Decision 2004/204 - 2004/204/EC: 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 (notified under document number C(2004) 540) - Main contents

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2004/204/EC: 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)

Official Journal L 065 , 03/03/2004 P. 0020 - 0022

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

(notified under document number C(2004) 540)

(Text with EEA relevance)

(2004/204/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to 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(1), and in particular Article 31(2) thereof,

Whereas:

• (1) 

  Different sets of information are required for the notification of genetically modified organisms, hereinafter "GMOs", pursuant to Directive 2001/18/EC. The data required relates to the individual GMO itself, to the environment into which the GMO is released and to the interaction between the GMO and the receiving environment, including any effects on human health.

• (2) 

  The information required in notifications concerning the deliberate release of GMOs is listed in Annex III to Directive 2001/18/EC. Annex IV to that Directive describes in general terms the additional information to be provided in notifications for placing GMOs on the market. It also specifies the labelling information required for GMOs as products or in products to be placed on the market. Some of that additional information should be placed on one or several registers, namely information concerning genetic modifications, which can be used for detection and identification of particular GMO products, including detection methods relating to thresholds established pursuant to Directive 2001/18/EC, in order to facilitate post-marketing control and inspection.

• (3) 

  According to Article 31(2) of Directive 2001/18/EC, the Commission is to establish one or several register(s), hereinafter "the registers", for the purpose of recording the information on genetic modifications in GMOs specified in Section A, point 7 of Annex IV to that Directive.

• (4) 

  That information should include, where appropriate, the lodging of samples of the GMO, as or in products, or of its genetic material, with the competent authority and details of nucleotide sequences or other types of information necessary for the identification of the GMO product and its progeny, including the methodology for detecting and identifying the GMO product, and the experimental data demonstrating the validation parameters of the method supplied.

• (5) 

  In establishing the list of information to be recorded in the registers, account has been taken of the fact that other sets of information - such as the environmental risk assessment, the scientific studies, including studies which demonstrate the safety of the product, including, where available, references to independent and peer-reviewed studies, and to methods for identification and detection, and all other information submitted by the notifier, methods and plans for monitoring the GMO(s) and for emergency response, and results of the post-market monitoring - are in principle accessible according to the relevant provisions of Directive 2001/18/EC, Regulation (EC) No 1946/2003 of the European Parliament and the Council of 15 July 2003 on transboundary movements of genetically modified organisms(2) and Regulation (EC) No 1049/2001 of the...

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