Chinese Regulation Guidance May 23
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Chinese Regulation Guidance May 23 Chinese Regulation Guidance May 23 Presentation Transcript

  • HelpyouknowitChina REACH | Hazardous & Toxic Chemicals | GHS | Disinfectant + ….
  • HelpyouKnowit It is complex, but no need to worry Chemical-regulation related departments Mai Fung | Chemical Regulatory Affair SpecialistSpecial thanks to the contribution ofCora Knutson | Craig Deegan | Chris Maes | Li Hou
  • HelpyouKnowit>> Content Recent 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 China “Linkedin” me What will come soon?  New information of tests for New chemical notification (Order 7) is being prepared Maij1217@gmail.com  Narration is considered to be added in this presentation material
  • HelpyouKnowit>> Key updates May 18 12 China Disinfectant Product regulation A briefing introduction of the Disinfectant laws in ChinaChina Disinfectant Products New slides added on 23/05 Extension of Disinfectant Product Hygienic License Reissue or modification of Disinfectant Product Hygienic License Apr 19 12 Overview of China GHS & SDS China GHS & SDS More added to complete these parts (Transport symbol) Mar 30 12 Newly-added slides China GHS label How to practically handle the GHS label on different types of packages in China
  • The top rankState Council All the departments would be involved in some The Ministry parts of the regulations either New Chemical Notification(Order 7 by MEP) or Decree 591 by SC MEP Ministry of Environmental Protection MoH Ministry of Health MoR Ministry of Railways MoA Ministry of Agriculture MIIP Ministry of Industry and Information Technology MoT Ministry of Transport MPS Ministry of Public Security MOH Ministry of Health The 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 AQSIQ Supervision, Inspection and Quarantine (In charge of local CIQ)
  • Regulation Releasing and Management Leading Major Inspection and Enforcement State Council Regulation releasing MIIP MoH MEP MoR MEP Local MEP MoT MoA SAWSSEPA(State of EnvironmentalProtection Agency) became MEP in2008, and the latter one is short for MPS The status of Administration isMinistry of Environmental Protection lower than Ministry, although they are in charge of critical specific areas. Pollution prevention SAWS Division(-MEP) … Customs Chemical Registration National Registration AQSIQ Center (-MEP) Center for Chemical (-SAWS) Local CIQ of AQSIQ HelpyouKnowit Driving Green Chemical
  • CHINAREACHOrder 7 by MEP > HelpyouKnowit Driving Green Chemical
  • 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-registration chemicalsrequirements 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 Cantox New Chemical (similar to Non phase-in substance) Non-Phase-in substance Phase-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) HelpyouKnowit Driving Green Chemical
  • 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
  • Updates on 05 Dec 2011 NEXTPAGE >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 submitted The company will be warned, fined and even forced to close And 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
  • Updated on 29 Feb 2012 NEXTPAGE >Step by stepTo evaluate if you have been affected by the regulation beforeyou start your compliance Who are affected What substances Comply are newWhether your products Whether those chemicals If you do have been affected,have be affected because of some chemicals are new in China then learn how to comply with it HelpyouKnowit Driving Green Chemical
  • 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 drugs Please 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 additives IECSC: Inventory of Existing Chemicals Substances - 45,602 existing chemical substances (till Dec 7 2010) Where to find IECSC (in English) http://www.crc-mep.org.cn/iecscweb/IECSC.aspx?La=1 HelpyouKnowit Driving Green Chemical
  • Updated on 29 Feb 2012 NEXTPAGE > A chemical regulation on New Chemical SubstancesSome categories of chemicals may benefit from exemption from this law Exempt from Chemical substances or related products the 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 regulations feed 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 nature Heat 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)
  • Updates on 03 Dec 2011 NEXTPAGE > Notification body – like EU REACH, only within ChinaWho shall and who is not obligated Out of China Mainland China Mainland Hong Kong & Macao are not affected by 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 required Notification required * Notification Agent= NA Notify on behalf of Foreign companies The uses under “Priority hazards for environmental management” on IECSC
  • NEXTPAGE >What the notification Process looks like? Different Roles Process MEP MEP issued Order 7 MEP decides the results Catalog of Hazardous Chemicals (SAWS) Ministry of State Council MEP takes charge of management New hazardous chemicals classified Hazardous and Priority Environmental Management of MEP Would likely be included Catalog of Hazardous Chemicals of SAWS Technical evaluation Taskforce for Evaluation provide Feedbacks Receive Registration Application CRC-MEP Formal Check of submitted documents(CRC) 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 Management Call for technical supports from CRC Local MEP Inspection Submit related dossier and data 9 qualified labs in China for eco-toxic  Search through IECSC portal Notification Body to find your substance in the list or not  Make enquiry for 3166 confidential Substances (22Euro or 30USD)  Confidential substance: another database to help define substance
  • Updates on 29 Nov 2011 NEXTPAGE > Foreign companies – choosing notification bodies strategically Please be advised: choose the notifier carefully be careful if you choose your Chinese customer(importer) as the notifier instead of you, you may lose your upper hand because you have to rely on them because of their notification certificates in China. Out of China Mainland China Mainland Role A : * Parent Companies Role B : Assigned by A NA Company 1 1 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 2 2 The Factories or Subsidiary Companies applying for certificate as importer will benefit more themselves when they sell or Belongs to A: Notification Agent make purchase . Factory Plant & Subsidiary 3 3 The Factories 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 Body Importer and Manufacturer 4 4 Your business partners, Importers or Manufacturers , as (business partner) notification body would hold predominant positions and Role D: Unqualified more say throughout supply chains. Distributor X 5 5 If Distributors are not the direct importers of the substance, they are unobligated to complete notification . Who is the Certificate Holder? NA’s name is Certificate Holder 1 3 Role A’s 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 2 4 Certificate Holder & Applicant
  • Updates on 14 Dec 2011 NEXTPAGE >Implementation- before notification Preparation Notification Post-notification Preliminary Stage Necessary Certificate Steps Management 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 here Simplified 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
  • Updates on 05 Dec 2011 NEXTPAGE > 3 Notification types based on different cases Typical Notification > Simplified Notification > Scientific Research RecordTonnage band At or Above Annual Volume of New Chemicals Annual Volume of New Chemicals Criteria the 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 parts Used for scientific researchOther Criteria 1-10 ; 10-100; 100-1000; over 1000tpa Basic condition and Specific condition or the sample is to be lab tested in China Time for 4-18 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 is a) New chemicals for export lower than 1tpa Scientific Research Record is the necessary work required (not recommended) b) For scientific research with tonnage between 0.1 before Typical Notification and basic condition to 1 ton per year of Simplified Notification because samples need c) For technological research with tonnage less to be tested in China Low concern Polymer: than 10 ton per year Only chem-physic data for typical notification d) For polymer consisting of monomers already Not Low-concern polymer: listed in IECSC Full tests for typical notification e) for polymers containing less than 2% new chemical substance weight by weight Low concern condition: (no quantity limit of such polymer imported) No Heavy metal a) 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 solutions For 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 Development HelpyouKnowit Driving Green Chemical
  • Updates on 14 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Typical Notification Preparation Notification Post-notification Preliminary Necessary Steps Data & Dossier Certificate Stage The body of notification 4 Special formats of typical notification Management IECSC Tonnage level unrelated  Serial Notification Inquiry  -Similar substances notification at same time Joint Notification - Co-notification(data or cost-share policy needed to be talked between co-notification bodies)  Repeated Notification - Notification by referring to the data owned by previous notification bodies. HelpyouKnowit  Re-notification - Notification for amount increased or uses changed; additional data required; old notification certificate replaced by the new Driving Green Chemical one Find more by contacting maij1217@gmail.com
  • Updates on 14 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Typical Notification Preparation Notification Post-notification Preliminary Necessary Steps Data & Dossier Submission Certificate Stage Management The body of notification IECSC Data gap analysis You need more attention to this work; it affects cost and time Inquiry Testing Proposal Largely dependent on the capacity of the contracted lab Testing arrangement Largely dependent on the capacity of the contracted lab Dossier generation Dossier template decided by CRC, some information needed from company (like uses of new chemical)  Spectrum  Toxic data  Eco-toxic data HelpyouKnowit 1  Chem-physic data 2 3 Driving Green Chemical
  • Updates on 14 Dec 2011 NEXTPAGE >Data & Lab- Must all data be generated in China? Typical Notification The data of 1st and 2nd category is preferred 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 about whether data generated outside China Minimum tests accepted. conducted 1-10tpa Around 3 Months Tests must be in 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 country carried out in Chinashowed in front of the western nations. Most Recommend: 10-100tpa Around 3-5 Monthsstudies may be referenced if they were performedto accepted standards by a lab meeting MEP 1-10tpa 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 between solid 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 Months 1-10tpa +10-100tpa tests + chronic toxicity Chronic toxicity test for fishes test for fishes 9 Eco-toxic labs approved by the MEP http://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm
  • Updates on 14 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Typical Notification Preparation Notification Post-notification Preliminary Necessary Certificate Management Stage Steps  MSDS and hazardous information General New Chemicals IECSC Notify communicated to downstream users  Risk management measures conducted Inquiry  First-activity report submission Hazardous  Registered information to be updated New Chemicals (tonnage level, uses, activity, the Authorized Approved by MEP holder of the notification certificate) Priority hazardous new  Keep documents on file for over 10 chemical substances for years environmental  New hazard to be updated if needed be management  Only downstream users who are Restricted capable of the implementation of risk For those 2, more measures allowed to buy products obligations added from the certificate holders.
  • Updates on 14 Dec 2011 NEXTPAGE > Implementation- Compliant guidance Typical Notification 5-year Notification completed New chemicals Added in IECSC First activity Using (sale) or Manufacturing of the Hazardous New Chemicals(Authorization) + new chemical for the first time after its - 1st activity report + annual activity report notification in China Priority hazardous new chemical substances 1st The activity should be reported to for environmental management (Restricted ) - 1st activity report + each activity report + the MEP as the first date of 5-year5-year annual 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 would triggered the action of being added in the IECSC automatically. For other 2 categories, Hazardous new chemicals, Priority hazardous new chemical substances for environmental management would be evaluated from multi-aspect during the 5 years. So the process could be much more complex.
  • Updates on 31 Dec 2011 NEXTPAGE > Implementation- Compliant guidance Simplified Notification > Basic Condition Studies required Notification duration: 5-10 Months Preparation Notification Post-notification Preliminary Data & Dossier & Doc Development Submission Annual Report to the authority: Stage   Scientific Record Form Simplified Notification Form Before 01 Feb  The figures of the production of  Test report notified new chemical substance IECSC  Other information: ES, production process (annual tonnage, production days ); or Inquiry tonnage imported etc.  Chem-physic data  Eco-toxic data 1 2  The transfer information of the notified  melting point within China  water-solubility  Ready biodegradation new chemicals, including the overall  Partition coefficient  Acute toxicity test for fishes tonnage of transfer and major n-octanol/water  Acute toxicity test for recipients etc. in last year earthworm Test duration: 4-6 Months  The updated or renewed information9 Eco-toxic labs approved by the MEP of the notified new chemicalhttp://www.mep.gov.cn/info/bgw/bgg/200903/t20090327_135772.htm substances during last year.
  • Updates on 31 Dec 2011 NEXTPAGE >Implementation- Compliant guidanceSimplified Notification > Special Condition No Studies required Notification duration: 3-4 Months Acquiring certificate consumes much time Preparation Notification Post-notification Preliminary Annual Report to the authority: Stage Dossier and Document Development 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 ); or Inquiry   Documents as proof of specific condition Other information: ES, production process tonnage imported etc. Polymer: GPC –  The transfer information of the notified Gel Permeation Chromatography new chemicals, including the overall tonnage of transfer and major recipients etc. in last year  The updated or renewed information of the notified new chemical substances during last year.
  • Updates on 31 Dec 2011 NEXTPAGE > Implementation- Compliant guidanceBring your doubts after reading the following pages Simplified Notification > Special Condition No Studies required Case 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 enough Order 7 by MEP entered into force Oct 2010 1 year 2% < A new substance in Polymer Monomer is less than 2% (w/w) Aug 2011 Simplified NotificationPlease be advised:No tonnage limit on the import of such polymer product is required,so please consider about higher tonnage band during notification “Please be noticed: One year of exemption transitional time has passed.”
  • Updates on 31 Dec 2011 NEXTPAGE >Implementation- Compliant guidance Scientific Research Record Scientific Preparation Post-notification Research Record Preliminary For scientific Stage research use only  Scientific project starts Notification Material Submission Development to be conducted Typical notification  Laboratories conduct IECSC 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
  • 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-effective Cost 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 fee the 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 cases 80% 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 pages Data & 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. Administrative Local 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)
  • Updates on 31 Dec 2011 NEXTPAGE > How we offer our helpNot just providing compliance work, we are also well known to your suppliers in China Preparation 1 1. Typical Notification Preliminary Stage IECSC Search & Decide 2. Simplified Notification 3. Scientific Record Notification 2 Scientific Record  Information collection The easiest notification  document preparation Basic or Special Condition? Basic Condition Specific Condition Simplified Notification + Scientific Record  Information collection  Forms and documents and document  Studies analysis and tests preparation proposal  Notification dossier  Eco-toxicology properties submission and follow tests arrangement & up follow up  Dossier develop and submission; progress report + Scientific Record Typical Notification  Forms and documents preparation  Data valuation, literature review, tests proposal  Tests arrangements and follow up  Dossier develop and submission; progress report Post-Notification 3 & follow up 1. Preparation and Updating of information 2. Keep contacting the local authorities, reporting necessary issues to fulfill obligation
  • Updates on 22 Nov 2011 NEXTPAGE > Please be advised-Way of Simplified Notification changed soon Transitional Time Till 31 Dec 2011 Online Simplified Notification Started 2012 Alternative 1: Alternative 1: Paper Notification Material (SEAL) Paper Notification Material (SEAL) CRC-MEP Alternative 2: Email Notification Material (SEAL) Ok XNotification Body On test: Alternative 2: Web-based Notification System Web-based Notification System CRC-MEP Client-side Download: http://www.crc- mep.org.cn/news/NEWS_DP.aspx?TitID=379&T0=01000&Lan guageType=CH&Sub=125 Contact: Ma Xin - Max@crc-mep.org,cn IT Support: Deng Qing- Dengq@crc-mep.org,cn Simplified Notification Material Basic condition: Specific condition: Limited Information & 3 Studies needed Very Limited information needed
  • Updates on 27th Apr 2012 NEXTSECTOR > Please be advised-Way of Scientific Research Record has changed Transitional Time Till 01 May 2012 Online Record Started afterward Alternative 1: Alternative 1: Paper Notification Material (SEAL) Paper Notification Material (SEAL) CRC-MEP Alternative 2: Email Notification Material (SEAL) Ok XNotification Body On test: Alternative 2: Web-based Notification System Web-based Notification System CRC-MEP Client-side Download: http://www.crc- mep.org.cn/news/NEWS_DP.aspx?TitID=392&T0=01000&Lan guageType=CH&Sub=125 Contact:+ 86 010-849 176 56 Zhao Yuan- Zhaoyuan@crc-mep.org.cn IT Support:+86 010-849 152 89 Deng Qing- Dengq@crc-mep.org,cn Contact: Ma Xin - Max@crc-mep.org,cn IT Support: Deng Qing- Dengq@crc-mep.org,cn
  • NEXTSECTOR >Next sector is about“Decree 591”This is the major hazardous chemical control law in China, which is highly related withChina GHS implementation and other inspection issues mentioned in later sectors HelpyouKnowit Driving Green Chemical
  • State CouncilDECREE591 > HelpyouKnowit Driving Green Chemical
  • NEXTPAGE > Decree 591 is revised State Council State Council[2002] Decree 344 replaced by Decree 591 by SC Substance + Mixture regulated at same timeSC Decree 591 WillEnter into force The 1st Regulation replaced by 01 Dec 2011 State Council[2002] Decree 344SC Decree 591 Issued 02 Mar 2011 X China GHS started on 1 May 2011 (both Substance + MixtureSC Decree 344 Entered regulated at same time) 15 Mar 2002into force XSC 1st Regulation 17 Feb 1987Issued & Entered into force 1987: Regulation Decree 344: Regulation Decree 591: Regulation On the safe on the Control over on Safe Management of Management of Safety of Hazardous Hazardous Chemicals Hazardous Goods Chemicals HelpyouKnowit Driving Green Chemical
  • Updates on 28 Nov 2011 NEXTPAGE >What the registration looks like? Different Roles Process State Council Regulation issued by State Council Regulation releasing SAWS SAWS takes charge of management State Administration of Work SAWS 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.htm Receive Registration Application +86 532 8378 659 3 NRCC-SAWS Formal Check of materials (NRCC) Registration Call-in Submit information (easier than China REACH) for 3-year-valid certification & Renew 3 Registrant months before expiry Importer & 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 | MPS Administration of Custom | AQSIQ
  • Updates on 16 Dec 2011 NEXTPAGE >2 Major catalog of chemicals under SC Decree 591 Finally Over 7,000 in new versionNew China GHS and Catalog ofHazardous Chemicals(first 4000 Likely to be mergedsubstances) would be published firsthalf year of 2012 Catalog of Hazardous Chemicals Catalogue of Extremely Toxic Chemicals(2002rev.) Pure Substance Over 3,800 335 This is a domestic rule, import and export of those toxic chemicals are 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 year chemical substances were borrowed from “Catalog of Dangerous Goods (GB12268- Manufacturers, Importer, other roles (distributors, 1990)- now has been replaced by 2012 ver.” warehousing and storing companies ) chemicals or even other lists. within Chinese territory need to be sure whether any of their chemical products are listed in the If purchase or transport of chemicals in the Catalog, especially sensitive to the newest version catalog of extremely toxic chemicals happens, upcoming. companies will be required to apply for some licenses before actions. But as we believe, the new version firstly comes up as a draft before it become the decided one. Download
  • 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 Trouble HelpyouKnowit Driving Green Chemical
  • Updates on 05 Dec 2011 NEXTPAGE > Under Decree 591, registration is the responsibility of Importer & Manufacturers in China But, 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, storage obligation, registration, license, implementation, company enforcement authorities Transportation company in China Manufacturer (chemical user) in China You should pay more attention to under 591 Companies located outside China GHS compliant, SDSs and labels are necessary You may have your contracted suppliers or partners in China be aware of this law
  • Updates on 05 Dec 2011 NEXTPAGE > Obligation: Registration & License Led by SAWs Roles Registration Main License Chemical List Manufacturer Registration Certificate License of Manufacturing Safety 1 China Importer Registration Certificate License of Operation Safety 2 China Classification & labels SDS Distributor License of Operation Safety 3 Warehousing X Transportation License of Transportation on Road 4 Companies X License of Transportation in Water Manufacturer License of Using Safety 5 Chemical User X Roles Chinese Manufacturers Distributors1 Bulk Chinese producers of Hazardous Chemicals Catalog of Hazardous2 Hazardous Chemicals importers within Chinese territory Chemicals (Ver.2002 to be updated)3 Hazardous Chemicals Distributor s or warehousing service providers Chinese Manufacturers4 Bulk Chinese producers of Hazardous Chemicals Distributors Inventory of Toxic Chemicals Chinese Manufacturer5 Companies 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
  • Updates on 05 Dec 2011 NEXTPAGE > Your roles decide your obligations under Decree 591 Different roles mean different obligations and enforcement authorities Manufacturers in China Obligation Responsible Authorities What to be prepared (different forms and documents usually) In case that a company using hazardous chemicals Submit Registration  NRCC of SAWS  Registration Form in its production and the - (final check)  Technical Safety Instruction of final product still a  Local registration chemicals (Important) hazardous chemicals in the offices(province)  Label (Important) Catalog of Hazardous - (receive registration and check)  Emergency call (or contracted service) Chemicals, this company NRCC registration platform:  Business license issued by Industrial and needs to do registration and http://register.nrcc.com.cn/ apply for the License of Commercial Bureau Manufacturing Safety.  Documents and ApplicationThis company should be  Manufacturing Safety rulesconsidered as a Manufacturer Routine Practicerather than a Manufacturer License of Manufacturing Safety State Administration of Work Stewardship 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 & Record are being manufactured after  Emergency Rescue Checklist acquiring registration … certificate and license, the manufacturer needs to Safety License of Occupational NA NA update both certificate as Hygiene well as License of Manufacturing Safety SAWS: http://www.chinasafety.gov.cn/newpage/ NRCC: http://www.nrcc.com.cn/ TEL: +86 (0)532 83 8891 91 Local Registration office: HelpyouKnowit http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=243&ChannelID=180 Driving Green Chemical
  • Updates on 05 Dec 2011 NEXTPAGE > 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 and http://register.nrcc.com.cn/ Commercial Bureau  Application form of business license of hazardous chemicals  Catalog of relevant production safety documents License of Operation Safety Local Work Safety Department  Work safety standards and manual (Same required as Distributor – (province )  Safety training and training materials Warehousing & Storing)  Budget raised for manufacturing safety of hazardous chemicals and budget report FIND 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-declaration inspection  Local CIQ (for direct - SDS and label document implementation - If the Record completed, submit it (to 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 91 HelpyouKnowit Driving Green Chemical Local Registration office: http://www.nrcc.com.cn/Web/Information/InformationList.aspx?CategoryID=24 3&ChannelID=180
  • Updates on 09 Dec 2011 NEXTPAGE > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authorities Distributor Obligation Responsible Authorities What to be prepared (different forms and documents usually) Warehousing & Storing Local Work Safety Department  Application form of business license of – (City-level) hazardous chemicals  Catalog of relevant production safety Responsible 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 safety of hazardous chemicals and budget License of Operation Safety report (Same required as Importer )  Injury Insurance for employees or Local Work Safety Department production liability insurance proof – (County-level )  Business license issued by Industrial and Commercial Bureau Responsible 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 a company is equipped with storage facilities(gas station for example) *Extremely toxic chemicals – a list of chemicals issued in 2002 (335 chemicals up till now) *Explosive chemicals - also a separated list of chemicals 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 have HelpyouKnowit 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.
  • Updates on 15 Dec 2011 NEXTPAGE > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authoritiesTransportation Companies Obligation Responsible Authorities Implementation (different forms and documents usually)  “TDG business” Application Form  Daft report of dangerous goods, Transport License of Dangerous Goods Ministry 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 Road Investor and personnel in charge  Testimonial documents of parking area for special vehicles, capabilities of safety protection, environmental protection and fire fighting device equipped … NA NA NA Transport of Dangerous Goods by Water  Report of toxic chemicals and quantity to be transported Transport License of Toxic Chemicals Public 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 Chemicals by the Customs on Road  The qualification of drivers and other certificates * GB12268-2012: (here in Chinese) the inventory of dangerous goods MoT: 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 below http://issuu.com/mai.fung/docs/inventory_of_toxic_chemicals__for_transport_and_pu?mode=window&backgroundColor=%23222222
  • Updates on 09 Dec 2011 NEXTSECTOR > Your roles decide your obligations under Decree 591Different roles mean different obligations and enforcement authorities Manufacturers in China Obligation Responsible Authorities Implementation (different forms and documents usually) Chemical User  Emergency Rescue Plan & Record A Company using  Emergency Rescue document hazardous chemicals as  Technical Safety Instruction of major materials or even Chemicals additives 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 and rules … 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. HelpyouKnowit Driving Green Chemical
  • NEXTPAGE >Next sector is about“China GHS – SDS + Label” HelpyouKnowit Driving Green Chemical
  • Updates on 27 Apr 2012 NEXTPAGE > + HelpyouKnowit Driving Green Chemical
  • Updates on 27 Apr 2012 NEXTPAGE > Chemicals
  • Updates on 27 Apr 2012 NEXTPAGE >
  • Updates on 27 Apr 2012 NEXTPAGE >   
  • 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  GB15258-2009 Instruction 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
  • 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 . HelpyouKnowit Driving Green Chemical
  • Updates on 13 Apr 2012 NEXTPAGE >Content – Introduction of the SDS part China SDS National Standard GHS Comparison Content and Sample of SDS Download Section (qualified copy) GB 16483-2008 English ver.
  • Updates on 13 Apr 2012 NEXTPAGE >Content – Introduction of the SDS part China SDS National Standard GHS Comparison Content and Sample of SDS Download Section (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 GHS New China GHS and Catalog of Hazardous Chemicals (first 4000 substances) would be published first half year of 2012 Download classification national standards Chinese ver.
  • NEXTPAGE > China | UN | EU GHS comparison table helps you work easilyPhysical Hazards Health Hazards Environmental Hazards HelpyouKnowit Driving Green Chemical
  • Updates on 13 Apr 2012 NEXTPAGE >UN GHS 4th – Do you know something new happened? Hazardous statement newly added in 4th Version + Content deleted in 4th Version - P281 H229 P285 Pressurized container: may burst if heated. P307 | P309 | P322 | P341 H230 P350 | 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 P223 P244 statement modified Precautionary statement newly added in 4th Version + P251 P284P364 P310 P311And wash it before reuse. P312 P340P308+311IF exposed or concerned: Call a POISONCENTER/doctor/... P352 P361P361+364 P362 P378Take off immediately all contaminated clothing andwash it before reuse. P301+310 P301+312P362+P364Take off contaminated clothing and wash it before P302+352 P304+312reuse. P304+340 P342+311 Find UN GHS
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – Category Table I : physical hazards Hazard categories under GHS in different areas UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008) Current China GHS Replacing DSD & DPD since Jun 1 2015 Based on UN GHS 2007 Ver.02PhysicalHazards 2.1 Explosive GB 20576-2006 Explosive 2.2 Flammable gases GB 20577-2006 Flammable gases 2.3 Flammable aerosols GB 20578-2006 Flammable aerosols 2.4 Oxidising gases GB 20579-2006 Oxidizing gases 2.5 Gases under pressure GB 20580-2006 Gases under pressureDownload GB 2.6 Flammable liquids GB 20581-2006 Flammable liquids 2.7 Flammable solids The same as UN GHS GB 20582-2006 Flammable solids 2.8 Self-reactive substances and GB 20583-2006 Self-reactive mixtures substances(mixture included) 2.9 Pyrophoric liquids GB 20584-2006 Self-heating substances 2.10 Pyrophoric solids (mixture included) Slightly different 2.11 Self-heating substances and GB 20585-2006 Pyrophoric Liquids mixtures GB 20586-2006 Pyrophoric Solids 2.12 Substances and mixtures which in GB 20587-2006 Substance which, in contact contact with water emit flammable with water, emit flammable gases (water gases reactive) 2.13 Oxidising liquids GB 20588-2006 Corrosive to Metals 2.14 Oxidising solids GB 20589-2006 Oxidizing liquids Slightly different 2.15 Organic peroxides GB 20590-2006 Oxidizing solids 2.16 Corrosive to metals GB 20591-2006 Organic peroxides 16 hazards 16 hazards 16 hazards Remark: 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 you confused while reading. Some classification could be different: Flammable gases | Flammable aerosols EU CLP DSD - 67/548/EEC Dec 01 Classification Labeling Packaging (EC 1272/2008) Jun 01 Only CLP remained Timeline DPD -1999/45/EC 2010 + DPD & DSD 2015
  • Updates on 13 Apr 2012 NEXTPAGE >Help you to read the following content Building-block-adopted differentiation China GHS EU GHS UN GHS 4th Unstable | Div. 1.1 Div.1.2 Div. 1.3 Div. 1.4 Div. 1.5 Div. 1.6 Building blocks GHS 01 GHS 02 GHS 03 GHS 04 GHS 05 GHS 06 GHS 07 GHS 08 GHS 09
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for physical hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20576-2006 Explosive Unstable | Div. 1.1 Div.1.2 Div. 1.3 Div. 1.4 Div. 1.5 Div. 1.6 No No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 Danger | 危险 H 200 | H 201 H 202 H 203 H 204 H 205 China GHS EU GHS UN GHS 4th A (Chemically B (ChemicallyGB 20577-2006 Flammable Gases Category 1 Category 2 unstable gases) stable gases) No Danger | 危险 Warning | 警告 H 220 H 221 China GHS EU GHS UN GHS 4thGB 20578-2006 (Flammable) Aerosols Category 1 Category 2 Category 3 Danger | 危险 Warning | 警告 H 222 H 223
  • HelpyouKnowitChina GHS – H statementGB 20576-2006 Explosive 不稳定爆炸物 D 爆炸物:整体爆炸危险 Unstable | Div. 1.1 D 爆炸物;严重喷射危险 Div.1.2 D 爆炸物:燃烧,爆 轰或喷射危险 Div. 1.3 W 燃烧或喷射危险 Div. 1.4 No D 燃烧中可爆炸 Div. 1.5 No Div. 1.6• X please follow GB 22234-2008
  • HelpyouKnowitChina GHS – H statement GB 20577-2006 Flammable Gases D 极易燃气体 Category 1 W 易燃气体 No Category 2 UN GHS A UN GHS B
  • HelpyouKnowitChina GHS – H statement GB 20578-2006 (Flammable) Aerosols D Category 1 易燃性极高的压力下气体(加热可能爆炸) W Category 2 可燃,易燃压力下气体UN GHS W Category 3• 易燃性极高的压力下气体 极易燃气溶胶 X 可燃,易燃压力下气体 易燃气溶胶 X
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for physical hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20579-2006 Oxidizing Gases Category 1 Danger | 危险 H 270 China GHS UN GHS 4th EU GHS RefrigeratedGB 20580-2006 Gases under pressure Compressed gases Liquefied gases liquefied gases Dissolved gases Warning | 警告 Warning | 警告 Warning | 警告 Warning | 警告 H 280 H 280 H 281 H 280 China GHS EU GHS UN GHSGB 20581-2006 Flammable Liquids Category 1 Category 2 Category 3 Category 4 No Danger | 危险 Danger | 危险 Warning | 警告 H 224 H 225 H 226 H 227
  • HelpyouKnowitChina GHS – H statement GB 20579-2006 Oxidizing Gases D 可能导致或加剧燃烧; Category 1 氧化剂 Labeling of Chemicals Based on GHS X
  • HelpyouKnowitChina GHS – H statement GB 20580-2006 Gases under pressure W 压力下 Compressed gases 气体;加热可能爆炸 W 压力下气 Liquefied gases 体;加热可能爆炸 W Refrigerated 冷冻液化气体;可能造成低温灼伤或损伤 liquefied gases W 压力下气 体;加热可能爆炸 Dissolved gases
  • HelpyouKnowitChina GHS – H statement GB 20581-2006 Flammable Liquids D 极易燃的液体及气体 Category 1 D 高度易燃的液体及气 Category 2 体 W 易燃的液体及气体 Category 3 W 可燃性气体 No Category 4
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for physical hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20582-2006 Flammable Solids Category 1 Category 2 Danger | 危险 Warning | 警告 H 228 H 228 China GHS UN GHS 4th EU GHS Self-reactiveGB 20583-2006 Type A Type B Type C & D Type E& F Type GSubstances (mixtures included) No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 H 240 H 241 H 242 H 242 China GHS UN GHS EU GUS Self-heatingGB 20584-2006 Category 1 Category 2Substances (mixtures included) Danger | 危险 Warning | 警告 H 251 H 252
  • HelpyouKnowitChina GHS – H statement GB 20582-2006 Flammable Solids D 易燃固体 Category 1 W 易燃固体 Category 2
  • HelpyouKnowitChina GHS – H statementGB 20583-2006 Self-reactive substances (mixtures included) D 加热可能引起爆炸 Type A D 加热可能引发火灾或 Type B 爆炸 D 加热可能引发火灾 Type C & D W 加热可能引发火灾 Type E & F No Type G
  • HelpyouKnowitChina GHS – H statement GB 20584-2006 Self-heating substances (mixtures included) D 自热,可能引起火灾 Category 1 W 大量时,自热, Category 2 可能引起火灾
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for physical hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20585-2006 Pyrophoric Liquids Category 1 Danger | 危险 H 250 China GHS UN GHS 4th EU GHSGB 20586-2006 Pyrophoric Solids Category 1 Danger | 危险 H 250 China GHS UN GHS 4th EU GUSGB 20587-2006Substance which, in Category 1 Category 2 Category 3contact with water, emit flammablegases (water reactive) Danger | 危险 Danger | 危险 Warning | 警告 H 260 H 261 H 261
  • HelpyouKnowitChina GHS – H statement GB 20585-2006 Pyrophoric Liquids D 与空气会发生自 Category 1 燃
  • HelpyouKnowitChina GHS – H statement GB 20586-2006 Pyrophoric Solids D 与空气会发生自 Category 1 燃
  • HelpyouKnowitChina GHS – H statement Substance which, in contact with water, emit flammable GB 20587-2006 gases (water reactive) D 接触到水后,会产生可能引起自燃的可燃性, Category 1 易燃性气体 D 接触到水后, 会产生可燃性,易燃性气体 Category 2 W 接触到水后, 会产生可燃性,易燃性气体 Category 3
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for physical hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20588-2006 Corrosive to Metals Category 1 Warning | 警告 H 290 China GHS UN GHS 4th EU GHSGB 20589-2006 Oxidizing Liquids Category 1 Category 2 Category 3 Danger | 危险 Danger | 危险 Warning | 警告 H 271 H 272 H 272 China GHS UN GHS 4th EU GUSGB 20590-2006 Oxidizing Solids Category 1 Category 2 Category 3 Danger | 危险 Danger | 危险 Warning | 警告 H 271 H 272 H 272
  • HelpyouKnowitChina GHS – H statement GB 20588-2006 Corrosive to Metals W 可能腐蚀金属 Category 1
  • HelpyouKnowitChina GHS – H statement GB 20589-2006 Oxidizing Liquids D 可能会引起燃烧 Category 1 或者发生爆炸;强氧化物 D 可能助加剧燃烧;氧化物 Category 2 W 可能助加剧燃烧;氧化物 Category 3 Labeling of Chemicals Based on GHS X
  • HelpyouKnowitChina GHS – H statement GB 20590-2006 Oxidizing Solids D 可能会引起燃烧 Category 1 或者发生爆炸;强氧化物 D 可能助加剧燃烧;氧化物 Category 2 W 可能助加剧燃烧;氧化物 Category 3 Labeling of Chemicals Based on GHS X
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for physical hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20591-2006 Organic peroxides Type A Type B Type C & D Type E& F Type G No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 H 240 H 241 H 242 H 242 HelpyouKnowit Driving Green Chemical
  • HelpyouKnowitChina GHS – H statementGB 20591-2006 Self-reactive substances (mixtures included) D 加热可能引起爆炸 Type A D 加热可能引发火灾或 Type B 爆炸 D 加热可能引发火灾 Type C & D W 加热可能引发火灾 Type E & F No Type G
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – Category Table II : health hazards Hazard categories under GHS in different areas UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008) Current China GHS Replacing DSD & DPD since Jun 1 2015 Based on UN GHS 2007 Ver.02HealthHazards 3.1 Acute toxicity(Oral | Skin | Inhalation) GB 20592-2006 Acute toxicity(Oral | Skin | Inhalation) 3.2 Skin corrosion/irritation GB 20593-2006 Skin corrosion/irritation 3.3 Serious eye damage/eye irritation GB 20594-2006 Serious eye damage/eye irritation 3.4 Respiratory or skin sensitization GB 20595-2006 Respiratory or skin sensitization 3.5 Germ cell mutagenicity GB 20596-2006 Germ cell mutagenicityDownload GB 3.6 Carcinogenicity GB 20597-2006 Carcinogenicity 3.7 Reproductive toxicity The same as UN GHS GB 20598-2006 Reproductive toxicity 3.8 Specific target organ toxicity — single GB 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 exposure repeated exposure 3.10 Aspiration hazard Absent from China GHS 10 hazards 10 hazards 9 hazards Remark: China GHS mostly copied from UN GHS 2007 version, but some classification has been changed. Specifically Skin | Respiratory sensitization STOT-single exposure Aspiration hazard
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for health hazards A combination with which you work even more easily China GHS EU GHS UN GHS 4thGB 20592-2006 Acute Toxicity Category 1 Category 2 Category 3 Category 4 Category 5(Oral) No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 Warning | 警告 + H 300 H 300 H 301 H 302 H 303 China GHS EU GHS UN GHS 4thGB 20592-2006 Acute Toxicity Category 1 Category 2 Category 3 Category 4 Category 5(Skin) No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 Warning | 警告 + H 310 H 310 H 311 H 312 H 313 China GHS EU GHS UN GHS 4thGB 20592-2006 Acute Toxicity Category 1 Category 2 Category 3 Category 4 Category 5(Inhalation) No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 Warning | 警告 H 330 H 330 H 331 H 332 H 333
  • HelpyouKnowitChina GHS – H statementGB 20592-2006 Acute Toxicity (Oral) D 吞咽致命 (口服) Category 1 D 吞咽致命(口服) Category 2 D 吞咽会中毒(口服) Category 3 W 吞咽有害(口服) Category 4 W 吞咽可能有害(口服) No Category 5
  • HelpyouKnowitChina GHS – H statementGB 20592-2006 Acute Toxicity (Skin) D 接触皮肤致命 皮肤 Category 1 D 接触皮肤致命 皮肤 Category 2 D 接触皮肤会中毒 皮肤 Category 3 W 接触皮肤有害 皮肤 Category 4 W 接触皮肤可能 No 有害 皮肤 Category 5
  • HelpyouKnowitChina GHS – H statementGB 20592-2006 Acute Toxicity (Inhalation) D 吸入致命(气体 蒸汽 Category 1 粉尘 烟雾) D 吸入致命(气体 蒸汽 粉尘 烟雾) Category 2 D 吸入会中毒(气体 蒸汽 粉尘 烟雾) Category 3 W 吸入有害(气体 蒸汽 粉尘 烟雾) Category 4 W 吸入可能有害(气体 蒸 No 汽 粉尘 烟雾) Category 5
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for health hazards A combination with which you work even more easily China GHS EU GHS UN GHS 4thGB 20593-2006 Skin corrosion/ Category 1A Category 1B Category 1C Category 2 Category 3irritation No Danger | 危险 Danger | 危险 Danger | 危险 Warning | 警告 Warning | 警告 H 314 H 314 H 314 H 315 H 316 China GHS EU GHS UN GHS 4thGB 20594-2006 Serious eye damage Category 1 Category 2A Category 2B/eye irritation No Danger | 危险 Warning | 警告 Warning | 警告 H 318 H 319 H 320
  • HelpyouKnowitChina GHS – H statementGB 20593-2006 Skin corrosion/ irritation D 严重灼伤皮肤,损 Category 1A 伤眼睛 D 严重灼伤皮肤,损 Category 1B 伤眼睛 D 严重灼伤皮肤,损 伤眼睛 Category 1C W 对皮肤有刺激 Category 2 W 对皮肤有轻度刺激 No Category 3
  • HelpyouKnowitChina GHS – H statement GB 20594-2006 Serious eye damage /eye irritation D 造成眼的严重损伤 Category 1 W 对眼有强烈的刺激 Category 2A W 刺激眼 No Category 2B
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for health hazards A combination with which you work even more easily China GHS EU GHS UN GHS 4th RespiratoryGB 20595-2006 Category 1 Category 1A Category 1Bsensitization Danger | 危险 Danger | 危险 Danger | 危险 + H 334 H 334 H 334 China GHS EU GHS UN GHS 4thGB 20595-2006 Skin sensitization Category 1 Category 1A Category 1B Warning | 警告 Warning | 警告 Warning | 警告 H 317 H 317 H 317
  • HelpyouKnowitChina GHS – H statement GB 20595-2006 Respiratory sensitization D Category 1 吸入后可能引起过敏,哮喘或呼吸困难
  • HelpyouKnowitChina GHS – H statement GB 20595-2006 Skin sensitization W 可能引起皮肤过敏 Category 1
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for health hazards A combination with which you work even more easily China GHS UN GHS 4th EU GHSGB 20596-2006 Germ cell Category 1A Category 1B Category 2mutagenicity Danger | 危险 Danger | 危险 Warning | 警告 H 340 H 340 H 341 China GHS UN GHS 4th EU GHSGB 20597-2006 Carcinogenicity Category 1A Category 1B Category 2 Danger | 危险 Danger | 危险 Warning | 警告 H 350 H 350 H 351 China GHS UN GHS 4th EU GHS Additional:GB 20598-2006 Reproductive Category 1A Category 1B Category 2 Lactationtoxicity No Danger | 危险 Danger | 危险 Warning | 警告 H 360 H 360 H 361 H 362
  • HelpyouKnowitChina GHS – H statement GB 20596-2006 Germ cell mutagenicity D 可能导致遗传性疾病(如果很确定地证明没有其他接触 Category 1A 途径会产生这一危险,那么应说明会产生这一会还的接触途径) D 可能导致遗传性疾病(如果很确定地证明没有其他接触 Category 1B 途径会产生这一危险,那么应说明会产生这一会还的接触途径) 怀疑有可能导致遗传性疾病(如果很确定地证明没有 W 其他接触途径会产生这一危险,那么应说明会产生这一会还的接 Category 2 触途径)
  • HelpyouKnowitChina GHS – H statement GB 20597-2006 Carcinogenicity D 可能致癌 (如果很确定地证明没有其他接触途径会产生这一危险,那么应 Category 1A 说明会产生这一会还的接触途径) D 可能致癌 (如果很确定地证明没有其他接触途径会产生这一危险,那么应 Category 1B 说明会产生这一会还的接触途径) W 怀疑有可能致癌(如果很确定地证明没有其他接触途径 Category 2 会产生这一危险,那么应说明会产生这一会还的接触途径)
  • HelpyouKnowitChina GHS – H statementGB 20598-2006 Reproductive toxicity 可能影响生育能力或胎 D 儿有损害(如果已明确,要说明影响的具体内容)或(如果很确 定地证明没有其他接触途径会产生这一危险,那么应说明会产生 Category 1A 这一会还的接触途径) 可能影响生育能力或胎 D 儿有损害(如果已明确,要说明影响的具体内容)或(如果很确 定地证明没有其他接触途径会产生这一危险,那么应说明会产生 Category 1B 这一会还的接触途径) 怀疑影响生育能力或胎 D 儿有损害(如果已明确,要说明影响的具体内容)或(如果很确 定地证明没有其他接触途径会产生这一危险,那么应说明会产生 Category 2 这一会还的接触途径) W 可能对哺乳期的婴儿 No Additional: 造成伤害 “ ”(可能) Lactation
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for health hazards A combination with which you work even more easily UN GHS 4th China GHS EU GHSGB 20599-2006 Specific target Category 1 Category 2 Category 3organ system toxicity-singleexposure (STOT) Danger | 危险 Warning | 警告 Warning | 警告 H 370 H 371 H 335 | H 336 China GHS UN GHS 4th EU GHSGB 20601-2006 STOT-repeated Category 1 Category 2exposure Danger | 危险 Warning | 警告 H 372 H 373 EU GHS UN GHS 4th Category 1 Category 2Aspiration hazardCurrently absentfrom China GHS ! Danger | 危险 Warning | 警告 H 304 H 305
  • HelpyouKnowitChina GHS – H statement GB 20599-2006 Specific target organ system toxicity-single exposure 造成器官的损害 (如 D 果已明确,要说明受影响的所有器官)或(如果很确定地证明没 有其他接触途径会产生这一危险,那么应说明会产生这一会还的 Category 1 接触途径) 可能造成器官的损害 W (如果已明确,要说明受影响的所有器官)(如果很确定地证明 没有其他接触途径会产生这一危险,那么应说明会产生这一会还 Category 2 的接触途径) UN GHS W Category 3• (刺激气管)可能造成对呼吸器官的刺激 X 麻醉作用 可能引起嗜睡或头晕 X
  • HelpyouKnowitChina GHS – H statement GB 20601-2006 Specific target organ system toxicity-repeated exposure 由长期或反复接触引起的器官损害 (如果已明 D 确,要说明受影响的所有器官)或(如果很确定地证明没有其他 接触途径会产生这一危险,那么应说明会产生这一会还的接触途 Category 1 径) 由长期或反复接触 可能引起的器官损害 (如果 W 已明确,要说明受影响的所有器官)或(如果很确定地证明没有 其他接触途径会产生这一危险,那么应说明会产生这一会还的接 Category 2 触途径)
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – Category Table III : environmental hazards Hazard categories under GHS in different areas UN GHS (2011 Ver. 04) EU CLP (EC 1272/2008) Current China GHS Replacing DSD & DPD since Jun 1 2015 Based on UN GHS 2007 Ver.02EnvironmentalHazards 4.1 Hazardous to the aquatic GB 20602-2006 Hazardous to the aquatic environment environment 4.2 Hazardous to the ozone layer Absent from China GHSDownload GB The same as UN GHS 2 hazards 2 hazards 1 hazards Remark: China GHS mostly copied from UN GHS 2007 version, but some classification has been changed. Specifically Hazardous to the ozone layer
  • Updates on 13 Apr 2012 NEXTPAGE > China GHS – classification and pictogram for environmental hazards A combination with which you work even more easily China GHS EU GHS UN GHS 4th Hazardous toGB 20602-2006 Category 1 Category 2 Category 3the aquatic environment No No(Acute) Warning | 警告 H 400 + H 401 H 402 China GHS UN GHS 4th EU GHSGB 20602-2006 Hazardous to Category 1 Category 2 Category 3 Category 4the aquatic environment No No(Chronic | Long-term) Warning| 警告 H 410 H 411 H 412 H 413 EU GHS UN GHS 4th Category 1 Category 1Hazardous to the OzoneLayer No VSCurrently absentfrom China GHS ! Danger | 危险 EUH 059 Warning | 警告 H 420 EUH 059 H 420 Hazardous to the ozone layer Harms public health and the environment by destroying ozone in the upper atmosphere
  • HelpyouKnowitChina GHS – H statement GB 20602-2006 Hazardous to the aquatic environment (Acute) W 对水生生物有非常强的毒害 Category 1 对水生生物有毒害 No Category 2 对水生生物有害 No Category 3
  • HelpyouKnowitChina GHS – H statement GB 20602-2006 Hazardous to the aquatic environment (Chronic | Long-term) W 对水生生物 Category 1 毒性非常大并且有长期持续影响 对水生生物有 毒并且有长期持续影响 Category 2 No 对水生生物有 害并且有长期持续影响 Category 3 No 可能对 Category 4 水生生物产生长期持续的有害影响
  • Updates on 13 Apr 2012 NEXTPAGE > 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 01 GHS 02 GHS 03Physical | Healthhazards If or then optional GHS 06 GHS 02 GHS 04Health hazards Health hazards If then absent If then absent GHS 06 GHS 07 GHS 08 GHS 07Health hazards For Respiratory sensitization If then absent For Skin sensitization or In hazards of Skin or eye irritation Skin & Eye irritation GHS 05 GHS 07 (GB20593-2006 | GB 20594-2006)
  • Updates on 13 Apr 2012 NEXTPAGE > 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 APPEAR Health 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.
  • Updates on 13 Apr 2012 NEXTPAGE > SDS – hazard communication always matters China SDS National Standard GHS Comparison Content and Sample of SDS Download Section (qualified copy) Under Under GB16483-2008Regulation (EC) No 1907/2006 (REACH) EU SDS China 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 call English ver. number Different concentration limits Different concentration limits H/P statements in local language H/P statements in Chinese XV section, local regulations added XV section, Chinese regulations XVI section, Risk phrases XVI section, NO Risk phrases Major differentiation between EU SDS & China MSDS
  • Updates on 13 Apr 2012 NEXTPAGE >SDS – hazard communication always matters Largely, current SDS guidance (GB 16483-2008) is quite a Before you read copy cat of both guidance on the preparation of safety (UN GHS) & Annex II (EU REACH) The requirements of each section are not specified in detail, which means that you may not easily prepare your China SDS by following the GB 16483-2008 Moreover, some translation mistakes in the GB 16483-2008 from EU REACH or UN GHS might lead you to confusion So you may need more assistance HelpyouKnowit Driving Green Chemical
  • Updates on 13 Apr 2012 NEXTPAGE > Content – 16 sections one by one (Part I) National Standard: GB 16483-2008 Identification (of product and supplier) S1 1 Chemical Name | Product Code 2 Identification of supplier | Contact | 24h ER # 3 Recommended & Restriction on useSection 1 or Heading 1 Hazard identification (Substances or mixture) S2 Classification of products Hazards profile (H statements) Pictogram | Signal word | H statements 1 2 3 under China GHS Physical | Health | Environmental P Statements (in four sectors) | Other hazards Composition/information on ingredients S3 Substance Define the product Substance Name + CAS # + EC# Substance or Mixture GHS classification All ingredient (impurities included) applied + GHS classification + Concentration (range) Mixture Each name of Concentration (range) & (not all ingredients) Classified ingredients + Classification Only 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 measures S4 General description Subheading:Treatments for different routes Most important symptoms/effects, 1 2 3 Skin | Eye | Inhalation | Ingestion acute and delayed (detailed in section 11) 4 Professional assistance Medical attention or Or doctor’s advice + Special treatment
  • Updates on 13 Apr 2012 NEXTPAGE > Content – 16 sections one by one (Part II)National Standard: GB 16483-2008 Fire-fighting measuresS5 Suitable extinguishing media Special hazards of the product & Special protective equipment & 1 2 3 Unsuitable extinguishing media Special hazards arising from the product precautions for fire-fighters Accidental release measuresS6 1 Personal precautions, 2 Environmental precautions 3 Methods and materials for containment & cleaning Protective equipment up (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 3 Conditions for safe storage (including including advice on technical contact in ways of … incompatibilities) & requirements such as measures materials used in packaging and container of product (substance or mixture) Exposure controls/personal protection Special protection under special conditionsS8 1 Control parameters or 2 Appropriate engineering 3 Individual protection measures and equipment - Exposure limit value controls; providing - Respiratory (Content same as it under EU supplemental information - Hand EU SDS requires - Eye environmental Annex II under EU REACH) besides Section 7 - Skin exposure control
  • Updates on 13 Apr 2012 NEXTPAGE > Content – 16 sections one by one (Part III)National Standard: GB 16483-2008 Physical and chemical properties (endpoints to be filled) Vapour pressure (20°C) (蒸汽压)S9 1 9.1 General Info pH (pH值) Vapour density (蒸气密度) Appearance (形态) Melting point/freezing point (熔点/凝固点) Relative Density (20°C)(密度/相对密度) Form (形状) Initial boiling point and boiling range (沸点 沸程) Water solubility (g/l) (溶解性) Color (颜色) Flash point (闪点) n-Octanol/Water (log Po/w) (n-辛醇/水分配系数) Odour (气味) Upper/lower flammability or explosive(燃烧上下 Auto-ignition temperature (自燃温度) 极限 或爆炸极限) Decomposition temperature (分解温度) 9.2 Other Info Supplementary information 2 Odour threshold (气味阀值) Radioactivity (放射性) Evaporation rate (蒸发速率) Bulk Density (体积密度) Testing methods required if necessary Flammability (Solid, gas) 易燃烧 Explosive properties (爆炸性) Stability and reactivityS10 1 Chemical Stability 2 Reactivity 3 Condition to avoid 4 Incompatible materials 5 Hazard decomposition products Toxicological information Acute toxicity (oral Dermal Inhalation) – mammalS11 1 Toxicokinetics, metabolism and 2 Info on toxicological effects Skin corrosion/Irritation distribution (Supplementary part) Serious eye damage/irritation - EU SDS needs “Aspiration hazard” but China GHS does not require this Respiratory or skin sensitization Germ cell mutagenicity classification Carcinogenicity Provide reliable data generated from tests or referred to 1 competitive source Reproductive toxicity If hazards of a mixture has not been identified through 2 test, then hazards of each ingredients shall be offered STOT-single exposure STOT-repeated exposure
  • Updates on 13 Apr 2012 NEXTPAGE > Content – 16 sections one by one (Part IV)National Standard: GB 16483-2008 More data provided is highly recommended. Ecological information Please indicate the reference.S12 Eco-Toxicity Persistence and Bioaccumulative Mobility in soil 1 2 3 4 (data on aquatic life and degradability potential Other organisms) Disposal ConsiderationsS13 1 Disposal methods 2 Contaminated container and packaging Informed the Down-stream users of the disposal treatment methods methods Transport informationS14 In 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 informationS15 Whether a substance / mixture Safety, health & environmental Informed the Down-stream users 1 2 3 (main ingredients) has been legislation in China for this of the disposal methods - included in some Catalogue or chemical product EU SDS requires Chemical safety assessment Inventory under EU REACH (EU 453/2010) Other informationS16 Advice on professional training, if Disclaimer or other information, 1 Indication of changes 2 3 applicable Recommended restrictions on - Version amended, if applicable EU SDS requires relevant R use phrase in this part.
  • Updates on 13 Apr 2012 NEXTPAGE > Last tips – 16 sections one by one (Part VI)National 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 SDS The 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 understandable Congratulations ! You almost finish China SDS part
  • Updates on 13 Apr 2012 NEXTPAGE >Content – Introduction of the SDS part China SDS National Standard GHS Comparison Content and Sample of SDS Download Section (qualified copy) I am sorry, but you may have to contact me for this template Contact me Or Linkedin me
  • NEXTPAGE >GHS | SDS part is goneNow, it is about GHS Label HelpyouKnowit Driving Green Chemical
  • Updates on 30 Mar 2012 NEXTPAGE > GHS label and packaging Combination Single packaging packaging HelpyouKnowit Driving Green Chemical
  • Updates on 30 Mar 2012 NEXTPAGE > Label elements - GHS hazard warning label I National Standard: GB 15258-2009In accordance with 4.2.1 of GB 15258-2009 1 CAS号: 浓度:Part I: Name of the product 2 Chemical or chemical substance: name should be given in Chinese (English is optional) on top Substance or Mixture: Trade name / product name should be given ; main ingredients in mixture contributed to specific classification of the whole product should be added (Name, Concentration or range | 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小时
  • Updates on 30 Mar 2012 NEXTPAGE > Label elements - GHS hazard warning label II National Standard: GB 15258-2009In accordance with 4.2.2-4.2.5 of GB 15258-2009 1 CAS号: 浓度:Part 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 rather than pick at most 6 statements like guidance of EU label regulatory)In accordance with 4.2.9 of GB 15258-2009The rules of making this part:- Pictogram applied should follow the same precedence of UN GHS (No specific rules for pictogram size in label)- Hazard Statement: all statements arranged in order Physical hazards | Health hazards | Environment hazards- Precautionary Statements: all statement (under EU CLP, 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 20602-2009 24小时
  • Updates on 30 Mar 2012 NEXTPAGE > Label elements - GHS hazard warning label III National Standard: GB 15258-2009 1 CAS号: 浓度: 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 be Chinese phone number, either of the supplier itself or qualified service provider assigned. 3NRCC 24/7 ER service will be charged 3000RMBannually for 8 chemical products http://en.nrcc.com.cn/ 24小时
  • Updates on 30 Mar 2012 NEXTPAGE > Label , Label , Label- Combination Packaging I National Standard: GB 15258-2009 Applies to GHS label Normal GHS Label on Single packaging Container capacity Size for China label EU GHS label 0.1 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 L 200 * 300 (mm)Inner packaging Black 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 least Or Red frame | White background | Black icon Elements same as normal GHS label Simplified GHS Label - Chemical product name - Signal word and pictogram If either container or packaging is less - Hazard statement than or equal to 100ml, simplified - “Please refer to Safety data sheet” label 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
  • Updates on 10 Apr 2012 NEXTPAGE > Label , Label , Label- Combination Packaging IINational Standard: GB 15258-2009 & GB 190-2009 Normal 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 number In case of no need for transport symbol, GHS label could be applied instead Contradiction: In the light of Decree 591(Thanks for Chris’s 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 packaging Packing symbol of dangerous goods Symbol size category Symbol size: GB 190-2009 (Chinese only) Select correct transport symbol 1 50 * 50 (mm) Annex I of UN GHS 4 Apply the color according to 2 100 * 100 (mm) How to choose corresponding GB 190-2009 transport symbol according to 3 150 * 150 (mm) GHS pictogram The size rules apply to the transport symbol used for 4 200 * 200 (mm) single packaging “UN Recommendations on the Transport Transport symbol of Dangerous Goods - Model Regulations” => 100*100mm
  • Updates on 19 Apr 2012 NEXTPAGE >Prepare Transport Symbol according to GHS pictogram Physical Hazards
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyExplosive Unstable | Div. 1.1 Div.1.2 Div. 1.3 Div. 1.4 Div. 1.5 Div. 1.6 No NoFlammable Gases Category 1 Category 2 No(Flammable) Aerosols Category 1 Category 2
  • 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 pressure Compressed gases Liquefied gases liquefied gases Dissolved gasesFlammable Liquids Category 1 Category 2 Category 3 Category 4 No
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyFlammable Solids Category 1 Category 2 China GHS UN GHS 4th EU GHSSelf-reactive Type A Type B Type C & D Type E& F Type GSubstances (mixtures included) NoSelf-heating Category 1 Category 2Substances (mixtures included)
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyPyrophoric Liquids Category 1Pyrophoric Solids Category 1Substance which, in Category 1 Category 2 Category 3contact with water, emit flammablegases (water reactive)
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyCorrosive to Metals Category 1Oxidizing Liquids Category 1 Category 2 Category 3Oxidizing Solids Category 1 Category 2 Category 3
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyOrganic peroxides Type A Type B Type C & D Type E& F Type G No HelpyouKnowit Driving Green Chemical
  • Updates on 19 Apr 2012 NEXTPAGE >Prepare Transport Symbol according to GHS pictogram Health Hazards
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyAcute Toxicity Category 1 Category 2 Category 3 Category 4 Category 5(Oral) No +Acute Toxicity Category 1 Category 2 Category 3 Category 4 Category 5(Skin) No +Acute Toxicity Category 1 Category 2 Category 3 Category 4 Category 5(Inhalation) No
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilySkin corrosion/ Category 1A Category 1B Category 1C Category 2 Category 3irritation NoSerious eye damage Category 1 Category 2A Category 2B/eye irritation No
  • 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 sensitization Category 1
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyGerm cell Category 1A Category 1B Category 2mutagenicityCarcinogenicity Category 1 Category 2A Category 2BReproductive toxicity Category 1 Category 2 Category 3 Category 4 No
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilySpecific target Category 1A Category 2organ system toxicity-singleexposure (STOT)STOT-repeated Category 1 Category 2exposureAspiration hazardCurrently absentfrom China GHS !
  • Updates on 19 Apr 2012 NEXTPAGE >Prepare Transport Symbol according to GHS pictogram Environmental Hazards
  • Updates on 19 Apr 2012 NEXTPAGE > Convert your GHS pictogram to Transport symbol A combination with which you work even more easilyHazardous to the aquatic Category 1 Category 2 Category 3environment No No(Acute) +Hazardous to Category 1 Category 2 Category 3 Category 4the aquatic environment(Chronic | Long-term) No NoHazardous to the OzoneLayer Currently absent from China GHS !
  • Updates on 30 Mar 2012 NEXTPAGE > Label , Label , Label- Single PackagingNational Standard: GB 15258-2009 | Decree 591 Follow GB 190-2009 | GB 15258-2009 Packing symbol of dangerous goods In case of large tanker or container Product name UN number Transport symbol Can not be treated as single packaging  Only Transport Symbol is applied, no GHS label needed GHS hazard warning Label  Large tanker or container Over 450L should be posted with  Both labels are necessary on a Transport Symbol on both single-packed product sides  If pictogram(GHS) and symbol (Transport) are  The minimum size of transport repeated, pictogram should not appear symbol for a tanker vehicle shall 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
  • NEXTSECTOR >Next sector is about“Regulation on Import & Export of Hazardous Chemicals ”Mainly focused on inspection over SDS and Label developedfor hazardous chemical products exported and importedin accordance with China GHS HelpyouKnowit Driving Green Chemical
  • Regulation on Import & Export of AQSIQ Hazardous Chemicals >Specific implementations since 01 Feb 2012 HelpyouKnowit Driving Green Chemical
  • Updates on 10 Feb 2012 NEXTPAGE > Import & export of Hazardous chemical products The vehicle has been rolling since o1 Feb 2012 DECREE591 by State Council Catalog of  01 Dec 2011 … Entered into force Hazardous Chemicals  Catalog of Hazardous Chemicals to be Ver.2002 The ver.2002 is to be updated under the updated from Ver.2002 to a new version Decree 591  SAWS is responsible for the Inspection and enforcement of the Decree 591 within China;  taking care of the new version of the Catalog new version AQSIQ + Customs Selected from the Catalog of Hazardous Chemicals Ver.2002  Importer or exporter of the chemicals in Part of Statutory Inspection Catalogue 160* the Statutory Inspection Catalogue 2012 2012 should fulfill the obligations under AQSIQ 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 of Inspection Catalog ; for other chemicals in import & export of hazardous chemicals the Catalog of Hazardous Chemicals, they will not be taken as top priority of AQSIQ’s 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 Inspection Catalog”• 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)
  • Updates on 10 Feb 2012 NEXTPAGE >The obligations of import & Export of Hazardous chemical goodsCHINA GHS | SDS | LABELLING Related Rules Import into China Export from China & Inventory - SDS & Labeling preparation - SDS & Labeling preparation National laws and standards;1 Following the newest version of UN GHS(Ver. 4th) Documents should be translated in Chinese if the Industrial standards Documents should be prepared in Chinese original copies written in foreign language (follow the local regulations where your products are about to be shipped to ) China TDG & GHS - The report of hazard profile prepared - Sample required to be tested in local CIQ approved Special requirements agreed2 by the approved labs labs between national including classification report of TDG & - The report of hazard profile prepared governments GHS by local CIQ approved labs including classification report of TDG & GHS - Packing decided by the exporter according to the classification report of TDG - Exporter requires test reports of packaging and containers from packing suppliers Food 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 the Hazardous chemicals used in authority in Chinese) food as additives is supposed to meet the requirements of food hygiene and product inspection The 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 same inspection 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 is HelpyouKnowit not leaked. Driving Green Chemical
  • Updates on 2 Mar 2012 NEXTPAGE > 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 SC Catalog of Hazardous Chemicals (2002) to be updated CIQ 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 responsible According to for Export & Import CN GHS Both hazardous chemical substances or chemicals in mixtures CN Lab- should be complied with hazardous chemical control law. SDS el Notice Emergency call should be Chinese domestic phone number and the contact also located in China. 24h Emergency Call Outside China Inside 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 SDS Driving Green Chemical- GB 15258_2009 General rules for SDS development- GB 13690-2009 General principles of hazard classification and profile under CN GHS
  • 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) Chemical Chemical products substances Ingredients are already listed in the chemical substances China Catalog Ver.2002 listed in the Catalog Existing hazardous REACH Ver.2002 chemical New chemicals identified as hazardous chemicals
  • Updates on 10 Feb 2012 NEXTPAGE > 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 Province More & more… The authorities of the above areas have 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 delay business partners, get material well papered HelpyouKnowit Driving Green Chemical
  • Updates on 21 Mar 2012 NEXTPAGE >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 upon Chemicals with GHS label but not in the Catalog chemicals out of the Catalog of Haz. Chemicals even with GHS label GHS label could be referred to GHS rules of exporting countries.
  • NEXTSECTOR >Next sector is about“Toxic Chemicals Severely restricted from import & export”Be 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
  • Toxic Chemicals MEPSeverely restricted from import & export> HelpyouKnowit Driving Green Chemical
  • Updates on 07 Mar 2012 NEXTSECTOR >Learning steps – it is about restricted toxic chemicalsWhat would be the key issues you need to know? Who Restricted Comply May be affected Chemicals Strategy Who might be Whether those chemicals If you do have been affected, affected because of some chemicals have been or will be restricted in China then learn how to comply with it The purpose of restriction regulation of toxic chemical import & export + Toxic chemicals should be strictly under control. The authority will have clear minds of what toxic chemicals imported or exported, the amount, where the chemicals transported , who will be responsible people, and impacts against the environment caused by the toxic chemicals HelpyouKnowit Driving Green Chemical
  • Updates on 07 Mar 2012 NEXTPAGE >Who may be affected ? What responsibilities?Who will be affected | what would be the main responsibilities? Out of China In ChinaForeign Companies Domestic CompaniesLocated outside China Located in ChinaExport toxic chemicals into China Importer & Exporter of toxic chemicals Who will be affected Who will be affected > > Importer Exporter Registration Certificate for the Environmental Management on the  Import Clearance Notification Export Clearance Import of Toxic Chemicals CRC  Registration Certificate for the Notification of MEP Environmental Management on Responsibilities > the Import of Toxic Chemicals Responsibilities > Foreign companies that export toxic chemicals listed in the “Catalog of toxic chemicals severely restricted to be imported or exported(the newest version is 2012)” shall  An Export Clearance is  An Import Clearance Notification apply one Registration for each type of toxic chemicals Notification with a valid is with a valid period of 6 Months Chinese importer should apply for import clearance period of 6 Months  Import Clearance Notification Notification by the Registration Certificate during import of  Export Clearance Notification shall be applied for each time each batch of same toxic chemicals shall be applied for each time Please be informed > Please be informed >  Registration Certificate shall be applied each type of chemicals exported  Importer could apply for Registration Certificate instead of a foreign+ to China once with a valid period of 2 years. + companies, but we recommend foreign companies should take the responsibilities on your own or assign Chinese representative to do so.  Import Clearance Notification shall be applied for each batch of each toxic chemical to be imported into China with a valid period of 6 months by providing Registration Certificate for this chemical.
  • Updates on 07 Mar 2012 NEXTPAGE > Let’s review who would be responsible for application Under different regulations Toxic chemical import & export Order 7(China REAH) & Decree 591Business players Under toxic chemical Under Order 7 & Decree import and export X Foreign company 591, foreign companies regulation, foreigners are are not qualified for recommended to finish Chinese manufacturer notification of registration application Chinese importer Out of China Chinese representative In China Subsidiary of Foreign Under toxic chemical Decree 591 | Order 7 Companies but in China import and export regulation, importers are Decree 591 | Order 7 qualified for registration but not preferred Order 7 Notice: Order 7* Importers could apply for registration certification on * - if a subsidiary of a foreign companies in behalf of foreign companies China is acting as manufacturer or importer of hazardous chemicals under Decree 591, it shall apply for registration certificate. Registration body under Order 7 & Decree 591 | Order 7 >> Decree 591 >>
  • Updates on 07 Mar 2012 NEXTPAGE >The Catalog of restricted toxic chemicalsCheck the catalog before export chemical products to China2012 version ReplacedCatalog of toxic chemicals severely 2010 version of catalog 2012 version of catalog byrestricted to be imported or exported 158 Pure substances Chinese version English version > > http://www.box.com/s/illcyl3i95p0e1me04jd http://www.box.com/s/3jbg9g1tn69o6pk48r6r & Chemicals China MEP and Customs jointly issued the 91 statement on 2012 version of the “Catalog of Toxic Chemicals severely restricted to be imported or exported” News source in Chinese HelpyouKnowit http://www.crc-mep.org.cn/news/NEWS_DP.aspx?TitID=387&T3=10&LanguageType=CH&Sub=12 Driving Green Chemical
  • Updates on 07 Mar 2012 NEXTPAGE > The Registration Certificate application process Different Roles 30 work days Process a) Discussion MEP b) Public consultation (3 days) c) Final approval MEP Publicity board: Ministry of State Council d) Certificate issued http://www.mep.gov.cn/zhxx/gsq/ Division of pollution prevention Failure in approval, CRC notifies the applicant X Technical evaluation Taskforce for Evaluation provide Feedbacks X Fail in approval Invoice or notify Receive Registration Application CRC-MEP application failure Formal Check of materials (5 work days) Inspection and management after certificate issued • CRC software for some Fail in preparation Local MEP • • materials Other materials (hard copy) Registration fee X of registration materials Inspection  Check 2012 version Catalog of toxic chemicals severely Registration restricted to be imported or exported applicant Online registration:! http://www.crc-mep.org.cn/A107/A107_R17.aspx Certificate could be applied by either side of the business, a foreign company or its Chinese importer (3 roles played by importer: chemical user, trader, or representative of foreign companies )
  • Updates on 07 Mar 2012 NEXTPAGE > What to be prepared for Regulation Certificate application Help your with compliant workType 1 Foreign companies + Necessary materials to be submitted Application form of Registration Certificate (template avail.) Business Contract (Original Copy) The source of toxic chemicals; hazardous profile; C&L; emergency response & fist aid ; disposal; environmental CRC effects; chemical control laws of countries where the source of MEP located etc. CRC supports + 10,000USD or equivalent RMB Tel: + 86 10 4915286 (hazardous chemical only) Email: weihua@crc-mep.org.cnType 2 Chinese importers Not all materials listed FC = Foreign companies Importers of toxic chemicals Importers of toxic chemicals Importers of toxic chemicals as user as trader as representative of FC* • Application form • First 6 points are same • Include all materials of importer as • Toxic chemical profile • License of Operation Safety trader • Business license (Decree 591) of both importers • First and second grade • Original business contract & Downstream trader downstream roles’ License of • Copy of import & export approval • Annual record of toxic chemicals Operation Safety (trader) and HelpyouKnowit certificate sales Environment report for each • Environment report for each • Sales information of toxic chemicals and comments from the authorities (users) required chemicals and comments from the chemicals within recent 2 years Driving Green Chemical authorities • DU inventory(only applied to some • Business license of importer and certain chemicals) first grade DU required + 10,000USD or equivalent RMB + 10,000USD or equivalent RMB + 10,000USD or equivalent RMB
  • NEXTSECTOR >Next several sectors are planned for regulatory over“Pesticide | Cosmetics | Disinfectant Products” HelpyouKnowit Driving Green Chemical
  • SFDA license and label Cosmetics Regulations > HelpyouKnowit Driving Green Chemical
  • MOH license and label Disinfectant Regulations > HelpyouKnowit Driving Green Chemical
  • NEXTPAGE >* +***+ HelpyouKnowit Driving Green Chemical
  • NEXTPAGE > Order 27 by MOH since 2002 “The Measures on Disinfection Management” Order 22 changed to Order 27 by MOHOrder 27 by MOHEntered into force 01 Jul 2002Order 27 by MOHIssued 28 Mar 2002Order 27: The Measures onDisinfection Management XOrder 22 by MOH 31 Aug 1992IssuedOrder 22: Older version of TheMeasures on Disinfection Management 10 years Order 27 by MOH http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohwsjdj/pgz/200804/16529.htm HelpyouKnowit Driving Green Chemical
  • NEXTPAGE >The Catalog Disinfectant Products (ver. 2002)Disinfectants in the Catalog Disinfectants : The currently existing Catalog Ver. 2002 3 Categories of Products in the Catalog 3 products erased from the scope of administrative inspection of MOH Hygienic License for products below Suspended HelpyouKnowit Driving Green Chemical
  • NEXTPAGE > Your responsibilities under Regulations License to be applied for being issued by the authority: ! : 卫消证字 ! 卫消备字 卫消字 卫消备进卫消进字 字
  • NEXTPAGE >One more thing about Manufacturer Hygienic LicenseSome additional information for your reference 卫消证字 HelpyouKnowit Driving Green Chemical
  • NEXTPAGE > Hygienic Administrative Licensing for Domestic disinfectants Disinfectant Product Hygienic License 卫消字 卫消证字 !www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33327.htm www.hygiene.net.cn (in Chinese)
  • NEXTPAGE >Hygienic Administrative Licensing for Imported disinfectants IImported Disinfectant Product Hygienic License 卫消进字 ! www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm
  • NEXTPAGE >Hygienic Administrative Licensing for Imported disinfectants IIImported Disinfectant and disinfecting apparatus Hygienic License 卫消进字 Please be noticed: This application form applies to both disinfectants and disinfecting apparatus + Original Product Hygienic License (卫消进字) Product Formulation Quality Standard or Recorded Corporation Standard Label (or nameplate in disinfecting apparatus case) of disinfectant product on market The Product Catalogue If notified through authorized agent, then authorization letter is a must Other supportive material One original copy of each submitted material + + Sealed small-packaged sample product www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm
  • NEXTPAGE > Hygienic Administrative Licensing for Imported disinfectants II Imported Disinfectant Product Hygienic License 卫消进字 Please be noticed: This application form applies to 1. Cosmetics products 2. Disinfectant and disinfecting apparatus 3. Products involved drinking waterThe 1st case + Original Product Hygienic License (卫消进字)1) Documents issued by the authority from the originalplace where disinfectants were manufactured should Other materials to be providebe provided as evidence in case of company name orseat change. Contract could also be valid in case of Case 1: Company name or Company seat changescompany name change resulting from mergence etc.All documents used as evidence should be translated Case 2: Chinese name of imported disinfectant changesin Chinese and then formally notarized in China. The reason of name change should be specified in the2) If the subsidiary is invested by companies located in Application Form, and provide re-designed packaging of theHK Macao or other places out of China Mainland, product; Foreign name shall be remained unchanged.“Certificate of Approval for establishment ofenterprises with foreign investment in the PRC” is a Case 3: Other content changesmust. Reason of content change should be detailed and provide related documents.3) Regarding changes of manufacturing sites,, hygienictesting report of imported disinfectants produced inthe new site is a must. Testing over 3 batches of If notified through authorized agent, thendisinfectants for active ingredients, Ph value s and authorization letter is a muststability are required . The authority may put an on-site inspection over manufacturing place in some One original copy ofcases. + each submitted material www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm
  • NEXTPAGE >Hygienic Administrative Licensing for Imported disinfectants IIImported Disinfectant Product Hygienic License 卫消进字 Please be noticed: This application form applies to 1. Cosmetics products 2. Disinfectant and disinfecting apparatus 3. Products involved drinking water In case of License destruction, the original + 1 license provided as evidence In case of License Lost, lost notice on news 2 paper provided as evidence For your information 1. It should be provincial-level newspaper 2. Notice published for a period no less than 20 days One original copy of + each submitted material www.moh.gov.cn/publicfiles/business/htmlfiles/zwgkzt/pxzxke/200804/33326.htm
  • NEXTPAGE >Hygienic Administrative Licensing for New DisinfectantsNew Disinfectants to be licensed ! HelpyouKnowit Driving Green Chemical http://www.moh.gov.cn/sofpro/cms/previewjspfile/zwgkzt/cms_0000000000000000187_tpl.jsp?requestCode=33190&CategoryID=2798
  • NEXTPAGE > Disinfectant products License I Certificate to be applied for being issued by the authority:卫生许可证卫消证字 +批准文号卫消字 + + + HelpyouKnowit Driving Green Chemical
  • NEXTPAGE >Disinfectant products License IICertificate to be applied for being issued by the authority: HelpyouKnowit Driving Green Chemical
  • NEXTPAGE >One more thing about Product Hygienic LicenseSome additional information for your reference 卫消字 HelpyouKnowit Driving Green Chemical
  • NEXTPAGE > Label and Product Catalogue of Disinfectants Only about the rules of label and catalogue of Disinfectants1) Product Name 1) Product Name 1) Product Name2) Disinfectant Product Hygienic License 2) Disinfectant Product Hygienic License3) The name & address of the license 2) Disinfectant Product Hygienic License 3) The name & address & contact of theholder 3) The name & address of the license license holder4) Disinfectant Product Manufacturer holder 4) Disinfectant Product ManufacturerHygienic License(Imported disinfectants 4) Disinfectant Product Manufacturer Hygienic License(Imported disinfectantsfall out of this scope) Hygienic License(Imported disinfectants fall out of this scope)5)Original place (Domestic disinfectants fall out of this scope) 5)Original place (Domestic disinfectantsfall out of this scope 5)Original place (Domestic disinfectants fall out of this scope6)Date of Manufacture; Period of validity fall out of this scope 6)Active ingredients and contents 6)Active ingredients and contents 7) Period of validity 7)Date of Manufacture; Period of validity 8) General uses and guidance 9) Matters need attention 10) Dosage form and specification 11) Effective for what kinds of microbeBe noticed
  • NEXTPAGE >Packaging example of disinfectant 批准文号 卫消字 ! 粤卫消证字 (2008)第0882号 卫生许可证 卫消证字 卫消字 卫消械字
  • Pesticide & Agrochemical Pesticide Regulations > HelpyouKnowit Driving Green Chemical