The function of the traceability and labelling regime could be concluded as “to allow consumers to be informed of the history of the food concerned (such as the ingredients and additives used)
161 Ibid. Article 9 and 21 162 See Regulation No.178/2000 Article 53 and 54 163 European Commission Evaluation of the EU legislative framework in the field of GM food and feed (2010) DG SANCO Evaluation Framework Contract Lot3 (Food Chain) p.14 164 Ibid. Article 6(7), 18(7) and 29 165 Marine Friant‐Perrot, p.89
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and, thereby, to follow their preferences when choosing what to eat.”166 The Traceability and Labelling Regulation contributed great improvement to the management system of GMOs and also consolidated and extended the regulatory framework in the European Union.167 It established a harmonised framework at the Union level for tracing and identifying GMOs, GMO food products and feed and covered all stages of through the production and distribution chains.168 The Regulation is applicable to all GMOs placed on the market including: products
consisting of, or containing GMOs, placed on the market in accordance with the Union legislation; food produced from GMOs, placed on the market in accordance with the Union legislation; and animal feed produced from GMOs, placed on the market in accordance with the Union legislation.169
Traceability
The general requirements of the traceability regulated under the General Food Law170 that all food, animal feed, food-producing animals, and any other substance intended or expected to be incorporated into a food or feed shall be traceable at all stages of production, processing and distribution.171 In other words, any person who supply food, feed, food-producing animal, or
any substance intended or expected to be incorporated into a food or feed and the business operator who has been supplied to, must identify each other. The system and procedures shall be recorded and the related information shall be available to the competent authorities. The Traceability and Labelling Regulation provided more specific provision for the GMO food and feed to be placed on the market.
The Traceability and Labelling Regulation defines its objectives in the Article 1 as: “facilitating accurate labelling; monitoring the effects on the environment and, where appropriate, on health;
166 ibid
167 Michael Cardwell, The European Model of Agriculture (OUP, 2004) p.150
168 Lisa Carson and Robert Lee, ‘Consumer sovereignty and the regulatory history of the European market for genetically
modified foods’ (2005) 7 (3) Environmental Law Review 173 p.180
169 Directive 1830/2003 Preamble (11)
170 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general
principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
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and implementing appropriate risk management measures including, if necessary, withdrawal of products. ”172 It defines traceability of GMOs as “the ability to trace GMOs and products produced from GMOs at all stages of their placing on the market though the production and distribution chains.”173 This traceability regime is also generally called as ‘from farm to fork’ regime. The Traceability and Labelling Regulation also requires a paper trail for each GM food and feed to ensure traceability internally.
At the first stage of placing a product consisting of or containing GMOs on the market, the business operators who supply the GMO product must record in file of information which indicate that the product contains or consists of GMOs and provide the unique indentifier(s) assigned to those GMOs products. The file will be sent to the operator receiving the product. At every following stage, the same information must be passed on.174
In 2004, the European Commission devised a system of unique identifiers to be assigned to each GMOs and promulgated the Regulation (EC) No 65/2004 to establish this new system.175
The Annex of this regulation prescribes the format of the identifier. The function of the unique identifier is that in any stage of the GMO product to be placed on the market from production to distribution, the information of the former supplier of the product and the next operator of the product (on step up and one step down) could be tracked through the information recorded in identifier. To the GMOs, the format of unique identifier is created by the Organization for Economic Cooperation and Development and it has been used for its Bio-Track product database and the Biosafety Clearing House.176 The European Commission requires a document accompanied to each GMOs food and feed or GMOs for processing to indicate each GMOs ingredient the product concerns.177 The Cartagena Protocol on Biosafety to the Convention on Biological Diversity in Article 18(2) provides specific requirements for those accompanied 172 Regulation (EC) No. 1830/2003 173 Regulation (EC) No. 1830/2003, Art.3 174 Ibid. Art. 4(1) and 4(2) 175 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms [2004] OJ L10/5 176 Regulation (EC) 65/2004, Preamble. 177 Ibid, Art. 2.
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document of GMOs food and feed.178
The Commission requires the applicant must develop the unique identifier for each GMO food and feed as the condition in the authorization decision179 and it shall be recorded in the relevant register.180 The Commission shall ensure the unique identifier and relevant information to be
forwarded to the Biosafety Clearing-House as soon as possible.181
As noted above, the unique identifier system was introduced in 2004 by the Regulation 65/2004, therefore for the GMOs product was granted to entry into the market before the Regulation 65/2004 would not have the unique identifier. Under this situation, the consent holders or the competent authority is obliged to consult with the Organization for Economic Cooperation and Development BioTrack product database and the Biosafety Clearing-House to affirm if a unique identifier has been created for that GMO product. 182 In case that GMO product has a unique identifier, the information shall be notified to the European Commission; for the GMO product has no unique identifier, the consent holder of the origin application and competent authority shall must develop one for that GMO. And the consent hold must inform the Commission about the details of the identifier within 90 days after the Regulation 65/2004 took effect.183
Labelling
The informed choice in one of the principles of European General Food Law and has been prescribed in the Article 8 that “…food law shall aim at the protection of the interests of consumers and shall provide a basis for consumers to make informed choices in relation to the foods they consumer. It shall aim at the prevention of: (a) fraudulent or deceptive practices; (b) the adulteration of food; and (c) any other practices which may mislead the consumer”.184
178 Dayuan Xue (ed.), Biosafety and Regulation for Genetically Modified Organisms (Beijing Science Press, 2009) p.140 179 Ibid, Art 3(a) 180 Ibid, Art 3(c), 5(3) 181 Ibid, Art 5(4) 182 Ibid, Art 4. 183 Ibid, Art 6. 184 General Food Law, Regulation 178/2002, Art. 8
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The Traceability and Labelling Regulation follows a similar authorization procedure applied to the food labelling only limits the objective to the scope of food and food ingredients consisting of, or produced from, GMOs. The Traceability and Labelling states that the labelling 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 the ingredients produced from GMOs.”185 Labels do not have to conclude of information on the
use of GM processing aids and for the animal products, whether or not the animal was fed by GM feed does not need to be mentioned on the label.186
Regarding to the GM food, the customers will be able to be informed through the labels that the use of GMOs in the production of the food products they purchase in accordance with the principle of informed choice. Therefore, the Article 13 of the Food and Feed Regulation regulated that “the words ‘genetically modified’ or ‘produced from genetically modified [name of the ingredient]” shall appear in the list of ingredients’.187 These requirements have been
further developed in Article 4 of the Traceability and Labelling Regulation that operators shall ensure that: “ a)for pre-package products consisting of, or containing GMOs, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified (name of organisms)’ shall appear on a label; b) for non-pre-packaged products offered to the final consumer the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified (name of organisms(s))’ shall appear on, or in connection with, the display of the product.”188
These labelling requirements apply to all products produced from GMOs including highly refined products with a few exceptions. The labeling requirement does not apply GMOs foods or feeds containing material which contains, consists of, or is produced from GMOs in a
185 Regulation (EC) No. 1830/2003, Art. 12(1)
186 Or generally speaking, processing aids do not need to be labeled. See Directive 2000/13/EC of the European Parliament
and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [2000] OJ L109/32 at Art. 6(4)
187 Regulation (EC) No. 1829/2003, Art 13 188 Regulation (EC) No. 1830/2003, Art 4
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proportion no higher than 0.9% of the food ingredients considered individually or food consisting of a single ingredient, provided that this presence is adventitious or technically unavoidable.189 The burden of proof is on industry regarding to “establish that the presence of this material is adventitious or technically unavoidable, operators must be in position to supply evidence to satisfy the competent authorities that they have taken appropriate steps to avoid the presence of such material.”190 It means in the whole production chain, the GM food production
must be completely segregated from the conventional food production.