Chinese Regulation Guidance May 23

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Helpyouknowit China REACH | Hazardous & Toxic Chemicals | GHS | Disinfectant + ….

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Transcript of Chinese Regulation Guidance May 23

  • 1. HelpyouknowitChina REACH | Hazardous & Toxic Chemicals | GHS | Disinfectant + .

2. HelpyouKnowitIt is complex, but no need to worry Chemical-regulation related departmentsMai Fung| Chemical Regulatory Affair SpecialistSpecial thanks to the contribution ofCora Knutson | Craig Deegan | Chris Maes | Li Hou 3. HelpyouKnowit>> ContentRecent update> Order 7 by MEP (not applied in Hong Kong neither Macao) Updated on 29 Feb 2012Notification of New Chemicals> State Council Decree 591(not applied in Hong Kong neither Macao)Updated on 16 Dec 2011Existing Hazardous Chemicals> China GHS, SDS and labeling (GHS label and Transport label) Updated on 19 Apr 2012(GHS | SDS | Label)A unified path but on its half way> Hazardous Chemical of Import & Export Updated on 07 Mar 2012AQSIQ implements inspection and enforcement> 158 Toxic Chemicals restricted from Import & Export Updated on 06 Mar 2012MEP released the 2012 version of the catalog of restricted toxic chemicals> SFDA: cosmetic products notification in China In Progress since 2 May 2012Cosmetics regulations in China (Part I: Finished Imported Cosmetics)> Order 27 by MOH Updated on 18 May 2012Disinfectants regulations in ChinaLinkedin meWhat will come soon? New information of tests for New chemical notification (Order 7) is being prepared [email protected] Narration is considered to be added in this presentation material 4. HelpyouKnowit>> Key updatesMay 18 12China Disinfectant Product regulation A briefing introduction of the Disinfectant laws in ChinaChina DisinfectantProducts New slides added on 23/05 Extension of Disinfectant Product Hygienic License Reissue or modification of Disinfectant Product Hygienic LicenseApr 19 12Overview of China GHS & SDS China GHS & SDS More added to complete these parts (Transport symbol) Mar 30 12Newly-added slides China GHS label How to practically handle the GHS label on different types of packages in China 5. The top rankState Council All the departments would be involved in someThe Ministry parts of the regulations either New Chemical Notification(Order 7 by MEP) or Decree 591 by SC MEPMinistry of Environmental Protection MoHMinistry of Health MoRMinistry of Railways MoAMinistry of Agriculture MIIP Ministry of Industry and Information Technology MoTMinistry of Transport MPSMinistry of Public Security MOHMinistry of HealthThe State Administration State Administration of SAWS Work Safety of State Council General Administration of Customs Customs of China HelpyouKnowit General Administration of Quality Driving Green Chemical AQSIQSupervision, Inspection and Quarantine In charge of local CIQ 6. Regulation Releasing and Management LeadingMajor Inspection and Enforcement State CouncilRegulation releasing MIIPMoH MEP MoR MEP Local MEP MoT MoASAWSSEPA(State of EnvironmentalProtection Agency) became MEP in2008, and the latter one is short for MPSThe status of Administration isMinistry of Environmental Protectionlower than Ministry, although theyare in charge of critical specific areas.Pollution preventionSAWS Division(-MEP)CustomsChemical Registration National Registration AQSIQ Center (-MEP)Center for Chemical (-SAWS) Local CIQ of AQSIQHelpyouKnowitDriving Green Chemical 7. CHINAREACHOrder 7 by MEP > HelpyouKnowit Driving Green Chemical 8. NEXTPAGE >China REACH is not a proper nameChina REACH is just a name that helps you to quickly understandOrder 7 by MEP or Environmental Administration of New ChemicalSubstances in China should replace the current name as China REACHUnlike EU REACH: China REACH: Order 7 by MEP for new the EU REACH program (where there is pre-registrationchemicalsrequirements and then submission of dossiers by a certain date,Make an enquiry to the authority for the confirmation whether thefollowed by government assessment of a small fraction of chemical substance is new or not; the complaint implementation would be different dependent on tonnage band or according tothose submitted dossiers, and authorization/substitution of some detailed requirements. Limited data is required as wellsubstances deemed to be of concern)>> By Karen Levins from Intertek CantoxNew Chemical (similar to Non phase-in substance)Non-Phase-in substancePhase-in substance Existing chemical (especially hazardous chemicals) The management may be involved in data requirements, testing data r, risk assessment report required, national standard of risk assessment is being drafted and discussion >> By Xiao (X) Zhang from Dow Corning Existing chemical(similar to phase-in substance)HelpyouKnowitDriving Green Chemical 9. NEXTPAGE >Order 7 by MEP is New SEPA changed to MEP Order 17 changed to Order 7 .Order 7 by MEPEntered into force 15 Oct 2010Order 7 by MEPIssued 19 Jan 2010Order 7: Revision of Provisions on theEnvironmental Administration of NewChemical Substances in China XOrder 17 by SEPA 15 Oct 2003Entered into forceOrder 17: Provisions on theEnvironmental Management of NewChemical Substances in China 7 years HelpyouKnowit Driving Green Chemical 10. Updates on 05 Dec 2011NEXTPAGE >Notification under Order 7 matters to you & your BusinessNo Notification, No MarketYour new substances shall be prohibited in China without notificationSevere punishmentIf a new substance notification failed to be submittedThe company will be warned, fined and even forced to closeAnd not be allowed to submit notifications within next 3 years;It also matters to the environmentWhether a new substance has been notified is a crucial aspect of environmentalimpact assessment, so please do obey the rules HelpyouKnowit Driving Green Chemical 11. Updated on 29 Feb 2012 NEXTPAGE >Step by stepTo evaluate if you have been affected by the regulation beforeyou start your complianceWho are affected What substancesComplyare newWhether your productsWhether those chemicalsIf you do have been affected,have be affected because of some chemicals are new in Chinathen learn how to comply with it HelpyouKnowit Driving Green Chemical 12. Updated on 29 Feb 2012 NEXTPAGE > A chemical regulation on New Chemical SubstancesThe new rule clearly specify what should be regulated and taken under control What would be regulated in the scope of Order 7 by MEP New Chemicals (Not in IECSC) A New Substance itself New substances in Preparation New substances in articles intended to be released ----------------------------------------------------- New substances used as ingredients or intermediates for producing Pharmaceuticals Pesticides Veterinary drugsPlease be informed, we are now confirm TGAI(Technical Grade Active Ingredient) and technical are not in the scope of Order 7 by MEP, because the use of those products have Cosmetics been identified as pesticide products. Food additives Feed additivesIECSC: Inventory of Existing Chemicals Substances- 45,602 existing chemical substances (till Dec 7 2010) Where to find IECSC in Englishhttp://www.crc-mep.org.cn/iecscweb/IECSC.aspx?La=1HelpyouKnowitDriving Green Chemical 13. Updated on 29 Feb 2012NEXTPAGE > A chemical regulation on New Chemical SubstancesSome categories of chemicals may benefit from exemption from this law Exempt fromChemical substances or related productsthe Order 7 by MEP Radioactive substances, military industry products, pyrotechnics, biotic substances, Category 1: pesticides, veterinary drugs, pharmaceuticals, cosmetics, foods, food additives, feed, Products subject to other existing regulationsfeed additives, tobacco and tobacco products. 1. Chemical substances unprocessed or only processed in the ways below Category 2: 1) Manual; 2) Mechanical; 3) Gravitational; 4) Soluble in water; 5) Floatation in water; 6) Substances exist in natureHeat dehydration. 2. By any means, substances extracted from the air 3. Natural polymer with no chemical modification 4. Biomacromolecule like RNA, DNA or protein Chemicals for Non-commercial purpose or chemicals unintentionally produced Category 3: 1. Impurity, produced from raw materials or secondary reactions. One single of those Substances of noncommercial purpose or unintentionally produced impurities in final products should not be over 10% w/w, all impurities in final products should not occupy over 20% w/w 2. Chemical produced from reactions 1) new chemicals from random reactions 2) new chemicals produced from random reactions between chemicals, mixtures or articles in storage 3) new chemicals produced from random reactions between chemicals, mixtures or articles in final use (unintentionally) 3. Waste water, gas or solid waste or other by-products Category 4: 1 Material: Glass; .Frit; Pottery raw materials and ceramic ware; Steel and steel products; High-alumina cement; Portland cement; Substances of special categories 2. Homogeneous and heterogeneous alloys, except for metal compounds and precisely defined intermetallic compounds 3. Non-isolated intermediates 4. New chemicals in Articles expect 1) new chemicals intentionally released from the final articles 2) new chemicals intentionally released from the final articles in use (quite the same as the definition under EU REACH) 14. Updates on 03 Dec 2011 NEXTPAGE > Notification body like EU REACH, only within ChinaWho shall and who is not obligatedOut of China MainlandChina MainlandHong Kong & Macao are not affectedby this law Chinese NA* Subsidiary 1 of Foreign Companies Foreign Companies Manufacturers Selling new substances to China of New Chemicals Importer of New Chemicals or Companies hope to change the registered uses of New Chemicals Notification not requiredNotification required * Notification Agent= NA Notify on behalf of Foreign companies The uses under Priority hazards for environmental management on IECSC 15. NEXTPAGE >What the notification Process looks like?Different RolesProcessMEP MEP issued Order 7MEP decides the resultsCatalog of HazardousChemicals (SAWS) Ministry of State CouncilMEP takes charge of managementNew hazardous chemicals classified Hazardousand Priority Environmental Management of MEPWould likely be included Catalog of HazardousChemicals of SAWSTechnical evaluationTaskforce for Evaluationprovide Feedbacks Receive Registration Application CRC-MEP Formal Check of submitted documentsCRC Notification Result Every 6-month reported New chemical classified: - General (5 years before included in IECSC) - Hazardous (Pending and Evaluation) +86 10 8491 765 6 - Priority Environmental ManagementCall for technical supports from CRC Local MEP InspectionSubmit related dossier and data9 qualified labs in China for eco-toxic Search through IECSC portal Notification Bodyto find your substance in the list or not Make enquiry for 3166 confidentialSubstances (22Euro or 30USD) Confidential substance: another database to help define substance 16. Updates on 29 Nov 2011 NEXTPAGE >Foreign companies choosing notification bodies strategicallyPlease be advised: choose the notifier carefullybe careful if you choose your Chinese customer(importer) as thenotifier instead of you, you may lose your upper hand because youhave to rely on them because of their notification certificates in China. Out of China Mainland China Mainland Role A : * Parent CompaniesRole B : Assigned by ANA Company 11 Service Providers playing as NA will serve Foreign companies* better. They are not involved in real business, but offer Belongs to A: ImporterPredominant technical supports and keep confidentiality.Factory Plant & Subsidiary 22 The Factories or Subsidiary Companiesapplying for certificateas importer will benefit more themselves when they sell or Belongs to A: Notification Agentmake purchase .Factory Plant & Subsidiary33 TheFactories or Subsidiary Companies assigned as NA will bePredominant allowed to notify on behalf of their Parent companies(Role A)But they have to meet NA requirements* as Role B. Role C: Notification BodyImporter and Manufacturer44 Your business partners, Importers or Manufacturers , as (business partner)notification body would hold predominant positions andRole D: Unqualifiedmore say throughout supply chains.Distributor X55If Distributors are not the direct importers of the substance,they are unobligated to complete notification . Who is the Certificate Holder? NAs name is Certificate Holder 13Role As name is Applicant *Predominant: - This is more about what Role A may benefit *NA requirements: - approx. 330,000euro registered capital (for more, please make requests) Importer(Manufacturer)s name is both 24Certificate Holder & Applicant 17. Updates on 14 Dec 2011 NEXTPAGE >Implementation- before notificationPreparation Notification Post-notification Preliminary StageNecessary CertificateStepsManagement What information needed during inquiry Company information Substance profile (CAS# | molecular formula etc.) IECSC Inquiry Typical Notification For confidential substances Some more information helps to decide 3 types of Notification (next page) No need for other information hereSimplified Notification The inquiry is submitted online, after payment. The result would be sent back as Scientific Research Record paper copy. 200RMB + (service charge by 3rd party consultant) No obligation under the law 18. Updates on 05 Dec 2011NEXTPAGE > 3 Notification types based on different casesTypical Notification >Simplified Notification>Scientific Research RecordTonnage band At or AboveAnnual Volume of New Chemicals Annual Volume of New Chemicals Criteriathe Annual Volume of 1 ton of New Chemicals Between 0.1 Ton to 1 Ton Less than 0.1 Ton (4 tonnage level) Divided into 2 partsUsed for scientific researchOther Criteria1-10 ; 10-100; 100-1000; over 1000tpa Basic condition and Specific conditionor the sample is to be lab tested in ChinaTime for4-18 Months 3-10 Months(basic condition)14 workdays Notification(largely dependent on testing arranged and 4-5 Months (specific condition) conducted) Remark For polymers containing less than 2% new Basic :chemical substance (w/w), if the polymer is planned to Specific: *Please be informed that:be included in the IECSC, then typical notification isa) New chemicals for export lower than 1tpaScientific Research Record is the necessary workrequired (not recommended)b) For scientific research with tonnage between 0.1before Typical Notification and basic condition to 1 ton per year of Simplified Notification because samples needc) For technological research with tonnage lessto be tested in China Low concern Polymer: than 10 ton per year Only chem-physic data for typical notificationd) For polymer consisting of monomers already Not Low-concern polymer:listed in IECSC Full tests for typical notificatione) for polymers containing less than 2% new chemical substance weight by weight Low concern condition: no quantity limit of such polymer imported No Heavy metala) for low concern polymers (if the polymer itself Not Soluble in water is not listed in IECSC);. Not Soluble in organic solvent Unstable in different PH solutionsFor Chemicals used for PPORD * to be notified, and Scientific Research Record could be started oncespecific case notification maintained valid within 2 years afterward the notification form submitted (other 2 not) Where you may find the required data for Notification: http://www.cirs.ie/China_Chemical_Regulation/Data_Requirements_New_Chemical_Notification_in_China_REACH.html Specific condition: A specific report for new chemicals (now developed by notification bodies on their own) PPORD: Product and Process Oriented Research and DevelopmentHelpyouKnowit Driving Green Chemical 19. Updates on 14 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Typical NotificationPreparation NotificationPost-notification Preliminary Necessary Steps Data & DossierCertificateStage The body of notification 4 Special formats of typical notificationManagement IECSC Tonnage level unrelated Serial NotificationInquiry -Similar substances notification at same timeJoint Notification- Co-notification(data or cost-share policy needed to be talkedbetween co-notification bodies) Repeated Notification- Notification by referring to the data owned by previousnotification bodies.HelpyouKnowit Re-notification- Notification for amount increased or uses changed; additionaldata required; old notification certificate replaced by the new Driving Green ChemicaloneFind more by contacting [email protected] 20. Updates on 14 Dec 2011NEXTPAGE >Implementation- Compliant guidance Typical Notification PreparationNotification Post-notification PreliminaryNecessary StepsData & Dossier SubmissionCertificateStageManagement The body of notificationIECSCData gap analysisYou need more attention to this work; it affects cost and time InquiryTesting Proposal Largely dependent on the capacity of the contracted labTesting arrangementLargely dependent on the capacity of the contracted lab Dossier generationDossier template decided by CRC, some information needed from company (like uses of new chemical) Spectrum Toxic data Eco-toxic data HelpyouKnowit1 Chem-physic data 2 3Driving Green Chemical 21. Updates on 14 Dec 2011 NEXTPAGE >Data & Lab- Must all data be generated in China? Typical Notification The data of 1st and 2nd category ispreferred being generated from GLP labs,following OECD methods if outside ChinaMostly Not Spectrum Toxic data Eco-toxic data 1 Chem-physic data 2 3 Part of data in the 3rd category is strictly required to be generated by 9 MEP-approved eco-toxic labs in China. We suggested more tests be carried out in China. Many companies would be worried aboutwhether data generated outside China Minimum testsaccepted.conducted1-10tpa Around 3 MonthsTests must bein China(At least )One Toxicity test for aquatic organismIt turns out that the data acceptance is not so & (Ready biodegradation)exclusive as its political system of this countrycarried out in Chinashowed in front of the western nations. MostRecommend:10-100tpa Around 3-5 Monthsstudies may be referenced if they were performedto accepted standards by a lab meeting MEP1-10tpa tests + inherent bio-degradation 14 days extended toxicity study in fish (about 3Months)requirements. + one of 3 optional tests Or Daphnia magna Reproduction study (about 4-5Months)Or Bioaccumulation (about 4-5Months)In some case, ready biodegradation would not be Please be informed again: necessary, if qualified tests generated outside China as Please be advised, at least one test must be picked betweensolid proof. So only inherent degradation needed all above 3 testsScientific Record is needed here since the sampleof the substance is imported for test in China 100+tpa- Around 6 Months1-10tpa +10-100tpa tests + chronic toxicityChronic toxicity test for fishestest for fishes9 Eco-toxic labs approved by the MEPhttp://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm 22. Updates on 14 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Typical NotificationPreparation NotificationPost-notification PreliminaryNecessary Certificate ManagementStage Steps MSDS and hazardous informationGeneral New Chemicals IECSC Notifycommunicated to downstream users Risk management measures conductedInquiry First-activity report submissionHazardous Registered information to be updatedNew Chemicals(tonnage level, uses, activity, theAuthorized Approvedby MEPholder of the notification certificate) Priority hazardous new Keep documents on file for over 10chemical substances foryears environmental New hazard to be updated if needed bemanagement Only downstream users who areRestrictedcapable of the implementation of risk For those 2, moremeasures allowed to buy productsobligations addedfrom the certificate holders. 23. Updates on 14 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Typical Notification5-yearNotification completed New chemicals Added in IECSC First activityUsing (sale) or Manufacturing of theHazardous New Chemicals(Authorization)+new chemical for the first time after its - 1st activity report + annual activity reportnotification in ChinaPriority hazardous new chemical substances 1stThe activity should be reported tofor environmental management (Restricted )- 1st activity report + each activity report +the MEP as the first date of 5-year5-yearannual activity report for the last year +period. (Report template given by MEP)annual activity plan for this yearThis period decided by the MEP is more like atransitional time after the first activity date beforenew chemicals allowed to be added in IECSC For general new chemicals, after 5 years, they wouldtriggered the action of being added in the IECSC automatically. For other 2 categories, Hazardous new chemicals, Priority hazardousnew chemical substances for environmental management wouldbe evaluated from multi-aspect during the 5 years. So the processcould be much more complex. 24. Updates on 31 Dec 2011NEXTPAGE > Implementation- Compliant guidance Simplified Notification > Basic Condition Studies requiredNotification duration: 5-10 Months Preparation Notification Post-notificationPreliminaryData & Dossier & Doc DevelopmentSubmissionAnnual Report to the authority: Stage Scientific Record Form Simplified Notification FormBefore 01 Feb The figures of the production of Test report notified new chemical substance IECSC Other information: ES, production process (annual tonnage, production days ); orInquirytonnage imported etc. Chem-physic data Eco-toxic data 12 The transfer information of the notified melting point within China water-solubility Ready biodegradationnew chemicals, including the overall Partition coefficient Acute toxicity test for fishestonnage of transfer and major n-octanol/water Acute toxicity test for recipients etc. in last yearearthwormTest duration: 4-6 Months The updated or renewed information9 Eco-toxic labs approved by the MEPof the notified new chemicalhttp://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htmsubstances during last year. 25. Updates on 31 Dec 2011NEXTPAGE >Implementation- Compliant guidanceSimplified Notification > Special Condition No Studies required Notification duration: 3-4 Months Acquiring certificateconsumes much timePreparation NotificationPost-notification PreliminaryAnnual Report to the authority:Stage Dossier and DocumentDevelopment Submission Before 01 Feb The figures of the production of notified new chemical substance IECSC Scientific Record Form Simplified Notification Form (annual tonnage, production days ); orInquiry Documents as proof of specific conditionOther information: ES, production process tonnage imported etc.Polymer: GPC The transfer information of the notifiedGel Permeation Chromatography new chemicals, including the overalltonnage of transfer and majorrecipients etc. in last year The updated or renewed informationof the notified new chemicalsubstances during last year. 26. Updates on 31 Dec 2011NEXTPAGE > Implementation- Compliant guidanceBring your doubts after reading the following pagesSimplified Notification > Special Condition No Studies requiredCase Study A Special case to know new substances in polymer Please remember, Polymer product Sep 2010 polymers containing less than 2% exempted from notification under Order 17 each new chemical substance weight by weight. ( later replaced by Order 7 by MEP ) Simplified Notification(Specific Condition) is enoughOrder 7 by MEP entered into force Oct 2010 1 year2%< A new substance in PolymerMonomer is less than 2% (w/w)Aug 2011Simplified NotificationPlease be advised:No tonnage limit on the import of such polymer product is required,so please consider about higher tonnage band during notificationPlease be noticed: One year of exemption transitional time has passed. 27. Updates on 31 Dec 2011 NEXTPAGE >Implementation- Compliant guidanceScientific Research RecordScientificPreparation Post-notification Research Record Preliminary For scientificStage research use only Scientific project starts Notification MaterialSubmission Development to be conducted Typical notification Laboratories conductIECSC Documents to be prepared: The Record Form (template offered) related tests for new Inquiry substances Simplified notification Attachments including license of basic condition notification companies and scientific research institutions (apply substances directly; test proposal The above 2 types of notification demand More than one substance notified together scientific record because allow to be covered in one scientific a sample is asked for research record testis 2 weeks 28. Updates on 17 Feb 2012 NEXTPAGE > About notification cost- you need to knowTo help you understand the structure of notification cost, and make it cost-effectiveCost breakdown MEP not charge for notification | Administrative fee IECSC search will be charged for a small amount of fee Companies who want to register new chemicals but located Local agent fee outside China need to appoint local service provider as notifier Test fee would take the largest part of your cost especially when 3% Test feethe cases fall into typical notification 17% Smart-cost tips Try saving test cost Be sure your notification type is correct: Test cost More information please refer to previous pages 3 Notification types based on different cases80% Reasonable data source is a key point: 80% (Dependent on specific cases) Avoiding unnecessary testing by taking advantage of referring to literature,some database or data resulted from QSAR, reading-across reference etc. Consider the lowest-required tests according to different notification types. Foreign companies may use GLP-generating data for notification using More information please refer to previous pagesData & Lab- Must all data be generated in China? Strategic arrangements of studies: basic studies first, then come the advanced Finish basic or compulsory studies, and then higher-level studies to be carried out; In some cases, based on the results from previous studies, higher-level studies would benefit from waiving. AdministrativeLocal agent service fee Test fee Source: Case- the applicant could firstly conduct skin corrosive study and if the result is positive, then 28-Eric Xiong from CIRS day repeated oral toxicity study could be waived, by which hundreds of thousands RMB for testing can be saved (from Eric Xiong from CIRS) HelpyouKnowit Special formats of typical notification may save you much money: Serial Notification -Similar substances notification for avoiding unnecessary tests on group substances. Joint Notification - Data or cost-sharing between co-notification bodies of the same substances. Driving Green Chemical (like Joint-submission of registration dossier under REACH) Repeated Notification - Notification by referring to the data owned by previous notification bodies (Like the game rule of LOA purchase under REACH) 29. Updates on 31 Dec 2011 NEXTPAGE > How we offer our helpNot just providing compliance work, we are also well known to your suppliers in ChinaPreparation1 1. Typical NotificationPreliminary Stage IECSC Search & Decide2. Simplified Notification 3. Scientific RecordNotification 2 Scientific Record Information collection The easiest notification document preparation Basic or Special Condition?Basic ConditionSpecific ConditionSimplified Notification+ Scientific Record Information collection Forms and documents and document Studies analysis and testspreparationproposal Notification dossier Eco-toxicology properties submission and followtests arrangement & upfollow up Dossier develop andsubmission; progressreport+ Scientific RecordTypical Notification Forms and documents preparation Data valuation, literature review, tests proposal Tests arrangements and follow up Dossier develop and submission; progress reportPost-Notification3& follow up 1. Preparation and Updating of information2. Keep contacting the local authorities, reporting necessary issues to fulfill obligation 30. Updates on 22 Nov 2011 NEXTPAGE >Please be advised-Way of Simplified Notification changed soonTransitional Time Till 31 Dec 2011Online Simplified Notification Started 2012 Alternative 1: Alternative 1: Paper Notification Material SEAL Paper Notification Material SEALCRC-MEP Alternative 2: Email Notification Material SEAL Ok XNotification BodyOn test: Alternative 2: Web-based Notification SystemWeb-based Notification System CRC-MEPClient-side Download:http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=379&T0=01000&LanguageType=CH&Sub=125ContactMa Xin - [email protected],cnIT SupportDeng Qing- [email protected],cn Simplified Notification Material Basic condition:Specific condition: Limited Information & 3 Studies neededVery Limited information needed 31. Updates on 27th Apr 2012NEXTSECTOR >Please be advised-Way of Scientific Research Record has changed Transitional Time Till 01 May 2012Online Record Started afterward Alternative 1:Alternative 1: Paper Notification Material SEALPaper Notification Material SEALCRC-MEP Alternative 2: Email Notification Material SEAL OkXNotification BodyOn test:Alternative 2: Web-based Notification System Web-based Notification System CRC-MEPClient-side Download:http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=392&T0=01000&LanguageType=CH&Sub=125 Contact+ 86 010-849 176 56 Zhao Yuan- [email protected] IT Support+86 010-849 152 89 Deng Qing- [email protected],cnContactMa Xin - [email protected],cnIT SupportDeng Qing- [email protected],cn 32. NEXTSECTOR >Next sector is aboutDecree 591This is the major hazardous chemical control law in China, which is highly related withChina GHS implementation and other inspection issues mentioned in later sectorsHelpyouKnowitDriving Green Chemical 33. State CouncilDECREE591 >HelpyouKnowitDriving Green Chemical 34. NEXTPAGE >Decree 591 is revisedState Council State Council[2002] Decree 344replaced by Decree 591 by SC Substance + Mixtureregulated at same timeSC Decree 591 WillEnter into forceThe 1st Regulation replaced by01 Dec 2011State Council[2002] Decree 344SC Decree 591 Issued02 Mar 2011 X China GHS started on 1 May 2011 (both Substance + MixtureSC Decree 344 Enteredregulated at same time)15 Mar 2002into forceXSC 1st Regulation17 Feb 1987Issued & Entered into force1987: Regulation Decree 344: RegulationDecree 591: RegulationOn the safeon the Control over on Safe Management ofManagement ofSafety of Hazardous Hazardous ChemicalsHazardous GoodsChemicals HelpyouKnowit Driving Green Chemical 35. Updates on 28 Nov 2011NEXTPAGE >What the registration looks like? Different Roles ProcessState CouncilRegulation issued by State Council Regulation releasingSAWSSAWS takes charge of managementState Administration of WorkSAWS plays as leader role in Decree 591 Safety of State Council& releases Catalog of Hazardous Chemicals Catalog of Hazardous Chemicals (2002)To be renewed Check catalog: www.chinasafety.gov.cn/whpcx.htmReceive Registration Application+86 532 8378 659 3NRCC-SAWS Formal Check of materials NRCCRegistration Call-in Submit information (easier than China REACH) for 3-year-valid certification & Renew 3Registrant months before expiryImporter & Manufacturer in CHINA Search through the Catalog to see if registration needed; Obligation: safety evaluation report, production license, safe use license, operating license, registration of hazardous chemicals, SDS and chemical labels (China GHS) Other government bodies involved in implementation of the law HelpyouKnowit Driving Green ChemicalMIIP | MoH | MEP | MoR | MoT | MoA | MPSAdministration of Custom | AQSIQ 36. Updates on 16 Dec 2011NEXTPAGE >2 Major catalog of chemicals under SC Decree 591 Finally Over 7,000in new versionNew China GHS and Catalog ofHazardous Chemicals(first 4000 Likely to be mergedsubstances) would be published firsthalf year of 2012Catalog of Hazardous Chemicals Catalogue of Extremely Toxic Chemicals(2002rev.)Pure Substance Over3,800335 This is a domestic rule, import andexport of those toxic chemicalsare not in the scope Version 2002 came up with Decree 344,Version 2002, substances majorly came from and the new Catalog is to be published early Catalog of Hazardous Chemicals , but some next yearchemical substances were borrowed fromCatalog of Dangerous Goods (GB12268- Manufacturers, Importer, other roles (distributors,1990)- now has been replaced by 2012 ver. warehousing and storing companies ) chemicalsor even other lists. within Chinese territory need to be sure whether any of their chemical products are listed in theIf purchase or transport of chemicals in the Catalog, especially sensitive to the newest versioncatalog of extremely toxic chemicals happens, upcoming.companies will be required to apply for somelicenses before actions. But as we believe, the new version firstly comes up as a draft before it become the decided one.Download 37. NEXTPAGE >You may feel less interested,You will also find information ofbecauseIf your company is located outside of mainlandChina, it will not be directly affected by Decree591.China GHSHowever,your suppliers, business partners, importers,or customers likely to have obligations underthe Decree which may affect your business.Be surethose companies are fullyunderstanding their requirementsso that your businessStays Out of TroubleHelpyouKnowitDriving Green Chemical 38. Updates on 05 Dec 2011NEXTPAGE > Under Decree 591, registration is the responsibility of Importer & Manufacturers in ChinaBut,If you are the roles below,what are your obligations? Key words found in next several pages Manufacturer in China Importer in China Distributor and warehouse, storageobligation, registration, license, implementation,companyenforcement authorities Transportation company in ChinaManufacturer (chemical user) in ChinaYou should pay more attention to under 591 Companies located outside ChinaGHS compliant, SDSs and labels are necessaryYou may have your contracted suppliers or partners inChina be aware of this law 39. Updates on 05 Dec 2011 NEXTPAGE >Obligation: Registration & License Led by SAWsRoles Registration Main LicenseChemical ListManufacturerRegistration Certificate License of Manufacturing Safety1ChinaImporterRegistration Certificate License of Operation Safety2China Classification & labels SDS Distributor License of Operation Safety3 Warehousing XTransportation License of Transportation on Road4 Companies XLicense of Transportation in WaterManufacturerLicense of Using Safety5 Chemical User X RolesChinese ManufacturersDistributors1Bulk Chinese producers of Hazardous ChemicalsCatalog of Hazardous2Hazardous Chemicals importers within Chinese territory Chemicals (Ver.2002 to beupdated)3Hazardous Chemicals Distributor s or warehousing service providersChinese Manufacturers4Bulk Chinese producers of Hazardous ChemicalsDistributors Inventory of Toxic ChemicalsChinese Manufacturer5Companies using Hazardous Chemicals to produce some chemical- Chemical User The Directory of Industries based goods in certain industries (follow the link by clicking here) Criteria for Limit Volume 40. Updates on 05 Dec 2011 NEXTPAGE > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authoritiesManufacturers in ChinaObligationResponsible AuthoritiesWhat to be prepared (different forms and documents usually) In case that a companyusing hazardous chemicals Submit Registration NRCC of SAWS Registration Formin its production and the- (final check) Technical Safety Instruction offinal product still a Local registrationchemicals (Important)hazardous chemicals in the offices(province) Label (Important)Catalog of Hazardous - (receive registration and check) Emergency call (or contracted service)Chemicals, this companyNRCC registration platform: Business license issued by Industrial andneeds to do registration andhttp://register.nrcc.com.cn/apply for the License of Commercial BureauManufacturing Safety. Documents and ApplicationThis company should be Manufacturing Safety rulesconsidered as a Manufacturer Routine Practicerather than a ManufacturerLicense of Manufacturing SafetyState Administration of WorkStewardship Documents(Chemical User)Information changed Safety of State Council (SAWS) Safety Management personnel document Safety Assessment Report by 3rd party If new hazardous chemicals Emergency Rescue Plan & Recordare being manufactured after Emergency Rescue Checklistacquiring registration certificate and license, themanufacturer needs toSafety License of Occupational NA NAupdate both certificate as Hygienewell as License ofManufacturing SafetySAWS: http://www.chinasafety.gov.cn/newpage/NRCC: http://www.nrcc.com.cn/TEL: +86 (0)532 83 8891 91Local Registration office: HelpyouKnowithttp://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=243&ChannelID=180 Driving Green Chemical 41. Updates on 05 Dec 2011NEXTPAGE > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authorities Importer in China Obligation Responsible Authorities What to be prepared(different forms and documents usually) Submit Registration NRCC of SAWS Registration Form - (final check) Technical Safety Instruction of Local registration offices(province) chemicals (Important) - (receive registration and check Label (Important) Emergency call (or contracted service) NRCC registration platform: License issued by Industrial andhttp://register.nrcc.com.cn/Commercial Bureau Application form of business license ofhazardous chemicals Catalog of relevant production safetydocumentsLicense of Operation SafetyLocal Work Safety Department Work safety standards and manual(Same required as Distributor (province ) Safety training and training materialsWarehousing & Storing) Budget raised for manufacturing safetyof hazardous chemicals and budgetreportFIND MORE IN NEXT PAGE The Record of Hazardous General Administration of The Record is Optional (suggested)Chemicals Imported Quality Supervision, Inspection The Application composed with The Application for quarantine and Quarantine - self-declarationinspection Local CIQ (for direct- SDS and label document implementation - If the Record completed, submit itto be confirmed SAWS: http://www.chinasafety.gov.cn/newpage/AQSIQ: http://www.aqsiq.gov.cn/ NRCC: http://www.nrcc.com.cn/ TEL: +86 (0)532 83 8891 91HelpyouKnowitDriving Green Chemical Local Registration office: http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=24 3&ChannelID=180 42. Updates on 09 Dec 2011NEXTPAGE > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authoritiesDistributor ObligationResponsible Authorities What to be prepared(different forms and documents usually)Warehousing & StoringLocal Work Safety Department Application form of business license of (City-level)hazardous chemicals Catalog of relevant production safetyResponsible for the management of documents Specialized in hazardous sales and Work safety standards and manual warehousing business Safety training and training materials Budget raised for manufacturing safetyof hazardous chemicals and budgetLicense of Operation Safety report(Same required as Importer ) Injury Insurance for employees orLocal Work Safety Departmentproduction liability insurance proof (County-level ) Business license issued by Industrial andCommercial BureauResponsible for the management of Property or leasing documents of Sales of toxic chemicals *business venues and facilities equipped Explosive chemicals * with Storing and sales of hazardous Emergency Rescue Plan & Record chemicals(gas station etc.) Extra documents required when acompany is equipped with storagefacilities(gas station for example) *Extremely toxic chemicals a list of chemicalsissued in 2002 (335 chemicals up till now) *Explosive chemicals - also a separated list ofchemicals SAWS: http://www.chinasafety.gov.cn/newpage/ Please be informed that you may find the contact information of Local Work Safety Departments, however we do not believe that is necessary, simply ask for help from your local distributors or consultants , they haveHelpyouKnowit ways.Driving Green Chemical All documents to be shown to city-level or county-level Work Safety Department dependent on the business your companies are running. 43. Updates on 15 Dec 2011NEXTPAGE > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authoritiesTransportation CompaniesObligationResponsible Authorities Implementation (different forms and documents usually) TDG business Application Form Daft report of dangerous goods,Transport License of Dangerous GoodsMinistry of Transport of P.R.C classification and operation plan on Road Special vehicles used for transport(GB12268-2012 *)Transport of Dangerous Identification documents and copies of(GB6944-2012P *)Goods on RoadInvestor and personnel in charge Testimonial documents of parking area for special vehicles, capabilities of safety protection, environmental protection and fire fighting device equipped NANA NATransport of Dangerous Goods by Water Report of toxic chemicals and quantity to be transportedTransport License of Toxic ChemicalsPublic Security Bureau The details of transport, plan, destination, on Road (County-level)route, fixed date (Inventory of Toxic Chemicals *) Purchase license or import license issued Transport of Toxic Chemicalsby the Customs on Road The qualification of drivers and other certificates* GB12268-2012: (here in Chinese) the inventory of dangerous goodsMoT: http://www.mot.gov.cn/(Be advised: some chemicals also found in the Catalog of Hazardous Chemicals ver.2002)* GB 6944-2012: (here in Chinese) the classification of dangerous goods* Inventory of Toxic Chemicals- English version please follow the link belowhttp://issuu.com/mai.fung/docs/inventory_of_toxic_chemicals__for_transport_and_pu?mode=window&backgroundColor=%23222222 44. Updates on 09 Dec 2011NEXTSECTOR > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authorities Manufacturers in ChinaObligation Responsible Authorities Implementation(different forms and documents usually)Chemical User Emergency Rescue Plan & RecordA Company using Emergency Rescue documenthazardous chemicals as Technical Safety Instruction ofmajor materials or even Chemicalsadditives in its production License of Using Safety Local Work Safety Department Emergency response (people equipment (City-level) and checklist) Safety assessment report by 3rd party Manufacturing Safety document andrules SAWS: http://www.chinasafety.gov.cn/newpage/ Please be noticed, hazardous chemicals need to apply for this license under Decree 591 only meet two descriptions below: -The Directory of Industries -Criteria for Limit Volume Find the copies for your information : http://issuu.com/mai.fung/docs/the_directory_of_industries_for_the_application_of ?mode=window&backgroundColor= Also please be informed that you may find the contact information of Local Work Safety Departments, however we do not believe that is necessary, simply ask for help from your local distributors or consultants , they have ways.HelpyouKnowitDriving Green Chemical 45. NEXTPAGE >Next sector is aboutChina GHS SDS + LabelHelpyouKnowitDriving Green Chemical 46. Updates on 27 Apr 2012NEXTPAGE > + HelpyouKnowit Driving Green Chemical 47. Updates on 27 Apr 2012 NEXTPAGE > Chemicals 48. Updates on 27 Apr 2012 NEXTPAGE > 49. Updates on 27 Apr 2012 NEXTPAGE > 50. NEXTPAGE >For whose>>Chemicals listed in Catalog of Hazardous Chemicals under SC Decree 591>>Or products in Statutory Inspection Catalogue 2012 AQSIQ Regulation on Import & Export of Hazardous ChemicalsThe company will have to follow 2 GB to prepare SDS and Labels under China GHS GB16483-2008 GB15258-2009Instruction of Safety Data Sheet, Content and Section General Rule for Preparation of Precautionary Label for Chemicals GB/T 22234-2008 Labeling of Chemicals Based on GHS 51. Updates on 13 Apr 2012 NEXTPAGE >Grab some key points in authoring Chinese SDS Should it be China SDS or China MSDS?China SDS would be the correct name, however in China,we hardly tell the differences between SDS and MSDS (SDS is officialname, but we treat 2 names the same often).Please be informed: No official template of SDS issued so far .HelpyouKnowitDriving Green Chemical 52. Updates on 13 Apr 2012 NEXTPAGE >Content Introduction of the SDS part China SDS National Standard GHS Comparison Content andSample of SDS DownloadSection (qualified copy) GB 16483-2008English ver. 53. Updates on 13 Apr 2012 NEXTPAGE >Content Introduction of the SDS part China SDS National Standard GHS Comparison Content andSample of SDS DownloadSection (qualified copy) Now please follow the currently-valid China GHS (Version 2007 UN GHS) Although The Up-coming new version of China GHS would completely adopt the content of 4th generation of UN GHSNew China GHS and Catalog of Hazardous Chemicals(first 4000 substances) would be published first halfyear of 2012 Download classification national standardsChinese ver. 54. NEXTPAGE >China | UN | EU GHS comparison table helps you work easilyPhysical HazardsHealth HazardsEnvironmental Hazards HelpyouKnowitDriving Green Chemical 55. Updates on 13 Apr 2012NEXTPAGE >UN GHS 4th Do you know something new happened?Hazardous statementnewly added in 4th Version +Contentdeleted in 4th Version- P281 H229P285 Pressurized container: may burst if heated. P307 | P309 | P322 | P341 H230P350 | P302+350 | P304+341 | P307+311 May react explosively even in the absence of air. P309+311 H231 May react explosively even in the absence of air at elevated pressure and/or temperature. Statements slightly modified in 4th Version ! Download table of P223P244 statement modified Precautionary statementnewly added in 4th Version + P251P284P364 P310P311And wash it before reuse. P312P340P308+311IF exposed or concerned: Call a POISONCENTER/doctor/...P352P361P361+364 P362P378Take off immediately all contaminated clothing andwash it before reuse. P301+310P301+312P362+P364Take off contaminated clothing and wash it beforeP302+352P304+312reuse. P304+340P342+311 Find UN GHS 56. Updates on 13 Apr 2012NEXTPAGE > China GHS Category Table I : physical hazardsHazard categories under GHS in different areas UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008) Current China GHSReplacing DSD & DPD since Jun 1 2015 Based on UN GHS 2007 Ver.02PhysicalHazards 2.1 ExplosiveGB 20576-2006 Explosive2.2 Flammable gasesGB 20577-2006 Flammable gases2.3 Flammable aerosols GB 20578-2006 Flammable aerosols2.4 Oxidising gasesGB 20579-2006 Oxidizing gases2.5 Gases under pressure GB 20580-2006 Gases under pressureDownload GB 2.6 Flammable liquidsGB 20581-2006 Flammable liquids2.7 Flammable solidsThe same as UN GHS GB 20582-2006 Flammable solids2.8 Self-reactive substances and GB 20583-2006 Self-reactivemixtures substances(mixture included)2.9 Pyrophoric liquids GB 20584-2006 Self-heating substances2.10 Pyrophoric solids (mixture included)Slightly different2.11 Self-heating substances and GB 20585-2006 Pyrophoric Liquidsmixtures GB 20586-2006 Pyrophoric Solids2.12 Substances and mixtures which inGB 20587-2006 Substance which, in contactcontact with water emit flammablewith water, emit flammable gases (watergasesreactive)2.13 Oxidising liquids GB 20588-2006 Corrosive to Metals2.14 Oxidising solidsGB 20589-2006 Oxidizing liquidsSlightly different2.15 Organic peroxides GB 20590-2006 Oxidizing solids2.16 Corrosive to metals GB 20591-2006 Organic peroxides 16 hazards16 hazards16 hazardsRemark: please be noticed, compared with UN GHS or EU CLP, physical hazard category is generally remained the same under China GHS.Only the order of GB 20584 GB 20586(2.9-2.11) , GB 20588-GB 20591 (2.13-2.16) have been changed slightly, which may cause youconfused while reading. Some classification could be different: Flammable gases | Flammable aerosols EU CLPDSD - 67/548/EECDec 01 Classification Labeling Packaging (EC 1272/2008)Jun 01Only CLP remainedTimeline DPD -1999/45/EC2010+ DPD & DSD 2015 57. Updates on 13 Apr 2012 NEXTPAGE >Help you to read the following content Building-block-adopteddifferentiationChina GHSEU GHSUN GHS 4th Unstable | Div. 1.1 Div.1.2Div. 1.3Div. 1.4Div. 1.5Div. 1.6 Building blocksGHS 01GHS 02GHS 03 GHS 04GHS 05 GHS 06 GHS 07GHS 08GHS 09 58. Updates on 13 Apr 2012NEXTPAGE > China GHS classification and pictogram for physical hazardsA combination with which you work even more easily China GHS UN GHS 4thEU GHSGB 20576-2006Explosive Unstable | Div. 1.1Div.1.2 Div. 1.3Div. 1.4 Div. 1.5 Div. 1.6 NoNo Danger | Danger | Danger | Warning | Danger | H 200 | H 201 H 202 H 203 H 204H 205 China GHSEU GHSUN GHS 4thA (Chemically B (ChemicallyGB 20577-2006Flammable GasesCategory 1 Category 2 unstable gases)stable gases)No Danger | Warning | H 220H 221 China GHSEU GHSUN GHS 4thGB 20578-2006(Flammable) AerosolsCategory 1 Category 2Category 3 Danger | Warning | H 222 H 223 59. HelpyouKnowitChina GHS H statementGB 20576-2006Explosive DUnstable | Div. 1.1D Div.1.2 D Div. 1.3W Div. 1.4 No D Div. 1.5 No Div. 1.6X please follow GB 22234-2008 60. HelpyouKnowitChina GHS H statement GB 20577-2006 Flammable Gases D Category 1 W No Category 2 UN GHS A UN GHS B 61. HelpyouKnowitChina GHS H statementGB 20578-2006 (Flammable) Aerosols D Category 1 W Category 2UN GHS W Category 3X X 62. Updates on 13 Apr 2012NEXTPAGE > China GHS classification and pictogram for physical hazardsA combination with which you work even more easilyChina GHSUN GHS 4th EU GHSGB 20579-2006Oxidizing Gases Category 1 Danger | H 270China GHSUN GHS 4th EU GHS RefrigeratedGB 20580-2006Gases under pressureCompressed gasesLiquefied gases liquefied gases Dissolved gases Warning | Warning | Warning | Warning | H 280 H 280 H 281 H 280China GHSEU GHSUN GHSGB 20581-2006Flammable LiquidsCategory 1Category 2Category 3Category 4 No Danger | Danger | Warning | H 224H 225H 226 H 227 63. HelpyouKnowitChina GHS H statement GB 20579-2006 Oxidizing Gases D Category 1Labeling of Chemicals Based on GHSX 64. HelpyouKnowitChina GHS H statement GB 20580-2006 Gases under pressureW Compressed gasesWLiquefied gasesWRefrigeratedliquefied gasesWDissolved gases 65. HelpyouKnowitChina GHS H statement GB 20581-2006 Flammable LiquidsDCategory 1DCategory 2 W Category 3WNoCategory 4 66. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for physical hazardsA combination with which you work even more easily China GHS UN GHS 4thEU GHSGB 20582-2006Flammable Solids Category 1Category 2 Danger | Warning | H 228 H 228 China GHS UN GHS 4thEU GHSSelf-reactiveGB 20583-2006 Type A Type B Type C & D Type E& FType GSubstances (mixtures included)No Danger | Danger | Danger | Warning | H 240 H 241 H 242H 242 China GHS UN GHSEU GUSSelf-heatingGB 20584-2006Category 1Category 2Substances (mixtures included) Danger | Warning | H 251H 252 67. HelpyouKnowitChina GHS H statement GB 20582-2006 Flammable SolidsD Category 1W Category 2 68. HelpyouKnowitChina GHS H statementGB 20583-2006 Self-reactive substances (mixtures included) DType A D Type BD Type C & D W Type E & F NoType G 69. HelpyouKnowitChina GHS H statement GB 20584-2006 Self-heating substances (mixtures included)D Category 1WCategory 2 70. Updates on 13 Apr 2012NEXTPAGE > China GHS classification and pictogram for physical hazardsA combination with which you work even more easily China GHS UN GHS 4thEU GHSGB 20585-2006 Pyrophoric LiquidsCategory 1 Danger | H 250 China GHS UN GHS 4thEU GHSGB 20586-2006 Pyrophoric Solids Category 1 Danger | H 250 China GHS UN GHS 4thEU GUSGB 20587-2006Substance which, in Category 1 Category 2Category 3contact with water, emit flammablegases (water reactive) Danger | Danger | Warning | H 260H 261H 261 71. HelpyouKnowitChina GHS H statement GB 20585-2006 Pyrophoric Liquids D Category 1 72. HelpyouKnowitChina GHS H statement GB 20586-2006 Pyrophoric Solids D Category 1 73. HelpyouKnowitChina GHS H statement Substance which, in contact with water, emit flammable GB 20587-2006 gases (water reactive) D Category 1 D Category 2W Category 3 74. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for physical hazardsA combination with which you work even more easilyChina GHSUN GHS 4th EU GHSGB 20588-2006 Corrosiveto Metals Category 1 Warning | H 290China GHSUN GHS 4th EU GHSGB 20589-2006 OxidizingLiquids Category 1Category 2Category 3 Danger | Danger | Warning | H 271H 272 H 272China GHSUN GHS 4th EU GUSGB 20590-2006 Oxidizing SolidsCategory 1Category 2Category 3 Danger | Danger | Warning | H 271H 272H 272 75. HelpyouKnowitChina GHS H statement GB 20588-2006 Corrosiveto Metals W Category 1 76. HelpyouKnowitChina GHS H statement GB 20589-2006 Oxidizing LiquidsDCategory 1D Category 2 WCategory 3 Labeling of Chemicals Based on GHSX 77. HelpyouKnowitChina GHS H statement GB 20590-2006 Oxidizing Solids D Category 1 D Category 2W Category 3Labeling of Chemicals Based on GHSX 78. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for physical hazardsA combination with which you work even more easily China GHS UN GHS 4thEU GHSGB 20591-2006Organic peroxidesType A Type B Type C & D Type E& FType GNo Danger | Danger | Danger | Warning | H 240 H 241 H 242H 242HelpyouKnowit Driving Green Chemical 79. HelpyouKnowitChina GHS H statementGB 20591-2006 Self-reactive substances (mixtures included) DType A D Type BD Type C & D W Type E & F NoType G 80. Updates on 13 Apr 2012NEXTPAGE > China GHS Category Table II : health hazardsHazard categories under GHS in different areasUN GHS (2011 Ver. 04)EU CLP (EC 1272/2008)Current China GHSReplacing DSD & DPD since Jun 1 2015 Based on UN GHS 2007 Ver.02HealthHazards3.1 Acute toxicity(Oral | Skin | Inhalation) GB 20592-2006 Acute toxicity(Oral | Skin | Inhalation) 3.2 Skin corrosion/irritationGB 20593-2006 Skin corrosion/irritation 3.3 Serious eye damage/eye irritationGB 20594-2006 Serious eye damage/eye irritation 3.4 Respiratory or skin sensitizationGB 20595-2006 Respiratory or skin sensitization 3.5 Germ cell mutagenicity GB 20596-2006 Germ cell mutagenicityDownload GB3.6 CarcinogenicityGB 20597-2006 Carcinogenicity 3.7 Reproductive toxicityThe same as UN GHSGB 20598-2006 Reproductive toxicity 3.8 Specific target organ toxicity singleGB 20599-2006 Specific target organ system toxicity- exposure single exposure 3.9 Specific target organ toxicity GB 20601-2006 Specific target organ system toxicity- repeated exposurerepeated exposure 3.10 Aspiration hazardAbsent from China GHS 10 hazards10 hazards 9 hazardsRemark: China GHS mostly copied from UN GHS 2007 version, but some classification has been changed. SpecificallySkin | Respiratory sensitizationSTOT-single exposureAspiration hazard 81. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for health hazardsA combination with which you work even more easily China GHS EU GHSUN GHS 4thGB 20592-2006Acute Toxicity Category 1 Category 2 Category 3Category 4 Category 5(Oral)No Danger | Danger | Danger | Warning | Warning | +H 300H 300H 301 H 302H 303China GHSEU GHSUN GHS 4thGB 20592-2006 Acute Toxicity Category 1 Category 2 Category 3Category 4 Category 5(Skin)No Danger | Danger | Danger | Warning | Warning | +H 310H 310H 311H 312 H 313China GHSEU GHSUN GHS 4thGB 20592-2006 Acute Toxicity Category 1 Category 2 Category 3Category 4 Category 5(Inhalation)No Danger | Danger | Danger | Warning | Warning | H 330H 330H 331H 332 H 333 82. HelpyouKnowitChina GHS H statementGB 20592-2006 Acute Toxicity (Oral) D Category 1 D Category 2D Category 3 W Category 4 W No Category 5 83. HelpyouKnowitChina GHS H statementGB 20592-2006 Acute Toxicity (Skin) D Category 1 D Category 2D Category 3 W Category 4 W No Category 5 84. HelpyouKnowitChina GHS H statementGB 20592-2006 Acute Toxicity (Inhalation) D Category 1 D Category 2D Category 3 W Category 4 W No Category 5 85. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for health hazardsA combination with which you work even more easilyChina GHSEU GHSUN GHS 4thGB 20593-2006Skin corrosion/Category 1A Category 1BCategory 1CCategory 2Category 3irritation No Danger | Danger | Danger | Warning | Warning | H 314H 314H 314 H 315H 316China GHS EU GHS UN GHS 4thGB 20594-2006 Serious eye damageCategory 1 Category 2ACategory 2B/eye irritationNo Danger | Warning | Warning | H 318 H 319 H 320 86. HelpyouKnowitChina GHS H statementGB 20593-2006 Skin corrosion/ irritation DCategory 1A DCategory 1BD Category 1C W Category 2 W No Category 3 87. HelpyouKnowitChina GHS H statement GB 20594-2006 Serious eye damage /eye irritationD Category 1W Category 2AW No Category 2B 88. Updates on 13 Apr 2012NEXTPAGE > China GHS classification and pictogram for health hazardsA combination with which you work even more easily China GHSEU GHS UN GHS 4thRespiratoryGB 20595-2006Category 1 Category 1ACategory 1Bsensitization Danger | Danger | Danger | + H 334 H 334H 334 China GHSEU GHS UN GHS 4thGB 20595-2006Skin sensitizationCategory 1 Category 1ACategory 1B Warning | Warning | Warning | H 317 H 317H 317 89. HelpyouKnowitChina GHS H statement GB 20595-2006 Respiratory sensitizationDCategory 1 90. HelpyouKnowitChina GHS H statement GB 20595-2006 Skin sensitization W Category 1 91. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for health hazardsA combination with which you work even more easilyChina GHSUN GHS 4th EU GHSGB 20596-2006 Germ cell Category 1A Category 1BCategory 2mutagenicity Danger | Danger | Warning | H 340H 340 H 341 China GHS UN GHS 4thEU GHSGB 20597-2006 CarcinogenicityCategory 1A Category 1BCategory 2 Danger | Danger | Warning | H 350 H 350 H 351 China GHSUN GHS 4thEU GHSAdditional:GB 20598-2006 ReproductiveCategory 1A Category 1BCategory 2 LactationtoxicityNo Danger | Danger | Warning | H 360H 360 H 361H 362 92. HelpyouKnowitChina GHS H statement GB 20596-2006 Germ cell mutagenicityD Category 1A D Category 1B W Category 2 93. HelpyouKnowitChina GHS H statement GB 20597-2006 CarcinogenicityD Category 1A D Category 1B W Category 2 94. HelpyouKnowitChina GHS H statementGB 20598-2006 Reproductive toxicity D Category 1A D Category 1B D Category 2W No Additional: Lactation 95. Updates on 13 Apr 2012NEXTPAGE > China GHS classification and pictogram for health hazardsA combination with which you work even more easily UN GHS 4thChina GHS EU GHSGB 20599-2006 Specific target Category 1Category 2Category 3organ system toxicity-singleexposure (STOT) Danger | Warning | Warning | H 370 H 371H 335 | H 336 China GHS UN GHS 4thEU GHSGB 20601-2006 STOT-repeatedCategory 1Category 2exposure Danger | Warning | H 372H 373 EU GHS UN GHS 4thCategory 1Category 2Aspiration hazardCurrently absentfrom China GHSDanger | Warning | H 304 H 305 96. HelpyouKnowitChina GHS H statementGB 20599-2006 Specific target organ system toxicity-single exposure D Category 1 W Category 2 UN GHS WCategory 3 X X 97. HelpyouKnowitChina GHS H statement GB 20601-2006 Specific target organ system toxicity-repeated exposure D Category 1 W Category 2 98. Updates on 13 Apr 2012NEXTPAGE > China GHS Category Table III : environmental hazardsHazard categories under GHS in different areas UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008)Current China GHSReplacing DSD & DPD since Jun 1 2015 Based on UN GHS 2007 Ver.02EnvironmentalHazards 4.1 Hazardous to the aquaticGB 20602-2006 Hazardous to the aquaticenvironment environment4.2 Hazardous to the ozone layerAbsent from China GHSDownload GBThe same as UN GHS 2 hazards2 hazards 1 hazardsRemark: China GHS mostly copied from UN GHS 2007 version, but some classification has been changed. SpecificallyHazardous to the ozone layer 99. Updates on 13 Apr 2012 NEXTPAGE > China GHS classification and pictogram for environmental hazardsA combination with which you work even more easily China GHS EU GHSUN GHS 4th Hazardous toGB 20602-2006Category 1 Category 2 Category 3the aquatic environmentNoNo(Acute) Warning | H 400 +H 401H 402China GHSUN GHS 4th EU GHSGB 20602-2006 HazardoustoCategory 1 Category 2Category 3Category 4the aquatic environmentNoNo(Chronic | Long-term) Warning| H 410H 411H 412 H 413 EU GHSUN GHS 4thCategory 1 Category 1Hazardous to the OzoneLayer NoVSCurrently absentfrom China GHSDanger | EUH 059 Warning | H 420EUH 059 H 420Hazardous to the ozone layerHarms public health and the environment bydestroying ozone in the upper atmosphere 100. HelpyouKnowitChina GHS H statement GB 20602-2006 Hazardous to the aquatic environment (Acute) W Category 1No Category 2No Category 3 101. HelpyouKnowitChina GHS H statement GB 20602-2006 Hazardous to the aquatic environment (Chronic | Long-term) W Category 1 Category 2 No Category 3 No Category 4 102. Updates on 13 Apr 2012NEXTPAGE >Pictogram and classification precedence rules same as EU GHS You may have been quite familiar with this partPhysical hazards Self-reactive (Type B) | GB20583-2006 If then &optional except Organic peroxides (Type B) | GB 20591 GHS 01GHS 02GHS 03Physical | Healthhazards If orthenoptional GHS 06GHS 02GHS 04Health hazardsHealth hazards If thenabsent Ifthen absentGHS 06GHS 07GHS 08 GHS 07Health hazards For Respiratory sensitization If thenabsentFor Skin sensitization or In hazards of Skin or eye irritation Skin & Eye irritation GHS 05 GHS 07(GB20593-2006 | GB 20594-2006) 103. Updates on 13 Apr 2012NEXTPAGE >Hazard Statement precedence rules same as UN GHS A combination with which you work even more easilyEnvironmental HazardsIf H410 (Very toxic to aquatic life with long lasting effects), H400 (Very toxic to aquatic life) NOT APPEAREnvironmental HazardsIf H411 (Toxic to aquatic life with long lasting effects), H401 (Toxic to aquatic life) NOT APPEAREnvironmental HazardsIf H412 (Harmful to aquatic life with long lasting effects), H402 (Harmful to aquatic life) NOT APPEARHealth HazardsIf H314 (Causes severe skin burns and eye damage), H318 (Causes serious eye damage) NOT APPEAR Tips: you could apply this rule in the SDS section 2.1 (Classification), however, you could still keep all of those Hazard statements in 2.2 (Label element) on China SDS. 104. Updates on 13 Apr 2012NEXTPAGE > SDS hazard communication always mattersChina SDS National Standard GHS ComparisonContent and Sample of SDS Download Section(qualified copy) Under Under GB16483-2008Regulation (EC) No 1907/2006 (REACH) EU SDSChina SDS Instruction of Safety Data Sheet, Content and Section REACH Registration Number DPD/DSD classification NO CSA | exposure scenario (eSDS) GB 16483-2008 24hr emergency response phone Emergency response callEnglish ver. number Different concentration limits Different concentration limits H/P statements in local languageH/P statements in Chinese XV section, local regulations added XV section, Chinese regulations XVI section, Risk phrases XVI section, NO Risk phrasesMajor differentiation between EU SDS & China MSDS 105. Updates on 13 Apr 2012 NEXTPAGE >SDS hazard communication always matters Largely, current SDS guidance (GB 16483-2008) is quite aBefore you read copy cat of both guidance on the preparation of safety (UNGHS) & Annex II (EU REACH)The requirements of each section are not specified in detail,which means that you may not easily prepare your China SDSby following the GB 16483-2008Moreover, some translation mistakes in the GB 16483-2008from EU REACH or UN GHS might lead you to confusion So you may need more assistanceHelpyouKnowitDriving Green Chemical 106. Updates on 13 Apr 2012NEXTPAGE > Content 16 sections one by one Part INational Standard: GB 16483-2008 Identification (of product and supplier)S1 1Chemical Name | Product Code 2Identification of supplier | Contact | 24h ER #3 Recommended & Restriction on useSection 1 or Heading 1 Hazard identification (Substances or mixture)S2Classification of productsHazards profile (H statements)Pictogram | Signal word | H statements 1 2 3under China GHS Physical | Health | Environmental P Statements (in four sectors) | Other hazards Composition/information on ingredientsS3Substance Define the productSubstance Name + CAS #+EC# Substance or Mixture GHS classification All ingredient (impurities included)applied+GHS classification + Concentration (range)MixtureEach name ofConcentration (range) &(not all ingredients)Classified ingredients+ClassificationOnly classified ones Confidential ingredients : name of these ingredients are allowed to be replaced by other names on SDS or Label. However, hazards of them shall be fully unfolded. First-aid measuresS4General descriptionSubheadingTreatments for different routesMost important symptoms/effects, 1 2 3 Skin | Eye | Inhalation | Ingestion acute and delayed (detailed in section 11) 4Professional assistanceMedical attention orOr doctors advice + Special treatment 107. Updates on 13 Apr 2012 NEXTPAGE > Content 16 sections one by one Part IINational Standard: GB 16483-2008 Fire-fighting measuresS5 Suitable extinguishing media Special hazards of the product &Special protective equipment & 1 23 Unsuitable extinguishing media Special hazards arising from the productprecautions for fire-fighters Accidental release measuresS6 1 Personal precautions, 2Environmental precautions3 Methods and materials for containment & cleaning Protective equipmentup (Specify methods if different from Section 13) Emergency procedures Not existing in Methods applied to prevent from UN or EU GHS+ 4 next accident Handling and storageS7 1 Precautions for safe handling 2 Advice on preventing from 3Conditions for safe storage (including including advice on technical contact in ways of incompatibilities) & requirements such as measures materials used in packaging and container ofproduct (substance or mixture) Exposure controls/personal protectionSpecial protection under special conditionsS8 1 Control parameters or 2 Appropriate engineering 3Individual protection measures and equipment - Exposure limit valuecontrols; providing- Respiratory (Content same as it under EUsupplemental information - Hand EU SDS requires- Eyeenvironmental Annex II under EU REACH)besides Section 7- Skin exposure control 108. Updates on 13 Apr 2012NEXTPAGE > Content 16 sections one by one Part IIINational Standard: GB 16483-2008Physical and chemical properties (endpoints to be filled) Vapour pressure (20C) ()S9 1 9.1 General Info pH (pH)Vapour density () Appearance ()Melting point/freezing point (/) Relative Density (20C)(/) Form ()Initial boiling point and boiling range ( ) Water solubility (g/l) () Color () Flash point ()n-Octanol/Water (log Po/w) (n-/) Odour () Upper/lower flammability or explosive(Auto-ignition temperature () ) Decomposition temperature () 9.2 Other InfoSupplementary information 2 Odour threshold ()Radioactivity () Evaporation rate () Bulk Density ()Testing methods required if necessary Flammability (Solid, gas) Explosive properties ()Stability and reactivityS101 Chemical Stability 2 Reactivity3Condition to avoid4 Incompatible materials 5Hazard decomposition productsToxicological information Acute toxicity (oral Dermal Inhalation) mammalS111 Toxicokinetics, metabolism and 2 Info on toxicological effectsSkin corrosion/Irritation distribution (Supplementary part)Serious eye damage/irritation-EU SDS needs Aspiration hazard but China GHS does not require thisRespiratory or skin sensitizationGerm cell mutagenicity classification Carcinogenicity Provide reliable data generated from tests or referred to1competitive source Reproductive toxicity If hazards of a mixture has not been identified through2test, then hazards of each ingredients shall be offeredSTOT-single exposureSTOT-repeated exposure 109. Updates on 13 Apr 2012 NEXTPAGE > Content 16 sections one by one Part IVNational Standard: GB 16483-2008More data provided is highly recommended. Ecological information Please indicate the reference.S12 Eco-Toxicity Persistence and BioaccumulativeMobility in soil 1 234(data on aquatic life anddegradability potentialOther organisms) Disposal ConsiderationsS131Disposal methods2 Contaminated container and packaging Informed the Down-stream users of the disposaltreatment methodsmethods Transport informationS14In accordance with each of the modal regulations:ADR/RID | IMDG | ICAO/IATA UN Number UN Proper Shipping Name Transport hazard classes Packing group, if applicable Environmental hazards (Marine pollutant) Special precautions for user Regulatory informationS15Whether a substance / mixture Safety, health & environmentalInformed the Down-stream users 123 (main ingredients) has been legislation in China for this of the disposal methods - included in some Catalogue or chemical productEU SDS requires Chemical safety assessment Inventory under EU REACH (EU 453/2010) Other informationS16Advice on professional training, if Disclaimer or other information, 1 Indication of changes23 applicableRecommended restrictions on - Version amended, if applicable EU SDS requires relevant R use phrase in this part. 110. Updates on 13 Apr 2012NEXTPAGE > Last tips 16 sections one by one Part VINational Standard: GB 16483-2008 Heading for 16 sections Ensure the format of the SDS well designed for the DU and authority review Each heading and sub-heading should be clearly marked with index No. Sub-headings under each section should be arranged in accordance with the order given in Content 16 sections one by one(I-V) previously. 1 2 3 Other requirements Ensure the name of the chemical product put on each page of the SDSThe abbreviation of a longer chemical name should be explained in S1 & S3 SDS No. together with date of SDS generated should be given on each page Ensure words selected for the SDS readable and understandableCongratulations !You almost finish China SDS part 111. Updates on 13 Apr 2012NEXTPAGE >Content Introduction of the SDS partChina SDS National Standard GHS Comparison Content and Sample of SDS DownloadSection(qualified copy)I am sorry,but you may have to contactme for this template Contact me Or Linkedin me 112. NEXTPAGE >GHS | SDS part is goneNow, it is about GHS Label HelpyouKnowit Driving Green Chemical 113. Updates on 30 Mar 2012 NEXTPAGE >GHS label and packaging CombinationSingle packagingpackagingHelpyouKnowitDriving Green Chemical 114. Updates on 30 Mar 2012NEXTPAGE > Label elements - GHS hazard warning label INational Standard: GB 15258-2009In accordance with 4.2.1 of GB 15258-20091CAS Part I: Name of the product2 Chemical or chemical substance: nameshould be given in Chinese (English is optional) on top Substance or Mixture: Trade name / productname should be given ; main ingredients in mixturecontributed to specific classification of the wholeproduct should be added (Name, Concentration orrange | CAS# is highly recommended)No more than 5 ingredients recommended Confidential ingredients : name of these ingredients are allowed to be replaced by other names on SDS or Label. However, hazards of them shall be clearly listed.Different from Alternative chemical name inmixtures (EU CLP)You are not required to request for an alternativename for your confidential ingredient in China if youpromise hazards and concentration to be disclosedon SDS and Label.3 GB 15258-2009 (English)24 115. Updates on 30 Mar 2012 NEXTPAGE > Label elements - GHS hazard warning label IINational Standard: GB 15258-2009In accordance with 4.2.2-4.2.5 of GB 15258-2009 1CASPart II: Body of LabelWhat needs to be put in this part: 2- One signal word (Danger or Warning)- GHS pictogram Hazard Statement (Below Signal word)- Precautionary Statements (Put all statement ratherthan pick at most 6 statements like guidance of EUlabel regulatory)In accordance with 4.2.9 of GB 15258-2009The rules of making this part:- Pictogram applied should follow the same precedenceof UN GHS (No specific rules for pictogram size in label)- Hazard Statement: all statements arranged in orderPhysical hazards | Health hazards | Environment hazards- Precautionary Statements: all statement (under EUCLP, only 6 selected in accordance with certain rules)shall be listed but correspondingly arranged in[Prevention] [Response] [Storage] [Disposal] also in order 3For specific classification rulesReference Documentation (National Standards)GB 20576-2009 - GB 20599-2009GB 20601-2009 - GB 20602-200924 116. Updates on 30 Mar 2012 NEXTPAGE >Label elements - GHS hazard warning label III National Standard: GB 15258-2009 1CAS 2In accordance with 4.2.6 -4.2.8 of GB 15258-2009Part III: Supplier Identification Please refer to Safety Data Sheet (a must) Supplier identification: supplier name | company seat| Contact number | Zip code (a must) 24/7 Emergency Response Call. The call shall beChinese phone number, either of the supplier itself orqualified service provider assigned. 3NRCC 24/7 ER service will be charged 3000RMBannually for 8 chemical products http://en.nrcc.com.cn/24 117. Updates on 30 Mar 2012 NEXTPAGE > Label , Label , Label- Combination Packaging INational Standard: GB 15258-2009Applies to GHS labelNormal GHS Labelon Single packagingContainer capacitySize for China labelEU GHS label0.1 L - 3 L (3 included) 50 * 75 (mm) 52*74 (mm)3 L- 50 L (50 included)75 * 100 (mm) 74*105 (mm)50 L-500 L (500 included)100 * 150 (mm) 105*148 (mm)500 L-1000 L (1000 150 * 200 (mm) 148*210 (mm)included)over 1000 L200 * 300 (mm)Inner packagingBlack Border Line of China GHS label Printed GHS pictogram color- A space remained outside the border line of label (3mm at least) - All black & white- The width of border Line should be remained as 1mm at leastOr Red frame | White background | Black iconElements same as normal GHS label Simplified GHS Label - Chemical product name- Signal word and pictogramIf either container or packaging is less- Hazard statementthan or equal to 100ml, simplified- Please refer to Safety data sheetlabel is allowed to be utilized.- Supplier name and contact- 24/7 ER contact (Chinese landline)No requirements for Size was specified.--------------------------------------------------Elements deleted from normal label- Precautionary Statements 118. Updates on 10 Apr 2012 NEXTPAGE > Label , Label , Label- Combination Packaging IINational Standard: GB 15258-2009 & GB 190-2009Normal GHS Label Should I put on a GHS hazard warning label on the outer packaging? In accordance with GB 15258-2009 Inner packaging: GHS label | Outer packaging: Product name + Transport symbol + UN numberIn case of no need for transport symbol, GHS label could be applied instead Contradiction: In the light of Decree 591(Thanks for Chriss contribution) Article 15 Inner packaging: GHS label | Outer packaging: Transport symbol + GHS label Conclusion: Post both GHS label and Transport symbol on the Outer Packaging but separate them from each other (for example put the symbol on the opposite side of GHS label on a outer box)Transport symbol Follow GB 190-2009 |Outer packagingPacking symbol of dangerous goodsSymbol size category Symbol size: GB 190-2009 (Chinese only) Select correct transportsymbol150 * 50 (mm) Annex I of UN GHS 4Apply the color according to2100 * 100 (mm) How to choose correspondingGB 190-2009 transport symbol according to3150 * 150 (mm) GHS pictogramThe size rules apply to thetransport symbol used for4200 * 200 (mm)single packagingUN Recommendations on the TransportTransport symbolof Dangerous Goods - Model Regulations=> 100*100mm 119. Updates on 19 Apr 2012NEXTPAGE >Prepare Transport Symbol according to GHS pictogramPhysical Hazards 120. Updates on 19 Apr 2012 NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyExplosive Unstable | Div. 1.1Div.1.2Div. 1.3 Div. 1.4 Div. 1.5 Div. 1.6NoNoFlammable Gases Category 1Category 2 No(Flammable) Aerosols Category 1Category 2 121. Updates on 19 Apr 2012 NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyOxidizing Gases Category 1 RefrigeratedGases under pressureCompressed gases Liquefied gases liquefied gases Dissolved gasesFlammable LiquidsCategory 1 Category 2Category 3Category 4 No 122. Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbolA combination with which you work even more easilyFlammable Solids Category 1Category 2 China GHS UN GHS 4thEU GHSSelf-reactive Type AType B Type C & D Type E& F Type GSubstances (mixtures included)NoSelf-heatingCategory 1Category 2Substances (mixtures included) 123. Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbolA combination with which you work even more easilyPyrophoric Liquids Category 1Pyrophoric SolidsCategory 1Substance which, in Category 1 Category 2 Category 3contact with water, emit flammablegases (water reactive) 124. Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbolA combination with which you work even more easilyCorrosive to MetalsCategory 1Oxidizing LiquidsCategory 1Category 2Category 3Oxidizing SolidsCategory 1Category 2Category 3 125. Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbolA combination with which you work even more easilyOrganic peroxidesType A Type B Type C & D Type E& F Type GNoHelpyouKnowit Driving Green Chemical 126. Updates on 19 Apr 2012NEXTPAGE >Prepare Transport Symbol according to GHS pictogram Health Hazards 127. Updates on 19 Apr 2012NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyAcute ToxicityCategory 1Category 2Category 3Category 4Category 5(Oral) No+Acute Toxicity Category 1Category 2Category 3Category 4Category 5(Skin) No+Acute Toxicity Category 1Category 2Category 3Category 4Category 5(Inhalation) No 128. Updates on 19 Apr 2012 NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilySkin corrosion/ Category 1ACategory 1BCategory 1CCategory 2 Category 3irritation NoSerious eye damageCategory 1Category 2ACategory 2B/eye irritation No 129. Updates on 19 Apr 2012 NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyRespiratory sensitization Category 1+Skin sensitizationCategory 1 130. Updates on 19 Apr 2012 NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyGerm cell Category 1ACategory 1BCategory 2mutagenicityCarcinogenicity Category 1Category 2A Category 2BReproductive toxicity Category 1 Category 2 Category 3Category 4No 131. Updates on 19 Apr 2012NEXTPAGE > Convert your GHS pictogram to Transport symbolA combination with which you work even more easilySpecific targetCategory 1ACategory 2organ system toxicity-singleexposure (STOT)STOT-repeatedCategory 1Category 2exposureAspiration hazardCurrently absentfrom China GHS 132. Updates on 19 Apr 2012NEXTPAGE >Prepare Transport Symbol according to GHS pictogram Environmental Hazards 133. Updates on 19 Apr 2012NEXTPAGE >Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyHazardous to the aquaticCategory 1Category 2 Category 3environmentNoNo(Acute)+Hazardous to Category 1Category 2 Category 3 Category 4the aquatic environment(Chronic | Long-term)No NoHazardous to the OzoneLayerCurrently absentfrom China GHS 134. Updates on 30 Mar 2012NEXTPAGE > Label , Label , Label- Single PackagingNational Standard: GB 15258-2009 | Decree 591 Follow GB 190-2009 | GB 15258-2009 Packing symbol of dangerous goodsIn case of largetanker or containerProduct nameUN numberTransport symbolCan not be treated as singlepackaging Only Transport Symbol isapplied, no GHS label neededGHS hazard warning Label Large tanker or container Over450L should be posted withBoth labels are necessary on a Transport Symbol on bothsingle-packed product sidesIf pictogram(GHS) and symbol (Transport) are The minimum size of transport repeated, pictogram should not appearsymbol for a tanker vehicleshall be 250mm*250mm Comply with Global transport Annex I of UN GHS 4 How to choose corresponding transport symbol convention (IATA etc.) according to GHS pictogram 135. NEXTSECTOR >Next sector is aboutRegulation on Import & Export of Hazardous Chemicals Mainly focused on inspection over SDS and Label developedfor hazardous chemical products exported and importedin accordance with China GHSHelpyouKnowitDriving Green Chemical 136. Regulation on Import & Export of AQSIQ Hazardous Chemicals >Specific implementations since 01 Feb 2012 HelpyouKnowit Driving Green Chemical 137. Updates on 10 Feb 2012 NEXTPAGE >Import & export of Hazardous chemical products The vehicle has been rolling since o1 Feb 2012DECREE591 by State Council Catalog of 01 Dec 2011Entered into force Hazardous Chemicals Catalog of Hazardous Chemicals to beVer.2002 The ver.2002 is to be updated under the updated from Ver.2002 to a new versionDecree 591 SAWS is responsible for the Inspectionand enforcement of the Decree 591within China; taking care of the new version of theCatalog new versionAQSIQ + Customs Selected from theCatalog of HazardousChemicals Ver.2002 Importer or exporter of the chemicals inPart of Statutory Inspection Catalogue 160* the Statutory Inspection Catalogue 2012 2012 should fulfill the obligations underAQSIQ is responsible for the hazardous related regulations issued by the AQSIQ chemical products import and export; Local CIQ implements inspection and currently focused mainly on the Statutory management of compliance work ofInspection Catalog ; for other chemicals in import & export of hazardous chemicalsthe Catalog of Hazardous Chemicals, they will not be taken as top priority of AQSIQs and packaging inspection work for now The Statutory Inspection Catalogue 2012 (over 200 products) or named as the list of hazardous chemicals in the Legal InspectionCatalog But now only including 160 chemical products from the Catalog of Hazardous Chemicals Ver.2002 Please find the Statutory Inspection Catalogue 2012 in Chinese here (http://www.box.com/s/vged6ilflnv285x1no5x) 138. Updates on 10 Feb 2012NEXTPAGE >The obligations of import & Export of Hazardous chemical goodsCHINA GHS | SDS | LABELLINGRelated RulesImport into China Export from China& Inventory- SDS & Labeling preparation- SDS & Labeling preparationNational laws and standards;1 Following the newest version of UN GHS(Ver. 4th)Documents should be translated in Chinese if theIndustrial standardsDocuments should be prepared in Chineseoriginal copies written in foreign language(follow the local regulations where your products areabout to be shipped to )China TDG & GHS-The report of hazard profile prepared- Sample required to be tested in local CIQ approvedSpecial requirements agreed2 by the approved labslabsbetween nationalincluding classification report of TDG &- The report of hazard profile prepared governmentsGHS by local CIQ approved labs including classificationreport of TDG & GHS- Packing decided by the exporter according to theclassification report of TDG- Exporter requires test reports of packaging andcontainers from packing suppliersFood additives- Conformity Declaration of Hazardous-chemical- Conformity Declaration of Manufacturer of3 importer (Template offered by the authority in Chinese) Hazardous-chemical imported (Template offered by theHazardous chemicals used inauthority in Chinese) food as additives is supposed tomeet the requirements of foodhygiene and product inspectionThe authority will be responsible for as well as food safety4 - Ensuring all information of components in the products to be imported or exported are the sameinspection accordingly. as reported in the information included Conformity Declaration for inspections- Checking hazards classification information on the packing; checking if labeling is designed to be complied with TDG(or IMDG, IATA DGR) and GHS- Ensuring Chinese SDS provided affixed on packaging; checking if the SDS, labeling are correct- Identify whether the packing method meets standard requirements and whether the use of packaging is appropriate; check whether the packaging is sealed tightly; ensure whether the goods inside the packaged isHelpyouKnowit not leaked.Driving Green Chemical 139. Updates on 2 Mar 2012NEXTPAGE > Inspection on chemical substances only, or chemicals in mixtures The inspection is an extension of the implementation of Decree 591 Decree 591>>Decree 591 by SCCatalog of Hazardous Chemicals (2002) to be updatedCIQ inspection Inspection of CIQ on 160 hazardous chemical products ( Statutory Inspection Catalogue 2012 ) imported or exported is part of the implementation of Decree 591 CIQ inspections are only responsibleAccording to for Export & ImportCN GHSBoth hazardous chemical substances or chemicals in mixturesCNLab-should be complied with hazardous chemical control law.SDSelNotice Emergency call should be Chinese domestic phone number and the contact also located in China.24h Emergency CallOutside ChinaInside ChinaNational Standards help you with your SDS, labeling under China GHS- GB/T 22234-2008 labelling for chemical products under China GHS HelpyouKnowit- GBT16483-2008 Content and each section in SDSDriving Green Chemical- GB 15258_2009 General rules for SDS development- GB 13690-2009 General principles of hazard classification and profile under CN GHS 140. Updates on 07 Mar 2012 NEXTPAGE >Inspection list & Catalog of Hazardous Chemicals Ver.20022 lists but quite closely related Decree 591 >>How 2 lists are linked 160 chemicals Catalog of Hazardous Chemicals(updated regularly)The Statutory Inspection Catalogue 2012 (Ver.2002 currently still works)ChemicalChemicalproducts substances Ingredients are already listed in the chemical substancesChina Catalog Ver.2002 listed in the CatalogExisting hazardousREACHVer.2002chemical New chemicals identified as hazardous chemicals 141. Updates on 10 Feb 2012NEXTPAGE > The inspection has been implemented We list the areas where inspection is quite strict. Zhejiang Province Shandong Province Shandong Province Fujian Province Jiangsu Province City Shanghai Guangdong ProvinceMore & moreThe authorities of the above areashave started the inspection & enforcement alreadyFind out whether your business has been affected Ensure your implementation of compliance will be Cooperate with your service agents or yourCheck the catalog | Have news from the local partner or your consultant initiated with no delaybusiness partners, get material well paperedHelpyouKnowitDriving Green Chemical 142. Updates on 21 Mar 2012NEXTPAGE >One point to be noticed AQSIQ (local CIQ) Only inspect Chemicals in the Catalog of Hazardous Chemicals Imported chemical products are allowed to be put on with GHS label after clearance but in special warehouse Catalog of Hazardous Chemicals (Ver.2002 currently still works) AQSIQ X AQSIQ shall not put any inspection uponChemicals with GHSlabel but not in theCatalog chemicals out of the Catalog of Haz. Chemicals even with GHS label GHS label could be referred to GHS rules of exporting countries. 143. NEXTSECTOR >Next sector is aboutToxic Chemicals Severely restricted from import & exportBe care if your products to be exported or imported listed in the newest versionof Catalog of toxic chemicals severely restricted to be imported or exported HelpyouKnowit Driving Green Chemical 144. Toxic ChemicalsMEPSeverely restricted from import & export>HelpyouKnowitDriving Green Chemical 145. Updates on 07 Mar 2012NEXTSECTOR >Learning steps it is about restricted toxic chemicalsWhat would be the key issues you need to know? WhoRestrictedComply May be affectedChemicals Strategy Who might beWhether those chemicals If you do have been affected, affected because of some chemicalshave been or will be restricted in China then learn how to comply with itThe purpose of restriction regulation of toxic chemical import & export+ Toxic chemicals should be strictly under control. The authority will have clear minds of what toxicchemicals imported or exported, the amount, where the chemicals transported , who will beresponsible people, and impacts against the environment caused by the toxic chemicals HelpyouKnowitDriving Green Chemical 146. Updates on 07 Mar 2012NEXTPAGE >Who may be affected ? What responsibilities?Who will be affected | what would be the main responsibilities?Out of China In ChinaForeign CompaniesDomestic CompaniesLocated outside ChinaLocated in ChinaExport toxic chemicals into ChinaImporter & Exporter of toxic chemicals Who will be affectedWho will be affected>> Importer ExporterRegistration Certificate for theEnvironmental Management on the Import Clearance Notification Export ClearanceImport of Toxic ChemicalsCRC Registration Certificate for theNotification of MEPEnvironmental Management on Responsibilities > the Import of Toxic ChemicalsResponsibilities> Foreign companies that export toxic chemicals listed in theCatalog of toxic chem