V.Registration of Existing Chemical Substances
5.1 Definition of Existing Chemical Substances
Existing chemical substances refer to chemicals listed in the TCSI which was published by the Ministry of Labor in Taiwan in 2014 after several revisions, aiming to implement a chemical substance registration system. Currently, a total of 100,000 chemical substances are added to the TCSI.
The registration types for existing chemical substances are mainly divided into Phase 1 registration and Standard registration. Details of the registration type are specified in the following chart.
5.2 Phase 1 Registration
Registrants are required to submit Phase 1 registration documents to competent authorities prior to manufacture or import if the annual volume of manufactured or imported existing chemicals above 100kg. If the annual volume is below 100kg, manufacturers or importers may apply for Phase I registration in advance.
5.2.1 Data Requirements of Phase I Registration
|
Data |
Details |
1 |
Registrant and substance identification |
1.1 Registrant information
1.2 CAS No. or serial number1
|
2 |
Substance manufacture and application |
2.1 Production and import
2.2 Intended use
|
Note: The serial number in the registrant and substance identification refers to the number assigned to existing chemical substances that have completed confidentiality approval or to existing chemical substances without a CAS No., within the TCSI established by the Ministry of Labor.
5.3 Standard Registration
The competent authority may, by stages, designate the lists of existing chemical substances subject to standard registration, including the names of chemical substances, quantity thresholds and deadlines for registration, based on the circumstances of the phase 1 registration of existing chemical substances.
The names of the existing chemical substances, quantity thresholds and deadlines for registration subject to the standard registration designated by stages pursuant to the previous paragraph are specified in Appendix 6 (106 substances), in the Guidance on Existing Chemical Substances Standard Registration (Version 1).
5.3.1 Deadlines for standard registration
Circumstances of the phase 1 registration |
Deadlines for standard registration |
Before Dec 31,2019,the phase 1 registration code is obtained for the first time. |
Annual volume of registration≥1ton |
Before Dec 31,2024 |
After Jan 1,2020, the phase 1 registration code is obtained for the first time. |
Annual volume of registration≥1ton |
Registration must be completed within 5 years from Jan 1 of the following year. |
Annual quantity<1ton when the phase 1 registration code is obtained for the first time. |
Before Dec 31,2019,actual annual volume≥1 ton |
Before Dec 31,2024 |
After Jan 1,2020,actual annual volume≥1 ton |
Registration must be completed within 5 years from Jan 1 of the following year. |
Note: If the re-application of phase 1 registration code is made after withdrawal, the standard registration shall be completed within the previous deadline upon obtaining the code. If the re-application is made after the designated deadline, the standard registration shall be completed together with the application.
5.3.2 Volume threshold for standard registration
Annual volume of chemicals manufactured or imported |
CMR Category 1 substance |
Other chemicals |
1 ton≤Q<10 ton |
Level 2 |
Level 1 |
10 ton≤Q<100 ton |
Level 3 |
Level 2 |
100 ton≤Q<1000 ton |
Level 4 |
Level 3 |
1000 ton≤Q |
Level 4 |
Level 4 |
Note: (1) CMR Category 1 Substance: Substances classified as carcinogenicity category 1 according to CNS 15030, or mutagenicity category 1 for germ cell mutations, or reproductive toxicity category 1. Currently, the Ministry of Environment has identified that CMR Category 1 substances containing sulfuric acid and N-methylpyrrolidone.
(2) After standard registration, if the actual annual quantity manufactured or imported increases, resulting in a change in quantity thresholds, the registrant shall submit additional documents to competent authorities according to the new quantity thresholds.
5.3.3 Data requirements of standard registration
Currently, if data in Item 1-7 is submitted, a registration code will be issued by the competent authority. With the registration code, the registrant shall complete items 8 and 9 within the specified period to the competent authority.
Data |
Standard registration Level 1
|
Standard registration Level 2
|
Standard registration Level 3
|
Standard registration Level 4
|
1. Registrant and substance identification |
V |
V |
V |
V |
2. Production, application and exposure information |
V |
V |
V |
V |
3. Hazard classification and labeling |
V |
V |
V |
V |
4.Safe use |
V |
V |
V |
V |
5. Physical and chemical properties |
V(13) |
V(13) |
V(15) |
V(15) |
6. Toxicological information |
V(15) |
V(8) |
V(8) |
V(9) |
7.Ecotoxicological information |
V(3) |
V(7) |
V(9) |
V(16) |
8.Hazard assessment |
|
V |
V |
V |
9.Exposure assessment |
|
V |
V |
V |
Note:
- The number in parentheses indicates the maximum number of testing items that must be submitted.
- If the chemical substance is not subject to hazardous substances and does not possess persistent, bioaccumulative, and toxic (PBT) properties or very persistent and very bioaccumulative (vPvB) properties, then the exposure assessment information (Item 9) may be exempted.
5.3.4 Data requirements of standard registration
Physical and Chemical Properties
Items |
Level 1 |
Level 2 |
Level 3 |
Level 4 |
Testing Specification |
Physical state |
○ |
○ |
○ |
○ |
— |
Freezing point |
○ |
○ |
○ |
○ |
OECD TG 102 |
Boiling point |
○ |
○ |
○ |
○ |
OECD TG 103 |
Density |
○ |
○ |
○ |
○ |
OECD TG 109 |
Partition coefficient n-Octanol/water |
○ |
○ |
○ |
○ |
OECD TG 107/117/123 |
Water solubility |
○ |
○ |
○ |
○ |
OECD TG 105 |
Vapor pressure |
○ |
○ |
○ |
○ |
OECD TG 104 |
Flash point |
○ |
○ |
○ |
○ |
ISO 1516:2002; ISO 1523:2002; ISO 3679:2004; ISO 3680:2004 |
Flammability |
○ |
○ |
○ |
○ |
UN RTDG: Manual of Tests and Criteria Part III. 33.4 Test N.5 etc.* |
Explosive property
|
○ |
○ |
○ |
○ |
UN RTDG: Manual of Tests and Criteria Part I |
Oxidizing property
|
○ |
○ |
○ |
○ |
UN RTDG: Manual of Tests and Criteria Part III. 34.4 Test O.1;UN RTDG: Manual of Tests and Criteria Part III. 34.4 Test O.2 |
pH value
|
○ |
○ |
○ |
○ |
OECD TG 122 |
Ignition temperature
|
○ |
○ |
○ |
○ |
ASTM E659-78(2005);ASTM G72/G72M-09
|
Viscosity
|
|
|
○ |
○ |
OECD TG 114 |
Metal corrosiveness
|
|
|
○ |
○ |
UN RTDG: Manual of Tests and Criteria Part III. 37.4 Test C.1 |
Note:
1. tems marked with “○“shall be submitted.
2. The flammability testing marked with "*" are not fully listed here.
More details are in the Table 5.3.1 in the Guidance on Existing Chemical Substances Standard Registration (Version 1).
Toxicological Information
Note: Items marked with ○ shall be submitted. Items marked with ● shall be submitted if the conditions are met. Items marked with ▲ can be submitted by test plans.
5.3.5 Types of Standard Registration Data Submission
For existing chemical substances, if the physical and chemical properties (Item 5), toxicology (Item 6), ecotoxicology (Item 7), etc. are included in the exemption listed, the registrant is exempted from submitting that information. If not, the recommended order for data by the registrant is as follows:
1. International public available databases.
2. Submit any of the following non-testing or non-experimental data types:
a. Quantitative Structure-Activity Relationship (QSAR Estimation) (applicable to certain items only).
b. Read Across data (applicable to certain items only).
c. Systematic Review report.
d. Testing Proposal (applicable to certain items only).
3. Submit testing reports.
With special reasons, submit designated data types after obtaining the approval of the competent authority.
5.4 Joint registration for existing chemical substances
When different registrants apply to register the same existing chemical substance jointly or sequentially, they may use common data in item 3, 5, 6, 7 and 8 for the registration.
After completing the registration, LR can provide a joint registration authorization code to other registrants. Other joint registrants only need to provide items 1, 2, 4, and 9 of the data requirements. With the joint registration authorization code, they can complete the registration data items.
5.5 Review period and validity period for existing chemical substance registration
The review period for the phase 1 registration of existing chemical substances is 7 working days, while the review period for the standard registration of existing chemical substances is 90 working days. The competent authority may extend the review period once and notify the registrant. If the registrant makes corrections based on the comments, the review time will be recalculated.
Upon receiving the correction notice, the registrant shall complete the correction within 30 working days, with a limit of two corrections. If the application is still not approved after two corrections, it will be rejected by the competent authority. If the registrant cannot complete the correction on time due to scientific/technical reasons, they may apply for an extension of the correction period from the competent authority.
After obtaining approval for Confidential Business Information (CBI) protection for existing chemical substances, the confidentiality period is 5 years. Six months before the expiration of the CBI protection period, the registrant may apply for an extension within 3 months. The cumulative maximum confidentiality period is 10 years.
5.6 Review fee for the registration of existing chemicals
Registration type |
Review fee for registration (NTD) |
Phase 1 Registration |
100 NTD/substance |
Standard Registration 1 |
50,000 NTD |
Confidentiality of information 2 |
12,500 NTD/item |
Confidentiality of information extension |
10,000 NTD/item |
Note:
1. If the registrant is from an academic institution or a small or medium-sized enterprise, the standard registration fee is charged at 75% of the review fee. For standard registration, if skin irritation/corrosion or eye irritation data is submitted in the form of in vitro tests, QSAR reports, or Read Across data, the official review fee is 37,000 yuan.
2. The items that can be applied for confidentiality include registrant information, chemical identification information, production or import information, and application information.