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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/11/22 11:51
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Chapter Law Content

Chapter 5 Supplementary Provisions
Article 23
The central competent authority may provide the information of the registered new and existing chemical substances to the industry competent authorities to manage chemical substances used in the subject industry.
A registrant selling or transferring new or existing chemical substances shall provide the guidance on safe use and other identifiable labels as permitted under the Registrations.
Article 24
For registered new and existing chemical substances, the registrant shall, starting from the following year after the registration is approved, submit a report annually on the manufactured or imported quantity in the previous year for the new or existing chemical substances, in accordance with Appendix 10, between April 1 and September 30.
Where the information reported by the registrant is incomplete as determined by the central competent authority, the central competent authority shall notify the registrant to make a correction within a prescribed period. Where the registrant fails to do so or the correction fails to meet the requirements, the central competent authority shall impose an administrative penalty in accordance with this Act.
The report and correction, pursuant to the previous two paragraphs, shall be submitted via the Internet transmission system designated by the central competent authority. However, a report or correction in writing may be submitted with the consent of the central competent authority.
Article 25
The review periods of all the applications accepted by the central competent authority in the Regulations are as follows:
I.New chemical substances small quantity registration, PLC prior verification, PLC small quantity registration, existing chemical substances phase 1 registration, protection of confidential information, and corresponding extension: 7 working days from the date of receipt of the application
II.New chemical substances simplified registration and the inclusion in the inventory of existing chemical substances: 14 working days from the date of receipt of the application
III.New chemical substances standard registration: 45 working days from the date of receipt of the application
IV.Existing chemical substances standard registration: 90 working days from the date of receipt of the application
The review periods for small quantity registration and simplified registration may be extended to 45 working days when the registration applications satisfy the conditions in Article 9.
The central competent authority shall notify the registrants if the review periods of the previous two paragraphs are extended. The number of extensions is limited to one.
Article 26
The central competent authority shall review application documents for all applications accepted under the Regulations. Should the review procedure find documents inadequate, mistaken, or unspecific, the central competent authority shall require the registrant to provide a correction within 30 working days from the date of receiving the notification from the central competent authority. The said corrections shall be given only twice. However, if the failure to provide a correction within this limited period is caused by scientific or technical factors, this requirement shall not apply to registrants who report to the central competent authority and obtain its consent.
The review periods, pursuant to any of the subparagraphs in the previous Article, shall be calculated anew from the date that the central competent authority receives the correction submitted by the registrant pursuant to the previous paragraph.
The application shall be rejected if the registrant fails to make the correction within the limited period or fails to make the correction within a given period more than two times.
Article 27
A registrant shall apply for changes to the registered information on chemical substances proactively or within 30 working days from the date of receiving the notification from the central competent authority.
If the change pursuant to the previous paragraph involves basic information related to a registrant, an application for change shall be made within 30 working days from receiving approval for change of company registration, business registration, factory registration, as well as other documentary proof issued by the industry competent authorities. An application for change of a designated responsible person to the registered information shall be made within 60 working days after the change in the designated responsible person approved by the industry competent authorities.
If the registration type for which a change is applied differs from the original registration type that has been approved, a new registration application shall be submitted.
Under any of the following circumstances, the registrant may file an application to the central competent authority for a revocation of an approval registration and a cancellation of the corresponding registration number:
I.A new registration has been submitted and approved pursuant to the preceding paragraph; or
II.A chemical substance with registration approval is no longer being manufactured or imported.
Article 28
If registrants who obtained chemical substances registration approval are found with any of the following circumstances, the central competent authority may withdraw or revoke approval of the registration and cancel their registration numbers:
I.False registration information;
II.Obtaining approval of chemical substances registration by fraud, coercion, or other improper means;
III.Manufacturing or importing chemical substances by using or forging registration numbers that belong to others;
IV.Improper use of chemical substances reported by the industry competent authorities;
V.Documentary proof of company registration, business registration, factory registration, or other equivalent permission of business establishment that has been withdrawn or revoked by the industry competent authorities; or
VI.Dissolution or termination of business.
Article 29
For chemical substances registered and approved under any of the following circumstances, the registrant shall provide supplementary information proactively or before the due date decided by the central competent authority:
I.New scientific evidence on chemical substances,
II.New information on the uses of chemical substances,
III.New information on toxicology or ecotoxicology of chemical substances,
IV.New information on hazard assessment or exposure assessment of chemical substances, or
V.Other information designated by the central competent authority.
Article 30
If a registrant has any concerns regarding the result of registration review, written appeal with stated reasons may be submitted within 30 working days from receiving the notification of the review result.
The number of appeals pursuant to the previous paragraph shall be only one.
Article 31
Registrants submitting all of the applications pursuant to the Regulations shall pay a corresponding fee according to the fee-charging standards set for this Act; the registrants shall submit the information on chemical substances via the Internet transmission system designated by the central competent authority.
The information as prescribed in the previous paragraph shall be written in Chinese. All foreign materials shall be written in English or in other foreign languages with a Chinese or English edition attached.
The central competent authority shall not accept any application if registrants fail to process their registration pursuant to the previous two paragraphs. However, this requirement shall not apply to registrants who report to the central competent authority and obtain its consent.
Article 32
The Regulations take into force upon the date of promulgation.
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