November 5, 2020
On October 30, 2020, Taiwan’s Environmental Protection Administration (EPA) promulgated “Categories and Management of Handling for Concerned Chemical Substances” (列管關注化學物質及其運作管理事項), a subsidiary regulation under Toxic and Concerned Chemical Substances Control Act (毒性及關注化學物質管理法). As of October 2020, Nitrous oxide is the only regulated concerned chemical substance.
Taiwan’s Toxic Chemical Substances Control Act (毒性化學物質管理法) was amended and renamed the Toxic and Concerned Chemical Substances Control Act (毒性及關注化學物質管理法) by Presidential Order No. 10800005221 on January 16, 2019. The amendment introduced a new category “Concerned Chemical Substances”, which refers to “chemical substances aside from toxic chemical substances, that have been officially announced by the central competent authority to pollute the environment or are a suspected threat to human health based on substance characteristics or public consumer issues of domestic or foreign concern and are controlled by the central competent authority.” The central competent authority is requested to announce the concerned chemical substances with the corresponding management requirements for different levels of handling.
Nitrous oxide is regulated as the first Concerned Chemical Substance. The management of handling is specified below:
- Manufacture, import, sell, usage and storage of a product containing Nitrous oxide at any concentration is subject to the Regulation and should be reported every month. The handling amount should be recorded by network transmission every day for each activity. The recording can be omitted if there is no change in handling amount.
- The labeling or mark for the container, packaging, handling place or facility of a Nitrous oxide product shall be completed and the Safety Data Sheet for the product shall be prepared. The label or mark shall contain the precautionary statement “Only for industrial use, no inhalation.” The text on the label or mark should be in a color contrasted with the background color.
- The approval document for manufacture, import, sell, usage and storage of a product containing Nitrous oxide shall be obtained.
- Sulfur dioxide should be added for the manufacture and import of Nitrous oxide with the added concentration over 100 ppm.
The implementation date for the first item is the date of publication (October 30, 2020) and for the rest of the items is May 1, 2021.
The regulation doesn’t apply to the use for military purposes or the use as an oxidizer and fuel for rocket propulsion. Selling or transferring of Nitrous oxide through mail order, e-shopping, or other trading platforms where the transaction parties cannot be identified is not allowed.
Recommended Action Items:
- Check your product(s) to see if any contain Nitrous oxide;
- For products that contain Nitrous oxide, complete the required actions before the specified deadlines.
EPA News on the promulgation of Categories and Management of Handling for Concerned Chemical Substances, October 30, 2020. (Source is only available in Traditional Chinese) https://gazette.nat.gov.tw/egFront/detail.do?metaid=119356&log=detailLog
Toxic and Concerned Chemical Substances Control Act (毒性及關注化學物質管理法) https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=O0060012