16.1.2004 Official Journal of the European Union L 10/5 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 COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Regulation (EC) No 1830/2003, of the Euro- pean 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 (), and in particular Article 8 thereof, Whereas: (1) Regulation (EC) No 1830/2003 lays down a harmonised framework for the traceability of genetically modified organisms, hereinafter ‘GMOs’, and of food and feed products produced from GMOs through the transmis- sion and holding of relevant information by operators for such products at each stage of their placing on the market. (2)  Under that Regulation, an operator placing on the market products containing or consisting of GMOs is required to include, as part of that relevant information, 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 authori- sation for placing that GMO on the market. (3)  Unique identifiers should be developed in accordance with a particular format in order to ensure consistency both at Community and international level. (4)  The consent or authorisation granted for the placing on the market of a given GMO under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environ- ment of genetically modified organisms and repealing Council Directive 90/220/EEC (¥ or other Community legislation should specify the unique identifier for that GMO. Moreover, the person applying for such consent should ensure that the application specifies the appro- priate unique identifier. (5)  Where, prior to the entry into force of this Regulation, consents have been granted for the placing on the market of GMOs under Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environ- ment of genetically modified organisms (), it is necessary () OJ L 268, 18.10.2003, p. 24. (*) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003. () OJ L 117, 8.5.1990, p. 15. Directive as last amended by Directive 2001/18/EC. to ensure that a unique identifier is or has been devel- oped, assigned and appropriately recorded for each GMO covered by those consents. (6)  In order to take account of and maintain consistency with developments in international fora, it is appropriate to have regard to the formats for unique identifiers established by the Organisation for Economic Coopera- tion and Development (OECD), for use in the context of its BioTrack product database and in the context of the Biosafety clearing house established by the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. (7)  For the purposes of the full application of Regulation (EC) No 1830/2003, it is essential that this Regulation apply as a matter of urgency. (8)  The measures provided for in this Regulation are in accordance with the opinion of the Committee set up under Article 30 of Directive 2001/18/EC, HAS ADOPTED THIS REGULATION: CHAPTER I SCOPE Atrticle 1 1. This Regulation shall apply to genetically modified organ- isms, hereinafter ‘GMOs’, authorised for the placing on the market in accordance with Directive 2001/18/EC or other Community legislation, and applications for placing on the market under such legislation. 2. This Regulation shall not apply to medicinal products for human and veterinary use authorised under Council Regulation (EEC) No 2309/93 (%), or applications for authorisation under that Regulation. CHAPTER II APPLICATIONS FOR THE PLACING ON THE MARKET OF GMOs Atticle 2 1. Applications for the placing on the market of GMOs shall include a unique identifier for each GMO concerned. () OJ L 214, 24.8.1993, p. 1.