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Japan e se and ASEAN GHS I mplementation

Japan e se and ASEAN GHS I mplementation

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Japan e se and ASEAN GHS I mplementation

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

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

  3. 1.GHSImplementation in Japan 1-1. Activities for GHS implementation in Japan 1-2. GHS ModelClassification 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, fromnow on

  4. 1-1. Activities for GHSimplementation in Japan

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

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

  7. Translation of “GHS Recommendation Text” into Japanese: Supervised by the Inter-Ministerial Committee on GHS Available from the web-site of: MHLW :http://www.mhlw.go.jp/bunya/roudoukijun/anzeneisei07/index.html METI :http://www.meti.go.jp/policy/chemical_management/int/ghs_text.html MoE :http://www.env.go.jp/chemi/ghs/kariyaku2.html 1st revised edition (Japanese Ver., Mar. 2006) 2nd revised edition (Japanese Ver., Mar. 2008) (Original text) 7

  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 hazardsThis manualis preparedfor 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”(1st Ver. Apr. 2005) (Latest Ver. Feb. 2006) 8

  9. “Technical Guidance Documents for GHS Classification”(Dec. 2005) “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) 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. 9

  10. Issue ofJapanese Industrial Standard (JIS)by Japanese Standards association Issue of JIS Z 7251 - 2006 “Labelling of chemicals based on GHS” ( Mar. 2006 ) JIS for preparation of Labels based on GHS. Revision ofJIS Z 7250 - 2005“Safety data sheet for chemical products – Part 1 : Content and order of sections” ( Dec. 2005 ) JIS for preparation of SDSbased on GHS. Transition period up to end of 2010 Revision ofJIS Z 7250- 2000 (based on ISO 11014-1-1994) 10

  11. JIS Z 7250 - 2005“Safety data sheet for chemical products – Part 1 : Content and order of sections” ( Dec. 2005 ) Japanese Industrial Standard JIS Z 7251 - 2006“Labelling of chemicals based on GHS” ( Mar. 2006 ) 11 (Japanese version and English version) (Japanese version only)

  12. Issue of “GHS Implementation Guidelines”based on JIS Z 7250 and JIS Z 7251 by Japan Chemical Industry Association Part 2: Safety Data Sheet Part 3: Labelling Part 1: General guidelines 12

  13. 1-2. GHS ModelClassification Project 13

  14. GHS Model Classification Project(1) Target chemicals:1,500 substances under regulation of; - Industrial Safety and Health Law (MHLW) - Poisonous and Deleterious Substances Control Law (MHLW) - Law Concerning Reporting, etc. of Releases to the Environment of Specific Chemical Substances and Promoting (PRTR Law) (METI / MoE) Model classification according to - “GHS Classification Manual” and - “Technical Guidance Documents for GHS Classification” Classification work was performed by experts selected from laboratories and industries. Classification results were checked by the member of Technical experts group of Inter-Ministerial Committee on GHS,so as to eliminate any different classification results among experts. Finished classification work in two years (2005~2006) 14

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

  16. Example of GHS model classification (a) Xylene CAS 1330-20-7 [Physical Hazards] 16

  17. Example of GHS model classification (b) Xylene CAS 1330-20-7 [Health Hazards (1)] 17

  18. Example of GHS model classification (c) Xylene CAS 1330-20-7 [Health Hazards (2)] Xylene CAS 1330-20-7 [Environmental Hazards ] 18

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

  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, 2006. (Penalty) The person who violate the provisions regarding labelling shall be punished witha penal servitudenot exceeding six monthsor with a finenot exceeding500,000 yen ( = US$5,000). 20

  21. Revision of Industrial Safety and Health Law (Labelling)Article 57. A person who is to transfer or provide substances explosive, combustible, and flammable and other substances which are liable to cause dangers to workers which are liable to inflict health impairment upon workers, shall, as provided for by Ministry of Health, Labour and Welfare Ordinance, label the container or the package. (Material Safety Data Sheet) Article 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 ] 21

  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. 2005 – Jun. 2006) The module of Workshop by JISHA - Introduction of GHS and principle of revised Industrial Safety and Health Law (2 hrs) - Physical hazard classification (1.5 hrs) - Health hazard and Environmental hazard classification (2 hrs) Workshops at 26 places in the whole country, and more than 3,000 participants totally. 24

  25. Pamphlet and Web-site (1)Ministry of Environmenthttp://www.env.go.jp/chemi/ghs/ [MoE GHS Pamphlet ] [MoE GHS Web-site] 25

  26. Pamphlet and Web-site (2)Ministry of Health, Labour and Welfarehttp://www.mhlw.go.jp/topics/bukyoku/roudou/ghs/index.html [Industrial Safety & Health Law Pamphlet ] [Poisonous & Deleterious Substances Control Law Pamphlet ] [MHLW GHS Web-site] 26

  27. Pamphlet and Web-site (3)Ministry of Economy, Trade and Industryhttp://www.meti.go.jp/policy/chemical_management/int/ghs.html [PRTR Law Pamphlet ] [MWTI GHS Web-site] 27

  28. Model Labels and MSDSs by Japan Industrial Health and Safety Association (JISHA) Model Labels and MSDS according to the results of GHS model classification project. • ModelLabelsfor 100 substances under ISH Law: http://www.jaish.gr.jp/anzen/gmsds_label/label_index.htm (in Japanese) • ModelMSDSsfor 700 substances under ISH Law: http://www.jaish.gr.jp/anzen_pg/GHS_MSD_FND.aspx (in Japanese) 28

  29. [JISHA GHS Web-site] http://www.jaish.gr.jp/user/anzen/kag/kag_main01.html [JISHA Model MSDS] [JISHA Model Label]

  30. Classification software for Mixtures Development of computer software for GHS classification of mixture, installed with the classification results of 1500 chemicals. Only 3 steps ; 1. Input GHS classification results of substances, 2. Input the percentage of substance in mixture, 3. Get the classificatin of the mixture. Software is available from the site below (in Japanese) http://www.meti.go.jp/policy/chemical_management/GHS/land%20of%20thousand%20of%20GHS%20classification.htm 30

  31. Educational publication (Books & CD-ROM) “Challenge of GHS” Supervision: Dr. Jonai Coauthor: Jonai, Sano, Noguchi The Chemical Daily (2006) “Guidebook on Preparation of Labels and MSDS, complying with GHS system ” Author: Sano The Chemical Daily (2007) “GHS Q&A” Coauthor: Jonai Miyagawa Morita The Chemical Daily (2008) “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) 31

  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” Almost chemical companies already finished GHS classification, labeling, and revision of MSDS of their products according to the GHS classification manual (Feb. 2006), in these work, they had to select cut-off limit value for mixture by their own responsibility. After setting policy on “Building block approach” and “Selection of cut-off value/concentration limits”, all chemical company must repeat all GHS classification, labeling, and must revise their MSDS again. 33

  34. Failure 2 Started GHS application simultaneously to Single substances, and Mixtures Transitional periods Japan Industrial Safety and Health Law (effective on Apr. 2006) Single chemicals and Mixture : Dec. 2006 (8 months) EU REACH and CPL Regulation (effective on Jul. 2007) Single chemicals : Dec. 2010 (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) 34

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

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

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

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

  39. Adoption of classification based on “Building block approach”do not adopt:“Acute toxicity Category5”, “Skin irritation Category3”,“Aspiration hazard Category2”Selection of “Concentration limits”as classification trigger for mixture.・Adoptedsameconcentration 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- singleexposure”. and“STOT- repeated exposure”. a) Work out GHS Classification standard (March, 2008) “Preparation of draft plan of GHS classification standard” Report of the Committee Supported by Ministry of Economy, Trade and Industry (METI), Observed by Ministry of Health, Labor and Welfare (MHLW), and Ministry of Environment (MoE). 39

  40. “Building block approach”inJapan JIS Z 2752

  41. by Japanese Standards Association & Japan Chemical Industry Association b) Issue of Japanese Industrial Standard (JIS) Issue of JIS Z 7251 - 2006 “Labelling of chemicals based on GHS” ( Mar. 2006 ) JIS for preparation of Labels based on GHS. Issue of JIS Z 7252 - 2009 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”. Revision ofJIS Z 7250 - 2005“Safety data sheet for chemical products – Part 1 : Content and order of sections” ( Dec. 2005 ) JIS for preparation of SDSbased on GHS. Revision ofJIS Z 7250- 2000 (based on ISO 11014-1-1994) 41

  42. JIS Z 7250 - 2005“Safety data sheet for chemical products – Part 1 : Content and order of sections” ( Dec. 2005 ) JapaneseIndustrial Standard JIS Z 7252 - 2009“Classification of Chemicals based on GHS” ( Mar. 2009 ) JIS Z 7251 - 2006“Labelling of chemicals based on GHS” ( Mar. 2006 ) JIS Japanese INDUSTRIAL STANDARD JIS Z 7252 – 2009 Classification of chemicals based on GHS (Japanese version and English version) (Japanese version only) 42

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

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

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

  46. e) The electronic bulletin board for GHS (J-Chemipedia) Trial establishment of the electronic bulletin boards for GHS classification with the data source of comments to the GHS classification results. http://www.ghs-net.jp/ Offer for board and initial data METI Technical comment for initial data Reference for data and comment Companies Experts 2014/6/6 46

  47. f) Risk-based labelling for consumer products (1) The decision to adopt risk-based labelling for consumer products. GHS Inter-Ministerial Committee (Jan. 2007) http://www.meti.go.jp/policy/chemical_management/GHS/Consumer_product _labelling.htm “Outlook on Risk Assessment for Consumer Products Based on Exposure for GHS Labeling” GHS Inter-Ministerial Committee (Jan. 2007)(in English)http://www.meti.go.jp/policy/chemical_management/03kanri/risk_based_label_interministrial080218set.doc 47

  48. f) Risk-based labelling for consumer products (2) The guidance documents of risk-based labelling for consumer products. National Institute of Technology and Evaluation (NITE) 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) 48

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

  50. g) Application of GHS to chemical risk management (2) Use GHS classification results as the means of hazard rating in risk assessment of hazardous chemicals. UK HSE: COSHH ESSENTIALS  -  Easy steps to control health risks from chemicals. (use EU R-phrase for hazard rating) http://www.coshh-essentials.org.uk/ UN ILO: Control Banding - Practical Tools for Controlling Exposure to Chemicals. (use EU R-phrase and GHS classification for hazard rating) http://www.ilo.org/public/english/protection/safework/ctrl_banding /index.htm US NIOSH: Control Banding -Qualitative Risk Characterization and Management of Occupational Hazards. (use OEL and R-phrase for hazard rating) http://www.cdc.gov/niosh/topics/ctrlbanding/ 50