Chemical Substances; INORGANIC CHEMICALS; ORGANIC OR INORGANIC COMPOUNDS OF PRECIOUS METALS, OF RARE-EARTH METALS, OF RADIOACTIVE ELEMENTS OR OF ISOTOPES (HS 28); ORGANIC CHEMICALS (HS 29); MISCELLANEOUS CHEMICAL PRODUCTS (HS 38); PLASTICS AND ARTICLES THEREOF (HS 39); CHEMICAL TECHNOLOGY (ICS 71)

Draft Amendments to Regulations for New and Existing Chemical Substances Registration (22 page(s), in English; 58 page(s), in Chinese)

Regulations of New and Existing Chemical Substances Registration (hereinafter referred to as the Regulations) were promulgated on 11 December 2014 and amended on 11 March 2019.

After reviewing the practice of annual reporting and standard registration of existing chemical substances through collecting stakeholders' opinions, the draft amendments to the Regulations is introduced under the consideration of the impacts of the COVID-19 pandemic, and in accordance with the Toxic and Concerned Chemical Substances Control Act amended on 16 January 2019. The highlights of the amendments are as follows:

1.    The name and the provisions of the Toxic and Concerned Chemical Substances Control Act, with which the Regulations are established in accordance, is amended.

2.    The controlled chemicals, as prescribed in the Occupational Safety and Health Act, as well as the concerned chemical substances, as defined by the Toxic and Concerned Chemical Substances Control Act, are not applicable to the Regulations.

3.    To reduce the highly overlapping contents of appendixes, the appendixes of the Regulations are combined and amended accordingly.

4.    The valid and confidential periods of the registration approval are unified as 5 years. Furthermore, for a new chemical substance that has been included in the inventory of existing chemical substances, the maximum confidential period is 15 years.

5.    The deadline for standard registration of existing chemical substances is extended to 4 years. In addition, the on-site isolated intermediates of existing chemical substances are exempted from standard registration.

6.    Completion numbers for the standard registration of existing chemical substances are issued to those who apply and complete information items regarding registrants and substances. The registrants shall complete the remaining information items proactively or before the appointed due date.

7.    The articles governing the notification of report supplementation and correction are also specified.

8.    The review periods and the number of extensions of review periods for applications are also amended.

9.    The article stating that registrants must retain all application documents for future reference is deleted.