國際間對內分泌干擾化學物質之管理策略研究

Abstract

內分泌干擾化學物質 (Endocrine Disrupting Chemicals, EDCs) 為20世紀末逐漸受到關注的一類化學物質，泛指某些透過干擾人類與動物的內分泌系統，並以此造成不良健康影響之化學物質。其種類繁多包括殺蟲劑（如DDT）、工業用化合物（如PCBs 與烷基酚類）、溴化阻燃劑（如多溴聯苯）及燃燒或化學物質製程中產生的副產物（如戴奧辛物質）等。由於目前各國和各組織對EDCs的定義不甚相同，不同的定義鬆緊程度將關係後續的管理措施與規範內涵蓋物質，間接導致目前尚未發展出統一且健全的管理和篩選檢測EDCs之策略。 美國從上世紀末開始推動EDCs之管理策略，透過成立內分泌干擾物篩選計畫 (Endocrine Disruptor Screening Program, EDSP) 發展2階段之篩檢方法，此計畫在2012年更新為21世紀美國內分泌干擾物篩檢計畫 (EDSP21)，致力於發展新測試方法，以加快速率來篩檢管理數以萬計的龐大化學物質數量。EDSP採用一個涵蓋多個計劃和辦公室的管理組織結構，並在管理架構的每一層級中均衡代表各辦公室，以確保機構內合作監管機構之間的協調和溝通。 歐盟則是透過修訂植物保護產品與殺生物產品法規，來開啟對EDCs的管理。與美國和日本不同，歐盟採用7步驟的內分泌干擾物篩檢策略，講求如何收集、評估和考慮所有相關資訊來進行判斷物質是否滿足EDCs標準。近兩年則是透過新增CLP中的ED危害類別，進一步提升消費者對EDCs的識別與保護，同時修訂化學物質註冊、評估、授權和限制法規(Registration, Evaluation, Authorisation and Restriction of Chemicals, REACH)附件新增內分泌干擾物，於物質註冊資料中要求業者備妥內分泌干擾性質相關的測試、證據權重或文獻資料等，增加監管力度。 日本透過約每5年一次的EXTEND計畫進行滾動式檢討，更新評估與管理方法。最新的EXTEND2022強調內容英語化以促進國際合作。日本採用與美國相同的2階段EDCs篩檢方法，並積極與美、英合作研究新測試方法，共享數據與資訊，參與國際研討會，展現其在EDCs管理上的積極作為。 本研究使用文獻整理的方式，回顧並介紹EDCs之定義、常見用途、暴露途徑及對健康的各種危害，並蒐集整理美國，歐盟和日本之東西方先進國家對EDCs之管理脈絡與篩選檢測方法，研究分析各國策略異同，且比對各國之（疑似）內分泌干擾物質清單，提出對於臺灣管理EDCs現況之初步建議。

Endocrine Disrupting Chemicals (EDCs) emerged as a subject of concern in the late 20th century. These chemicals interfere with the endocrine systems of humans and animals, potentially causing adverse health effects. EDCs encompass a wide range of substances, including pesticides (e.g., DDT), industrial compounds (e.g., PCBs and alkylphenols), brominated flame retardants (e.g., polybrominated biphenyls), and byproducts generated during combustion or chemical manufacturing processes (e.g., dioxins). Due to variations in definitions adopted by different countries and organizations, the scope of substances covered and the stringency of management measures vary accordingly. This lack of consensus has hindered the development of a unified and comprehensive strategy for regulating, screening, and testing EDCs. The United States has been implementing EDC management strategies since the late 20th century. The Endocrine Disruptor Screening Program (EDSP) was established to develop a two-tiered screening method, which was updated in 2012 as the 21st Century Endocrine Disruptor Screening Program (EDSP21). EDSP21 focuses on developing new testing methodologies to accelerate the screening and regulation of tens of thousands of chemicals. The EDSP adopts a management framework that integrates multiple programs and offices, ensuring balanced representation at each level of governance to facilitate coordination and communication among regulatory agencies. The European Union has taken a different approach by amending regulations for plant protection and biocidal products to initiate EDC management. Unlike the United States and Japan, the EU employs a seven-step endocrine disruptor screening strategy, emphasizing the collection, evaluation, and consideration of all relevant information to determine whether a substance meets the criteria for EDCs. In recent years, the EU has strengthened consumer protection and awareness by adding an endocrine disruptor hazard category to the Classification, Labelling and Packaging (CLP) regulation. Additionally, amendments to the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation have introduced new requirements for registering substances with endocrine-disrupting properties, mandating companies to provide relevant test results, weight-of-evidence assessments, or scientific literature, thereby enhancing regulatory oversight. Japan conducts periodic reviews of its EDC management and assessment methods approximately every five years through the EXTEND program. The latest iteration, EXTEND2022, emphasizes the use of English to facilitate international cooperation. Japan follows the same two-tiered screening approach as the United States and actively collaborates with the US and the UK on research into new testing methodologies. Through data and information sharing, as well as participation in international conferences, Japan demonstrates its proactive stance on EDC management. This study employs a literature review to examine and introduce the definitions, common applications, exposure pathways, and health risks of EDCs. It also compiles and analyzes the management frameworks and screening/testing methods employed by the United States, the European Union, and Japan—representing advanced regulatory approaches from both Western and Eastern perspectives. By comparing the similarities and differences in national strategies and EDC substance lists, this study provides preliminary recommendations for the management of EDCs in Taiwan