By Weisin Chai
After going through the regulatory process, the Taiwan Environmental Protection Administration (EPA) published the Regulation of New Chemical Substances and Existing Chemical Substances Data Registration on December 4, 2014. The regulation is enacted in accordance to Article 7(1) Paragraph 6 of the Toxic Chemical Substance Control Act (TCSCA). The regulation became effective on December 11, 2014.
Existing chemicals refer to chemical substances which have been published on the National Existing Chemical Substance Inventory (NECSI). New chemical substances are substances not listed on the NECSI. The NECSI has recently been updated to include more substances with data obtained through the Second Supplementary Existing Chemical Substance Nomination (SSECN). Currently, there are approximately 93,000 substances listed on the inventory. The inventory is searchable by substance through the Chemical Substance Nomination and Notification (CSNN) website. The entire content of the inventory is not available, and as such cannot currently be included in ChemADVISOR’s LOLI (List Of LIsts) Database.
The finalized regulations revised and provided more details for exempted substances, as described below:
- Substances which Occur in Nature
- Chemical substances accompanied in machines and equipment for test-run purposes
- Inseparable intermediates from the chemical reaction in the reaction vessel or production process
- Chemical substances for national defense purposes
- Chemical substances under customs supervision
- Incidental reaction products or impurities with no commercial use
- Mixtures (Reminder: the chemical substances in the mixture need to be registered)
- A polymer that is applicable to the 2% Rule, with new chemical substances or substances listed on the Existing Chemical Substance Inventory
- Substances controlled by other regulations as below:
- Pesticides in the Agro-pesticide Management Act
- Feeds and feed additives in the Feeds Control Act
- Fertilizers in the Fertilizer Management Act
- Veterinary drugs in the Veterinary Drugs Control Act
- Medicaments in the Pharmaceutical Affairs Act
- Controlled Drugs in the Controlled Drugs Act
- Cosmetics in the Statute for Control of Cosmetic Hygiene
- Foods or food additives in the Act Governing Food Sanitation
- Tobacco products in the Tobacco Hazards Prevention Act
- Tobacco and alcohol in the Tobacco and Alcohol Administration Act
- Radioactive materials in the Atomic Energy Law and Ionizing Radiation Protection Act
According to Article 7 Part 1 of the TCSCA, registration shall be done 90 days before manufacturing or importing new chemical substances. There are three types of registration, depending on the annual tonnage band and usage of the substance(s). The tonnage bands have been revised and lowered by a factor of ten by the EPA when compared to the draft Regulation of New Chemical Substances and Existing Chemical Substances Data Registration. The required data for the three types of registration, i.e. Standard Registration, Simplified Registration and Small Quantity Registration, are provided in Appendix 1, Appendix 2 and Appendix 3, respectively. The review periods and valid periods of registration documents for each type of registration are specified.
Registration is exempted for manufacture or import of polymers of low concern with annual tonnage less than 1 metric ton. For annual tonnage of more than 1 metric ton, Small Quantity Registration shall be completed. Before the exemption can be applied, the polymers shall first be certified by the EPA as a “polymer of low concern.”
New chemical substances which have been manufactured and imported between December 11, 2014 and December 31, 2015 shall be registered according to the Small Quantity Registration. Any substances which have been manufactured or imported in Taiwan and has not been included on the NECSI before the effective date of the regulation, needs to have manufacture or import records submitted and be registered with EPA before March 31, 2015.
Registration on manufacturing or importing of existing chemical substances shall be carried out in phases. Phase 1 registration applies to the manufacturing or importing of existing chemical substances with an average annual tonnage of 100 kilograms or above continuously in the past three years, or with a maximum annual tonnage of 100 kilograms or above in any one year of the past three years. It shall be completed between September 1, 2015 and March 31, 2016 by reference to Appendix 5 of the regulations.
Substances manufactured or imported for the first time since April 1, 2016, with an average annual tonnage of 100 kilograms or above shall be registered in accordance to Phase 1 registration within the designated deadline from the EPA. The details for the next phase of registration shall be announced by the Taiwan EPA. Based on the situation of the Phase 1 registration, the central competent authority will announce the list of existing chemical substances subjected to the next phase of existing chemical substances Standard Registration. The announcement shall include the range of quantities and the designated registration period.
Similar to the European Union Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), joint registration is permitted in both new and existing chemical substance registration. If the registrants are unable to reach an agreement on the registration cost apportionment, the average cost will be determined at the discretion of the EPA.
The registration shall be done through an on-line transmission system. The EPA and the Ministry of Labor (MOL) have worked together to create a single window for registration. The application shall be submitted in Traditional Chinese language. All the supporting documents attached to the application in foreign languages need to also be provided in Traditional Chinese.
After the registration is completed, the following data of the registered substance(s) shall be publicly announced online:
- Registrant’s information
- Chemical name
- Manufacture or import conditions
- Hazard classification and labelling
- Safe use information
- Physical and chemical properties
- Toxicological and eco-toxicological information
- Hazard assessment
- Exposure assessment
To protect content as Confidential Business Information (CBI), the following conditions shall be met:
- The information is not commonly known
- The information has economic value, actual or potential, due to its secretive nature
- Reasonable measures to maintain the secrecy has been taken
Only certain information can be protected as CBI, as provided below:
- Registrant’s information
- Chemical substance identity
- Information on manufacture or import of chemical substance
- Chemical substance use information
The application for data protection shall be done within 3 to 6 months prior to the new/existing chemical substance registration. The data is protected for 5 years for substances registered through Standard Registration and 2 years for substances registered through Simplified or Small Quantity Registration. The application for renewal shall be completed 3 months before the expiration. The protected periods for each renewal remain the same according to the type of registration. The maximum protected period is 15 years, despite the type of registration.
Other supplementary regulations, including registration processing time, the change of registered information, the revocation of registration, the cost of registration and so forth are stipulated in Chapter 5 of the regulations.
The processing time for each type of registration is provided as below:
- Certification of Polymer with Low Concern – 7 working days
- Small Quantity Registration of New Chemical Substance – 7 working days
- Phase 1 Registration of Existing Chemical Substance – 7 working days
- Simplified Registration of New Chemical Substance – 14 working days
- Standard Registration of New Chemical Substance – 45 working days
- Confidential Business Information Claim – 45 working days
The EPA may extend the processing time a maximum of one time. If this happens, the registrants will be informed accordingly. The EPA may also request further supporting documents or amending registration content, if necessary. In this case, the registrant shall revise and submit the required information within 30 working days. The revision shall not exceed two times, or the registration will be revoked.
Despite the request from the EPA, registrants shall take the initiative to make an amendment of registration if the registrants’ information and/or the chemical substance use information have changed. This shall be done within 30 working days. If the changes result in a change of type of registration, registrants shall re-apply according to the correct type of registration.
The registration document and application of data protection are required to be kept for at least 5 years and 10 years respectively.
To introduce the existing and new chemical substances registration, Taiwan hosted at least 50 seminars in the past three years. To further facilitate the enforcement of the chemical registration, the EPA opened telephone and e-mail services to handle inquiries from industry. The EPA welcomes phone calls to +886-(02)2314-2000 or e-mails to email@example.com.
National Existing Chemical Substance Inventory (NECSI)
Chemical Substance Nomination and Notification (CSNN) website
Toxic Chemical Substances Control Act (TCSCA)
News Announcement by the EPA