第三章 各國基因改造食品之標示規範與貿易爭議
第三節 歐盟基因改造食品標示規範
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第三節 歐盟基因改造食品標示規範
第一項 歐盟之基因改造食品管理政策
歐盟對於基因改造食品向來採取謹慎與保留之態度，尤其在基因改造食品之 安全議題在科學界尚未達成共識之前，歐盟消費者團體、環保團體、衛道人士以 及媒體均十分熱衷於基因改造食品安全性、生態環境、宗教與文化議題之探討；
歐盟亦發布委員會預防原則政策說明書（Communication from the Commission on the Precautionary Principle），建立歐盟對於生物科技產品之管理採取預防原則政 策之共識56。
歐盟從 1990 年代便開始訂定管理基因改造作物與基因改造食品之法規，甚 至基因改造飼料之專法，目的在於：一、保障人類、動物健康與環境；二、調和 風險評估程序，並建立有效率的、有時效性的、透明的基因改造產品許可制度；
三、確保標示制度清楚地使消費者與產業中之專業工作者享有「知」的權利；四、
建立基因改造產品之追蹤制度57。為達成以上目的，歐盟對基因改造食品之控管 項目包括田間試驗、上市、標示、追蹤、損害責任事宜、公眾參與及資訊公開等，
項目可謂十分全面，且於每個管理項目之嚴格度與掌控度亦為全球之冠。歐盟並 於 2002 年設置歐盟食品安全局（European Food Safety Authority, EFSA）為專門 管理單位。
歐盟基因改造管理法規之主要架構如下58：
56 COMMISSION OF THE EUROPEAN COMMUNITIES, Communication from the Commission on the Precautionary Principle, Feb. 2, 2000, available at:
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52000DC0001&from=EN (last visited Feb. 13, 2016).
57 EUROPEAN COMMISSION, GMO Legislation, Oct. 16, 2015, available at:
http://ec.europa.eu/food/plant/gmo/legislation/index_en.htm (last visited Feb. 13, 2016).
58 Id.
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使消費者享有選擇之自由（freedom to choose）；透過基因改造有機體生產與上市 流通所經每個階段之可溯及性管理，建立一套「安全網絡（safety net）」。
其中，2001/18 號指令基因改造有機體釋出環境規範、1829/2003 號規則基因
59 Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, 2001 O.J. (L 140) 1 [hereinafter the GMOs Deliberate Release Directive 2001/18], available at: http://eur-lex.europa.eu/legal-content/EN/LSU/?uri=celex:32001L0018 (last visited Feb. 15, 2016).
60 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, 2003 O.J. (L 268) 1 [hereinafter the GM Food and Feed Regulation 1829/2003], available at:
http://eur-lex.europa.eu/legal-content/EN/LSU/?uri=CELEX:32003R1829 (last visited Feb. 15, 2016).
61 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory, 2015 O.J. (L 68) 1, available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:JOL_2015_068_R_0001 (last visited Feb. 15, 2016).
62 Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, 2003 O.J. (L 268) 24 [hereinafter the GMOs Traceability and Labelling Regulation 1830/2003], available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:32003R1830 (last visited Feb. 15, 2016).
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（written consent）內容須含標示之規範（labelling requirements），其須依照附件 4 之規定；「本產品含基因改造成分」之文字須（shall）顯示（appear）於標示上。
附件 4 之第 A.8 點65規定，提交給專管單位之基因改造有機體釋出通知文件
（notification）中，須有提議之標示（proposed labelling），其至少須標明產品之 商業名稱、「本產品含基因改造成分」之敘述、所含基因改造成分之名稱、如何 透過註冊者提供之公開可得管道取得相關資訊，及標明第 A.2 點66所述之資訊：
63 The GMOs Deliberate Release Directive 2001/18, art. 21.1: “Member States shall take all necessary measures to ensure that at all stages of the placing on the market, the labelling and packaging of GMOs placed on the market as or in products comply with the relevant requirements specified in the written consent referred to in Articles 15(3), 17(5) and (8), 18(2) and 19(3).”
64 The GMOs Deliberate Release Directive 2001/18/EC, art. 19.3(e): “The written consent referred to in Articles 15, 17 and 18 shall, in all cases, explicitly specify: … (e) the labelling requirements, in compliance with the requirements laid down in Annex IV. The labelling shall clearly state that a GMO is present. The words "This product contains genetically modified organisms" shall appear either on a label or in a document accompanying the product or other products containing the GMO(s).”
65 The GMOs Deliberate Release Directive 2001/18, annex IV, A.8: “The following information shall be provided in the notification for placing on the market of GMOs as or in product in addition to that of Annex III: …8. proposed labelling on a label or in an accompanying document. This must include, at least in summarised form, a commercial name of the product, a statement that "This product contains genetically modified organisms", the name of the GMO and the information referred to in point 2, the labelling should indicate how to access the information in the publicly accessible part of the register.”
66 The GMOs Deliberate Release Directive 2001/18, annex IV, A.2: “…2. name and full address of the person established in the Community who is responsible for the placing on the market, whether it be
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additional labelling），其可能（may）係第 A.4、A.5、B.1、B.2、B.3 與 B.4 點所 述之資訊；其中，第 A.4 點68為：該產品與該基因改造成分之用途描述，該基因the manufacturer, the importer or the distributor.”
67 The GMOs Deliberate Release Directive 2001/18, annex IV, B.7: “The following information shall be provided in the notification, when relevant, in addition to that of point A, in accordance with Article 13 of this Directive: … 7. proposed additional labelling. This may include, at least in summarised form, the information referred to in points A 4, A 5, B 1, B 2, B 3 and B 4.”
68 The GMOs Deliberate Release Directive 2001/18, annex IV, A.4: “… 4. description of how the product and the GMO as or in product are intended to be used. Differences in use or management of the GMO compared to similar non-genetically modified products should be highlighted”
69 The GMOs Deliberate Release Directive 2001/18, annex IV, A.5: “… 5. description of the geographical area(s) and types of environment where the product is intended to be used within the Community, including, where possible, estimated scale of use in each area.”
70 The GMOs Deliberate Release Directive 2001/18, annex IV, B.1: “… 1. measures to take in case of unintended release or misuse.”
71 The GMOs Deliberate Release Directive 2001/18, annex IV, B.2: “… 2. specific instructions or recommendations for storage and handling.”
72 The GMOs Deliberate Release Directive 2001/18, annex IV, B.3: “…3. specific instructions for carrying out monitoring and reporting to the notifier and, if required, the competent authority, so that the competent authorities can be effectively informed of any adverse effect. These instructions should be consistent with Annex VII part C.”
73 The GMOs Deliberate Release Directive 2001/18, annex IV, B.4: “…4. proposed restrictions in the approved use of the GMO, for example where the product may be used and for what purposes.”
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者（final consumer）或餐飲服務商（caterer）之食品：(a)含有 或包含基因改造有機體；或(b)生產自基因改造有機體，或所用 上不可避免地（adventitious or technically unavoidable）含有、包含或生產自基因改造物質，且其含量不高於（no higher than）
該項食品組成成分之 0.9%者。
74 The GM Food and Feed Regulation 1829/2003, art. 12.1: “1. This Section shall apply to foods which are to be delivered as such to the final consumer or mass caterers in the Community and which: (a) contain or consist of GMOs; or (b) are produced from or contain ingredients produced from GMOs.”
75 “The labelling should include objective information to the effect that a food or feed consists of, contains or is produced from GMOs. Clear labelling, irrespective of the detectability of DNA or protein resulting from the genetic modification in the final product, meets the demands expressed in numerous surveys by a large majority of consumers, facilitates informed choice and precludes potential misleading of consumers as regards methods of manufacture or production.”
76 The GM Food and Feed Regulation 1829/2003, art. 12.2: “2. This Section shall not apply to foods containing material which contains, consists of or is produced from GMOs in a proportion no higher than 0,9 per cent of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.”
77 The GM Food and Feed Regulation 1829/2003, art. 12.3: “3. In order to establish that the presence of this material is adventitious or technically unavoidable, operators must be in a position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material.”
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modified）」或「生產自基因改造（成分之名稱）（produced from genetically modified (name of the ingredient))」78。2. 第 13.1(b)條規定，當一項（基因改造）成分係由一項食品類別
（category）之名稱為命名時，該成分表中須標明「含基因改造
（ 有 機 體 之 名 稱 ）（ contains genetically modified (name of organism)）」或「含基因改造（有機體之名稱）生產之（成分之 名稱）（contains (name of ingredient) produced from genetically modified (name of organism)）」79。
3. 第 13.1(c)條規定，倘無成分表，則應於標示上標明「基因改造」
或「生產自基因改造（有機體之名稱）」80。
4. 第 13.1(d)條規定，第(a)與(b)之文字得以成分表之註腳（footnote）
之方式呈現。其字體大小至少應與成分表中的字體同。倘無成 分表，則該文字應清楚地（clearly）呈現於標示上81。
5. 第 13.1(e)條規定，倘一項（基因改造）食品係非包裝 食品
（non-pre-packaged food），或係置於最大表面之面積少於 10 平 方公分之小型容器內之包裝食品（pre-packaged food），則本段 落要求之標示應以永久（permanently）且可見地（visibly）呈
78 The GM Food and Feed Regulation 1829/2003, art. 13.1(a): “1. Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, foods falling within the scope of this Section shall be subject to the following specific labelling requirements: (a) where the food consists of more than one ingredient, the words "genetically modified" or "produced from genetically modified (name of the ingredient)" shall appear in the list of ingredients provided for in Article 6 of Directive 2000/13/EC in parentheses immediately following the ingredient concerned.”
79 The GM Food and Feed Regulation 1829/2003, art. 13.1(b): “…where the ingredient is designated by the name of a category, the words "contains genetically modified (name of organism)" or "contains (name of ingredient) produced from genetically modified (name of organism)" shall appear in the list of ingredients.”
80 The GM Food and Feed Regulation 1829/2003, art. 13.1(c): “…where there is no list of ingredients, the words "genetically modified" or "produced from genetically modified (name of organism)" shall appear clearly on the labelling.”
81 The GM Food and Feed Regulation 1829/2003, art. 13.1(d): “…the indications referred to in (a) and (b) may appear in a footnote to the list of ingredients. In this case they shall be printed in a font of at least the same size as the list of ingredients. Where there is no list of ingredients, they shall appear clearly on the labelling.”
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現於食品陳列（food display），或於其正側方（immediately next to it），或於包裝上，並以容易被辨認與閱讀之大字體呈現82。 包含有該食品（the foods concerned）之性質（nature）與特性
（characteristics）之適當資訊84。
三、1830/2003 號規則（基因改造有機體之可溯及性與標示規範）
82 The GM Food and Feed Regulation 1829/2003, art. 13.1(e): “…where the food is offered for sale to the final consumer as non-pre-packaged food, or as pre-packaged food in small containers of which the largest surface has an area of less than 10 cm2, the information required under this paragraph must be permanently and visibly displayed either on the food display or immediately next to it, or on the packaging material, in a font sufficiently large for it to be easily identified and read.”
83 The GM Food and Feed Regulation 1829/2003, art. 13.2: “2. In addition to the labelling requirements referred to in paragraph 1, the labelling shall also mention any characteristic or property, as specified in the authorisation, in the following cases: (a) where a food is different from its conventional counterpart as regards the following characteristics or properties: (i) composition; (ii) nutritional value or nutritional effects; (iii) intended use of the food; (iv) implications for the health of certain sections of the population; (b) where a food may give rise to ethical or religious concerns.”
84 The GM Food and Feed Regulation 1829/2003, art. 13.3: “In addition to the labelling requirements referred to in paragraph 1 and as specified in the authorisation, the labelling of foods falling within the scope of this Section which do not have a conventional counterpart shall contain appropriate information about the nature and the characteristics of the foods concerned.”
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品含基因改造（有機體之名稱）」之文字應呈現於該產品陳列之處85。