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New Chemical Substances once Exempted need to Complete Re-notification under the 2010 version

The 2003 version of the Measures for the Administration of New Chemical Substances(SEPA Order 17) has been replaced by the MEP Order 7 since 15 October 2010. The scenarios where the notifier can apply for exemption from the notification, which are specified in the article 13 of SEPA Order 17, have been changed to other notification types under MEP Order 7. According to MEP Notice 123 of 2010 on clarifying the transitional issues relating to the China New Chemical Substance Notification(NCSN), the New Chemical Substance Exemption Notification granted under SEPA Order 17 can still be valid after 15 October 2010 when MEP Order 7 comes into force. However, the exemption period for new chemical substance under SEPA Order 17 has expired till now, any interested notifier should re-apply for the China NCSN under the new Measures.

The 2010 measures classify the notification of new chemical into three types, the regular notification, simplified notification and scientific research record notification, which have replaced the original five types, which are the typical notification, serial notification, joint notification, simplified notification, and notification exemption. Since the valid period for the New Chemical Substance Exemption Notification is one year from the date of issue, so far all the exemption notifications approved according to SEPA Order 17 have been invalid, indicating that the notifier should apply again for China NCSN under the new Measures.

The four cases of exemption notification specified in the SEPA Order 17 can be designated as the the scientific research record notification and the special case of simplified notification under the new Measures. Details of the designation of the four cases under 2010 version is summarized in the table below.

 

Exemption Cases under SEPA Order 17

Scientific research record notification(SRRN) under MEP Order 7

Special case of simplified notification under MEP Order 7

1

Applied to scientific research, and annually manufactured or imported less than 0.1 tonne

X

 

2

Classified as a polymer with the concentration a new chemical substance monomer below 2% (w/w)

 

                       X

3

Applied to the process research and development, and the total amount manufactured or imported below 1 tonne, which enjoys only one-year exemption from notification and no extension will be granted

 

                       X

4

Samples of new chemical substances imported for the purpose of performing the eco-toxicological tests of new chemical substances within the territory of China, using Chinese organisms.

  X

 

In the 2003 version, the notifier applying for exemption from notification shall provide evidentiary materials demonstrating conformities to the provisions pertaining to exemption notification apart from the application form to CRC-MEP. In the 2010 version, the same China new chemical substance exempted under SEPA Order 17 should apply for the scientific research record notification(SRRN) or the special case of simplified notification accordingly. The first case and the fourth case listed above are exactly the same as the cases of SRRN which now requires submitting the scientific research record form and other attachment materials to CRC-MEP such as the duplicate copies of the legal entity certificate and business license, etc. For the other two cases, they are much similar to the special cases of simplified notification under the 2010 version. In addition to completing the notification form, corresponding attachments required for each of the special cases of the simplified notification are specified in the 2010 China NCSN Guidance Document.

As for the post-notification obligations, difference also exists. The notifier of exemption notification is obliged to keep a record of the materials, including the scientific research, processing development, the quantities of the import and manufacture, etc. If the substance previously exempted falls into the scope of the special cases of the simplified notification, the requirements for the post-notification obligation will be higher, not only a report for next year’s plan is needed, but also the relevant notification materials are required to be kept for more than ten years. 

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