On 23 Nov. 2021, Taiwan has released the Revised Regulation on New and Existing Chemical Substances Registration (Regulation), which took effective from the date of promulgation.
The Regulation on New and Existing Chemical Substances Registration was prepared based on the Toxic and Concerned Chemical Substance Control Act. It specifies the data requirements when registrants go through the registration process for the manufacture or import of new and existing chemical substances. On 11 Mar. 2019, Taiwan EPA has amended the Regulation for the first time. In the first revision, the Regulation listed 106 substances as the first batch of existing substances subject to standard registration, and gave their tonnage band, registration deadlines, as well as the data requirements.
This is the second revision to the Regulation. According to the announcements from EPA, the revision was made based upon the Toxic and Concerned Chemical Substance Control Act (TCCSCA) released on 16 Jan. 2019 and had taken into consideration of the suggestions from the industry.
CIRS has analyzed the major changes to the Regulation as well as its impacts to related enterprises. Details are as follows:
Major Changes and its Impacts
Impacts on Enterprises
Controlled chemicals and concerned chemicals as prescribed in other laws and regulations are not applicable to this Regulation
Avoid duplicate of submission;
New substance registration are valid for 5 years.
Standard registration and PLC registration are valid for 5 years; simplified registration and small quantity registration are valid for 2 years;
The registration period for simplified registration and small quantity registration are extended, which will reduce enterprises’ work to apply for extension;
Registration deadlines for priority existing chemicals (PEC) standard registration will be extended to 31 December 2024 if first phase registration was completed before 31 December 2019; and 31 December 2025 if first phase registration was completed after 1 January 2020.
The registration deadline for standard registration of existing chemical no more than 100 t/y: before 31 December 2022;
The registration deadline for standard registration of existing chemical over 100t/y: before 31 December 2021;
The registration deadline is extended to lower enterprises’ burdens as enterprises have hit hard by the Covid-19 pandemic;
Registrants will obtain the registration code have they have provided the information items 1-7 and passed the approval;
Registrants will obtain the the registration code after they have provided the information items 1-9 and passed the approval;
The data requirements are reduced to encourage registrants to carry out the registration process;
On-site Isolated Intermediates are exempted from standard registration
Lower enterprises’ burdens;
The maximum confidential period for a new chemical substance is 15 years; for an existing chemical substance, the maximum confidential period is 10 years. For a new chemical substance that has been included in the inventory of existing chemical substances, the maximum confidential period is 15 years
The maximum confidentiality period for a new chemical substance is 15 years; for an existing chemical substance, the maximum confidentiality period is 10 years.
Regulate the upper limit of the maximum confidentiality period;
For registered new and existing chemical substances, the registrant shall, starting from the following year after the registration is approved, submit a report annually on the manufactured or imported quantity in the previous year for the new or the existing chemical substances;
Where the information reported by the registrant does not comply with the relevant regulations as determined by the competent authority, the competent authority shall notify the registrant to make a correction within a prescribed period. Where the registrant fails to do so or the correction fails to meet the requirements, the competent authority shall impose an administrative penalty;
For registered new and existing chemical substances, the registrant shall, starting from April 1st 2020, during the period from April 1st to September 30th of each year, submit a report on the manufactured or imported quantity in the previous year for the new chemical substance, or the existing chemical substance;
The Revised Regulation has made clear the time when enterprises shall start reporting, the corrections as well as the punishments;
The provisions on retention of registration-related documents are deleted;
Registrants shall keep copies of all the submitted information and relevant verification documents in written or electronic form for 5 years, for record keeping and reference.
Information, where business secrets are involved and information protection is applied for and approved by the central competent authority, shall be kept in written or electronic form for 15 years, for record and reference.
Reduce registrants’ works;
In addition to above revisions, EPA also made some changes to the text descriptions and simplify many procedures. For example, many attached tables are combined, a single effective deadline is set for registering different new chemical substances, and the scope is expanded for substances covered by the part of the Regulations that are no longer applicable. Other changes include adjusting the evaluation period for applications and rectification times, eliminating such requirements as registrants having to keep their application documents, etc.
To help enterprises better understand the changes to the Regulation, CIRS is to host a free webinar on the Revised Regulation of New and Existing Chemical Substance Registration in Taiwan. If you are interested, do not hesitate to join us!