Chemical Regulatory Updates in Taiwan
An Insider Look at the Toxic Chemical Substance Control Act
Registration And Safety - Revision of the Toxic Chemical Substance Control Act (TCSCA) in Taiwan has attracted attention from the chemical industry recently because a new REACH-like plan is expected to be introduced to another big chemical market in Asia soon.
In addition to the TCSCA amendment, Taiwan's Labor Safety and Health Act (LSHA) has also been revised this year, bringing changes to chemical companies in Taiwan. This article focuses on recent updates of the amendment of TCSCA and LSHA and analyzes their potential effect on chemical companies doing business in or with Taiwan.
Background and Updates of TCSCA Amendment
TCSCA was issued in 1986 and has gone through five revisions, the latest in 2007. It is the main legislation for industrial chemicals in Taiwan. Its primary focus is the control of toxic chemical substances, requiring business operators to apply for handling permits for designated substances from the Environmental Protection Administration (EPA).
The main reason for amendment is the lack of a chemical registration scheme in Taiwan. After so many countries (Korea, China, Japan) have implemented REACH-like chemical legislation and required risk assessment of chemical substances, Taiwan may become a test ground for new substances without a chemical registration scheme in place. In addition, the food plasticizer contamination incident in 2011 made authorities realize they do not have sufficient power under current TCSCA (i.e., request for toxicology data or requiring license) to control chemical substances for which there is concern of environmental pollution or endangerment of human health (Class 4 toxic chemical substances).
An internal government meeting in March reached consensus regarding the following two main revisions in the draft amendment of TCSCA proposed and published in November 2012:
- Establishment of chemical registration scheme for new substances and designated existing substances with concern.
- Amendment of provisions related to Class 4 toxic chemical substances to strengthen their management.
Details of Two Major Changes
Chemical Registration and Existing Substance Inventory: Article 7(1) of the draft amendment of TCSCA stipulates that domestic enterprises manufacturing or importing a given quantity of chemical substances designated by the central competent authority shall register the manufacturing or importing details; the physical, chemical and toxicology data; and the exposure and hazard assessment data before manufacturing or importing.
Taiwan's chemical registration scheme is expected to be similar to Korea's, focusing on the registration of new chemical substances and designated existing substances with concerns. For new substances, there would be standard registration, simplified registration and notice. The standard registration of new substances and designated existing substances with concerns would be similar to EU REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) with tiered data requirements for different volume bands. Joint submission is also mandatory according to article 7(2) in the draft amended TCSCA. However, there is no concept of only representative in the draft amended TCSCA, which means that registration obligations may only fall on domestic manufacturers or importers.
Companies can now go to the website of the National Chemical Register (NCSR) Office to search Taiwan's existing substance inventory which has been finalized and released after supplementary nomination ended last year. There are around 79,000 substances (including polymers) in the inventory; about 40% are produced or imported with volume above 1 ton per year.
Strengthened Management of Class 4 Toxic Chemical Substances: Many articles related to Class 4 toxic chemical substances have been revised. Enterprises would be required to declare relevant toxicological information and obtain approval from competent authorities prior to handling, as well as being subject to management measures concerning toxicity labeling, pollution control and safety data sheets.
New Occupational Health and Safety Act (OSHA)
The Labor Safety and Health Act (LSHA) has been renamed the Occupational Health and Safety Act (OSHA), which was officially promulgated and published on July 3. The new OSHA stipulates obligations of chemical operators to register new substances; and label, provide SDS and obtain handling permits for hazardous chemical substances. Yet the implementation date has not been decided by the Executive Yuan, the top legislative body in Taiwan. More implementation details are not available.
What You Need to Know
Although the new OSHA requiring new substance notifications has been issued and Taiwan's existing substance inventory has been finalized, enterprises do not need to submit new substance notifications at the moment.
The next step is to take the amended TCSCA to the Executive Yuan for final approval. It was originally scheduled for September, but it did not get prioritized. It is expected to be taken up again early next year. Once approved, the provisions related to chemical registrations and Class 4 toxic chemical substances in amended TCSCA would come into force one year after the date of promulgation. Meanwhile, detailed guidance documents on chemical substance registrations will be published, which might be more important than the amended TCSCA itself.
Companies shall closely monitor the promulgation date of the amended TCSCA and more guidance documents on chemical substance registrations and the implementation details of the new OSHA.