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According to insider sources, a new revision of guidance on China new chemical notification has been drafted based on the feedback received during the previous public consultation period. The recommendations for amendment of the previous version notified to the World Trade Organization (WTO) were proposed mainly by Japanese enterprises and industry associations. The new draft revision is currently soliciting comments from some associations and will be submitted to MEP in November for further internal deliberation.
Compared to the previous draft revision notified to the WTO on 8 Mar 2016 (CL news), the major updates are summarized as below.
1. An administrative fee for importation activities associated with new chemical substance notification will be charged
* the specific fee will be decided in the future, pending further discussion.
2. Polymers with low concentrations of new chemical substance monomer which are ≤2 % w/w (Case 1) or polymers of Low Concern (Case 2) will be subject to “Record Notification” rather than the current “Special Case of Simplified Notification”.
*So far about 70% of all the China new chemical notifications are fitting the case 1 and case 2 criteria listed above. The heavy review workload and relative low risk associated with case 1 and case 2 chemical notifications has stretched the capacities of Chinese authorities prompting the proposed changes in regulation. For “Record Notification”, manufacture or importation activities can be conducted directly after data submission and no certificate will be issued or required. In addition, there is no annual reporting requirement.
3. Provisions concerning qualification of testing institutes (home and abroad) accredited for data generation will be deleted
4. Minimum acute toxicity data for Band 1 regular notification will be reduced to include only one of the acute toxicity data by oral (preferred), dermal or inhalation route
5. Requirement of 28-days repeated dose toxicity test for Band 1 regular notification and 90-days repeated dose toxicity test for Band 2 regular notification will be deleted
6. Only toxicokinetics assessment report will be required for Band 2 (and above) regular notification, rather than the complete testing report.
7. The tonnage accumulation principle will not apply to joint notification and repeat notification any more
*For joint notification, the highest tonnage of one notifier will be used to determine the tonnage band of the whole joint notification rather than the aggregated tonnage of each individual notifier. However, if the new chemical substance from different suppliers is transferred to the same downstream user and the tonnage exceeds the notified tonnage, then the tonnage band should be determined based on the total amount transferred to the downstream user. For repeat notification, the notifier of a previously notified new chemical substance using the same testing reports from the original notifiers can apply for notification according to his own tonnage band. The same accumulation principles are used for repeat notification if the new chemical substance is transferred to a same downstream user.
8. The deadline for annual reporting will be extended from 1st Feb to 1st Apr
English version available!According to the WTO notification, the Guidance is proposed to enter into force on 1 Nov 2016, however it is not possible to meet the deadline. A further delay in release of the final version is inevitable. We suppose that it will be officially published in the first half of next year.
According to the current Guidance, the submission of the annual report detailing manufacture or import activities in the year of 2016 is due by the 1st of Feb 2017. Simplified notification and regular notification certificate holders are still required to prepare the annual report accordingly if no further announcement is made on the SCC-MEP website.
ChemLinked will continue to report the issues concerning China new chemical notification and will do our best to provide the first-hand information.
