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Taiwan will launch its existing chemical substance Phase 1 registration on September 1, 2015. Many potential registrants have been actively preparing themselves and it is strongly recommended to begin preparation and collection of information to be used for registration as soon as possible. This is of course to ensure full compliance to the regulation when it is enforced and also to reduce risks that may impact the outcome of business deals. Despite the pending implementation of new regulatory requirements there are still are some unanswered questions and ambiguous points that are yet to be clarified. Thus, this article has been prepared to help clarify some of these uncertainties.
1. Applicable Scope for Phase 1 Registration
Listed in the TCSI
Online searching website:
https://csnn.osha.gov.tw/content/home/Substance_Home.aspx
(Registrant should first complete an inventory check against the TCSI by inputting the CAS NO. serial number, chemical name, to confirm whether the substance is an existing one or a new substance.)
Tonnage band exceeding 100kg/year in the previous 3 years.
NOTE: For the manufacturer/importer with the current volume less than 100kg/year but estimated to exceed 100kg/year in the following one or two years, we still recommend them to apply for the phase 1 registration in advance.
2. Registrant and TPR
The registrant and TPR should be a Taiwanese legal company/natural person. Given the CBI issue or lack of relevant experiences, the registrant could appoint a Taiwan based TPR by signing a notarized POA, the TPR will do the technical work for the registrant and ensure non-disclosure of CBI.
NOTE: For one substance, the registrant can only appoint one TPR, the TPR will be responsible for not only the registration, but also for the post registration obligations such as certificate extension, certificate information change, etc. For different substances, the registrant is free to choose any TPR. When CBI is a concern, the registrants are not aware of what the specific substances they are applying for, under these circumstance registrants can appoint different TPRs.
3. System
According to the ERI plan, there are two ways to apply for phase 1 registration.
First is by using the one-step on line registration system. Registrants or TPR can only access the system with the help of the BAN/XCA card. At present, the online registration system is undergoing an internal test by the ERI, the beta version of the system will be released to the public before August 1st, 2015.
The other way is by the means of a 2-steps procedure. The first step is to prepare corresponding documents with the help of the CHEMIST. Afterwards, the off-line CHEMIST will produce a document to submit via the online system and complete the submission. The off-line CHEMIST and online registration system will be ready in the middle of August.
4. Data requirements
Information required by ERI for phase 1 registration, includes registrant information, substance information, volume information and usage information, more specifically,
Registrant information: Company name, address, telephone number, fax number, factory number, BAN, responsible person name and ID, email. The registration system will linked with the EMS information and thus above required company information will be filled out automatically.
Substance information: Only CAS NO./Serial number is required.
NOTE: The updated TCSI will be released in the middle of August by terms of a PDF version, registrant can do the check work with the help of the TCSI to confirm whether their product is listed or not, for the substance listed in the TCSI, one can also learn the corresponding CAS NO. or serial number.
Volume information: the registrant should chose the manufacture/import volume for the previous three years(2012, 2013, 2014), Six registration level will be listed for the applicant to choose from: >100kg/a, 100kg/a-1t/a, 1t/a-10t/a, 10t/a-100t/a, 100t/a-1000t/a, >1000t/a, but the ERI did not rule it out that in near further, for certain registrant, they can chose specified volume.
Usage information:
Including two parts, one is the category of industry; the other is the category of chemicals. Both of the two parts can be chosen by drop-down list.
For example,
Category of Industry: manufacturing industry;
Category of Chemical: adhesive composition.
5. CBI application
There is no need to apply for CBI application.
6. Public Information Dissemination Procedures
Similar to EU REACH phase 1 registration, the authority will only disclose the CAS NO./serial number and chemical name to the public. There will not be any information that would allow users to learn who the registrant of the corresponding chemical is. Frankly speaking, the information shared in the platform would only be able to be used to confirm whether or not a given registration number is correct.
7. Official review timeline
The official working period for the ERI to process the provided information would be 7 working days, excluding time to complete payment and confirmation. For supplementation of registration information, the registrant should complete the re-submittal within 30 days.
8. Third party submission
Submission by other parties (not TPR) of confidential chemical information will not be considered at this moment, which also means submission through TPR is the only way to avoid CBI disclosure to the Taiwanese importers.
9. Registration number
Different registrants who apply for the same existing chemical substance will be issued different registration numbers. In general, a registrant purchasing the same substance from different foreign manufacturers should only register once and be issued only one registration number. When CBI is taken into consideration, different foreign manufacturers may sell the same chemical to the Taiwanese importers but appoint different TPR to complete registration for each importer. In that case, multiple registration numbers for a single substance are obtained.
