Annexes to COM(2002)361 - Proposal for a Council Decision establishing, pursuant to Directive 2001/18/EC, the summary notification information format for notifications concerning the deliberate release into the environment of genetically modified organisms for purposes other than for placing on the market

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dossier COM(2002)361 - Proposal for a Council Decision establishing, pursuant to Directive 2001/18/EC, the summary notification information format ...
document COM(2002)361 EN
date October  3, 2002
ANNEX


SUMMARY NOTIFICATION INFORMATION FORMAT FOR THE DELIBERATE RELEASE OF A GMO OR A COMBINATION OF GMOs FOR PURPOSES OTHER THAN FOR PLACING ON THE MARKET

INTRODUCTION

The Summary Notification Information Format for deliberate releases of a GMO or of a combination of GMOs, has been established for the purposes and according to the procedures envisaged by Article 11 of Directive 2001/18/EC.

It is recognized that this Format is not designed to accommodate all the information required for carrying out an environmental risk assessment.

The space provided after each question is not indicative of the depth of the information required for the purposes of the Summary Notification Information Format.

The Summary Notification Information Format consists of a Part 1 and a Part 2.

Part 1 applies to products consisting of or containing genetically modified organisms other than higher plants and contains the following sections:

A General Information

B Information relating to the recipient or parental organisms from which the GMO is derived

C Information relating to the genetic modification

D Information on the organism(s) from which the insert is derived (donor)

E Information relating to the genetically modified organism

F Information relating to the release

G Interactions of the GMO with the environment and potential impact on the environment

H Information relating to monitoring

I Information on post-release and waste treatment

J Information on emergency response plans

In Part 1 the information entered should, however, adequately reflect (in a condensed form) the information submitted to the competent authority in accordance with Articles 6 and 7 of Directive 2001/18/EC under the conditions specified in the preface to Annex IIIA.

Part 2 applies to products consisting of or containing genetically modified higher plants. The term "higher plants" means plants which belong to the taxonomic group Gymnospermae and Angiospermae. Part 1 contains the following sections:

A General information

B Information on the genetically modified plant

C Information relating to the experimental release

D Summary of the potential environmental impact of the release of the GMPts

E Brief description of any measures taken for the management of risks

F Summary of planned field trials designed to gain new data on the environmental and human health impact of the release.

In Part 2 the information entered should, however, adequately reflect (in a condensed form) the information submitted to the competent authority in accordance with Articles 6 and 7 of Directive 2001/18/EC under the conditions specified in the preface to Annex IIIB.

PART 1

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PART 2

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