Taiwan officially issued and implemented the newly revised "Registration Measures for New Chemical Substances and Existing Chemical Substances"

Release time:

2021-12-01 14:39

On the 23rd of this month, the Taiwan region officially issued an announcement on the newly revised "Measures for the Registration of New Chemical Substances and Existing Chemical Substances" (hereinafter referred to as the "Registration Measures"). According to the announcement, the measures were officially announced on November 26. Implement.

Compared with the previous draft amendment, the officially released "registration method" has once again extended the deadline for registration of existing material standards. After many discussions, the relevant authorities in Taiwan set the date as December 31, 2024.

Apart from this important change, what are the changes to the new "registration method?

01
Added Exemption Scope
Under the new "registration scheme", the following two substances are exempted:

• Regulatory chemicals

Refers to the regulated chemicals listed in the Administrative Measures for the Designation and Operation Permit of Regulatory Chemicals (19 substances in total).

• Focus on chemicals

Refers to chemical substances other than toxic chemical substances, substances (nitrous oxide (nitrous oxide), ammonium nitrate, hydrogen fluoride) that are determined and announced by the competent authority to pollute the environment or endanger human health based on their substance characteristics or other related livelihood consumption issues.

02
Period of validity of unified registration and data confidentiality
According to the new "registration method", the validity period of registration and data confidentiality of each category is unified to 5 years. In addition, the total validity period of data confidentiality before and after the new chemical substances are included in the existing chemical substances is limited to 15 years.

03
Contents of hazard assessment and exposure assessment may not be submitted first
According to the new "registration method", for the existing substance standard registration (level 2 to level 4) that needs to submit hazard assessment and exposure assessment, when submitting data to apply for registration code, enterprises can not submit the contents of hazard assessment and exposure assessment first, and supplement relevant contents after obtaining the registration code.

04
New provision for exemption from registration of existing chemical substance standards for intermediates at restricted sites
If the existing substance manufactured or imported by the enterprise is an intermediate product at a defined site, the existing substance standard registration is not required.

05
Cancel the current provisions requiring enterprises to keep registration information.
Considering the difficulties of enterprises in preserving data, Taiwan's competent authorities already have a data preservation system, so the new "registration measures" exempt enterprises from the obligation to preserve application data.

06
Cancel modification of correction times and approval time
Due to the plan to increase the number of corrections of registration data and extend the examination time of registration cases, the registration cycle may be extended. Therefore, the new "registration method" cancels the revision of the number of corrections and the examination time.

At present, the new "registration method" fully takes into account the various difficulties that enterprises may encounter when preparing registration materials, and has made the above-mentioned amendments and adjustments, giving registered enterprises enough time to make relevant preparations. Therefore, the majority of registered enterprises can fully regulate, adjust the registration plan, and choose the most appropriate plan to complete the registration of new chemical substances and existing chemical substances in Taiwan.

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