TPKM/291/Rev.1
WTO/TBT
TW Taiwan
  • 71 - Chemische Verfahrenstechnik
2018-06-03
2018-04-09

Chemical substances

Amendments to Regulations of New and Existing Chemical Substances Registration (Draft) (32 page(s), in English; 67 page(s), in Chinese)

The Toxic Chemical Substances Control Act (TCSCA) was amended and promulgated on 11 December 2013. Pursuant to TCSCA, the subordinate implementing law "Regulations of New and Existing Chemical Substances Registration and Management" were enacted on 11 December 2014. This proposal aims to update the provisions under the "Regulations of New and Existing Chemical Substances Registration." Major amendments include the following:

1. Clarifying the scope of application of the Regulations. The Regulations shall not apply to Toxic Chemical Substances, as defined by TCSCA.

2. Harmonizing the information requirement between the EPA and the Ministry of Labour regarding hazard assessment and exposure assessment;

3. Issuing the registration number, instead of the registration document for the registration approved; 4. Clarifying the quantity that triggers the obligation for the existing chemical substance phase 1 registration. For an existing chemical substance manufactured or imported in the annual volume of 100 kilograms or more, the phase 1 registration must be made within 6 months. Also a voluntary phase 1 registration may be made for the existing chemical substance manufactured or imported in the annual volume less than 100 kilograms.

5. Designating the first stage of 106 chemical substances subject to the standard registration of existing chemical substances.

6. Clarifying the period of the information confidentiality of chemical substances included in the inventory of existing chemical substances, and ensuring consistency in the period of the information confidentiality and the validity of registration approval;

7. Requiring an annual report of the new and existing chemical substance registered and approved. For the chemical substance registered and approved, an annual report shall be completed from April to September each year;

8. Indicating the calculation of the review period, so that the review period is calculated anew upon the registrant's supplementation or modification of the registration application;

9. Extending the limit on the time period and the number of times that a supplementation and correction may be made for a registration application, by taking into account the scientific and technical feasibility assessed by the EPA.

10. Accepting written appeal with stated reasons for which the registrant may have concerns over the review result. 11. Deleting outdated provisions.