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    Title: 論新穎性食品管制措施在WTO/SPS協定下之合法性與貿易爭議
    A Study on the Legality and the Trade Issues of the Novel Food Regulations under WTO/SPS Agreement
    Authors: 賴珮萱
    Lai, Pei-Hsuan
    Contributors: 楊培侃
    Yang, Pei-Kan
    賴珮萱
    Lai, Pei-Hsuan
    Keywords: 新穎性食品
    新穎性食品規範
    傳統食品
    SPS協定
    食品安全性評估
    Novel food
    Novel food regulation
    Traditional food
    SPS Agreement
    Food safety assessment
    Date: 2020
    Issue Date: 2021-02-01 13:58:20 (UTC+8)
    Abstract: 隨著國際貿易的頻繁化及快速的科技發展,使用新興科技所生產之食品以及來自其他國家之未有安全食用歷史的食品,逐漸流通於各國之市場。對此等新穎性食品,因各國基於不同食品安全保護水準與飲食習慣所訂立之規範不盡相同,而此等規範差異逐漸形成貿易限制,從而引發新穎性食品管制規範是否符合世界貿易組織(World Trade Organization, WTO)食品安全檢驗與動物植物防疫檢疫措施協定(Agreement on the Application of Sanitary and Phytosanitary Measures,SPS協定)規範要求之疑慮。因此,本文擬先探討新穎性食品的基本概念後,分別針對新穎性食品之定義規範、風險評估措施與上市前核准機制等三種管制態樣,探討各國之新穎性食品規範內容之差別與可能引起貿易爭議之管制措施。

    經檢視WTO/SPS協定之規定與WTO會員曾經提出的貿易關切內容,本文認為屬於「未有安全食用歷史」而受管制之新穎性食品,管制上大多依據各國訂立之SPS適當保護水準(appropriate level of protection),因而可能引發審核規範本身是否基於科學證據原則,或是造成歧視性待遇之疑慮。又新穎性食品種類繁多,若統一適用同一審核程序,可能對食用風險較低之食品產生不必要貿易障礙。就程序性規範而言,其不僅應詳列流程,亦需從中減少可能產生不當遲延等事項,以減少進口產品進入市場所應花費之成本。針對以上可能引發之貿易爭議,本文透過法規與實務案例整理,更進一步瞭解新穎性食品法規制定之雛形。
    With the rapid development of technology and increasing international trade, foods that are produced by advance technology or those do not provide significant history of consumption have existed in markets globally. Governments usually enact food safety legislation on these so-called “novel foods” based on the patterns of diet of citizen as well as different appropriate levels of protection. Therefore, the regulations vary from country to country and may lead to trade barriers. The possibility of establishing trade restrictions triggers the discussion of legality on novel food regulations under WTO/SPS agreement. Considering the matter in this aspect, this essay first delineates the essential concept of novel food, and further examines the difference among novel food regulations together with potential trade disputes through three types of regulatory measures, including definition, risk assessment and pre-market authorisation.

    When it comes to the food without labeling the “history of safe use”, countries generally design inspectional measures based on individual “SPS appropriate level of protection”. By reviewing WTO/SPS agreement and specific trade concerns submitted by WTO members, this kind of measures may result in the violation of scientific justification and non-discrimination rules. Furthermore, due to the great variety of categories novel food includes, applying “one size fits all” option may create unnecessary trade barriers to low-risk food. With respect to procedural law, governments should reduce the cost that exporters should spend by listing the process thoroughly and decreasing the frequency of “undue delay”. Based on the trade rules and past jurisprudence under WTO, this article aims to analyze the legality of novel food regulations under WTO/SPS agreement based on existing novel food regulations and practices by selected states.
    Reference: 一、中文文獻
    (一)專書
    李國欽、徐慈鴻,GMO/GMF風險評估和風險管理方法,收於:郭華仁、牛惠之編,基因改造議題—從紛爭到展望(2004年)。
    林彩瑜,WTO制度與實務─世界貿易組織法律研究(三),2版(2013年)。
    林勤富、蘇昱心,我國輸入食品系統性查核規範之WTO適法性初探,收於:元照出版,月旦醫事法研究(四):食品風暴下的風險控制與事故責任(2019年)。
    羅昌發,國際貿易法,2版(2010年)。

    (二)期刊
    牛惠之,世界貿易組織之SPS協定關於風險評估與風險管理之規範體系與爭端案例研究,台灣國際法季刊,1卷2期,頁151,236(2004年)。
    林彩瑜,從歐體生技產品爭端之裁決論SPS協定對GMO規範之影響,臺大法學論叢,36卷4期,頁257-323(2007年)。
    高怡婷,食品原料安全管理,農業生技產業季刊,49期,頁26,28(2017年)。
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    黃慶輝,基因編輯食品之未來與國際情勢,農政與農情,329期,頁116-120(2019年)。
    楊培侃,從私營標準之發展論SPS協定在全球食品安全治理之功能與限制,科技法律評論,11卷1期,頁29-74(2014年)。
    葉安儀,奈米科技與食品,科學發展,418期,頁42-47(2007年)。
    譚偉恩、許耀明,論WTO《SPS協定》與Codex瘦肉精安全標準之適當性,科技法學評論,12卷1期,頁1-55(2015年)。

    (三)法規
    《新食品原料申報與受理規定》,第6、12、13、16、20、22條。
    《新食品原料安全性審查規程》,第4、7、8、10、11、14-23條。
    《新食品原料安全性審查管理辦法》,第22條
    《新食品原料安全性審查管理辦法》,第2條。
    食品安全衛生管理法,第3條第11項。

    (四)政府、機構文件
    非傳統性食品原料申請作業指引,頁1-5。
    徐遵慈,《加拿大食品安全法》(Safe Food For Canadians Act)之研析,2015年9月,中華經濟研究院(WTO及RTA中心)頁5,網址:https://www.trade.gov.tw/Files/Doc/94c4d580-9bc6-49b7-8d59-7523c2f2b286.pdf(最後瀏覽日:2020年11月14日)。
    國家衛生計生委政務公開辦關於新食品原料、普通食品和保健食品有關問題的說明。
    國家衛生計生委關於印發《新食品原料申報與受理規定》和《新食品原料安全性審查規程》的通知,衛食品發〔2013〕23號。

    (五)網頁資料
    日本認定符合技術與安全規範基因編輯食品將可採用既有之食品法規進行規範與販售,農業科技決策資訊平台,2019年4月9日,網址:https://agritech-foresight.atri.org.tw/article/contents/1734(最後瀏覽日:2020 年 11 月 10 日)。
    江昱瑩,「試析SPS協定第2.3條相同或類似情況要件之解釋——兼論日本食品輸台管制措施合致性」,政治大學國際經貿組織暨法律研究中心經貿法訊,255期,頁19,網址:http://www.tradelaw.nccu.edu.tw/epaper/no255/2.pdf(最後瀏覽日:2021年1月10日)。
    呂斯文,食品衛生檢驗及動植物檢疫措施與風險分析,行政院農業委員會全球資訊網,2001年5月,網址:https://www.coa.gov.tw/ws.php?id=3903&print=Y(最後瀏覽日:2021年1月6日)。
    谷艷杰,中國新食品原料申報與審批現狀及分析,中國REACH解決中心-杭州瑞旭科技集團有限公司,2020年4月10日,網址:http://www.cirs-group.com/foodcn/news/11584.html(最後瀏覽日:2020年11月17日)。
    林綺珊、李佩芬,越來越夯的機能性食品,聯合電子報,2011年5月26日,網址:https://paper.udn.com/udnpaper/POE0020/195190/web/(最後瀏覽日:2020年11月9日)。
    食品藥物管理局,什麼是「健康食品」?讓食品藥物管理署來告訴您!,衛生福利部,2014年7月24日,網址:https://www.mohw.gov.tw/cp-3203-21850-1.html(最後瀏覽日:2020年11月10日)。
    國際食品法典委員會(CODEX),行政院農業委員會動植物防疫檢疫局,網址:https://www.baphiq.gov.tw/ws.php?id=12340(最後瀏覽日:2021年1月8日)。
    黃貞禎,保健食品這樣吃,精巧補充所需營養素,中國醫藥大學附設醫院,2020年2月19日,網址:https://www.cmuh.cmu.edu.tw/NewsInfo/NewsArticle?no=4761(最後瀏覽日:2020年11月9日)。
    經濟部國際貿易局-多邊組第二科,OECD簡介及我國參與情形,經濟部國際貿易局經貿資訊網,2016年8月26日,網址:https://www.trade.gov.tw/Pages/Detail.aspx?nodeid=251&pid=573934(最後瀏覽日:2021年1月8日)。
    衛生福利部食品藥物管理署,可供食品使用原料彙整一覽表,衛生福利部食品藥物管理署,網址:https://consumer.fda.gov.tw/food/material.aspx?nodeid=160&p=5(瀏覽日期:2020年11月10)。
    賴珮萱,「試析『韓國—輻射案』—以SPS協定第5.6及2.3條為中心」,政治大學國際經貿組織暨法律研究中心經貿法訊,231期,頁17-36,網址:http://www.tradelaw.nccu.edu.tw/epaper/no231/3.pdf(最後瀏覽日:2020年11月18日)。
    賴珮萱、吳彥容,「從 SPS 協定觀點分析歐盟新穎性食品規則—— 以『來自第三國之傳統食品』爭議為中心」,政治大學國際經貿組織暨法律研究中心經貿法訊,241期,頁6-22,網址:http://www.tradelaw.nccu.edu.tw/epaper/no241/2.pdf(最後瀏覽日:2020年11月18日)。

    二、外文文獻
    (一)專書
    Fortin, Neal D., Food Regulation Law, Science, Policy, and Practice (2nd ed. 2017).
    Frestedt, Joy L., Food, Food Additives, and Generally Regarded as Safe (GRAS) Food Assessments, in Food Control and Biosecurity 543-565 (Alina Maria Holban & Alexandru Mihai Grumezescu eds., 2018).
    Gruszczynski, Lukasz, Regulating Health and Environmental Risks under WTO Law (1st ed. 2010).
    Gulati, Om P., et al., Botanical Nutraceuticals (Food Supplements and Fortified and Functional Foods) and Novel Foods in the EU, with a Main Focus on Legislative Controls on Safety Aspects, in Nutraceutical and Functional Food Regulations in the United States and around the World 315 (Debasis Bagchi ed. 2019).
    Hendrich, Suzanne, Novel Foods, in Encyclopedia of Food and Health, 79-83 (Benjamin Caballero, Paul M. Finglas & Fidel Toldrá eds., 2016).
    Knudsen, I., et al., Risk Management and Risk Assessment of Novel Plant Foods: Concepts and Principles (2005).
    Maria, Leena, et al., Ethical and Regulatory Issues in Applications of Nanotechnology in Food, in Food Nanotechnology Principles and Applications 67-92 (C. Anandharamakrishnan, S. Parthasarathi eds., 2019).
    Organization for Economic Cooperation and Development [OECD], Introduction to OECD Work on Novel Food and Feed Safety, in Safety Assessment of Foods and Feeds Derived from Transgenic Crops, Volume 3 (2019).
    Pisanello, Daniele and Caruso, Giorgia, Novel Foods in the European Union (Salvatore Parisi ed., 2018).
    Popa, M. E. and Popa, A., Consumer Behavior: Determinants and Trends in Novel Food Choice, in Novel Technologies in Food Science 137-158 (A. McElhatton et al. eds., 2012).
    Shao, Andrew, Global Market Entry Regulations for Nutraceuticals, Functional Foods, Dietary/Food/Health Supplements, in Nutraceutical and Functional Food Regulations in the United States and Around the World 279-290 (Debasis Bagchi ed., 2014).
    van der Meulen, Bernd M.J., Development of Food Legislation around the World, in Ensuring Global Food Safety 5-69 (Christine E. Boisrobert et al. eds, 1st ed. 2009).

    (二)期刊論文
    Howlett, J., et al., The Safety Assessment of Novel Foods and Concepts to Determine Their Safety in Use, Int’l J. of Food Sci. and Nutrition 54(Supp.) S1, S32 (2003).
    Kennody, Kevin C., Resolving International Sanitary and Phytosanitary Disputes in the WTO: Lessons and Future Directions, 55 Food & Drug L.J. (2000).
    Schebesta, Hanna & Sinopoli, Dominique, The Potency of the SPS Agreement’s Excessivity Test: The Impact of Article 5.6 on Trade Liberalization and the Regulatory Power of WTO Members to take Sanitary and Phytosanitary Measures, 21(1) J. of Int’l Economic Law (2018).

    (三)WTO協定、案例與相關文件
    Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, 1867 U.N.T.S. 493.
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    Committee on Sanitary and Phytosanitary Measures, Summary of The Meeting of 8-9 October 2008, WTO Doc. G/SPS/R/53 (Dec. 22, 2008).
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    Committee on Sanitary and Phytosanitary Measures, Comments on the Proposal for a Regulation of the European Parliament and of the Council on Novel Foods (Document G/SPS/N/EU/64), WTO Doc. G/SPS/GEN/1383 (Mar. 3, 2015).
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    (四)外國法規與條約
    21 C.F.R. § 170.3(f), (h), (i).
    21 C.F.R. § 170.30(b).
    21 C.F.R. Pt. 181.
    21 CFR 171.1.
    21 U.S.C. § 321(s).
    Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards System (with Annexes), Austl.-N.Z., Dec. 5 1995, 1938 U.N.T.S. 249.
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    The Comprehensive and Progressive Agreement for Trans-Pacific Partnership art. 7.7.2, Mar. 8, 2018 (entered into forced Jan. 14, 2019), https://www.mfat.govt.nz/assets/Trade-agreements/TPP/Text-ENGLISH/7.-Sanitary-and-Phytosanitary-Measures-Chapter.pdf (last visited Jan. 12, 2021).

    (五)聯邦公報
    Substances Generally Recognized as Safe, 62 Fed. Reg. 18938-18964 (proposed Apr. 17, 1997).
    Substances Generally Recognized as Safe, 81 Fed. Reg. 54960, 54960-55055 (Aug. 17, 2016) (to be codified at 21 C.F.R. Pt. 20, 25, 170, 184, 186, and 5707).

    (六)機構文件
    Advisory Committee on Novel Foods [ACNF], Guidance Tool for Determining Whether a Food is Novel or Not, https://www.foodstandards.gov.au/industry/novel/documents/Guidance%20Tool%20-%20for%20website%20_2_.pdf (last visited Nov. 17, 2020)
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    Commission Recommendation of 29 July 1997, Concerning the Scientific Aspects and the Presentation of Information Necessary to Support Applications for the Placing on the Market of Novel Foods and Novel Food Ingredients and the Preparation of Initial Assessment Reports under Regulation (EC) No 258/97 of the European Parliament and of the Council, art. 3.10, 1997 O.J. (L 253) 1, 36.
    Commission Staff Working Document Does Not Necessarily Represent the Views of the Commission Draft Report on Impact Assessment for a Regulation Replacing Regulation (EC) No 258/97 on Novel Foods and Novel Food Ingredients, COM (2007) 872 final.
    European Commission, Novel Food (2016), https://op.europa.eu/en/publication-detail/-/publication/f3040819-e136-11e6-ad7c-01aa75ed71a1/language-en/format-PDF.
    FAO and WHO, FAO, WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agricultural Sectors: Potential Food Safety Implication xvii-xviii, http://www.fao.org/3/i1434e/i1434e00.pdf.
    FAO and WHO, State of the Art on the Initiatives and Activities Relevant to Risk Assessment and Risk Management of Nanotechnologies in the Food and Agriculture Sectors: FAO/WHO Technical Paper (2013), http://www.fao.org/3/i3281e/i3281e.pdf.
    FSANZ, Food Standards Australia New Zealand Application Handbook 103-105 (2019), https://www.foodstandards.gov.au/code/applications/Documents/Application%20Handbook%20as%20at%201%20July%202019.pdf.
    FSANZ, Questionnaire to Be Completed by Enquirer, https://www.foodstandards.gov.au/industry/novel/Documents/Questionnaire%20-%20for%20ACNF%20enquiry.pdf (last visited Nov. 17, 2020).
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    Description: 碩士
    國立政治大學
    國際經營與貿易學系
    106351046
    Source URI: http://thesis.lib.nccu.edu.tw/record/#G0106351046
    Data Type: thesis
    DOI: 10.6814/NCCU202100030
    Appears in Collections:[國際經營與貿易學系 ] 學位論文

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