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 rules the registration type, tonnage, method of new and existing chemicals in Taiwan. 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. What are the implications to enterprises after the Regulations takes effect? How will the co-registration realize? How to realize other types of registrations? What enterprises need to do when there is no formal guideline?
1. Under the regulation, existing substances listed in the first batch of substances (over 1t/a) subject to standard registration shall complete standard registration
That is to say, enterprises can determine if standard registration is required based on the above principle:
- Substances between 1-10t/y are subject to first level standard registration;
- Substances between 10-100t are subject to second level standard registration;
- Substances between 100-1000t are subject to third level standard registration;
- Substances over 1000t are subject to fourth level standard registration;
Meanwhile, substances over 10t/y shall also provide hazard assessment and exposure assessment.
2. Existing Substance Standard Registration Deadline:
Enterprises that have obtained the Phase I Registration Code for the first time before 31 Dec.:
Tonnage per year |
Standard re gistration deadline |
1~100t |
Before 31 Dec. 2022 |
>100t |
Before 31 Dec. 2021 |
Enterprises that obtain the phase I registration code for the first time after 1 Jan. 2020:
Tonnage per year |
Standard registration 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 |
The tonnage reaches 1t after 1 Jan. 2020 |
The tonnage reaches 1t after 1 Jan. 2020 |
Within 3 years from 1 Jan. of the following year (the second year of registration) |
3. Under the Regulation, existing substances less than 100kg/y can also complete phase I registration (not available before).
4. Under the regulation, enterprises shall report to the competent authority on the tonnage of last year between 1 April and 30 September each year.