Commission Regulation (EC) No 65/2004 on unique identifiers for genetically modified organisms
The regulation establishes a unique identifier*, similar to a barcode, specific to each genetically modified organism* (GMO) brought to market. This is a key element in the traceability* and labelling of food and animal feed derived from GMOs, aiming to improve consumer choice and provide safeguards to health and the environment.
For consistency with developments in international fora, a unique identifier format is used by the Organisation for Economic Cooperation and Development BioTrack database and by the Biosafety Clearing-House of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
For each new application for the authorisation of a GMO to be put on the market, the applicant must check in the databases to make sure that an identifier has not already been assigned before creating a unique identifier in the prescribed format.
Where authorisation is granted for a GMO to be put on the market, the unique identifier is then communicated to the Biosafety Clearing-House by the European Commission and recorded in the EU register of authorised GMOs.
All GMOs authorised before the regulation came into force have been assigned unique identifiers under the regulation.
The format of the unique identifier is defined in the annex to the regulation, and consists of nine alphanumeric digits. The first two or three digits represent the company or organisation name. The second component of five or six digits represents the transformation event* and the final component is a single verification digit, all separated by a dash, for example: MON-00603-1.
It applies from 16 January 2004.
For more information, see ‘Traceability and labelling’ on the European Commission’s website.
* Unique identifier: a 9-digit alphanumeric code specific to a GMO enabling it to be readily identified on a product’s labelling.
* Genetically modified organisms: plants or animals bred to give higher yield or resist disease, through modification of their cellular and genetic make-up.
* Traceability: the ability to track GMOs, and products produced from GMOs, at all stages of the production and distribution chain, facilitating accurate labelling.
* Transformation event: a term used to differentiate genetically engineered (transformed) crop varieties and other organisms.
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 (OJ L 10, 16.1.2004, pp. 5-10)
Commission Regulation (EC) No 641/2004 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 (OJ L 102, 7.4.2004, pp. 14-25).
Successive amendments to Commission Regulation (EC) No 641/2004 have been incorporated into the original text. This consolidated version is of documentary value only.
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 (OJ L 268, 18.10.2003, pp. 24-28). See consolidated version.
last update 12.04.2016