Background Overview
Controlled Chemicals in Taiwan are regulated by “Regulations Governing Designation and Handling Permission of Controlled Chemicals” under the “Occupational Safety and Health Act (OSHA)”, which officially came into effect on December 31, 2014. These regulations aim to harmonize with international chemical conventions, authorizing the Competent Authority to prohibit or restrict the use of specific health-hazardous chemicals or require prior declaration and approval.
This initiative draws on advanced practices from countries and regions such as Japan, South Korea, Australia, and the European Union, implementing list-based regulatory management for Substances of Very High Concern (SVHC) that are carcinogenic, highly toxic, or persistent pollutants with high exposure risks.
According to the "Regulations Governing Designation and Handling Permission of Controlled Chemicals," manufacturers, importers, suppliers, or employers are prohibited from manufacturing, importing, supplying, or permitting workers to handle or use Controlled Chemicals without permission.
Read on to learn which substances are regulated, who must comply, and what steps are needed to secure and keep your permit in Taiwan.
Scope of Application under Regulations Governing Designation and Handling Permission of Controlled Chemicals
The term "handler" under the "Regulations Governing Designation and Handling Permission of Controlled Chemicals" refers to manufacturers, importers, suppliers, or employers handling Controlled Chemicals.
Manufacturer: Enterprises/units that manufacture Controlled Chemicals for wholesale, retail, handling, or use.
Importer: Enterprises/units that import Controlled Chemicals.
Supplier: Enterprises/units engaged in the wholesale or retail of Controlled Chemicals.
Employer: Business owners or business operators who permit workers to engage in the operation, including storage, of Controlled Chemicals.
The term "Regulations Governing Designation and Handling Permission of Controlled Chemicals" refers to the manufacturing, importing, supplying, or permitting workers to handle or use Controlled Chemicals.
Applicable Substances
| List Name | Examples | |
CAS.No | Name | |
Yellow Phosphorus Matches | - | Yellow phosphorus match |
Benzidine and its salts | 92-87-5 | Benzidine |
4-Aminodiphenyl and its salts | 92-67-1 | 4-Aminodiphenyl |
4-Nitrodiphenyl and its salts | 92-93-3 | 4-Nitrodiphenyl |
β-Naphthylamine and its salts | 91-59-8 | β-Naphthylamine |
bis-Chloromethyl ether | 542-88-1 | bis-Chloromethyl ether |
Chloromethyl methyl ether | 107-30-2 | Chloromethyl methyl ether |
Crocidolite | 12001-28-4 | Crocidolite |
Amosite | 12172-73-5 | Amosite |
Methyl mercury compounds | 22967-92-6 | Methyl mercury |
Pentachlorophenol and its sodium salts | 87-86-5 | Pentachlorophenol |
3,3'-Dichlorobenzidine and its salts | 91-94-1 | 3,3'-Dichlorobenzidine |
612-83-9 | 3,3'-Dichlorobenzidine dihydrochloride | |
α-Naphthylamine and its salts | 134-32-7 | α-Naphthylamine |
3,3'-Dimethyl-[1,1'-biphenyl]-4,4'-diamine and its salts | 119-93-7 | 3,3'-Dimethyl-[1,1'-biphenyl]-4,4'-diamine |
612-82-8 | o-Tolidine dihydrochloride | |
3,3'-Dimethoxybenzidine and its salts | 119-90-4 | 3,3'-Dimethoxybenzidine |
20325-40-0 | 3,3'-Dimethoxybenzidine dihydrochloride | |
Beryllium and its compounds | 7440-41-7 | Beryllium |
7787-56-6 | Sulfuric acid, beryllium salt (1:1), tetrahydrate | |
Benzotrichloride | 98-07-7 | Benzotrichloride |
Glue that contains benzene | - | Glue that contains benzene |
Non-applicable Substances
| Exempted Chemical Substances | |||
Hazardous industrial waste | Tobacco or tobacco products | Food, beverages, drugs, cosmetics | Manufactured articles |
General domestic consumer products are not for industrial uses | Fire extinguishers | Intermediate products undergoing chemical reactions in reactors or processes | Others designated by the central competent authority |
Permission Requirements and Procedures
According to Article 7 of the " Regulations Governing Designation and Handling Permission of Controlled Chemicals," handler applying for handling permission of the Controlled Chemicals must submit and upload permit application documents to the website designated by the Authority. Fees must be paid as per the announced fee standards.
If the required documents are not submitted or fees are not paid as stipulated, the Authority will not accept the application and will return it, as per Article 10 of the regulations.
Complete submissions, including payment, will proceed to the review process, and the authority shall notify the applicant of the permission result within 30 working days upon acceptance of the application; if necessary, the review process shall be extended for 30 working days. If additional documents are required after acceptance, review, or on-site inspection, the applicant will be notified to rectify the deficiencies within a specified period. Failure to comply will result in the rejection and return of the application.
A handler who has obtained the permit must annually update actual operation data between April and September, as stipulated in Article 14 of the regulations.
Note 1: Handlers with two or more operation sites in different locations must apply for separate permits for each site. If a head office exists, it may consolidate operator information and submit applications for each site through the designated website.
Note 2: After obtaining the permit,the relevant application documents and attached files must be retained for at least five years. Handler must cooperate with on-site inspections conducted by the Authority or Labor Inspection Agency and provide relevant documents as proof. During the permit validity period, any changes or modifications to the permit must be reported to the Authority through a change application or reapplication.
Permit Application Deadlines
For substances already designated as Controlled Chemicals, a permit must be obtained before handling. For substances newly designated as Controlled Chemicals, the handler must obtain a permit within 1 year of the effective date of the designated announcement. Those who fail to obtain a permit within the specified time limit are not allowed to handle Controlled Chemicals.
Regulatory Penalty Measures
Under Article 44, Paragraph 2 of the "Occupational Safety and Health Act," manufacturers, importers, suppliers, or employers who manufacture, import, supply, or permit workers to handle or use designated Controlled Chemical without a permit are liable to fines between NT$200,000 and NT$2,000,000. They will also be ordered to cease manufacturing, importing, or supplying within a specified period. Failure to comply will result in repeated penalties. Non-compliant substances may be confiscated, destroyed, or subjected to other necessary actions, with the costs borne by the operator.
The Competent Authority and Labor Inspection Agency will conduct inspections of the handler's operations and management. If any of the following violations occur, the handler will be ordered to correct them within a specified period. Non-compliance or serious violations may result in the revocation or termination of the permit, and handling may be partially or fully suspended:
Failure to update actual operation data, retain permit documents and related application materials, establish worker exposure records, or apply for changes as required.
Handling is inconsistent with the permit document.
Evasion, obstruction, or refusal of inspections by the Competent Authority or Labor Inspection Agency.
Our Services
With professional regulatory interpretation and extensive practical experience, REACH24H is dedicated to providing your business with one-stop compliance solutions for controlled chemical substances in Taiwan, ensuring full regulatory compliance:
Compliance Consulting and Applicability Assessment: Accurately assess whether your substances fall within the regulated scope, avoiding misjudgment or omission.
Full-service Permit Application: From document preparation and system login to communication with the Competent Authority, we provide professional end-to-end support.
Annual Reporting and Change Management: Assist businesses in completing annual periodic reporting and permit modification applications.
If you have any questions about Taiwan's controlled chemicals operation permit, please feel free to contact us at customer@reach24h.com.
