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Chemical Control System in Korea June, 2005

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Order of Presentation 1.Chemical Control System in Korea 2.Toxic Chemicals Control Law 3.Industrial Safety and Health Law 4.Label under TCCL & ISHL 5.Other Chemical Laws 6. International Harmonization 1

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1.Chemical Control System in Korea Products Legislation Authorities Explosive, Oxidizing & Dangerous Substance Ministry of Government Flammable Products Control Law Administration and Home Affairs Gunpowder Gun, Sword and Ministry of Government Gunpowder Control Administration and Law Home Affairs High-Pressured High-Pressured Gas Ministry of Commerce, Gas Safety Control Law Industry and Energy Ozone Layer Depleting Law Related to Manufac- Ministry of Commerce, Substances(CFC, etc) ture Control of Specific Industry and Energy Materials for the Purpose of Protecting Ozone Layer Pesticides Agricultural Chemicals Ministry of Agriculture Control Law 2

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1.Chemical Control System in Korea Products Legislation Authorities Hazardous Chemicals Toxic Chemicals Ministry of Environment (Industrial use) Control Law Industrial Safety Ministry of Labor and Health Law Pharmaceutical Pharmaceutical Affairs Ministry of Health Products Law and Welfare Cosmetics Cosmetic Law Ministry of Health and Welfare Food Additives Food Sanitation Law Ministry of Health and Welfare Radioactive Atomic Energy Law Ministry of Science Substances and Technology 3

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2.Toxic Chemical Control Law (TCCL) Status of Law Feb. 2, 1990 legislated Dec. 31, 1996 wholly amended Dec. 31, 2004 wholly amended * * Will be enforced from Jan. 1, 2006 * Enforcement Decree will be published on June or July this year Purpose & Definition of TCCL Prevention of harm to human health and the environment Definition of Chemical Substances: a substance created by artificial chemical reaction on elements or compounds substances extracted and purified from materials in nature 4

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2.Toxic Chemical Control Law (TCCL) Major Administration System New Chemical Notification Special Review of Existing Chemicals by test and literature review Control of Hazardous Chemicals Control of Endocrine disrupter (Observational Chemicals) Survey of Amount in Circulation Survey of Toxic Release Amount (TRI) 5

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2.Toxic Chemical Control Law (TCCL) Chemicals Notification Safety Test General Chemicals Toxic Chemicals New Chemicals Existing Chemicals Observational Chemicals Prohibition, Restriction in use Review for New and Existing Chemicals 6

2.Toxic Chemical Control Law (TCCL): 

2.Toxic Chemical Control Law (TCCL) Number of Notified New Chemicals 7

2.Toxic Chemical Control Law (TCCL): 

2.Toxic Chemical Control Law (TCCL) Number of Reviewed Existing Chemicals 8

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2.Toxic Chemical Control Law (TCCL) Definition of Hazardous Chemical Substances Restricted/Prohibited Chemicals: severely harmful to human health (4/55) and the environment * Business permit required Toxic Chemicals: harmful to human health and the environment (548) * Manufacturer registration, import report required Observational Chemicals: likely to be harmful to human health and the (18) environment * annual report required/additional data may be required Accident Protection Chemicals: Chemicals with concern of accident (from 2006) * Large volume, high Physico-chemical hazard, high acute toxicity 9

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2.Toxic Chemical Control Law (TCCL) Existing Chemicals List (ECL) Definition List of chemicals that have been manufactured domestically or imported before the enforcement date of Feb. 2, 1991. Structure In an alphabetical order (IUPAC or CA Index Name) CAS No. Index Confidential part + Non-confidential part 36,000 Chemicals are listed Can be searched by CAS Surveyer (CD-Rom); Chem list & STN(On-line) 10

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2.Toxic Chemical Control Law (TCCL) New Chemical Notification & Review * From Jan. 1, 2006, only by TCCL (Ministry of Environment) NIER Chemical Examination Committee Related Ministries Result of Review Public Notice Notifier Review Request of Restriction on Manufacture/ Import Notice 11

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2.Toxic Chemical Control Law (TCCL) New Chemical Notification - Chemicals Exempt from TCCL (Chemicals controlled under other relevant laws) Radioactive Substances Pharmaceutical Products, Quasi-Pharmaceutical Products and Cosmetics Narcotics Psychopharmaceuticals Agricultural Chemicals (Formulation only) Fertilizers Food and Food Additives Feeds Gunpowder Toxic Gases Defined under the High-Pressured Gas Safety Control Law 12

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2.Toxic Chemical Control Law (TCCL) New Chemicals Notification - Chemicals Excluded from Toxicity Review Toxic Chemicals Observational Chemicals Chemicals already Notified to the MOE as new chemical Other Substances to be Designated by Presidential Decree 13

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2.Toxic Chemical Control Law (TCCL) New Chemicals Not Subject to Notification 100 kg or less per year R & D Chemicals Chemicals enclosed in machinery Articles in solid state Some natural chemicals Chemicals accepted and announced by the Head of NIER as having been manufactured domestically or imported into Korea before Feb. 2, 1991 Review Period: 45 days 14

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2.Toxic Chemical Control Law (TCCL) Data Requirement for Notification * From 2006, will be expanded step by step (First year, ecotoxicity data) * Listed on at least Two Other Foreign Inventories Before 1991 ** Meet the Definition of OECD Polymer Types Basic Data Set One of following sets Simplified - Acute oral test + Ames test; Notification* - Acute oral test + Chromosomal aberration test; or - Biodegradability (for biodegradable chemicals) Polymer Molecular weight, Characteristics, Stability data Notification** Full Acute oral test + Ames test + Notification Chromosomal aberration test + Biodegradability test 15

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2.Toxic Chemical Control Law (TCCL) Required Information for Notification Notice Form Chemical Identity (name, structure, CAS No) Physico-chemical properties Information on Impurities (identity and percentage) Estimated volume per year for three years Information regarding exposure and its amount to Environment Toxicity Data (except for polymer)* GLP Data from July 1, 1997 * Non-GLP for polymer 16

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2.Toxic Chemical Control Law (TCCL) Protection of Confidential Information (adopted in June 1992) Items to be claimed : Chemical identities, testing data Items to be denied : Notifier, MSDS & any data already disclosed to the public Protection Period : five(5) years * Extension of five years upon request. Supporting Data : Generic name Reasons for confidentiality claim 17

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2.Toxic Chemical Control Law (TCCL) Report of Volume of Circulated Chemicals Future plan : per 4 years Result of 1999 Survey Use : 234.1 million ton (29,283 Chemicals) Domestic manufactured 181.2 million ton (3,480 Chemicals) Imported : 42.2 million ton Not open to public 18

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2.Toxic Chemical Control Law (TCCL) Custom Clearance NO NO NO NO Yes Go to Relevant Law Notice of Toxic Chemicals Custom Clearance Low Volume Exemption Yes Yes Yes (1) By Components Certificate (2) By Self-Certification Form 19 (From Jan. 1, 2006, Component Certificate would not be required)

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2.Toxic Chemical Control Law (TCCL) Confirmation Certificate for Customs Clearance * This process will be changed in next year Issued from Korea Chemicals Management Association (KCMA) Application for Issuance of Confirmation Certificate to KCMA Submission of Component Certificate prepared by foreign exporter Self-Certification for confidentiality Self-Certification for full confidentiality Claim. * This process will be changed in next year Preparation of “Self-Certification of Chemical Substance” form in English form by exporter Send to importer Importer -- KCMA with Korean form prepared by importer. 20

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2.Toxic Chemical Control Law (TCCL) Product Name Chemical name CAS No. % Abitol 72-63-9 1,3-Propanediol 504-63-2 HCl* 7647-01-0 8% An Example of Component Certificate Signature Name Position * A Product containing HCl Content of 10% or more is Classified as Toxic Chemical ** Even in the Case When New Chemicals Are Included, the Chemical Content Must be Indicated 21

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2.Toxic Chemical Control Law (TCCL) TRI (implemented Since 1999) * Reported by Feb. of next year Chemicals Business Type 1999 80 Petroleum Refinery; Chemical Companies (100 or more employees) 2000 80 23 Business Types (100 or more employees) 2001 160 23 Business Types (50 or more employees) 2002 240 28 Business Types (50 or more employees) 22

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2.Toxic Chemical Control Law (TCCL) International Harmonization PIC enforced under TCCL (from Feb.24, 2004) Consideration on introduction of GHS Future Plan From Jan. 1, 2006, amended TCCL will be in effect. Major Change Submission of new chemical notification -- Only to MOE(National Institute of Environmental Research) Data requirement for new chemical notification will be expanded Change of classification system of hazardous chemicals * new: Accident Protection Chemicals Change of customs clearance procedure * Self-Certificate only (proposed) 23

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3.Industrial Safety & Health Law (ISHL) Purpose To protect from hazardous facts (hazardous ray, chemicals, noise, etc.) For Chemicals Prohibition or Restriction of highly hazardous chemicals TWA Report of Hazard Review Result (began enforcing 2/1/1991) * will be deleted from next year MSDS (began enforcing 7/1/1996) Labeling Monitoring of hazardous chemicals at workplace 24

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Existing Chemicals Existing Chemicals List (8,000) Chemicals listed under other laws prior to 6/30/1991 * Including chemicals that have either received or are in the process of applying for authorization and approval of manufacture, import and use Combined with TCCL’s List in Dec. 1996 3.Industrial Safety & Health Law (ISHL) 25

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Hazard Review Procedure of New Chemicals (From 2006, this process will not be enforced) MOL Industrial Chemicals Research Center Related Ministries Result of Review Public Notice Notifier Hazard Review Request of Restriction on Manufacture/Import Notice 3.Industrial Safety & Health Law (ISHL) 27

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3.Industrial Safety & Health Law (ISHL) MSDS Business Owner Responsibility of MSDS Preparation, and Placement at workplace Also when transferring subject chemicals 29

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3.Industrial Safety & Health Law (ISHL) Contents of MSDS (16 headings) Chemical Product and Company Information Components, Contents and Related Information Hazardous Dangerous Property First Aid Measures Prevention Measures for Explosion Fire Spill Response Measures Handling and Storage Procedures Exposure Prevention Measures / Personal Protective Equipment Physical & Chemical Properties Stability and Reactivity Toxicological Information Effects on the Environment Precautions for Disposal Transport Information Regulatory Information Other Information 30

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3.Industrial Safety & Health Law (ISHL) Standard for Preparing and Keeping the MSDS on File Etc. (Public Notice 1997-27, MOL) IMDG Code and DGR Code : apply only until the business place for first use Exceptions from MSDS filing requirement Less than 1% of Hazardous Chemicals Content (0.1% for carcinogens) Solid Consumer Products (Except where carcinogenic chemicals are included) Exceptions from MSDS Translation Requirement: R&D reagents Accept Foreign Languages for Experimental or Laboratory Chemicals Accept EU's Orange Background Color as Hazard Symbol Specific Standards of Classification of Hazardous Chemicals Itemizing Size of Warning Labels for Solid Consumer Products Which Contain Carcinogenic Chemicals 31

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4. Label under TCCL & ISHL TCCL: Only for Toxic Chemicals Hazard Mark Product name …Substance …Substance …Substance Toxicity Handling precautions Hazard Mark Hazard Mark 32

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4. Label under TCCL & ISHL ISHL Hazard Pictogram Product name …Substance …Substance …Substance Toxicity Handling precautions Hazard Pictogram Hazard Pictogram 33 [Warning Label in accordance with Article 41 of ISHL] As for other details, refer to the MSDS

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Pictogram of Hazard EU type Yellow or Orange Color Background 4. Label under TCCL & ISHL 34 Explosives Oxidative Corrosive Hazardous to Environment Harmful Irritant sensitization Extremely flammable Highly flammable Flammable Water prohibition Highly Toxic Toxic Carcinogenic Mutagenic Reprotoxin

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5. Other Chemicals Laws The Law Regulating Manufacture of Specific Substances to protect Ozone Layer Regulated Chemicals Specific chemicals Article containing specific chemicals Permission for Manufacturer & Importer Approval of amount Seller : Sales plan (including usage, user) 35

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5. Other Chemicals Laws Laws Related to Manufacture and Import / Export regulations of specific chemical Substances for the purpose of restricting chemical weapons Chemical Weapon : prohibited for all activities Specific Chemicals Schedule 1 : permitted for Manufacture, Import/Export Schedule 2 : imported only from member countries Schedule 3 & Single Chemicals : reporting requirement only for manufacturer Reporting requirement Annual list (result of last year and plan of this year) 36

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6. Intenational Harmonization Stockholm Convention: adopted in May 17, 2004 PIC: adopted under TCCL in Feb. 24, 2004 GHS: 2004. 6. Task force was organized (Inter-government committee & working group) Translation of Text book by task force Now distributed for public comment by relevant authorities 37

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6. Intenational Harmonization Stockholm Convention: adopted in May 17, 2004 PIC: adopted under TCCL in Feb. 24, 2004 GHS: 2004. 6. Task force was organized (Inter-government committee & working group) Translation of Text book by task force Now distributed for public comment by relevant authorities 38

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