On May 27, 2021, the Taiwan Environmental Protection Administration announced the amendment of “Regulation for information registration of new chemical substances and existing chemical substances”, and released the draft to start collecting opinions. The period for submitting opinions will last 60 days from the day of announcement. The main amendments are as follows.
Addition of inapplicable objects
The following substances have been added to the inapplicable objects of the regulation.
- The “regulated chemical substances” defined in the “Occupational Safety and Health Law”.
- The “chemical substances of concern” defined in the “Regulation for management of toxic and chemical substances of concern”.
Addition of standard registration classification table for new chemical substances
The classification table of uses and properties for the standard registration of new chemical substances is added. (the contents of the classification are still same with the current regulation).
|Annual production/import volume||CMR substances (Carcinogenic, Mutagenic, Toxic for Reproduction )||Separation of intermediates, polymers on-site, scientific research and development, product and process oriented research and development||Other chemical substances|
|<1 t||Classification 1 (Level 1)||―||―|
|1t≤y<10t||Classification 2 (Level 2)||―||Classification 1 (Level 1)|
|10t≤y<100t||Classification 3 (Level 3)||Classification 1 (Level 1)||Classification 2 (Level 2)|
|100t≤y<1000t||Classification 4 (Level 4)||Classification 1 (Level 1)||Classification 3 (Level 3)|
|≥1000t||Classification 4 (Level 4)||Classification 1 (Level 1)||Classification 4 (Level 4)|
*Based on the classification, the materials(information) that shall be submitted differs at the time of registration.
Unification of the registration period of new chemical substances
Under the current regulation, different validity periods are set for standard registration and simple registration, while in the amendment draft, the validity periods for permitted registrations are unified to five years.
Unification of the protection period for confidential business information (CBI)
In the amendment draft, the protection periods for confidential information of new chemical substances and existing chemical substances have been unified to 5 years (under the current regulation, the protection period for simple / small amount registration is 2 years). In addition, the confidentiality protection period for new chemical substances have been revised to a maximum of 15 years, including the period before and after being added to existing chemical substances.
Extension of the standard registration period for existing chemical substances
For the substance which has obtained the first stage registration code before December 31,2019, the standard registration period will be extended to December 31, 2023. For the substance which has obtained the first stage registration code after January1,2020, the standard registration period will be extended to 4 years from January 1, the following year after obtained the registration code.
For the original text of the above amendment draft, please refer to the following URL (in traditional Chinese).