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Registering a New Chemical Substance in China

What steps are required for New Chemical Substance Registration?

In order to register a new substance in China, the following steps are usually required:

 

Step 1: IECSC formal search

The Inventory of Existing Chemical Substances in China (IECSC) can be partly searched online on the Chemical Registration Centre (CRC) website:

http://www.crc-mep.org.cn/iecscweb/


To search the confidential substances (and substances without CAS number etc.),  an IECSC formal comprehensive search is recommended to confirm the substance is not listed on the IECSC before commencing the registration process. This is currently the only administrative fee charged by the CRC-MEP. The approximate time is 8-10 working days.

 

Please This e-mail address is being protected from spambots. You need JavaScript enabled to view it to assist you in performing your IECSC comprehensive search (only Chinese registered entities are currently permitted to perform a comprehensive IECSC search).

 

Step 2: Scientific Research Record Notification (SRRN) for testing samples

For regular and general simplified registration, a SRRN needs to be submitted to the CRC for the export of testing samples to China of the substance to be registered. Samples need to be sent to China to complete the required eco-toxicological testing that must be conducted in approved Chinese laboratories. This takes approximately 8-10 working days. As no registration certificate is required, the shipment of the samples can start as soon as the SRRN notification is submitted.


Step 3: Data gap analysis & testing for data endpoints

This includes testing ofsamples and performing literature searches of existing data. There are different strategies for performing these tests and certain high-level testing can be waived if the low-level testing is first performed. The time for this step is quite variable depending on the testing required: 2-12 months.

 

Step 4: Notification Submission

Preparation of the notification material and submission to the CRC (2 weeks - 1 month).

 

Step 5: Processing of application by the CRC

Free  Web  Training

Stay Ahead of Chemical Compliance before Entering Chinese Market

Time:  May 15 (Tuesday), 2012

20:30 - 22:00 Beijing Time,

14:30 - 16:00 Brussels Time,

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Topics: Click for details

A. GHS compliance activities in China

B. Risk control on product quality before entering Chinese market

C. Compliance requirements for China new chemical substance notification

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