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The amendment of China New Chemical Substance Notification Guidance (China NCSN) has been a major concern for industry since its drafting in Jan 2014.
The basic principles of MEP Order 7 won’t be changed and all amendments articulated within the Jan 2014 revision should be made in accordance with the provisions of MEP Order 7. Amendments have been made only to clarify ambiguities, provide a more practical guidance and plug any administrative loopholes. The draft revision main changes are: the applicable scope, management policy, data requirements and waiving, risk assessment report requirements and post-registration requirements and procedures.
The draft was completed in Jan 2015 and then submitted for internal review by the MEP, and will be issued for public comment in the near future. The SCC is expected to complete the drafting and issue the final version within this year and will provide a clear schedule for implementation and specify the transition period between the current version and the revision. Below are some major amendments for your reference.
1. Qualification of domestic notifier
Under the current system domestic notifiers must be registered in the People's Republic of China with legal personality . Under the draft amendment this restriction will be removed. This amendment was made by the SCC after consulting legal counsel to ensure that notifiers without legal personality can still be held liable for violations under MEP Order 7. According to Mr. Liu Xiaojian from SCC-MEP another reason for the amendment was that the requirements specified in the guidance cannot exceed the requirements of MEP Order 7 which only defines that domestic notifiers should be registered in China.
2. Definition of holder of registration certificate
In the current system when the notifier is a foreign entity the local representative agent based in China is the holder of the registration certificate and will take all the responsibilities required of registration certificate holders as specified in MEP Order 7, e.g. updating new hazardous properties information to the SCC immediately If found any, submitting annual report, adding new risk control measures to the certificate and implementing new measures accordingly etc. The draft revision allows foreign notifiers to become the holder of the registration certificate. However, the responsibilities of registration certificate holders must be assumed by foreign notifier and the local representative jointly. The only difference is the foreign notifier can actually own the certificate after the revision.
3. Regular Notification tonnage
The current notification requirement for providing specific tonnage amounts will be changed. As drafted, when applying for regular notification (except Band 4), either specific tonnage amount or tonnage band can be accepted, which means the information appearing on the registration certificate can be a tonnage band instead of a specific amount. Only when manufacture or import exceeds the upper limit of the registered tonnage band should the new chemical substance be “re-notified”. Modification of tonnage amount within the registered tonnage band will be exempt from the current modification of notification, which is more practical since the registered amount is only predicted in advance and the actual volumes usually differ from the predicted amount.
4. Information publication
Drafted in the revised guidance, the hazard classification of hazardous new chemical substances of priority environmental concern should be issued for public reference as well as the currently required basic information, including the substance names, notifiers and notification type and management categories. Since the issuance of the 3rd batch of China new chemical substance notifications in 2014 the certificate holder’s name has no longer been released for public reference (CL news) (to avoid a disclosure of supply chain information). However, as mentioned above in Point 1, since under the draft revision the notifier will be the certificate holder there is no longer any concern about disclosure of supply chain information.
5. Notified Use information
Currently the use of new chemical substance should be specified in the notification application form without standard rules for uniform description. Drafted as a new annex, the Use Code List of Chemicals will be attached with the draft revision of guidance document. The format is similar to K-REACH which has 55 chemical uses to choose from. The use code will be incorporated into the online application system as a pull-down menu if approved.
6. Simplified notification of polymers
Below are the two conditions for polymers that apply to the special case of simplified notification:
Classified as the polymers of low concern (“Polymers of Low Concern”);
Polymers with low concentration of new chemical substance monomers which are (<2 % w/w) (“New Chemical Substance Monomer<2%”)
If the above criteria are met there is no tonnage limit for manufacturing or importing of the new polymer after notification. However, the current situation is that the notified tonnage amount is specified on the certificate. Manufacturing or importing in volumes in excess of the notified tonnage requires modification and application to the SCC. The draft revision will see the issuance of registration certificates without specific registration tonnage, which means there will be no need to apply for modification to the SCC in the future.
7. Reporting of each activity
As we know, all notified new chemicals will be categorized into three environmental management categories for post-notification management. Only new hazardous substances of priority environmental concern are required to report the transfer information to the authority within 30 days each time of when these substances are transferred to different downstream links in the supply chain. The current practice is that regardless of tonnage, this kind of new chemical substances is subject to the reporting of each activity. However, in the new draft, there will be a low volume exemption for substances transferred in quantities below 10 kg per time.
