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Taiwan’s new chemical registration system has been implemented since the end of 2014. There is increased demand from the industry for listing registered new chemical substances into Taiwan’s existing chemical substance inventory (TCSI).
New chemical qualified for listing into TCSI
According to the Regulation of New and Existing Chemical Substances Registration, registration certificate validity varies for different new chemical substance registration types. The certificate validity for standard registration is 5 years. Simplified registration and small quantity registration both have 2 years validity. For polymer of low concern (PLC>1 t/y, applicable to small quantity registration), the certificate is valid for 5 years.
Simplified registration and small quantity registration require an application for extension to be filed 3 months prior to the end of the 2-year validity period. The extension does not apply to the other two registration types as new chemical substances registered under these types are included into the ECSI after 5 years automatically. However, for (1) new substances registered under Band 4 standard registration and (2) new PLC finished small quantity registration, the registrants can opt to list it in the TCSI in advance.
So far, there is no new substance registered under Band 4 standard registration. The increased inquiries for listing their substances into TCSI in advance all come from registrants of new PLC. Taiwan EPA has expedited its work on the inclusion and there are some new PLC have been successfully listed into TCSI.
TCSI inclusion procedures
For standard registration and new PLC registration, the registered substance will be included into the TCSI automatically when the 5-year registration validity expires. The authority haven’t provided any instruction since the regulation has only been implemented for 3 years and no new chemical is qualified for automatic inclusion.
For inclusion in advance, a formal letter (公文) specifying the registration details (registration date, registration type, registration No., etc.) and reason for inclusion of qualified new chemical substances into TCSI in advance should be delivered to the chemical registration center located in Taipei by post. The authority will verify the case and reply with the official decision whether to add the substance into TCSI in advance.
CBI protection before/after listing into TCSI
CBI protection applies when registering new chemical substances. Quite a number of registrants have asked for full or partial confidentiality. Information of registered new substances are incorporated into the online information platform and for those haven’t applied for CBI protection their registration information will be disclosed.
Different registration types correspond to different CBI protection validity.
| Registration Type | Certificate/Registration No. validity | CBI protection validity | Included in TCSI | |
| New chemical substance | Standard registration | 5 years | 5 years | Included in TCSI after 5 years automatically or registrant of Band 4 standard registration can opt to list it in the TCSI in advance |
| Simplified registration | 2 years | 2 years | N/A | |
| Small quantity registration | 2 years | 2 years | N/A | |
| Polymer of low concern registration (>1 t/y, applicable to small quantity registration) | 5 years | 2 years | Included in TCSI after 5 years automatically or registrant can opt to list it in the TCSI in advance |
Application for extension should be made 3 months prior to the expiry of the confidentiality period via the online registration platform and costs NT$12,500 for one item every time. The four items subject to CBI protection are listed as below:
Identification of registrant
Identification of chemical substance
Information on manufacture or import
Use of chemical substance
However after the registered new substance is listed into the TCSI, there is no need to apply for confidentiality extension since the previous registration information incorporated into the online infromation platform will be concealed automatically. Then, you should apply for confidentiality of the chemical name and CAS No. /Serial No. in the TCSI (only these two items listed in the TCSI), which is totally different thing from the confidentiality application of the above mentioned four items.
The application procedures for confidentiality in the TCSI haven’t been introduced and the application fee hasn’t been decided. The method actually in use now is to apply for confidentiality in the formal letter (台湾公文) along with application for the inclusion of the substance into TCSI. The authority will confirm the case and add the substance into TCSI in advance if it is qualified and the application fee for confidentiality will be required to pay later when the authority has a charge standard.
