Request a Demo
At REACH24H’s 11th Chemical Regulatory Annual Conference in Xi’an on Sep 2nd, Ms. Cherish Ni, the vice president of ERI Company, shared insights into Taiwan’s chemical management updates. Several notable updates are summarized below:
SIEF-like Platform
Taiwan’s standard registration of 106 priority existing chemicals (PECs) will start from 2020. A very simple “SIEF-like” platform[1] has been released only to help find co-registrants. Functions e.g. voting for lead registrant (LR), data sharing are not incorporated. Registrants and TPRs (third party representative) of Phase 1 registration do not gain automatic entry to it. They still should apply to join the corresponding groups (106 groups corresponding to each PEC). Other data-holders (e.g. downstream users or labs) having relevant data that they could share with potential registrants cannot participate.
The authority is reluctant to intervene too much since the joint registration of PECs in Taiwan is optional. Industry associations are encouraged to help members accomplish registration obligations and act as a bridge between the industry and the government when necessary.
Volume Modification
The grace period for standard registration is granted based on the volume indicated when applying for phase 1 registration (see details[2]). However, most of the volume data submitted is based on the statistics generated from year 2012 to 2014, which may have changed in recent years. What’s worse, some TPRs designated to undertake registration work on behalf of the registrant have filled in a higher volume by mistake meaning the registrant will face a shortened grace period. Many of these enterprises have petitioned authorities to introduce a mechanism which would allow them amend volume data, but to date there has been no movement from authorities to provide this facility. Ms. Ni recommended that affected enterprises notify the Environmental Protection Agency (EPA) of the wrong volume by post and report the right volume in the first annual report which will start in April 2020.
Annual Reporting
The new annual reporting system will place a great burden on the industry, requiring submission of registrant information, registration No., and last year’s volume of registered new and existing substances. According to Ms. Ni, the annual reporting platform is under development. She shared some initial thoughts that for each registrant (or TPR) all his finished registrations would be listed after he logs in the platform. Additionally, there will be a mechanism to allow details of the registered substance to be submitted directly by clicking the corresponding registration No.
Registration Fee
Taiwan requires administrative fees for new and existing chemical registration. Ms. Ni introduced that the fee standards on toxic chemical handling application and chemical registration is under revision. The registration fee maybe increased to recover the cost of administration.
OR?
Another recurring issue raised during CRAC 2019 is about the possibility of adopting only representative (OR) instead of the current TPR mechanism in Taiwan. Unlike the OR model, Taiwan’s TPR only works for domestic importers and manufacturers. Overseas companies are not able to obtain registration certificates via TPR, which negatively affects their ability to comply with regulations. However, phase 2 standard registration requires submission of a large amount of testing data, which cannot be accomplished without the support from overseas producers who own the data. According to Ms. Ni, the TPR system has been implemented for years. There is little possibility to change it.
Other efforts
Ms. Ni reminded industry that this year more enterprises would be inspected compared to the number last year, however it doesn’t mean harsher penalties will be given to violators. The authorities are still inclined to give warning and more guidance during this early implementation period. In addition to strengthening the supervision on enterprises, the authority has made efforts to mobilize more resources. A National chemical substance management board has been established involving professionals from ministries, organizations and academic institutions. Taiwan EPA will establish a fund imposing additional charges for various activities related to chemical substances to finance administrative costs. Another improvement is that better protection for whistleblowers and better rewards will be offered which will act as a greater incentive for public engagement in policing the chemical sector.
