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.
化學品製造商委員會由衷感謝政府部會,持續地與產業界進行雙向溝通。2021年白皮書所提建言,透過修法、行文或於兩次國發會協調會議中,多數已解決或得到正面回應。
今年委員會祈望勞動部職安署進一步釐清「優先管理化學品指定名單」之危害分類依據及列入標準,持續改善「安全資料表」之商業機密揭示保留申請標準,並建立相關法規諮詢窗口。
委員會並希望,衛福部食藥署能將《管制藥品管理條例》之管轄範圍明確定義,並標示「化學文摘社登記號碼」(CAS NO.)。
另外,我們更希冀環保署化學局持續關注其危害及暴露評估指引發展進程。
建議一:公布《優先管理化學品清單》之危害分類依據及列入標準
針對2022年2月14日勞動部公告修正《優先管理化學品之指定及運作管理辦法》第2條指定之化學品名單,第2條第2款的889項化學品中,僅有186項化學品於備註欄載明其為致癌物質或生殖細胞致突變性物質或生殖毒性物質第1級,其餘721項化學品並無全球調和制度(GHS)相關資訊,該辦法第2條第3款具物理性或健康危害之163種化學品亦無提供參考資訊闡明其危害分類。
建議勞動部參照目前國際上「危害化學品清單」的建立方式,如歐盟ECHA的高關注物質(Substance of very high concern, SVHC),闡明該物質列入化學品清單中的原因,包含相關的危害分類資訊供業者及使用者參考,以利使用者更了解優先管理化學品和進行化學品分級管理,進而維護勞工及使用者的健康安全。
建議二:改善「安全資料表」之商業機密揭示保留申請標準
台灣為半導體、印刷電路板之供應鏈大國,因此化學品的研發之時效性與商業機密的保護性是企業投資台灣相關產業之重要指標。目前安全資料表之商業機密揭示保留申請標準並無區隔研發樣品與商品,且保留揭示之申請須針對每項健康危害繳交測試終點資料,因此在申請資料的準備上相當耗時與衍生測試成本,進而阻礙研發樣品的開發之時效性。
委員會建議勞動部職安署提供明確的安全資料表之商業機密揭示保留申請指引,將研發樣品與商品的申請要求做區隔,加速研發樣品之揭示保留申請。參考韓國為例,一般化學品的揭示保留申請審核時間為四周,而研發樣品則僅需兩周;另建請將暴露評估納入考量,以風險管理的概念作為審核安全資料表揭示保留之標準。
建議三:建立勞動部相關法規諮詢窗口
感謝勞動部目前就化學品相關法規,如優先管理化學品之指定及運作管理辦法、危害性危害性化學品標示及通識規則等,皆有定期舉辦說明會施供業者參加。然而,除了每年定期的法規說明會外,目前並未提供明確的諮詢窗口,協助即時解答業者在實際作業時的各式問題。根據業者過往詢問相關申請平台的經驗,也曾遭遇平台端和說明會方或勞動部方說法不一致的情形,讓業者對於如何正確理解法規並完成相關作業無所適從。
委員會建議勞動部能參考環保署現行之化學物質登錄平台,建立可靠的諮詢窗口,針對國內業者及消費者的疑問,即時提供正確且一致的回應。透過諮詢窗口建立,國內化學品業者和使用者能減少誤解相關規定的適用,更符合法規。
建議四:建議修正《管制藥品管理條例》之管制藥品分級及品項
自民國88年公告以來,管制藥品分級及品項經歷多次修正,近年管制藥品分級及品項更是頻繁增列或修正。然而,公告的管制藥品品項僅公告化學物質之中、英文名稱,並無提供物質相對應的「化學文摘社登記號碼」(CAS NO.),且品項管制範圍尚包括其異構物(Isomers)、酯類(Esters)、醚類(Ethers)及鹽類(Salts),卻無敘明究竟是哪些物質,大大地增加業者的負擔及在化學品管理上的難度。
同時,國內許多化學品同業對於是否受《管制藥品管理條例》所規範莫衷一是(例如製造或販售半導體用化學品〔多為混合物〕是否也受管制藥品管理條例所監管?),致電主管機關釐清,也僅得到公告前皆已與工業局討論等等之回覆。故建請主管機關:
一、 或可以函釋方式說明,協助業者釐清《管制藥品管理條例》之管轄範圍;
二、 管制藥品分級及品項修正時加上品項之「化學文摘社登記號碼」(CAS NO.),以及明確公告品項之異構物、酯類、醚類及鹽類,以及相對應的CAS NO.。
建議五:公布暴露評估危害指引草案
委員會感謝化學局回應2021年白皮書有關改善既有化學物質標準登錄制度之建議,於同年11月23日即公布修正《新化學物質及既有化學物質資料登錄辦法》,延展登錄期限至2024年,且將限定場址中間產物納入豁免機制。
標準登錄自2020年推動至今已兩年,但關於《化學物質危害評估及暴露評估指引》仍在草案階段,盼大局能盡快公告指引,並舉辦相關工作坊、訓練及諮詢機會,以協助台灣化學品管理達世界級水準。
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