中国、美国及欧盟化妆品监管体系的比较研究 Abstract Cosmetic industry came into being late in China. The Chinese cosmetic industry has begun since 1980's and developed rapidly since 1990's. It was not until 1989 that the first regulation on cosmetic administration------Cosmetic Hygiene Inspection Statute was issued, indicating that Chinese cosmetic hygiene administration has been on her track of according to 1aw. After over ten years, China has made great strides on cosmetic administration, but there are still some defects in it. Especially that the Chinese cosmetic industry is experiencing a rapid growth with a yearly increase over 15% in sale, but the regulations drawn in 1990's have appeared out of date. Otherwise, China is on the process of restructuring economy, both the market and the system are in their infancies, so the Chinese cosmetic industry has revealed quite a few problems during her development and are in urgent need of direction from government. In addition, China has entered the WTO and economic globalization has grown further, requirement for internationalization of law and administrative system has been placed on the agenda. U.S.A. and EU are ahead of cosmetic industry. Their legality buildings are also consummate. There are many advanced experiences on the aspect of cosmetic administration worth learning. On the other hand, there are essential differences among China, U.S.A. and EU. on legal system and legal culture, as well as on social system, political belief, cultural background, history and economic developing stage. So when we learn their experiences, we shall take account the current situation of China and base on the result of an in-depth study, get the cream purposefully and selectively, then can we find a suitable way to promote the overall progress of the industry. There are significant differences among China, U.S.A. and EU on cosmetic administration. China has successively issued over ten cosmetic regulations, there are several regulations relate to cosmetic, too; the Chinese cosmetic administrative system relies mainly on an examination and approval system but not a registration and recording system, belittles market supervision; there are several services in charge of the cosmetic industry. Whereas, both U.S.A. and EU have single complete act to administrate cosmetic; their administrative systems rely mainly on a registration and recording system, they stress on enterprises' self-discipline and has set up strong market supervising system to ensure cosmetic safety and market order; only one service is in charge of 澳門大學碩士學位論文 cosmetics. After comparison we find that there are several problems on the Chinese cosmetic administration: 1. Cosmetic regulations are out of date. There are quite a few defects in the basic law------Cosmetic Hygiene Inspection Statute and its enforcement regulation; regulations on cosmetic definition, classification, labeling, hygiene standard, manufacturing and market supervising are all in need of further improvement; there are conflicts in the contents of some regulations. 2. The examination and approval system has tied up a great deal of human and non-human sources and made against cultivating enterprises' self-discipline to develop the industry; the weak market-supervising power can not properly control adulterating occurrence. 3. Several departments in charging of cosmetics lead to duty conflict or buck-passing, administrative efficiency and effect are both poor; therefore, enterprises are at loose ends or take advantage of loopholes which hampering an orderly environment of competition to form. OBJECTIVES This thesis bases on current situation of China, makes an objective and intensive compare study of China, U.S.A. and EU cosmetic administrative systems, set forth suggestions and strategies about how to improve and how to accelerate the internationalization process of China cosmetic administrative system. I hope this thesis can be of help to related administrative departments of government and cosmetic enterprises. 1. To show differences of fundamentals of law among China, U.S.A. and EU. 2. To thoroughly understand the cosmetic legal and administrative system of three areas. 3. To find out defects of our cosmetic law and administrative system by comparing the legal and administrative systems of three areas. 4. To bring forward suggestions about how to amend the Cosmetic hygiene inspection statute and its enforcement regulations; and set forth strategies about how to improve and how to accelerate the internationalization process of China cosmetic administrative system. МЕТНOLODOGY Comparative method Policy study Literature survey study -5- 中国、美国及欧盟化妆品监管体系的比较研究 Comparative method is often used in social science, especially in realm of jurisprudence. This study uses comparative method to compare differences of cosmetic administrative substantive laws and systems of the three areas; Use policy study method, the main research materials are policy and regulation documents from government and official websites of the three areas; Use literature survey study method, thoroughly survey literatures and data on cosmetic hygiene inspection to provide evidences for my study. RESULTS AND STRATAGIES 1. Discuss flaws and make suggestions on Cosmetic hygiene inspection statute and its enforcement regulations, provide clear and strong basis for other regulations in the law system 2. to consummate. Comparative study found that the cosmetic definitions in several regulations are disaccord; oral hygiene products have not been in cosmetic range in actual administration. Set forth that cosmetic definition should be unified; oral hygiene products should be within cosmetic range no matter in law or in actual administration, making their labels and advertisements according to cosmetic standard are urgent affairs. 3. We shall put into practice an ingredient declaration and strengthen the demand for warnings in cosmetic labeling standard to help increase the admittance of cosmetic industry. 4. Some contents in cosmetic hygienic standard can not be put into effect limiting to our current economic and technique level, we should quicken research pace on method of hygienic chemical test, strengthen technique communication and cooperation among government, scientific institutions and advanced enterprises to optimize resource utilizing and promote technical progress. 5. Put forward strategy on how to consummate government administrative system: gradually transit current administrative mode of several services coordinating into single service taking full charge; reform administrative execution process and system to improve efficiency and effect; increase quality of law-executors to strengthen ranks building. 6. Bring forward strategy on how to improve cosmetic manufacture and distribution quality criterions: apply HACCP method to increase quality of manufacturing management; build -6- 7. 澳門大學碩士學位論文 distribution criterion by enhancing propagation and training to distributors to improve their legal consciousness. Found that our current administrating mode to adulterate products is time consuming and inefficient, set forth that we shall benefit from successful experiences of U.S.A. recall policy, expedite alerts speed and broaden alerts range to protect public health better and effectively punish illegal enterprises from aspect of social image. 8. Suggest government to establish cosmetic administration network information system to increase administrative efficiency and effect completely, also to promote administrative modernization. KEY WORDS Cosmetic Administrative system Legal system China U.S.A. EU

澳門大學碩士學位論文 摘要 化妝品行業在中國起步較晚,“八十年代起步,九十年代大發展”是對我國化妝品工業的 簡要概括。直到1989年我國才頒佈第一部化妝品衛生監管的法規《化妝品衛生監督條例》, 標誌著化妝品衛生監管走上法制化的軌道。經過十幾年的發展,我國在化妝品管理方面取 得了長足的進展,但仍存在許多缺陷。尤其是化妝品工業生產總值正在以高於15%的年增 長率發展,90年代制訂的法規則顯示出相對滯後。另外,我國正處在由計劃經濟向市場經 濟體制轉軌的過程中,市場和體制都仍處於較稚嫩的成長階段,因此化妝品產業在發展進 程中不斷暴露出很多新問題,亟待政府部門推出相應的法規和措施來為產業的健康有序發 展指明方向。而在我國已成為世界貿易組織(WTO)正式成員國和經濟全球化發展的今天,對 法律體系和監管體制國際化的要求也正被提上日程。 美國和歐盟的化妝品工業發展居世界領先地位,她們也是法制建設很完善的地區,在化 妝品管理體制和法律體系建設方面有很多值得我們學習和借鑒的先進經驗。但我們與美國、 歐盟在法律體系、法律文化方面都存在著根本的區別,在社會制度、政治信仰、文化背景、 發展歷史及經濟發展現狀等諸多方面也存在顯著的差異,這些都決定我們在參考發達國家 經驗的時候,必須結合我國的現實國情,在全面深入比較分析的基礎上有目的、有選擇地 取其精華,才能真正尋找到適合我國國情的健康快速發展之路。 在對化妝品監督管理方面,我國與美國、歐盟等發達地區就存在顯著的差異。我國先後 頒佈了十餘部化妝品管理法規,尚有多部其他法規與化妝品有關;實行以審批制為主,備 案制為輔的管理體制,重上市前審批而輕上市後監督;由政府多個行政單位協調管理化妝 品產業。而美國、歐盟等制訂實施一部完整健全的法案管理化妝品;實行以備案制為主的 管理體制,強調企業的自律,建立了強大的市場監督體系保證產品安全和市場有序;由政 府單一行政部門對化妝品行業進行管理。比較發現,我國的化妝品監督管理存在以下幾個 主要問題: 1. 化妝品法規滯後,基本大法——《化妝品衛生監督條例》及《實施細則》尚存在很多 缺陷;對化妝品的定義、分類、標籤、衛生標準、生產和市場監管各方面的法規規定也都 有待健全完善;多部法規間存在某些內容的衝突。 -1- 中国、美国及欧盟化妆品监管体系的比较研究 2. 審批制消耗大量人力物力,不利於培養行業的自律性以提高產業的整體素質;而市場 監督力量薄弱,無法有效控制假冒偽劣現象的發生。 3. 政府多頭管理導致職責重疊或責任推談,監督執法行政效率低且效果差,使企業無所 適從或有機可乘,不利於培育有序的競爭環境。 研究目的: 本文在認清我國現實國情的基礎上,對我國與歐盟、美國的化妝品監管體系進行深入客 觀地比較研究,提出促進我國化妝品監管體系進一步完善,加速其與國際接軌進程的策略 建議,以供政府有關部門和化妝品企業在實踐中參考。 1. 揭示我國與美國、歐盟化妝品監督管理的法律基礎的差別; 2. 全面系統地瞭解三地區的化妝品監管體系; 3. 通過比較研究發現我國化妝品監管體系中的不足和差距; 4. 提出我國《化妝品衛生監督條例》及《實施細則》 如何修改完善的建議;並提出我國 化妝品監管體制如何進一步健全,加快與國際先進監管體制接軌的策略。 研究方法: 比較法 政策研究法文獻調研法 在社會科學中,尤其是在法學領域,比較法是經常採用的。本課題運用比較的方法,重 在對三地區化妝品管理實體法和體制之間的比較研究;應用政策研究法,以三地區政府官 方網站上可獲得的法規性和政策性文件為主要研究資料;應用文獻調研法,對九八年以後 化妝品衛生監督方面的數據和資料進行深入調研,為本課題的研究提供論據。 研究結果和策略: 1. 探討和提出了我國《化妝品衛生監督條例》及《實施細則》現存的缺陷及進一步增強規範 性和可操作性的改進建議,為化妝品法律體系中其他法規規範的調整、補充和完善提供 明確堅實的基礎和依據。 2. 對三地區化妝品監管的比較研究發現,我國多部化妝品法規對化妝品定義不一致;口腔清 潔用品在監管操作中未歸入化妝品管理範圍。提出應統一化妝品定義;對口腔清潔用品 從法規上和監管實際工作中都歸入化妝品範圍,當務之急是將其標籤和廣告按化妝品標 準管理。 -2- 澳門大學碩士學位論文 3. 化妝品標籤標準應向歐美看齊,實行全成分標示,並加強對標籤警告語的要求,有助於促 進提高化妝品行業的技術准入門檻。 4. 化妝品衛生標準中的很多內容迫於我國目前經濟技術水準的限制無法切實落實,應加快對 其中衛生化學檢驗方法學的研究,並加強政府、科研機構和先進企業的技術交流及合作, 優化資源利用,共同推動技術進步。 5. 提出我國如何完善政府部門對化妝品行業管理和監督機制的策略:將目前的多個機構、協 調管理逐步轉變為單一機構、集中管理模式;健全行政執法制度和程式,提高行政執法 效率和效果;提高執法人員素質,加強執法監督隊伍建設。 6. 提出健全對化妝品生產和經營品質規範的策略:使用 HACCP 方法以提高化妝品生產品質 管制水準;通過加強宣傳和培訓提高經營者守法意識等措施建立對化妝品經營的規範。 7. 發現我國對缺陷產品的現有管理模式耗時低效,提出應借鑒美國化妝品召回制度的成功經 8. 驗,加快對不安全產品的警報速度,擴大警報範圍,以提高時效性,更好地保護公眾利 益,並從社會影響方面更加有效地懲治違規企業。 提出建立化妝品衛生管理網路資訊系統,轉變衛生行政監管的固有模式,以全面提高行政 效率和效果,促進行政管理現代化的策略。 關鍵字: 化妝品 法律體系 監管體制 中國 美國 歐盟 -3-