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Randis ChemWise (Shanghai) Co., Ltd
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Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai
Shanghai
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Iecsc registration - 07.06.2017
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| Place Of Origin: |
Unit 505, KeChuang Building, #350 Xianxia Road, Changning District, Shanghai |
| Posted on: |
07.06.2017 |
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| Description: |
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 |
| Price: |
10.00 |
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