Request a Demo
On November 23, 2021, the revision to Taiwan’s New and Existing Chemical Registration was published and took effect immediately. Compared with the previous draft version released on May 24, 2021 (ChemLinked news), the amendments are remained the same except for two adjustments in the final revision, including extending the deadline for the registration of 106 priority existing chemicals (PECs) to December 31, 2024 and maintain the official review period unchanged to reduce registrants' pressures associated with the time limit and to improve the registration efficiency.
According to Taiwan’s Environment Protection Agency (EPA), the major updates in the revision are summarized as the followings:
1. Registration Deadline
Deeply influenced by the pandemic, many enterprises have difficulties in fulfilling the registration obligation and operating their businesses. Taking into account such status quo, Taiwan’s EPA extends PECs registration (≥ 1 t/y) deadline to December 31, 2024 for those having obtained the phase 1 registration code before the end of 2019. For those obtaining the phase 1 registration code after 2020 for the first time and reaching 1 t/y at the same year, or for those having obtained the phase 1 registration code when the volume is below 1 t/y and after 2020 the volume reaches 1 t/y, they shall complete registration within 5 years counting from the second year when the phase 1 registration code is obtained.
2. Scope of Exemptions
The revision stipulates that the controlled chemicals (19 types) designated under the Regulation on Designation and Operation Permission of Controlled Chemicals under OSHA and the concerned chemicals (nitrous oxide, ammonium nitrate and hydrogen fluoride) designated under TCCSCA are beyond the scope of the regulation. Therefore, the clarified scope avoids duplicative chemical management with other laws and regulations.
In addition, the existing on-site isolated intermediates are exempted from standard registration, considering their limitation in use and their risk of exposure is easy to control. If enterprises manufacture or import such chemicals, they can start relevant activities without standard registration.
3. Registration Validity and Confidentiality Validity
Unify the periods of registration validity and confidentiality validity for all types of new chemical registration as 5 years.
Clarify that a maximum duration of confidentiality protection for new chemical registration information is 15 years, including the period before and after the new chemical substance is listed on the existing chemical substance inventory.
4. Data Submission
The revised regulation allows registrants to submit partial information (only items 1~7) to obtain a registration code. The hazard and exposure assessment information (required for Band 2~4) can be submitted later within the allocated time. Registrants can start chemical activities immediately after obtaining the registration code, and then fulfill the remaining items.
For registrants who obtained the code before December 31, 2019, although there are still three years left, it is suggested to hurry up preparing documents of hazard and exposure assessment information. For the reason that the process of preparation of such information takes a long time, let alone the time consumed for the review period, dossier supplementation or correction.
5. Punishment
In accordance with Taiwan’s Toxic and Concerned Chemical Substances Control Act (TCCSA), a fine of from NT$30,000 to NT$300,000 on registrants is set for failing to supplement or correct unqualified annual reports within the allocated time. Punishment is imposed for each violation. If the enterprise fails to make improvements within the allocated time twice, it may be ordered to stop work, suspend business, or re-export the chemical substances.
6. Exempt from Data Preservation Obligation
Since all the data has been saved in the Internet transmission system, there is no need for enterprises to keep copies of all the submitted information and relevant verification documents for recordkeeping and reference.
Notably, there’s no change to the review period in the final revision, for industry it’s good news. No extension to the review period means no further delays in registration timeline. Taiwan’s EPA announces that counselling service on corresponding data items for standard registration of existing chemical substance will continue to be provided, expecting relevant enterprise seize the opportunity to cooperate with the EPA to complete the registration as soon as possible.
The full contents of the revision are accessible here (in traditional Chinese).
