Taiwan Amended Regulation of New and Existing Chemical Substances Registration Comes into Effect

11 March 2019, Taiwan Environmental Protection Administration released the Amended Regulation of New and Existing Chemical Substances Registration (hereinafter referred to as Regulation). This Regulation will screen out substances with high risks for priority registration. Appendix 6 to the Regulation listed 106 substances as the first batch of existing substances subject to standard registration. The Regulation takes effect as of the date of issue, yet it will grant an appropriate grace period to first batch of existing substances subject to registration – the standard registration for existing substances formally starts from 1 Jan. 2020.

Major Amendments:

1. Enterprises may carry out Phase I registration for chemical substances in tonnages less than 100kg/y (not available before amendments);

2. Information required for hazard and exposure assessment is adjusted:

• Chemical substances in tonnage of 10t or over shall submit hazard assessment report (the tonnage was 1000t or over before amendments).
• If the registered substances are harmful to human health and the environment, registrants also need to submit the exposure assessment as well (the full risk assessment report);

3. Requirements for polymer registration is amended:

In accordance with the requirements of the amended Regulation, polymers, for which 2% rule is applicable and are listed on the existing substances lists, can be considered as existing substances as well and are exempted from registration.

If the original polymer is a new chemical substance, and this substance has completed new chemical substance registration (or exemption confirmation), polymers for which 2% rule is applicable:

• calculated the tonnage together with the original polymer (if the tonnage band changes, registration shall be updated);
• considered as a new polymer and shall complete registration (exemption confirmation);

4. Information concerning the application of confidentiality is improved:

• Enterprises may apply for confidentiality for existing substances Phase I registration and the confidentiality period is 5 years (10 years at most);
• The confidentiality period for PLC small quantity registration is 5 years (consistent with the validity period of the registration code)

5. Annual report is required:

From 2020, registrants need to report the annual manufacturing/importing tonnage of the last year to the competent authority between 1 Apr. and 30 Sep. each year.

6. Existing substance standard registration deadline

Enterprises obtaining Phase I registration code for the first time before 31 Dec. 2019:

Tonnage per year	S tandard registration de adline
1~100t	Before 31 Dec. 2022
＞100t	Before 31 Dec. 2021

Enterprises obtaining the Phase I registration code for the first time after 1 Jan. 2020:

Tonnage per ye ar	Standard regist ratio n deadline
1~100t	Within 3 years from 1 Jan. of the following year (the second year of registration)
＞100t	Within 2 years from 1 Jan. of the following year (the second year of registration)

Enterprises whose manufacturing/ importing tonnage is less than 1t when obtaining the Phase I registration code for the first time:

Tonnage per year	Standard registration deadline
The tonnage reaches 1t before 31 Dec. 2019	Before 31 Dec. 2022
The tonnage reaches 1t after 1 Jan. 2020	Within 3 years from 1 Jan. of the following year (the second year of registration)

• The Regulation published a list of 106 substances as the first batch of existing chemicals subject to standard registration. Related authority may release the second batch of existing substances subject to standard registration in the future.
• Currently in Taiwan, related enterprises must complete Phase I registration if the import/export volume exceeds 100kg; besides, the implantation of standard registration does not mean enterprises do not need to complete Phase I registration for the 106 substances. Actually, related enterprises still have to obtain the Phase I registration code.
• The Regulation does not have detailed rules on existing substance standard registration. It is estimated that related departments will release detailed guideline.

Reference:

Official News (in Chinese)