Korea Chemicals Management Association Jae-sung, Kim 1/18 CONTENTS Ⅰ Ⅱ Introduction of K-REACH Related works for K-REACH implementation 2/18 Ⅰ Introduction of K-REACH 3/18 1. Reformed TCCA System ~ 2014.12.31 Management Stage 2015.1.1 ~ Chemical Registration Toxic Chemicals Control Act (TCCA) Chemical Evaluation Designation of Toxic Substance Management of Toxic Substance Chemical Containing Product Management 4/18 Act on Registration and Evaluation etc. of Chemical Substance (K-REACH) Registration & Evaluation Chemicals Control Act (CCA) Chemicals Safety 2. Comparison of TCCA & K-REACH TCCA` New Chemicals Registration Toxicity Examination Hazardous substances Hazard Examination Risk Assessment Authorized substance Hazardous substances Restricted/ Prohibited substance K-REACH Existing Chemicals (Substance subject to registration) Registration New Chemicals 5/18 3. K-REACH Flowchart Registration → Examination/Assessment → designation of hazardous chemicals Chemical Substance Existing chemicals (above1ton) Substance subject to registration (above 1ton) Reporting on manufacture Registration New Chemicals Hazard Examination Hazardous substance 6/18 Risk Assessment Authorized substance Restricted/Prohibited substance 3. K-REACH Flowchart Designation of risk concerned product→ Assessment → Management standard Products Mixture Product (0.1% & above 1 ton) Notification Not announced prodcucts Designation of risk concerned product Risk Assessment Safety·Labelling standard Non-compliance Sale prohibition /Recall measures 7/18 Manufacture/Import approval 4. Changes During K-REACH Introduction Main Scheme MOE Proposal Reporting (manufacture etc.) Both new and existing chemicals in 1 ton or more (yearly basis) Reporting every 2 yr Manufacturer & importer Registration Submission of risk assessment Both new and existing chemicals in 1 ton or more (yearly basis) Both new and existing chemicals in 100 tons or more (yearly basis) Information provision - High Risk Concerned products - Penalty - private member’s Proposal All new and existing chemicals in 1 ton or more (yearly basis) Every year Manufacturer, importer, seller, user All new and existing chemicals Both new and existing chemicals in 10 tons or more (yearly basis) Information provided by downstream user and product sellers Product reporting, hazard examination etc. No set value * Certain amount paid in a ratio of company’s sales 8/18 Final version All new and existing chemicals in 1 ton or more (yearly basis) Every year Manufacturer, importer, seller All new and existing chemicals in 1 ton or more (yearly basis) Both new and existing chemicals in 100 tons (yearly basis) * gradually tighten up to 10 tons until Year 2020) Only upon requests from manufacturers/importers Article is exempted Default 5. Registration procedure Distinction between completeness check (Registration) and quality check (Examination) K-REACH system Current system Regist ration Examination result < Examination period : 60 days > Registration Manufacture Import Possible completeness check <30 days> < Low volume 3-7 days > 9/18 Manufacture Import Possible Exami nation 6. Registration data Information on chemical identity, hazard and risk etc. Information Registration criteria Remarks 1 Information of manufacturer or importer - Name, address, representative person 2 Chemical substance Identification information -Identity information including name, molecular formula, chemical structure etc. 3 Use 4 Classification and Labeling 5 Physico-chemical properties 6 Hazard information 7 Guidance on safe use -New chemical -Existing chemical (1 ton or more per year) - Use classification system, known use, prohibited use - GHS - Differentiation according to tonnage (46 max.) - Full data or examination plan -protective equipment, emergency measures - Hazard assessment 8 Risk information 9 Exposure, estimated volume 100 ton or more per year 10/18 - Exposure scenario - Safety confirmation 7. K-REACH implementation schedule Reporting: all new chemicals, 1 ton or more existing chemicals reporting Grace period [3yrs] Grace period [3yrs] Grace period [3yrs] Substance subject to registration ≥ 1 ton/year Registration Pre announcement Target substance Risk Ass. 14.1.1 New chemicals < 1 ton/year < 100㎏/year New chemicals ≥ 100 ton/yr 15.1.1 16.1.1 ≥ 70 ≥ 50 ≥ 20 ton/yr ton/yr ton/yr 17.1.1 18.1.1 (enforcement) 11/18 19.1.1 20.1.1 ≥ 10 ton/yr 21.1.1 24.1.1 <Reference> Classification TCCA K-REACH REACH Registration target New chemicals Existing chemicals subject to registration New chemicals Existing chemicals New chemicals Reporting of annual quantity X O X Registrant Manufacturer, importer Manufacturer, importer, Only representative Manufacturer, importer, Only representative Quantity requiring registration 0.1~1T >1T 1~10T 10~100T 100~1000T >1000T 1~10T 10~100T 100~1000T >1000T Processing time 60 days 30 days 1~2 weeks Standard for chemical evaluation hazards risks risks Listing on existing chemical inventory After 3 years X X Product control X O O 12/18 Ⅱ Related works for K-REACH implementation 13/18 1. Help desk operation by MOE (Purpose) Consultation system for domestic and foreign industries to support implementation of K-REACH (Online) Korean/English Homepage (www.chemnavi.or.kr) (2014.8) (Offline) Experts available for consultation with domestic and overseas companies (2014.4) 14/18 2. Joint-Registration Pilot Project by MOE (Purpose) To identify potential operational problems of joint registration system and develop industry support measures for K-REACH settlement (Period) 2014.8~2015.7 (1 year) (Subject) 7 substances that are to be included in the 1st priority list of existing chemicals subject to registration1 Chemical Substance (CAS No.) Chemical Substance (CAS No.) Diisocyanatomethylbenzene (26471-62-5) Hydrogen bromide (10035-10-6) Benzoyl peroxide (94-36-0) 2,4-Diisocyanatotoluene (584-84-9) 4,4'-Methylenedianiline (101-77-9) (Butoxymethyl)oxirane (2426-08-6) Trichloroethylene (79-01-6) - (Content) From consortium formation to actual registration Consortium formation • Substance identification • Representative selection Registration Preparation Registration Application • Dossier preparation • Cost sharing • Registration dossier submission 15/18 Registration Completion • Submission of required additional data 3. Establishment of Joint-registration support system (Purpose) To identify potential registrants beforehand, and provide support in preparing for joint registration (Similar to EU REACH의 SIEF) (Period) 2014.8~2014.12 (4 months) (User) Korean manufacturer/importer, Only Representative, owner (Content) Room per substance, group e-mail/SMS, data exchange forum etc. Room per substance (registrants of same substance to know each other) Help Desk Homepage E-mail, SMS (communication between joint registrants) 16/18 Data exchange forum (communication between data owner and purchaser) 4. Joint-registration Support by KCMA Installation of Joint-registration Center (K-REACH Center; KRC), support in formation/operation of potential registrants consortium - Potential registrants who wants jointly register needs to join KRC. Through KRC-IT, potential registrants of same substance are identified and consortium is formed. - KRC will support joint registration through mutual cooperation and dividing function among consulting agency and experts from relevant field (chemistry/ toxicity/ legal/ tax) KRC-IT (KCMA) Potential Registrant - Communication Platform - LoA Shop - Document library Identification on potential registrants Consulting agency Consortium formation Joint-registration preparation 17/18 Technical consultation Expert group 18/18
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