Commission report: on the experience of member states with GMOs placed on the market under Directive 2001/18/EC and incorporating a specific report on the operation of parts B and C of the Directive

September 6, 2004

Commission report: on the experience of member states with GMOs placed on the market under Directive 2001/18/EC and incorporating a specific report on the operation of parts B and C of the Directive
Full Text 2. OVERVIEW OF IMPLEMENTATION

The Commission convenes twice-yearly meetings with the competent authorities (CAs) of the MS in order to exchange views on specific implementation issues. Since April 2001, the date of entry into force of Directive 2001/18/EC , seven meetings have taken place. Working groups were established to develop the content of six implementing measures which have since been adopted by either the Commission or the Council in the framework of Directive 2001/18/EC . Two of these measures are specific to Part B of the Directive: (1) a standard format for summary notifications and (2) a standard format for reports on releases. Three are specific to Part C of the Directive: (1) a standard format for summary notifications; (2) guidelines for monitoring; and (3) the establishment of a register to record information related to genetic modifications. The sixth measure provides guidelines for environmental risk assessment concerning both Part B and Part C of the Directive.

Furthermore, Regulation 1830/2003 3 concerning the traceability and labelling of GMOs and the traceability of food and feed products produced from GMOs and amending Directive 2001/18/EC was adopted on 22 September 2003 and became fully applicable as of 15 April 2004. In the framework of this Regulation, and in relation to Article 19 of Directive 2001/18/EC , an additional implementing measure addressing the development and assignment of unique identifiers for GMOs was adopted on 14 January 2004.

Currently, additional working groups of CAs, chaired by the Commission, have been established to address specific issues such as herbicide resistance, Bt toxin, antibiotic resistance marker genes, post-market monitoring and ease of access to and exchange of information. In addition, as a result of the regular exchange of views among MS, the CAs have arrived at a common understanding on the implementation of specific articles of the Directive.

A full list of implementing measures and CA meetings is attached in Annex 1.

Regarding transposition of the Directive by the MS, it should be noted that, at the time of preparing this report, seven of the EU 15 MS and eight of the acceding countries had communicated transposition measures. Details are provided in Annex 2. The Commission has taken eight of the EU 15 States to court for non-transposition.

3. NUMBER OF APPLICATIONS FOR PART B AND PART C RELEASES

The number of Part B applications (by type of GMO) as of 26 February 2004 under Directive 2001/18/EC and its predecessor Directive 90/220/EEC 4 is presented in Annex 3, Table 1.

Since the adoption of Directive 2001/18/EC , a slight increase in the number of summary notifications has occurred in France, Germany, Spain and the UK. In all other countries there

Brussels, 31.8.2004 COM(2004) 575 final

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