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Taiwan’s New and Existing Chemical Registration Regulation was revised and promulgated on 11 March 2019. The amendment details have been reported by ChemLinked (CL news).
During the industry focused seminar held on 26 Mar 2019 in Taipei, the revised regulatory landscape was introduced to aid in timely preparation of annual reporting and the standard registration of existing chemical substances. Some issues that may be of your interest are introduced as below.
1. Annual reporting
Annual reporting of registered new and existing substances between 1st of Apr to 30th of Sep is mandatory from 2020. For existing chemical substances manufactured or imported below 100kg/year, registrants can voluntarily apply for phase 1 registration. The annual reporting is mandatory as long as the substance is registered.
If a company receives the registration code in March 2020 and there is no manufacture/import activities in the last year, it is still necessary to submit an annual report and the filled quantity should be “0”.
The information that the annual report needs to contain includes the information of the registrant, the registration code and the quantity in the last year. If an overseas manufacturer designates a TPR to complete registration, it is very likely to still rely on the TPR for the submission of annual report. Otherwise for mixtures, if the importer does not know the content of the substance with the corresponding registration code, the final tonnage cannot be calculated, and the overseas manufacturer still needs to assist with the annual report.
2. Standard registration of existing chemical substances
The deadline and requirement of existing chemical standard registration for 106 priority existing chemical substances depend on the tonnage band you submitted in phase 1 registration (see details). However, the volume of phase 1 registration based on the statistics generated from the year of 2012 to 2014 may have changed in recent years. If you expect to adjust the business plan (increase/decrease the volume) or cancel the activity, you should file a formal notice to the authority to update or abolish the former phase 1 registration information, which is free of charge.
3. Data source
Existing chemical standard registration can receive diversified data, such as test reports, RSS, QSAR, Read across, literature review, test plan, and international public database data. Previously, rationality and reliability verified by an accredited third part are required for QSAR, Read across, and literature review. This time it is said that this verification is not a must. However, the verification can probably increase the possibility of acceptance in some ways. The third part includes but is not limited to universities, laboratories, international institutions, etc.
Regarding the international public database, the official has recommended some databases, while they did not disclose which endpoint can be acquired from the public database.
4. Eco-toxicity data
The data requirements of the existing substances are basically the same as the new substances. In the Eco-toxicity part, the new substances require 5 tests to be completed and other endpoints can accept the test plan. According to the draft Guidance for Standard Registration of Designated Chemical Substances, for the existing chemical standard registration the authority will not accept the test plan for microorganisms toxicity, adsorption and desorption, Daphnia magna reproduction, long term fish toxicity, and bioaccumulation, etc.
5. Joint registration
Joint registration is optional for standard registration of PECs. The registrant having finished standard registration with higher tonnage levels can let the enterprises of the same level or enterprises with lower tonnage levels buy the LOA (letter of access) and give them access to the joint submission with a data token. However, for registration of higher tonnage levels, the data cannot be passed in the form of data token from the registrant with a lower tonnage level. The data should be purchased from the data holder and complete additional experiments required by higher level to complete the registration.
6. Registration platform
A SIEF-like platform for registrants to communicate and share data will be established. As planned, it will set up 106 groups corresponding to each PEC. Stakeholders could use information including phase 1 registration code, CAS No. and business certificate, etc. to apply to join the corresponding groups. If a TPR wants to log in, an authorization letter should be submitted.
In addition, the beta version of the standard registration platform is now available here. Registrants could use the registration code to identify whether a substance requires standard registration.
