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4. Desarrollo de la aplicación

1.02. Ingreso a la aplicación

From the perspective of the legislative principle and legislative concept, the Chinese legislation on GM food labelling is similar to the EU’s. The GM labelling and traceability regime which constructed by the Regulation 1829/2003110 and the Regulation 1830/2003111 is regarded as the most comprehensive management regime on GMOs and will be very valuable to China and also will help China to avoid similar problems that the EU already have encountered.112

The history of EU’s establishment of GMOs labelling could be traced back to 1990s. The first legal requirement on GM food labelling was stated in the Regulation (EC) No. 258/97.113

From that time on the EU has made persistent efforts on reviewing and improving the legislation on GM labelling.114 Subsequently the Regulation 1139/98115 expended the range

of labelling varieties which included the GM maize varieties and GM soy varieties. The following Regulation 50/2000 include the all GM additives and GM flavoring in to the object of GMO labelling requirement.116 In 2003, the Regulation 1829/2003 and Regulation 1830/2003 were enacted and the current GMOs labelling and traceability management regime was therefore completed. The Regulation 1829/2003 applies to both foods and animal feeds which produced from GMOs or contain ingredients produced from GMOs while the 110  Regulation 1829/2003 of the European Parliament and of the Council of 22 September 2003 on Genetically Modified  Food and Feed [2003] OJ L 268/1  111  Regulation 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] OJ L 268/24  112  Yu Zhuang and Wenxuan Yu, ‘Improving the Enforceability of the Genetically Modified Food Labelling Law of China with  Lessons From the European Union’ (2013) 14 (3) Vermont Journal of Environmental Law 465 p.470  113  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and  novel food ingredients OJ L43/1  114  Yu Zhuang and Wenxuan Yu, ‘Improving the Enforceability of the Genetically Modified Food Labelling Law of China with  Lessons From the European Union’ (2013) 14 (3) Vermont Journal of Environmental Law 465 p.474 

115  Council  Regulation  (EC)  No  1139/98  of  26  May  1998  concerning  the  compulsory  indication  of  the  labelling  of  certain 

foodstuffs  produced  from  genetically  modified  organisms  of  particulars  other  than  those  provided  for  in  Directive  79/112/EEC 

116  Commission Regulation (EC) No 50/2000 of 10 January 2000 on the labelling of foodstuffs and food ingredients 

containing additives and flavourings that have been genetically modified or have been produced from genetically modified  organisms; See also Yu Zhuang and Wenxuan Yu, ‘Improving the Enforceability of the Genetically Modified Food Labelling  Law of China with Lessons From the European Union’ (2013) 14 (3) Vermont Journal of Environmental Law 465 p.474 

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Regulation 1830/2003 provide legal requirements for traceability and labelling of GMOs. These regulations apply to products originating in the EU and imported from third countries. Bulk shipments and raw materials must be labeled, as well as packaged food and feed.

In the EU, the products exempt from labeling obligations are: Animal products originating from animals fed with GM feed (meat, dairy products, eggs); Products that contain traces of authorized GM ingredients in a proportion no higher than 0.9 percent, provided that this presence is adventitious or technically unavoidable; products that are not legally defined as ingredients according to Article 6.4 of Directive 2000/13/EC117, such as processing aids (like food enzymes produced from GE microorganisms).

Labeling regulations for food products are presented in Regulation (EC) No 1829/2003, Articles 12 to Article 13:

Where the food consists of more than one ingredient, the words ‘genetically modified’ or ‘produced from genetically modified [name of ingredient]’ must follow in brackets immediately after the ingredient concerned. A compound ingredient with a GE component should be labeled “contains [name of ingredient] produced from genetically modified [name of organism].”;

Where the ingredient is designated by the name of a category (e.g., vegetable oil), the words “contains genetically modified [name of organism]” or “contains [name of ingredient] produced from genetically modified [name of organism]” must be used;

The designations may appear in a footnote to the ingredients list, provided they are printed in a font at least the same size as that of the list of ingredients.

117  Directive 2000/13/EC of the European Parliament and of the Council on the approximation of the laws of the Member 

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Where there is no list of ingredients, the words “genetically modified” or “produced from genetically modified [name of ingredient]” must appear clearly in the labeling. For example, “genetically modified sweet corn;” or “containing caramel produced from genetically modified corn” for a product with no list of ingredients.

In the case of products without packaging the labels must be clearly displayed in close proximity to the product.

Labeling regulations for animal feed are presented in Regulation (EC) No 1829/2003, Articles 24 and Article 25:

For feed containing or consisting of GE ingredients, the words “genetically modified” or “produced from genetically modified [name of the organism]” must follow in brackets immediately after the name of the feed.

For feed produced from genetic engineering, the words “produced from genetically modified [name of organism]” must follow in brackets immediately after the name of the feed.

Alternatively, these words may appear in a footnote to the list of feed. They shall be printed in a font of at least the same size as the list of feed.

In addition, the traceability rules defined in Regulation 1830/2003 require all business operators involved to transmit and retain information on GM products in order to identify both the supplier and the buyer of the product.118 Operators must provide their customers

with the following information, in writing: an indication that the product, or certain ingredients, contains, consists of, or is obtained from ‘GMOs’; information on the unique

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identifier(s) for these ‘GMOs’; in the case of products consisting of or containing mixtures of ‘GMOs’ to be used only as food or feed or for processing, this information may be replaced by a declaration of use by the operator. It has to be accompanied by a list of the unique identifiers for all those ‘GMOs’ that have been used to constitute the mixture.119 In addition, for a period of five years after every transaction within the supply chain, every operator must keep a record of this information and be able to identify the operator from whom they bought the products and the one to whom they supplied them.120

The unique identifier approach is a great contribution by the European Union regarding to the implement of traceability regime. 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.121 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.122 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.123 The Cartagena Protocol on Biosafety to the Convention on Biological Diversity in Article 18(2) provides specific requirements for those accompanied document of GMOs food and feed.124 The Commission requires the applicant must develop the unique identifier for each GMO food and feed as the condition in the authorization decision125 and it shall be recorded in the relevant register.126 119  Ibid.  120  Ibid.  121  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    122  Regulation (EC) 65/2004, Preamble.  123  Ibid, Art. 2.  124  Dayuan Xue (ed.), Biosafety and Regulation for Genetically Modified Organisms (Beijing Science Press, 2009) p.140  125  Regulation 65/2004, Art 3(a)  126  Ibid, Art 3(c), 5(3) 

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