Substance A : PB , PT or BT
Addition of new usage of Substance A after new use registration
Substance A & B : All applicants ( including the original applicant ) must apply for new usage registration if they are not used for Usage M
Regular registration IECSC
Uses approved : e . g . Usage M
Substance B : Highly hazardous substances
Substance B : New applicants must apply for new usage registration for any uses
Figure 3 – Treatment of hazardous substances under Order No . 12
‣ substance names , this shall not exceed five years from the date of first registration or record . For other information , CBI protection will be valid from the date when the information protection application is approved until the applicant applies for withdrawal of the information protection requirement , or the information is disclosed by MEE , since it may have a significant impact on the environment and public health . Order No . 12 also stipulates environmental management requirements for new usages of certain substances listed on the IECSC . For PB , PT or BT substances in usages that have not been approved , all applicants ( new and original ) must apply for new usage registration . The new usage will be added into IECSC after the new usage registration is approved ( Figure 3 ). For highly hazardous substances , new applicants must apply for new usage registration for both approved and new uses , while the original applicant must apply for new usage registration only for new uses . The scope of new usage environmental management will not change after the registration .
Supervision and administration after registration are also changing . Under the guidance documents , a first activity report is required for both regular registration and simplified registration within 60 days from the date of first activity or import . An annual report is required for regular registration when indicated in the certificate . Enterprises shall submit it before 30 April each year . Finally , procedures for the supplementation of IECSC were optimised . Under Order No . 7 , new chemical substances were added onto IECSC and were regulated as existing substances five years after the date when they were first imported or manufactured . Under Order No . 12 , new substances will be added into IECSC and regulated as existing substances five years after the date they are first registered .
Conclusion
Order No . 12 has been comprehensively revised and supplemented in terms of management and control priorities , registration types , material requirements and follow-up management after registration , which will have significant impacts on the environmental management of new chemical substances . For environmentally friendly substances and substances in low tonnage bands , it will be much easier to obtain the registration with a lower cost and shorter period . However , for substances with high health and environmental risks , enterprises will face higher data requirements , and the cost and period of registration will be difficult to predict and grasp . Considering the gradual strengthening of supervision by the authorities , companies need to recognise the importance of new chemical substance compliance and act accordingly . CIRS will continue to track the progress of the implementation of Order No . 12 , and provide timely professional regulatory interpretation and compliance advice to the companies manufacturing or importing new chemical substances into China . •
J j
Kaiji Zhang
CHEMICAL REGULATORY AFFAIRS CONSULTANT
CIRS zkj @ cirs-group . com www . cirs-group . com
47