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    Title: 中國化妝品管理法規與WTO技術性貿易障礙協定之適法性分析
    Analysis on Legality of Cosmetics Regulation in China under WTO/TBT Agreement
    Authors: 謝欣晏
    Hsieh, Hsin-Yen
    Contributors: 楊培侃
    謝欣晏
    Hsieh, Hsin-Yen
    Keywords: 世界貿易組織
    化妝品
    TBT協定
    中國
    技術性貿易障礙
    特定貿易關切
    WTO
    cosmetics
    TBT Agreement
    China
    technical barrier to trade
    specific trade concern
    Date: 2020
    Issue Date: 2020-03-02 10:58:03 (UTC+8)
    Abstract: 隨著經濟發展、人均可支配收入提高,化妝品不再只是奢侈品,而是人們日常生活用品之一部分,並因著全球化及國際貿易之發展,各國人民有更多機會購買到其他國家之化妝品,各國化妝品產業隨之蓬勃發展。

    近十年來,中國化妝品產業之市場規模不斷地增長,根據Euromonitor所調查之數據,中國消費額就全球化妝品市場占比率自2018年開始已超越美國,成為全球最大的化妝品市場。然而中國化妝品目前之管理架構及法規係源於1989年間訂定之《化妝品衛生監督條例》(Regulations Concerning the Hygiene Supervision over Cosmetics)及其他相關規定,對於這個不斷更新進步迅速之產業,這個已經使用了30年的規範體系似乎不足以因應現今化妝品產業之快速發展,加上中國之化妝品規範沒有一個系統性的架構,多個機構之規定可能重複甚至解釋不一,導致法規適用不易。中國當局未忽視其化妝品市場之規模和增長,自2018年開始,對化妝品主管機關整合及規範進行系統性大調整。

    有關化妝品法規,常涉及技術性貿易障礙之爭議,中國自加入WTO以來,被WTO會員提出多次有關化妝品規範之技術性貿易障礙關切,而針對近兩年中國化妝品規範之調整,亦衍生出新的關切案。基於中國為目前國際上最大之化妝品市場,且其規範可能對其他WTO會員之化妝品進口造成影響,是以本文將從中國化妝品法規有關之TBT特定貿易關切切入,針對中國現行化妝品管理法規以及正在修訂之重要草案進行分析,探討各該法規或草案與WTO技術性貿易障礙協定間之適法性,並做出初步之評估。
    With the growth of economy and increase of per capita disposable income, cosmetics are no longer just luxury goods, but a part of people's daily necessities. Due to the development of globalization and international trade, people have more opportunities to buy cosmetics from other countries through international trade.

    In the past ten years, the market size of China's cosmetics industry has been continuously increasing. According to Euromonitor’s data, China ’s consumption has surpassed the United States in terms of the global cosmetics market share since 2018, and becomes the largest cosmetics market in the world. However, the current rules and regulatory structure of cosmetics in China are derived from the Regulations Concerning the Hygiene Supervision over Cosmetics and other related regulations established in 1989. For this industry that is constantly updated and progressed, the China cosmetics regulation system, which has been in use for 30 years, seems to be insufficient to cope with the rapid developments of the cosmetics industry today. In addition, China's cosmetic regulations do not have a systematic structure, and the regulations of multiple agencies may be repeated or even interpreted differently, resulting in difficult application of regulations. However, the Chinese authorities have not neglected the scale and growth of their cosmetics market. Since 2018, they have systematically adjusted and integrate its regulation and authorities.

    Cosmetics regulations often involve disputes over technical barriers to trade. Since China's accession to the WTO, other WTO members have raised various specific trade concerns about technical barriers to trade in cosmetics rules and standards, and China’s regulatory reforms of cosmetics in the past two years have also generated new concerns about trade. Given that China’s cosmetics market is currently the largest in the world, and its regulations may affect the import of cosmetics by other WTO members, this thesis will summarize TBT specific trade concerns related to China's cosmetics regulations, and analyze China's current regulatory reforms on cosmetics and revised rules introduced in the draft regulations. Finally, this thesis will examine the legality of selected rules with the WTO TBT Agreement, and conclude with policy recommendations.
    Reference: 壹、中文部分

    一、專書
    1. 羅昌發,國際貿易法(2010)。
    2. 經濟部國際貿易局,有關東協化妝品指令重點說明及印尼、泰國、馬來西亞、菲律賓、越南、緬甸進口化妝品流程及相關規定(2017)。

    二、期刊/論文
    1. 周燈學,我國化妝品監管體制和法規介紹(進口化妝品),上海市食品藥品監督所審核科報告(2011)。
    2. 張晉京,我國化妝品的法規、監管及挑戰,口腔護理用品工業ORAL CARE INDUSTRY,第21卷第1冊(2011)。
    3. 莊涵因,「技術性法規」?─初步評析 TBT 協定是否適用於歐盟化妝品動物實驗禁令,貿易政策論叢,第20期(2013)。
    4. 莊涵因,動物福利措施於WTO規範之合致性─以歐盟化妝品規則為個案研究,國立政治大學國際經營與貿易研究所碩士論文(2013)。
    5. 姚金成、曾令貴、林新文、胡領、杜娟、黎銀波、饒健,我國化妝品安全監測體系的現狀及相關對策,中國藥房,第25卷第9期(2014)。
    6. 張南薰,從WTO之「歐體海豹產品案」看TBT協定第2.1條及第2.2條與GATT1994第XX之關係,貿易政策論叢,第24期(2015)。

    三、政府資料
    1. 中華人民共和國國家統計局統計資料,網址:http://data.stats.gov.cn/easyquery.htm?cn=A01&zb=A070403&sj=201911
    2. 中華人民共和國海關總署統計資料,網址:http://www.customs.gov.cn/customs/302249/302274/302277/index.html
    3. 中華人民共和國中央人民政府,第十屆全國人民代表大會第一次會議關於國務院機構改革方案的決定,國務院公報(2003年)。
    4. 中華人民共和國中央人民政府,關於國務院機構改革和職能轉變方案的說明(2013)。
    5. 中華人民共和國國務院令,第709號(2019)。
    6. 國務院辦公廳,國務院辦公廳關於印發國家食品藥品監督管理局主要職責內設機構和人員編制規定的通知,國辦發[2003]31號(2003)。
    7. 國家質量監督檢驗檢疫總局,中華人民共和國國家質量監督檢驗檢疫總局令第100號(2007)。
    8. 國家食品藥品監督管理局,國食藥監許[2009]856號(2009)。
    9. 國家食品藥品監督管理局,國家食品藥品監督管理局關於印發化妝品命名規定和命名指南的通知,國食藥監許〔2010]72號(2010)。
    10. 國家食品藥品監督管理局,關於印發化妝品行政許可檢驗管理辦法的通知,國食藥監許〔2010〕82號(2010)。
    11. 國家食品藥品監督管理局,關於印發化妝品行政許可檢驗機構資格認定管理辦法的通知,國食藥監許〔2010〕83號(2010)。
    12. 國家藥品監督管理局,關於印發化妝品中可能存在的安全性風險物質風險評估指南的通知,國食藥監許〔2010〕339號(2010)。
    13. 國家藥品監督管理局,關於印發化妝品技術審評要點和化妝品技術審評指南的通知,國食藥監許〔2010〕93號(2010)。
    14. 國家藥品監督管理局,關於實施化妝品產品技術要求規範(國食藥監許〔2010〕454號)有關問題的通知,國食藥監許〔2011〕119號(2011)。
    15. 國家食品藥品監督管理局,關於印發國產非特殊用途化妝品備案管理辦法的通知,國食藥監許〔2011〕181號(2011)。
    16. 國家食品藥品監督管理局,關於印發化妝品新原料申報與審評指南的通知,國食藥監許〔2011〕207號(2011)。
    17. 國務院辦公廳,國務院辦公廳關於印發國家食品藥品監督管理總局主要職責內設機構和人員編制規定的通知,國辦發〔2013〕24號(2013)。
    18. 國家食品藥品監督管理總局,2014年第11號—關於發布已使用化妝品原料名稱目錄的通告(2014)。
    19. 國家食品藥品監督管理總局,關於發布已使用化妝品原料名稱目錄(2015版)的通告,2015年第105號函(2015)。
    20. 國家質量監督檢驗檢疫總局,國家質量監督檢驗檢疫總局令第163號(2015)。
    21. 國家食品藥品監督管理總局,關於徵求調整更新已使用化妝品原料名稱目錄意見的函,食藥監藥化管便函〔2015〕657號(2015)。
    22. 國家食品藥品監督管理總局CFDA,關於做好化妝品生產許可有關工作的通知,食藥監藥化監〔2015〕265號(2015)。
    23. 國家食品藥品監督管理總局(CFDA),關於《化妝品監督管理條例(修訂草案送審稿)》的說明(2015)。
    24. 國家食品藥品監督管理總局(CFDA),關於《化妝品監督管理條例(修訂草案送審稿)》公開徵求意見的通知(2015)。
    25. 國家工商行政管理總局,國家工商行政管理總局令第92號(2017)。
    26. 國家食品藥品監督管理總局,總局辦公廳公開徵求《化妝品分類規範(徵求意見稿)》意見(2018)。
    27. 國務院,國務院關於機構設置的通知,國發〔2018〕6號(2018)。
    28. 國家藥品監督管理局,關於發布實施化妝品註冊和備案檢驗工作規範的公告,國家藥監局公告2019年第72號(2019)。
    29. 國家藥品監督管理局,《關於發布實施化妝品註冊和備案檢驗工作規範的公告》政策解讀(2019)。
    30. 國家藥品監督管理局,關於取消36項證明事項的公告(2019年第34號)(2019)。
    31. 衛生部,衛監督發[2006]124號(2006)。

    四、 網路資料
    陳燕飛,2019年化妝品監管六大任務出爐,中國醫藥報,2019年1月23日,網址:https://new.qq.com/omn/20190123/20190123A130PV.html

    貳、英文部分

    一、網路資料
    China’s Consumers Drive Global Beauty Demand, MORGAN STANLEY RESEARCH, Oct. 21, 2019, available at: https://www.morganstanley.com/ideas/china-beauty-products-growth

    二、WTO文件
    1. WTO ANALYTICAL INDEX, TBT Agreement – Article 2 (Jurisprudence)
    2. WTO ANALYTICAL INDEX, TBT Agreement – Article 5 (Jurisprudence)
    3. WTO ANALYTICAL INDEX, TBT Agreement – Annex 1 (Jurisprudence)

    三、WTO案件
    1. Appellate Body Report, Japan-Taxes on Alcoholic Beverages, WT/DS8/AB/R, WT/DS10/AB/R, WT/DS11/AB/R (Oct. 4, 1996).
    2. Appellate Body Report, European Communities-Measures Affecting Asbestos and Asbestos-Containing Products, WT/DS135/AB/R (Mar. 12, 2001).
    3. Appellate Body Report, United States-Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, WT/DS381/AB/R (May 16, 2012).
    4. Appellate Body Report, European Communities-Measures Prohibiting the Importation and Marketing of Seal Products, WT/DS400/AB/R and WT/DS401/AB/R (May 22, 2014).
    5. Panel Report, United States-Measures Affecting the Production and Sale of Clove Cigarettes, WT/DS406/R (Sep. 2, 2011).
    6. Panel Report, United States-Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, WT/DS381/R (Sep. 15, 2011).
    7. Panel Report, United States-Certain Country of Origin Labelling (COOL) Requirements, WT/DS384/R, WT/DS386/R (Nov. 8, 2011).
    8. Panel Report, European Communities-Measures Prohibiting the Importation and Marketing of Seal Products, WT/DS400/R and WT/DS401/R (Nov. 25, 2013).
    9. Panel Report, United States- Certain Country of Origin Labelling (COOL) Requirements, WT/DS384/39 and WT/DS386/40 (Dec. 11, 2015).
    10. Panel Report, Russia-Measures Affecting the Importation of Railway Equipment and Parts Thereof, WT/DS499/R (adopted Aug. 27, 2018)
    11. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/730 (Mar. 25, 2010).
    12. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/821 (June 8, 2011).
    13. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/937 (Dec. 21, 2012).
    14. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/1019 (Feb. 4, 2014).
    15. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/1064 (Dec. 12, 2014).
    16. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/1310 (Dec. 18, 2018).
    17. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/1311 (Feb. 22, 2019).
    18. WTO, Committee on Technical Barriers to Trade, Notification, G/TBT/N/CHN/1331 (June 6, 2019).
    19. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 24-25 MARCH 2011, Note by the Secretariat, G/TBT/M/53 (May 26, 2011).
    20. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 15-16 JUNE 2011, Note by the Secretariat, G/TBT/M/54 (Sep. 20, 2011).
    21. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 10-11 NOVEMBER 2011, Note by the Secretariat, G/TBT/M/55 (Feb. 9, 2012).
    22. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 20-21 MARCH 2012, Note by the Secretariat, G/TBT/M/56 (May 16, 2012).
    23. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 13-15 JUNE 2012, Note by the Secretariat, G/TBT/M/57 (Sep. 18, 2012).
    24. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 27-28 NOVEMBER 2012, Note by the Secretariat, G/TBT/M/58 (Feb. 6, 2013).
    25. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 6-7 MARCH 2013, Note by the Secretariat, G/TBT/M/59 (May 8, 2013).
    26. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 17, 19 AND 20 JUNE 2013, Note by the Secretariat, G/TBT/M/60 (Sep. 23, 2013).
    27. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 18-19 MARCH 2015, Note by the Secretariat, G/TBT/M/65 (May 28, 2015).
    28. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 17-18 JUNE 2015, Note by the Secretariat, G/TBT/M/66 (Sep. 17, 2015).
    29. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 4-6 NOVEMBER 2015, Note by the Secretariat, G/TBT/M/67 (Feb. 3, 2016).
    30. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 9-10 MARCH 2016, Note by the Secretariat, G/TBT/M/68 (May 12, 2016).
    31. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 15-16 JUNE 2016, Note by the Secretariat, G/TBT/M/69 (Sep. 22, 2016).
    32. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 10-11 NOVEMBER 2016, Note by the Secretariat, G/TBT/M/70 (Feb. 17, 2017).
    33. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 29-30 MARCH 2017, Note by the Secretariat, G/TBT/M/71 (June 2, 2017).
    34. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 14-15 JUNE 2017, Note by the Secretariat, G/TBT/M/72 (Sep. 25, 2017).
    35. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 8-9 NOVEMBER 2017, Note by the Secretariat, G/TBT/M/73 (Mar. 6, 2018).
    36. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 21-22 MARCH 2018, Note by the Secretariat, G/TBT/M/74 (May 22, 2018).
    37. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 20-21 JUNE 2018, Note by the Secretariat, G/TBT/M/75 (Sep. 14, 2018).
    38. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 14-15 NOVEMBER 2018, Note by the Secretariat, G/TBT/M/76 (Feb. 7, 2019).
    39. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 6-7 MARCH 2019, Note by the Secretariat, G/TBT/M/77 (May 15, 2019).
    40. WTO, Committee on Technical Barriers to Trade, MINUTES OF THE MEETING OF 20-21 JUNE 2019, Note by the Secretariat, G/TBT/M/78 (Sep. 23, 2019).

    四、 其他法律文件
    1. ASEAN Cosmetic Directive
    2. Appendix II–ASEAN Cosmetic Labeling Requirements Guidelines
    3. REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products
    Description: 碩士
    國立政治大學
    國際經營與貿易學系
    102351044
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0102351044
    Data Type: thesis
    DOI: 10.6814/NCCU202000173
    Appears in Collections:[國際經營與貿易學系 ] 學位論文

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