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 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(1), 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 transmission 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 authorisation 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 environment of genetically modified organisms and repealing Council Directive 90/220/EEC(2) 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 appropriate 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 environment of genetically modified organisms(3), it is necessary to ensure that a unique identifier is or has been developed, 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 Cooperation 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,
1. This Regulation shall apply to genetically modified organisms, 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(4), or applications for authorisation under that Regulation.
CHAPTER II APPLICATIONS FOR THE PLACING ON THE MARKET OF GMOs
1. Applications for the placing on the market of GMOs shall include a unique identifier for each GMO concerned.
2. Applicants shall, 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.
Where consent or authorisation is granted for the placing on the market of a GMO:
(a) the consent or authorisation shall specify the unique identifier for that GMO;
(b) the Commission, on behalf of the Community, or, where appropriate, the competent authority that has taken the final decision on the original application shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house;
(c) The unique identifier for each GMO concerned shall be recorded in the relevant registers of the Commission.
CHAPTER III GMOs FOR WHICH CONSENT FOR THEIR PLACING ON THE MARKET HAS BEEN GRANTED PRIOR TO THE ENTRY INTO FORCE OF THIS REGULATION
1. Unique identifiers shall be assigned to all GMOs in respect of which, prior to the entry into force of this Regulation, consent has been granted under Directive 90/220/EEC for their placing on the market.
2. Relevant consent holders or where appropriate the competent authority that has taken the final decision on the original application shall consult 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 the formats set out in the Annex.
1. Where, prior to the entry into force of this Regulation, consent has been granted for the placing on the market of a GMO and where a unique identifier has been developed for that GMO in accordance with the formats set out in the Annex, paragraphs 2, 3 and 4 shall apply.
2. Each consent holder, or where appropriate the competent authority that has taken the final decision on the original application, shall within 90 days following the date of entry into force of this Regulation, communicate the following, in writing, to the Commission:
(a) the fact that the unique identifier has already been developed in accordance with the formats set out in the Annex;
(b) the details of the unique identifier.
3. The unique identifier for each GMO concerned shall be recorded in the relevant registers of the Commission.
4. The Commission, on behalf of the Community, or, where appropriate, the competent authority that has taken the final decision on the original application shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house.
1. 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, paragraphs 2, 3, 4 and 5 shall apply.
2. Each consent holder or, where appropriate, the competent authority that has taken the final decision on the original application, shall develop a unique identifier for the GMO concerned in accordance with the formats set out in the Annex.
3. The consent holder shall, within 90 days following the date of entry into force of this Regulation, communicate the details of the unique identifier, in writing, to the competent authority granting consent, which in turn shall immediately transmit these details to the Commission.
4. The unique identifier for each GMO concerned shall be recorded in the relevant registers of the Commission.
5. The Commission, on behalf of the Community, or, where appropriate, the competent authority that has taken the final decision on the original application shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house.
CHAPTER IV FINAL PROVISION
This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.