Unique identifiers for GMOs

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Unique identifiers for GMOs

Outline of the Community (European Union) legislation about Unique identifiers for GMOs


These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Specific themes

Unique identifiers for GMOs

Document or Iniciative

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

Related Acts

Regulation (EC) No 641/2004 of the Commission of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (Official Journal L 102 of 07/04/2004).

Regulation (EC) No 1830

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 (Official Journal L 268 of 18/10/2003).


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