Commission Regulation (EC) No 65/2004Show full title

CHAPTER I SCOPE

Article 1

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(1), or applications for authorisation under that Regulation.

CHAPTER II APPLICATIONS FOR THE PLACING ON THE MARKET OF GMOs

Article 2

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.

Article 3

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

Article 4

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.

Article 5

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.

Article 6

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

Article 7

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.

Done at Brussels, 14 January 2004.

For the Commission

Margot Wallström

Member of the Commission