# Commission Decision of 23 February 2004 laying down detailed arrangements for the operation of the registers for recording information on genetic modifications in GMOs, provided for in Directive 2001/18/EC of the European Parliament and of the Council (Text with EEA relevance) (notified under document number C(2004) 540) (Text with EEA relevance) (2004/204/EC), Article 3

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eudn/2004/204/article/3 (the official version)
Page: https://openlegislation.uk/eu-decision-2004-204/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

