Small Science Popularization of Existing Chemical Substances Registration in Taiwan

Release time:

2020-11-13 11:55

On October 27, our company published a tweet on "small science popularization of existing chemical substance registration in Taiwan", which introduced the existing chemical substance registration in Taiwan, including laws and regulations, registration types, data requirements, countermeasures, etc. As we all know, the controlled chemical substances in Taiwan include existing substances and new chemical substances, so what are the contents of the registration of new chemical substances? this article will give you a detailed introduction to the registration of new chemical substances in Taiwan.

Regulatory situation

New chemical substances in Taiwan are regulated by the "Measures for the Registration of New Chemical Substances and Existing Chemical Substances" under the "Measures for the Administration of Toxic Chemical Substances" (TCSCA, referred to as the Toxic Control Law), which was officially implemented on December 11, 2014. The centralized management department is Taiwan's "Environmental Protection Agency" (EPA). At the same time, new chemical substances in Taiwan are regulated by the "Administrative Measures for the Registration of New Chemical Substances" under the "Occupational Safety and Health Measures" (OSHA, referred to as the Occupational Safety Law). The measures have been formally implemented on January 1, 2015. The management department is the "Ministry of Labor" (MOL).

The Drug Administration Law requires that all new chemical substances produced and imported in Taiwan be registered in small quantities, simple registration and standard registration according to different tonnage levels.

The occupational safety law requires that manufacturers and importers of new chemical substances must submit safety assessment reports of chemical substances to the competent authorities, and only after approval and registration can they produce or import corresponding chemical substances.

Definition of new chemical substances

The list of chemical substances in Taiwan is abbreviated as TCSI, which is the basis for judging new chemical substances and existing chemical substances. If it is not in the TCSI list, it is a new chemical substance in Taiwan. The website of the list is as follows:http://csnn.osha.gov.tw/content/home/Substance_Home.aspx

Registrant

According to the relevant provisions of the Drug Control Act, manufacturers and importers in Taiwan can register new chemical substances in Taiwan, while enterprises in non-Taiwan regions cannot directly register, and must be registered by their importers or agents (TPR) appointed by importers in Taiwan. Local importers or TPR provide necessary information support or relevant information.

In addition, enterprises in Taiwan can also entrust TPR to register.

Countermeasures

Time	Countermeasures	Regulations
From 11 December 2014	Registration of new chemical substances (small, simple, standard)	poison tube method
From January 1, 2020	Submission of annual reports for approved new chemical substances	poison tube method
From January 1, 2015	Registration of new chemical substances (small, simple, standard)	Job Safety Law

Information Requirements

Note: Hazard assessment information shall be submitted when the annual manufacturing or input of the standard registration is more than 10 tons. When the annual manufacturing or input of the standard registration is more than 10 tons, and the substance has a specific hazard classification, or the annual manufacturing or input is more than 1000 tons, hazard assessment and exposure assessment information must be submitted.

New Anrun advisory tips:

For the registration of new chemical substances in Taiwan, since there is no pre-registration system, registration must be completed before sales can be made. Therefore, it is suggested that enterprises can contact us to evaluate the registration cycle and cost, and then enterprises can decide whether to complete the registration independently in combination with the project.

Dynamic inventory of 2020 hazardous chemicals topics

Interpretation of the announcement on the convergence matters related to the environmental management registration of new chemical substances

Dynamic inventory of 2020 hazardous chemicals topics

Interpretation of the announcement on the convergence matters related to the environmental management registration of new chemical substances

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