Currently, there are over 300 chemicals in the List of Toxic Chemical Substances which is published by the Environmental Protection Administration of Taiwan Executive Yuan in accordance with the Toxic and Concerned Chemical Substances Control Act (TCCSCA). Chemicals on the List are classified into 4 classes based on their toxicological characteristics, namely, Class 1 toxic chemical substances (substances that are not prone to decompose), Class 2 toxic chemical substances (substances that have chronic toxicity), Class 3 toxic chemical substances (substances that have acute toxicity), and Class 4 toxic chemical substances. This List can improve the management of toxic chemical substances, strengthen hazard assessment and prevention measures to prevent disasters from toxic chemicals.
► In accordance with the TCCSCA, all chemicals in the List of Toxic Chemical Substances are subject to management requirements in the following:
1. Permit and registration: A manufacturer, importer or seller of Class 1, 2 or 3 toxic chemical substances shall apply for a permit, and shall operate in compliance with the content of the permit when the amount of chemical substances reaches the graded handling quantity. An enterprise using, storing or disposing Class 1, 2 or 3 toxic chemical substances shall apply for registration with necessary registration documents. When the total quantity of Class 1, 2 or 3 toxic chemical substances is less than the graded handling quantity, enterprises manufacturing, importing, selling, using, storing or disposing these chemicals shall report for permit. Importers of Class 1, 2 or 3 toxic chemical substances shall apply for import registration. Prior to handling Class 4 toxic chemical substances, toxicity and relevant information of these toxic chemicals shall be reported for permit.
2. Report: Operators of toxic chemical substances shall produce and regularly report records concerning the handling of toxic chemical substances and their release quantities, such records shall be preserved properly for future reference. Records concerning the handling of toxic chemical substances shall be made monthly before the 10th of the following month. If the total amount of toxic chemical substances for manufacture, usage, and storage uses reaches 300 metric tons, or if the daily amount reaches 10 metric tons, records of release amount shall be made before January 31 every year.
3. Prevention and labeling: The handler shall mark toxicity and pollution control items in compliance with regulations on chemical substance containers, packaging, and handling premises and facilities, and shall keep safety data sheets for toxic chemical substances on hand. An enterprise manufacturing, using, storing or transporting Class 1, Class 2, and Class 3 toxic chemical substances shall employ professional technical management personnel.
4. Notification: when an accident occurs, operators are responsible to report it to the local competent authority within a limited time period and dispatch professional emergency response personal to the site of the accident.
► Chemical substances not included in the List are not subject to relevant management requirements.
Regulations and standards
► Toxic and Concerned Chemical Substances Control Act (Jan 16,2019)
► Toxic and Concerned Chemical Substances Control Act Enforcement Rules（Sep 3,2019）
► Permit Registration and Approval Regulations for Toxic and Concerned Chemical Substances（Jan 15,2020）
► Regulations for the Management of Records on the Operation and Release Amounts of Toxic and Concerned Chemical Substances (Dec 25, 2019)
► Regulations for the Appointment and Management of Professional Technical Management Personnel for Toxic and Concerned Chemical Substances (Dec 25, 2019)
► Regulations for the Labeling and Safety Data Sheets for Toxic and Concerned Chemical Substances（Nov 4,2022）
► Regulations on the Management of Emergency Responders of the Toxic and Concerned Chemical Substances（Nov 3,2020）
► Categories and Management of Handling for Toxic Chemical Substance（Feb 20,2020）
Regulatory authorities
► Environmental Protection Administration of the Executive Yuan in Taiwan
► Toxic and Chemical Substances Bureau of Environmental Protection Administration, Executive Yuan in Taiwan
Exemptions
- Substances or articles regulated by the following laws or regulations: Agro-pesticides Management Act, Fertilizer Management Act, Feed Control Act, Veterinary Drugs Control Act, Pharmaceutical Affairs Act, Medical Devices Act, Controlled Drugs Act, Cosmetics Hygiene and Safety Act, Act Governing Food Safety and Sanitation, Tobacco Hazards Prevention Act, Industrial Explosives Administrative Act, Petroleum Administration Act, Natural Gas Enterprise Act, Atomic Energy Law, Ionizing Radiation Protection Act, Air Pollution Control Act, Environmental Agents Control Act, Waste Disposal Act, and Commodity Inspection Act.
- Finished products containing regulated chromium compounds, which presents the appearance of cementing agent or lacteous state due to the addition of a binder;
- Lindane for pharmaceutical manufacture and captan for agricultural pesticide manufacture;
- Products containing mercury, such as fluorescent lamps, high-pressure mercury lamps, switches and relays, thermometers, pressure gauges, barometers, hygrometers, blood pressure meter, hydrometer, and so on;
- Products such as television kinescope containing cadmium, electrodes for cadmium vapor lamps, plates for cadmium batteries, rectifiers, semiconductors and other finished products;
- Phthalates, nonylphenol, nonylphenol polyethoxylated alcohol, and bisphenol A used as additives, and do not pose environmental hazards under normal conditions of use after curing;
- Fragrances and other finished products containing less than 50% of diethyl phthalate
How to obtain the list?
- Click here to search for the latest inventory
- Search on the official website:
https://flora2.epa.gov.tw/ToxicC/Query/database.aspx - Contact CIRS Group to purchase the latest version (in Excel)
Our services
- Consulting and training services
- New Chemical Substance Search
- Data assessment and data gap analysis (including testing data assessment)
- Commissioned testing service
- Existing substance pre-registration and late pre-registration
- Existing substance standard registration
- New substance registration (in compliance with both TCSCA and OSHA): standard registration, simplified registration and its extension, small quantity registration and its extension, Pre-listing consultation, etc.
- Chemical safety report (CSR) compilation
- Preparation of SDS and label in compliance with Taiwan GHS
If you have any questions, please contact us at chemicals@cirs-group.com.
