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Implementation of GHS in Japan

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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Implementation of GHS in Japan

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  1. Implementation of GHS in Japan Hiroshi SANO Technical Consultant Japan Chemical Database Ltd. Lecturer Dep. of Occupational Health and Toxicology KITASATO University

  2. The Globally Harmonized System of Classification and Labelling of Chemicals : GHSso called“Purple book” Recommendation by : United Nations Economic and Social Council (UN ECOSOC), Committee of Experts on the Transports of Dangerous Goods and on the Globally Harmonized system of Classification and Labelling of Chemicals, Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals. First Ed. Jul. 2003 First Revised Ed. Jul. 2005 Second Revised Ed. Mar. 2007 (Revised every other year) UN GHS Recommendation

  3. Implementation of GHS in Japan 1. Activities for GHSimplementation in Japan 2. GHS ModelClassification Project 3. Revision of Industrial Safety and Health Law 4. Supporting tools for GHS implementation 5. GHS implementation, development hereafter

  4. 1. Activities for GHSimplementation in Japan 4

  5. Change Labels Revise MSDS Activities for GHS Implementation in Japan 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) Government 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 --)

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

  7. Available from the web-site of: MHLW :http://www.mhlw.go.jp/bunya/roudoukijun/anzeneisei07/index.html METI :http://www.meti.go.jp/policy/chemical_management/int/ghs_text.html MoE :http://www.env.go.jp/chemi/ghs/kariyaku2.html * It is very important and takes long time to harmonize the technical terminology in the Japanese GHS text, because there were several inconsistent uses of the terms among the Japanese laws. 2nd Edition (Mar. 2008) 1st revised version (Mar. 2006) (Original text) Translation of “GHS Recommendation Text” into Japanese: Supervised by the Inter-Ministerial Committee on GHS

  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”

  9. “Technical Guidance Documents for GHS Classification” “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.

  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 of JIS 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)

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

  13. 2. GHS ModelClassification Project 13

  14. GHS ModelClassification 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)

  15. ModelGHS Classification project(2) Results of GHS ModelClassification Projectis available from the web-site of NITE:http://www.safe.nite.go.jp/ghs/index.html 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]

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

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

  19. 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 ( = RM17,000).

  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. 4. Supporting tools for GHS implementation

  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 Safety and Health Association (JISHA) How to classify chemicals especially mixed compounds, according to GHS criteria and to make labels and SDSs under GHS requirements. (Nov. 2005 – Jun. 2006) The module of Workshop by JISHA - Introduction of GHS and principle of revised Industrial Safety and Health Law (2 hrs) - Physical hazard classification (1.5 hrs) - Health hazard and Environmental hazard classification (2 hrs) Workshops at 26 places in the whole country, and more than 3,000 participants totally. 24

  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 LawPamphlet] [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 Safety and HealthAssociation (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 classification of the mixture. Software is available from the site below (in Japanese) http://www.meti.go.jp/policy/chemical_management/GHS/land%20of%20thousand%20of%20GHS%20classification.htm

  31. Educational publication (Books & CD-ROM) “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 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)

  32. 5. GHS implementation, developmenthereafter 32

  33. a) Classification of Non Regulated Chemicals Japan Industrial Safety and HealthAssociation (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 !

  34. 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.

  35. 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.

  36. 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

  37. 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

  38. e) Risk-based labelling for consumer products (1) The decision to adopt risk-based labelling for consumer products. GHS Inter-Ministerial Committee (Jan. 2007) http://www.meti.go.jp/policy/chemical_management/GHS/Consumer_product _labelling.htm “Outlook on Risk Assessment for Consumer Products Based on Exposure for GHS Labeling” GHS Inter-Ministerial Committee (Jan. 2007)(in English)http://www.meti.go.jp/policy/chemical_management/03kanri/risk_based_label_interministrial080218set.doc 38

  39. e) Risk-based labelling for consumer products (2) The guidance documents of risk-based labelling for consumer products. National Institute of Technology and Evaluation (NITE) http://www.safe.nite.go.jp/ghs/risk_consumer.html “Guidance for implementation the GHS of consumer products” (Draft) Guidance documents for the implementation of the GHS in collaboration with Asian countries. Japan Soap & Detergent Association (JSDA) 39

  40. 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.

  41. f) Application of GHS to chemical risk management (2) Use GHS classification results as the means of hazard rating in risk assessment of hazardous chemicals. UK HSE: COSHH ESSENTIALS  -  Easy steps to control health risks from chemicals. (use EU R-phrase for hazard rating) http://www.coshh-essentials.org.uk/ UN ILO: Control Banding - Practical Tools for Controlling Exposure to Chemicals. (use EU R-phrase and GHS classification for hazard rating) http://www.ilo.org/public/english/protection/safework/ctrl_banding /index.htm US NIOSH: Control Banding -Qualitative Risk Characterization and Management of Occupational Hazards. (use OEL and R-phrase for hazard rating) http://www.cdc.gov/niosh/topics/ctrlbanding/ 41

  42. 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 HealthAssociation (JISHA) JISHA Method Chemical Health Risk Assessment (use EU R-phrase and GHS classification for hazard rating) 42

  43. Terima Kasih !Arigato-gozaimashita!

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