In July 2023, the Ministry of Environment of Taiwan, China announced amendments to the Regulations on the Classification and Management of Toxic Chemical Substances. It came into effect on April 24, 2024. Under the United Nations Stockholm Convention on Persistent Organic Pollutants, the amendments added 147 types of Perfluorohexane sulfonic acid (PFHxS), its salts and PFHxS-related compounds to the List of Class 1 Toxic Chemical Substances and implemented controls over them.
On April 24, 2024, the MoE announced new compliance timelines and control requirements for PFHxS and its related compounds. The amendments includes adjusting the compliance timelines for PFHxS, its salts and PFHxS-related compounds, Perfluorooctane sulfonic acid (concentration below 0.01%), Perfluorooctane sulfonyl fluoride (concentration below 0.01%), Lithium perfluorooctane sulfonate (concentration below 0.01%), Perfluorooctanoic acid (concentration below 0.01%)under various obligations. Additionally, new exemptions for substances or mixtures containing Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) were introduced.
★ Compliance timelines for PFHxS, its salts and PFHxS-related compounds, Perfluorooctane sulfonic acid (concentration below 0.01%), Perfluorooctane sulfonyl fluoride (concentration below 0.01%), Lithium perfluorooctane sulfonate (concentration below 0.01%), Perfluorooctanoic acid (concentration below 0.01%) (amended)
From April 24, 2024, operation and release records must be kept and regularly notified.
| Original Timeline Published in July 2023 | Amended Timeline on April 24, 2024 |
| Submit the hazard prevention and response plan by November 1, 2024. | Submit the hazard prevention and response plan by May 1, 2025. |
| Complete the labeling of containers, packaging, operational sites and facilities, and prepare safety data sheets by November 1, 2024. | Complete the labeling of containers, packaging, operational sites and facilities, and prepare safety data sheets by May 1, 2025. |
| Prepare emergency response tools and equipment by November 1, 2024. | Prepare emergency response tools and equipment by May 1, 2025. |
| Submit the setup and operation plan for response equipment, detection, and alarm devices by February 1, 2025. | Submit the setup and operation plan for response equipment, detection, and alarm devices by August 1, 2025. |
| Submit the plan for establishing a Civil Defense Organization by February 1, 2025. | Submit the plan for establishing a Civil Defense Organization by August 1, 2025. |
| Appoint technical professionals by May 1, 2025. | Appoint technical professionals by November 1, 2025. |
| Obtain permits, registration documents, or approval documents by May 1, 2025. | Obtain permits, registration documents, or approval documents by November 1, 2025. |
| Transport toxic chemical substances by May 1, 2025. | Transport toxic chemical substances by November 1, 2025. |
| Install detection and alarm devices by May 1, 2025. | Install detection and alarm devices by November 1, 2025. |
| Implement the approved hazard prevention and response plan by May 1, 2025. |
Implement the approved hazard prevention and response plan by November 1, 2025. |
| Complete the training and registration of professional emergency response personnel by May 1, 2025. |
Complete the training and registration of professional emergency response personnel by November 1, 2025. |
The extension of the compliance timelines provide operators with a longer buffer period.
★ Exemptions for substances or mixtures containing PFAS (Addition)
Substances or mixtures containing PFAS are not regulated if their concentration meets the following conditions and they are not intentionally added:
- The total concentration of Perfluorooctane sulfonic acid, Perfluorooctane sulfonyl fluoride, Lithium perfluorooctane sulfonate does not exceed 10 mg/kg.
- The concentration of Perfluorooctanoic acid does not exceed 0.025 mg/kg.
- The individual concentration of PFHxS and its salts does not exceed 0.025 mg/kg.
- The total concentration of PFHxS -related compounds does not exceed 1 mg/kg.
★ Regulation of PFHxS, its salts and PFHxS-related compounds
Due to PFHxS, its salts and PFHxS -related compounds being listed in Annex A (Elimination) of the Stockholm Convention, Taiwan prohibits the manufacture, import, sale, and use of PFHxS, its salts and PFHxS -related compounds, except for research, testing, and educational purposes.
| Chinese Name | English Name | Controlled Concentration （％） | Threshold Operating Quantity (kg) | Toxicity Classification |
| 全氟己烷磺酸（PFHxS）及其盐和相关化合物 | Perfluorohexane, sulfonic acid (PFHxS), its salts and PFHxS related compounds | Full concentration | 50 | 1 (Class 1 Toxic Chemical Substance) |
Compliance Background
What are Class 1 Toxic Chemical Substances?
Substances in the List of Toxic Chemical Substances in Taiwan, China are classified into four categories according to their chemical properties: Class 1 (persistent substances), Class 2 (chronic toxic substances), Class 3 (acute toxic substances), and Class 4. Class 1 toxic chemical substances refer to those that are not easily degradable in the environment or that cause environmental pollution or harm to human health due to bioaccumulation, biomagnification, biotransformation, etc.
Obligations for Class 1 Toxic Chemical Substances
According to the Regulations on the Classification and Management of Toxic Chemical Substances, the obligations for Class 1 toxic chemical substances are as follows:
(1)Manufacturing, importing, and selling Class 1 toxic chemical substances that reach the threshold operating quantity require a permit.
Using, storing, and discarding Class 1 toxic chemical substances require a registration document.
Manufacturing, importing, selling, using, storing, and discarding Class 1 toxic chemical substances that below the threshold operating quantity require an approval document.
Exporting Class 1 toxic chemical substances requires export registration.
(2) Operators must keep records of their operations and release quantities, report them regularly, and maintain these records for inspection.
(3) Operators must label the containers, packaging, operational sites, and facilities with toxicity and pollution prevention information and prepare corresponding safety data sheets.
(4) In the event of an accident, operators must report to the local competent authority within the specified time.
The complete list of PFHxS, its salts, and related compounds can be accessed for free on ChemRadar (i.e., the List of Toxic Chemical Substances in Taiwan, China).
Further Information
The Executive Yuan Gazette Online
