An easy outline of Chinese Chemical Regulations A revised versionSpecial thanks to the contribution ofCora Knutson
HelpyouKnowitMai Fung | Global Chemical Regulatory Consultant HelpyouKnowit The file is made by Mai.Fung, which intends to help you know more about the content n of Chinese chemical legislation. Additional information please let me know by sending email.
HelpyouKnowit>> Content Recent update> Order 7 by MEP (not applied in Hong Kong neither Macao) Updated on 29 Feb 2012Notification of New Chemicals> Decree 591 by State Council (not applied in Hong Kong neither Macao) Updated on 16 Dec 2011Existing Hazardous Chemicals> China GHS, and labelingTo be finished> 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> Order 27 by MOH Updated on 16 Mar 2012 (middle way)Disinfectants Regulation in China “Linkedin” me What will come soon? A topic of label on industrial or consumer products is being planned Maij1217@gmail.com Narration is considered to be added in this presentation material
HelpyouKnowit >> Key updates Mar 21 12 One point to be noticed Decree 591;China GHS inspection Specific explanation of AQSIQ inspection over Haz. chemicals Mar 14 12 The catalog added for download (English) 335 extremely toxic chemical substances under Decree 344 Extremely Toxic Catalog Many mistakes fixed and format adjusted Mar 07 12 Newly-added slidesNew regulatory added Regulation of toxic chemicals import and export by MEP
HelpyouKnowitIt is complex, but no need to worryChemical-regulation related departments
The top rankState Council Please be informed: All the departments would be involved in some parts of the regulations either New Chemical The Ministry 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 The State Administration State Administration of SAWS Work Safety of State Council General Administration of Customs Customs of China General Administration of Quality AQSIQ Supervision, Inspection and Quarantine HelpyouKnowit Driving Green Chemical
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 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 http://www.cirs.ie/China_Chemical_Regulation/IECSC_China_REACH_China_Ne w_Chemical_Registration.html 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 materials （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 - CIRS will help you with information collection and make inquires. 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 Mai.email@example.com or firstname.lastname@example.org
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 in China (At least )One Toxicity test for aquatic organismIt turns out that the data acceptance is not so & (At least) one study on Degradationexclusive as its political system of this countryshowed in front of the western nations. Most 10-100tpa Around 3-5 Monthsstudies may be referenced if they were performedto accepted standards by a lab meeting MEP 14 days extended toxicity study in fish (about 3Months)requirements. Or Daphnia magna Reproduction study (about 4-5Months) Or Bioaccumulation (about 4-5Months) Please be informed again: Please be advised, at least one test must be picked between all above 3 testsScientific Record is needs here for the sample ofthe substance to be tested in China 100+tpa- Around 6 Months Chronic toxicity 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 > Specific Condition No Studies required Notification duration: 3-4 Months 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 > Specific 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 substances notified scientific record because together allow to be covered in one a sample is asked for scientific 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 Specific 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 NEXTSECTOR > Please be advised-Way of Simplified Notification has changed 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
DECREE591byState Council > HelpyouKnowit Driving Green Chemical
NEXTPAGE > Decree 591 is revised State Council State Council Decree 344 replaced by Decree 591 by SC Substance + Mixture regulated at same timeDecree 591 by SCWill Enter into force The 1st Regulation replaced by 01 Dec 2011 State Council Decree 344Decree 591by SC 02 Mar 2011Issued X China GHS started on 1 May 2011 (both Substance + MixtureDecree 344 by SC regulated at same time) 15 Mar 2002Entered into force X1st Regulation by SC 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 Decree 591 Over 7,000 in new version Likely to be merged 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 “List of Dangerous Goods (GB12268-90)” or Manufacturers, Importer, other roles (distributors, even other lists. warehousing and storing companies ) chemicals within Chinese territory need to be sure whether If purchase or transport of chemicals in the any of their chemical products are listed in the inventory of toxic chemicals happens, companies Catalog, especially sensitive to the newest version will be required to apply for some licenses before upcoming. actions. But as we believe, the new version firstly comes up as a draft before it become the decided one. Download HelpyouKnowit Driving Green Chemical
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 Application Manufacturing Safety rulesThis company should beconsidered 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 > You will also find information of China GHS The comparison of differences between China and other areas. GB15258-2009 General Rule for Preparation of Precautionary Label for Chemicals GB16483-2008 Instruction of Safety Data Sheet, Content and Section 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) –• 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 & GHS2 - The report of hazard profile prepared - Sample required to be tested in local CIQ approved Special requirements agreed 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 additives3 - Conformity Declaration of Hazardous-chemical - Conformity Declaration of Manufacturer of Hazardous chemicals used in importer (Template offered by the authority in Chinese) Hazardous-chemical imported (Template offered by the authority in Chinese) food as additives is supposed to meet the requirements of food hygiene and product inspection4 The authority will be responsible for as well as food safety - 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. Shandong Shandong Zhejiang Province Province Province Fujian Province Jiangsu Province City Shanghai Guangdong More & more… Province 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 NEXTSECTOR >One point to be noticed AQSIQ (local CIQ) Only inspect Chemicals in the Catalog of Haz. 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.
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 & 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) Publicity for comments (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 NEXTSECTOR > 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: email@example.comType 1 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
SFDA license and label Cosmetics Regulations > HelpyouKnowit Driving Green Chemical
MOH license and label Disinfectant Regulations > HelpyouKnowit Driving Green Chemical
NEXTPAGE > Order 27 by MOH since 2002 Order 22 changed to Order 27 by MEPOrder 27 by MOHEntered into force 01 Jul 2002Order 27 by MOHIssued 28 Mar 2002Order 7: Revision of Provision onAdministration of Disinfection in China XOrder 22 by MOH 31 Aug 1992IssuedOrder 22: Provision on Administrationof Disinfection 10 years Order 27 by MOH http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohwsjdj/pgz/200804/16529.htm HelpyouKnowit Driving Green Chemical
NEXTPAGE >Be NoticedAfterwards, we talk mainly aboutDisinfectant HelpyouKnowit Driving Green Chemical
Pesticide & Agrochemical Pesticide Regulations > HelpyouKnowit Driving Green Chemical
Will be updated by Mai SOON HelpyouKnowit Driving Green Chemical