Randis ChemWise (Shanghai) Co., Ltd

Date: 9th January 2017
IECSC Registration
A Thorough Introduction on? New Chemical Substance Registration for China IECSC ?The revised version of the Measures on Environmental Administration of New Chemical Substances (the decree No. 7) was published on 19 Jan. 2010 by Ministry of Environmental Protection of China (MEP). According to this regulation, no chemical products containing NEW chemical substance are allowed to be imported/manufactured/used in Mainland China, before the new chemical substance is registered to MEP?a pre-marketing / pre-manufacturing principle, also known as Chinese REACH/TSCA system. New Chemical Substance (NCS) refer to these chemicals that are not listed in IECSC (Inventory of Existing Chemical Substance of China). There are three New Chemical Substance Notification types in China: Scientific Research Record Notification, Simplified Notification and Regular Notification (Normal/Typical notification). Before submitting the notification dossier to MEP, it is necessary to check whether a substance is new or not and whether it could be excluded, then determine the notification type according to Substance Properties, Notification Quantity, Notification Usage, Entrusting Party, and so on. Different notification type has different demands on notification material, test data, notification process and post-notification obligations. 1.Confirm whether a chemical substance is new to China ?New Chemical Substances are these chemical substances not listed in IECSC (Inventory of Existing Chemical Substance of China). IECSC has been revised several times. The latest one was released on 14 Jan., 2013, which is known as IECSC 2013. There are totally 45609 substances in IECSC 2013, among which 42342 are open to the public (Publication of Inventory) and 3270 are confidential (Confidential of Inventory). ?For IECSC inventory verification --- to check whether a chemical substance is in IECSC, companies can verify themselves by searching in IECSC. IECSC 2013 can be downloaded at: http://www.randis.cn/html/ywb/Ezlxz_264_175.asp. As 3270 existing substances' exact identification are not disclosed in the above version for confidentiality reasons, so it is recommended that a formal verification be submitted to MEPSCC (China Solid waste and Chemical Management Center of MEP, former known as CRC or CRC-MEP) to check whether a substance is new or not before conducting tests for new chemical registration in China. The fee for IECSC inventory verification (IECSC inventory verification confirmation) to MEPSCC was increased dramatically from 6000 Chinese Yuan to 5000 Chinese Yuan from January 1st of 2016! 2.Check if a chemical is exemptedThere are four major categories for exemption of registration:(1) Finished products already regulated by other laws and regulationsThese include medicine, pesticide, veterinary drug, cosmetics, food, food additive, feed and feed additive, radioactive substance, military product, explosive product, initiating explosive products and tobacco etc.(2) Natural substances1) Natural substances that are unprocessed, or only processed/treated in manual, mechanical, gravity, water dissolving, water flotation, thermal dehydration and other physical ways;2) Natural substances extracted from air in various ways;3) Natural polymers, except those subject to chemical processing and treatment;4) Living substance, such as ribonucleic acid, deoxyribonucleic acid, protein and other biomacromolecules. (3) Substances of noncommercial purposes or unintentionally produced.1). Impurities (<20w/w% in total, <10w/w% for each impurity); 2). Substances from accidental or un-designed reaction; 3). Waste water, waste gas, solid waste, and by-products.(4) Other special substances 1). Glass; 2).Frit; 3). Pottery raw materials and ceramic ware; 4). Steel and steel products;? 5). High-alumina cement;? 6). Portland cement; 7). Homogeneous and heterogeneous alloys, except for metal compounds and precisely defined intermetallic compounds 8). Non-isolated intermediates.(5). Articles. 3.Determination of notifierNotifiers can be China local companies or overseas companies.China local notifiers are the manufacturer or importer of NCS registered in mainland China.Overseas notifiers are these foreign companies who directly export new substances to China (including companies registered in Taiwan, Hongkong, Macau). If an overseas company (A) sells NCS or products containing NCS to companies (B) outside mainland China and company B exports to mainland China, then company B should be the notifier.Note: Overseas notifiers shall entrust a local Chinese agent to function as Representative of the notifier for new chemical substance registration. 4: Determination of the Registration TypeThe chart below show how to determine the registration type: For example, a domestic company A expect to manufacture new chemical substance B (NCS B):(1)If NCS B is used for Research and Development purpose (R&D), and the registration quantity is under 100 kg per year, a Scientific Research Record Registration (SRR) can made; If the registration quantity is between 0.1 to 1 tonne per year; or under 10 tonne per year for 2 years, a Simplified Registration (special type) can be made. (2)A Simplified Registration (special type) can be made for situations below.I.Annul tonnage of the intermediate manufactured/imported is less than 1 ton per year;II.For exporting only, and its annual quantity is less than 1 ton per year;III.For scientific research, annual manufacture/imported quantity is above 0.1 ton and below 1 ton;IV.Polymer with monomers among which less than 2% are not listed in IECSC (Polymer 2% rule) and Low concern polymer;V.For the purpose of process and product orientated research and development --- PPORD, annual manufacture/import quantity is below 10 tons for less than 2 years.(3)If NCS B is used for commercial purpose, and does not meet above two conditions, the registration type will depend on the registration quantity: for less than 1 tonne per year, Simplified registration (Basic type) can be made; for more than 1 tonne per year Typical Registration should be made.The Typical Registration has four registration levels: level 1 (1~10 t/a), level 2 (10~100 t/a), level 3(100~1000t/a), level 4 (>1000t/a). For different registration types above, the latter the registration type is, the longer time is needed for the registration and the more costly the registration is. So choose of the registration type is suggested reversed order to the above based on the substance's suitability to these registration types. ? Scientific Record Registration (no Certificate is issued)??Simplified Registration (Certificate is issued) ? ??Special Type ? ??Basic Type ??Typical Registration (Certificate is issued. Registered substances will be listed into IECSC after 5 years) 5: Requirement Evaluation and data gap analysis Different registration types have different data requirement. Data requirements are as set by New Chemical Substance Registration Guideline as issued by China MEP. The new version Guideline is to be issued in second half of 2016.Normally, the majority of total registration cost is cost for obtaining data. For Scientific Record Registration, no test data are mandatory.For special type Simplified Registration, normally no test data are mandatory either (except for the molecular weight distribution analysis report for polymer).For basic type Simplified Registration, as basis, biodegradation test conducted in China is mandatory.For typical Registration, dozens of test reports for physical-chemical property, toxic and eco-toxic property obtained through tests in qualified labs are mandatory. The paragraphs below have summarized the data requirements for different types of registration. You shall evaluate existing data based on the principles listed as below and carry out data gap analysis. 1). Data source ?Data from the following source are theoretically acceptable for the China NCS registration: test report by qualified labs, published authoritative literatures, authoritative databases, or data generated from method including QSAR, cross reference, etc. (including expert statement). While data from non-testing reports (literature, etc.) are regarded generally only as reference, unless the testing could not be conducted scientifically.For different data sources, the required supporting documents are different. If data generated from tests through accepted test methods, qualification certificates of test organization shall be attached and test reports in Chinese or English should be provided; if data are from published literature, full text of original literature including abstract or quotation shall be provided; if data are from database, relevant information including database name, issue institution, version, etc. shall be submitted; if data are from QSAR estimate, information including estimate model and parameter used, model recommendation or developing institution, version and effectiveness of the results etc. shall be submitted; and if such data are from expert statement, brief introduction of expert shall be provided, including title/post, employer, research field, major research findings, etc. 2). Data sharingMaking registrations using test reports entitled by a different company name is allowed and does not lead to consequences for simplified registration, while for typical notification it would cause the latter notifier to accumulate the notification quantity of the previous notifier. 3). Tests that must be conducted in ChinaFor basic type Simplified Registration and Typical Registration, normally readily biodegradation test and 1 toxic test to aquatic organism (generally acute fish toxicity test) must be conducted in China by labs recognized by MEP. The other tests can be conducted by recognized labs (normally GLP labs) in other countries. 4). Data Requirement for Different Types of RegistrationFor the three types of registrations: Scientific Research Record, Simplified Registration (Special type and Basic type) and Typical Registration (Level 1, 2, 3, 4), the difference between Scientific Research Record Registration and other two types of registrations is that for the former the related activities could be started once the registration form is submitted but for the latters related activities (manufacturing or importation) can only be started after the registration is approved and Registration Certificate is issued.(1). For Simplified Registration (Basic type), 1~3 tests must be conducted in China by recognized labs. For organic substances, biodegradation test shall be conducted. If not biodegradable, acute toxicity test of aquatic organisms (fish is preferred) also shall be submitted.For inorganic substances, acute toxicity test of aquatic organisms (fish is preferred) shall be submitted.If the substance's water solubility is less than 100mg/L and its LC50 to aquatic organisms is above its saturated concentration, then acute toxicity test of terrestrial life (earthworm is preferred) shall be provided. (2). For typical registration, there are four levels depending on the tonnage band: 1-10t/y, 10-100t/y, 100-1000t/y and 1000t+/y.The data requirement is increasing with tonnage band increases. The table below shows typical necessary tests for different levels. No. Test Item State/Level Physi-chemical property Gas. Liq. Sld. NMR/IR/UV ? ? ? Melting point ? Boiling point ? Flash point* ? Density ? ? LogKow ? ? Vapor pressure ? Surface tension* ? pH ? Water solubility ? ? Particle size* ? Oxidizing property* ? ? ? Self-ignition temperature* ? ? ? Flammability ? ? ? Explosivity* ? ? Explosive limit ? Critical point ? Toxicity L1 L2 L3 L4 Acute oral toxicity* ? ? ? ? Acute dermal toxicity* ? ? ? ? Acute inhalation toxicity* ? ? ? ? Acute skin irritation* ? ? ? ? Acute eye irritation* ? ? ? ? Skin sensitization* ? ? ? ? 28d repeated oral toxicity* ? AMES test ? ? ? ? In vitro chromosome aberration ? ? ? ? In vivo Micronucleus assay/Mammalian bone marrow chromosome aberration test ? ? ? 90d repeated oral toxicity ? ? ? Reprod./devel. Screening ? Teratogenicity ? ? Two-generation reproduction ? ? Toxicokinetics information * ? ? ? Chronic toxicity* ? Carcinogenicity* ? Eco-toxicity L1 L2 L3 L4 Algae growth inhibition ? ? ? ? Daphnia acute toxicity ? ? ? ? Acute fish toxicity ? ? ? ? Activated sludge* ? ? ? ? Adsorption/desorption* ? ? ? ? Ready biodegradation test ? ? ? ? Inherent biodegradation * ? ? ? Hydrolysis as a Function of pH * ? ? ? Acute earthworm toxicity* ? ? ? ? 14d fish toxicity* ? Daphnia magna reproduction ? ? ? Fish bioaccumulation * ? ? ? Chronic fish toxicity ? ? Seed Germination/Root Elong. * ? ? Remark: *: can be exempted if certain condition is met. ?L1: 1~10 ton; L2: 10~100 ton; L3: 100~1,000 ton; L4: >1,000 ton 6: Filling Data Gaps After collecting all the available information of the substance and analyzing the data gaps based on the tonnage band, a plan shall be made to fill the data gaps. This might involve arranging tests by recognized labs, searching for literatures, etc. based on the requirement and known properties of the substance. This will involve also,?Application of Scientific Research Record Registration before introducing sample to China for testing; ?Determination of recognized labs, confirm the test schedule.?Delivery of sample to labs and signature of test contract; ?Approval of test protocol; ?Finalization of testing reports. 7: Preparation and Submission of Registration DossierAfter all needed information and documents are gathered, registration dossier shall be prepared, which might include:?Signature of Registration Form; ? GHS classification of the substance; ? Risk assessment report; ? Other documents needed; 8: Post-registration ObligationsFor Scientific Research Record, NCS should be conducted in designated facilities under direction of professionals, by strictly following relevant management rules. NCS can only be manufactured and imported for the purpose of scientific research. For the simplified registrations, there are mainly two requirements for Post-registration Obligations?1). Annual report about the actual manufacturing or importing status of the NCS for the previous year;2). NCS registration dossier, as well as NCS' manufacturing/importing status etc. shall be archived for more than 10 years. For Typical Registration, there are different post-registration obligations depending on different management categories.According to standards on chemical hazard identification and classification, NCS is classified into 3 management categories: General New Chemical Substance, Hazardous New Chemical Substance, and Critical New Chemical substance. Category Post-registration Obligations General New Chemical Substance ? ? ?(6 requirements) Hazard of the NCS shall be described clearly in SDS, and SDS shall be passed to the downstream users; Implementation of risk control measures?according to the requirements on the Certificate? Submission of the first-activity report; NCS registration dossier, as well as NCS? manufacturing/importing status etc. shall be archived for more than 10 years; Prohibition of selling chemicals to downstream users that are not capable of implementing risk control measures; Reporting of newly obtained hazard information of the substance; Hazardous New Chemical Substance ? ? ?(9 requirements) Annual report ; Application for listing the substance into IECSC in about 5 years; Supervision by local EPA; Critical Environment-Risk NCS ? ? ?(11 requirements) Monitor on NCS? release to environment; report of NCS transfer to each different user. tration Certificate of China, obtained via Randis