
Article 1 
This Decision lays down the detailed arrangements for the operation of registers (hereinafter referred to as ‘the registers’) to be established by the Commission pursuant to Article 31(2) of Directive 2001/18/EC, for the purpose of recording information on genetic modifications in genetically modified organisms (hereinafter referred to as ‘GMOs’).
Article 2 
The information referred to in Article 1 shall include, in accordance with the provisions of Article 3, details of nucleotide sequences or other types of information necessary to identify the GMO product and its progeny, such as the methodology for the detection and identification of the GMO product, including detection methods relating to thresholds established under Directive 2001/18/EC, and experimental data demonstrating the validation of the methodology.
The registers shall be consistent and compatible with those established under other relevant Community legislation.
Article 3 
The following shall be recorded in the registers:
(a) details concerning the notifier and responsible persons:
(i) the name and full address of the notifier,
(ii) the name and full address of the person established in the Community who is responsible for the placing on the market, whether it be the manufacturer, the importer or the distributor, if different from the notifier;
(b) general information concerning the GMO(s):
(i) the commercial name(s) of the GMO products and the names of the GMOs contained therein, including scientific name(s) and common name(s) of the recipient or, where appropriate, parental organism of the GMO,
(ii) the unique identifier(s) of the GMO(s) contained in the product(s),
(iii) the Member State of notification,
(iv) the notification number,
(v) the decision authorising the GMO(s);
(c) information on the insert:
(i) information on the nucleotide sequence of the insert used to develop the detection method, including, where appropriate, the complete sequence of the insert as well as the number of base pairs of the host flanking sequences needed to establish an event-specific detection method and detection methods relating to thresholds established pursuant to Directive 2001/18/EC as well as accession numbers for public databases and references containing sequence data of the insert or parts of it,
(ii) a detailed map of the inserted DNA, including all genetic elements, coding and non-coding regions as well as the indication of their order and their orientation;
(d) information concerning the detection and identification methods:
(i) description of identification and detection techniques for event-specific detection, including, where appropriate, detection methods relating to thresholds established pursuant to Directive 2001/18/EC;
(ii) information on detection and identification tools such as PCR primers and antibodies,
(iii) where appropriate, information on validation parameters, in accordance with international guidelines;
(e) information on the lodging, storage and supply of samples:
(i) the name and address of the person(s) responsible for the lodging, storage and supply of control samples,
(ii) information on the stored samples such as the kind of material, the genetic characterisation, the amount of repository material, the stability, the conditions of appropriate storage and the shelf-life.
Article 4 
The registers shall be available to the public in accordance with Article 25 of Directive 2001/18/EC and with Regulation (EC) No 1049/2001.
The information recorded shall be divided as follows:
(a) a set of data accessible to the public;
(b) a set of data comprising additional confidential data, accessible only to the Member States, the Commission and the European Food Safety Authority.
Article 5 
The competent authorities shall extract from the notifications they receive pursuant to Article 13(1) of Directive 2001/18/EC all data relating to the information listed in Article 3 of this Decision. They shall submit that data, using the submission form supplied by the Commission for that purpose, to the Commission, either at the time of submitting the assessment report or no later than two weeks thereafter, in order to enable the Commission to record it in the registers. The form may be completed by the notifier, subject to verification of its content by the competent authorities.
Links may be provided to other registers or databases, such as the summary notification information formats (SNIFs), the opinion of the European Food Safety Authority, the assessment report of the competent authority, the Biosafety Clearing-House established pursuant to the Cartagena Protocol on Biosafety and the Molecular Register of the Joint Research Centre, in order to avoid duplication of information.
Article 6 
No later than two weeks after receiving any information relating to the updating of the registers, the competent authority shall forward it to the Commission. That information shall be entered in those registers no later than two weeks after receipt.

Article 7 
This Decision is addressed to the Member States.
Done at Brussels, 23 February 2004.For the Commission
Margot WALLSTRÖM
Member of the Commission
