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Updates on New Chemical Substance Notification in China from MEP-SCC during ChemCon 2015

original article from CIRS

Mr. Ethan Zheng, Regulatory Consultant and BD Manager from CIRS, has attended ChemCon 2015 in Hong Kong. During the conference, Mr. Xiaojian Liu, from MEP-SCC, was invited to give a talk on the topic of “Implementation, Development and Guidance Documents for the New Chemical Substance Notification in China”.

The following contents are the first-hand information regarding to the new chemical substance notification in China compiled by CIRS.

The revision work for the Guidance for New Chemical Substance Notification and Registration has started since early 2014. It is a very important document for the management of new chemical substance in China. The currently used guidance is the version that came into effect on October 15, 2010, which is a very old one. The content includes application scope, notification types and procedures, document requirements, polymer provisions, post-registration management, etc. However, some defects and problems have been found in the old version, so, MEP-SCC decided to revise the guidance from January 2014.

Revision Principles

  1. Guidance framework will not be changed. Works will be done majorly on supplementation, completion, clarification and modification of relevant problems.
  2. Both regulations of oversea countries and the real situation in China will be considered simultaneously.
  3. Expert comments, governmental requirements and industry advices will be taken into consideration to make the final decision.
  4. Related provisions of MEP Order 7 shall be complied.


Main Changes in the Revision Draft

1. Management Policy Revision

Revised Item

Current Guidance

Revised Draft Guidance

Qualification of domestic notifier

Business bodies registered in China with legal personality

Business bodies registered in China (no requirement for legal personality)

Definition of holder of registration certificate

The domestic notifier is the registration certificate holder; the local representative agent is the registration certificate holder for foreign notifier

Either the domestic notifier or the foreign notifier will be the registration certificate holder

Qualification of local representative agent

  1. requirements:

1.Pass the annual inspection
3.Possess registered capital of over 3,000,000 RMB

1. Requirement 1 and 3 are deleted.
2. Management of representative agent is enhanced

Scope of application territories

China; the Bonded and Export Processing Zone

China; the Bonded and Export Processing Zone; China Pilot Free Trade Zones

Notification Way

With specific tonnage quantity

Applicant can choose to notify with specific tonnage quantity or tonnage level (level 4 is required for specific tonnage)

Publicity and announcement of registration information

Registered substance name, notifier, notification type, new chemical substance management category

The hazard classification of “Key Hazardous New Chemical Substance for Environmental Management” shall also be included

Submission of notification dossiers

Complete set of dossiers shall be mailed or delivered in person

Complete set of dossiers can be submitted via notification software issued by MEP-SCC. Paperless notification is planned to be launched in the future.

Simplified notification for polymers


Special situation of simplified notification does not apply to unstable, degradable or water-absorbing polymers

Modification of information on registration certificate

The registration certificate holder shall submit application

If the registration certificate is a foreign company, both the holder and local representative agent shall submit the application jointly..

2. Data Requirement Revision

Revised Item

Current Guidance

Revised Draft Guidance

Test report validity


1.Test report conducted in China shall be completed within the validity of their qualifications in the test report issued
2.If the testing method has been updated more than 5 years, the test report shall be performed in accordance with the current test method

Test method

The first version of The Guidelines For The Testing Of Chemicals

The latest version of The Guidelines for the Testing of Chemicals, which was published in 2013

Chinese test organism

Organisms cultivated and bred in China, including Gobiocypris rarus (Rare minnow), Xiphophorus helleri (Sward-tail fish), Brachydanio rerio or Daniorerio (Zebra Fish), activated sludge etc.

Local organisms cultivated and bred in China, especially Gobiocypris rarus (Rare minnow), activated sludge etc.

Data requirement and data waiving


  1. Clarify the requirement of data sources and test sample;
  2. Adjust the list of test institutes accreditation;
  3. Clarify data requirements of spectrum;
  4. Modify the current criteria of exemprions;
  5. Add more waiving conditions
  6. Delete some waiver criteria;
  7. Remove the fish prolonged toxicity test;
  8. Clarify the submission requirement of toxicokinetics;
  9. Add long-term toxicity test on terrestrial organism to eco-toxicological data requirement of level 4;


Risk Assessment Report Requirement

Safety rules for classification, precautionary labeling and precautionary statements of chemicals (GB 2006 series)

  1. Replaced by Rules for classification and labeling of chemicals (GB 30000 series);
  2. Explain the application of quantitative assessment and qualitative assessment in detail;
  3. Enhance management of compiling organizations and persons of risk assessment report;
  4. Supplement the contents on risk assessment report of serial substances;
  5. Provide the format requirement of risk assessment report as an annex;
  6. Increase contents on the identification of PBT substances

3. Addition of Annexes

Revised Item

Current Guidance

Revised Draft Guidance

Notified Use

Notifier completes with actual situation

Use code list of chemicals is provided as annex

Post-registration report


Report format has been redesigned and added as annexes in the guidance

4. Simplification of the Management Procedures

Revised Item

Current Guidance

Revised Draft Guidance

Modification of information on registration certificate

If modification is approved, the old registration certificate shall be changed for a new one

Modification receipt will be issued by MEP-SCC, the old registration certificate does not need to be changed

New Chemical Substance for Each Activity Report

No minimum limit of the transfer

If the transfer amount of Key Hazardous New Chemical Substance for Environmental Management is more than 10 kg, the New Chemical Substance for Each Activity Report is required

Simplified notification of polymers

Registration tonnage is limited and will be present on the registration certificate

There is no tonnage limits, and registration tonnage will not be listed on the registration certificate

Next Step on Guidance Revision

Public comments will be collected and reviewed by expert committee and management authorities. Training programs will be carried out by MEP after officially publication of the guidance.

CIRS Advice

  1. Enterprises are recommended to choose experienced representative agent to assist them to finish the notification, in order to save time and reduce cost;
  2. For those who have not started the testing projects, it is recommended to get prepared in advance according to the latest requirement;
  3. It is recommended that enterprises study the updates or work with their representative agents to make a better business strategy.

Contact Us

  • CIRS China
    Hangzhou CIRS Co. Ltd (CIRS China)
    11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
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