Companies exporting chemical substances or chemical products to Taiwan should first determine how the substances are identified, registered and managed under Taiwan’s chemical regulatory framework.
Taiwan operates a chemical registration system under the Regulations of New and Existing Chemical Substances Registration. The system requires manufacturers and importers to provide information on chemical identity, manufacture or import volume, use, hazards and other relevant data, depending on the applicable registration category.
For registration purposes, chemical substances are broadly classified as new chemical substances or existing chemical substances.
New chemical substances are generally subject to Small Quantity Registration, Simplified Registration or Standard Registration according to annual manufacture or import volume and other applicable conditions. Existing chemical substances manufactured or imported at 100 kg or more per year are subject to Phase 1 Registration, while designated substances may also be subject to Standard Registration.
For overseas manufacturers and exporters, a practical approach is to review the requirements in the following order:
Substance identification → New or existing status → Intended use → Annual import volume → Registration category → Required information → Roles of the Taiwan importer and overseas supplier
This article provides a practical overview of Taiwan’s new and existing chemical substance registration system and the key points companies should consider before exporting chemicals to Taiwan in 2026.
1. What Is Taiwan’s New and Existing Chemical Substance Registration System?
Taiwan’s chemical registration system is designed to collect information on chemical substances manufactured in or imported into Taiwan and to support the management and evaluation of chemical risks.
The principal regulation governing the system is the Regulations of New and Existing Chemical Substances Registration, administered by Taiwan’s Ministry of Environment (MOENV).
The Regulations were established pursuant to Article 30 of the Toxic and Concerned Chemical Substances Control Act (TCCSCA).
In practice, the first step is to identify the substance and determine whether it is classified as a new chemical substance or an existing chemical substance in Taiwan.
The applicable registration category and information requirements are then determined by factors including annual manufacture or import volume, intended use and the characteristics of the substance.
2. New Chemical Substances and Existing Chemical Substances
A key step in Taiwan chemical registration is determining whether a substance is new or existing.
This generally involves checking whether the substance is listed in Taiwan’s existing chemical substance inventory.
| Category | General Approach | Main Registration Types |
|---|---|---|
| New Chemical Substance | A substance that is not listed in Taiwan’s existing chemical substance inventory | Small Quantity, Simplified or Standard Registration |
| Existing Chemical Substance | A substance listed in Taiwan’s existing chemical substance inventory | Phase 1 Registration and Standard Registration |
Companies should identify the substance using information such as the chemical name, CAS Registry Number and other substance identification data, and then confirm its status in Taiwan.
New chemical substances that have been registered may also be added to the existing chemical substance inventory when the conditions specified under the Regulations are met.
3. Identifying the Substances Subject to Registration
In addition to determining whether a substance is new or existing, companies should identify which substances within a product require registration review.
This is particularly important for mixtures and formulated chemical products.
Under Taiwan’s registration framework, mixtures themselves are excluded from registration under the Regulations, while the individual chemical substances contained in a mixture should be assessed separately for registration purposes.
For products such as adhesives, coatings, inks and cleaning agents, a practical review can follow this sequence:
Products and substances regulated under specific legislation, including pesticides, fertilizers, pharmaceuticals, cosmetics, food and food additives, should also be reviewed in relation to the applicable sector-specific regulatory framework.
4. Three Registration Types for New Chemical Substances
For general new chemical substances, the registration type is primarily determined by the estimated annual volume manufactured in or imported into Taiwan.
| Estimated Annual Volume | Registration Type |
|---|---|
| Less than 100 kg | Small Quantity Registration |
| 100 kg or more but less than 1 tonne | Simplified Registration |
| 1 tonne or more | Standard Registration |
The amount and scope of information required generally increase from Small Quantity Registration to Simplified Registration and Standard Registration.
Specific registration provisions also apply to new chemical substances intended for scientific research and development, product and process research and development, on-site isolated intermediates, polymers and pre-verified polymers of low concern.
For a new chemical substance, the registration pathway should be determined by considering annual volume + intended use + substance characteristics.
5. What About Samples and Evaluation Materials?
When a small quantity of a chemical substance is shipped to Taiwan for testing or evaluation, companies should still confirm the substance identity, new or existing status, intended use and annual import volume.
For new chemical substances, specific registration provisions apply to scientific research and development and product and process research and development, depending on the intended use, substance characteristics and volume.
For existing chemical substances, Phase 1 Registration applies when the annual manufacture or import volume reaches 100 kg or more.
For sample shipments, the practical assessment should focus on the substance, its intended use and annual volume, rather than relying solely on descriptions such as “sample,” “free of charge” or “small quantity.”
6. How Do Information Requirements Differ by Registration Type?
The scope of information required for new chemical substances varies according to the applicable registration type.
Small Quantity Registration
The required information focuses primarily on basic substance and registrant information and other items specified for this registration type.
Simplified Registration
A broader range of information is required, including additional information relating to the substance and its properties.
Standard Registration
Standard Registration covers a wider range of information, including substance information, physicochemical properties, toxicological and ecotoxicological information, and hazard and exposure assessment information according to the applicable requirements.
Standard Registration also uses annual volume bands, making it important to identify the applicable tonnage level before determining the required data package.
7. Phase 1 Registration of Existing Chemical Substances
For existing chemical substances, 100 kg per year is an important threshold.
When an existing chemical substance is manufactured in or imported into Taiwan at an annual volume of 100 kg or more, the registrant must apply for Phase 1 Registration within six months from the date on which the threshold is reached.
Once the application is approved, the competent authority issues a Phase 1 registration number. Existing chemical substances below 100 kg per year may also be registered voluntarily.
For overseas suppliers, it is therefore important to coordinate with the Taiwan importer and confirm both the expected annual volume and the registration status of the substance.
8. Standard Registration of Existing Chemical Substances
In addition to Phase 1 Registration, Taiwan also provides for Standard Registration of designated existing chemical substances.
Based on the implementation of Phase 1 Registration, the competent authority may designate existing chemical substances subject to Standard Registration and specify the applicable quantity thresholds and registration deadlines.
For designated substances, the required information may include substance information, physicochemical properties, toxicological and ecotoxicological information, and hazard and exposure assessment information according to the applicable requirements.
Phase 1 Registration
↓
Check whether Standard Registration applies
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Prepare and submit the required information
9. Who Is the Registrant?
For chemicals supplied from overseas to Taiwan, it is important to establish who will act as the registrant in Taiwan.
Under Taiwan’s system, manufacturers and importers subject to the registration requirements act as registrants. A registrant may also appoint an eligible representative in Taiwan to process applications and reporting matters in accordance with the Regulations.
The overseas manufacturer or supplier will typically need to organize and provide relevant information such as:
- Chemical substance name
- CAS Registry Number
- Composition and concentration
- Expected annual export/import volume
- Intended use
- Safety Data Sheet (SDS)
- Relevant physicochemical, toxicological and ecotoxicological information, where required
Early coordination between the overseas supplier holding the technical information and the Taiwan entity responsible for registration can help establish a clear and efficient registration process.
10. Protection of Business Secrets
Chemical registration may involve commercially sensitive information, including substance identity, composition and technical data.
Taiwan’s registration system provides a mechanism for eligible registration information to be protected as business secrets, subject to the applicable requirements.
Information potentially covered includes registrant identification, chemical substance identification, manufacture or import information and use information.
Companies should therefore consider regulatory data requirements and the protection of confidential business information together when coordinating registration with importers and other parties in Taiwan.
11. Post-Registration Management
Chemical registration also involves ongoing management of manufacture or import volumes and registered information.
For approved registered new and existing chemical substances, registrants are required, starting from the year following registration approval, to report the previous year’s manufacture or import volume between April 1 and September 30 each year.
Additional information may also need to be submitted when new scientific evidence, new use information, new toxicological or ecotoxicological information, or new hazard or exposure assessment information becomes available.
12. Coordination Between the MOENV and MOL Systems
Taiwan’s chemical regulatory framework includes the chemical registration system administered by the Ministry of Environment (MOENV) as well as a new chemical substance registration framework administered by the Ministry of Labor (MOL) under occupational safety and health legislation.
Companies introducing new chemical substances into Taiwan should therefore review the applicable requirements under both regulatory frameworks and determine how they apply to the substance and transaction concerned.
13. Relationship with the TCCSCA
The Regulations of New and Existing Chemical Substances Registration are established pursuant to Article 30 of Taiwan’s Toxic and Concerned Chemical Substances Control Act (TCCSCA).
Chemicals that fall within other regulatory categories, including toxic and concerned chemical substances under the TCCSCA, should also be reviewed under the applicable management requirements.
For companies supplying chemicals to Taiwan, the overall regulatory review can therefore be structured as follows:
14. Practical Pre-Export Checklist for Companies Supplying Chemicals to Taiwan
STEP 1 — Organize Product and Composition Information
Compile the chemical name, CAS Registry Number, composition, concentration, SDS and intended use.
STEP 2 — Determine the Regulatory Treatment
Identify whether the material is treated as a chemical substance, mixture, article, polymer or another relevant category.
STEP 3 — Determine New or Existing Status
Check the substance against Taiwan’s existing chemical substance inventory.
STEP 4 — Confirm the Intended Use
Identify the intended use in Taiwan, including general use, scientific research and development, or product and process research and development where applicable.
STEP 5 — Confirm the Annual Import Volume
Determine the expected annual quantity imported into Taiwan.
STEP 6 — Identify the Registration Type
Determine the applicable registration pathway, such as Small Quantity, Simplified or Standard Registration for new chemical substances, or Phase 1 and Standard Registration for existing chemical substances.
STEP 7 — Identify the Required Information
Determine the substance information and technical data required for the applicable registration type.
STEP 8 — Define the Taiwan Registration Structure
Clarify the roles of the Taiwan importer, representative and overseas manufacturer or supplier.
STEP 9 — Review Related Regulatory Requirements
Consider the applicable MOENV and MOL requirements and other relevant chemical controls.
STEP 10 — Establish Post-Registration Management
Maintain annual volume records, reporting requirements and updates to registered information.
Completing these steps before shipment can help companies identify the applicable registration pathway, information requirements, responsibilities of the parties involved and the actions required before commercial supply begins.
Taiwan chemical registration begins with accurate substance identification, followed by confirmation of inventory status, intended use and annual import volume.
For formulated chemical products in particular, organizing information such as CAS Registry Numbers, composition, SDS, intended use and annual volume can help the Taiwan importer determine the appropriate registration pathway and data requirements efficiently.
Managing this information as a common chemical data foundation can also support regulatory compliance across multiple markets, including Taiwan, the EU, China and Korea.
Rather than managing each market as an isolated registration exercise, companies can use chemical substance information management as part of a broader global market-access strategy.
TICnology Japan supports companies by structuring regulatory requirements, identifying the information needed for Taiwan market access, and selecting appropriate specialist service providers for regulatory research, testing and registration support according to the needs of each project.
TICnology Japan can help structure the applicable regulatory requirements and identify an appropriate compliance approach for your project.
References
- Taiwan Ministry of Environment, “Regulations of New and Existing Chemical Substances Registration”
- Taiwan Ministry of Environment, Chemical Substances Administration, “Chemical Substances Registration – Registration Type”
- Taiwan Ministry of Environment, Chemical Substances Administration, “New Chemicals”
- Taiwan Ministry of Environment, Chemical Substances Administration, “Existing Chemicals”
- Taiwan Ministry of Environment, Chemical Substances Administration, “Annual Reporting”
- Taiwan Ministry of Labor, Occupational Safety and Health Administration, “Regulations Governing New Chemical Substances Registration”
Information current as of October 16, 2026.
This article provides general information on Taiwan’s chemical regulatory framework. Companies should review the latest laws, regulatory announcements, substance-specific requirements, intended uses, annual volumes and transaction-specific circumstances when planning registration or import activities.
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