Taiwan Tightens Control on Organotin Compounds

On February 20, 2023, Taiwan’s Environmental Protection Administration (EPA) published the revised Categories and Management of Handling for Toxic Chemical Substance (hereinafter referred to as the Regulation), which took effect immediately.

The main purpose of this revision is to enhance the regulation of organotin compounds. In accordance with the International Convention on the Control of Harmful Anti-fouling Systems on Ships on the management of organotin compounds, the use of organotin compounds in antifouling paints，antifouling systems and biocidal products will be prohibited in Taiwan. The toxicity of 10 organotin compounds is reclassified and 4 organotin compounds are assigned new CAS numbers to facilitate better control. Companies will be given a grace period of six months to one and a half years to comply with the relevant requirements.

Here are the major changes made in the new Regulation as summarized by ChemLinked:

Expansion of exemption scope (Article 5)

The new Regulation broadens the exemption scope to cover substances and items controlled under the following laws:

1.   Agro-pesticides Management Act;

2.   Fertilizer Management Act (new);

3.   Feed Control Act;

4.   Veterinary Drugs Control Act;

5.   Pharmaceutical Affairs Act;

6.   Medical Devices Act (new);

7.   Controlled Drugs Act;

8.   Cosmetic Hygiene and Safety Act;

9.   Act Governing Food Safety and Sanitation;

10. Tobacco Hazards Prevention Act;

11. Industrial Explosives Administrative Act (new);

12. Petroleum Administration Act (new);

13. Natural Gas Enterprise Act (new);

14. Atomic Energy Law;

15. Ionizing Radiation Protection Act;

16. Air Pollution Control Act;

17. Environmental Agents Control Act;

18. Waste Disposal Act (new); and

19. Commodity Inspection Act.

Clarification of testing methods for toxic chemical substances (Article 14)

Taiwan CNS standards have priority in testing toxic chemical substances. If CNS standards are not established, the following testing methods can be used freely as long as they are scientifically reliable and provide accurate data. However, previously the following methods must be used in the specified order. 

1. Standard environmental methods from Taiwan’s National Institute of Environmental Analysis (NIEA);

2. Methods announced by U.S. Environmental Protection Agency (US EPA);

3. Standard methods for the examination of water and wastewater from American Public Health Association (APHA);

4. Japanese Industrial Standards (JIS) from the Japan Industrial Standards Committee;

5. Methods from the American Society for Testing and Materials (ASTM);

6. Standard methods from the Association of Official Analytical Chemists (AOAC) International;

7. Standard measurement methods from the International Organization for Standardization (ISO);

8. Testing methods adopted by the European Union.

Update of toxic chemical substances list (Appendix Tables)

l  Update of the toxicity classification of ten organotin compounds (Appendix Table 1), as well as their prohibited operations (Appendix Table 2) and permitted uses (Appendix Table 3)

l  Addition of CAS numbers for four organotin compounds (Appendix Table 1) 

l  Specification of deadlines for the completion of relevant matters in regard to these organotin compounds. (Appendix Table 4)