Chemical Compliance
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New Chemical Substance Regular Notification Application Form
Local Title:
新化学物质常规申报表
Country/Region:
Chinese Mainland
Competent Authority:
Ministry of Environmental Protection (now MEE)
Type:
Form
Status:
Invalid
Release Date:
2010-09-16
Implementation Date:
2010-10-15
Document
Language Source Title Access
ZH
Official New Chemical Substance Regular Notification Application Form_CN
ZH
Official Guidance on New Chemical Substance Regular Notification Application Form_CN
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New Chemical Substance Regular Notification Application Form
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Summary

The application form with a guidance on how to prepare it was issued by MEP Notice 124 of 2010 as one of the supporting documents for China MEP Order 7. The 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 addition to the individual notification, there are special types for the regular notification including,

  • Serial notification

  • Joint notification

  • Joint-serial notification

  • Repeat notification

  • Re-notification (increased tonnage band or use change)

The higher the tonnage, the more test data requirements. On average, the testing cycle of a regular notification could last two to three years or even longer. Companies subject to the NCSN Regular Notification shall prepare for submission of three main notification documents:

  • New chemical substance regular notification application form;

  • Risk assessment report of the notified new chemical substance; and

  • Testing reports of the corresponding physical-chemical properties, toxicology and eco-toxicology as well as other relevant testing documents and credentials of the testing institutions. It is worth noting that the eco-toxicity tests need to be conducted on Chinese test organisms in accredited MEP-approved Chinese laboratories (so far there are 10 in total).

The application form for regular notification contains 7 aspects, including,

  • Information of the notifier

  • Basic information of regular notification

  • Identification of the notified substance

  • Exposure information of the notified substance

  • Inherent properties of the notified substance

  • Information of environmental safety

  • Other information such as the measures for the control of environmental hazards and health hazards, hazard classification results, labeling, MSDS, etc.

The expert committee in responsible for the review of notification dossiers will divide the notified new chemical substances into three environmental management categories according to the hazard properties, i.e. general chemical substance; hazardous chemical substance and hazardous chemical substance of priority environmental concern. 

History
2020-11-17
Merge Regulations
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New Chemical Substance Regular Notification Application Form
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Release Date: 2010-09-16
Implementation Date : 2010-10-15
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2012-12-27
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2011-04-02
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2011-01-05
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2010-09-16
New Chemical Substance Regular Notification Application Form
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Implementation Date : 2010-10-15
2010-09-16
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2003-09-22
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Release Date: 2003-09-22
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Obligations