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Unique identifiers for GMOs
Genetically modified organisms (GMOs) are identified by a code that is specific to them, similar to a barcode. This code is called a "unique identifier", which makes it possible to identify easily a specific GMO on a product's labelling. The code is uniform and is made up of letters and numbers, enabling each product type to be identified precisely. It contributes to the traceability of GMOs and to consumer information.
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.
The Regulation applies to all genetically modified organisms that will be imported into the Community for cultivation and for human food and animal feed, except medicinal products for human and veterinary use.
Authorisation to place on the market
Since the beginning of the 1990s, the placing on the market of genetically modified organisms has been regulated by Directive 90/220/EEC. Since 1997, the regulations on GMOs, limited to Directive 90/220/EEC (covering the import, processing and cultivation of GMOs and their use in animal feed) have been strengthened by a Regulation concerning novel foods and novel food ingredients intended for human food (Regulation 97/258/EC).
The regulatory framework for GMOs was amended and updated by the adoption of Directive 2001/18/EC repealing the above-mentioned Directive 90/220/EEC, and by the adoption of two Regulations, one relating to GMOs in human food and animal feed (Regulation 1829/2003/EC) and the other to the labelling and traceability of GMOs (Regulation 1830/2003/EC).
All GMOs must be assessed before they can be sown or placed on the market. This risk assessment is carried out on a case-by-case basis and examines the expected or unexpected possible effects that the GMO is likely to have on health and on the environment. Therefore, effects linked to a GMO's potential toxicity/allergenicity or its effects on non-target organisms for example are evaluated by national and Community scientific bodies (including the European Food Safety Authority).
Once GMO products have been authorised to be placed on the market (Directive 2001/18/EC or Regulation 1829/2003), the appropriate identifier unique to each GMO must be included on the labelling.
The identifier is made up of 9 characters, including letters and numbers, combined in a uniform way (see the Regulation's annex). This format was approved within the framework of the Organisation for Economic Cooperation and Development (OECD). The identifier for each specific GMO is therefore listed in the OECD's BioTrack database.
The Commission or the authority that approved the product's marketing must inform the Biosafety Clearing-House (set up under the Cartagena Biosafety Protocol) in writing of this unique identifier.
The unique identifier is a GMO identification measure that is also linked to labelling and which facilitates the traceability of these products throughout the food chain, in application of Regulation 1830/2003.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 65/2004||16/01/2004||-||OJ L 10 of 16/01/2004|
For further information on GMOs, visit the website of the Directorate-General for Health and Consumer Protection.