Format for presenting results of deliberate GMO release into environment otherwise than for placing on the market

Brussels, 8 October 2003

Commission Decision of 29 September 2003 establishing pursuant to Directive 2001/18/EC of the European Parliament and of the Council a format for presenting the results of the deliberate release into the environment of genetically modified higher plants for purposes other than placing on the market (notified under document number C(2003) 3405) (OJ L254/21 8.10.2003). Full text [NB link expires 45 days from publication date]

... (3) Since genetic engineering is not restricted to higher plants, it will be necessary to establish formats for other types of GMOs, such as genetically modified (GM) animals (including GM insects), veterinary and medicinal products (containing or consisting of GMOs) or GM plants which could produce pharmaceutical products. Future developments may also make it necessary to adapt the report formats which have already been established.

Article 1
For the purposes of presenting to the competent authority the results of the deliberate release into the environment of genetically modified higher plants (GMHP) pursuant to Article 10 of Directive 2001/18/EC , the notifier shall use the format set out in the Annex to this Decision, hereinafter 'the report format'.

Article 2
A report format shall relate to no more than one consent issued by the competent authority and shall be identified by a single notification number.

Article 3
1. For each notification number, a final report shall be delivered by the notifier, and final as well as intermediary postrelease monitoring report(s) shall be delivered where appropriate. Both types of report shall be drawn up in accordance with the report format.

2. The final report shall be delivered after the last harvest of the GMHPs. Where no post-release monitoring is required for a notification, no further reports shall be necessary.

3. The final post-release monitoring report shall be delivered after completion of the post-release monitoring. The competent authority shall, where appropriate, specify in the consent the duration of the post-release monitoring as well as the timetable for submission of the intermediary post-release monitoring reports.

4. The competent authority shall encourage notifiers to provide the report in an electronic form.

Article 4
The competent authority may require from the notifier additional information, in particular in the form of a logbook or interim reports, to be delivered in the course of the research programme, before the completion of a release.

Article 5
This Decision is addressed to the Member States.

Official Journal of the EC, L254/21 8.10.2003