AmCham Taiwan Healthy Aging Forum:
2025健康台灣樂齡論壇:公私協力促進全人健康
AmCham Taiwan Healthy Aging Forum:
2025健康台灣樂齡論壇:公私協力促進全人健康
Committee Events & Luncheons
The Committee greatly appreciates the efforts of the government to engage in two-way communication with industry stakeholders.
This year, the Committee calls on the Ministry of Environment (MOENV) to adjust the chemical registration framework, revise the official fee remittance process, and reevaluate the requirements for hazard and exposure assessment reporting. We also urge the Ministry of Labor (MOL) to align its hazard communication requirements with international standards.
Suggestion 1: Revise the existing chemical phase II registration framework and government fee remittance process.
1.1 Revamp the existing chemical phase II registration regulatory framework. Every chemical substance has its specific physicochemical toxicology and ecotoxicology properties, and collation and organization of that data provides downstream users with valuable information about potential hazards. Evaluation of the hazards presented by a substance may change over time due to advancements in analytical instruments or techniques, causing different clinical trial outcomes.
Under the existing chemical substance standards in Taiwan, some registrants use complete information authorized by data owners under the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program, including testing reports. Other submissions, however, rely solely on public databases and test plans, leading to varying hazard classifications for the same chemical due to the use of inconsistent data sources. The risk of depending on unreliable data is especially high for SMEs that lack their own testing capability.
Under the EU REACH registration system, all registrants compile their own data and submit it to the European Chemicals Agency or member states for final evaluation. The result is a fair, efficient, and cost-reducing process for industry and regulatory authorities. Lead registrants with higher tonnage levels provide up-to-date data, and co-registrants with lower tonnage levels then use the same data after sharing costs and fees with lead registrants. This approach allows the authorities to steadily improve the quality of the data received and obtain updated and consistent information at a lower cost throughout the registration process.
We suggest that the government reevaluate the current registration framework, conducting discussions with companies to learn from the experiences of other countries in handling their registration systems and to align with such international chemical substance management systems as REACH, which is the case in neighboring South Korea.
1.2 Create a fixed account for official fee remittance. The use of virtual accounts for the remittance of official fees allows the authorities to check reconciliation swiftly. For businesses, however, paying fees to a virtual account through a Web ATM presents significant challenges. Employees must first put personal funds into the authority’s account and then seek reimbursement from their company, posing substantial inconvenience for both registrants and their employees.
We urge the government to either 1) set up a fixed account for fee payments and integrate all fees to be paid to the MOENV within a single system, or 2) accommodate credit card functionality, allowing registrants to pay directly with a company credit card without needing to advance funds.
Suggestion 2: Consult with registrants before requiring additional information in hazard and exposure assessment reports for chemical substances.
The standard registration procedure for existing chemical substances will end this year. From 2025, the MOENV’s Chemicals Administration (CHA) will begin requiring registrants to submit hazard and exposure assessment reports. The Committee commends the CHA for publishing guidelines for conducting hazard and exposure assessments, and creating a manual for chemical hazard assessment tools, in 2023. Recently, the CHA has invited lead registrants to discuss subsequent guidance mechanisms and planning to aid in the smooth submission of these reports. The Committee urges the CHA to also conduct related training and workshops to build domestic industry capacity for exposure assessment and to maintain regular communication with the industry in the interest of further improving Taiwan’s existing chemical substance registration standards.
For the registration of new chemical substances, the CHA has asked several businesses to provide hazard and exposure assessments beyond what is required for their registration tier, with approval withheld if those requests are not met. This not only greatly prolongs the review process, delaying the import of new products, but also substantially increases registration costs. Furthermore, before demanding these assessments, the CHA did not discuss the specifics of the cases with registrants. Instead, it has relied solely on the inherent hazards of the substances involved, rather than considering the level of usage and exposure detailed in the registration dossier. The result has been confusion and dissatisfaction among domestic registrants.
The Committee suggests that the CHA consider both the hazard information submitted in the dossier and the context of the substance’s use. Additionally, the CHA should discuss the specifics of cases with registrants in advance, allowing them to provide further explanations or information. This approach would help eliminate difficulties in the hazard and exposure assessment reporting process that significantly impact companies’ operations in Taiwan and their willingness to introduce new products to the market.
Suggestion 3: Align GHS implementation with global regulatory standards.
3.1 Communicate revisions and implementation timelines with industry. In the MOL’s latest amendment of the Regulations for the Labeling and Hazard Communication of Hazardous Chemicals, the definition of the term “GHS requirements” (CNS 15030) refers to Revision 4 of the UN’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS, also known as “the Purple Book”), published in 2011.
The MOL reportedly plans to further revise CNS 15030 to match Revision 8 of the Purple Book (although the latest version of the Purple Book is Revision 10). To minimize the impact on industry, we recommend that the MOL provide a detailed implementation schedule with a sufficient buffer period and arrange training sessions with stakeholders. Doing so would increase understanding of how to generate labels in compliance with the new regulatory requirements.
3.2 Align GHS implementation with international standards. Implementation of the hazardous chemicals labeling and identification rules in Taiwan is not fully aligned with the UN GHS system. The Purple Book’s safety data sheet preparation guidelines (Article A4.3.3.2) require disclosure of the identity and concentration range of components in mixtures that pose health and environmental hazards, while the disclosure of components presenting physical hazards is not mandatory. Other markets like Canada and the EU also do not require the disclosure of hazardous components in section three of the safety data sheet. In Taiwan, however, the disclosure criteria in the Regulations Governing the Labeling and Hazard Communication of Hazardous Chemicals remain vague. We therefore suggest that Taiwan align its GHS implementation with international standards by amending laws, issuing guidelines, or providing FAQs to exclude the disclosure of physical hazard components from the safety data sheet preparation rules.
3.3 Allow the submission of information in foreign languages. Article 5 of Taiwan’s Regulations for the Labeling and Hazard Communication of Hazardous Chemicals states that the purpose of providing contact information to manufacturers, importers, or suppliers is to enable further consultation if users have any concerns. For imported hazardous chemicals where the manufacturer or supplier is a foreign company without a Chinese name, translating the information into Chinese may lead to confusion and impede the reader’s ability to recognize and contact the company.
We strongly suggest that the names and addresses of foreign companies be allowed to remain untranslated, following the precedent set by the Ministry of Economic Affairs in the Commodity Labeling Act, where foreign company information on imported products can be displayed in a foreign language. After adoption of this approach, the rule should be clarified by the MOL through FAQs or guidelines.
化學品製造商委員會由衷感謝政府部會,持續地與產業界保持雙向溝通。
今年委員會提出三項建言,祈望環境部化學物質管理署重新審視既有化學物質標準登錄制度與改善政府規費付款方式,以及評估化學物質危害及暴露評估報告之額外要求;同時希望勞動部職業安全衛生署將《危害性化學品標示及通識規則》與《化學品分類及標示全球調和制度》(Globally Harmonized System of Classification and Labelling of Chemicals, GHS)調和一致。
建議一:建議修改既有化學物質第二階段資料登錄辦法與改善政府規費繳納流程
1.1 重新審視既有化學物質第二階段資料登錄辦法
每種化學物質都有其特別的物化特性、毒理及生態毒理資料,將這些資料整理後代表的危害結果對於下游使用者們來說可提供潛在危害的寶貴訊息。而物質的危害結果隨著時間可能有所改變,因為分析儀器或技術的進步,經由不一樣的臨床實驗結果而產生更新的資料。
目前台灣的既有化學物質標準登錄中,有部分的登錄人採用歐盟之化學品註冊、評估、授權與限用法規(Regulation on the registration, evaluation, authorisation and restriction of chemicals, REACH)下由資料所有人授權的完整資訊(具有測試報告),然而,其他登錄人單純採用公開資料庫與測試計畫書來進行繳交;除增加了中小企業使用來源不可靠之資料的風險,也導致同樣的化學物質因採取不同的資料來源而具有不一致的危害分類。
在歐盟REACH登錄制度下,所有登錄人將各種不同資料進行彙整並交由歐洲化學總署(ECHA)或會員國來進行最後總評估的方式,對產業界與主管機關來說是公平、有效率且節約整體成本的方式。擁有較高噸數級距的領導登錄人也能隨時提供最新的資料, 具較低噸數級距的共同登錄人在與領導登錄人分攤成本與費用後使用一樣的數據資料。這樣主管機關不僅能在一開始即收到確切資料, 更能以較低的成本透過登錄人取得最新且一致的資訊。
我們在此建議主管機關重新檢視目前的登錄架構,並與企業一起討論,借鏡其他具相似登錄制度的國家經驗(如歐盟、南韓),使台灣與國際化學物質管理制度接軌。
1.2 建立政府規費繳納固定帳戶
使用虛擬帳戶繳納政府規費可立即讓政府進行對帳;但對企業來說,通過Web ATM匯款繳納政府規費到虛擬帳戶是重大挑戰。以此方式支付,必須讓員工先向政府帳戶繳納款項,個人再向公司報帳,這對各企業或其員工來說造成重大不便。
我們建議考量以下選項:(1) 為政府規費繳納設立固定的帳戶,並將整個環境部的規費繳納整合入單一系統中;(2) 開放信用卡繳費功能,讓企業與登錄人可使用公司信用卡進行繳款而不需要預繳代墊。
建議二:籲請主管機關諮詢登錄人,審慎評估化學物質危害及暴露評估報告之額外要求
既有化學物質標準登錄將於113(今)年底截止,114年起環境部化學物質管理署(下稱化學署)勢必將開始要求登錄人提交危害及暴露評估報告。化學品製造商委員會肯定化學署於112年陸續公布之《化學物質危害及暴露評估撰寫指引》及《化學物質危害評估工具操作手冊》,近期領頭登錄業者亦已接獲主管機關之委辦單位邀請,參與討論後續之輔導機制與規劃,以協助國內業者們順利提交後續危害及暴露評估報告。化學品製造商亦敦請化學署開辦相關培訓與研討會,以建立國內業者進行暴露評估之能力,並保持與業界的定期溝通與交流,期能令台灣的既有化學物質標準登錄更臻完善。
然而,針對新化學物質登錄,數家業者收到化學署要求額外提供非屬該登錄級距所應提交的危害及暴露評估,且未提交或承諾提交將無法取得核准登錄,此情形不僅顯著延長了案件的審查期程,導致業者延遲進口新產品,也讓業者的登錄成本大幅增加,且化學署在要求業者提供危害及暴露評估前,並未與業者討論個別案件的特殊性,僅僅以純物質的危害性作為評判依據,而未同時考量登錄文件上描述之申請物質使用及暴露情形,實令國內登錄業者不解。
委員會建請化學署除了考量文件中已提交的危害資訊外,亦應同時考慮物質的使用情境,並事先與登錄業者適當討論案件的特殊性,讓業者得提供進一步說明或資訊,避免業者無所適從,嚴重影響業者在台灣的營運與推出新產品至台灣市場的意願。
建議三:建議《化學品分類及標示全球調和制度(Globally Harmonized System of Classification and Labelling of Chemicals, GHS)》應與全球標準保持一致
3.1 充分與業界溝通GHS版本更新與實施期程
依勞動部最新修正版本之《危害性化學品標示及通識規則》,其危害性分類及標示(CNS 15030) 係參考2011年聯合國 《化學品全球分類及標示調和制度第四版( UN Globally Harmonized System of Classification and Labelling of Chemicals, Revision 4 ) 》。
近日獲悉勞動部已擬定計畫將台灣危害性分類及標示(CNS 15030) 依全球 GHS 紫皮書第八版修訂(然而該書目前最新版本為第十版)。因此建議勞動部能完善該版本修訂計畫、提供實施的詳細時程、安排溝通訓練及設定足夠的緩衝期,盼能將對業界的衝擊降至最低;不僅使業者能順利更新安全資料表(Safety Data Sheet, SDS),也能製備合規之GHS標示。
3.2 GHS實施內容應與國際標準接軌
目前危害性化學品標示及通識規則的實施與全球GHS 系統並未調和一致,依照全球 GHS 紫皮書之SDS 製備準則(Article A4.3.3.2),針對混合物應揭露造成健康與環境危害之危害成分辨識及濃度範圍,其並未要求揭露物理性危害成分。又,其他國家如加拿大、歐盟,亦不要求揭露於SDS 第三項之物理性危害成分。關於成分揭露的規範,於台灣法規《危害性化學品標示及通識規則》中的內容尚不夠明確。因此建議台灣應與國際標準接軌,考慮修法、發布指引或提供問答集的方式,將物理性危害的成分揭露排除在 SDS製備規則。
3.3 籲允許使用外文提交公司資訊
依照《危害性化學品標示及通識規則》法規第5條,「有關製造者、輸入者或供應者之名稱、地址及電話」欄位內容,係提供使用者有疑慮時,可進一步聯繫諮詢之資訊。對於進口之危害性化學品,其製造者、供應者為國外廠商,因國外廠商本無中文名稱,如改以中文標示,常因無適當翻譯文字,反而讓處理人員難以辨識,增加聯繫困難度。
委員會建議國外廠商名稱及地址可免譯成中文,可參考經濟部法規《商品標示法》,其第六條第二項對於進口之商品標示:「進口之商品除應依前項第二款規定標示外,並應標示國外製造商或國外委製商之外文名稱。」望主管機關依此參考且發布問答集或指引。