By Hung Ou Yang
Toxic Chemical Substances Categorization of the Environment Protection Administration
Under the Taiwanese Toxic Chemical Substances Control Act (“TCSC Act”), it classifies the toxic chemical substances into four categories, Class 1, Class 2, Class 3, and Class 4, on the basis of their toxicity. See Article 3 of the TCSC Act. Anyone can check the announced toxic chemical substances on the website of the Environmental Protection Administration, Executive Yuan, R.O.C. (Taiwan) (hereinafter “EPA”) for the current categorization of toxic chemical substances. However, the background of the toxic chemical substances categorization of EPA is somewhat complicated.
Background of EPA’s Review
The TCSC Act and the Taiwanese Occupational Safety and Health Act (“OSH Act”) require that importers and producers of chemical substances have to register a wide variety of chemical substances for any sale, utilization or production with the Ministry of Labor (“MOL”) and with the EPA. In this regard, MOL and EPA use two separate registration programs, the Existing Chemical Notification (ECN) program and the New Chemical Notification (NCN) program. Because the U.S. government argued that the duplicative the TCSC Act and the OSH Act registrations constituted trade barriers, EPA became the single registration window in Taiwan since around 2015. On March 29, 2018, EPA issued a draft amendment of NCN and ECN Registration Guidelines, including the list covering 106 types of chemicals. However, the draft is still under EPA’s for review. See 2019 National Trade Estimate Report on Foreign Trade Barriers issued by the United States Trade Representative, p. 463. Currently, this reoprt is lisitng ECN and NCN programs and the unapproved draft amendment as trade barriers for chemical substances.
TCSI Search System for the New and Existing Chemical Substances
When a chemical substance has not been categorized and announced by the EPA, the toxic chemical substances would be “existing chemical substances” if listed in the TCSI Search system, which is established by the EPA, the Occupational Safety and Health Administration of MOL (hereinafter “OSHA”), and other authorities. If not listed in the TCSI Search system, the toxic chemical substances would be defined as “new chemical substances”. See Article 3 of the TCSC Act.
Here, if listed as “existing chemical substances”, the importer may be entitled to an exemption of registration. According to the Rules on the Data Registration of New Chemical Substances and Existing Chemical Substances (“Data Registration Rules”) issued by the EPA, Article 18 and Article 19 provide that the importer may be exempted from the registration if the yearly imported amount of the existing chemical substances does not exceed 100kg.
If listed as “new chemical substances”, the importer of such chemical substances shall file an application to the EPA, 90 days before the importation for a registration approval. In the absence of such approval, the importer would be subject to penalties. See Section 1 of Article 7-1 of the TCSC Act. Further to this, when the yearly estimated imported amount does not exceed 100kg, the importer shall apply for “small quantity registration” under Section 3 of Article 5 of the Data Registration Rules.
Penalties Imposed by the EPA under the TCSC Act
When the importer fails to obtain the registration approval for the new chemical substances, the EPA would (a) issue a fine no less than NTD 200,000 but no more than NTD 2 million, and (b) order the importer to correct it within 30 days. If the importer fails to finish the corrections, that is, fails to file the registration approval and comply with the EPA’s order, if any, within the time limits, the importer may be fined again. The EPA may further order the importer to suspend its business or return the chemical substances when the importer fails to finish the corrections for two times. See Section 1 of Article 35-1 of the TCSC Act. However, before the chemical substance is categorized and announced by the EPA, the importer will not be subject to criminal liability. That being said, the fine imposed by the EPA is an administrative sanction, not a criminal penalty.
The Penalties under the OSH Act
In addition, Article 13 of the OSH Act further provides that the importer, who fails to submit a safety evaluation report regarding the “new chemical substances” to the MOL for a registration approval before importing such “new chemical substances”, will be prohibited from importation. Section 2 of Article 44 of the OSH Act further articulates the penalties, that is, the MOL may also issue a fine no less than NTD 200,000 but no more than NTD 2,000,000, and may prohibit the importer from such importation for a period of time. If the importer does not cease such importation, the MOL may issue a fine for each violation. Again, the fine imposed by the MOL is an administrative sanction, not a criminal penalty.
The Application/Registration Process
When the importer files an application for any new chemical substances, the EPA may attach terms and conditions in granting the registration approval during the registration process. See Section 3 of Article 7-1 of the TCSC Act. When the EPA considers that the new chemical substances might be categorized as Class 1, Class 2, or Class 3 toxic chemical substances pursuant to Article 3 of the TCSC Act, the EPA shall attach additional terms and conditions in the registration approval during the registration process, that is, imposing a ban or restriction on handling such chemicals, and requiring a handling report to be submitted. Id. The importer may be required to comply with the terms and conditions mentioned here not only during the registration process but also after the registration approval.
Further to this, when the EPA considers that the chemicals might cause environmental pollution or endangerment to human health, the EPA shall attach additional terms and conditions in the registration approval, that is, during the registration process, imposing a restriction on handling such chemicals, and requiring an exposure and risk assessment to be submitted. Id. Again, the importer may be required to comply with the terms and conditions mentioned here not only during the registration process but also after the registration approval.
The EPA may spend as much as SEVEN working days on reviewing the registration. However, the EPA would request the applicant to provide supplement or correct the errors for no more than two times if the application documents are missing, erroneous, or unclear. The applicant shall provide supplement or correct the errors as requested within THIRTY days each time. When the applicant fails to provide supplement or correct the errors within THIRTY days or the applicant fails to provide supplement or correct the errors as requested by the EPA for two times, the EPA will reject the registration application. The THIRTY-day period will not be considered as part of the reviewing process. Thus, the whole registration process may take as long as 67 (7 + 30 + 30) days.
For any legal assistance with regard to TCSC Act and further registration process, you may contact Brain Trust International Law Firm. We will be glad to assist you.
Authour: Hung Ou Yang
Copyright Brain Trust International Law Firm
Disclaimer: While every effort has been made to ensure the accuracy of this publication, it is not intended to provide legal advice as individual situations will differ and should be discussed with an expert and/or lawyer. For specific technical or legal advice on the information provided and related topics, please contact the author.