preparation and use of Material Safety Data Sheets” Singapore standard SS286 : 1984 “Hazard Communication for Hazardous Substances and Dangerous Goods” Singapore standard SS586 : 2008 “Hazard Communication for Hazardous Substances and Dangerous Goods” 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) 3-9. Singapore

75 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. 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 WhomFor WhatBy When Chemical Manufacturers Single substancesby end 2010 Mixturesby end 2012 Chemical Users Single Substancesby end 2011 Mixturesby end 2013

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

77 77 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 Selection of “Cut-off value/concentration limits” 4-1. Policy on “Building block approach”

78 Category GHSEUJAPANKOREACHINATAIWAN MALAYS IA SINGAPO RE 2nd Rev. CLP Reg.. JISZ725 2 MOLMOEGBCNS CLASSSS 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 Cat. 1○○ ○○○○○○ Cat. 2○○ ○○○○○○ 2.4 Oxidizing gases Cat. 1○○ ○○○○○○ 2.5 Gases under pressure Compress. g. ○○ ○○○○○○ Liquefied g. ○○ ○○○○○○ Refriger.li q. ○○ ○○○○○○ Dissilved g. ○○ ○○○○○○ 2.6 Flammable liquids Cat. 1○○ ○○○○○○ Cat. 2○○ ○○○○○○ Cat. 3○○ ○○○○○○ Cat. 4○X XX○○XX

79 Category GHSEUJAPANKOREACHINATAIWAN MALAY SIA SINGAPORE 2nd Rev.CLP Reg.JISZ7252MOLMOEGBCNSCLASSSS 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 Cat. 1○○ ○○○○○○ 2.10 Pyrophoric solids Cat. 1○○ ○○○○○○ 2.11 Self-heating substances Cat. 1○○ ○○○○○○ Cat. 2○○ ○○○○○○ 2.12 Substances which, in ontact with water, emit flammable gases Cat. 1 ○○ ○○○○○○ Cat. 2 ○○ ○○○○○○ Cat. 3 ○○ ○○○○○○ 2.13 Oxidizing liquids Cat. 1 ○○ ○○○○○○ Cat. 2 ○○ ○○○○○○ Cat. 3 ○○ ○○○○○○ 2.14 Oxidizing solids Cat. 1 ○○ ○○○○○○ Cat. 2 ○○ ○○○○○○ Cat. 3 ○○ ○○○○○○ 2.15 Organic peroxides Type A○○ ○○○○○○ Type B○○ ○○○○○○ Type E& F ○○ ○○○○○○ Type C& D ○○ ○○○○○○ Type G○○ ○○○○○○ 2.16 Corrosive to metals Cat. 1○○ ○○○○○○

80 Category GHSEUJAPANKOREACHINATAIWAN MAL AYS IA SINGAPO RE 2nd Rev.CLP Reg..JIS Z7252MOLMOE GB CNS CLASSSS Acute toxicity Chapter Cat. 1 ○○○○○○○○○ Cat. 2 ○○○○○○○○○ Cat. 3 ○○○○○○○○○ Cat. 4 ○○○○○○○○○ Cat. 5 ○XXXX○○XX 3.2 Skin corrosion /irritation Cat. 1 ○○○○○○○○○ Cat. 2 ○○○○○○○○○ Cat. 3 ○XXXX○○XX 3.3 Serious eye damage /eye irritation Cat. 1 ○○○○○○○○○ Cat. 2A ○ ○ ○ ○○ ○○ ○○ Cat. 2B ○○○○ 3.4 Respiratory or skin sensitization Cat. 1 ○○○○○○○○○ ○○○○○○○○○ 3.5 Germ cell mutagenicity Cat. 1A ○○○○○○○○○ Cat. 1B ○○○○○○○○○ Cat. 2 ○○○○○○○○○ 3.6 Carcinogenicity Cat. 1A ○○○○○○○○○ Cat. 1B ○○○○○○○○○ Cat. 2 ○○○○○○○○○ 3.7 Reproductive toxicity Cat. 1A ○○○○○○○○○ Cat. 1B ○○○○○○○○○ Cat. 2 ○○○○○○○○○ Add, Cat. ○○○○○○○○○ 3.8 STOT – Single exposure Cat. 1 ○○○○○○○○○ Cat. 2 ○○○○○○○○○ Cat. 3 ○○○○○ ○○○ 3.9 STOT – Repeated exposure Cat. 1 ○○○○○○○○○ Cat. 2 ○○○○○○○○○ Cat. 3 ○○○○○○○○○ 3.10 Aspiration hazard Cat. 1 ○○○○○ ○○○ Cat. 2 ○XX○X ○XX

81 Category GHSEUJAPANKOREACHINATAIWAN MAL AYS IA SINGA POR E 2nd Rev. CLP Re g.. JIS Z MOLMOEGBCNS CLASSSS Hazardous to the aquatic environment (Acute toxicity) Cat. 1 ○○○○○○○○○ Cat. 2 ○X○X○○○XX Cat. 3 ○X○X○○○XX 4.1 Hazardous to the aquatic environment (Chronic toxicity) Cat. 1 ○○○○○○○○○ Cat. 2 ○○○○○○○○○ Cat. 3 ○○○○○○○XX Cat. 4 ○○○○○○○XX

82 Selection of “Cut-off value/concentration limits ” GHS Recommendation Cat. 1Cat. 2Cat. 3Cat. 4Cat. 5 EU CLP Regulation Cat. 1Cat. 2Cat. 3Cat. 4 - Japan JIS Z Cat. 1Cat. 2Cat. 3Cat. 4 - Korea MOL Cat. 1Cat. 2Cat. 3Cat. 4 - 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

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

84 84 Skin sensitizerRespiratory sensitizer All physical statesSolid / Liquid Gas GHS Recommendation Skin sensitizer ≧ 0.1 %-- ≧ 1.0 %-- Respiratory sensitizer -≧ 0.1 % -≧ 1.0 %≧ 0.2 % EU CLP Regulation Skin sensitizer ≧ 0.1 % *1 -- ≧ 1.0 % *2 -- Respiratory sensitizer - ≧ 0.1 % *1 - ≧ 1.0 % *3 ≧ 0.2 % *3 Japan JIS Z Skin sensitizer ≧ 1.0 % -- Respiratory sensitizer - ≧ 1.0 % ≧ 0.2 % Korea MOL Skin sensitizer ≧ 1.0 %-- Respiratory sensitizer -≧ 1.0 %≧ 0.2 % * 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.

85 85 GHS Recommendation Category 1Category 2 Carcinogen Category 1 ≧ 0.1 % Carcinogen Category 2 - ≧ 0.1 % ≧ 1.0 % EU CLP Regulation Category 1A Category 1BCategory 2 Carcinogen Category 1A ≧ 0.1 %-- Carcinogen Category 1B -≧ 0.1 %- Carcinogen Category 2 -- ≧ 1.0 % *1 Japan JIS Z Category 1 Category 2 Carcinogen Category 1 ≧ 0.1 % Carcinogen Category 2 - ≧ 1.0 % Korea MOL Category 1 Category 2 Carcinogen Category 1 ≧ 0.1 %- Carcinogen Category 2 -≧ 1.0 % *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.

86 GHS Recommendation Category 1Category 2Additional Category for Effects on or via Lactation Reproductive Toxicant Category 1 ≧ 0.1 %-- ≧ 0.3 %-- Reproductive Toxicant Category 2 -≧ 0.1 %- -≧ 3.0 %- Additional Category Toxicants for effects on or via Lactation --≧ 0.1 % --≧ 0.3 % EU CLP Regulation Reproductive Toxicant Category 1 ≧ 0.3 % *1 -- Reproductive Toxicant Category 2 -≧ 5.0 % → ≧ 3.0 % *1 - Additional Category Toxicants for effects on or via Lactation - - ≧ 0.3 % *1 Japan JIS Z Reproductive Toxicant Category 1 ≧ 0.3 %-- Reproductive Toxicant Category 2 -≧ 3.0 %- Additional Category Toxicants for effects on or via Lactation --≧ 0.3 % Korea MOL Reproductive Toxicant Category 1 ≧ 0.3 %-- Reproductive Toxicant Category 2 ≧ 3.0 %- Additional Category Toxicants for effects on or via Lactation -- ? *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 GHS Recommendation Category 1 Category 2Category 3 Category 1 ≧ 1 % *1 ≧ 1% but < 10% - ≧ 10 % Category 2 -≧ 10 % *1 - Category 3 -- *2*2 EU CLP Regulation Category 1 ≧ 10 % ≧ 1% but < 10% - Category 2 -≧ 10 %- Category 3 -- *2*2 Japan JIS Z Category 1 ≧ 10 % ≧ 1% but < 10% Category 2 ≧ 10 % Category 3 *2*2 Korea MOL Category 1 ≧ 10 % ≧ 1% but < 10% - Category 2 -≧ 10 %- Category 3 -- ≧ 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 GHS Recommendation Category 1 Category 2 Category 1 ≧ 1 % *1 ≧ 1% but < 10% ≧ 10 % Category 2 -≧ 10 % *1 EU CLP Regulation Category 1 ≧ 10 % ≧ 1% but < 10% Category 2 -≧ 10 % Japan JIS Z Category 1 ≧ 10 % ≧ 1% but < 10% Category 2 ≧ 10 % Korea MOL Category 1 ≧ 10 % ≧ 1% but < 10% Category 2 -≧ 10 % *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 89 GHS Recommendation Category 1Category 2 Aspiration Hazard Substance Category 1 ≧ 10% *1 --- Aspiration Hazard Substance Category 2--- ≧ 10% EU CLP Regulation Category 1Category 2 Aspiration Hazard Substance Category 1 ≧ 10% *1 --- Aspiration Hazard Substance Category Japan JIS Z Category 1Category 2 Aspiration Hazard Substance Category 1 ≧ 10% *1 --- Aspiration Hazard Substance Category 2--- Korea MOL Category 1Category 2 Aspiration Hazard Substance Category 1 ≧ 10% *1 --- Aspiration Hazard Substance Category 2--- *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 mm 2 /s or less, measured at 40 o C, shall be classified in Category 1.

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


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