Taiwan EPA completed the revision of Toxic Chemical Substance Control Act in 2013 and implemented the new chemical substance and existing chemical substance registration from 11 December 2013. After the implementation, EPA held about 20 regulatory training seminars during January to March in 2015 in Taiwan. During July to August in 2015, EPA again is going to hold several training seminars in Taiwan. The seminars will focus on the regulatory interpretation and the phase I registration tool and system training.
CIRS experts Ms. Grace Ma, Deputy Manager of R&D Dept, and Ms. Jane Song, Senior Regulatory Consultant attended the training seminar held by Taiwan EPA on 21 July. After the seminar, they had some discussion with the EPA experts regarding the existing chemical substance registration.
According to provision 18 in the act, the existing chemical substance being manufactured or imported with an average tonnage larger than 100kg per year in the past three years or a single annual tonnage larger than 100kg per year in the past three years shall be completed for the phase I registration during 1 September 2015 to 31 March 2016. After the registration, a registration number will be filed by the EPA. The registration number is required to be shown when manufacturer or importer selling or transferring the existing chemical substances to show that the phase I registration has been completed. After 1 April 2016, the companies manufacture or import existing chemical substances larger than 100kg per year shall complete the Late-Pre Registration within due time.
Companies who manufacture or import small than 100kg per year in the past three years but expect to increase their manufacture or import tonnage to larger than 100kg per year do not have to wait until 1 April 2016 to submit the Late-Pre-Registration. Instead, they can submit the registration as early as 1 September 2015 to save more time.
The information required for registration would be registrant information, substance information, manufacture information and use information. It is expected that in the early August this year, the substance registration center will published a testing system for phase I substance registration.
After the registration, Taiwan importer can not use the registration number to check the substance information; the existing chemical substance registration system will not include the CBI protection option. So when the companies located outside of Taiwan appointing a third party representative to do the phase I registration, there is no need to apply for CBI protection since the CBI disclosure will no longer be a concern.
After the training seminar, CIRS experts met Ms. Ni, Deputy Manager of Chemical Registration Center, in EPA. They had a discussion about the governmental enforcement regarding to the new chemical and existing chemical registration in the future.
Taiwan EPA is still discussing with the Customs about the supervision issue of the new and existing chemical substance registration. So far, the Taiwan Customs has not started to supervise the new and existing chemical substance registration. Once it is started, it can be traced back to the company activities before the supervision started.
For the dossier review process, the EPA and MoL will review the dossier separately. Basically, the registration center will receive the dossier and do the primary review, and then transfer to MoL for final review. After the review passed, the registration center will be sending out the registration number.
CIRS will carry out a free webinar about the registration of new and existing chemical substances in Taiwan on 6 August. Please click here for more information regarding the free webinar.
Should you have any question regarding the new and existing chemical substance registration in Taiwan, please do not hesitate to contact our senior regulatory consultant Ms. Jane Song by email: firstname.lastname@example.org or Tel: +86 571 87206590