When exporting chemical products to Taiwan, companies need to determine the applicable regulatory requirements based on factors such as the chemical substances contained in the product, their concentrations, import volumes, and intended uses.
One of Taiwan’s key laws governing such substances is the Toxic and Concerned Chemical Substances Control Act (TCCSCA), known in Chinese as the 毒性及關注化學物質管理法.
Under the TCCSCA, chemical substances that may pose risks to human health or the environment can be designated as either Toxic Chemical Substances or Concerned Chemical Substances. Their manufacture, import, sale, use, storage, and other operations are subject to regulatory controls.
Depending on the substance and operating conditions, businesses may be required to obtain permits, registrations, or approvals, as well as comply with requirements relating to Safety Data Sheets (SDS), labeling, operational records, accident prevention, and emergency response.
For companies exporting chemicals from Japan to Taiwan, the key is to take a systematic approach: starting with product and composition information, determining whether regulated substances are present, identifying the procedures required of the Taiwanese importer, and confirming post-import management obligations.
This article provides a practical overview of Taiwan’s regulatory framework as of 2026, including the distinction between Toxic Chemical Substances and Concerned Chemical Substances, how regulated substances are identified, the permit and approval system, the relationship with Taiwan’s chemical substance registration framework, and key considerations for import operations.
1. What Is Taiwan’s Toxic and Concerned Chemical Substances Control Act?
The Toxic and Concerned Chemical Substances Control Act is one of Taiwan’s principal laws for preventing environmental pollution caused by chemical substances and protecting human health.
Taiwan expanded its previous regulatory framework for toxic chemical substances, and the category of “Concerned Chemical Substances” was introduced through legislative amendments in 2019.
This framework allows Taiwan to regulate not only substances designated on the basis of toxicity and environmental effects, but also substances considered to require management in light of their characteristics and broader concerns.
Under the Act, regulated “operations” may include manufacturing, importing, exporting, selling, transporting, using, storing, and disposing of chemical substances.
Taiwan’s regulatory framework therefore covers the chemical lifecycle from import and distribution through use, storage, transportation, and disposal.
2. Toxic Chemical Substances and Concerned Chemical Substances
The TCCSCA broadly distinguishes regulated substances into two categories: Toxic Chemical Substances and Concerned Chemical Substances.
| Item | Toxic Chemical Substances | Concerned Chemical Substances |
|---|---|---|
| Chinese term | 毒性化學物質 | 關注化學物質 |
| Basis for designation | Toxicity, environmental effects, and related characteristics | Substance characteristics and broader concerns |
| Classification | Categories 1–4 | Substance-specific designation |
| Main controls | Permits, registration, approval, etc. | Approval and other controls based on individual designation requirements |
Toxic Chemical Substances
Toxic Chemical Substances are substances designated by Taiwan’s central competent authority based on toxicological, environmental, and other characteristics specified under the Act. They are classified into Categories 1 through 4 according to their characteristics.
Concerned Chemical Substances
Concerned Chemical Substances are substances considered to require regulatory management in order to prevent environmental pollution or adverse effects on human health, taking into account their characteristics and other relevant concerns.
For these substances, control concentrations, regulated operations, quantity thresholds, and other management conditions may be established through substance-specific announcements.
In practice, companies should check both the regulatory classification of the substance and the specific management conditions established for that substance.
3. The Four Categories of Toxic Chemical Substances
Taiwan classifies Toxic Chemical Substances into four categories according to their characteristics.
| Category | Typical Characteristics | Management Focus |
|---|---|---|
| Category 1 | Persistence, bioaccumulation, etc. | Environmental persistence and accumulation |
| Category 2 | Carcinogenicity, reproductive toxicity, etc. | Long-term health effects |
| Category 3 | Acute toxicity | Acute effects resulting from exposure |
| Category 4 | Endocrine-disrupting effects and other concerns | Other environmental or health effects |
Category 1 generally covers substances that are difficult to degrade in the environment or may bioaccumulate or bioconcentrate and thereby affect human health or the environment.
Category 2 covers substances associated with chronic health effects such as carcinogenicity, reproductive toxicity, teratogenicity, or genetic effects.
Category 3 covers substances capable of causing acute adverse effects on human health or living organisms following exposure.
Category 4 covers substances with characteristics such as endocrine-disrupting effects or other environmental and health concerns.
A substance may fall within more than one category. In practice, companies should identify substances using information such as CAS Registry Numbers and confirm their current designation under the latest information published by Taiwan’s competent authorities.
4. How to Determine Whether a Substance Is Regulated
Taiwan’s Ministry of Environment designates Toxic Chemical Substances and Concerned Chemical Substances and establishes applicable management conditions.
The following information should generally be organized when determining regulatory status:
- Substance name and CAS Registry Number
- Concentration in the product
- Intended use
- Quantity handled in Taiwan
- Type of operation, such as import, manufacture, use, or storage
For mixtures in particular, the regulatory status of each constituent should be reviewed.
A regulated substance may be assigned a control concentration (管制濃度). The actual concentration of that substance in the product should therefore be compared with the applicable control concentration when determining the regulatory requirements.
Because regulated substance lists and management conditions may be updated, companies should check both the latest designation list and the specific conditions applicable to each substance.
5. Key Considerations When Exporting Chemicals to Taiwan
1. Product and Composition Information
For a single substance, confirm the substance name and CAS Registry Number. For mixtures, organize information on each constituent, including its name, CAS Registry Number, and concentration.
2. Regulatory Status
Determine whether each constituent is designated as a Toxic Chemical Substance or Concerned Chemical Substance. Where a regulated substance is identified, check its category, control concentration, and regulated operations.
3. Import Volume and Intended Use
Confirm the quantity to be imported, used, and stored in Taiwan, together with the intended use. These are key inputs for determining the applicable authorization and management requirements.
4. Taiwanese Importer
Identify the entity that will import, use, store, or otherwise handle the chemical in Taiwan and determine the procedures applicable to each activity.
5. Import and Customs Requirements
Check the applicable tariff classification and import regulations, together with the documentation and customs procedures required for importation.
Organizing product and composition information on the exporter side and confirming import and operational requirements on the Taiwan side helps clarify the necessary procedures and allocation of responsibilities.
6. Permit, Registration, and Approval Framework
The TCCSCA establishes permit, registration, and approval mechanisms according to factors such as the classification of the regulated substance, the type of operation, and the quantity handled.
| Substance | Typical Operation / Condition | General Procedure |
|---|---|---|
| Category 1–3 Toxic Chemical Substances | Manufacture, import, sale | Permit |
| Category 1–3 Toxic Chemical Substances | Use, storage | Registration |
| Category 1–3 Toxic Chemical Substances | Operations below specified quantity thresholds | Approval |
| Category 4 Toxic Chemical Substances | Specified operations | Approval |
| Concerned Chemical Substances | Operations specified in the relevant designation | Approval and other applicable controls |
* Applicable procedures vary depending on the individual substance, designated operations, quantity, use, and other regulatory conditions.
For Category 1–3 Toxic Chemical Substances, manufacture, import, and sale are generally managed through permits, while use and storage are managed through registration.
Where the quantity handled falls below specified thresholds, an approval-based mechanism may apply.
Category 4 Toxic Chemical Substances and Concerned Chemical Substances are also subject to procedures based on the applicable operations and substance-specific requirements.
These procedures are generally undertaken by the entity handling the regulated substance in Taiwan. Japanese exporters therefore play an important role in providing the information needed by the Taiwanese operator, including composition data, CAS Registry Numbers, concentrations, SDS information, and intended use.
7. Control Concentrations and Graded Handling Quantities
In Taiwan’s regulatory framework, both concentration and the quantity handled are important factors in addition to the designation of the substance itself.
Control Concentration (管制濃度)
The control concentration is a concentration threshold used in determining the regulatory management of a designated substance.
For mixtures, the concentration of the designated substance in the product should be compared with the applicable control concentration.
Graded Handling Quantity (分級運作量)
Graded handling quantities are quantity thresholds used to determine the level of management applicable to the handling of a regulated substance.
For Category 1–3 Toxic Chemical Substances, the applicable permit, registration, approval, or other management requirements may vary depending on the quantity handled. Quantity thresholds may also be established for individual Concerned Chemical Substances.
What is in the product? — Substance / CAS Registry Number
↓
How much is in the product? — Concentration
↓
How much will be handled? — Import / use / storage quantity
8. SDS, Labeling, Operational Records, and Emergency Response
For regulated Toxic Chemical Substances and Concerned Chemical Substances, compliance continues beyond the initial authorization process and extends to ongoing management in Taiwan.
SDS and Labeling
Depending on the substance and applicable conditions, requirements may apply to labeling of containers, packaging, and handling locations, as well as the preparation and maintenance of Safety Data Sheets.
Operational Records and Reporting
Businesses may be required to prepare, retain, and report records relating to manufacture, import, sale, use, storage, and other regulated operations.
Storage and Transportation
Management requirements for storage locations and transportation may apply depending on the characteristics of the substance and the quantity handled.
Accident Prevention and Emergency Response
For certain substances and quantities, operators may be required to establish accident prevention and emergency response plans, equipment, and management systems.
For Taiwanese importers and users, it is therefore important to plan the process from importation through use, storage, and transportation as an integrated compliance workflow.
9. Relationship with Taiwan’s Chemical Substance Registration System
Taiwan also operates registration systems for new and existing chemical substances alongside the TCCSCA framework for managing designated substances.
The chemical substance registration framework is designed to collect and evaluate information on chemical substances. The TCCSCA, meanwhile, regulates operations involving designated Toxic Chemical Substances and Concerned Chemical Substances, including import, use, and storage.
| Item | Chemical Substance Registration | Toxic / Concerned Chemical Substance Management |
|---|---|---|
| Primary purpose | Collection and evaluation of chemical information | Risk management of designated substances |
| Primary scope | New and existing chemicals subject to registration | Designated Toxic and Concerned Chemical Substances |
| Key factors | Substance status, quantity, registration conditions | Classification, concentration, quantity, type of operation |
| Main procedure | Chemical substance registration | Permit, registration, approval, etc. |
Taiwan’s Regulations of New and Existing Chemical Substances Registration establish the scope and conditions of the environmental chemical registration system.
Taiwan also has a new chemical substance registration framework administered by the Ministry of Labor.
For chemicals destined for Taiwan, companies should first determine the regulatory status of the substance and then map the applicable chemical registration requirements together with the operational controls under the TCCSCA.
10. Import and Customs Considerations
For chemical products exported to Taiwan, customs requirements should be reviewed alongside the applicable chemical regulatory requirements.
Taiwan uses import regulation code “553” and export regulation code “533” in connection with the import and export management of Toxic Chemical Substances and Concerned Chemical Substances.
Depending on the tariff classification and regulatory status of the substance, the Taiwanese importer may need to complete relevant verification procedures and provide specified documentation.
Substance identity, CAS Registry Number, concentration, quantity, intended use, type of operation, permits and approvals
Customs review
Tariff classification, import regulations, required documentation, and importer-side procedures
Reviewing these elements in parallel helps connect customs clearance with the subsequent handling of the chemical product in Taiwan.
11. Practical Compliance Flow Before Exporting to Taiwan
For companies planning to export chemical products to Taiwan, the following sequence provides a practical way to organize the regulatory review.
STEP 1 — Organize product and composition information
Confirm the product name, intended use, substance names, CAS Registry Numbers, concentrations, and other relevant information.
STEP 2 — Determine whether regulated substances are present
Check whether any constituent is designated as a Toxic Chemical Substance or Concerned Chemical Substance.
STEP 3 — Check control concentrations
Compare the concentration of the regulated substance in the product with the applicable control concentration.
STEP 4 — Confirm quantities, intended use, and operations
Organize information on import volume, use quantity, storage quantity, intended use, and the operations to be conducted in Taiwan.
STEP 5 — Determine applicable authorization requirements
Confirm the permits, registrations, approvals, or other procedures required for the Taiwanese importer or operator.
STEP 6 — Review the relationship with chemical substance registration
Determine the applicable registration framework based on the regulatory status of the substance.
STEP 7 — Confirm import and customs requirements
Review tariff classification, import regulation codes, and required documentation.
STEP 8 — Confirm post-import management requirements
Review applicable SDS, labeling, recordkeeping, use, storage, transportation, and emergency response requirements.
Following this sequence helps both the Japanese exporter and Taiwanese importer understand their respective responsibilities and coordinate the information and procedures required for compliance.
Under Taiwan’s chemical regulatory framework, it is important to begin with product and composition information and review the regulatory status of the substances, control concentrations, quantities handled, authorization requirements, and post-import management as one connected process.
For chemical products in particular, organizing information such as CAS Registry Numbers, component concentrations, SDS information, and intended uses — and sharing it with the Taiwanese importer — can make it easier to determine the procedures required.
The same structured product information can also support chemical compliance in other markets, including the EU, China, and South Korea.
Rather than treating regulatory compliance as a separate procedure for each export market, companies can use well-structured product information as a foundation for broader global market development.
TICnology Japan supports companies in structuring the appropriate compliance approach and identifying suitable service providers for regulatory research, testing, and application support according to the requirements of each project.
TICnology Japan helps companies structure regulatory requirements and develop an appropriate compliance approach for their products and target markets.
Contact TICnology JapanReferences
- Taiwan Laws & Regulations Database — Toxic and Concerned Chemical Substances Control Act
- Taiwan Ministry of Environment — Regulations Governing Permits, Registration and Approval for Toxic and Concerned Chemical Substances
- Taiwan Chemicals Administration, Ministry of Environment — Information on Toxic Chemical Substances
- Taiwan Chemicals Administration, Ministry of Environment — Information on Concerned Chemical Substances
- Taiwan Chemicals Administration, Ministry of Environment — Designated Toxic and Concerned Chemical Substances
- Taiwan Ministry of Environment — Regulations of New and Existing Chemical Substances Registration
- Taiwan Chemicals Administration, Ministry of Environment — Import / Export Regulations “553” and “533”
Information current as of October 15, 2026.
Disclaimer: This article is provided for general informational purposes only and does not constitute legal advice for any specific case. Companies should confirm the latest laws, regulations, official designations, and transaction-specific requirements before taking compliance action.
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