I．Introduction

Competent authorities in Taiwan implement a chemical substance registration management system for new chemical substances and existing chemical substances produced in or imported to Taiwan. Registrants must complete the registration and obtain a registration code prior to production or import.

According to the provision of Paragraph 1, Article 30 of the Toxic and Concerned Chemical Substances Control Act (hereinafter referred to as the TCCSCA), manufacturers or importers of existing chemical substances at certain amount are required to submit registration data to competent authorities in Taiwan. Manufacturing or importing new chemical substances are required to submit registration data to competent authorities in Taiwan 90 days prior to manufacture or import. The manufacture or importing of existing or new chemical substances may only happen with the registration approval.

In accordance with the provision of Paragraph 1, Article 30 of the TCCSCA, the Regulations of New and Existing Chemical Substances Registration (hereinafter referred to as the Regulations) was formulated and its latest version was published and implemented on November 23, 2021. The Regulations specifies the types of registered chemical substances, quantity ranges, the production or import circumstances, data on physical, chemical, toxicological, exposure and hazard assessments, registration deadlines, standard, simplified, small quantity and joint registration methods, review procedure, approval or rejection, revocation or abolition of registration approval, prohibition or restriction of operations, declaration or supplementation of post-registration chemical substance data, document keeping, information disclosure, protection of trade and industrial secrets, and other compliance matters.

The Guidance for New and Existing Chemical Substances Phase 1 Registration Version 1 and Guidance on Existing Chemical Substances Standard Registration specify requirements related to the registration type, registration range, registration method, registration information, and the validity period of registration codes of new chemicals registration, existing chemical substances Phase 1 registration and standard registration. 

In addition, the Ministry of Labor in Taiwan also manages new chemical substances produced or imported in Taiwan. According to the provision of Paragraph 1, Article 13 of the Occupational Safety and Health Act (OSHA), the manufacture or import of new chemical substances not listed by the competent authority in Taiwan is prohibited for manufacturers and importers without submitting a Chemical Substance Safety Assessment Report for approval and registration. The Regulations on New Chemical Substances Registration specifies the registration process, assessment report, review procedure, public disclosure, and other compliances related to new chemical substances.

It should be noted that under the management of competent authorities in Taiwan, the Ministry of Environment and the Ministry of Labor have unified the acceptance window for the new chemical substance registration. Since August 19, 2015, producers or importers of new chemical substances are only required to submit registration applications through the Chemical Substance Registration Platform established by the Ministry of Environment. Once the application is approved, the registrant is qualified to conduct following procedures.

 

II.  Registrant and Agent

Registrant: Manufacturers or importers of chemical substances in Taiwan.

Agent: Legal entities or individuals in Taiwan, authorized by the registrant, can act as an agent. Overseas enterprises exporting chemical substances to Taiwan can submit registration applications through an agent if they are required to apply for protection of Confidential Business Information (CBI).

Overseas manufacturers: Non-Taiwan manufacturing enterprises or import enterprises cannot complete the registration by themselves, and they need to entrust Taiwan import enterprises to complete the registration.

 

III. Scope of Exemption

3.1 Scope of Exemption

• Naturally occurring substances；

• Chemical substances accompanied in the machines and equipment for test-run purpose；

• Non-isolated intermediates from chemical reaction in the reaction vessel or in the production process；

• Chemical substances for national security or national defense；

• Chemical substances under customs supervision；

• Chemical wastes produced or released from industrial process；

• By-products or impurities not for commercial purpose；

• Mixtures (not applicable to the individual chemical constituents of the mixture)；

• Articles；

• Polymers listed on the TCSI (Taiwan Chemical Substance Inventory) and subject to the 2% rule. 

3.2 Substances Controlled by Other Regulations

• Agro-pesticides, as defined by the Agro-pesticides Management Act；

• Feeds and feed additives, as defined by the Feed Control Act；

• Fertilizers, as defined by the Fertilizer Management Act；

• Veterinary drugs, as defined by the Veterinary Drugs Control Act；

• Medicaments, as defined by the Pharmaceutical Affairs Act；

• Controlled drugs, as defined by the Controlled Drugs Act；

• Cosmetics, as defined by the Cosmetic Hygiene and Safety Act；

• Foods, food additives, food utensils, food containers or packaging, and food cleansers, as defined by the Act Governing Food Safety and Sanitation；

• Tobacco products, as defined by the Tobacco Hazards Prevention Act；

• Tobacco and alcohol, as defined by the Tobacco and Alcohol Administration Act；

• Radioactive materials, as defined by the Atomic Energy Act and the Ionizing Radiation Protection Act；

• Industrial use explosive materials, as defined by the Industrial Explosives Administrative Act；

• Controlled chemicals as prescribed in the Occupational Safety and Health Act；

• Chemical substances regulated by the Montreal Protocol under the Air Pollution Control Act；

•  Environmental agents, as defined by the Environmental Agents Control Act；

• Toxic and concerned chemical substances.

 

IV. New Chemical Substances Registration

4.1 Definition of New Chemical Substances

New chemical substances refer to substances that are not listed in the Taiwan Chemical Substance Inventory (TCSI). You can query the substance by inputting CAS number, Chinese name, or English name on the following website: https://csnn.osha.gov.tw/content/home/Substance_Query_Q.aspx. If there is no matching result in the TCSI, then this substance can be identified as a new chemical substance.

New chemical substances are classified into 8 categories, including general new chemical substances, substances used for the purposes of scientific and research development (SRD), substances used for the purpose of 'product and process orientated research and development'(PPORD), polymer, Polymer of Low Concern (PLC), on-site isolated intermediates, substance of Carcinogenic, Mutagenic or Toxic for Reproduction (CMR category 1) and nanomaterials.

• Scientific Research and Development(SRD): refers to any scientific experimentation, education, analysis or chemical research carried out under scientific or academic research，most of which are chemical research (Such as scientific research in colleges and laboratory). 

• Product and Process Orientated Research and Development(PPORD): refers to any scientific research and development related to development of a substance.

• Polymer: refers to molecules characterized by the sequence of one or more types of monomer units or a molecule containing at least three monomer units through covalent bonds.

• Polymer of Low Concern (PLC): refers to polymers that meet specific criteria and have passed a PLC priority verification. These can be registered under regulations of PLCs. If a polymer does not pass the verification, it must be registered according to general chemical registration rules or regulations for special category polymers.

• On-site Isolated Intermediates: refer to intermediates that produced and consumed on the same site.

• Substance of Carcinogenic, Mutagenic or Toxic for Reproduction category 1 (CMR category 1): refers to a substance that is classified as carcinogenicity category 1, mutagenicity category 1, or reproductive toxicity category 1, based on the R.O.C. National Standards (CNS 15030).

• Nanomaterials: refer to tiny substances with sizes ranging from 1 to 100nm.

 

4.2 Calculation of the Annual Volume of Manufactured or Imported New Chemical Substances

Details of calculation methods:

1. The total annual volume of manufactured or imported pure substances;

2. For mixtures, the manufactured or imported quantity of each ingredient (pure substance) should be calculated separately;

3. If a chemical substance is contained in multiple mixtures, the content of this chemical in each mixture shall be calculated and totaled;

4. If a chemical substance is contained in mixtures within a concentration range, the highest concentration shall be adopted to calculate.

 

4.3 Registration Types of New Chemical Substances

The registration of new chemical substances is classified into small quantity registration, simplified registration and standard registration based on the annual volume of manufacture or import. 

 

4.4 Data Requirements for New Chemical Substance Registration  

Nine types of data are required. The larger the annual volume is, the more data shall be provided. The minimum information is required for small quantity registration, while standard registration requires integrate data.

• Data Requirements for Small Quantity Registration

Data	Details
1. Registrant and substance information	1.1 Information on registrant 1.2 Substance information 1.3 Special form
2. Substance manufacture and intended use	2.1 Manufacture and import information 2.2 Intended use 2.3 Exposure data

• Data Requirements for Simplified Registration

Data	Details
1. Registrant and substance information	1.1 Registrant information 1.2 Substance identification 1.3 Special form
2. Substance manufacture and intended use	2.1 Production and import 2.2 Application 2.3 Exposure
3. Hazard classification and labeling	3.1 Physical hazard 3.2 Health hazard 3.3 Environmental hazard 3.4 Labeling
4. Safety use	SDS
5. Physicochemical Properties	5.1 Physical state 5.2 Melting point/freezing point 5.3 Boiling point 5.4 Density 5.5 Partition coefficient n-Octanol/water 5.6 Water solubility

• Data Requirements for Standard Registration

Standard registration is categorized into 4 levels: Level 1, Level 2, Level 3, and Level 4. Registration in different levels varies, primarily reflected in the data such as physicochemical property, toxicology, and ecotoxicology.

Registration	Level 1	Level 2	Level 3	Level 4
1. Registrant and substance information	V	V	V	V
2. Manufacture, intended use and exposure	V	V	V	V
3. Hazard classification and labelling	V	V	V	V
4. Safety use	V	V	V	V
5. Physical and chemical properties	V(13)	V(13)	V(15)	V(13)
6. Toxicological information	V(5)	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

• Hazard Assessment and Exposure Assessment

1. Standard registration of general substances with the annual manufacture or import volume above 10 tons but not meet the criteria for hazardous substances, only the hazard assessment needs to be submitted.

2. Standard registration with the annual manufacture or import volume above 10 tons, hazard assessment and exposure assessment are both required to be submitted if the substance is identified as a hazardous substance.

3. Hazard assessment and exposure assessment are required to be submitted when the annual volume of new chemical substances manufactured or imported above 1,000 tons.

4. For CMR Category 1 substances, hazard assessment and exposure assessment are both required to be submitted when the annual manufactured or imported volume exceeds 1 ton.

5. For special new chemical substances, hazard assessment and exposure assessment are not required to be submitted.

• Data Requirements for Special New Chemical Substances

SRD and PPORD: Special forms for SRD product and manufacture procedure is required.

Polymer: Additional information on polymers is required, including average molecular weight, monomer information, etc.

PLC: Special form for PLC under prior review is required to be submitted. Only PLCs with prior review can be registered.

On-site Isolated Intermediates: Details of on-site isolated intermediates shall be provided such as substance quantity, intended use, and exposure scenario.

 

4.5 Testing Specifications for New Chemical Substance Registration

Physical and chemical tests can be conducted by laboratories with CNAS certification or OECD GLP certification, while toxicological and ecotoxicological tests must be conducted only by laboratories with OECD GLP certification.

• Physical and Chemical Properties

  Items	Level 1	Level 2	Level 3	Level 4	Testing Specification
  Physical state	○	○	○	○	--
  Melting point/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	○	○	○	○	ISO1516/1523/3679/3680/2719/13736
  Flammability	○	○	○	○	UN RNTG
  Explosive property	○	○	○	○	UN RNTG
  Oxidizing property	○	○	○	○	UN RNTG
  PH value	○	○	○	○	OECD TG 122
  Ignition temperature	○	○	○	○	ASTM E659-78(2005); ASTM G72/G72M-09;
  Viscosity			○	○	OECD TG 114
  Metal corrosiveness			○	○	UN RNTG

  Note: Items marked with"○" must be submitted. 

• Toxicological Information

Items		Level 1	Level 2	Level 3	Level 4	Testing Specification
Acute toxicity	Oral	○ (Choose one of the three items.)	○ (Choose two of the three items.)	○ (Choose two of the three items.)	○ (Choose two of the three items.)	OECD TG 420/423/425
	Dermal					OECD TG 402
	Inhalation					OECD TG 403/436
Skin irritation/corrosion		○	○	○	○	OECD TG 430/431/435/439(in vitro) OECD404(in vivo)
Eye irritation		○	○	○	○	OECD TG 437/438/460/491/492/494/496/467(in vitro) OECD405(in vivo)
Skin sensitization		○	○	○	○	OECD TG 497/442C/442D/442E (in vitro) OECD TG 406/429/422A/422B(in vivo)
Genotoxicity	Bacterial reverse mutation test AMES	○	○	○	○	OECD TG 471
	In vitro mammalian cell genotoxicity test	●	○	○	○	OECD TG 473/476/487/490
	In vivo genotoxicity test	●	●	▲	▲	OECD TG 474/475/486/488/489
Basic toxicokinetics			▲	▲	▲	OECD TG 417
Repeated dosing	28-day repeated dosing		○			OECD TG 407/412/410
	90-day repeated dosing			○	○	OECD TG 408/413/411
Reproductive/developmental toxicity	Reproductive/developmental toxicity screening		●	○	○	OECD TG 414
	Fetal developmental toxicity test		●		▲	OECD TG 416/443
	Two-generation reproductive toxicity test				○	OECD TG 451/453

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 proposals.

 

• Ecotoxicological Information

  Items		Level 1	Level 2	Level 3	Level 4	Testing Specification
  Short-term toxicity to non-vertebrates (e.g., daphnia)		○	○	○	○	OECD TG 202
  Toxicity to aquatic algae and cyanobacteria		○	○	○	○	OECD TG 201
  Aquatic biodegradation: screening tests	Rapid biodegradability	○	○	○	○	OECD TG 301A-F/310/211
  	Inherent biodegradability	●	●	●	●	OECD TG 302A-C
  Short-term toxicity to fish			○	○	○	OECD TG 203
  Hydrolysis reaction			○	○	○	OECD TG 111
  Toxicity to microorganisms			▲	▲	▲	OECD TG 209/224
  Adsorption/desorption behavior			▲	▲	▲	OECD TG 106/121
  Long-term toxicity to non-vertebrates (e.g., daphnia)				▲	▲	OECD TG 211
  Long-term toxicity to fish				▲	▲	OECD TG 210/212/215
  Toxicity to soil macroorganisms (excluding arthropods)					▲	OECD TG 220/222
  Toxicity to terrestrial plants					▲	OECD TG 208/227
  Toxicity to soil microorganisms					▲	OECD TG 216/217
  Biodegradation in water and sediment: simulation tests					▲	OECD TG 303A-B/306/308/309
  Biodegradation in soil					▲	OECD TG 304A/307
  Bioaccumulation: aquatic organisms sediment					▲	OECD TG 305 includes 305-I、305-II、 305-III
  Sediment toxicity					▲	OECD TG 218/219/225

  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 proposals.

 

4.6 Joint Registration of New Chemical Substances

When different registrants apply to register the same new chemical substance jointly or sequentially, they may share common data for the registration through consultation.

The new chemical substance, subject to the joint registration, is to be registered according to the Regulations, for which the overall quantity of the joint registration shall be the sum of the individual quantities from each co-registrant.

By taking into account the overall manufactured or imported quantity of the new chemical substances registered and approved, the central competent authority may require registrants to apply for the new registration under the designated registration type or to apply for joint registration.

 

4.7 Review Period and Validity Period for New Chemical Substance Registration

• Review Period

7 working days for new chemical substances with small quantity, PLC prior verification, PLC registration with small quantity and CBI protection;

14 working days for simplified registration or inclusion to the TCSI;

45 working days for standard registration.

Competent authority shall notify the registrants if the review periods to be extended, up to 1. If additional data is requested or corrected, the review period will restart.

• Correction Period

Corrections should be completed within 30 working days from the date of receipt of the correction notice. The number of corrections are limited to twice. If the application still does not pass the review after two corrections, it will be rejected. If corrections cannot be completed on time due to scientific or technical reasons, an application shall be made to the competent authority, and the correction time will not be included in the review time.

• Confidential Period

The confidential period of the information on chemical substances approved by the central competent authority is valid for 5 years. A registrant may apply for extension of a confidential period three to six months prior to expiry of the period. The maximum confidential period for a new chemical substance is 15 years. For a new chemical substance that has been included in the TCSI, the maximum confidential period is 15 years.

• Validity Period of Registration

The validity period of the information on chemical substances approved by the central competent authority is 5 years. For joint registration sequentially, the validity period of the later applicant's registration is the same as the approved registration validity period of the earlier applicant.

A registrant may apply for extension of a validity period three to six months prior to expiry of the period.

A new chemical substance under any one of following circumstances may be included in the TCSI:

（1）It shall be at least 5 years after the standard registration is filed and completed;

（2）It shall be at least 5 years after the PLC registration is filed and completed in accordance with the small quantity registration;

（3）A new chemical substance becomes a toxic or concerned chemical substance announced by the central competent authority;

（4）Standard registration filed and completed through submission of information on hazard assessment and exposure assessment;

（5）PLC registration in accordance with the small quantity registration.

Note: Items (1)-(3) are included in the TCSI by the competent authority, while items (4)-(5) are applied by the registrant.

 

4.8 Review Fee for New Chemical Substance Registration

Registration Type	The Review Fee for Registration Information (NTD)	The Extension of Registration Information
Standard Registration	50,000 *	2000
Simplified Registration	20,000	1000
Small Quantity Registration	2000	1000
PLC Review	1000	---
Confidentiality of information	12,500 /item
Confidentiality of information extension	10,000 /item

Note:

(1) If the registrant belongs to an academic institution or a small or medium-sized enterprise, the standard registration, simplified registration, and small quantity registration are charged at 75% of the review fee.

(2) For standard registration, if data on skin irritation/corrosion or eye irritation is submitted in the form of in vitro tests, QSAR reports, or read-across data, the review fee is 37,000 NTD.

(3) Items eligible for confidentiality include registrant information, chemical identification information, production or importation information and application information.

(4) Reference: Fee-charging Standards for Toxic and Concerned Chemical Substances Control Act (2021).

 

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:

1. The number in parentheses indicates the maximum number of testing items that must be submitted.
2. 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.

 

VI. Annual Declaration

According to Article 24 of the Regulations of New and Existing Chemical Substances Registration, for new and existing chemical substances with registration approval, the registrant shall declare the quantity of substances manufactured and imported in the previous year from Apr 1 to Sep 30.

Two methods can be adopted to submit the annual declaration for new and existing chemicals: the registrant can choose to submit by themselves or they can designate an agent (if any) to submit. If competent authority find that the annual declaration data is incomplete after review, they will notify the registrant to make corrections within a specified period. If the registrant fails to make corrections within the specified period or if the corrections still do not meet the requirements, the competent authority will impose penalties on the registrant in accordance with the TCCSCA.

Data requirements for annual declaration:

Item	Details
1. Registrant and registration code	1.1 Information on Registrant 1.2 Approval registration code
2. Quantity of chemicals manufactured/imported	2.1 Quantity of chemicals manufactured last year 2.2 Quantity of chemicals imported last year