Taiwan Explained the Supporting Measures for Existing Substances Standard Registration

On August 22, 2018, an illustration meeting on Supporting Measures for Existing Substances Standard Registration was held by the Toxic and Chemicals Bureau of Environmental Protection Agency, the Executive Yuan of Taiwan. This illustration meeting aimed to assist manufacturers in preparing for the related work ahead of schedule and importing or producing the first batch of existing substances (106 substances) that require the completion of standard registration, before the Regulation of New and Existing Chemical Substances Registration comes into force. CIRS will share the important contents involved in the illustration meeting as below.

1. Existing Substances subject to Specified Existing Standard Registration

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P.s.: In phase I registration (also referred to as pre-registration), the import or manufacture volume submitted should be in the period of 2012 to 2014. If an enterprise applies for the phase I registration for a substance yet does not carry out the import or production when the standard registration begins, then it is feasible to ask for the annulment of the registration number directly.

2. Registration Deadline of Existing Substances

For those enterprises that obtain the phase I registration number before the implementation of the Regulation of New and Existing Chemical Substances Registration:

Annual Amount

Transitional Period

>100t

2 years (calculated from the day of implementation of the Regulation of New and Existing Chemical Substances Registration)

<100t or more than 1t before the implementation of the Regulation of New and Existing Chemical Substances Registration

3 years (calculated from the day of implementation of the Regulation of New and Existing Chemical Substances Registration)

more than 1t before the implementation of the Regulation of New and Existing Chemical Substances Registration

3 years (calculated from the time the tonnage reaches 1t)

For those enterprises that apply for phase I registration after the implementation of the Regulation of New and Existing Chemical Substances Registration:

Annual Amount

Transitional Period

>100t

2 years (calculated from the time when the tonnage reaches 1t)

<100t

3 years (calculated from the time when the tonnage reaches 1t)

Exceptional Circumstances: When the enterprise has already obtained a phase I registration number before the implementation of the Regulation of New and Existing Chemical Substances Registration yet annulled the registration number. If the enterprise needs to re-apply for the phase I registration number: the application is submitted before the implementation of Regulation of New and Existing Chemical Substances Registration, then the registration deadline is determined according to the time when the enterprise obtains the first registration number; if the latter application falls after the implementation of the Regulation of New and Existing Chemical Substances Registration, the enterprise is required to fulfill the standard registration at the same time of application.

3. Material Preparation for Existing Substances Standard Registration

Material Requirements for all levels of existing substances standard registration are as follows (consistent with the data requirements for new substances):

Registration Information

St. reg. I

St. reg. II

St. reg. III

St. reg. IV

1. Registrant and Substance Identification Information

2. Manufacturing, Application and Exposure Information

3. Hazard Classification and Labeling

4.  Safe Use Information

5. Physicochemical Properties Information

√(13)

√(13)

√(15)

√(15)

5. Toxicological Information

√(5)

√(8)

√(8)

√(9)

7. Ecotoxicological Information

√(3)

√(7)

√(9)

√(16)

8. Hazard Evaluation Information

 

9. Exposure Assessment Information

 

Prompt:

1) It is suggested that data collection should be started as soon as possible. According to the officials, the preferential fee enjoyed by the first batch of enterprises carrying out the existing substance standard registration is under discussion.

2) Given that existing chemical substances might have been circulating in the market for a long time, the officials accept a diversified data in all data nodes, including test reports, structural activity relationship estimation reports, systematic literature reviews and test plans.

3) If the registrant is not the owner of the original test report, he or she should provide the authorization certificate of the owner or authorization unit of the original test report.

4) A third party testing unit needs to verify the rationality and reliability of the structural activity relationship estimation report and systematic literature review to verify the rationality and reliability by a third party related units.

5) Test Reports should be written by laboratories meeting the qualification requirements.

4.  Data Sharing of the Existing Substances Standard Registration

Registrant has the free choice whether to share the data or not during the existing substance standard registration. If data sharing is decided, part of the data is under unified use of every registrant, but the registrant still needs to shoulder the responsibility for the submission and subsequent update and maintenance of the dossier. Data which are under unified use does not have to be simultaneously submitted. Then order can be mixed. But registrant and substance identification information, production, application and exposure information, safe use information, and exposure assessment information still need to be submitted separately. If, in the case of data sharing, each registrant is unable to achieve the purpose of data sharing through agreement, the central competent authority may adjudicate that each of them shall be equally apportioned at the request of the registrants. However, the competent authority shall not intervene in or bear the responsibility for any possible risks and disputes arising from the agreement among the registrants.

The key principles of reference for agreement among registrants are as follows:

(1) Make sure that the your substance is the same as the substance whose data is shared;

(2) Define the purpose and scope of shared information;

(3) Confirm whether the shared information is authorized or whether the ownership of the report is transferred or not, etc.;

(4) Determine the method of handling the fee agreement and dispute arbitration of both sides.

5. Procedure of Existing Substance Standard Registration

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Prompt

1) The procedure is basically the same as that of the new substances standard registration, but the archive creation tool, registration platform, and the official examination time are different.

2) In addition to the registration platform and registration tool, the officials disclosed that an information sharing communication platform for existing substances standard registration will be put forward. For those existing substances requiring standard registration, the platform will form groups with corresponding number, and all interested parties of registration can apply for entry to the communication group according to their phase I registration number, CAS number, POA and other relevant documents and will be admitted after official examination.

6. Summary

1. The officials indicated that the Regulation of New and Existing Chemical Substances Registration is still under amendment and the formal announcement in the future will be the main version.

2. It is suggested that registrants make good use of relevant measures to ensure security information and reduce the cost of repeated tests, such as multi-information submission, unified data use and communication platform in order to successfully complete the registration.

3. The specified existing substances registration guidance document (tentative), registration tool, specified standard registration platform and communication platform will be published after the approval for the Regulation of New and Existing Chemical Substances Registration.

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