Late Pre-Registration Launched for Taiwan Existing Chemical Substances - Regulatory News - Chemicals

The pre-registration of Taiwan existing chemical substances has been closed on 31 March, 2016. According to the Article 19 in Regulation of New and Existing Chemical Substances Registration, after April 1st, 2016, an existing chemical substance first manufactured or imported in annual volume of 100 kilograms or more, shall apply for late pre-registration and attach chemical information within the deadline determined by the central competent authority.

Who shall do Late Pre-Registration
(1) Manufacturer or Importer who manufacture or import existing chemical substances for the first time with tonnage 0.1t/y or more since 1 April 2016, or

(2) The quantity of manufactured or imported existing substances didn’t reach 0.1 t/y in the past, but first reach 0.1 t/y or more after 1 April 2016.

Timeline of Late Pre-Registration
Registrants should not manufacture or import existing chemicals until the late pre-registration has been down. The application of late pre-registration should be submitted in 90 days after the first manufactured or imported in annual volume of 0.1 ton per year or more.

Procedures of Late Pre-Registration

Registrants（manufactures or importers）

Submit the Late Pre-Registration related application materials 90 days after the first production or import annual volume of 100 kilograms or more
Fill in the dossier through the online system; upload supporting evidence and power of attorney
Central Competent Authority: receive and check the completion and compliance of supporting evidence
Pay EPA Official fee
Central Competent Authority: check the completion of the dossier
Central Competent Authority: approval and issue the registration code for the first phrase

Documents requirement of Late Pre-Registration
(1) Documentary evidence
Enclosed documentary evidence should indicate the name and other identifiable information of chemicals and provide supporting documents to show the time point of the manufacture or import. Taking importation as an example, documents like declaration for importation, trade receipt, sales contract or shipment certificate from initial manufacturers shall be provided.

(2) Registration items and content
The information requirements of late pre-registration include the following sections: basic identification of the registrant, basic identification of the substance, and substance manufacture and use information.

Penalty
Manufacturers or importers who failed the 1st Item in Article 7 of Toxic Chemical Substances Control Act (TCSCA) in Taiwan to produce or import existing chemical substances without registration shall be fined NT$30,000 to NT$300,000 and be required to amend within a limited time. Manufactures and importers who don’t amend within a limited time will be fined by the times they fail. For repeated infringement, business shall be suspended or returned export.

Manufacturers or importers who failed the 6th Item in Article 7 of Toxic Chemical Substances Control Act (TCSCA) in Taiwan about manufacture or import situation, registration duration, joint submission, the notification or supplement of chemical materials after registration, and preservation of documents, shall be fined NT$30,000 to NT$300,000 and be required to amend within a limited time. Manufactures and importers who don’t amend within a limited time will be fined by the times they fail. For repeated infringement, business shall be suspended or returned export.

The management of imported chemical substances in Taiwan has officially been initiated. Please click here for more information.

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