China New Chemical Substance Notification - "China REACH"

  •   6 Nov 2013
  •    Nadine He
    Chinese regulation:
    MEP Order 7
    Measures for the Environmental Management of New Chemical Substances – “China REACH”
    Passed byMinistry of Environmental Protection
    Competent Authority
    Ministry of Environmental Protection (MEP)
    History
    Published19 Jan 2010
    Come into force15 Oct 2010
    Legislative evolution
    15 Oct 2003SEPA Order 17 Measures for the Environmental Management of New Chemical Substances (replaced)
    Main supporting legislation in force
    16 Sep 2010China New Chemical Substances Notification Guidance Document (2010 version)
    22 Jul 2011Technical Requirements for the Identification Information of New Chemical Substance Notification (trial)
    1 Apr 1 2008HJ/T 420 - 2008 The Guidelines for the Generic Name of New Chemical Substances
    1 Jun 2004HJ/T 153-2004 The Guidelines for the Testing of Chemicals
    HJ/T 154-2004 The Guidelines for the Hazard Evaluation of New Chemical Substances
    HJ/T 155-2004 The Guidelines of Chemical Testing Good Laboratory Practices

    Hidden
    Standard or Corporate members only

    CRC - MEP © Copyright 2013 Jim Wei,  All Rights Reserved

    SCC - MEP © Copyright 2014 Jim Wei,  All Rights Reserved

    The “Measures for the Environmental Management of New Chemical Substances" (MEP Order 7) is a revision of the 2003 legislation on China new chemical substance notification (China NCSN). It was enacted by China MEP on 15 Oct 2010. This REACH-style legislation adopts several of the same principles and concepts of the EU REACH, and thus has been dubbed "China REACH", even though only new chemical substances are regulated, compared with EU REACH. Despite dispute over the justification of its nickname, "China REACH" is widely adopted in the industry.

    This webpage is designed as a navigator for non-Chinese companies wishing to comply with China NCSN (a.k.a. China REACH).

    * Note: China’s New Chemical Substance Notification Guidance is under revision. China MEP notified the World Trade Organization (WTO) on the revised draft on 8 Mar 2016 for international comments. According to insider sources, a new revision of guidance has been drafted based on the feedback received during the previous public consultation period (ChemLinked News). It is noteworthy that the new draft is just notified to the WTO for comments and before its actual implementation it is still need to follow the current Guidance.

    Contents

     

    History

    Fig. 1 - History of China NCSN (China REACH)

    This legislation is a significant update on the previous Measures (SEPA Order 17) enacted on 15 Oct 2003. The new system has retained certain fundamentals from its predecessor and introduces a series of new concepts also contained in EU REACH, such as GHS-based classification, chemical risk assessment, notification tonnage bands and the “Only Representative”, etc.

     

     

     

     

     

     

     

     

     

     

    Substances to be Notified

    China NCSN requires registration of “new” chemical substances in China. Substances to be notified under NCSN include:


    Fig. 2 - Substances to be Notified under China NCSN (China REACH)

    • New chemical substances not listed in IECSC (the Inventory of Existing Chemical Substances manufactured or Imported in China);
    • Raw materials (ingredients) or intermediates, if not listed in IECSC, used to produce cosmetics, pharmaceuticals, pesticides, veterinary medicine, feed additives, radioactive materials, etc.;
    • New substances presented in preparations or mixtures such as surfactants, plasticizers, preservatives, dispersing agents, flame retardants etc., and which are manufactured after 2003 (not included);
    • New substances of variable composition and complex reaction products without unique structural formulae;
    • Low concern polymer and polymers with one or more monomers present in a low concentration (<2% w/w);
    • New substances in articles, which are designed to release by intention. For example, scented product, ink cartridge and fire-fighting equipment.

     

    Stakeholders Involved

    China New Chemical Substance Notification involves a number of national and local enforcement authorities as well as other interested stakeholders. These include the Ministry of Environmental Protection (MEP), the Chemical Registration Centre of MEP (CRC-MEP), local authorities of environmental protection at province/city/county level (local authorities), and etc.

    • Ministry of Environmental Protection (MEP): Policy maker of MEP Order 7, authority which published MEP Order 7 and made it into force in 2010, in charge of the macro-control on the environmental management of China new chemical substances.
    • Chemical Registration Centre of MEP (CRC-MEP): A supporting sub-institute of MEP, non-governmental organization, working on the daily administration of China NCSN (China REACH), involved in the reception and processing of dossiers submitted by notifiers, etc.

    Note: The CRC and the National Center of Solid Waste Management were merged into the Solid Waste and Chemicals Management Center (SCC-MEP) in June 2013. The original CRC-MEP website closed from the 1st of Jul 2014 and was replaced by www.mepscc.cn (ChemLinked News).

    • Evaluation Committee: responsible for the scientific reviewing and evaluation of China NCSN (China REACH) dossiers (mainly Regular Notification); 100 external experts are employed on a three-year term, who are mainly selected from the testing and academic institutes in the fields of chemistry, chemical, toxicological, environmental science and chemical safety assessment, etc. The name list is confidential.

    Note: Please find more details of the "Evaluation Committee" in ChemLinked Expert Article

    • Local authorities: responsible for the supervision of new chemical substance management within its own administrative regions; including tracking management of the notified new chemical substances and supervision on risk control measures and administrative requirements specified on the certificate issued by the MEP, etc. (ChemLinked News)
    • Testing institutes: responsible for carrying out physic-chemical, toxicological, eco-toxicological tests required of China NCSN (China REACH); both the Chinese domestic and overseas institutes can produce data for China NCSN (China REACH) with some qualification conditions. However, some of the eco-toxicity tests need to be conducted on Chinese test organisms in accredited MEP-approved Chinese laboratories (so far 13 in total).

    Note: From 1 Apr 2017, testing institutes intending to provide eco-toxicological testing data acceptable for China new chemical notification should fill in relevant information using the newly launched “chemical test data quality management system”. The previous qualification system will be abolished and only the institutes listed on the management platform are accredited to provide testing data (ChemLinked News). 

    • Notifiers: new substance manufacturers or importers in China mainland, and non-Chinese companies exporting new chemical substance to China (hereafter referred to as “non-Chinese exporters”)
    • Representative agents: Appointed by the non-Chinese exporters with a similar role to “Only Representative” under EU REACH, often known as China-based “Only Representative” or “Only Representative”-like agent (hereafter referred to as “OR”)

     

    Companies Affected

    New substances manufactured or imported in China need to be notified with the CRC-MEP prior to entering the Chinese market. Companies are not permitted to engage in manufacturing or import activities without first obtaining a registration certificate.

    • Chinese manufacturers and importers shall directly perform the China new chemical substance notification
    • Non-Chinese exporters are not allowed to notify directly but are rather required to appoint a OR to complete the notification on their behalf. A Chinese importer can also notify, thereby relieving its foreign supplier of its notification obligations.Companies based in Hong Kong, Macau and Taiwan are also regarded as non-Chinese notifiers.

     

    Accredited Testing Institutes 

    Although the new chemical substance notification recognizes data from both Chinese and non-Chinese testing organizations, Article 10 (3) of MEP Order No.7 stresses that an eco-toxicological test report for Regular Notification under China NCSN must include data generated by MEP-approved testing institutes in China (mainland).

    A non-Chinese laboratory has to pass the inspection of the country where it is based or follow the GLP standards of the United Nations. Chinese laboratories have more specific requirements, which should be qualified with the following credentials as shown below.

    Domestic institutesEndpoints CategoryCredentials
    Physic-chemical dataLaboratory Accreditation Certificate issued by China National Accreditation Service for Conformity Assessment (CNAS)
    Metrology Accreditation Certificate (national level) issued by Certification and Accreditation Administration of China (CNCA)
    Pesticide GLP Certificate issued by Ministry of Agriculture (MOA)
    Toxicological datapharmaceutical nonclinical study GLP certificate issued by SFDA (renamed as CFDA in 2013)
    Certification of Occupational Health Service for Chemical Toxicity Testing issued by Ministry of Health (MOH)
    GLP Compliance Statement issued by CNAS
    Eco-toxicological dataMEP-approved (so far 11 institutes)

    The qualification of testing institutes to provide data for the notification dossier under China NCSN has always been a major concern for notifiers domestic as well as overseas. For details please refer to Ebook9

    Testing institutes available for eco-toxicological data are published in the MEP website. So far, only 13 qualified testing institutions (updated in Feb 2015) can provide eco-toxicological testing data accepted under China NCSN (China REACH).

    Table 5. List of MEP-approved Eco-toxicological Testing Institutes 

    No.

    Chinese Name

    English Name

    Applicable Scope

    Approved by MEP Announcement No.14 in 2009 (abolished concurrently when the MEP Announcement No.77 in 2012 issued)

    Approved by MEP Announcement No.78 in 2010 (abolished concurrently when the MEP Announcement No.5 in 2014 issued)

    Approved by MEP Announcement No.77 in 2012

    Approved by MEP Announcement No.5 in 2014

    Approved by MEP Announcement No.4 in 2015
    1上海市检测中心生物与安全检测实验室Shanghai Academy of Public MeasurementBand 4 Regular NotificationY Y  
    2沈阳化工研究院安全评价中心Shenyang Research Institute of Chemical IndustryBand 4 Regular NotificationY Y  
    3南京环境科学研究所国家环境保护农药环境评价与污染控制重点实验室MEP-approved Key Laboratory for Environmental Evaluation and Pollution Control under Nanjing Institute of Environmental ScienceBand 4 Regular NotificationY Y  
    4上海市环境科学研究院环境监测实验室Shanghai Academy of Environmental SciencesBand 3 Regular NotificationY Y  
    5广东省微生物分析检测中心生态毒理与环境安全实验室Guangdong Detection Center of MicrobiologyBand 3 Regular NotificationY Y  
    6江苏衡谱分析检测技术有限公司Jiangsu Hope Analytest IncBand 1 Regular Notification  Y  
    7苏州西山中科药物研究开发有限公司Suzhou Xishan Zhongke Drug R&D Co., LtdBand 1 Regular Notification  Y  
    8中国环境科学研究院中国环境保护部化学品生态效应与风险评估重点实验室MEP-approved Key Laboratory of Ecological Effect and Risk Assessment of Chemicals under Chinese Research Academy of Environmental SciencesSimplified NotificationY Y  
    9上海化工研究院检测中心Shanghai Research Institute of Chemical Industry Testing CenterUpgrade from General Case of Simplified Notification to Band 3 Regular Notification Y Y 
    10浙江省农业科学院农产品质量标准研究所Institute of Quality Standards for Agricultural Products, Zhejiang Academy of Agricultural SciencesBand 1 Regular Notification   Y 
    11北京协和建昊医药技术开发有限责任公司Institute of Materia Medica, Chinese Academy of Medical Science & Pecking Union Medical College (IMM)Simplified Notification   Y 
     贵州省理化测试分析研究中心Guizhou Research Center for Physical Test and Chemical AnalysisGeneral Case of Simplified Notification; Band 1 Regular Notification Y   
     浙江大学农药与环境毒理研究所Institute of Pesticide and Environmental Toxicology under Zhejiang University Y    
    12贵州省分析测试研究院Guizhou Academy of Testing and AnalysisBand 1 Regular Notification    Y
    13苏州华测安评化学品技术服务有限公司CTI CSERC (Suzhou) Co., Ltd.Simplified Notification    Y

    Note:As mentioned above in the "Stakeholders Involved", from 1 Apr 2017, only the institutes listed on the SCC-MEP management platform are accredited to provide eco-toxicological testing data for China NCSN (ChemLinked News). The test items already entrusted to the previous MEP-GLP approved 13 institutes will not be affected. 

    Inventory of Existing Chemical Substances - IECSC

    The Inventory of Existing Chemical Substances in China (IECSC) contains all existing chemical substances manufactured, processed, sold, used or imported inside mainland China between 1 January 1992 and 15 October 2003. Chemical substances not listed in IECSC are identified as new chemical substances under China new chemical substance notification. On Jan 30th 2013, China MEP issued the 2013 version of the Inventory of Existing Chemical Substances in China (IECSC 2013 in PDF). The IECSC 2013 contains 45,612 substances, among which 42,342 substances are released with all information on public and the remaining 3,270 substances are listed as confidential bearing only the Chinese and English generic names and listed serial number. 37,126 substances have CAS number, 8,486 substances have no CAS No. and are coded with serial No. instead; 31,088 substances have identified chemical structural formula and 14,524 have not. In comparison, the IECSC 2010 consists of 45,602 substances with 3,166 substances as confidential. (CRC-MEP statistics)

     The experts have modified around 1246 entries of information and deleted some repeated entries from the IECSC 2010, so the statistics of IECSC 2010 is not correct.

    The IECSC 2013 is the latest update of the 2010 version. Apart from the substances supplemented before the issue of the MEP Notice 1366 of 2011: Notice on Ceasing the IECSC Supplementation, some new chemical substances notified under the SEPA Order 17 (the 2003 version of Measures for the Environmental Management of New Chemical Substances) are included into the inventory. So it is recommended to re-apply for an IECSC comprehensive search to verify the substance of your concern is still deemed as new chemical substance to avoid unnecessary registration work (ChemLinked News).

    Note: Updated on 10 Mar 2016, 31 substances that were registered previously under NCSN and five years have passed since they were first manufactured, imported or exported were supplemented to IECSC 2013 (ChemLinked News).

    IECSC Search 

     

    Fig. 3 - IECSC Search 

    IECSC Search - The Inventory of Existing Chemical Substances (IECSC) in China serves as the basis to judge whether a substance is identified as new chemical substance subject to China new chemical substance notification (China NCSN). Therefore, confirmation of whether the substance in your product falls under IECSC is essential before your entering the Chinese market.

    Prior to IECSC 2013, the previous IECSC inventories were not published. The CRC-MEP only provided the free online search for the non-confidential substances, while the standalone search software for conducting a more detailed search was available for purchase. Since the full IECSC 2013 has already been disclosed to the public, the online search webpage of CRC-MEP has been deleted. Chemlinked has incorporated the IECSC 2013 into the free online ChemLinked Inventory Toolbox, where you can search by inputting the substance CAS number or full English/Chinese name. However, as some confidential substances are not accessible, it does not necessarily mean the substance is a new chemical substance in China if no match is found through the online search . In this instance, a comprehensive inquiry to the CRC-MEP is recommended, costing 5000RMB per substance.

     

    IECSC 2013 Software

    CRC-MEP updated the standalone version of IECSC software on 7 Feb 2013. The software costs RMB 8,500 and offers a two-year free upgrade service starting the day the account is activated. With this software a search can be made with the CAS No., chemical name or structural formula and displays more detailed results than the IECSC 2013 PDF version. Those who have already purchased the 2009 or 2010 version at the full price can upgrade to IECSC 2013 free of charge (ChemLinked News).

     

    IECSC Supplementation

    MEP published the MEP Notice 1366 of 2011: Notice on Ceasing IECSC Supplementation announcing that from 18 Nov 2011, the applications for inclusion into the IECSC of substances circulated in the Chinese market prior to 15 Oct 2003 was to be terminated.

    Prior to this notice, companies could apply for IECSC inclusion without supplying any test data if there was proof that the substance has been produced or used in China before 15Oct 2003. If this criterion was fulfilled, approval was granted and substances would be added into IECSC as “existing”, circumventing the necessity for NCSN.

    Due to concerns that the materials submitted for IECSC supplementation were too complicated and difficult to verify data authenticity, the MEP stopped this channel of IECSC supplement. Applications after the deadline of 18 November 2011 require companies to comply with China NCSN (China REACH) in accordance with the 2010 Measures on Environmental Management of New Chemical Substances (MEP Order 7), irrespective of whether the substance has been produced or used prior to 2003. According to CRC-MRP Director Mr. Nie, MEP is most unlikely to reopen the supplementation procedure in the future.

     

    IECSC Inclusion of New Chemical Substance

    Fig. 4 - IECSC Inclusion of New Chemical Substances

    Notifiers who have completed Regular Notifications and received registration certificates should take careful note of several timelines for inclusion of their substances into IECSC based on the environmental management category of the substance.

    Substances in Simplified Notifications or Scientific Research Record Notifications cannot be listed in the IECSC.

    A new general substance: registered under Regular Notification will be listed into the IECSC at least 5 years from the first date of its manufacturing or import.

    new hazardous substance or hazardous substance with priority environmental concern: These substances must be notified under Regular Notification and are required of reporting to the CRC-MEP of all activities submitted by the registration certificate holder within 6 months prior to the end of the five-year period from the first date of their manufacturing or import. After that, a revaluation on the substance hazard information will be conducted by the evaluation committee. It is ultimately up to the MEP to incorporate the substance into IECSC based on the findings of the evaluation committee.

    Fig. 5 - Report of Inclusion of Notified New Chemical Substance into Iecsc(Trial)

    Apart from substances notified under MEP Order 7, new chemical substances certified under SEPA Order 17 (predecessor of MEP Order 7)also have a chance to be listed into IECSC. Stipulated in the MEP notice 123 of 2010, China NCSN certificates obtained under the MEP Order 17 can be valid until the notified new chemical substance is added into the IECSC. Certificate holders applying for the inclusion of a substance into the IECSC are required to submit the activity report to the CRC-MEP within a month after the 5th year of manufacturing or import. However applications will require more information and supplementary material evidence. The procedure for adding new chemical substances notified under the MEP Order 17 into the IECSC hasn’t been published yet. The form attached on the right (Fig 5) is for reference only and the official version is subject to change.

    When the registered substance gets listed in the IECSC, it will be exempted from stringent supervision since there is significantly less management over existing chemical substances. Only when it is listed into other inventories according to its hazard and risk properties, such as C&L inventory, Inventory of Chinese Highly Toxic Chemicals, etc., the new chemical substance will be subject to the stricter supervision according to certain categories of China’s existing chemical management regime.

    The new chemical substances notified under the MEP Order 17 will be gradually included into the IECSC when the relevant guidance documents are ready. Besides, as 2015 is approaching, the new chemical substance granted certification of Regular Notification under MEP Order 7 will also have the chance to be added into the IECSC. To expedite the IECSC inclusion procedure of qualified new substances and to avoid the unnecessary notification resulting from the IECSC update are the two urgent tasks to be tackled by the CRC-MEP in the near future.

     

    How to Comply

    Notification Types and Procedures

    Fig. 6 - Notification Procedure of China NCSN (China REACH)

    Fig. 7 - Approval Procedure of China NCSN (China REACH)

    There are three types of notification under NCSN, depending on the purpose of manufacturing/export/import and the quantities.

    Scientific Research Record Notification:

    Scientific Research Record has the lowest requirements among all the three notification types. To apply for a scientific research record, your substance should be manufactured/imported/exported:

    • for the purpose of scientific research and development (R&D), in very low quantities (<0.1 tonne per annum), or
    • as samples used for a compulsory eco-tox test that must be performed in a verified Chinese laboratory (which is also viewed as the prerequisite to the Regular Notification for imported new substances).

    Simplified Notification:

    Simplified Notification applies for tonnage quantities <1 tonne per annum. There are four special cases of Simplified Notification, by applying for which substances have less registration requirements than the general case of simplified notification.

    • General Case:

      • Manufactured/imported in quantities < 1 tonne per annum.
    • Special Case:

      • Intermediates manufactured/imported < 1 tonne per annum) (“Intermediate”);
      • Only for the purpose of exporting from China, in quantities < 1 tonne per annum (“Manufacture for Export Only”);
      • Classified as the polymers of low concern (“Polymers of Low Concern”);
      • Polymers with low new chemical substance concentration of monomer which are (<2 % w/w) (“New Chemical Substance Monomer<2%”);
      • For the purpose of scientific research and development, in quantities of 0.1-1 tonne (not included) per annum (“Scientific Research”);
      • For the purpose of product research or process technology <10 tonnes per annum for less than 2 years (“PPORD”).

    Regular Notification

    The general case of Regular Notification applies to tonnage quantities > 1 tonnes per annum. There are four tonnage bands:

    • Band 1: 1-10 tonnes per annum
    • Band 2: 10-100 tonnes per annum
    • Band 3: 100-1000 tonnes per annum
    • Band 4: 1000+ tonnes per annum

    In the case of a Regular Notification, dossiers need to be submitted to the CRC-MEP for processing. The dossier is first checked for technical completeness, next evaluated by the evaluation committee and finally submitted to MEP for approval. The notification dossier documents are required to be in Chinese with notarized translations for non-Chinese languages.

     

    Data Requirements 

    Fig. 8 - Data Requirements for China NCSN (China REACH)

    Under China NCSN (China REACH), the minimum data requirements vary for different notification types and tonnage bands. The tests involve physico-chemical, toxicological and eco-toxicological testing.

      Some eco-toxicological testing is required to be carried out using Chinese target organisms within Chinese territory in MEP-approved Chinese testing institutes.

    Scientific Research Record Notification (SRRN): This is the simplest form of notification and requires minimum information.

    Simplified Notification: An eco-toxicological test report is required with the required testing, which is dependent on the nature and properties of the substance. For example, if the substance is organic, the ready biodegradability of the substance would be required. For the case of an inorganic substance, a report of the acute aquatic organism toxicity is required. No eco-toxicological data is required for the special cases of Simplified Notification.

    Regular Notification: For Regular Notification, the ‘Tonnage principle’ (Article 11 of the "Measures") applies which requires more data as the tonnage band increases. The amount of physico-chemical testing is the same for all tonnage bands and the testing required depends on the physical state of the substance (solid, liquid or gas). The tonnage principle generally applies for the toxicological and eco-toxicological testing. For example, the number of eco- and toxicological tests for tonnage Band 4 are more than double of those required for tonnage Band 1. Classification & Labelling of the substance according to GHS criteria is a necessity. A risk assessment report may also be required.

    A summary of the data requirements for different notification types are shown below:

    Notification TypeConditionsData Requirements
    Regular Notification1st Tonnage Band: 1-10 t/y
    2nd Tonnage Band: 10-100 t/y
    3rd Tonnage Band: 100-1000 t/y
    4th Tonnage Band: 1000+ t/y
    Regular Notification Form
    Classification &Labelling
    Risk Assessment Report
    Eco-toxicological Properties
    Toxicological Properties
    Physico-chem Properties
    Chinese SDS
    SimplifiedSpecial CaseSimplified Notification Form
    Basic Physico-chemical data
    General Case+ Eco-toxicological testing>
    Scientific Research Record Notification (SRRN)R&D < 0.1 tonne
    Import of testing samples
    SRRN Form

    Table 1. Physico-chemical testing data (irrespective of tonnage):


    Physical State
    (at 20°C and 101.3 kPa)
    Minimum Data Requirements
    Gasoxidizing properties, self-ignition temperature (°C), explosive limit and critical point
    LiquidBoiling point (°C), density (kg/m3), vapour pressure (kPa, °C), partition coefficient n-octanol/water (Log Pow), water solubility (g/L), surface tension1 (N/m), pH value, flash-point (°C), oxidizing properties, self-ignition temperature (°C), flammability and explosive properties.
    SolidMelting point (°C), density (kg/m3), partition coefficient n-octanol/water (Log Pow), water solubility (g/L), granulometry (μm), oxidizing properties, self-ignition temperature (°C), Flammability and explosive properties.
    OthersAccording to the above data requirements of the three physical states of matter, the notifier should provide all the applicable testing data. For a chemical substance near its critical point, the details of the stability and degradation properties within an organic solvent shall be provided. If applicable, the critical temperature should also be calculated

    Table 2. Toxicological testing data (based on the specific tonnage band):


    Minimum data requirements
    Band 1
    (1-10 t/y)
    Band 2
    (10-100 t/y)
    Band 3
    (100-1000 t/y)
    Band 4
    (1000+ t/y)
    Acute toxicityXXXX
    28-day repeated dose toxicityXXXX
    MutagenicityXXXX
    90-day repeated dose toxicity XXX
    Reproductive/developmental toxicity XXX
    Toxicokinetics XXX
    Chronic toxicity   X
    Carcinogenicity   X
    Others    
    Note: 'Q' standards for the notified quantities.

    Table 3. Eco-toxicological testing data (based on the specific tonnage band):


    Minimum data requirements
    Band 1
    (1-10 t/y)
    Band 2
    (10-100 t/y)
    Band 3
    (100-1000 t/y
    Band 4
    (1000+ t/y)
    Algae growth inhibition studyXXXX
    Acute toxicity testing on Daphnia magnaXXXX
    Fish, Acute toxicity testingXXXX
    Activated sludge respiration inhibition testingXXXX
    Adsorption/desorptionXXXX
    DegradationXXXX
    Earthworm, Acute toxicity testingXXXX
    Fish, Prolonged toxicity testing (14-day study) X  
    Daphnia magna reproductive testing XXX
    Bioaccumulation XXX
    Fish, Chronic toxicity testing  XX
    Seed Germination & Root Elongation Toxicity Test  XX
    Note: 'Q' standards for the notified quantities.

    Table 4. The data from the following sources can be accepted by CRC-MEP:


    Data source
    Remarks
    Laboratory test reportPreferred data source
    Certification of the test institute needs to be provided
    Test data may originate from Chinese or accredited overseas test institutes (i.e. GLP-compliant)
    Published literatureFull official document needs to be provided
    Only the abstract or certain is not acceptable
    DatabaseDetails of the database should be provided
    QSAR estimatesEstimation models and read-across endpoints can be used as reference only
    Expert statementExpert statement can be provided

     

    GLP Compliance

    Measures for the Administration of Chemical Testing Good Laboratory Practices covers the application procedures and management of the laboratories accredited to conduct testing for NCSN etc. The Chinese domestic testing institutes approved by the MEP will have to submit annual reports to the authority every January and will be subject to several random inspections and targeted supervision.

    The development of these standards has borrowed heavily from the OECD principles of Good Laboratory Practice. Four draft standards were issued in 2012 for China MEP’s GLP. The draft proposals are:

    Since the MEP manages GLP labs in a dynamic way, the approved testing institutions will be subject to surveillance and inspection by the MEP every 3 years, according to Article 19 of MEP Order 7. It has been three years since the last qualification inspection was conducted by the MEP in 2009. Compared with 2009, the qualification inspection has been improved. Inspection items have increased from 20 to 160. The 2004 version of Guidelines of Chemical Testing Good Laboratory Practices (HJ/T 155-2004) is more of a coarse framework, while the 2012 draft version (HJ/T 155-20xx) adopts more OECD principles, indicating the authority’s intention to prioritize global harmonization. According to draft version of the Guidelines, testing institutions will have to pass the qualification inspection, which is composed of both technical competence evaluation and on-site inspection. For the testing institutions that fail the GLP inspection, the MEP will possibly revoke the status of the labs. (ChemLinked News).

     

    Post-Notification Duties 

    NCSN adopts different management requirements for different categories of new substances. New chemical substances registered for Regular Notification will be divided in three environmental management categories following the expert panel's evaluation. They are the "general chemical substance", "hazardous chemical substance" and "hazardous chemical substance of priority environmental concern", respectively.

    Fig. 9 - Post-Notification Duties

    •  If you have submitted a Scientific Research Record Notification (SRRN), you should

      • 1. Manage the notified substance by using the specialized facilities and under the guidance of professional personnel;
      • 2. Apply the regulations on dangerous waste when disposing of the new substances under SRRN.
    •  If you have submitted a Simplified Notification (SN), you should perform a yearly checkup to

      • 1. Report to competent authorities the activities of the registered substance over the past year;
      • 2. Keep relevant documentation materials over 10 years.
    •  If you have submitted a Regular Notification (RN), you should:

      •  In the case of a general new chemical substance (general category):

        • 1. Identify the hazard information in the MSDS of the substance and communicate it to its processers and downstream users;
        • 2. Exercise risk control measures indicated in the registration certificate;
        • 3. Inform competent authorities of its first-time activity report;
        • 4. Keep relevant documentation materials over 10 years;
        • 5. Avoid transferring or selling in any way your registered substance to a third processing or using unit who is unable to take effective risk control measures (Article 33);
        • 6. Informing competent authorities about the newly arising hazard or risk information of the registered substance;
        • 7. Apply the regulations on dangerous waste when disposing of the new substances. 
      •  In the case of a hazardous new chemical substance (hazard category), besides the above 7 requirements in "general category":

        • 8. Report to competent authorities the activities of the registered substance over the past year;
        • 9. Comply with the State Council Decree No. 591 and other related laws, which is also applicable to the substance processors and downstream users;
        • 10. Submit a 5-year activity report before inclusion of  the registered substance into IECSC
      •  In the case of a hazardous new chemical substance of priority environmental concern (environmental priority category), besides the above 10 requirements provided in "hazardous category":

        • 11. Have competence in monitoring emissions and management of environmental impact.
        • 12. Report to competent authorities the transferring information of the registered substance;
        • 13. Report to competent authorities your next year's plan of the manufacture/import of registered substance.
        • 14. Re-notify the substance in case of change of registered usages

     

    Cost

    Notification Cost:

    The total cost for China NCSN consists of three major parts, namely the administration fee, the testing fee and the consulting fee.

    Fig. 10 - Cost of China NCSN (China REACH)

    Administrative fee: According to current regulations, application and evaluation for China NCSN or issuance of registration certificate requires any administration fee. A comprehensive inquiry with the CRC-MEP to confirm whether the substance is new and subject to China NCSN costs 5000 Yuan.

    Consulting fee: The consulting fee will be charged by the OR-like representative mainly for the preparation of dossiers and the fulfillment of post-notification obligations, e.g. preparation of risk assessment report and annual report, etc.

    Testing fee: The notifying companies still need to take account of their own capital investment on notification dossiers preparation, especially the test data production. The testing fee accounts for a large proportion of the total costs, compared with the administrative fee and consulting fee. The higher the tonnage band, the more test data is required. However, some testing items can be exempted through data gap analysis, e.g. the soil & sludge adsorption coefficient estimation is usually considered a prior determinant for whether the two eco-toxicological tests (the earthworm acute toxicity test or the seed germination & root elongation toxicity test) can be exempted from the Regular Notification.

    Notifiers of General Case of Simplified Notification and Regular Notification are required to submit the domestically generated eco-toxicological testing data in their dossier. Companies planning to submit eco-toxicological testing data in their China NCSN dossier are expected to designate a bigger compliance budget for the coming year since the testing charges rises substantially. According to the statistics collected from three MEP-approved eco-toxicological testing institutes, potential notifiers should expect an elevation from 3,000 to 30,000 RMB for one single testing item, which is around 30-40% increase compared with the year 2012 (ChemLinked News). The rising cost for eco-toxicological testing is the official explanation for this substantial rise in price.

    Fig. 11 - Risk Assessment

      Please contact us in relation to the quotation from the eco-toxicological testing.

    Nevertheless, compared with the eco-toxicological testing fee charged by the international OECD testing institutions, the quotations of domestic testing institutions are still comparatively low. However, China is not an OECD member country and the eco-toxicological testing data produced by MEP-approved testing institutions will not be accepted for chemical regulations in other countries, i.e. EU REACH, USA TSCA, etc.

     

    Risk Assessment 

    Under the regime of China new chemical substance notification, regular notifications for substances must include the risk assessment report. The format of the risk assessment report required under China NCSN was published in the MEP's NCSN guidance document in September 2010. It details the main components of the risk assessment report – classification and labelling, hazard assessment, exposure prediction and risk characterization, which are similar to the REACH chemical safety report (CSR). However, in contrast to REACH, where a CSR is required for substances produced in annual quantities above ten tonnes, a risk assessment report under China NCSN must be provided for those produced or imported in annual quantities above one tonne.

     

    China NCSN (China REACH) FAQ

    The SCC-MEP updated on 7 Dec 2015 the FAQs concerning China New Chemical Substance Notification (China NCSN), which includes 196 the most-frequently-asked questions submitted by notifiers to the authority. Some of them are China NCSN regulatory basics that should be known to potential company notifiers and others are specific cases come across in China NCSN compliance practices. 

    FAQs updated in Chinese

    The full PDF version in English of FAQs is available on Chemlinked. Any feedback concerning the China NCSN is welcome and we’ll collect and submit them to the CRC-MEP.

     

     

    China NCSN (China REACH) Statistics

    Sample of China NCSN Statistics Report

    From 2011 to 2016, MEP has approved 5,864 Scientific Research Record Notifications, 16,887 Special Case of Simplified Notifications, 2,334 General Case of Simplified Notifications, and 600 Regular Notifications (including the ones under public consultation). Besides, China MEP also approved several applications for the modification of the registration certificates in the past years. If you want to have the newest statistics report please contact us. 

    Below is a chart which offers a graphical representation of the number of new chemical notification numbers approved in the last six years (from 2011 to 2016).

     

    News

     

    Expert Articles & Ebook

    1. Nadine He, 27 Oct 2016 "China Considers Data Reduction for New Chemical Notification"
    2. Nadine He, 16 Jul 2015 "China New Chemical Substance Notifictaion Guidance: Comparative Analysis of Current Version and Pending Draft"
    3. Nadine He, 30 Apr 2015 "Minimum Mandatory Ecotoxicological Data Required to Be Generated in China for China New Chemical Substance Notification"
    4. Nadine He, 17 Dec 2014 "The Working of China's NCSN Expert Evaluation Committee"
    5. Jim Wei, 16 Dec 2014 "Chinese Guidelines for the Testing of Chemicals-Health Effect"
    6. Chen Ying, 4 Aug 2014 "China NCSN: Notification of Mixtures"
    7. Shawn Xiang, 26 Dec 2013 "Notification of Inorganic Compound under China REACH"
    8. Mona Zhang, 24 Dec 2013 "Three Administrative Management Categories in China New Chemical Substance Notification: General, Hazardous, Hazard of Priority Environmental Concern"
    9. Atlans Dale, 20 Dec 2013 "Expediting Simplified Notification (General Case) of China New Chemical Substance Notification - Advice for non-Chinese entities"
    10. Renee Liang & Nadine He, 14 Oct 2013 "Seminar on China NCSN - Management and Administration"
    11. Alva Chen, 12 Oct 2013  "Seminar on China NCSN - Toxicology"
    12. Collin Yan, 12 Oct 2013 "Seminar on China NCSN - Ecotoxicology and Risk Assessment
    13. Rita Qiu, 1 Jul 2013 "Overview of China GLP System"
    14. Mary Lin, 8 Jan 2013 "Is General Case of Simplified Notification Simple?"
    15. Martin Hu, 23 Nov 2012 "Guidance for the Plant Extract Manufacturers/Importers to Comply with China REACH"
    16. Anthea Zhou, 19 Nov 2012 "Information Publicity and Confidentiality under China NCSN and EU REACH"
    17. Olivia Sun, 14 Nov 2012 "Is Short-term Toxicity to Earthworm Test Conducted in China a Must?"
    18. Collin Yuan, 17 Oct 2012 "Are Reasons for 'No Classification' under China REACH Equal to CLP Regulation?"
    19. Lizzy Liu, 12 Sep 2012 "China REACH FAQs"
    20. Martin Hu, 4 Sep 2012 "How to Apply Generic Names in Your China New Substance Notification
    21. Lizzy Liu, 18 Jun 2012 Challenges of Joint Notification under China New Chemical Substance Notification (NCSN)
    22. Olivia Sun, 25 May 2012 "'China REACH' Typical Case Studies"
    23. Lizzy Liu, 25 Apr 2012 "Case Study: Exemptions Under China REACH"
    24. Lizzy Liu, 21 March 2012 "Case Study On Data Requirements Under China REACH"
    25. Linda Li, 20 Oct 2011 "Preparing Risk Assessment Reports for China REACH"
    26. Martin Hu, 11 May 2011 "Guidance for 'China REACH': Focus on New Chemical Substances"
    27. Lizzy Liu, 29 March 2011 "New Chemical Substance Notification in China (China REACH)"
    28. Jim Wei, 8 Feb 2011 "Overview of China New Chemical Substance Notification (China REACH)"
    29. Lizzy Liu, 5 Feb 2011 "What Is the Scope of China REACh?"
    30. Lizzy Liu, 10 Nov 2010 "Data Requirements under China REACH and EU REACH: What are the Similarities and the Differences?"
    31. Lizzy Liu, 6 Oct 2010 "Data Requirements under China REACH"
    32. Lizzy Liu, 5 Aug 2010 "IECSC Search under China REACH"
    33. Lizzy Liu, 5 Aug 2010 "What is 'China REACH'?"
    34. Lizzy Liu, 30 Apr 2010 "2010, a Challenging Year for the Implementation of China REACH"
    35. 1 May 2010 Ebook01: Measureas on the Environmental Management of New Chemical Substance (MEP Order 7),
    36. 15 Aug 2012 Ebook02: New Chemical Substance Notification Guidance Document
    37. 1 Jan 2012 Ebook07: The Guidelines for Risk Assessment of Chemicals, China (draft)
    38. 1 Jan 2011 Ebook08: The Guidelines for Hazard Identification of New Chemical Substances, China (draft)
    39. Tommy Kong, 22 Nov 2012, Ebook09: Qualification Requirement of Testing Institutes under China NCSN

     

     

     

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