The Chemical Manufacturers Committee greatly appreciates the efforts of government agencies to engage in two-way communication with industrial stakeholders. Most of the suggestions raised by the Committee in its 2021 White Paper have been resolved through amendments to regulations or positive feedback provided by the competent authorities in both working- and policy-level meetings convened by the National Development Council.
This year, the Committee calls on the Ministry of Labor (MOL) to specify the chemical classification data and criteria in the Priority Management Chemicals List, continuously refine the withholding criteria for confidential business information (CBI) on Safety Data Sheets (SDS), and establish a helpdesk for firms to contact regarding chemical-related regulations.
With respect to the Controlled Drugs Act, the Committee urges the Ministry of Health and Welfare (MOHW) to clearly define the controlled items, as well as add corresponding CAS Registry Numbers.
Lastly, the Committee hopes to receive an update from the Environmental Protection Administration (EPA) regarding its progress on issuing guidance on conducting hazard and exposure assessments for existing chemical substance registrations.
Suggestion 1: Provide the classification data and criteria for chemicals included in the Priority Management Chemicals List
Amendments to the list of priority management chemicals appended to Article 2 of the “Regulations for the Governing, Designating, and Handling of Priority Management Chemicals” were announced on February 14, 2022. According to the amended list, only 186 out of the 889 chemicals under Subparagraph 2, Article 2 are classified as a carcinogen, mutagen, or reproductive toxicant, and no Globally Harmonized System of Classification and Labelling of Chemicals (GHS) data is provided for the remaining 721 chemicals. Furthermore, no physical or health hazard classification for the 163 chemicals listed under Subparagraph 3, Article 2 has been provided.
The Committee suggests that MOL adopt an international-standard approach to the Priority Management Chemicals list by providing hazard classifications for each chemical and the reasons for such classification. One model it can refer to is the European Chemicals Agency’s “substance of very high concern” (SVHC) candidate list. With clear hazard classifications, chemical companies and downstream users can better manage hazardous chemicals and ensure the safety of those who use them.
Suggestion 2: Refine the SDDS CBI review criteria.
The speed of R&D development and degree of CBI protection are critical elements in maintaining Taiwan’s leading role in the global semiconductor and printed circuit board supply chains. However, the MOL’s current CBI review criteria for SDS do not distinguish between R&D samples and finished products, and the provision of information on testing endpoints is required for each hazard classification. The criteria thus present an obstacle to carrying out time-sensitive R&D activities.
The Committee urges the MOL to provide clear guidance on the CBI review criteria and consider revising the criteria to distinguish between R&D samples and finished products in order to accelerate the review process. We note that such a distinguishment is made in the CBI criteria of South Korea, where the review time for R&D samples is a mere two weeks, while only four weeks is needed to review finished products. We also urge the MOL to include exposure assessments in
the review criteria as part of a broader approach to risk management.
Suggestion 3: Establish a chemical regulations helpdesk under the MOL.
The Committee thanks the MOL for holding regular seminars regarding chemical regulations, including the “Regulations for Governing Designating and Handling of Priority Management Chemicals” and “Regulations for the Labeling and Hazard Communication of Hazardous Chemicals.” However, we note the absence of a clear contact window that chemical companies or downstream users can consult on questions related to relevant regulations. In many cases, speakers at MOL seminars and MOL staff have provided different responses to the same question, which has caused confusion among users trying to correctly understand and follow the regulations.
We therefore call on the MOL to set up a reliable helpdesk – like the one established by the EPA in relation to the Existing Chemical Substance Registration process – to provide correct and consistent responses to chemical companies’ and downstream users’ questions in a timely manner. Doing so would minimize misunderstandings and ensure that both chemical companies and downstream users comply fully with relevant regulations.
Suggestion 4: Amend the Controlled Drugs Schedules and Items list under the “Controlled Drugs Act.”
The Controlled Drugs Schedule and Items list has undergone several revisions since its promulgation in 1999, with the frequency of revisions and number of items increasing markedly in recent years. However, when new items are added, only their Chinese and English names are made public; their corresponding CAS Registry Numbers are not included. Furthermore, the listing for added items also names the isomers, esters, ethers, and salts in their composition, but without the CAS numbers there is no clear indication of what the substances actually are. The unclear scope and specifications have created a huge burden on the chemical industry and increased the difficulty of chemicals management.
At the same time, chemical industry players have questioned whether they should be regulated by the Controlled Drugs Act at all. For example, is a manufacturer or supplier of semiconductor chemicals (mostly mixtures) regulated by the Act? Committee members once tried to clarify this distinction with Taiwan’s Food and Drug Administration but were told that the TFDA had consulted the Industrial Development Bureau (IDB) before announcing the additional Controlled Drugs items. We therefore ask that the competent authorities:
Issue an official letter clarifying the scope of the Controlled Drugs Act.
Include the CAS No. of items added to the Controlled Drugs Schedules and Items list and specify and provide the CAS No. for those items’ isomers, esters, ethers, and salts.
Suggestion 5: Issue guidance on conducting hazard and exposure assessments for existing chemical substance registrations.
We appreciate the EPA’s positive response to our 2021 White Paper suggestion to improve the efficiency of the Existing Chemical Substance registration system. On November 23 last year, it announced amendments to the “Regulations of New and Existing Chemical Substances Registration,” including extending the registration deadline to 2024 and exempting on-site isolated intermediates from the standard registration process.
However, we note that although the existing chemical standard registration process went into effect in 2020, technical guidance on the hazard and exposure assessments required for registration is still being drafted. The Committee urges the EPA to publish such guidance as soon as possible and help build competencies by offering workshops, training, or counseling programs to achieve the goal of implementing world-class chemicals management in Taiwan.