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Taiwan Drafts Regulation on Commissioning Agency for Chemical Registration Dossier Review and Approval

1. New and existing chemical registration and approval related issues will be commissioned to competent agencies. 2. The term of each commission shall be three years.

Taiwan published the draft Regulation on Commission on New Chemical Substances and Existing Chemical Substances Registration Dossier Review on 30 June 2014, pursuant to the Article 7-2, Paragraph 2 of the revised Taiwan TCSCA which will come into force on 11 Dec 2014.

According to the revised TCSCA, the central competent authority may commission judicial associations, administrative corporations and professional groups, etc. to handle the registration and approval of new and existing chemical substances. This regulation was compiled to standardize the qualification and obligations of commissioned agencies.  

The commissioned agency should be experienced in provision of technical services concerning chemical management, hazard classification and communication. The staff responsible for dossier review should have at least two years of chemical related working experience and the corresponding educational background as specified in Article 5 of the draft regulation.

They will be commissioned to be responsible for registration dossier review, approval, rejection, issuance of the registration certificate, certificate extension, modification, renewal and reissuance.

The commissioned agency should submit registration related documents every 6 months to the EPA for recording. The term of each commission shall be three years and commission renewal is limited to two times (two years each time). The commissioned agency can only be authorized for new and existing chemical registration related affairs for a maximum of seven years which can be achieved through a special contract extension.

There is currently no idea how many agencies will be commissioned and whether each agency can handle all registration categories including low-volume registration, simplified registration and standard registration. According to Mr. Hsu from the Taiwan EPA, it is possible that standard registration related issues will be handled by EPA directly. 

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