Mai fung @Globalchem

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A comprehensive present for anyone who is interested in chemical control laws, including GHS, hazardous chemicals and new chemicals in China. Some valued tips also given in the present as well.

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Mai fung @Globalchem

  1. 1. CHINA CHEMICALLEGISLATION PRESENTATION Feb 27 | GLOBALCHEM 2013 Gaylord National Resort & Convention Center Mai Fung REACH24H Consulting Group
  2. 2. About my presentation This is a presentation tells what chemical legislation system looks like in China through the introduction of main regulations. Useful links This is a presentation giving you the knowledge and providing you with tips, useful links as well as additional information for practical your use in compliance with Chinese regulations. Additional information REACH24H Consulting Group GlobalChem 2013
  3. 3. China New Chemicals (MEP Order 7- Revision of Provisions on the Environmental Administration of New ChemicalSubstances)China Hazardous Chemicals (State Council Decree 591 | SAWS Order 53 | MEP Order 22 | SAWS Order 55)& China GHS SDS + Labeling (National standards | AQSIQ Inspection Letter [2012] NO.30) PRESENTED BY MAI FUNG OF REACH24H SPECIALLY FOR GLOBALCHEM 2013
  4. 4. Chemical legal frameworkDifferent from the western developed countries, chemical legislationframework in China could be shown as the chart below in general. Class in legislation system From top to lower level Top level 2nd level 3rd level 4th level Law: Administrative Law: Measures: GB & GB/T On this level, the laws was On this level, the laws was On this level, the laws was Known as National Standard; usually be legislated through the legislated through the state legislated by each functional divided into GB(/T) People’s Congress Council Ministry GB: National Standard (Compulsory) GB/T: Recommended Standard For example For example For example Constitution State Council Decree 591 MEP Order 7 For example MEP Order 22 GB 15258-2009 SAWS Order 53 GB 20584 – GB 20586 (CN GHS Classification) REACH24H Consulting Group GlobalChem 2013
  5. 5. Competent authoritiesThis page is just for your reference. Ministry Administration MEP Ministry of Environmental Protection 環保部 SAWS State Administration of Work Safety 安監局 (Replacing SEPA) MOR Ministry of Railways 鐵道部 CUSTOMS General Administration of Customs of 海關總署 (GAC) P.R.C. MOA Ministry of Agriculture 農業部 AQSIQ General Administration of Quality 品質監督檢驗檢 Supervision, Inspection and Quarantine 疫總局 MIIT Ministry of Industry and Information 工信部 SAIC State Administration for Industry and 工商總局 Technology Commerce MPS Ministry of Public Security 公安部 SDPC National Development and Reform 國家發展和改革 Commission 委員會 MOT Ministry of Transport 交通運輸部 MOH Ministry of Health 衛生部 Responsible institutes NRCC-SAWS National Registration Center For 化學品登記中心 Chemicals of SAWS CRC-MEP Chemical Registration Center of MEP 環保部化學品登 記中心 REACH24H Consulting Group GlobalChem 2013
  6. 6. Chem-environmentalManagement in China • General new chemical substances • New hazardous chemical substances 45,000+ • New hazardous chemicals of priority environmental concern (NHCPEC)• General hazardous chemicals 3,800+ Existing Chemical substances with no particular management MEP Order• HCPEC (list to be released).• Toxic chemicals restricted to be 7,000+ 7 imported or exported Catalog of Hazardous Chemicals (to be re- issued) + extremely toxic chemicals + … “Revision of Provisions on theMEP Order 22 Environmental Administration of State Council Decree 591 SAWS Order 53(registration system) New Chemical Substances” SAWS Order 41 55 57…(License system) Existing chemicals New chemicals Ministry of State Ministry of Environmental Administration Environmental Protection of Work Safety Protection REACH24H Consulting Group GlobalChem 2013
  7. 7. China New Chemicals Never call me “China REACH”Overview of MEP Order 7 Preparation | Notification | Post-notification Roadmap of MEP Order 7 The key part REACH24H Consulting Group GlobalChem 2013
  8. 8. China New Chemicals Order 17 by SEPA Order 7 by MEPOverview of Order 7 Provisions on the Environmental Management of New Chemical Substances in China Revision of Provisions on the Environmental Administration of New Chemical Substances in China“Revision of Provisions on the Environmental Administrationof New Chemical Substances”. It is administered by the MEP Invalid Issued Came into forceand implemented by Chemical Registration Center (CRC- 2002 2010 Oct 15 2010MEP). SEPA has replaced by MEP. What chemical substances Exemption from notification X are subject to it • Finished products subject to other existing regulations • New chemical substance out of IECSC • Substances exist in nature • New substance in preparation/mixtures • Substances of noncommercial purpose or unintentionally produced (surfactants, plasticizers, preservatives etc.) (Impurity <10% w/w | Chemical produced from reactions | Waste water, gas or solid waste or other by-products) • Article with intended release of new substance • Substances of special categories • UVCB (Substances of Unknown or Variable (Material: glass materials, ceramics, etc. | Homogeneous and heterogeneous alloys | Non-isolated intermediates Composition, Complex) New chemicals in Articles: intended release chemical in article excluded) • Polymer Applicable Applied to a Chinese entity Territories • Within Chinese Customs Boundary Who will be affected • Affiliate of a foreign company in China • Bonded areas & Export • Manufacturers of new chemicals Processing Zones Territories • Importer of new chemicals under the regulation • Representative agent in China assigned by a foreign company Inapplicable (A representative agent shall meet some requirements) • Hong Kong, Macau, Taiwan • Cargos temporarily stored in A notifier could be a foreign entity; the applicant and holder of a certificate will processing zones or to be be Chinese entity. exported with no processing
  9. 9. China New ChemicalsStatistics recap of Order 7Recap notification cases under MEP Order 7 in 2012Source: Chemlinked.com | CRC-MEP (Jan 30 2013) 406 1,474 11 Jan-Jun2012 Jan-Jun 2012 Jan-Jun 2012 484 3,402 30 Jul-Dec2012 Jul-Dec 2012 Jul-Dec2012 47.9% 42.7% 95.3% 890/1,854 3402/7,969 41/43 Scientific Research Record Notification Simplified Notification Regular Notification Special case | General case 14 submission in 2012 left to be approved (3,009) (393) Approved 14 general hazardous substances | 21 NHCPEC
  10. 10. China New Chemicals Notification Preparation Details of notification procedures will be unfolded at each stage. 5+ years before listed in IECSC Preparation Notification Post-notification 42,436 (200M software) It additionally includes 42,436 Online (Free) 3,166 Confidential substancesIECSC inquiry 8,175 with no CAS# includedIECSC since 2003 Search with one of 3 identities: Not easy for some products with English name | Chinese name | CAS# same generic name but different CAS#• To get to know whether your PC version of IECSC chemical substance is new or not It returns with either of 2 results: 8,500CNY (1,400USD) …listed in IECSC• No need for additional information …is not found in IECSC at this stage 42,436 (10 work day) It additionally includes 3,166 confidential substances Up-to-date database CRC-MEP has its own internal identification method for substances with no CAS# Formal inquiry Useful link: Additional information: 600CNY (100USD) Different IECSC version on CRC-MEP Valued tips for applying IESCE inquiry
  11. 11. China New ChemicalsIECSC 2013 was publishedPDF of IECSC has come out and been kept updated. IECSC database 2010 IECSC database 2013 What is new? 42,436 42,342 • Minor mistakes of chemical name 8,175 with no CAS# included and molecular formula fixed; Updated on Jan 30 • Some new chemicals notified under 2013 SEPA Order 17 (2002) included; • Chemicals through IECSC 3,166 confidential chemical 3,270 confidential chemical supplementation (Supplementation substances substances should be submitted before Dec 01 2011) during Nov. 2010 & Nov.2011 in accordance with MEP Notice [2011] No. 1366 45,602 in total 45,612 in total IECSC Ver. 2010 IECSC Ver. 2013 • Online database (free) • PDF • Pc version • Online database updated in early Feb. • Pc version (2010 ver. purchasers get updated for free) released in early Feb. Additional information: IECSC (2013) PDF download
  12. 12. China New ChemicalsNotification implementationDetails of notification procedures will be unfolded at each stage. 5+ years before listed in IECSC Preparation Notification Post-notification IECSC inquiry Existing Substances not subject to MEP Order 7 X New substances (SRRN): for testing sample Subject to MEP Order 7 (Risk Assessment): for regular (Review): for regular notification notification & general case of simplified Regular Notification • Data gap analysis notification • Testing proposal • (Scientific Research Record) CRC-MEP Certification or Simplified Notification • Testing execution Submission & (Review) Public announcement • (Risk Assessment ) Scientific Research Record • Dossier generation (SRRN) 3 types of Dossier and Submission and notification submission material certification 1 2 3
  13. 13. 1 3 types of notification Regular Notification Simplified Notification Scientific Research Record (SRRN)Applied Tier 1: 1-10t/a Tier 2: 10-100t/atonnage band 0.1 – 1t/a <0.1t/a Tier 3: 100-1000t/a Tier 4: 1000+t/aSupplemental Special cases of regular notification General case For the scientific research purposeinformation • Serial Notification Similar substances notification once • Joint Notification Special case Joint notification(data or cost-share) • Intermediate, <1t/a Testing samples imported for • Repeated Notification • only for export, <1t/a compulsory eco-toxicological tests Notification by referring to the data • for scientific research 0.1 to 1t/a SRRN is necessary for regular notification owned by previous notifiers. • for polymer with new monomer and general case of simplified • Re-notification (<2%w/w) (no volume limited) notification because of sample needed Tonnage increase; registered use change • new polymer of low concern (No volume for tests. • Joint Serial Notification limited) PPORD: Process and Product • for PPORD,1-10t/a (2-year validity) Orientated Research & DevelopmentNotification 8-18 Months 5-10 Months(general case) 14 workdaysDuration (largely dependent on testing arrangements: 2-3 Months (special case) Tier 4 may need much more time) Complication indicator documents | data | procedures
  14. 14. 2 Complication indicator Dossier and submission material documents | data | procedures Regular notification Simplified notification SRRN Notification Application Form Notification Application Form Notification Application Form + Research information Compliance statement (special case) English and Chinese chemical name Scientific Record Form Scientific Record Form (general case) + • Test reports/data (Phyiso-chemical, Eco-toxic test reports (general case) Testing institute information toxicology & eco-toxicology) (1-3 tests) • C&L for hazardous substances (China Phyiso-chemical data GHS)  Melting point • Risk Assessment Report(since 1t/a)  Water-solubility • SDS…  Partition coefficient noctanol/water  Tests required according to different Data acceptable indicator Data could be secured from testing Data sources acceptance by MEP tiers; institutes out of China but preferred being  Phyiso-chemical and toxic data could be Accreditation proof of lab generated from GLP labs, following OECD Laboratory test report secured from testing institutes out of provided methods (preferred): Data from SDS could China but preferred being generated be also acceptable from GLP labs, following OECD methods Full official document will be Publish literature  Some eco-toxic data must be generated Eco-toxic data within China accepted only by MEP-accredited Chinese testing  Ready biodegradation (only for organic) institute* with Chinese organism  Acute toxicity test for fishes Details on the database required Database  Acute toxicity test for earthworm name, publish institute, edition etc.  Eco-toxic data generated by MEP- Models, parameter, developing QSAR accredited Chinese testing institute with unit, edition, effectiveness provided Chinese organism;  No data requirement for special case Profile of expert is a must; statement Expert only as supplemental supportUseful link: 10 (8+2) MEP-accredited testing institutesThe list of MEP-accredited Eco-toxic testing institutes
  15. 15. 3 Submission and certification Regular notification Simplified notification SRRN • Application form &Hazardous • Online submission software • Online submission softwareEmail or CD classification form (only in simplified Chinese) is (only in simplified Chines) is the only accepted submission the only accepted submission or • Test reports required and risk method since Jan 2012 Online method since May 2012 assessment report, SDS & label + • Printed Application form with stamp and signature • Original copy printed through • Original copy printed through Hard • Other necessary documents the submission software shall the submission software shall Hard copy be submitted with stamp and copy (POA, authorization letter if a be submitted with stamp and foreign company appoints 3rd signature as well signature as well party to carry out notification) Submit to CRC-MEP Submit to CRC-MEP Submit to CRC-MEP 1 Regular notification through General case through 2 Expert Committee review Expert Committee review Reviewed by MEP and decided to approve (much time consumed) 3 • Notification number • Notification type • Regular notification- Valid since date of issue till • Certificate holder (Foreign Notification Certificate being listed in IECSC after 5 years. company is presented) Issued by MEP for Simplified and • Simplified notification – Valid since date of issue • Notifier regular notification till the certificate cancellation applied for or • EN & CN chemical substance name repealed by the holder. • CAS# • Post-notification obligation shall be fulfilled to remain the validity of the certificate. Online Public Announcement For Scientific Research Record Notification (SRRN)
  16. 16. China New ChemicalsPost-notification obligationDetails of notification procedures will be unfolded at each stage. Preparation Notification Post-notification IECSC inquiry Submission & Notification Certificate Obligation will be fulfilled according to 3 different management categories based on “Guidance for Hazardous Identification of new chemical substances” HJ 154-201* to replace HJ/T 154-2004 Obligation indicator General new chemical substances More obligations put on New hazardous chemical substances New hazardous chemicals of priority environmental concern (NHCPEC) Useful link: HJ/T 154-201* (Chinese ver.) Guidance for Hazardous Identification of new chemical substances
  17. 17. Obligation indicator More obligations put on General new chemical New hazardous chemical NHCPEC substances substances 1 1 2 1 2 3 • Communicate MSDS to downstream users • Submit Annual Report (for previous • Submit report on disposal information year, submitted before Feb 01 each year) • Implement risk management measures • Submit substance flow chart • Comply with <<Measures for The • Do not sell chemicals to downstream users Administration of Registration of • Submit annual plan (for next year) who are not capable of implementing risk Hazardous Chemicals>> SAWS order 53 management measures • Submit first-activity(manufacture or import) 2 3 report • Keep documents on file for over 10 years The categories of “new hazardous chemical substances” and “new hazardous chemicals with priority environmental concern” are decided according to • Submit updates if new hazard arises evaluation of substances through regular notification or simplified notification (general case) given by expert committee based on HJ/T 154-201. 1General substances will be listed in IECSC after 5 years Hazardous chemicals (with priority concern) will be decided to be included bysince the first activity. the 5-year activity report submitted 6 months before the 5-year duration.Substances through SRRN or Simplified notification will In pursuant of Decree 591, new chemicals with hazardous properties shall beNOT be listed in IECSC automatically. registered, and the competent authority is NRCC-SAWS . Additional information: Annual Report Guidance on Annual Report of New Chemical Substances (Trial | En)
  18. 18. China New ChemicalsRoadmap of Order 7It will be a long way before stricter enforcementimplemented, but you have to remain alert on that. LastPage of MEP Order 7 Fully inspection & MEP Order 7 published Improving and progressing enforcement Currently The authority is now being much stricter with assessment and verification of notification submitted. What is the focus for now? Enforcement Milestone • Improve the internal work flow MEP, CRC-MEP, local MEP Order 7 came into • Consolidate the communication with active notifiers for better mutual understanding Environmental Protection Bureaus. force on 15 Oct. • Erase the unclear points in the regulation, and make it “applicable” and “unambiguous” 2010, replacing SEPA Order • Guidance and supportive documents like: Short in man power and 17 in 2003 Guidance on Risk Assessment Report experience, that will need more Guidance for Hazardous Identification of new chemical substances time to be changed. Measures on Expert Management for Chemical Environmental Management Notice Case 1: Generic name of a serial products Penalty: • 10,000CNY-30,000CNY Case 2: Plant extract – whether a plant • Repeal certificate extract shall be notified only for itself (but “Mild” punishment purification seems difficult); or notification of plant extract in a solvent is allowed
  19. 19. China Hazardous ChemicalsOverview of the legislation framework SAWS Order 53 and MEP Order 22 (Comes into force Mar 2013) SAWS Order 57 REACH24H Consulting Group GlobalChem 2013
  20. 20. China Hazardous ChemicalsOverview of HazardousChemical legislation Catalog of Hazardous Chemicals (China Classification & Labeling (C&L) inventory) Registration System SAWS Order 53 | MEP Order 22 (SEPA Order [1994] NO.140 | MEP Notice [2009] NO.113)State Council Decree 591 Permit for (SAWS Order 41, SAWS Order 55 and SAWS Order 57)Regulations on the Control over Safety of Permit & License Manufacturer | Importer | Operation | Distributor & storage | Transporting | UserHazardous Chemicals (top law) China GHS Leave to the 3rd part Dec 2011 SAWS Order 41 Measures for the Administration of Hazardous Aug 2012 SAWS Order 53 May 2013 SAWS Order 57 Chemicals Safe Production Measures for the Measures for the Permit Administration of Registration administration of Hazardous of Hazardous Chemicals Chemicals Safe Use Permit Feb 1987 Mar 2002 Decree 344 2011 Decree 591 Sep 2012 SAWS Order 55 Mar 2013 MEP Order 22 Regulation on the Safe Regulation on the Control Regulation on Safe Measures for the Measures for Environmental Management of over Safety of Hazardous Management of Hazardous Administration of Hazardous Management of Registration Hazardous Goods Chemicals Chemicals Chemicals Operation Permit of Hazardous Chemicals Invalid Invalid Issued Came into force Came into force Came into force Come into force Come into force 1986 2002 2011 Dec 01 2011 Aug 01 2012 Sep 01 2012 Mar 01 2013 May 01 2013
  21. 21. China Hazardous ChemicalsState Council Decree 591Hazardous chemicals are administrated through a complexregulatory network in China, with more than ten ministriesinvolved. As the key legal document, Decree 591 sits at thetop of this structure. English ver. available onChemlinked.com Who will be the enforcement The specific responsibilities ? bodies? SAWS: • Implementation of registration of hazardous chemicals; MIIT (Primary authorities) • License system (Order 41 Order 55 Order 57 – manufacturing; operation; use) NRCC-SAWS + SAWS MEP AQSIQ: MOT • Implementation of registration of hazardous chemicals; Each enforcement body • Implementation of enforcement actives over packaging and SAIC will be responsible for storing of hazardous chemicals; also the QS license(license specific part. for industrial product manufacturing) MOA MPS MPS: AQSIQ • License of purchase of extremely toxic chemicals ; • Permit of transport of extremely toxic chemicals on road; SDPC
  22. 22. China Hazardous ChemicalsWhose obligation? Who will be affected by the ? Decree 591? What actions shall be subject to ? the Decree 591 Manufacturer in China Production Use Importer in China Sales and storage Transportation Only Chinese companies Distributor and storage company will be affected directly. Transportation company in China It will affect the whole supply chain Chemical user in China
  23. 23. China Hazardous ChemicalsWhy Decree 591 also mattersto foreign companies? On one hand, even though your company is located far away from China Mainland, the suppliers or importers of hazardous chemicals listed in the catalogue in China will have to 1 face even stricter inspection of the enforcement authorities. So get to know whether your business partners have been aware of the responsibilities they shall fulfill in pursuant of SAWS Order 53. It is a domestic law, then why it ? matters to overseas enterprises? One the other hand, because the implementation of China GHS draws extremely high 2 attention of the competent authorities, companies outside China shall pay much more attention to their preparation of GHS compliance, especially classification, labeling, SDS and packaging instead of roughly doing translation or simply ignoring differences of standards applied from area to area.
  24. 24. China Hazardous ChemicalsCatalog of Hazardous ChemicalsThe to-be-released new Catalog of Hazardous Chemicals 7000+ Inventory of Hazardous Chemicals(China C&L Inventory) is the spirit of China GHS. (China C&L Inventory), first batch of 4,000 chemicals might be released around Jun. (But with no classification this time…) To be updated 3800+ 335+ Extremely Toxic chemicals (2002ver.) synthetic substances & mixtures(agrochemicals) • came from Catalog of Hazardous Chemicals (2002). • This is a domestic rule, import and export of What are the hazardous The current Catalog of Hazardous those toxic chemicals are not in the scope ? chemicals under Decree 591? Chemicals came up with Decree 344 + • Under Decree 591, Art (23) (24) (25) (35) (38) (39) (40) (48) (50) has regulated the Those chemicals have been defined as production, use, sell and “highly toxic chemicals” or other chemicals purchase, transporting of extremely toxic with toxic, corrosive, explosive, flammable chemicals and other properties, which will do harm to people , facilities and environment. C&L Inventory from EU, Japan will also be Out of scope (under specific control laws) referred to for the update of the new Catalog - explosives for civil use ; - fire cracker, fireworks; Hazardous chemicals or those with priority environmental concern under MEP Order 7 may - radio-active substances; likely be one source where the new Catalog of Hazardous Chemicals come from - dangerous chemical for national defense; in the future Additional information: Additional information: 335 toxic chemicals: Company holding safe 3800+ Catalog of Hazardous Chemicals (2002rev.|EN) 335 Extremely Toxic Chemicals(2002rev.| EN) production, operation, use permit (SAWS Order 41 55 57) to conducting purchase.
  25. 25. China Hazardous ChemicalsWhat new Catalog looks like?The new catalog(China C&L Inventory) will be specific, more elementsintroduced. “In the new version of Catalog, the chemicals will come with the information and hazardous properties .” New Version to be New Catalog of Hazardous Chemicals published (China C&L Inventory) Product name Other name English name Other EN name CAS# UN# Hazardous classification GHS pictogram Signal word Hazardous statement Remark 7000+ Current version 2002 Current Catalog of Hazardous Chemicals 3800+
  26. 26. China Hazardous ChemicalsEmergency Response CallA question everyone will ask. ER call has been a must for registrationof hazardous chemicals (Art.22 SAWS Order 53), China GHS-compliant Keep these in mindSDS and label. Last page of overview of Decree 5911) For companies those are planning ER Unit on their own• ER call should be a Chinese landline; 24h on-duty• designated staffer as 24h supporter; Chinese• staffer should be well trained with competent capabilities of hazardous chemicals handling; Landline +2) Other companies shall appoint accredited agent to handleER responsibilities.Importers of hazardous chemicals shall set up ER unit or commit the preparation of Designated-&ER work to import agent or registration institutes. As we have noticed there is only -trained staffone qualified 24h ER call institute (NRCC- SAWS Order 53 Art.6(4)) located in Chinaso far till now. Or3) Penalty: <30,000CNY for failure in preparation of ER call.We have been aware that NRCC will take random inspection over the ER call installation. Hand this to service provider Useful link: NRCC emergency response call http://er.nrcc.com.cn | t: (+86) 0532 8388 9090
  27. 27. Registration systemOverview of SAWS Order 53 (I) Registration onlineMeasures for the Administration of Registration of Hazardous Chemicals. Thisnew regulation specifies the procedures of registration of hazardouschemicals, and stresses the implementation of China GHS. English ver. isavailable on chemlinked.com • Manufacturer of hazardous chemicals in China • Phyiso-chemical and hazardous properties; • Importer of hazardous chemicals in China Focus • Classification and labelling; Who Chemical users or storage companies of hazardous chemicals on • Storage condition, safe use &transport; affected have been released from registration obligation under this new • Protection and emergency response; order. • Main uses & restricted uses Competent NRCC-SAWS | SAWS AuthorityOct 2002Measures for the Administration of 2012 SAWS Order 53Registration of Hazardous Chemicals by Measures for thethe former State Economic Trade Administration of RegistrationCommission (now integrated in the of Hazardous ChemicalsMinistry of Commerce) Invalid Issued Came into force 2002 2012 Aug 01 2012
  28. 28. China Hazardous ChemicalsRegistration systemOverview of SAWS Order 53 (II) • Catalog of Hazardous Chemicals • Build files for hazardous chemicals; What 3800+ chemicals (version 2002) to be re-issued or know as China C&L Inventory Registrant • Register hazardous chemicals & accept inspection; • Designate staff to be responsible for registration;chemicals obligation • Entrust qualified institutes to conduct hazard • Chemicals not subject to the Catalog but with hazardous classification identification; by accredited institutes • Set up 24h emergency telephone consultation. Specific guidance will be published later for hazardous identification and classification 1) List of chemicals of required for hazard identification and • A Company producing and importing same hazardous classification(unavailable) chemicals shall register as manufacturer, providing the 2) Measures for the Administration of hazardous identification and classification Notice information of the imported hazardous chemicals. update: Measures on the Management of Physical Hazard Identification • An importer importing same hazardous chemicals from and Classification for Chemicals and more practical guidance will be given different manufacturers shall register chemicals of the 3) Accredited institutes manufacturers for its first trade , and furthermore provide • For physical hazards identification: 2 Labs (one attached to NRCC) the information of such chemicals from other • For toxic hazards identification: 20 MOA-accredited labs manufacturers. • For eco-toxic hazard identification: 9 MEP-accredited labs • Manufacturers and importers importing same hazardous chemicals from the same manufacturers for many times shall only register the chemical once. Useful link: Measures for the Management of Physical Hazard Identification Source: officer from NRCC-SAWS and Classification for Chemicals (chemlinked.com)
  29. 29. China Hazardous ChemicalsRegistration of Manufacturerunder SAWS Order 53 Content of registrationKey points of registration to be carried out by a manufacturer • Information of manufacturer (the registrant)of hazardous chemicals 1) Extremely toxic chemicals (the list of 335 substances) 2) Hazardous Chemicals under Priority Management (2 batches, 13 chemicals in the 2nd batch have been published formally on 10 Feb 2013) Prior to the final acceptance of a  List of produced chemicals (all chemicals in one certificate) When newly-built chemical plant  Identification of source of major hazards to register  Identification of priority-management process of hazardous chemicalsManufacturer: • 2 original copies of Registration form of • Information of each hazardous chemical (core)Companies make concentrated hazardous hazardous chemical producer/manufacturer; 1) information of chemical • Business license of registrant; What to be 2) the manufacturer of hazardous chemicals importedchemicals. However, hazardous chemical • 1 copy of SDS and China GHS-compliant 3) compositionpurchasers, repacking or dilute it with non- submitted 4) classification & labeling (hazard category, pictogram, Precautionary Label (GB 15258-2009);hazardous solvents are not considered as • Emergency response call number (Art.22 SAWS warning signals, hazard statements, precautionary statements)manufacturer Order 53) or 1 copy Emergency service contract; 5) physic and chemical properties • Product standard of the hazardous chemicals to 6) main uses and advised uses against be registered (national standard-GB or industrial 7) hazardous properties (physical hazards, health hazards & standard to be provided) environmental hazards) 8) occupational exposure limits in working place 9) storage conditions and transportation information 10) protection measures and emergency response Useful link: Useful link: The interpretation of registration form for manufacturer and importer List of Hazardous Chemicals under Priority Management (2nd Batch) (chemlinked.com) of hazardous chemicals in China
  30. 30. China Hazardous ChemicalsRegistration of importerunder SAWS Order 53 Content of registrationKey points of registration to be carried out by an importer • Information of downstream user of chemicals importedof hazardous chemicals or Information of trader of chemical imported 1) Extremely toxic chemicals (the list of 335 substances) When 2) Hazardous Chemicals under Priority Management Prior to any importing activities to register  List of imported chemicals (all chemicals in one certificate)  Identification of source of major hazards  Identification of priority-management process of hazardous • 2 original copies of Registration form of hazardous chemicals (only for downstream user or companies with storage chemical producer/manufacturer; facilities) • Business license of registrant and 1 copy of anyImporter (trader or downstream of following document or certificate: What to be • Information of each hazardous chemical (core)  Foreign trader registration certificate or submitted 1) Information of chemicalchemical user)  Import and export enterprise qualification certificate 2) the manufacturer of hazardous chemicals imported• Companies have secured business or 3) composition licenses and the certain documents  Foreign investment approval certificate; or 4) classification & labeling (hazard category, pictogram, or certificates, being allowed to  Hong Kong and Macao and overseas Chinese warning signals, hazard statements, precautionary statements) conduct importing activities of investment enterprise approval certificate. 5) physic and chemical properties hazardous chemicals. • 1 copy of SDS and China GHS-compliant Precautionary 6) main uses and advised uses against• For chemical user after importing Label (GB 15258-2009); 7) hazardous properties (physical hazards, health hazards & activities, company will put • Emergency response call number (Art.22 SAWS Order environmental hazards) hazardous chemicals into industrial 53) or 1 copy Emergency service contract; 8) occupational exposure limits in working place • Product standard of the hazardous chemicals to be 9) storage conditions and transportation information production. registered (national standard-GB or industrial standard 10) protection measures and emergency response to be provided)
  31. 31. China Hazardous ChemicalsRegistration procedureunder SAWS Order 53In this section, let’s go through the registration procedure for importer ofhazardous chemicals under Order 53. Legal liabilities Step1 Step2 Fail Fail • Fail in registering Notice of rejection of registration Notice of rejection of registration • Fail in updating information of application application hazardous chemicals or new hazards Fine:<50,000 or Registration Registration 50,000-100,000CNYApply through online office Submit hardcopies of office NRCCregistration software (provincial registration materials (provincial level) Final check Registration Certificate (NRCC) level) to registration office format check Validity period: 3 years • Fail to provide ER number or format check at provincial level • Remain the information on the certificate unqualified ER service up-to-date (update online within 15 days • Fail to update information of when changes occur) registrant, ER number, company seat • Extend the certificate after 3 years (apply • Fail to apply for extension as 3 work days 20 work days 15 work days for verification of extension of certificate certificate expires online 3 months before it expires) • Forge certificate etc. • Illegally obstruct enforcement activities and inspection Useful link: Fine:<30,000 CNY Online registration software (NRCC-Chinese only) Chrome “Adblock plus” may block the pop-out tab
  32. 32. China Hazardous ChemicalsSupportive documentsThis page is just for your reference. SAWS Notice [2012] No. 144 Registration form of hazardous chemical 1 producer/manufacturer 2 major supportive 8 Registration form of hazardous chemical importer documents Doc. 2 (Sections to be finished by trader & downstream user separately) Oct.17 2012 • Application form of subject registrant 3-8 • Application form of registration modification • Evidential document of registration modification (no registration certificate to be re-issued after modification) • Application form of registration certificate renewal (certificate expires) • Notice of rejection of registration application • Notice of requesting supplementary materials Useful link: NRCC Consults on 8 Supporting Documents for SAWS Order 53 (chemlinked.com)
  33. 33. China Hazardous Chemicals Roadmap of Order 53 Brief the plans of the authority for the registration and management of hazardous chemicals. Last Page of SAWS Order 53 Currently Look into future Supportive documents, tons of guidelines Registration officers to be trained with necessary Complete the procedure of registration and post- to be published (8 documents and more) knowledge – GHS, data evaluate, procedure (Mar registration (review and renewal) 2013) Heavy workload of online registration Guidance for the registration of substances & New database of hazardous chemicals is planned system optimization mixtures with unknown hazardous properties to be established within 3 years in the future The registration of hazardous chemicals is promoted The implementation of hazardous identification for mainly amongst Chinese importers at the 1st stage chemicals with unknown hazardous properties Source: officer from NRCC-SAWS No clear timeline for the implementation of plan above specificallySAWS Order 53 is different from
  34. 34. another registration regulation MEP Order 22 Registration system Overview of MEP Order 22 (I) Measures for Environmental Management of Registration of Hazardous Chemicals. Taking existing hazardous chemicals • Manufacturer and user of hazardous chemicals in China Focus the managementis available on chemlinked.com of general hazardous under control. Englishtoxic chemicals and chemicals with ver. Who • Importer and exporter of toxic chemicals in China (foreign chemicals, companies qualified under MEP Notice [2009] No. 113) on higher hazardous properties against human health affected Application scope is to be confirmed. However, in Art.2 of MEP Order 22, it and environment. Some content may be also indicates that only companies located in China will be subject to the law; shared with SAWS Order 53 Useful link: Competent MEP Order 22 vs SAWS Order 53 (chemlinked.com) CRC-MEP | MEP Authority 1994 SEPA Order [1994] 140 1994 SEPA Order [1994] No.140 2009 MEP Notice [2009] No.113 2012 MEP Order 22 Regulation of Environmental Revision of Regulation of Notice of the Environmental Measures for Environmental Management on the First Import Environmental Management on the Administration of Registration of the Management of Registration of of Chemicals and the Import and First Import of Chemicals and the Import and Export of Toxic Hazardous Chemicals Export of Toxic Chemicals Import and Export of Toxic Chemicals (practical guidance on Order 140 and Notice 113 to be Chemicals toxic import & export registration) incorporated into MEP Order 22 41 items revised May 01 1994 ]= Valid No regulations for Valid Issued (Trail) Come into force production or use of SEPA replaced by MEP Jan 2 2003 toxic chemicals SEP 2009 Oct 2012 Mar 2013
  35. 35. China Hazardous ChemicalsRegistration systemOverview of MEP Order 22 (II) What Refer to extremely toxic chemicals Only the regulation of MEP Order 22 has Supportive been published, other guidance or and other chemicals listed in Catalogchemicals of Hazardous Chemicals. documents supportive documents are still absent. Manufacturer and user of Importer and exporter of toxic chemicals hazardous chemicalsCatalog of Hazardous Chemicals List of Toxic Chemicals Severely Restricted to• General hazardous chemicals be Imported into or Exported from China 3800+ chemicals (version 2002) to be re-issued 158 chemicals (version 2012) for 2009 MEP or know as China C&L Inventory but not listed in Notice [2009] 113 “Notice of the Environmental HCPEC list. Administration of Registration of the Import and• Hazardous Chemicals of High Priority Export of Toxic Chemicals” Concern (Currently more important) Chemicals listed in the New Catalog will be Notice: through assessment according to the certain Under SAWS Order 53, before import of these 158 benchmark of hazardous and environmental toxic chemicals, a Chinese importer should be risk level and later be decided as HCHEC or not. register them by submitting application to NRCC- Chemicals like PBT, vPvB, EDC or seriously SAWS as well. CRC-MPE is mainly taking in charge environmentally-hazardous chemicals with of the management of those 158 toxic chemicals solid evidential proof will mostly be treated as HCHEC (This list will be published by MEP) Useful link: Additional information: 158 chemicals Chinese Official Clarifies Must-Know Issues on MEP Order 22 List of Toxic Chemicals Severely Restricted to be Imported into or Exported from China (chemlinked.com)
  36. 36. China Hazardous Chemicals Obligation of each role in one table Under MEP Order 22 Role Chemicals Registration & License Materials prepared Related Responsible regulation authorities Application form of registration certificate; registrant information; produced or used EIA: MEP will issue guidanceManufacturer & General hazardous Registration Certificate of hazardous chemicals including quantity; MEP Order 22(Trial) Local environmental for EIA operationUser of hazardous chemicals (in Catalog environmental management of classification; SDS; prevention and control under Decree 591 protection authorities Environmental monitoring of hazardous hazardous chemicals measures; emission of the typical pollutants; (County level)chemicals report: shall be generated chemical) Environmental Impact Assessment(EIA); contingency plans for emergency; disposal; by the applicant or the annual report (Jan each year) to public on hazards, qualified environmental emission of pollutants, protection measures; monitoring agency Environmental monitoring report Annual report: For Addition to the material required from general manufacturer or user ofManufacturer & Registration Certificate of hazardous chemicals; Environmental Risk MEP Order 22(Trial) Local environmental HCPEC to submit before JanUser of hazardous HCPEC environmental management of Assessment(ERA) conducted by qualified under Decree 591 protection authorities 31 each year to the hazardous chemicals institutes; Annual report of emission, migration (provincial level) administration ofchemicals and monitoring result of particular pollutants, and Environmental Protection at protection measures against pollutants and county level. environmental risks Importer and exporter of • Registration Certificate for • Application through CRC software + other toxic chemicalsImporter and Toxic Chemicals environmental management on documents submission MEP Notice [2009] CRC-MEP (a foreign company couldexporter of toxic Severely Restricted to Import (and export) of Chemicals • Materials are different according to foreign NO. 113 & MEP do registration on their own be Imported into or & Import release permit for importer companies; importer as user; importer as In future MEP Order or appoint Chinesechemicals Exported from China • Export release permit for exporter trader; importer as representative of foreign 22 importers to finish it on companies: their behalf) Useful link: MEP Order No 22: A Big Step but Long Way Ahead (chemlinked.com)

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