LEGISLATIVE ACT : Commission Regulation 65/2004/EC establishing a system for the development and assignment of unique identifiers for genetically modified organisms.
CONTENT : Under Regulation 1830/2003/EC, an operator placing on the market products containing or consisting of GMOs is required to include the unique identifier assigned to each GMO as a means of indicating its presence and reflecting the specific transformation event covered by the consent or authorisation for placing that GMO on the market. This Regulation provides that applications for the placing on the market of GMOs must include a unique identifier for each GMO concerned. Applicants must, in accordance with the formats set out in the Annex, develop the unique identifier for each GMO concerned, following consultation of the OECD BioTrack product database, and the Biosafety clearing house, to determine whether or not a unique identifier has already been developed for that GMO in accordance with these formats.
In addition:
- where consent is granted for the placing on the market of a GMO, the consent must specify the unique identifier for that GMO;
- the competent authority that has taken the final decision on the original application must ensure that the unique identifier for that GMO is communicated to the Biosafety clearing house;
- the unique identifier for each GMO concerned will be recorded in the relevant registers of the Commission;
- unique identifiers will be assigned to all GMOs in respect of which, prior to the entry into force of the Regulation, consent has been granted under Directive 90/220/EEC for their placing on the market; they must also be appropriately recorded;
- there are provisions dealing with the situation where, prior to the entry into force of this Regulation, consent has been granted for the placing on the market of a GMO but where a unique identifier has not been developed for that GMO in accordance with the formats set out in the Annex.
ENTRY INTO FORCE : 16/01/04.�