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Taiwan Draft Regulation Governing Commission on New Chemical Substances and Existing Chemical Substances Registration and Examination

Posted on: August 12, 2014

By Weisin Chai

Taiwan published the Draft Regulation Governing Commission on New Chemical Substances and Existing Chemical Substances Registration and Examination on June 30, 2014 through Environmental Protection Administration (EPA) Document No. 1030053979. The regulation is enacted in accordance to Article 7(2) Paragraph 2 of the Toxic Chemical Substances Control Act (TCSCA).

According to TCSCA, the central competent authority (the EPA) shall appoint a professional agency to handle the registration and approval of existing and new chemical substances. This regulation, therefore, provides the scopes and obligations of the appointing agency.

To ensure the quality, efficiency, professionalism and convenience of the registration process, Article 3 and Article 5 of the regulation provide requirements on the qualifications and experiences of the appointing agency. The appointing agency shall be able to provide technical services in chemical management and consulting services in chemical hazard classifications. The examiners of the agency shall have at least two years of chemical related working experiences and educational background as specified in Article 5.

In addition, the appointing agency shall take legal responsibility while handling the registration, particularly for issues related to business confidentiality and external articulation. The appointing agency’s scope of work includes the examination of registration information, approval and rejection of registration(s), the issuance of documents related to approval(s), extension(s), amendment(s), renewal(s) and reissuance(s). Other obligations of the appointing agency are provided in Article 7 of the draft regulation. The appointing agency will submit the registration documents and related information to the EPA every 6 months.

The EPA shall make decisions to determine the appropriate agency and prepare a contract for the agency. The maximum appointing period is three years. The renewal shall be done six months before the expiration of the appointment. The maximum granted renewal period is two years, and the renewals are limited to two times. The contract is subject to complete or partial termination if the appointing agency fails to be compliant with the specified stipulations.

In the future, instead of the EPA, existing and new chemical registration applicants from the industry shall expect to deal with the appointing agency directly.

References:

Draft Regulation Governing Commission on New Chemical Substances and Existing Chemical Substances Registration and Examination
Toxic Chemical Substances Control Act (TCSCA)


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